knee injury measures
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Summary of Clinical Outcome Measures for Sports-Related Knee Injuries
Final Report
June 5, 2012
AOSSM Outcomes Task Force
James Irrgang, PT, PhD, ATC, FAPTA
Table of Contents
AOSSM Outcomes Task Force……………………………………………………………………..…..1
Summary Table for All Clinical Outcome Measures……………………………………………….....2
International Knee Documentation Committee (IKDC) Subjective Knee Form………………………….…....6
Lysholm Knee Score ……………………………………………………....………………………………...........41
Tegner Activity Scale………………………………………………………………………………………….……74
Cincinnati Knee Scale …………………………………..…………………………………………………………87
Knee Injury and Osteoarthritis Outcome Score (KOOS) – Symptoms Subscale………………….…….…104
Knee Injury and Osteoarthritis Outcome Score (KOOS) – Pain Subscale…………………………….…...136
Knee Injury and Osteoarthritis Outcome Score (KOOS) – ADL Subscale………………………….…...….168
Knee Injury and Osteoarthritis Outcome Score (KOOS) – Sport/Rec Subscale…………………….…..…200
Knee Injury and Osteoarthritis Outcome Score (KOOS) – QOL Subscale…………………………….…...232
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Pain Subscale……….…264
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Function Subscale….….289
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Stiffness Subscale…..…314
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Overall Subscale……....336
Western Ontario Meniscus Evaluation Tool (WOMET)……………………………………………………....356
Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency………………………………….…361
Marx Activity Scale……………………………………………………………………………………………......369
Kujala Knee Score……………………………………………………………………………………………...…374
International Knee Documentation Committee (IKDC) Subjective Knee Form – Pediatric Version…..…381
AOSSM Task Force on Clinical Outcome Measures
AOSSM-Affiliated Members: Members External to AOSSM:
• James Irrgang PT PhD
• Allen Anderson MD
• Warren Dunn MD MPH
• Min Kocher MD MPH
• Robert Marx MD MSc
• Bart Mann PhD
• Bruce Miller MD
• Matt Provencher MD
• Bruce Reider MD
• John Richmond MD
• Julie Agel MA ATC
• Mark Clatworthy MD
• Jeffrey Katz MD MSc
• RobRoy Martin PT PhD
• Lori McLeod PhD
• Marc Swiontkowski MD
1
Clinical Outcome Measures Table for All Instruments
IKDC PEDS IKDC Lysholm Cincinnati
Designed to assess
Variety of knee conditions: ACL, PCL, meniscus,
cartilage patellafemoral problems
Knee condition: ACL, PCL, meniscus,
cartilage patellafemoral problems
Initially designed for ACL. Subsequently used for variety of
other knee conditions
ACL, PCL, MCL, Lateral/postlateral knee
ligaments, meniscal repairs and allografts,
high tibial osteomy
How to obtain instrument
http://www.sportsmed.org/Medical-
Professionals/Research/Grants/IKDC-Forms/
http://www.sportsmed.org/Medical-
Professionals/Research/Grants/IKDC-Forms/
Provided in reference: Lysholm, Am J Sports Med 10:150-154, 1982
Provided in reference: Barber-Westin. Am J
Sports Med. 1999 Jul-Aug;27(4):402-16
Permission No No No No
Cost and licensing fees No No No No
Generation and Selection of Items
Clinical expert, Statistical model
Clinical Experts, Patient input Clinical expert Clinical expert
Normative data available Yes Not reported Yes Yes
Number of questions 18 13 8
Symptoms (4), Patient Perception (1), Sports
Activity (4), ADL function (3), Sports function (3),
Occupational (7), Time to administer ~10 minutes Not reported ~5 minutes Not reported
Time to score by hand Not reported Not reported Not reported Not reported
Automated Scoring available
Yes (http://www.sportsmed.org/
Medical-Professionals/Research/Gr
ants/IKDC-Forms/)
Not available Not Available Not Available
Languages available
Brazilianⱡ, Simplified Chineseⱡ, Traditional
Chineseⱡ, Englishⱡ, French, German, Greek, Italianⱡ,
Japanese, Korean, Swedish, Dutchⱡ
English English English
Scale (scoring) 0-100 (100 best) (Verifying) 0 -100 (100 best) 0 – 100 (100 best)
*Various calculations possible
Recall period 4 weeks 4 weeks Present Present
Validity
Demonstrates hypothesized relationships to other similar
measures and to measures of general physical and emotional
function
Demonstrates hypothesized
relationships to measures of general
physical and emotional function
Demonstrates hypothesized relationships to other similar measures and to measures
of general physical and emotional function
Demonstrates hypothesized relationships to other similar
measures and to measures of general physical and emotional
function
Internal consistency α = .77-.97 α = 0.91 α = .65-.72 Not reported
Test-retest reliability ICC = .87-.98 ICC = .91 ICC = .68-.97 ICC= .80 - .98
Responsiveness - Effect Size ES = .76 - 2.11 ES = 1.39 ES = .76 - 1.2 ES = .60 - 3.49 Responsiveness -
Standardized Response Mean SRM = .57 - 1.5 SRM = 1.35 SRM = .73 – 1.14 SRM = .52 - 2.48
Responsiveness - Minimal Detectable Change MCD = 6.7 – 20.5* MCD = 18.3* MCD = 8.9 – 15.8* MCD = 27.5*
Responsiveness- Minimal Clinically Important Difference MCID = 3.19 - 16.7 Not reported MCID = 10.1 14.0 – 26.0
*Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report
Clinical Outcome Measures Table for All Instruments
KOOS (Symptoms) KOOS (Pain) KOOS (ADL) KOOS (Sports/Rec) KOOS (QOL)
Designed to assess Post traumatic osteoarthritis (OA); i.e. ACL, meniscus, chondral injuries
How to obtain instrument
http://www.koos.nu/
Permission No
Cost and licensing fees No
Generation and Selection of Items Clinical expert, Patient input
Normative data available Yes
Number of questions 7 9 17 5 4
Time to administer ~10 minutes for all 5 scales
Time to score by hand Not reported
Automated Scoring available
Yes (http://www.koos.nu/)
Languages available
Austrian-German, Czech, Chineseⱡ, Croatian, Danish, Dutchⱡ, Estonian, English, Frenchⱡ, German, Italian, Japanese, Latvian, Lithuanian, Norwegian, Persianⱡ, Portuguese, Polish, Russian, Singapore English, Slovakian, Slovenian,
Spanish, Swedishⱡ, Thai, Turkish, Ukranian
Scale (scoring) Total: 0-100 (100 best)
Recall period Last Week
Validity
Demonstrates hypothesized
relationships to other similar measures and
to measures of general physical and emotional
function
Demonstrates hypothesized
relationships to other similar measures and
to measures of general physical and emotional function
Demonstrates hypothesized
relationships to other similar measures
and to measures of general physical and emotional function
Demonstrates hypothesized
relationships to other similar
measures and to measures of
general physical and emotional
function
Demonstrates hypothesized
relationships to other similar
measures and to measures of
general physical and emotional
function Internal consistency α = .25 - .83 α = .65 - .94 α = .78 - .97 α = .84 - .98 α = .64 - .90
Test-retest reliability ICC= .74 - .95 ICC= .80 - .92 ICC= .73 - .94 ICC= .45 - .89 ICC= .60 - .95
Responsiveness - Effect Size ES = .72 - 1.63 ES = .82 - 2.59 ES = .67 - 2.25 ES = .90 - 1.31 ES = 1.15 - 2.8
Responsiveness - Standardized Response
Mean SRM = .61 - 1.45 SRM = .71 - 1.85 SRM = .75 - 1.8 SRM = .87 - .89 SRM = .76 - 1.93
Responsiveness - Minimal Detectable
Change 9.9 – 24.3* 11.8 - 29.0* 11.9 – 31.5* 12.2 - 70.0* 14.2 – 34.0*
Responsiveness- Minimal Clinically Important
Difference Not reported Not reported Not reported Not reported Not reported
*Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report
3
Clinical Outcome Measures Table for All Instruments
WOMAC (Pain) WOMAC (Function) WOMAC (Stiffness) WOMAC (overall)
Designed to assess Rheumatoid arthritis, hip/knee OA
Rheumatoid arthritis, hip/knee OA
Rheumatoid arthritis, hip/knee OA
Rheumatoid arthritis, hip/knee OA
How to obtain instrument www.womac .org
Permission Yes
Cost and licensing fees Yes
Generation and Selection of Items Clinical experts, Patient input
Normative data available Yes
Number of questions 5 17 2 24
Time to administer ~12 minutes for all 3 scales
Time to score by hand ~5-10 minutes
Automated Scoring available Not Available (Permission required)
Languages available Over 65 including: English, Arabic, Chinese, Dutch, French-Canadian, German, Hebrew, Italian, Thai, Turkishⱡ, Spanishⱡ
Scale (scoring) 5 Point Likert scale: Pain (0-20 pts), Stiffness (0-8 pts), Function (0-68 pts)
VAS scale: Pain (0-500 pts), Stiffness (0-200 pts), Function (0-1700 pts) Composite scores can be converted to 0-100 scale (0 best)
Recall period Current
Validity
Demonstrates hypothesized
relationships to other similar measures and to
measures of general physical and emotional
function
Demonstrates hypothesized
relationships to other similar measures and to
measures of general physical and emotional
function
Demonstrates hypothesized
relationships to other similar measures and to
measures of general physical and emotional
function
Demonstrates hypothesized relationships to other similar measures
and to measures of general physical and emotional function
Internal consistency α = .75 - .82 α = .84 - .96 α = .71-.84 α = .84 - .96
Test-retest reliability ICC= .78 - .85 ICC= .81 - .93 ICC= .67 - .86 ICC= .86 - .93
Responsiveness - Effect Size ES = .74 - 17.7 ES = .18 - 8.7 ES = .07 - 1.0 ES = .50 - 10.0
Responsiveness - Standardized Response Mean SRM = .35 - 1.5 SRM = .23 - 1.3 SRM = .08 - .64 SRM = .24 - 1.13
Responsiveness - Minimal Detectable Change MCD = 14.4 – 16.2* MCD = 10.6 – 15.0* MCD = 22.9-30.6* MCD = 10.7 – 15.3*
Responsiveness- Minimal Clinically Important Difference MCID = 7.5 - 17.5 MCID = 5.89 - 8.1 MCID = 6.3 - 18.8 MCID = 11.5
* – Minimal detectable change ranges reported in article based on 5 point Likert version of the WOMAC
ⱡ Formal assessment of psychometric properties included in this report
4
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*Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report
Clinical Outcome Measures Table for All Instruments
WOMET Mohtadi Kujala Tegner Marx
Designed to assess Meniscus injury Health related
quality of life due to ACL injury
Patellofemeral disorders
Activity level – competitive sports, recreational sports,
work and activities of daily living
ACL injury
How to obtain instrument
Sharon Griffin - s.griffin@uwo.ca
Provided in reference:
Mohtadi. Am J Sports Med.1998
May-Jun;26(3):350-9
Contact author: Kujala UM -
urho.kujala@sport.jyu.fi
Provided in reference: Tegner, Clin Orthop
198:43-49, 1985.
Provided in reference: Marx,Am J Sports Med. 2001 Mar-Apr;29(2):213-8
Permission No No No No No
Cost and licensing fees No No No No No
Generation and Selection of Items Patient input
Clinical expert, Patient item generation
Clinical Expert Clinical expert Clinical expert, Patient input
Normative data available Not reported Not reported Not reported Yes Not reported
Number of questions 16 31 13 1 (10 levels) 4
Time to administer ~5 - 10 minutes ~10 - 15 minutes ~10 - 15 minutes ~1 - 2 minutes ~1 minute
Time to score by hand Not reported Not reported Not reported Not reported Not reported
Automated Scoring available Not available Not available Not available Not Available Not available
Languages available English English English, Turkishⱡ English English
Scale (scoring) 0-1600 (0 best) 0-100 (100 best) 0-100 (100 best) 0 -10 (10 best) 0 – 16 (16 best)
Recall period 1 week Last 3 months Present Present Past year
Validity
Demonstrates hypothesized
relationships to other similar measures and
to measures of general physical
function
Not reported
Demonstrates hypothesized
relationships to other similar measures and
to measures of general physical
function
Demonstrates hypothesized relationships to other similar measures
and to measures of general physical and emotional function
Demonstrates hypothesized
relationships to similar scales
Internal consistency α = .91 - .92 Not reported α = .82 - .84 Not reported Not reported
Test-retest reliability ICC = .92 Not reported ICC= .86 - .94 ICC = 0.82 - 0.92 ICC = .97
Responsiveness - Effect Size ES = 1.17 Not reported Not reported ES = .61 - 1.1 Not reported
Responsiveness - Standardized
Response Mean SRM = .65 - .90 Not reported Not reported SRM = .60 - 1.0 Not reported
Responsiveness - Minimal Detectable
Change Not reported Not reported Not reported MCD = 1.0 9.9
Responsiveness- Minimal Clinically
Important Difference Not reported Not reported Not reported Not reported Not reported
IKDC SUBJECTIVE KNEE FORM
Irrgang (1) Padua (2) Anderson (3)
Study Characteristics
Purpose Reliability, validity Reliability, validity of Italian translation Normative Data
Study Population/Sample (inclusion/exclusion)
Patients with a variety of knee problems
Patients undergoing ACL reconstruction
Random sample representative of general population
Number 533 50 2670
Age range (average ± SD, min-max) 37.5 years ±16.2 (6.2-86.6) 24 (18-42) 39 years ±14 (18-65)
Sex (% female) 47% (identified) 18% 51%
Reliability
Internal consistency α = 0.92 α = 0.91 NA
Test-retest reliability ICC = 0.94 ICC = 0.90 NA
Time interval 50 days 5 days NA
Validity
Correlation to similar scale NA NA NA
Correlation to general measures of Physical function
Fair (25%), Moderate (75%) correlation to general measures of physical function
Little (33%), Moderate (66%) correlation to general measures of physical function
NA
Correlation to general measures of mental function
Little (75%), Fair (25%) correlation to general measures of mental function
Little (66%), Moderate (33%) correlation to general measures of mental function
NA
Responsiveness
ES NA NA NA
SRM NA NA NA
MDC 12.83(calc) 19.98 (calc) NA
MCID NA NA NA
Time Interval NA NA NA
Other
Floor/Ceiling Effect No No No
Normal Distribution NA Yes No
Normal Data NA NA Yes
OA – Osteoarthritis
6
IKDC SUBJECTIVE KNEE FORM
Irrgang (4) Haverkamp (5) Crawford (6)
Study Characteristics
Purpose Reliability, validity Reliability, validity of Swedish translation Validity, Responsiveness
Study Population/Sample (inclusion/exclusion)
Patients with a variety of knee problems
Patients with a variety of knee problems Patients with meniscus pathology
Number 207 145 Test re-test = 31, Construct/Content = 246, SF-12 group = 50, Responsiveness = 100
Age range (average ± SD, min-max) 40.5 years ± 16.7 (12.5-81.3) 54.6 (21-84)
Test re-test = 50.6 (19-73); Construct/Content = 45.4 (18-81); Responsiveness = 47.9 (18-81)
Sex (% female) 53% 58% Test re-test = 32%, Construct/Content = 29%, Responsiveness = 29%
Reliability
Internal consistency NA α = 0.9 α = 0.773
Test-retest reliability NA ICC = 0.96 ICC = 0.95
Time interval NA 1 week 4 weeks
Validity
Correlation to similar scale NA Little (66%), Excellent (33%) correlation to similar scales NA
Correlation to general measures of Physical function NA
Moderate (100%) correlation to general measures of physical function
Moderate (100%) correlation to general measures of physical function
Correlation to general measures of mental function NA
Little(50%), Fair(50%) correlation to general measures of mental function
NA
Responsiveness
ES 1.13 NA 2.11
SRM 0.94 NA 1.5
MDC 11.5 (sens =.82 spec = .64) 20.5 (sens =.84 spec = .64) NA 8.8
MCID 11.5 NA 3.19
Time Interval 19 months NA 12 months
Other
Floor/Ceiling Effect NA No No
Normal Distribution NA Yes Yes
Normal Data NA NA NA
7
IKDC SUBJECTIVE KNEE FORM
Lertwanich (8) Greco (10) Metsavahl (11) Fu (12)
Study Characteristics
Purpose Validity, Responsiveness of Thai Translation
Reliability, validity Reliability, validity of Brazilian translation
Reliability, validity of Chinese translation
Study Population/Sample (inclusion/exclusion)
Various knee related complaints
Patients following articular cartilage surgery
Patients with general knee complaints
Patients with various knee injuries
Number 55 Reliability = 17, Responsiveness = 50 117 84
Age range (average ± SD, min-max)
27.6 (18-50)
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56)
46.7 (15-84) 52.6 (16-85)
Sex (% female) 1.8% Reliability = 39%, Responsiveness = 39.2% 50.4% 36%
Reliability
Internal consistency α = 0.92 NA α = .928 ; .935 (test ; retest) α = 0.97
Test-retest reliability ICC = 0.92 ICC 6mo. = 0.91 ICC 12mo. = 0.93 ICC = 0.988 ICC = .87
Time interval 7 days 6 mo. 12 mo. 1 week 10 days
Validity
Correlation to similar scale NA NA Excellent (100%)
correlation to similar scale NA
Correlation to general measures of Physical function
Fair (25%), Moderate (75%) correlation to general measures of physical function
NA
Moderate (75%), Excellent (25%) correlation to general measures of physical function
Moderate (100%) correlation to general measures of physical function
Correlation to general measures of mental function
Fair (100%) correlation to mental function NA Fair (100%) correlation to
mental function
Little (50%), Fair (50%) correlation to mental function
Responsiveness
ES NA 6mo = .76 12mo = 1.06 NA NA
SRM NA 6mo = 0.57 12mo = 1.0 NA NA
MDC 8.8 11.4 (calc) 6.7 NA
MCID NA 6mo = 6.3 12mo = 16.7 NA NA
Time Interval NA 6 and 12 months Equation NA
Other
Floor/Ceiling Effect No Yes No NA
Normal Distribution NA NA NA NA
Normal Data NA NA NA NA
8
IKDC SUBJECTIVE KNEE FORM
Schmitt (13)
Study Characteristics
Purpose Validity, Reliability
Study Population/Sample (inclusion/exclusion)
Variety of knee injuries
Number 673
Age range (average ± SD, min-max)
6 - 18
Sex (% female) 54%
Reliability
Internal consistency α = 0.91
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function
Excellent (100%) correlation to physical
function
Correlation to general measures of mental function
NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution NA
Normal Data NA
9
IKDC STUDY CONSOLIDATION
REFERENCES
1) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 Sep-Oct; 29(5): 600-13
2) Padua R, Bondi R, Ceccarelli E, Bondi L, Romanini E, Zanoli G, Campi S. Italian version of the International Knee Documentation Committee Subjective Knee Form: cross- cultural adaptation and validation. Arthroscopy. 2004 Oct; 20(8): 819-23
3) Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. 2006 Jan; 34(1): 128-35
4) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct; 34(10): 1567-73
5) Haverkamp D, Sierevelt IN, Breugem SJ, Lohuis K, Blankevoort L, van Dijk CN. Translation and Validation of the
Dutch Version of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct; 34(10):1680-4
6) Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the IKDC score for
meniscus injuries of the Knee. Arthroscopy. 2007 Aug: 23(8): 839-44 8) Lertwanich P, Praphruetkit T, Keyurapan E,Lamsam C, Kulthanan T. Validity and reliability of Thai version of the
International Knee Documentation Committee Subjective Knee Form. J.Med Assoc Thai.2008 Aug; 91(8):1218-25 10) Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee
Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. Epub 2009 Dec 31.
11) Metsavaht L, Leporace G, Riberto M, Sposito MM, Batista LA.Translation and Cross-Cultural Adaptation of the
Brazilian Version of the International Knee Documentation Committee Subjective Knee Form: Validity and Reproducibility. Am J Sports Med. 2010 May 14.
12) Fu SN, Chan YH. Translation and validation of Chinese version of International Knee Documentation Committee
Subjective Knee Form. Disabil Rehab. 2011; 33(13-14):1186-9 - Epub 2010 Oct 22 13) Schmitt LC, Paterno MV, Huang S. Validity and internal consistency of the international knee documentation
committee subjective knee evaluation form in children and adolescents. Am J Sports Med. 2010 Dec;38(12):2443-7. Epub 2010 Aug 30. PubMed PMID: 20805408.
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IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Irrgang Title of the Article Development and Validation of the International Knee
Documentation Committee Subjective Knee Form Year 2001 PubMed ID: 11799013 Reviewer’s Name Travis Hamilton Date of Review June 16, 2011
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input NA Reported that content was developed from statistical modeling 1 Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2; positively skewed/platykurtic distribution
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: Pearson coefficients PF=.63, RP=.47, BP=.64,
PCS=.66 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: RE=.26, MH=.25, MCS=.16 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
.92
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1
11
Indicate value: .94 Testing interval (time between repeated measures) 49.7 days ± 24.4 (4-92)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 37.5 years ±16.2 (6.2-86.6) Number: 533 Sex
Male 252/479 (patients sex not recorded in 54 cases) Female
Diagnosis Table 2 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 1
Notes:
12
13
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Padua Title of the Article Italian Version of the International Knee Documentation
Committee Subjective Knee Form: Cross-Cultural Adaptation and Validation
Year 2004 PubMed ID: 15483542 Reviewer’s Name Travis Hamilton Date of Review 6.25.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Italian)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF = .67, BP = .56, PCS = -.60 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-35: MH = -.65, MCS = -.40 RE = .44 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.91
14
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: .90 Testing interval (time between repeated measures) 5 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 24 (18-42) Number: 50 (20 Pts. Randomly for reproducibility) Sex
Male 41 Female 9
Diagnosis ACL injury/surgery 100% PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2
Notes:
Correlation between the Italian IKDC and the SF-36 was calculated using the Spearman correlation (R).
15
16
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Anderson Title of the Article The International Knee Documentation Committee Subjective
Knee Evaluation Form: Normative Data Year 2006 PubMed ID: 16219941 Reviewer’s Name Travis Hamilton Date of Review June 16, 2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 3 (was not established for age group <18 years)
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. People experiencing knee problems would score
lower than those without knee problems.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated NA
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
17
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 39 years ±14 (18-65) Number: 2670 returned, used: 2625 right knee 2621 left knee (5246
Knees) Sex
Male 1285 Female 1385
Diagnosis NA ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 1 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2
18
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC Subjective Knee Form Author’s Last Name Irrgang Title of the Article Responsiveness of International Knee Documentation
Committee Subjective Knee Form Year 2006 PubMed ID: 16870824 Reviewer’s Name Travis H Date of Review June 16, 2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” 1 Predictive of a future outcome NA If yes to either of above, report how this was demonstrated Group level analysis of between-groups differences used 7-
level global rating of change scale in comparison to IKDC. ANOVA = 37.1% of change in IKDC was accounted for by global scale.
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
19
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES = 1.13, SRM = 0.94 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MCID 11.5 Previous data suggests minimal change ±12.8 (from initial study)
Change in measure related to change in external standard 1 Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 19 months ±2.9 (6-28.0)
Descriptive Features
Age range of sample 40.5 years ± 16.7 (12.5-81.3) Number: 207 Sex
Male 47.1% Female 52.9%
Diagnosis Table 1 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
Notes:
20
21
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Haverkamp Title of the Article Translation and Validation of the Dutch Version of the
International Knee Documentation Committee Subjective Knee Form
Year 2006 PubMed ID: 16816150 Reviewer’s Name Travis Hamilton Date of Review 6.24.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 (Figure 1) Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Dutch)
Construct Validity
Correlated with a generic instrument/scale 1 (Table 1) If yes. Indicate instrument/scale and correlation coefficient SF-36: PF= .71, RP = .55, BP = .69 Correlated with theoretically similar scale 1 (Table 1) If yes. Indicate instrument/scale and correlation coefficient VAS = -0.62, WOMAC = .77, Oxford 12 = -0.77 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: RE = 0.30, MH = 0.21 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = .9
22
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.96; Pearson correlation (r = 0.92, P <.01) Testing interval (time between repeated measures) 1 Week
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 54.6 (21-84) Number: 145 Sex
Male 42% Female 58%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL 13 (9%) Meniscus. Articuler artroscopy +ACL 42 (29%)
OA 90 (62%) PF 17
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report 1; Dutch Is this the first or primary report about this instrument? 2
Notes:
• Floor and ceiling effects were not investigated after treatment. It is possible that a ceiling effect occurs after treatment of the knee injury; however, this did not occur in the original version of the IKDC.
23
24
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Crawford Title of the Article Reliability, Validity, and Responsiveness of the IDKC Score for
Meniscus Injuries of the Knee Year 2007 PubMed ID: 17681205 Reviewer’s Name Travis Hamilton Date of Review 6.24.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1
Construct Validity
Correlated with a generic instrument/scale 1; If yes. Indicate instrument/scale and correlation coefficient Physical Component of SF-12: P < 0.05; r = 0.60 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Tegner; P < .001 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses were significant (P < .05);
- Pts. with Workers’ Compensation claim had lower IKDC than pts w/o claim – P < .001 - Pts. with more difficulty with ADL had lower IKDc scores than pts with less difficulty – P < .001, r = 0.680 - Pts. w/ difficulty working bc of knee had lower IKDC scores than pts that did not – P < .001, r = 0.645 - Pts. w/ difficulty w/ sports bc of knee had lower IKDC then pts. who did not – P < .001, r = 0.638 - Pts. with abnormal knee assessment had lower IKDC scores than pts. w/ normal assessments of overall function – P < .001 - Pts. with degenerative/complex meniscus tears had lower IKDC scores than pts. w/ simple tears – P = .004
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
25
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Cronbach α = 0.773
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.95 Testing interval (time between repeated measures) Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES = 2.11; SRM = 1.5 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MDC = 8.8; SE = 3.19 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 12 months
Descriptive Features
Group A Group B Group C Group D Age range of sample 50.6 (19-73) 45.4 (18-81) 47.9 (18-81) Number: 31 264 50 100 Sex
Male 21 186 71 Female 10 78 29
Diagnosis All pts. had meniscus pathology
ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 100% 100% 100% 100%
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
26
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Lertwanich Title of the Article Validation and reliability of Thai Version of the International
Knee Documentation Committee Subjective Knee Form Year 2008 PubMed ID: 18788694 Reviewer’s Name Travis Hamilton Date of Review 6.25.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; PF = .75, RP = .37, BP = .76 PCS = .63 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; MH = .29, RE = .34, MCS = .34 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.92
27
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.92 Testing interval (time between repeated measures) 7 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 27.6 (18-50) Number: 55 Sex
Male 54 Female 1
Diagnosis Table 1. ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4-WEEKS Language(s) of instrument used in this report Thai Is this the first or primary report about this instrument? 2
28
29
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.
Year 2009 PubMed ID: Reviewer’s Name Travis Hamilton Date of Review 17-Jun-11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 (for all instruments except IKDC) If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
30
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: IKCD (6 mo., 12mo.) = 0.91 ; 0.93 Testing interval (time between repeated measures) see above
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s IKDC ES (6 mo., 12mo.) = 0.76 ; 1.06
IKDC SRM (6 mo., 12mo.) =0.57 ; 1.00 (table 2)
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 month: IKDC MCID: 6.3 (Sens = 0.79 ; Spec = 0.74)
MCD: 15.6 12 month: IKDC MCID: 16.7 (Sens = 0.74 ; Spec = 0.8) MCD: 13.7 (table 3)
Change in measure related to change in external standard 1 (global scale) Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months
Descriptive Features
Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 17 50
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 4 weeks Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2
31
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC SUBJECTIVE KNEE FORM Author’s Last Name Metsavaht Title of the Article Translation and Cross-Cultural Adaptation of the Brazilian
Version of the International Knee Documentation Committee Subjective Knee Form
Year 2010 PubMed ID: 20472755 Reviewer’s Name Travis Hamilton Date of Review 6.24.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Portuguese)
Construct Validity
Correlated with a generic instrument/scale 1 (table 2) If yes. Indicate instrument/scale and correlation coefficient SF-36; PCS = .79, PF = .75, RF = .54, BP = .63 Correlated with theoretically similar scale 1 (table 2) If yes. Indicate instrument/scale and correlation coefficient Lysholm = .89, WOMAC = .85 Uncorrelated with theoretically distinct scale 1 (table 2) If yes. Indicate instrument/scale and correlation coefficient SF-36; MCS = .51, MH = .40, RE = .50 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = .928 ; .935 (test ; retest)
32
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.988 P< .001 Testing interval (time between repeated measures) 1 week
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MDC = 6.7 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments NA
Descriptive Features
Pretest Group (before accepted translation)
Final Testing Group (statistical and correlational analysis)
Age range of sample 48.9 ± 18.6 (20-82) 46.7 (15-84) Number: 32 117 Sex
Male 31.3% 49.6% Female 68.7% 50.4%
Diagnosis ACL injury/surgery 18.8% PCL injury/surgery
Other ligament injury/surgery + ACL Hamstring insetional tendinopathy (2.6%), patellofemoral pain syndrome (7.7%), patellar tendinopathy (1.7%), tibial shaft fracture (1.7%), knee effusion (1.7%), posterior cruciate ligament injury (.9%), adductor bursitis (.9%), knee replacement (.9%)
Meniscus. Articuler artroscopy +ACL 20.5% OA 37.6% PF 2.6%
General knee pain 100% Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report 1; Portuguese Is this the first or primary report about this instrument? 2
33
Notes:
• For cultural adaptation, question relating to “skiing” was changed to “surfing”
34
IKDC Subjective Knee form
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC Subjective Knee Form Author’s Last Name Fu Title of the Article Translation and validation of Chinese version of International
Knee Documentation Committee Subjective Knee Form Year 2011 PubMed ID: 20969433 Reviewer’s Name Travis Hamilton Date of Review 7.6.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA; (No effects were observed in the 20 pt. cohort
validation) If yes. <30% of sample scored at endpoint Data normally distributed NA Was there a standard for translation? 1 If yes. How? Backward and Forward translation by professionals.
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 (Chinese version): PF = .64; RP = .50; BP = .64 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 (Chinese version): RE - .24; MH = .41 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.97
35
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.87 Testing interval (time between repeated measures) 7 – 10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 52.6 (16-85) Number: 84 Sex
Male 54 Female 30
Diagnosis Table 1. ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4-WEEKS Language(s) of instrument used in this report 1; chinese Is this the first or primary report about this instrument? 2
36
37
IKDC SUBJECTIVE KNEE FORM
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC Subjective Knee Form – Pediatric Version Author’s Last Name Schmitt Title of the Article Validity and Internal Consistency of the International Knee
Documentation Committee Subjective Knee Evaluation Form in Children and Adolescents
Year 2010 PubMed ID: 20805408 Reviewer’s Name Travis Hamilton Date of Review 8.10.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient PedsQL PCS: r = 0.83 (pediatric, r = .84; adolescnet, r = .84;
young adult, r = .79) Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: No deleted items = 0.911; 3 deleted items = 0.934
38
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 6-18 Number: 673 Sex
Male 312 Female 361
Diagnosis Table 2. ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) 4 WEEKS Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2
Notes:
3 items deleted were questions 2 (pain frequency), 3 (pain severity), and 6 (locking/catching) did not appreciably influence internal consistency. However the data indicate that the items may contribute to measurement error in the age group studied.
39
40
Lysholm Knee Score
Tegner (2) Bengtsson (3) Risberg (4) Marx (5) Paxton (6)
Study Characteristics
Purpose Reliability, validity Sensitivity, Reliability Sensitivity Reliability, validity, responsiveness Validity, Reliability
Study Population/Sample (inclusion/exclusion)
ACL injury ACL, MT, PFPS, and LAS injury***
ACL + combined injury Variety of knee injuries Acute patellar dislocation
Number 76 31 120 Reliability = 41, Validity = 133, Responsiveness = 42
Validity = 110, Test=retest = 81
Age range (average ± SD, min-max)
27
ACL = 26.3 ± 7.8; MT = 39.1 ± 13.8; PFPS = 24.1 ± 7.0; LAS 29.8 ± 5.6
27.8
Reliability = 32.6 (16-60), Validity = 31.5 (14-65), Responsiveness = 30.9 (15-61)
Validity =First dislocation: 16 (9-67), Prior dislocation: 18 (8-65) Test-retest= First dislocation: 16 (9-48), Prior dislocation: 22 (8-65)
Sex (% female) 28% NA 47% Reliability = 51%, Validity = 48%, Responsiveness = 54%
NA
Reliability
Internal consistency NA NA NA NA α = 0.71
Test-retest reliability Intrapersonal CC = .97 Interpersonal CC = .90
Days 1-3: t = 0.75; Days 1-14: t = 0.69; Days 3 – 14: t = 0.68 (Kendall's correlation)
NA ICC = 0.95 r = 0.88
Time interval 2 weeks 1-3 days, 1-14 days, 3-14 days NA 5 days 21 days
Validity
Correlation to similar scale
Excellent (100%) correlation to similar scales
NA
Little (29%) Fair (25%), Moderate (29%), Excellent (16%)
Moderate (50%), Excellent (50%) correlation to similar scales
Little (50%), Excellent (50%) correlation to similar scales
Correlation to general measures of Physical function
NA NA NA
Fair (33.3%), Moderate (66.6%) correlation to general measures of physical function
Fair (66.6%), Moderate (33.3%) correlation to general measures of physical function
Correlation to general measures of mental function
NA NA NA
Little (50%), Fair (50%) correlation to general measures of mental function
NA
Responsiveness
ES NA NA NA NA NA
SRM NA NA NA 0.9 NA
MDC NA NA NA 11.6 (calc) NA
MCID NA NA NA NA NA
Guyatt NA NA NA NA NA
Time Interval NA NA 3, 6, 12, 24 months (scores) NA NA
Other
Floor/Ceiling Effect NA NA NA No No
Normal Distribution NA NA NA NA No
Normal Data NA NA NA NA NA *** MT - Meniscus Tear, PFPS - Patello-femoral Pain Syndrome, LAS - Lateral Ankle Sprain
41
Lysholm Knee Score Continued
Kocher (7) Briggs (8) Heintjes (9) Briggs (10)
Study Characteristics
Purpose Reliability, Responsiveness
Validity, Reliability, Responsiveness
Reliability, validity, responsiveness
Reliability, validity, responsiveness
Study Population/Sample (inclusion/exclusion)
Patients with Choldral lesions Meniscal Injury General knee complaints ACL (plus concurrent)
injuries
Number 76 Test-retest group = 122, Validity group 1 = 191, Validity group 2 = 477
314 Reliability = 41, Validity = 133, Responsiveness = 42
Age range (average ± SD, min-max) 27
Test-retest group = 48 (14-76), Validity group 1 = 40 (13-81), Validity group 2 = 39 (18-62)
24.6 ± 7.5 (12-35)
Reliability = 32.6 (16-60), Validity = 31.5 (14-65), Responsiveness = 30.9 (15-61)
Sex (% female) 28% Test-retest group = 36%, Validity group 1 = 32%, Validity group 2 = 23%
44% Reliability = 51%, Validity = 48%, Responsiveness = 54%
Reliability
Internal consistency α = 0.65 α = 0.729 NA α = .72
Test-retest reliability ICC = 0.91 ICC = 0.92 NA ICC = 0.94
Time interval 4 weeks 4 weeks NA 4 weeks
Validity
Correlation to similar scale Little (100%) correlation to similar scales NA
Little (29%) Fair (25%), Moderate (29%), Excellent (16%)
Excellent (100%) correlation to similar scales
Correlation to general measures of Physical function
Fair (33.3%), Moderate (66.6%) correlation to general measures of physical function
Moderate (100%) correlation to measures of physical function
NA Fair (100%) correlation general measures of physical function
Correlation to general measures of mental function NA NA NA
Little (100%)correlation to general measures of mental function
Responsiveness
ES 1.16 Validity Group 1 = 1.2, Validity Group 2 = 1.2
Traumatic pts = 1.15 Nontraumatic pts = 0.76
6mo. = 1.0 , 9mo. = 1.0, 12mo. = 1.1, 24mo. = 1.1
SRM 1.1 Validity Group 1 =0.97, Validity Group 2 = 1.13
Traumatic pts = 1.14 Nontraumatic pts = 0.73
6mo. = 0.925 , 9mo. = 1.1, 12mo. = 1.2, 24mo. = 0.93
MDC 15.8 (calc) 15.2 (calc) NA 8.9
MCID NA 10.1 NA NA
Guyatt NA NA Traumatic pts = 0.94 Nontraumatic pts = 1.11 NA
Time Interval 52 months 12 months 12 months 6, 9, 12, 24 months
Other
Floor/Ceiling Effect No No No No
Normal Distribution NA NA NA Yes
Normal Data NA NA NA NA *** MT - Meniscus Tear, PFPS - Patello-femoral Pain Syndrome, LAS - Lateral Ankle Sprain
42
Demirdjian (11)
Study Characteristics
Purpose Normative Data
Study Population/Sample (inclusion/exclusion)
High School and College Students
Number 246
Age range (average ± SD, min-max) 17.6 (13 – 25)
Sex (% female) 40%
Reliability
Internal consistency NA
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function NA
Correlation to general measures of mental function NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution NA
Normal Data Yes
43
LYSHOLM STUDY CONSOLIDATION
REFERENCES
2) Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985; 198:43-9
3) Bengtsson J, Mollborg J, Werner S. A study for testing the sensitivity and reliability of the Lysholm knee scoring scale. Knee Surg Sports Traumatol Arthrose 1996; 4: 27-31
4) Risberg MA, Holm I, Sten H, Beynnon BD. Sensitivity to changes over time for the IKDC form, the Lysholm score, and the Cincinnati knee score a prospective study of 120 ACL reconstructed patients with a 2 year follow up Knee Surg Sports Traumatol Arthroscopy 1999 7: 152-59
5) Marx RG, Jones EC, Allen AA, Altchek DW, O'Brien SJ, Rodeo SA, Williams RJ, Warren RF, Wickiewics TL. Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001; 83: 1459-69
6) Paxton EW, Fithian DC, Stone ML, Silvia P. The reliability and validity of knee specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med 2003; 31 : 487-92
7) Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee. J Bone Joint Surg AM. 2004; 86: 1139-45
8) Briggs KK, Kosher MS, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the Lysholm Knee Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee. J Bone Joint Surg Am. 2006; 88(4): 698-705
9) Heintjes EM, Bierma-Zeinstra SM, Berger MY, Koes BW. Lysholm scale and WOMAC index were responsive in prospective cohort of young general practice patients. J Clin Epidemol. 2008; 61 (5): 481-8
10) Briggs K, Lysholm J, Tegner Y, Rodkey WG, Kosher MS, Steadman R. Reliability, Validity, and Responsiveness of the Lysholm Knee Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 years later. Am J Sports Med, 2009; 37: 890-897
11) Demirdjian AM, Petrie SG, Guanche CA, Thomas KA. The outcomes of two knee scoring questionnaires in a normal population. Am J Sports Med. 1998 Jan-Feb;26(1):46-51
44
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Tegner Title of the Article Rating System in the Evaluation of Knee Ligament Injuries Year 1985 PubMed ID:
4028566 Reviewer’s Name Travis Hamilton Date of Review 6.29.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Marhall Scoring Scale; ( r = 0.78; p < .001) (r = Pearson
coefficient) Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Intrapersonal correlation coefficient = .97 ( 2 weeks)
Interpersonal correlation coefficient. = .90 (same occasion by physician and physiotherapist)
Testing interval (time between repeated measures) 2 weeks
45
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA Descriptive Features
Age range of sample 27 Number: 76 Sex
Male 55 Female 21
Diagnosis ACL injury/surgery 100% PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
This a comparative study investigating the differences between the Lysholm score and the Marshall score relative to knee injury. The results suggests that patients who sore higher on the Lysholm scale, have “too-low” values when scored on the Marshall scale. Also, patients who score low on the Lyholms scale are overestimated by the Marshall scale.
The intrapersonal coefficient of variation was estimated by letting the same orthopedic surgeon determine the score of 15 patients twice with an interval of two weeks. To establish the interpersonal variation, an orthopedic surgeon and a physiotherapist determined the score for the same 15 patients on one and the same occasion.
The intrapersonal coefficient of variation = 3%
The interpersonal coefficient of variation = 4%
46
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Bengtsson Title of the Article A study for testing the sensitivity and reliability of the Lysholm
knee scoring scale Year 1996 PubMed ID: 8819060 Reviewer’s Name Travis Hamilton Date of Review 6.30.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
47
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Days 1-3: τ = 0.75, P < .0001; Days 1-14: τ = 0.69, P < .0001;
Days 3 – 14: τ = 0.68, P < .0001 τ = Kendall’s correlation test
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value: NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments Descriptive Features
Age range of sample Table 1 Number: 31 Sex
Male Female
Diagnosis Table 1 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2 NOTES: Patients that have not undergone surgery and have one of four knee/leg related injuries (ACL rupture, MT, PFPS, and LAS) were included in the study. Patients were mailed a copy of the Lysholm scale and were assessed by phone interview their ratings for each category at 1, 3, and 14 day increments. The sensitivity data show that patients in the ACL group scored significantly higher (P<0.01) on the Lysholm scale than for any of the other groups. Therefore, the conclusion can be made that the Lysholm scale is less sensitive for patients with ACL injury as compared to any of the other knee injuries studied. Group comparisons show there were significant differences between the ACL and MT group (P<0.01), as well as the ACL and LAS group (P < 0.05) (table 3.)
48
49
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Risberg Title of the Article Sensitivity to changes over time for the IKDC form, the
Lysholm score, and the Cincinnati knee score Year 1999 PubMed ID: 10401651 Reviewer’s Name Travis Hamilton Date of Review 6.30.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC1-4 and IKDC-final form, Cincinnati – table 3. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: NA Testing interval (time between repeated measures)
50
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s NA; table 2 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 mo., 6.mo., 1 year, 2 years
Descriptive Features
Age range of sample 27.8 Number: 120 Sex
Male 64 Female 56
Diagnosis ACL injury/surgery 58 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury 62 (+ACL)
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
120 subjects with either ACL or ACL combined injuries who underwent reconstruction using a bone-patellar-tendon –bone graft were included in this study. Patients were assessed with 3 instruments (IKDC form, Lycholm, and Cincinnati score) at 4 different time periods (3mo., 6mo., 1 year, 2 years). A linear regression analysis comparing the Lysholm scale to the Cincinnati scale is as follows: y = 0.73x + 27.8 (y = Lysholm, x = Cincinnati). The study indicates that the Lysholm scale gave significantly better results (high score) up to 1 year after surgery compared to the Cincinnati. The Lysholm score was sensitive to clinical changes from 3 to 6 moth follow-up only and remained unchanged thereafter.
51
52
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Marx Title of the Article Reliability, validity, and responsiveness of four knee outcome
scales for athletic patients Year 2001 PubMed ID:
11679594 Reviewer’s Name Travis Hamilton Date of Review 7.6.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF = .66,;RP = .49; BP = .57 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Cincinnati scale = .70; Activities of Daily Living Scale = .85 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF – 36: RE = .18; MH = .29 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Confirmed Hypotheses:
• The instruments would all correlate better with each other than they would with the physical component scale or the mental component scale and the physical component scale would correlate more strongly with the knee scales.
• The knee-rating scales would correlate better with each other than they would with any of the eight SR-36 scales.
• The knee scales would correlate better with physical function and role-physical than they would with vitality or social function and that they would correlate better with GH, BP, VT, and SF than they would with RE or MH.
• Knee scales would be significantly correlated with clinician-rated and patient-rated severity.
• There would be a difference in the mean scores on the knee specific instruments for patients who had different patient rated severity scores as well as for those who had different clinician-rated severity score.
• There would be no veiling or floor effects.
53
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.95 Testing interval (time between repeated measures) Mean = 5.2 (2-14)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s SRM = .9 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 months minimum
Descriptive Features
Reliability Validity Responsiveness Age range of sample 32.6 (16-60) 31.5 (14-65) 30.9 (15-61) Number: 41 133 42 Sex
Male 20 69 19 Female 21 64 23
Diagnosis ACL injury/surgery 28 57 12 PCL injury/surgery 1 2
Other ligament injury/surgery + ACL 4 5 (MCL) 4 (OCD), 3 (PT), 3 (PTO), 1 (OSD) , 5(misc)
3
Meniscus. Articuler artroscopy +ACL 2 17 6 OA PF 2 21 15
General knee pain 4 2 Combined injury
Sport related Cartilage degeneration or surgery 6
Provide normative data NA 54
Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
Spearman coefficient was used for all values testing for validity.
55
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Paxton Title of the Article The reliability and validity of knee-specific and general health
instruments in assessing acute patellar dislocation outcomes Year 2003 PubMed ID: 12860533 Reviewer’s Name Travis Hamilton Date of Review 7.7.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; PF = 0.57, RP = 0.38, BP = 0.50 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient ** Tegner = 0.24, Fulkerson = 0.93, Kujala = 0.86 , Modified
IKDC knee ligament form = -0.51 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.71
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ** ρ = 0.88 Testing interval (time between repeated measures) Mean 21 (13-42)
56
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample TABLE 1. Number: Sex
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Acute patellar dislocation 100% Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
**Spearman’s rho coefficient was used to assess test-retest reliability and intercorrelations between instruments.
57
58
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Kocher Title of the Article Reliability, Validity, and Responsiveness of the Lsholm Knee
Scale for Various Chondral Disorders of the Knee Year 2004 PubMed ID: 15173285 Reviewer’s Name Travis Hamilton Date of Review 7.8.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12: PF = 0.537; RP = 0.476; BP = 0.559 (Pearson coeff.) Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient WOMAC: Pain ρ = -0.802; stiffness ρ = -0.657; function ρ = -
0814 (Spearman ρ) : Tegner: = 0.346 (Pearson) Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All were confirmed and significant (P<0.05)
1. Patients with lower activity levels would have lower scores on the Lysholm knee scale.
2. Patients with a greater number of chondral surfaces with Outerbridge grade-4 changes would have lower scores on the Lysholm knee scale.
3. Patients with full0thickness chondral defects would have lower scores on the Lysholm Knee scale than would patients with partial-thickness chondral defects.
4. Patients with chondral defects and associated meniscal tears would have lower scores on the lysholm knee scale than would patients with isolated chondral defects.
5. Patients who had more difficulty with activities of daily living would have lower scores on the Lysholm scale than would patients who had les difficulty with the activities of daily living.
6. Patients who had more difficulty working because of the knee would have lower scores on the Lysholm scale than would patents who had les difficulty working because of the knee.
7. Patients who had more difficulty with sports because of the knee would have lower scores on the Lysholm
59
knee scale than would patients who had less difficulty with sports because of the knee.
8. Patients with previous knee surgery would have lower scores on the Lysholm knee scale than would patients without previous knee surgery.
9. Patients with a poorer assessment of overall knee function would have lower scores on the Lysholm knee scales than would patients with a better assessment of overall knee function.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.65
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.91 *component scores Table 1. Testing interval (time between repeated measures) Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES = 1.16; SRM = 1.10 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 51.2 months (12.5-79.4)
Descriptive Features
Age range of sample 44 (14-88) Number: 1657 (Group A) Sex
Male 1011 Female 646
Diagnosis
Traumatic unicompartmental chondral lesions 679 (ligament injury = 230, meniscal injury = 285) Traumatic multicompartmental chondral lesions 249 (ligament injury = 65, meniscal injury = 107)
60
Degenerative chondral lesions 729 (ligament injury = 80, meniscal injury = 277)
Group B (subset of main group - A) 57 Group C (subset of main group - A) 248
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2 Notes:
Internal consistency and content and construct validity was determined from patients in Group A. Test-retest reliability data was taken from patients included in Group B. Criterion validity and Responsiveness was determined from group C. There were no overall floor and ceiling effects observed. However, for the domains of squatting had a high (>30%) floor effect, and the domains of limp, instability, support, and locking had high (>30%) ceiling effects
61
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Briggs Title of the Article Reliability, Validity, and Responsiveness of the Lysholm Knee
Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee
Year 2006 PubMed ID: 16595458 Reviewer’s Name Travis Hamilton Date of Review 7.8.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12; r = 0.551 (p < 0.05) Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses significant (p< 0.05)
1. Patients with lower activity levels would have lower Lysholm scores.
2. Bc of the pain, swelling, possible use of crutches and overall disability associated with an acute nee injury, patients with such an injury would have a lower mean Lysholm score than would patients with a chronic knee injury.
3. Patients with a Worker’s Compensation claim would have a lower mean Lysholm score than would patients without a Workers’ Compensation claim.
4. Patients with more difficulty with activities of daily living would have lower Lysholm scores than would patients with less difficulty with activities of daily living.
5. Patients with more difficulty working because of problems with knee would have lower Lysholm scores than would patients with less difficulty because of problems with the knee.
6. Patients with more difficulty participating in sports activity because of problems with the knee would have lower Lysholm scores than would patients with less difficulty participating in sports activity because of
62
problems with the knee. 7. Patients who assessed their overall knee function as
abnormal or severely abnormal would have a lower mean Lysholm score than would patients who assessed it as normal or nearly normal.
8. Patients with a degenerative and/or complex mensical tear would have a lower mean Lysholm score than would patients with a simple tear of the meniscus.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.729
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.927 Testing interval (time between repeated measures) 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Group 1: ES = 1.2, SRM = 0.97; Group 2 = ES = 1.2, SRM = 1.13
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MDC = 10.1 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 12 months
Descriptive Features
Test-retest group
ICC/Content Val./Construct val./ Group 1
ICC/Content Val./Criterion Val. Group 2
Age range of sample 48 (14-76) 40 (13-81) 39 (18-62) Number: 122 191 477 Sex
Male 77 129 367 Female 45 62 110
Diagnosis 63
Test-retest group
ICC/Content Val./Construct val./ Group 1
ICC/Content Val./Criterion Val. Group 2
ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 1; MML = 59;
LML = 40; MML+LML = 23; IML = 28
MML = 117; LML = 60; MML+LML = 14
Meniscal lesion + associated intra-articular diseases
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
MML – Medial meniscal lesion, LML – lateral meniscal lesion, IML – Isolated meniscal lesion. In the Lysholm score, the domain of squatting and a high floor effect and the domains of limp, instability, support, and locking had a high ceiling effect. Thus, these domains may lack the discriminative ability to differentiate the functional status of patients with a meniscal injury of the knee.
64
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Heintjes Title of the Article Lysholm scale and WOMAC index were responsive in
prospective cohort of young general practice patients Year 2008 PubMed ID: 18394542 Reviewer’s Name Travis Hamilton Date of Review 7.8.11 Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Overall hypotheses confirmed (combined groups)
1. Baseline pain and instrument scores should be moderately correlated.
2. Changes in pain and instrument scores should be moderately correlated.
3. The correlation between recovery scores and change scores on the instruments adjusted for baseline scores should be high.
4. Patients with good baseline COOP/WONCA physical fitness scores should have better instrument scores than patients with poor physical fitness scores.
5. Patients refraining from daily duties because of their knee complaints (employment, domestic work, and school) should show lower scores than patients who do not.
6. Patients bothered by their knee complaints during daily duties (employment, domestic work, and school) should show lower scores than patients who are not.
7. Patients reporting moderate to severe pain with at least four our of seven activities (walking stairs, prolonged sitting with flexed knees, running, jumping, squatting, kneeling, and cycling) should show lower scores.
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Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures) NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Traumatic patients: ES = 1.15, SRM = 1.14, Guyatt = 0.94; Nontraumatic patients: ES = 0.76, SRM = 0.73, Guyatt = 1.11
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 1 year
Descriptive Features
Age range of sample 24.6 ± 7.5 years (12-35) Number: 314
Sex Table 1. Male
Female Diagnosis
ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Traumatic – 184; Nontraumatic - 117 Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA
66
Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
Notes:
• Analyses were performed for all patients combined and stratified per age group (aged 12-17 or 18 – 35) and per type of knee complain (nontraumatic and traumatic). For responsiveness analysis, baseline scores and 1-year follow-up scores as well as perceived recovery scores, which were available for 137 nontraumatic patients and 91 traumatic patients.
• Construct validity was unsatisfactory in the analysis of the nontraumatic young adults. This is in part due to hypothesis 3. The correlation between change scores and recovery (convergent construct validity) was unsatisfactory. However, because the Guyatt’s statistic is high, the clinically important changes can still be detected in young adults.
67
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lyscholm Knee Score Author’s Last Name Briggs Title of the Article The Reliability, Validity, and Responsiveness of the Lysholm
Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 Years Later
Year 2009 PubMed ID:
19261899 Reviewer’s Name Travis Hamilton Date of Review 6.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12: r = .43 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC: r = .78, P > .001 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12 (mental component): r = .07, P < .05 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All constructs were significant:
• Patients with moderate to severe difficulty running had lower Lysholm scores than patients with none to mild difficulty. (P<.001)
• Patients with more difficulty with activities of daily living (ADL) had lower Lysholm score than patients with less difficulty with ADL. (P<.001)
• Patients with more difficulty working becaue3 of their knee had lower Lysholm scores than patients with less difficulty working because of their knee. (ρ = 0.43; P<.001)
• Patients with more difficulty with sports because of their knee had lower Lysholm scores than patients with less difficulty with sports because of their knee. (ρ = 0.33; P<.001)
• Patients with abnormal or severely abnormal assessment of overall knee function had lower Lysholm scores than patients with a normal or nearly normal assessment of overall knee function. (P<.001)
• Patients with ACL tears with associated complex miniscal injuries requiring suture repair had a lower Lysholm score than patients with isolated tears. (P<.001)
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Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = .72
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.94 Testing interval (time between repeated measures) Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: 6 mo. = 1; 9 mo. = 1; 12 mo. = 1.1; 24 mo. = 1.1 SRM: : 6 mo. = .925; 9 mo. = 1.1; 12 mo. = 1.2; 24 mo. = .93
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MDC = 8.9 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 mo., 9 mo., 12 mo., 24 mo.
Descriptive Features
Age range of sample 37 (18-77) Number: 1783 (table 1) Sex
Male 1034 Female 749
Diagnosis ACL injury/surgery 100%; 593 ACL tears, 1190 concurrent injuries (meniscal
and/or cartilage damage) PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA 69
Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
70
Lysholm Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Lysholm Knee Score Author’s Last Name Demirdjian Title of the Article The Outcomes of Two Knee Scoring Questionnaires in a
Normal Population Year 1998 PubMed ID: 9474400
Reviewer’s Name Travis Hamilton Date of Review 2.27.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
71
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 17.6 (13 – 25) Number: 246 (215 used for study) Sex
Male 131 Female 84
Diagnosis Normal Population 100%
Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2
72
Notes:
The average score for male subject is 99.10 ± 2.73 (77 – 100) and for female subjects is 97.16 ± 5.26 (75 – 100). For all categories of the Lysholm questionnaire, the male subjects reported higher scores than the female subjects except for the Limp and Support categories. The total scores were significantly greater for the male subjects than the female subjects (P = 0.00005)
73
Tegner Activity Scale
Paxton (2) Briggs (3) Briggs (4) Briggs (5)
Study Characteristics
Purpose Validity, Reliability
Validity, Reliability, Responsiveness
Reliability, validity, responsiveness
Normative data, validity
Study Population/Sample (inclusion/exclusion)
Acute patellar dislocation
Meniscal injury
ACL (plus concurrent) injuries
Normal Knees
Number Validity = 110, Test-retest = 81
Test-retest group = 122, Validity group 1 = 191, Validity group 2 = 477
1783
488
Age range (average ± SD, min-max)
Validity =First dislocation: 16 (9-67), Prior dislocation: 18 (8-65) Test-retest= First dislocation: 16 (9-48), Prior dislocation: 22 (8-65)
Test-retest group = 48 (14-76), Validity group 1 = 40 (13-81), Validity group 2 = 39 (18-62)
37 (18-77)
41 ( 18-85)
Sex (% female) NA
Test-retest group = 36%, Validity group 1 = 32%, Validity group 2 = 23%
42%
50.00%
Reliability
Internal consistency NA NA NA NA
Test-retest reliability r = 0.92 ICC = 0.82 ICC = .82 NA
Time interval 21 days 4 weeks 4 weeks NA
Validity
Correlation to similar scale Little (75%), Fair (25%) correlation to similar scales NA Little (100%) correlation to
similar scales Little (100%) correlation to similar scales
Correlation to general measures of Physical function
Little (66.6%), Fair (33.3%) correlation to general measures of physical function
Fair (100%) correlation to general measures of physical function
Little (100%) correlation to general measures of physical function
NA
Correlation to general measures of mental function
NA NA Little (100%) correlation to general measures of mental function
NA
Responsiveness
ES NA Validity Group 1 = .61, Validity Group 2 = .83
6mo = .74 , 9mo. = 1.1, 12mo. = 1.0, 24mo. = 1.1 NA
SRM NA Validity Group 1 = .60, Validity Group 2 = .704
6mo. = 0.61 , 9mo. = .84, 12mo. = .96, 24mo. = 1.0 NA
MDC NA 1 1 NA
MCID NA NA NA NA
Guyatt NA NA NA NA
Time Interval NA 12 months 6 mo., 9 mo., 12 mo., 24 mo. NA
Other
Floor/Ceiling Effect No No No NA
Normal Distribution No NA No No
Normal Data NA NA NA Yes
74
TEGNER STUDY CONSOLIDATION
REFERENCES
2) Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003; 31: 487-92.
3) Briggs KK, Kosher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006; 88(4): 698-705
4) Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kosher MS, Steadman R. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med, 2009; 37: 890-897
5) Briggs KK, Steadman JR, Hay CJ and Hines SL: Lysholm score and Tegner activity with normal knees. Am J Sports Med, 2009; 37: 898-901
75
Tegner Activity Level
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Tegner Activity Level Author’s Last Name Paxton Title of the Article The reliability and validity of knee-specific and general health
instruments in assessing acute patellar dislocation outcomes Year 2003 PubMed ID: 12860533 Reviewer’s Name Travis Hamilton Date of Review 7.7.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; PF = 0.37, RP = 0.22, BP = 0.20 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient ** Lysholm = 0.24, Fulkerson = 0.26, Kujala = 0.33 ,
Modified IKDC knee ligament form = -0.54 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
NA
76
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ** ρ = 0.92 Testing interval (time between repeated measures) Mean 21 (13-42)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample TABLE 1. Number: Sex
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Acute patellar dislocation 100% Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
**Spearman’s rho coefficient was used to assess test-retest reliability and intercorrelations between instruments.
77
78
Tegner Activity Level
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Tegner Activity Level Author’s Last Name Briggs Title of the Article Reliability, Validity, and Responsiveness of the Lysholm Knee
Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee
Year 2006 PubMed ID: 16595458 Reviewer’s Name Travis Hamilton Date of Review 7.8.11 Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12; r = .46 ; P < 0.05 ;Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses significant
9. Patients with moderate-to-severe pain with activity would have a lower mean Tegner activity level than would patients with no or mild pain with activity
10. Patients with moderate-to-severe difficulty running would have a lower mean Tegner activity level than would patients with no or mild difficulty running.
11. Patients with more difficulty with activities of daily living would have lower Tegner activity levels than would patients with less difficulty with activities of daily living.
12. Patients with more difficulty working because of problems with knee would have lower Tegner activity levels than would patents with less difficulty working because of problems with the knee.
13. Patients with more difficulty participating in sports activity because of problems with the knee would have lower Tegner activity levels than would patients with less difficulty participating in sports activity because of problems with the knee.
14. Patients who assessed their overall knee function as abnormal or severely abnormal would have a lower mean Tegner activity level than would patients who assessed it as normal or nearly normal.
15. Because of the pain, swelling, possible use of crutches, and overall disability associated with an acute knee
79
injury, patients with such an injury would have a lower mean Tegner activity level than would patients with a chronic knee injury.
16. Patients with a degenerative and/or complex meniscal tear would have a lower mean Tegner activity level than would patients with a simple meniscal tear.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.817 Testing interval (time between repeated measures) 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Group 1: ES = .61, SRM = 0.60; Group 2 = ES = .836, SRM = .704
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MDC = 1 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 12 months
Descriptive Features
Test-retest group
ICC/Content Val./Construct val./ Group 1
ICC/Content Val./Criterion Val. Group 2
Age range of sample 48 (14-76) 42 (16-81) 39 (18-62) Number: 122 80 477 Sex
Male 77 50 367 Female 45 30 110
Diagnosis ACL injury/surgery PCL injury/surgery
80
Test-retest group
ICC/Content Val./Construct val./ Group 1
ICC/Content Val./Criterion Val. Group 2
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 1; MML = 59;
LML = 40; MML+LML = 23; IML = 28
MML = 42; LML = 29; MML+LML = 9
Meniscal lesion + associated intra-articular diseases
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
MML – Medial meniscal lesion, LML – lateral meniscal lesion, IML – Isolated meniscal lesion.
81
Tegner Activity Level
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Tegner Activity Level Author’s Last Name Briggs Title of the Article The Reliability, Validity, and Responsiveness of the Lysholm
Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 Years Later
Year 2009 PubMed ID:
19261899 Reviewer’s Name Travis Hamilton Date of Review 6.28.11 Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12 (Physical component): ρ = .2, P<.05 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC: ρ = .22, P > .001 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-12 (mental component): ρ = -0.01, P = .92 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All constructs were significant:
• Patients with moderate to severe pain with activity had lower Tegner activity levels than patients with none to mild pain with activity. (P < .05)
• Patients with moderate to severe difficulty running had lower Tegner activity levels than patients with none to mild difficulty. (P < .01)
• Patients with more difficulty with activities of daily living had lower Tegner activity levels than patients with less difficulty with activities of daily living. (ρ = 0.37, P < .01)
• Patients with more difficulty working because of their knee had lower Tegner activity levels than patients with less difficulty working because of their knee. (ρ = 0.38, P < .01)
• Patients with more difficulty with sports because of their knee had lower Tegner activity levels than patients with less difficulty with sports because of their knee. (ρ = 0.35, P < .01)
• Patients with abnormal or severely abnormal assessment of overall knee function had lower Tegner activity levels than patients with a normal or nearly normal assessment of overall knee function. (P < .01)
82
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: .82 Testing interval (time between repeated measures) Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: 6 mo. = .74; 9 mo. = 1.1; 12 mo. = 1.0; 24 mo. = 1.0 SRM: : 6 mo. = .61; 9 mo. = .84; 12 mo. = .96; 24 mo. = 1.0
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
1
Report statistics: MDC = 1 Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 mo., 9 mo., 12 mo., 24 mo.
Descriptive Features
Age range of sample 37 (18-77) Number: 1783 (table 1) Sex
Male 1034 Female 749
Diagnosis ACL injury/surgery 100%; 593 ACL tears, 1190 concurrent injuries (meniscal
and/or cartilage damage)0. PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related 83
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
84
Tegner Activity Scale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Tegner Activity Scale Author’s Last Name Briggs Title of the Article Lysholm Score and Tegner Activity Level in Individuals with
Normal Knees Year 2009 PubMed ID: 19307332 Reviewer’s Name Travis Hamilton Date of Review 7.12.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient NA Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm: ρ = .07; P = .17 (not correlated) Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures) NA
85
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 41 (18-85) Number: 488 Sex
Male 244 Female 244
Diagnosis Normal Knees 100%
ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 1 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? NA
Notes:
Tegner activity level was inversely correlated with age (ρ = -.40, P = .001). This was consistent for both men (ρ = -.48, P = .001) and women (ρ = -.34, P = .001).
86
Cincinnati Knee Scale
Barber-Westin (1) Risberg (2) Marx (3) Greco (5)
Study Characteristics
Purpose Reliability, Responsiveness, Validity Validity Reliability, Responsiveness,
Validity Reliability,
Responsiveness
Study Population/Sample (inclusion/exclusion)
Normal, Injured, ACL reconstruction
ACL injury, combined injury Various injuries Patients following articular
cartilage surgery
Number
Validity/Responsiveness Groupn1 = 250, Test-retest Group 2 = 50, Test-retest
Group 3 = 50
120 Reliability group = 41, Validity group = 133, Responsiveness
group = 42
Reliability = 17, Responsiveness = 50
Age range (average ± SD, min-max)
Validity/Responsiveness Groupn1 = 29 (14-58),
Test-retest Group 2 = 36 (13-65), Test-retest Group
3 = 34 (20-59)
27.8
Reliability group = 32.6 (16-60), Validity group = 31.5 (14-65), Responsiveness group = 30.9
(15-61)
Reliability = 43.8 years ± 10.4 (21-60),
Responsiveness = 36.6 years±9.7 (15-56)
Sex (% female)
Validity/Responsiveness Groupn1 = 29%, Test-retest Group 2 = 44%, Test-retest
Group 3 = 56%
46%
Reliability group = 52%, Validity group = 46%,
Responsiveness group = 54%
Reliability = 39%, Responsiveness = 39.2%
Reliability
Internal consistency NA NA NA NA
Test-retest reliability
ICC: Sports activity = .98 (uninjured), .98 (patients) Occupational rating = .87 (uninjured), .97 (patients)
NA ICC = 0.88 6mo = 0.91, 12mo = 0.80
Time interval 7 days NA 5.2 days 6 mo, 12 mo
Validity
Correlation to similar scale NA
Little(29%), Fair (13%), Moderate (33%), Excellent
(25%) correlation to similar scales
Moderate (50%), Excellent (50%) correlation to similar
scales NA
Correlation to general measures of Physical function
NA NA Moderate (100%) correlation to general measures of physical
function NA
Correlation to general measures of mental function
NA NA
Little (100%) correlation between general measures of
mental function
NA
Responsiveness
ES 3.49 NA NA 6mo = 0.60, 12mo = 1.09
SRM 2.48 NA 0.8 6mo = 0.52, 12mo = 0.76
MDC NA NA 27.5 (calc)
(1.96)*(sqrt(2))*((28.7)*sqrt(1-.88))
NA
MCID NA Na NA
6mo = 14.0 (Sens = 0.64 ; Spec = 0.70), 12mo = 26.0
(Sens = 0.55 ; Spec = 0.85)
Guyatt NA NA NA NA
Time Interval 27 months NA 3 months 6, 12 months
Other
Floor/Ceiling Effect No NA No Yes
Normal Distribution NA NA NA NA
Normal Data NA NA NA NA
Subscales used All subscales Symptoms and Function
Symptoms, function, and daily activities
Sports activity, symptoms, and overall rating scale
87
Demirdjian (6)
Study Characteristics
Purpose Normative Data
Study Population/Sample (inclusion/exclusion)
High School and College Students
Number 246
Age range (average ± SD, min-max) 17.6 (13 – 25)
Sex (% female) 40%
Reliability
Internal consistency NA
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function NA
Correlation to general measures of mental function NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution NA
Normal Data Yes
Subscales used Symptoms, Sports activity, Function, and Overall
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CINCINNATI KNEE SCALE CONSOLIDATION
REFERENCES
1) Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999 Jul-Aug;27(4):402-16
2) Risberg MA, Holm I, Sten H, Beynnon BD. Sensitivity to changes over time for the IKDC form, the Lysholm score, and the Cincinnati knee score. A prospective study of 120 ACL reconstructed patients with a 2-year follow-up. Knee Surg, Sports Traumatol, Arthroscophy (1999) 7:152-159
3) Marx RG, Jones EC, Allen AA, Altchek DW, O'Brien SJ, Rodeo SA, Williams RJ, Warren RF, Wickiewicz TL.
Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001;83:1459-69
5) Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International
Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
6) Demirdjian AM, Petrie SG, Guanche CA, Thomas KA. The outcomes of two knee scoring questionnaires in a normal population. Am J Sports Med. 1998 Jan-Feb;26(1):46-51
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Cincinnati Knee Scale (all subscales)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Cincinnati Knee Scale Author’s Last Name Barber-Westin (all subscales) Title of the Article Rigorous Statistical Reliability, Validity, and Responsiveness
Testing of the Cincinnati Knee Rating System in 350 Subjects with Uninjured, Injured, or Anterior Cruciate Ligament-Reconstructed Knees
Year 1999 PubMed ID: 10424208
Reviewer’s Name Travis Hamilton Date of Review 7.24.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? For those who had ACL injuries, there would be lower
results in the following: 1. Chronic injuries 2. Deteriorated articular cartilage 3. Prior failed ACL reconstructions 4. Poor or fair overall patient perception scores 5. (Not confirmed) Concurrent major operative
procedures such as a meniscus repairs or other ligament reconstructions
6. Operative complications 7. Symptoms with sports or work at follow up 8. Inability to return to work or sports because of the
knee condition 9. Work related injuries
Criterion Validity
90
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Table 1. Testing interval (time between repeated measures) 7 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Overall ES = 3.49 Overall SRM = 2.48
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 27 months
Descriptive Features
Group 1 (Validity and Responsiveness)
Group 2 (test-retest)
Group 3 (test-retest)
Age range of sample 29 (14-58) 36 (13-65) 34 (20-59) Number: 250 50 50 Sex
Male 177 28 22 Female 73 22 28
Diagnosis ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL 1 Meniscus. Articuler artroscopy +ACL 1
OA PF 1
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Other 1 No Knee related problems 1
91
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
1
Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? NA
Notes:
92
Cincinnati Knee Scale – Symptoms and Function subscales
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Cincinnati Knee Scale (Symptoms and Function subscales) Author’s Last Name Risberg Title of the Article Sensitivity to changes over time for the IKDC form, the
Lysholm score, and the Cincinnati knee score Year 1999 PubMed ID: 10401651 Reviewer’s Name Travis Hamilton Date of Review 6.30.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient IKDC1-4 and IKDC-final form, Lysholm – table 3. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
93
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: NA Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s NA; table 2 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 mo., 6.mo., 1 year, 2 years
Descriptive Features
Age range of sample 27.8 Number: 120 Sex
Male 64 Female 56
Diagnosis ACL injury/surgery 58 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury 62 (+ACL)
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
The Symptoms and Function Subscales were used as described by Noyes in 1984
120 subjects with either ACL or ACL combined injuries who underwent reconstruction using a bone-patellar-tendon –bone graft were included in this study. Patients were assessed with 3 instruments (IKDC form, Lysholm, and Cincinnati score) at 4 different time periods (3mo., 6mo., 1 year, 2 years). A linear regression analysis comparing the Lysholm scale to the Cincinnati scale is as follows: y = 0.73x + 27.8 (y = Lysholm, x = Cincinnati). The study indicates that the Lysholm scale gave significantly better results (high score) up to 1 year after surgery compared to the Cincinnati. The Cincinnati scale was the only outcome measurement sensitive enough to measure significant changes between all follow-up
94
intervals. This score has previously been found to be a sensitive outcome measurement both early and during long term follow up after ACL reconstruction.
The papers cites the Cincinnati Scale used in the reference: “Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture,” By Noyers et al. Which is indicative of the Sports Activity subscale.
95
Cincinnati Knee Scale – Sports Activity subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Cincinnati Knee Scale (Symptoms, Daily Activities, Sports Function subscales)
Author’s Last Name Marx Title of the Article Reliability, validity, and responsiveness of four knee outcome
scales for athletic patients Year 2001 PubMed ID:
11679594 Reviewer’s Name Travis Hamilton Date of Review 7.7.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF = .68,;RP = .52; BP = .51 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm scale = .70; Activities of Daily Living Scale = .80 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF – 36: RE = .18; MH = .24 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Confirmed Hypotheses:
• The instruments would all correlate better with each other than they would with the physical component scale or the mental component scale and the physical component scale would correlate more strongly with the knee scales.
• The knee-rating scales would correlate better with each other than they would with any of the eight SR-36 scales.
• The knee scales would correlate better with physical function and role-physical than they would with vitality or social function and that they would correlate better with GH, BP, VT, and SF than they would with RE or MH.
• Knee scales would be significantly correlated with clinician-rated and patient-rated severity.
• There would be a difference in the mean scores on the knee specific instruments for patients who had different patient rated severity scores as well as for those who had different clinician-rated severity score.
• There would be no veiling or floor effects. 96
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.88 Testing interval (time between repeated measures) Mean = 5.2 (2-14)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s SRM = 0.8 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 month minimum
Descriptive Features
Reliability Validity Responsiveness Age range of sample 32.6 (16-60) 31.5 (14-65) 30.9 (15-61) Number: 41 133 42 Sex
Male 20 69 19 Female 21 64 23
Diagnosis ACL injury/surgery 28 57 12 PCL injury/surgery 1 2
Other ligament injury/surgery + ACL 4 5 (MCL) 4 (OCD), 3 (PT), 3 (PTO), 1 (OSD) , 5(misc)
3
Meniscus. Articuler artroscopy +ACL 2 17 6 OA PF 2 21 15
General knee pain 4 2
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Reliability Validity Responsiveness Combined injury
Sport related Cartilage degeneration or surgery 6
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 2
Notes:
The Symptoms, Daily Activities, and Sports function subscales were used as described by Barber-Westin (ref 1)
98
Cincinnati Knee Scale – (Sports activity, symptoms, and overall rating scale)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Cincinnati Knee Scale – (Sports activity, symptoms, and overall rating scale)
Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.
Year 2010 PubMed ID: 20044494 Reviewer’s Name Travis Hamilton Date of Review 7.23.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 2 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
99
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: CKRS (6 mo., 12mo.) = 0.91 ; 0.80 Testing interval (time between repeated measures) 6 mo, 12 mo
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s CKRS ES (6 mo., 12mo.) = 0.60 ; 1.09
CKRS SRM (6 mo., 12mo.) =0.52 ; 0.76 (table 2)
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 month: CKRS MCID: 14.0 (Sens = 0.64 ; Spec = 0.70)
12 month: CKRS MCID: 26.0 (Sens = 0.55 ; Spec = 0.85) (table 3)
Change in measure related to change in external standard 1 (global scale) Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) NA Time interval between baseline and follow-up assessments 6 months and 12 months
Descriptive Features
Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 17 50
Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
100
Cincinnati Knee Score – (Cincinnati Knee Score (Symptoms, Sports activity, Function, and Overall subscales)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Cincinnati Knee Score (Symptoms, Sports activity, Function, and Overall subscales)
Author’s Last Name Demirdjian Title of the Article The Outcomes of Two Knee Scoring Questionnaires in a
Normal Population Year 1998 PubMed ID: 9474400
Reviewer’s Name Travis Hamilton Date of Review 2.27.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
101
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 17.6 (13 – 25) Number: 246 Sex
Male 131 Female 84
Diagnosis Normal Population 100%
Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2
102
Notes:
The scores for the Cincinnati are based on the Symptoms, Sports activity, Function, and Overall subscales as described by Noyes in 1990.
The average score for male subject is 99.10 ± 3.77 (68 – 100) and for female subjects is 97.82 ± 4.97 (72 – 100). For all categories of the Cincinnati questionnaire, the male subjects reported higher scores than the female subjects except for the walking category. The total scores were significantly greater for the male subjects than the female subjects (P = 0.0051)
103
KOOS- SYMPTOMS SUBSCALE
Roos (1) Roos (2) Xie (4) Ornetti (6)
Study Characteristics
Purpose Reliability, Responsiveness, Validity
Validity, Reliability of Swedish Version
Validity, Reliability of Singapore English and Chinese Version
Validity, Reliability of French version
Study Population/Sample (inclusion/exclusion)
ACL Injury/Surgery Variety of knee disorders/injury Osteoarthritis Osteoarthritis
Number 21 142 Singapore English = 127 Chinese = 131
Medicine Group = 37, Surgery Group = 30
Age range (average ± SD, min-max)
32 (18-36) 14-89 Singapore English = 65.3 Chinese = 67.8
Medicine Group = 70 10 (45-91), Surgery Group = 71 10 (42-85)
Sex (% female) 57% 37% Singapore English = 76% Chinese = 88%
Medicine Group = 68% Surgery Group = 73%
Reliability
Internal consistency NA α = .74 α:Singapore English = .70 Chinese = .64 α = .76
Test-retest reliability ICC = .93 ICC = .84 ICC: Singapore English = .87 Chinese = .85 ICC = .91
Time interval 9 days 8 days 6 days 2 weeks
Validity
Correlation to similar scale NA Fair (100%) correlation to
similar scale
English: No(100%) Chinese: No (100%) correlation to similar scales
Little (20%), Fair (80%) correlation to similar scales
Correlation to general measures of Physical function
Little (33%), Fair (66%) correlation to general measures of physical function
Little (33.3%), Fair (66%) correlation to general measures of physical function
English: Little (33.3%),Fair (66.6%) Chinese: Little (33.3%), Fair (66.6%) correlation to general measure of physical function
NA
Correlation to general measures of mental function
Litle (100%) correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
English: Little (100%) Chinese: Little (50%), Fair (50%) correlation to general measures of mental function
NA
Responsiveness
ES 0.87 0.93 NA 1.63
SRM NA NA NA 1.45
MDC 9.9 (calc) 21.5 (calc) Singapore English = 19.0 (calc) Chinese = 19.1 (calc)
16.6 (calc)
MCID NA NA NA NA
Guyatt NA NA NA NA
Time Interval 6 month 3 months NA 3 month
Other
Floor/Ceiling Effect NA No No No
Normal Distribution NA NA NA NA
Normal Data NA NA NA NA
104
KOOS- SYMPTOMS SUBSCALE CONTINUED
De Groot (7) Salavati (10) Bekkers (11)
Study Characteristics
Purpose Validity, Reliability of Dutch version Validity, Reliability of Persian version Validity, reliability
Study Population/Sample (inclusion/exclusion)
Osteoarthritis Meniscus, ACL, Combined Knee injury Cartilage Degeneration/Surgery
Number Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54
147 40
Age range (average ± SD, min-max)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) , Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision TKA = 77(36-89)
31.4 (16 – 59) 35±12 (18-55)
Sex (% female) Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%
11% 30%
Reliability
Internal consistency α: Mild OA = .71 , Moderate OA = .83 , Severe OA = .56 , TKA = .74 , Revision TKA = .78
α = .25 α = 0.74
Test-retest reliability ICC: Mild OA = .74 , Moderate OA = .87 , Revision TKA = .89 ICC = .83 ICC = 0.95
Time interval 3 weeks 8 days 2 days
Validity
Correlation to similar scale NA NA NA
Correlation to general measures of Physical function
Little (20%), Fair(33.3%), Moderate (46.7%) correlation with general measures of physical function
Little (66.6%), Fair (33.3%) correlation with general measures of physical function
NA
Correlation to general measures of mental function
Little (50%), Fair (50%) correlation with general measures of mental function
Little (100%) correlation to general measures of mental function NA
Responsiveness
ES NA NA 0.72
SRM NA NA 0.61
MDC ICC: Mild OA = 10.0 , Moderate OA = 24.3 , Revision TKA = 19.7 14.74 (calc) 10.5 (calc)
MCID NA NA NA
Guyatt NA NA NA
Time Interval NA NA 36 months
Other
Floor/Ceiling Effect Yes No No
Normal Distribution NA NA NA
Normal Data NA NA NA
105
Paradowski (12)
Study Characteristics
Purpose Normative Data
Study Population/Sample (inclusion/exclusion)
General Population
Number 568
Age range (average ± SD, min-max)
568
Sex (% female) 52.0%
Reliability
Internal consistency NA
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function
NA
Correlation to general measures of mental function
NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution No
Normal Data Yes
106
KOOS SYMPTOMS SUBSCALE CONSOLIDATION SUBSCALE
REFERENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
107
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms subscale
Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure Year 1998 PubMed ID: 9699158 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - PF = .29 , RP = .27 , BP = .08 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - RE =-.17 , MH = .13 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
108
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: symptoms = .93 Testing interval (time between repeated measures) Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s TABLE 5. Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Table 4
Time interval between baseline and follow-up assessments 3 and 6 month
Descriptive Features
Age range of sample 32 (18-46) Number: 21 Sex
Male 9 Female 12
Diagnosis ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 2 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 1 week Language(s) of instrument used in this report 1; English and Swedish Is this the first or primary report about this instrument? 1
109
110
111
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – symptoms subscale
Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version Year 1998 PubMed ID: 9863983 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Table 2. Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .32 , RP = .14 , BP = .29 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - RE =.0 , MH = .04 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Symptoms = .74
112
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Symptoms = .84 Testing interval (time between repeated measures) Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Symptoms = .93 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
na
Report statistics: Change in measure related to change in external standard na Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments 3 months
Descriptive Features
Age range of sample Number: 142 Sex Table 1.
Male Female
Diagnosis Figure 1 and 2 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Past week Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2 Notes:
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
113
114
115
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms Subscale
Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis outcome score koos in Asians with knee osteoarthritis in Singapore
Year 2006 PubMed ID: 16814575 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: PF = .40 RB = .21 BP = .44/Chinese SF-36 PF =
.31 RB = .18 BP = .43
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = .14 MH = .23/Chinese SF-36 RE = .17 MH
= .29 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
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Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α :Singapore English:, Symptoms = .70 Chinese: Symptoms = .64
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; Symptoms = .87
Chinese; Symptoms = .85 Testing interval (time between repeated measures) 6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Singapore English Chinese Age range of sample 65.3 67.8 Number: 127 (test-retest = 47) 131 (test-retest = 55) Sex
Male 30 15 Female 97 116
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English Is this the first or primary report about this instrument? 2
117
118
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms Subscale
Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in knee osteoarthritis patients
Year 2008 PubMed ID: 17905602 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Translation – back translation
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient OAKHQOL, Table 2 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with the OAKHQOL pain and physical activities domain, and would correlate weakly with the other OOAKHQOL domains.
2. The KOOS sports and recreation domain would correlate weakly with all OAKHQOL domains, since this domain has previously been reported as weakly correlated with all 36-item short form health survey SF-36 domains.
3. The KOOS QOL domain would correlate strongly or moderately with all OAKHQOL domains.
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Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Symptoms = .76
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Symptoms = .91 Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Symptoms = 1.63 SRM: Symptoms = 1.45
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 Months
Descriptive Features
Medicine Group Surgery Group Age range of sample 70 ± 10 (45-91) 71 ± 10 (42-85) Number: 37 30 Sex
Male 32% 27% Female 68% 73%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA
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Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
121
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms subscale
Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis
outcome score a validation study Year 2008 PubMed ID: 18302729 Reviewer’s Name Travis Hamilton Date of Review 7.15.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Convergent hypotheses:
1. The correlation between KOOS Pain and Sf-36 BP, between KOOS Pain and SF-36 PF, KOOS (all subscales) and VAS for Pain and KOOS ADL and SF-36 PF should be ≥ 0.60.
2. KOOS Pain has a stronger correlation with SF-36 BP compared to the correlation with SF-36 PF. This difference should be at least 0.05 higher.
3. KOOS Pain has a stronger correlation with VAS for pain compared to the correlation of the other subscales of the KOOS with the VAS for Pain. This difference should be at least 0.05 higher.
4. KOOS ADL was expected to have a 0.05 higher correlation with SF-36 PF compared to the correlation of the other subscales of the SF-36. Divergent hypotheses:
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1. All other correlations between the KOOS subscales and the SF-36 should be higher than 0.30 and lower than 0.60
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA Symptoms = .74
MODERATE OA Symptoms = .87 REVISION of TKA: Symptoms = .89
Testing interval (time between repeated measures) 3 WEEKS
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Mild OA Moderate OA
Severe OA TKA Revision of TKA
Age range of sample 36 (27-50)
56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)
Number: 36 62 47 63 54 Sex
Male 78 68 48 49 22 Female 22 32 52 51 78
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
123
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Dutch Is this the first or primary report about this instrument? 2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
124
125
126
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score- Symptoms subscale
Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee injuries
Year 2008 PubMed ID:
18411065 Reviewer’s Name Travis Hamilton Date of Review 7.17.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - PF = .16 , RP = .15 , BP = .34 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - RE =.13 , MH = .15 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:
1. The correlations between the KOOS Pain and SF=36 BP subscales should be high.
2. The correlations between the KOOS ADL and Sport/Rec and Sf-36 PF subscales should be high.
3. The correlations between the KOOS subscales and the SF-36 subscales of Physical Health (PF, RP, BP) should be higher than between the KOOS subscales and the SF-36 subscales of Mental Health (GH, VT, RE, MH)
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Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome A If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α : Symptoms = .25
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC Symptoms = .83 Testing interval (time between repeated measures) 6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 31.4 (16 – 59) Number: 147 Sex
Male 131 Female 16
Diagnosis ACL injury/surgery 60 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 31
OA PF
General knee pain Combined injury 56
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1
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Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
129
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Symptoms subscale
Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions Year 2009 PubMed ID:
19454278 Reviewer’s Name Travis Hamilton Date of Review 7.17.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? A priori moderate – strong hypotheses:
1. KOOS symptoms with SF-36 physical functioning 2. KOOS pain with SF-36 bodily pain and WE-VAS 3. KOOS ADL with the complete SF-36 questionnaire. 4. KOOS sport and recreation with the Lysholm knee
scoring scale 5. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
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Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Symptoms = 0.74
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.95. table 1 Testing interval (time between repeated measures) 2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Symptoms = .72 SRM: Symptoms = .61
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 36 MONTH
Descriptive Features
Age range of sample 35±12 (18-55) Number: 40 Sex
Male 70% Female 30%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 1
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
131
132
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Paradowski Title of the Article Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS)
Year 2006 PubMed ID: 16670005 Reviewer’s Name Travis Hamilton Date of Review 11.8.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale NA (Notes) If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
133
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 568 (figure 1) Number: Sex
Male 274 (48%) Female 294 (52%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General Population 100%
Provide normative data 1 (table 1./ notes) Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
134
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower extremity functions.
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KOOS - PAIN SUBSCALE
Roos (1) Roos (2) Xie (4)
Study Characteristics
Purpose Reliability, Responsiveness, Validity Validity, Reliability of Swedish version
Validity, Reliability of Singapore English and Chinese version
Study Population/Sample ACL injury/ Surgery Variety of Knee disorders/injury Osteoarthritis
Number 21 142 Singapore English = 127 Chinese = 131
Age range 32 (18-46) 14-89 Singapore English = 65.3 Chinese = 67.8
Sex (% female) 57% 37% Singapore English = 76% Chinese = 88%
Reliability
Internal consistency NA α = .84 α:Singapore English = .79 Chinese = .65
Test-retest reliability ICC = .85 ICC = .91 ICC: Singapore English = .88 Chinese = .87
Time interval 9 days 8 days 6 days
Validity
Correlation to similar scale NA Moderate (100%) correlation to
similar scale English: No(100%) Chinese: No (100%) correlation to similar scales
Correlation to general measures of Physical function
Little (66%), Fair (33%) correlation to general measures of physical function
Little (33%), Fair (33%), Moderate (33%) correlation to general measures of physical function
English: Little (33%) Fair (66%) Chinese: Little (33%), Fair (66%) correlation to general measure of physical function
Correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
English: Little (100%) Chinese: Little (50%), Fair (50%) correlation to general measures of mental function
Responsiveness
ES 0.84 1.11 NA
SRM NA NA NA
MDC 13.8 (calc) 13.9 (calc) Singapore English = 15.3 (calc) Chinese = 12.8 (calc)
MCID NA NA NA
Guyatt NA NA NA
Time Interval 6 month 3 months NA
Other
Floor/Ceiling Effect NA No No
Normal Distribution NA NA NA
Normal Data NA NA NA
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KOOS - PAIN SUBSCALE CONTINUED
Ornetti (6) DeGroot (7)
Study Characteristics
Purpose Validity, Reliability of French version Validity, Reliability of Dutch version
Study Population/Sample Osteoarthritis Osteoarthritis
Number Medicine Group = 37, Surgery Group = 30
Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54
Age range Medicine Group = 70 ± 10 (45-91), Surgery Group = 71 ± 10 (42-85)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) , Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision TKA = 77(36-89)
Sex (% female) Medicine Group = 68% Surgery Group = 73% Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%
Reliability
Internal consistency α = .84 α: Mild OA = .94 , Moderate OA = .93 , Severe OA = .80 , TKA = .92 , Revision TKA = .87
Test-retest reliability ICC = .88 ICC: Mild OA = .80 , Moderate OA = .87 , Revision TKA = .80
Time interval 2 weeks 3 weeks
Validity
Correlation to similar scale
Little (20%), Fair (80%) correlation to similar scales NA
Correlation to general measures of Physical function
NA Little (13.3%), Fair (33.3%), Moderate (53.3%) correlation with general measures of physical function
Correlation to general measures of mental function
NA Little (60%), Fair (40%), correlation with general measures of mental function
Responsivenss
ES 2.59 NA
SRM 1.85 NA
MDC 15.3 (calc) (1.96)*(sqrt(2))*((16)*sqrt(1-.88)) ICC: Mild OA = 22.9 (calc) , Moderate OA = 25.6 (calc) , Revision TKA = 29.0 (calc) **used baseline group**
MCID NA NA
Guyatt NA NA
Time Interval 3 month NA
Other
Floor/Ceiling Effect No Yes
Normal Distribution NA NA
Normal Data NA NA
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KOOS - PAIN SUBSCALE
Salavati (10) Bekkers (11) Paradowski (12)
Study Characteristics
Purpose Validity, Reliability of Persian version Validity, Reliability Normative Data
Study Population/Sample Meniscus, ACL, Combined Knee injury Cartilage Degeneration/Surgery General Population
Number 147 40 568
Age range 31.4 (16 – 59) 35±12 (18-55) 568
Sex (% female) 11% 30% 52.0%
Reliability
Internal consistency α = .88 α = .88 NA
Test-retest reliability ICC = .91 ICC = .92 NA
Time interval 8 days 2 days NA
Validity
Correlation to similar scale NA NA NA
Correlation to general measures of Physical function
Fair (66.6%), Moderate (33.3%) correlation with general measures of physical function NA NA
Correlation to general measures of mental function
Little (50%), Fair (50%) correlation to general measures of mental function NA NA
Responsivenss
ES NA 0.82 NA
SRM NA 0.71 NA
MDC 16.54 (calc) 11.8 (calc) NA
MCID NA NA NA
Guyatt NA NA NA
Time Interval NA 36 months NA
Other
Floor/Ceiling Effect No No NA
Normal Distribution NA NA No
Normal Data NA NA Yes
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KOOS PAIN SUBSCALE CONSOLIDATION
REFRENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation
of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10)Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis
Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
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KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure Year 1998 PubMed ID: 9699158 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. PF = .29 , RP = .07 , BP = .46 Correlated with theoretically similar scale If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. RE =-.02 , MH = .09 Tested specific hypothesis to demonstrate construct validity? If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
140
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .85 Testing interval (time between repeated measures) Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s TABLE 5. Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Table 4
Time interval between baseline and follow-up assessments 3 and 6 month
Descriptive Features
Age range of sample 32 (18-46) Number: 21 Sex
Male 9 Female 12
Diagnosis ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 2 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 1 week Language(s) of instrument used in this report 1; English and Swedish Is this the first or primary report about this instrument? 1
141
142
143
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version Year 1998 PubMed ID: 9863983 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint Table 2. Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .49 , RP = .24 , BP = .65 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4, RE =.15 , MH = .23, Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Pain = .84
144
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .86 Testing interval (time between repeated measures) Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Pain = 1.11 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 months
Descriptive Features
Age range of sample Number: 142 Sex Table 1.
Male Female
Diagnosis Figure 1 and 2 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Past week Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2 Notes:
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
145
146
147
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain Subscale Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis outcome score koos in Asians with knee osteoarthritis in Singapore
Year 2006 PubMed ID: 16814575 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: PF = .50 RB = .23 BP = .37/Chinese SF-36 PF =
.48 RB = .23 BP = .31
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = -.01 MH = -.05/Chinese SF-36 RE = .13
MH = .30 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
148
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α :Singapore English: Pain = .79 Chinese: Pain = .65
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; Pain = .88
Chinese; Pain = .87 Testing interval (time between repeated measures) 6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Singapore English Chinese Age range of sample 65.3 67.8 Number: 127 (test-retest = 47) 131 (test-retest = 55) Sex
Male 30 15 Female 97 116
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English Is this the first or primary report about this instrument? 2
149
150
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain Subscale Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in knee osteoarthritis patients
Year 2008 PubMed ID: 17905602 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Translation – back translation
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient OAKHQOL, Table 2 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 4. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with the OAKHQOL pain and physical activities domain, and would correlate weakly with the other OOAKHQOL domains.
5. The KOOS sports and recreation domain would correlate weakly with all OAKHQOL domains, since this domain has previously been reported as weakly correlated with all 36-item short form health survey SF-36 domains.
6. The KOOS QOL domain would correlate strongly or moderately with all OAKHQOL domains.
Criterion Validity
Correlated with “gold standard” NA
151
Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Pain = .84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .88 Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Pain = 2.59 SRM: Pain = 1.85
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 Months
Descriptive Features
Medicine Group Surgery Group Age range of sample 70 ± 10 (45-91) 71 ± 10 (42-85) Number: 37 30 Sex
Male 32% 27% Female 68% 73%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present
152
Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
153
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis
outcome score a validation study Year 2008 PubMed ID: 18302729 Reviewer’s Name Travis Hamilton Date of Review 7.15.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Convergent hypotheses:
5. The correlation between KOOS Pain and Sf-36 BP, between KOOS Pain and SF-36 PF, KOOS (all subscales) and VAS for Pain and KOOS ADL and SF-36 PF should be ≥ 0.60.
6. KOOS Pain has a stronger correlation with SF-36 BP compared to the correlation with SF-36 PF. This difference should be at least 0.05 higher.
7. KOOS Pain has a stronger correlation with VAS for pain compared to the correlation of the other subscales of the KOOS with the VAS for Pain. This difference should be at least 0.05 higher.
8. KOOS ADL was expected to have a 0.05 higher correlation with SF-36 PF compared to the correlation of the other subscales of the SF-36. Divergent hypotheses:
2. All other correlations between the KOOS subscales and
154
the SF-36 should be higher than 0.30 and lower than 0.60
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: Pain = .80
MODERATE OA: Pain = .87 REVISION of TKA: Pain = .80
Testing interval (time between repeated measures) 3 WEEKS
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Mild OA Moderate OA
Severe OA TKA Revision of TKA
Age range of sample 36 (27-50)
56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)
Number: 36 62 47 63 54 Sex
Male 78 68 48 49 22 Female 22 32 52 51 78
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 155
PF General knee pain
Combined injury Sport related
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Dutch Is this the first or primary report about this instrument? 2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
156
157
158
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee injuries
Year 2008 PubMed ID:
18411065 Reviewer’s Name Travis Hamilton Date of Review 7.17.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - PF = .48 , RP = .38 , BP = .65 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - RE =.26 , MH = .17 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:
4. The correlations between the KOOS Pain and SF=36 BP subscales should be high.
5. The correlations between the KOOS ADL and Sport/Rec and Sf-36 PF subscales should be high.
6. The correlations between the KOOS subscales and the SF-36 subscales of Physical Health (PF, RP, BP) should be higher than between the KOOS subscales and the SF-36 subscales of Mental Health (GH, VT, RE, MH)
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome A If yes to either of above, report how this was demonstrated
159
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α : Pain = .88
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Pain = .91 Testing interval (time between repeated measures) 6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 31.4 (16 – 59) Number: 147 Sex
Male 131 Female 16
Diagnosis ACL injury/surgery 60 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 31
OA PF
General knee pain Combined injury 56
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2
160
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
161
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Pain subscale Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions Year 2009 PubMed ID:
19454278 Reviewer’s Name Travis Hamilton Date of Review 7.17.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? A priori moderate – strong hypotheses:
6. KOOS symptoms with SF-36 physical functioning 7. KOOS pain with SF-36 bodily pain and WE-VAS 8. KOOS ADL with the complete SF-36 questionnaire. 9. KOOS sport and recreation with the Lysholm knee
scoring scale 10. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
162
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Pain = 0.88
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.92. table 1 Testing interval (time between repeated measures) 2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Pain = .82 SRM: Pain = .71
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 36 MONTH
Descriptive Features
Age range of sample 35±12 (18-55) Number: 40 Sex
Male 70% Female 30%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 1
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
163
164
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Paradowski Title of the Article Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS)
Year 2006 PubMed ID: 16670005 Reviewer’s Name Travis Hamilton Date of Review 11.8.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale NA (Notes) If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
165
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 568 (figure 1) Number: Sex
Male 274 (48%) Female 294 (52%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General Population 100%
Provide normative data 1 (table 1./ notes) Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
166
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower extremity functions.
167
KOOS - ADL SUBSCALE
Roos (1) Roos (2) Xie (4)
Study Characteristics
Purpose Reliability, Responsiveness, Validity Validity, Reliability of Swedish Version Validity, Reliability of Singapore English and Chinese Version
Study Population/Sample ACL Injury/Surgery Variety of knee disorders/injury Osteoarthritis
Number 21 142 Singapore English = 127 Chinese = 131
Age range 32 (18-46) 14-89 Singapore English = 65.3 Chinese = 67.8
Sex (% female) 57% 37% Singapore English = 76% Chinese = 88%
Reliability
Internal consistency NA α = 0.95 α:Singapore English = .92 Chinese = .82
Test-retest reliability ICC = 0.75 ICC = 0.91 ICC: Singapore English = .91 Chinese = .84
Time interval 9 days 8 days 6 days
Validity
Correlation to similar scale NA Moderate (100%) correlation to similar
scale English: No (100%) Chinese: No (100%) correlation to similar scales
Correlation to general measures of Physical function
Fair (66%) , Moderate (33%) correlation to general measures of physical function
Fair (33%), Moderate(66%) correlation to general measures of physical function
English: Fair (66%), Moderate (33%) Chinese Little (33%), Fair (33%), Moderate (33%) correlation to general measure of physical function
Correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
English: Little (100%) Chinese: Fair (100%) correlation to general measures of mental function
Responsiveness
ES 0.94 0.67 NA
SRM NA NA NA
MDC 11.9 (calc) 15.3 (calc) Singapore English = 14.0 (calc) Chinese = 14.4 (calc)
MCID NA NA NA
Guyatt NA NA NA
Time Interval 6 month 3 months NA
Other
Floor/Ceiling Effect NA No No
Normal Distribution NA NA NA
Normal Data NA NA NA
**Used preop SD to calculate MCD 168
KOOS - ADL SUBSCALE
Ornetti (6) DeGroot (7)
Study Characteristics
Purpose Validity, Reliability of French Version Validity, Reliability of Dutch Version
Study Population/Sample Osteoarthritis Osteoarthritis
Number Medicine Group = 37, Surgery Group = 30 Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54
Age range Medicine Group = 70 10 (45-91), Surgery Group = 71 +/- 10 (42-85)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) , Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision TKA = 77(36-89)
Sex (% female) Medicine Group = 68% Surgery Group = 73%
Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%
Reliability
Internal consistency α = .93 α: Mild OA = .78 , Moderate OA = .97 , Severe OA = .94 , TKA = .94 , Revision TKA = .93
Test-retest reliability ICC = .85 ICC: Mild OA = .85 , Moderate OA = .94 , Revision TKA = .73
Time interval 2 weeks 3 weeks
Validity
Correlation to similar scale Little (20%), Fair (60%), Moderate (20%) correlation to similar scales NA
Correlation to general measures of Physical function NA
Little (6.6%), Fair (33.3%), Moderate (53.3%), Excellent (6.6%) correlation to general measures of physical function
Correlation to general measures of mental function NA
Little (30%), Fair (60%), Moderate (10%) correlation to general measures of mental function
Responsiveness
ES 2.25 NA
SRM 1.8 NA
MDC 17.1 (calc) ICC: Mild OA = 16.2 , Moderate OA = 15.0 , Revision TKA = 31.5 (calc) **used baseline group**
MCID NA NA
Guyatt NA NA
Time Interval 3 month NA
Other
Floor/Ceiling Effect No Yes
Normal Distribution NA NA
Normal Data NA NA
**Used preop SD to calculate MCD 169
KOOS - ADL SUBSCALE
Salavati (10) Bekkers (11) Paradowski (12)
Study Characteristics
Purpose Validity, Reliability of Persian version Validity, reliability Normative Data
Study Population/Sample
Meniscus, ACL, Combined Knee Injury Cartilage Degeneration/Surgery General Population
Number 147 40 568
Age range 31.4 (16 – 59) 35±12 (18-55) 568
Sex (% female) 11% 30.00% 52.0%
Reliability
Internal consistency α = .94 α = 0.95 NA
Test-retest reliability ICC = .90 ICC = 0.87 NA
Time interval 8 days 2 days NA
Validity
Correlation to similar scale NA NA NA
Correlation to general measures of Physical function
Fair (33%), Moderate(66%) correlation to general measures of physical function
NA NA
Correlation to general measures of mental function
Little (50%), Fair (50%) correlation to general measures of mental function NA NA
Responsiveness
ES NA 0.7 NA
SRM NA 0.75 NA
MDC 17.3 (calc) 13.9 (calc) NA
MCID NA NA NA
Guyatt NA NA NA
Time Interval NA 36 months NA
Other
Floor/Ceiling Effect No No NA
Normal Distribution NA NA No
Normal Data NA NA Yes
**Used preop SD to calculate MCD
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KOOS ADL SUBSCALE CONSOLIDATION
REFERENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
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KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure Year 1998 PubMed ID: 9699158 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. – PF = .57 , RP = .34 , BP = .35 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. RE = -.05, MH =.22 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
172
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: adl = .75 Testing interval (time between repeated measures) Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s TABLE 5. Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Table 4
Time interval between baseline and follow-up assessments 3 and 6 month
Descriptive Features
Age range of sample 32 (18-46) Number: 21 Sex
Male 9 Female 12
Diagnosis ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 2 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 1 week Language(s) of instrument used in this report 1; English and Swedish Is this the first or primary report about this instrument? 1
173
174
175
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version Year 1998 PubMed ID: 9863983 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Table 2. Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .68 , RP = .36 , BP = .65 , Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 RE =.18 , MH = .16, Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: ADL = .95
176
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: ADL = .91 Testing interval (time between repeated measures) Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: ADL = .67 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments 3 months
Descriptive Features
Age range of sample Number: 142 Sex Table 1.
Male Female
Diagnosis Figure 1 and 2 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Past week Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2 Notes:
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
177
178
179
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL Subscale Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis outcome score koos in Asians with knee osteoarthritis in Singapore
Year 2006 PubMed ID: 16814575 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: PF = .65 RB = .33 BP = .38/Chinese SF-36 PF =
.64 RB = .36 BP = .14; Table 4. Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D: Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = .10 MH = .14/Chinese SF-36 RE = .33 MH
= .32 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
180
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α :Singapore English: ADL = .92 Chinese: ADL = .82
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; ADL = .91
Chinese; ADL = .84
Testing interval (time between repeated measures) 6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Singapore English Chinese Age range of sample 65.3 67.8 Number: 127 (test-retest = 47) 131 (test-retest = 55) Sex
Male 30 15 Female 97 116
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English Is this the first or primary report about this instrument? 2
181
182
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in knee osteoarthritis patients
Year 2008 PubMed ID: 17905602 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Translation – back translation
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient OAKHQOL, Table 2 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 7. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with the OAKHQOL pain and physical activities domain, and would correlate weakly with the other OOAKHQOL domains.
8. The KOOS sports and recreation domain would correlate weakly with all OAKHQOL domains, since this domain has previously been reported as weakly correlated with all 36-item short form health survey SF-36 domains.
9. The KOOS QOL domain would correlate strongly or moderately with all OAKHQOL domains.
183
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: ADL = .93
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC ADL = .85 Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ESADL = 2.25 SRMADL = 1.8
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 Months
Descriptive Features
Medicine Group Surgery Group Age range of sample 70 ± 10 (45-91) 71 ± 10 (42-85) Number: 37 30 Sex
Male 32% 27% Female 68% 73%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA
184
Medicine Group Surgery Group Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
185
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis
outcome score a validation study Year 2008 PubMed ID: 18302729 Reviewer’s Name Travis Hamilton Date of Review 7.15.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Convergent hypotheses:
9. The correlation between KOOS Pain and Sf-36 BP, between KOOS Pain and SF-36 PF, KOOS (all subscales) and VAS for Pain and KOOS ADL and SF-36 PF should be ≥ 0.60.
10. KOOS Pain has a stronger correlation with SF-36 BP compared to the correlation with SF-36 PF. This difference should be at least 0.05 higher.
11. KOOS Pain has a stronger correlation with VAS for pain compared to the correlation of the other subscales of the KOOS with the VAS for Pain. This difference should be at least 0.05 higher.
12. KOOS ADL was expected to have a 0.05 higher correlation with SF-36 PF compared to the correlation of the other subscales of the SF-36. Divergent hypotheses:
3. All other correlations between the KOOS subscales and the SF-36 should be higher than 0.30 and lower than 0.60
186
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: ADL = .85
MODERATE OA ADL = .94 REVISION of TKA: ADL = .73
Testing interval (time between repeated measures) 3 WEEKS
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Mild OA Moderate OA
Severe OA TKA Revision of TKA
Age range of sample 36 (27-50)
56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)
Number: 36 62 47 63 54 Sex
Male 78 68 48 49 22 Female 22 32 52 51 78
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related 187
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Dutch Is this the first or primary report about this instrument? 2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
188
189
190
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee injuries
Year 2008 PubMed ID:
18411065 Reviewer’s Name Travis Hamilton Date of Review 7.17.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - PF = .63 , RP = .38 , BP = .62 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 RE =.34 , MH = .23 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:
7. The correlations between the KOOS Pain and SF=36 BP subscales should be high.
8. The correlations between the KOOS ADL and Sport/Rec and Sf-36 PF subscales should be high.
9. The correlations between the KOOS subscales and the SF-36 subscales of Physical Health (PF, RP, BP) should be higher than between the KOOS subscales and the SF-36 subscales of Mental Health (GH, VT, RE, MH)
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome A If yes to either of above, report how this was demonstrated
191
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α : ADL = .94
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: ADL = .90 Testing interval (time between repeated measures) 6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 31.4 (16 – 59) Number: 147 Sex
Male 131 Female 16
Diagnosis ACL injury/surgery 60 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 31
OA PF
General knee pain Combined injury 56
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2
192
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
193
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – ADL subscale Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions Year 2009 PubMed ID:
19454278 Reviewer’s Name Travis Hamilton Date of Review 7.17.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? A priori moderate – strong hypotheses:
11. KOOS symptoms with SF-36 physical functioning 12. KOOS pain with SF-36 bodily pain and WE-VAS 13. KOOS ADL with the complete SF-36 questionnaire. 14. KOOS sport and recreation with the Lysholm knee
scoring scale 15. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
194
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
ADL = 0.95
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.87. table 1 Testing interval (time between repeated measures) 2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: ADL = .70 SRM: ADL = .75
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 36 MONTH
Descriptive Features
Age range of sample 35±12 (18-55) Number: 40 Sex
Male 70% Female 30%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 1
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
195
196
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Paradowski Title of the Article Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS)
Year 2006 PubMed ID: 16670005 Reviewer’s Name Travis Hamilton Date of Review 11.8.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale NA (Notes) If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
197
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 568 (figure 1) Number: Sex
Male 274 (48%) Female 294 (52%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General Population 100%
Provide normative data 1 (table 1./ notes) Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function comared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
198
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower extremity functions.
199
KOOS- SPORT/REC SUBSCALE
Roos (1) Roos (2) Xie (4)
Study Characteristics
Purpose Reliability, Responsiveness, Validity
Validity, Reliability of Swedish version
Validity, Reliability of Singapore English and Chinese version
Study Population/Sample (inclusion/exclusion)
ACL injury/ Surgery Variety of Knee disorders/injury Osteoarthtis
Number 21 142 Singapore English = 127 Chinese = 131
Age range (average ± SD, min-max) 32 (18-46) 14-89 Singapore English = 65.3
Chinese = 67.8
Sex (% female) 57% 37% Singapore English = 76% Chinese = 88%
Reliability
Internal consistency NA α = .85 α:Singapore English = .89 Chinese = .88
Test-retest reliability ICC = .81 ICC = .78 ICC: Singapore English = .65 Chinese = .78
Time interval 9 days 8 days 6 days
Validity
Correlation to similar scale NA Moderate (100%) correlation to similar scale
English: No(100%) Chinese: No (100%) correlation to similar scales
Correlation to general measures of Physical function
Little (33%), Fair (66.6%) correlation to general measures of physical function
Fair (66.6%), Moderate (33.3%) correlation to general measures of physical function
English: Fair (100%) Chinese: Little (100%) correlation to general measure of physical function
Correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
Little (50%) to fair (50%) correlation to general measures of mental function
English: Little (100%) Chinese: Little (100%) correlation to general measures of mental function
Responsiveness
ES 1.16 0.9 NA
SRM NA NA NA
MDC 22.9 (calc) 30.68 (calc) Singapore English = 20.0 (calc) Chinese = 12.2 (calc)
MCID NA NA NA
Guyatt NA NA NA
Time Interval 6 months 3 months NA
Other
Floor/Ceiling Effect NA No Yes*
Normal Distribution NA NA NA
Normal Data NA NA NA
200
KOOS- SPORT/REC SUBSCALE Ornetti (6) DeGroot (7) Salavati (10) Bekkers (11)
Study Characteristics
Purpose Reliability, Responsiveness, Validity
Validity, Reliability of Dutch version
Validity, Reliability of Persian version Validity, reliability
Study Population/Sample
Osteoarthtis Osteoarthtis Meniscus, ACL, Combined Knee injury
Cartilage Degeneration/Surgery
Number Medicine Group = 37, Surgery Group = 30
Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54
147 40
Age range (average ± SD, min-max)
Medicine Group = 70 10 (45-91), Surgery Group = 71 10 (42-85)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) , Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision TKA = 77(36-89)
31.4 (16 – 59) 35±12 (18-55)
Sex (% female) Medicine Group = 68% Surgery Group = 73%
Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%
11% 30%
Reliability
Internal consistency α = .84
α: Mild OA = .87 , Moderate OA = .95 , Severe OA = .98 , TKA = .88 , Revision TKA = .95
α = .89 α = 0.89
Test-retest reliability ICC = .82 ICC: Mild OA = .85 , Moderate OA = .87 , Revision TKA = .45
ICC = .61 ICC = 0.89
Time interval 2 weeks 3 weeks 8 days 2 days
Validity
Correlation to similar scale
Little (80%), Fair (20%) correlation to similar scales NA NA NA
Correlation to general measures of Physical function
NA
Little (26.6%), Fair (53.3%), Moderate (20%) correlation with general measures of physical function
Fair (100%)correlation with general measures of physical function
NA
Correlation to general measures of mental function
NA Little (70%), Fair (30%) correlation with general measures of mental function
Little (100%) correlation to general measures of mental function
NA
Responsiveness
ES 1.31 NA NA 0.98
SRM 0.89 NA NA 0.87
MDC 23.5 (calc)
ICC: Mild OA = 25.1 , Moderate OA = 31.9 , Revision TKA = 70.0 (calc) **used baseline group**
39.8 (calc) 23.9 (calc)
MCID NA NA NA NA
Guyatt NA NA NA NA
Time Interval 3 month NA NA 36 months
Other
Floor/Ceiling Effect No Yes No No
Normal Distribution NA NA NA NA
Normal Data NA NA NA NA
201
KOOS- SPORT/REC SUBSCALE
Paradowski (12)
Study Characteristics
Purpose Normative Data
Study Population/Sample
General Population
Number 568
Age range (average ± SD, min-max) 568
Sex (% female) 52.0%
Reliability
Internal consistency NA
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function
NA
Correlation to general measures of mental function
NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution No
Normal Data Yes
202
KOOS SPORT AND REC SUBSCALE CONSOLIDATION
REFERENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
203
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score- Sport/Rec subscale
Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure Year 1998 PubMed ID: 9699158 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - PF = .47 , RP = .24 , BP = .27 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - RE =.03 , MH = .23 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
204
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: sport and rec function = .81 Testing interval (time between repeated measures) Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s TABLE 5. Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Table 4
Time interval between baseline and follow-up assessments 3 and 6 month
Descriptive Features
Age range of sample 32 (18-46) Number: 21 Sex
Male 9 Female 12
Diagnosis ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 2 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 1 week Language(s) of instrument used in this report 1; English and Swedish Is this the first or primary report about this instrument? 1
205
206
207
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec subscale
Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version Year 1998 PubMed ID: 9863983 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Table 2. Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .57 , RP = .43 , BP = .43 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - RE =.26 , MH = .12 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α Sport/Rec = .85
208
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Sport and Rec. function = .78 Testing interval (time between repeated measures) Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Sport/Rec = .90 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments 3 months
Descriptive Features
Age range of sample Number: 142 Sex Table 1.
Male Female
Diagnosis Figure 1 and 2 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Past week Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2 Notes:
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
209
210
211
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec Subscale
Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis outcome score koos in Asians with knee osteoarthritis in Singapore
Year 2006 PubMed ID: 16814575 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 2. 66.9% - Singapore English; 73.3% - Singapore
Chinese Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: PF = .47 RB = .25 BP = .31/Chinese SF-36 PF =
.24 RB = .10 BP = -.04
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = -.06 MH = -.02/Chinese SF-36 RE = -.01
MH = -.03 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
212
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α :Singapore English: Sprt/Rec = .89 Chinese: Sprt/Rec = .88
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English: Sprt/Rec = .65
Chinese; Sprt/Rec = .78 Testing interval (time between repeated measures) 6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Singapore English Chinese Age range of sample 65.3 67.8 Number: 127 (test-retest = 47) 131 (test-retest = 55) Sex
Male 30 15 Female 97 116
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English
213
Is this the first or primary report about this instrument? 2
214
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec subscale
Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in knee osteoarthritis patients
Year 2008 PubMed ID: 17905602 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Translation – back translation
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient OAKHQOL, Table 2 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 10. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with the OAKHQOL pain and physical activities domain, and would correlate weakly with the other OOAKHQOL domains.
11. The KOOS sports and recreation domain would correlate weakly with all OAKHQOL domains, since this domain has previously been reported as weakly correlated with all 36-item short form health survey SF-36 domains.
12. The KOOS QOL domain would correlate strongly or moderately with all OAKHQOL domains.
Criterion Validity
215
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Sport/Rec = .84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Sport/Rec = .82 Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ESSport/Rec = 1.31 SRM: Sport/Rec = .89
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 Months
Descriptive Features
Medicine Group Surgery Group Age range of sample 70 ± 10 (45-91) 71 ± 10 (42-85) Number: 37 30 Sex
Male 32% 27% Female 68% 73%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1
216
Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
217
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec subscale
Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis
outcome score a validation study Year 2008 PubMed ID: 18302729 Reviewer’s Name Travis Hamilton Date of Review 7.15.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Convergent hypotheses:
13. The correlation between KOOS Pain and Sf-36 BP, between KOOS Pain and SF-36 PF, KOOS (all subscales) and VAS for Pain and KOOS ADL and SF-36 PF should be ≥ 0.60.
14. KOOS Pain has a stronger correlation with SF-36 BP compared to the correlation with SF-36 PF. This difference should be at least 0.05 higher.
15. KOOS Pain has a stronger correlation with VAS for pain compared to the correlation of the other subscales of the KOOS with the VAS for Pain. This difference should be at least 0.05 higher.
16. KOOS ADL was expected to have a 0.05 higher correlation with SF-36 PF compared to the correlation of the other subscales of the SF-36. Divergent hypotheses:
4. All other correlations between the KOOS subscales and the SF-36 should be higher than 0.30 and lower than 0.60
218
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: Spt/Rec = .85
MODERATE OA Spt/Rec = .87 REVISION of TKA: Spt/Rec = .45
Testing interval (time between repeated measures) 3 WEEKS
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Mild OA Moderate OA
Severe OA TKA Revision of TKA
Age range of sample 36 (27-50)
56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)
Number: 36 62 47 63 54 Sex
Male 78 68 48 49 22 Female 22 32 52 51 78
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain 219
Combined injury Sport related
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Dutch Is this the first or primary report about this instrument? 2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
220
221
222
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec subscale
Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee injuries
Year 2008 PubMed ID:
18411065 Reviewer’s Name Travis Hamilton Date of Review 7.17.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - PF = .48 , RP = .32 , BP = .48 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - RE =.20 , MH = .07 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:
10. The correlations between the KOOS Pain and SF=36 BP subscales should be high.
11. The correlations between the KOOS ADL and Sport/Rec and Sf-36 PF subscales should be high.
12. The correlations between the KOOS subscales and the SF-36 subscales of Physical Health (PF, RP, BP) should be higher than between the KOOS subscales and the SF-36 subscales of Mental Health (GH, VT, RE, MH)
223
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α : Sport/Rec = .89
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC:, Sport/Rec = .61 Testing interval (time between repeated measures) 6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 31.4 (16 – 59) Number: 147 Sex
Male 131 Female 16
Diagnosis ACL injury/surgery 60 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 31
OA PF
General knee pain Combined injury 56
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1
224
Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
225
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – Sport/Rec Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions Year 2009 PubMed ID:
19454278 Reviewer’s Name Travis Hamilton Date of Review 7.17.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? A priori moderate – strong hypotheses:
16. KOOS symptoms with SF-36 physical functioning 17. KOOS pain with SF-36 bodily pain and WE-VAS 18. KOOS ADL with the complete SF-36 questionnaire. 19. KOOS sport and recreation with the Lysholm knee
scoring scale 20. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
226
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Sport/Rec. = 0.89
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.89. table 1 Testing interval (time between repeated measures) 2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: Sport/Rec = .98 SRM: Sport/Rec = .87
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 36 MONTH
Descriptive Features
Age range of sample 35±12 (18-55) Number: 40 Sex
Male 70% Female 30%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 1
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
227
228
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Paradowski Title of the Article Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS)
Year 2006 PubMed ID: 16670005 Reviewer’s Name Travis Hamilton Date of Review 11.8.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale NA (Notes) If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
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Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 568 (figure 1) Number: Sex
Male 274 (48%) Female 294 (52%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General Population 100%
Provide normative data 1 (table 1./ notes) Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
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daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower extremity functions.
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KOOS- QOL Subscale
Roos (1) Roos (2) Xie (4)
Study Characteristics
Purpose
Reliability, responsiveness, validity
Validity, Reliability of Swedish version
Validity, Reliability of Singapore English and Chinese version
Study Population/Sample (inclusion/exclusion)
ACL Injury/Surgery Variety of knee disorders/injury Osteoarthritis
Number 21 142 Singapore Englsih = 127 Chinese = 131
Age range (average ± SD, min-max) 32 (18-46) 14-89 Singapore English = 65.3
Chinese = 131
Sex (% female) 57% 37% Singapore English = 76% Chinese = 88%
Reliability
Internal consistency NA α = .71 Α:Singapore English = .74 Chinese = .71
Test-retest reliability ICC = .86 ICC = .83 ICC: Singapore English = .86 Chinese = .60
Time interval 9 days 8 days 6 days
Validity
Correlation to similar scale NA Moderate (100%) correlation to similar scale
English: No (100%) Chinese: No (1005) correlation to similar scales
Correlation to general measures of Physical function
Little (100%) correlation to general measures of physical function
Fair (66.6%), Moderate (33.3%) correlation to general measures of physical function
English: Fair (66.6%) Moderate (33.3) Chinese: Fair (100%) correlation to general measure of physical function
Correlation to general measures of mental function
Little (50%), Moderate (50%) correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
English: Little (100%) Chinese: Little (50%), Fair (50%) correlation to general measures of mental function
Responsiveness
ES 1.65 1.15 NA
SRM NA NA NA
MDC 15.4 (calc) (1.96)*(sqrt(2))*((14.9)*sqrt(1-.86))
17.8 (calc) (1.96)*(sqrt(2))*((15.6)*sqrt(1-.83))
Singapore English = 19.5 (calc) (1.96)*(sqrt(2))*((18.8)*sqrt(1-.86)) Chinese = 34.0 (calc) (1.96)*(sqrt(2))*((19.4)*sqrt(1-.60))
MCID NA NA NA
Guyatt NA NA NA
Time Interval 6 month 3 months NA
Other
Floor/Ceiling Effect NA No No
Normal Distribution NA NA NA
Normal Data NA NA NA
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KOOS- QOL Subscale Ornetti (6) DeGroot (7) Salavati (10) Bekkers (11)
Study Characteristics
Purpose Validity, Reliability of French version
Validity, Reliability of Dutch version
Validity, Reliability of Persian version Validity, reliability
Study Population/Sample (inclusion/exclusion)
Osteoarthritis Osteoarthritis Meniscus, ACL, Combined Knee Injury
Cartilage Degeneration/Surgery
Number Medicine Group = 37 Surgery Group = 30
Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 , TKA = 63 , Revision TKA = 54
147 40
Age range (average ± SD, min-max)
Medicine Group = 70 10 (45-91), Surgery Group = 71 10 (42-85)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) , Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision TKA = 77(36-89)
31.4 (16 – 59) 35±12 (18-55)
Sex (% female) Medicine Group = 68% Surgery Group = 73%
Mild OA = 22% , Moderate OA = 32% , Severe OA = 52% , TKA = 51% , Revision TKA = 78%
11% 30%
Reliability
Internal consistency α = .83
α: Mild OA = .81 , Moderate OA = .85 , Severe OA = .73 , TKA = .81 , Revision TKA = .90
α = .64 α = 0.90
Test-retest reliability ICC = .75 ICC: Mild OA = .88 , Moderate OA = .91 , Revision TKA = .84
ICC = .88 ICC = 0.95
Time interval 2 weeks 3 weeks 8 days 2 days
Validity
Correlation to similar scale
Little (20%) Fair (60%) Moderate (20%) correlation to similar scales
NA NA NA
Correlation to general measures of Physical function
NA
Little (6.6%), Fair (53.3%), Moderate (40%) correlation with general measures of physical function
Fair (100%) correlation with general measures of physical function
NA
Correlation to general measures of mental function
NA Little (60%), Fair (40%) correlation with general measures of mental function
Little(50%), Fair (50%) correlation to general measures of mental function
NA
Responsiveness
ES 2.8 NA NA 1.32
SRM 1.93 NA NA 0.76
MDC 23.5 (calc) (1.96)*(sqrt(2))*((17)*sqrt(1-.75))
ICC: Mild OA = 20.7 , Moderate OA = 21.8 , Revision TKA = 29.5 (calc) **used baseline group**
16.9 (calc) (1.96)*(sqrt(2))*((17.7)*sqrt(1-.88))
14.2 (calc)
MCID NA NA NA NA
Guyatt NA NA NA NA
Time Interval 3 month NA NA 36 months
Other
Floor/Ceiling Effect No Yes No No
Normal Distribution NA NA NA NA
Normal Data NA NA NA NA
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KOOS- QOL Subscale
Paradowski (12)
Study Characteristics
Purpose Normative Data
Study Population/Sample (inclusion/exclusion)
General Population
Number 568
Age range (average ± SD, min-max)
568
Sex (% female) 52.0%
Reliability
Internal consistency NA
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function
NA
Correlation to general measures of mental function
NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution No
Normal Data Yes
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KOOS QOL SUBSCALE CONSOLIDATION
REFERENCE
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
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KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Roos Title of the Article Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure Year 1998 PubMed ID: 9699158 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. - PF = .19 , RP = .20 , BP = .02 , Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; TABLE 3. RE =-.02 , MH = .33 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .86 Testing interval (time between repeated measures) Within 9 days
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Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s TABLE 5. Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Table 4
Time interval between baseline and follow-up assessments 3 and 6 month
Descriptive Features
Age range of sample 32 (18-46) Number: 21 Sex
Male 9 Female 12
Diagnosis ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data 2 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) 1 week Language(s) of instrument used in this report 1; English and Swedish Is this the first or primary report about this instrument? 1
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238
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KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Roos Title of the Article Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version Year 1998 PubMed ID: 9863983 Reviewer’s Name Travis Hamilton Date of Review 7.13.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Table 2. Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - PF = .45 , RP = .36 , BP = .54 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm. Table 4 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. Table 4 - RE =.11 , MH = .06 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: QOL = .71
240
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .83 Testing interval (time between repeated measures) Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: QOL = 1.15 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 months
Descriptive Features
Age range of sample Number: 142 Sex Table 1.
Male Female
Diagnosis Figure 1 and 2 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Past week Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2 Notes:
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
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242
243
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL Subscale Author’s Last Name Xie Title of the Article Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis outcome score koos in Asians with knee osteoarthritis in Singapore
Year 2006 PubMed ID: 16814575 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA; cultural adaptation Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient English SF-36: PF = .56 RB = .32 BP = .37/Chinese SF-36 PF =
.41 RB = .34 BP = .38
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient EQ-5D; Table 4. Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient English SF-36: RE = .12 MH = .13/Chinese SF-36 RE = .18 MH
= .35 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found? NA
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
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Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α :Singapore English: QOL = .74 Chinese:QOL = .71
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: Singapore English; QOL = .86
Chinese; QOL = .60
Testing interval (time between repeated measures) 6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Singapore English Chinese Age range of sample 65.3 67.8 Number: 127 (test-retest = 47) 131 (test-retest = 55) Sex
Male 30 15 Female 97 116
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1; no missing items
245
Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report 1; Chinese and Singapore English Is this the first or primary report about this instrument? 2
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KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Ornetti Title of the Article Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in knee osteoarthritis patients
Year 2008 PubMed ID: 17905602 Reviewer’s Name Travis Hamilton Date of Review 7.14.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Translation – back translation
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient OAKHQOL, Table 2 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 13. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with the OAKHQOL pain and physical activities domain, and would correlate weakly with the other OOAKHQOL domains.
14. The KOOS sports and recreation domain would correlate weakly with all OAKHQOL domains, since this domain has previously been reported as weakly correlated with all 36-item short form health survey SF-36 domains.
15. The KOOS QOL domain would correlate strongly or moderately with all OAKHQOL domains.
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Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: QOL = .83
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .75 Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: QOL = 2.8 SRM: QOL = 1.93
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 3 Months
Descriptive Features
Medicine Group Surgery Group Age range of sample 70 ± 10 (45-91) 71 ± 10 (42-85) Number: 37 30 Sex
Male 32% 27% Female 68% 73%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA
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Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report French Is this the first or primary report about this instrument? 2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
249
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score- QOL subscale Author’s Last Name de Groot Title of the Article The Dutch version of the knee injury and osteoarthritis
outcome score a validation study Year 2008 PubMed ID: 18302729 Reviewer’s Name Travis Hamilton Date of Review 7.15.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36; VAS. Table 4, 5, 6, 7, 8 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Convergent hypotheses:
17. The correlation between KOOS Pain and Sf-36 BP, between KOOS Pain and SF-36 PF, KOOS (all subscales) and VAS for Pain and KOOS ADL and SF-36 PF should be ≥ 0.60.
18. KOOS Pain has a stronger correlation with SF-36 BP compared to the correlation with SF-36 PF. This difference should be at least 0.05 higher.
19. KOOS Pain has a stronger correlation with VAS for pain compared to the correlation of the other subscales of the KOOS with the VAS for Pain. This difference should be at least 0.05 higher.
20. KOOS ADL was expected to have a 0.05 higher correlation with SF-36 PF compared to the correlation of the other subscales of the SF-36. Divergent hypotheses:
5. All other correlations between the KOOS subscales and
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the SF-36 should be higher than 0.30 and lower than 0.60
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: MILD OA: QOL = .88
MODERATE OA: QOL = .91 REVISION of TKA:, QOL = .84
Testing interval (time between repeated measures) 3 WEEKS
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Mild OA Moderate OA
Severe OA TKA Revision of TKA
Age range of sample 36 (27-50)
56 (27-72) 65 (42-81) 61 (42-78) 77 (36-89)
Number: 36 62 47 63 54 Sex
Male 78 68 48 49 22 Female 22 32 52 51 78
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 251
PF General knee pain
Combined injury Sport related
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values:
NA
Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Dutch Is this the first or primary report about this instrument? 2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
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253
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KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Salavati Title of the Article Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee injuries
Year 2008 PubMed ID:
18411065 Reviewer’s Name Travis Hamilton Date of Review 7.17.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint notes Data normally distributed NA Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4- PF = .41 , RP = .37 , BP = .45 , Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36. TABLE 4 - RE =.28 , MH = .13 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses supported:
13. The correlations between the KOOS Pain and SF=36 BP subscales should be high.
14. The correlations between the KOOS ADL and Sport/Rec and Sf-36 PF subscales should be high.
15. The correlations between the KOOS subscales and the SF-36 subscales of Physical Health (PF, RP, BP) should be higher than between the KOOS subscales and the SF-36 subscales of Mental Health (GH, VT, RE, MH)
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome A If yes to either of above, report how this was demonstrated
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Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α : QOL = .64
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC: QOL = .88 Testing interval (time between repeated measures) 6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 31.4 (16 – 59) Number: 147 Sex
Male 131 Female 16
Diagnosis ACL injury/surgery 60 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 31
OA PF
General knee pain Combined injury 56
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report Persian Is this the first or primary report about this instrument? 2
256
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
257
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score – QOL subscale Author’s Last Name Bekkers Title of the Article Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions Year 2009 PubMed ID:
19454278 Reviewer’s Name Travis Hamilton Date of Review 7.17.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? A priori moderate – strong hypotheses:
21. KOOS symptoms with SF-36 physical functioning 22. KOOS pain with SF-36 bodily pain and WE-VAS 23. KOOS ADL with the complete SF-36 questionnaire. 24. KOOS sport and recreation with the Lysholm knee
scoring scale 25. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
258
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
QOL = 0.90
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.95. table 1 Testing interval (time between repeated measures) 2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES: QOL = 1.32 SRM: Sport/Rec = .76
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 36 MONTH
Descriptive Features
Age range of sample 35±12 (18-55) Number: 40 Sex
Male 70% Female 30%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 1
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 2 Recall period (eg. “in the last month”) Last week Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
259
260
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Knee Injury and Osteoarthritis Outcome Score Author’s Last Name Paradowski Title of the Article Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS)
Year 2006 PubMed ID: 16670005 Reviewer’s Name Travis Hamilton Date of Review 11.8.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale NA (Notes) If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
261
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 568 (figure 1) Number: Sex
Male 274 (48%) Female 294 (52%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General Population 100%
Provide normative data 1 (table 1./ notes) Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Swedish Is this the first or primary report about this instrument? 2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
262
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower extremity functions.
263
WOMAC PAIN SUBSCALE
Davies (1) Angst (2) Escobar (3)
Study Characteristics
Purpose Responsiveness Responsiveness Validity, Reliability of Spanish translation
Study Population/Sample (inclusion/exclusion)
Hip/Knee OA Hip/Knee OA Hip/Knee OA
Number Placebo group = 50, Ibuprofen group = 54 223 Hip Group = 100,
Knee Group = 103
Age range (average ± SD, min-max)
Placebo group = 62.1 ± 7.2 (45-79), Ibuprofen group = 61 ± 9.3 (45 – 77)
65.1 ± 10.0 (37-86) Hip Group = 68.6 ± 10.3, Knee Group = 70.9 ±6
Sex (% female) Placebo group = 64% Ibuprofen group = 63% 71% Hip Group = 56%
Knee Group = 70%
Reliability
Internal consistency NA
NA α = 0.82
Test-retest reliability NA NA ICC = 0.78
Time interval NA
NA 15 days
Validity
Correlation to similar scale NA NA NA
Correlation to general measures of Physical function
Moderate (100%) correlation to general measures of physical function
NA Little (100%) correlation to general measures of physical function
Correlation to general measures of mental function NA NA Little (100%) correlation to general
measures of mental function
Responsiveness
ES 7 day = 9.4, 14 day = 6.6, 28 day = 17.7 .33 1.8
SRM NA 0.37 1.5
MDC NA NA NA
MCID NA NA NA
Guyatt NA 0.52 NA
Time Interval 7, 14, 28 days 3 months 6 months
Other
Floor/Ceiling Effect NA No NA
Normal Distribution NA NA NA
Normal Data NA NA NA
OA – Osteoarthritis
264
WOMAC PAIN SUBSCALE
Salaffi (4) Tuzun (5) Kersten (7)
Study
Purpose Reliability, Validity Reliability, Validity, Responsiveness of Turkish translation
Validity, Responsiveness
Study Population/Sample (inclusion/exclusion)
Patients following articular cartilage surgery OA Hip/Knee OA
Number Reliability = 17, Responsiveness = 50 72 221
Age range (average ± SD, min-max)
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56)
61 ± 9 (41-80) 66.8 ± 8.3
Sex (% female) Reliability = 39%, Responsiveness = 39.2% 86% 58%
Reliability
Internal consistency NA α: Baseline = 0.75, Treatment = 0.81 α = 0.82
Test-retest reliability ICC: 6mo = 0.81, 12mo = 0.85 NA NA
Time interval 10 days NA NA
Validity
Correlation to similar scale Moderate (100%) correlation to similar scales
Moderate (100%) correlation to similar scales NA
Correlation to general measures of Physical function
Little (100%) correlation to general measures of physical function
Little (100%) correlation to general measures of physical function
NA
Correlation to general measures of mental function
Little (100%) correlation to general measures of physical function
Little (100%) correlation to general measures of physical function
NA
Responsiveness
ES NA Group 1 = 0.88, Group 2 = 0.74 NA
SRM NA Group 1 = 1.0 Group 2 = 0.78
Raw score – 0.55 Rasch score = 0.35
MDC 144 (calc) NA NA
MCID NA NA NA
Guyatt NA 0.52 NA
Time Interval 7, 14, 28 days 3 months 6 weeks
Other
Floor/Ceiling Effect No No NA
Normal Distribution No NA NA
Normal Data NA NA NA
OS - Osteoarthritis
265
WOMAC PAIN SUBSCALE CONTINUED
Greco (8) Bellamy (9)
Study Characteristics
Purpose Reliability , Responsiveness Normative Data
Study Population/Sample (inclusion/exclusion)
Patients following articular cartilage surgery General Population
Number Reliability = 17, Responsiveness = 50 7420
Age range (average ± SD, min-max)
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56) 27-104
Sex (% female) Reliability = 39%, Responsiveness = 39.2% 50%
Reliability
Internal consistency NA NA
Test-retest reliability ICC: 6mo = 0.81, 12mo = 0.85 NA
Time interval 6 month, 12 months NA
Validity
Correlation to similar scale NA NA
Correlation to general measures of Physical function NA NA
Correlation to general measures of mental function NA NA
Responsiveness
ES 6mo = 0.98, 12mo = 1.14 NA
SRM 6mo = 0.91, 12mo = 1.13 NA
MDC 6mo = 16.2, 12mo = 14.4 NA
MCID 6mo = 17.5 (sens = .68, spec = .70), 12mo = 7.5 (sens = .87, spec = .5)
NA
Guyatt NA NA
Time Interval 6, 12 months NA
Other
Floor/Ceiling Effect No NA
Normal Distribution NA NA
Normal Data NA Yes
OA - Osteoarthritis
266
WOMAC PAIN SUBSCALE CONSOLIDATION
REFERENCES
1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a randomized, clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis 2001;60:834-840
3) Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clin Rheumatol. 2001 Nov;21(6):466-71
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
7) Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80
8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
267
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Pain subscale Author’s Last Name Davies Title of the Article Comparison of the Responsiveness and Relative Effect Size of
the WOMAC and Short-Form Medical Outcomes Study Survey in a Randomized, Clinical Trial of Osteoarthritis Patients
Year 1999 PubMed ID: 10513507 Reviewer’s Name Travis Hamilton Date of Review 7.26.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 075 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
268
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES Pain; 7day = 9.4, 14 day = 6.6, 28 day = 17.7 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
TABLE 3
Time interval between baseline and follow-up assessments 7, 14, 28 DAYS
Descriptive Features
Placebo Ibuprofen Age range of sample 62.1 ± 7.2 (45-79) 61 ± 9.3 (45 – 77) Number: 50 54 Sex
Male 36% 37% Female 64% 63%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA Hip = 12%, Knee = 70%, Both = 18%
Hip = 5.6%, Knee = 66.7%, Both = 27.8%
PF General knee pain
Combined injury Sport related
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2 Notes:
Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.
269
270
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC - Pain Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the leg undergoing a comprehensive rehabilitation intervention
Year 2001 PubMed ID: 11502609 Reviewer’s Name Travis Hamilton Date of Review 7.27.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
271
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s 3 month: ES: Pain = .33, SRM : Pain = .37 Guyatt: Pain = .52
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
End of rehabilitation(3-4 weeks): ES: Pain = .56 SRM : Pain = .72 Guyatt: Pain = .87
Time interval between baseline and follow-up assessments 1 month, 3 month
Descriptive Features
Age range of sample 65.1 ± 10.0 (37-86) Number: 223 Sex
Male 64 Female 159
Diagnosis Hip 93
Knee 130 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
Notes:
272
273
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Pain subscale Author’s Last Name Escobar Title of the Article Validation of the Spanish Version of the WOMAC
Questionnaire for Patients with Hip or Knee Osteoarthritis Year 2002 PubMed ID: 12447629 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 Table 3.
PAIN:BP = -0.6, PF = -0.4, RP = -0.35, Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36
PAIN RE = -0.31, MH = -0.41
Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Pain = 0.82
274
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC
Pain = 0.78
Testing interval (time between repeated measures) 15 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES Pain = 1.8 SRM Pain = 1.5
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 months
Descriptive Features
Hip Replacement Knee Replacement Age range of sample 68.6 ± 10.3 70.9 ±6 Number: Sex
Male 44 30 Female 56 73
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report Spanish Is this the first or primary report about this instrument? 2
Notes:
275
The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related Quality of Life
276
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with osteoarthritis of the knee
Year 2003 PubMed ID: 12880577 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Pain: BP = -0.6, PS = -0.61, SF-36 overall = -.608
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Pain = 0.70
Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: MCS
Pain = -0.58
Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
277
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Pain = 0.91
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC
Pain = 0.86
Testing interval (time between repeated measures) 10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 65.7 ± 9.3 (50 – 82) Number: 304 Sex
Male 30% Female 70%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2
278
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Pain subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index Year 2005 PubMed ID: 15639634 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Pain: PS = -0.55, RP = -0.36, BP = -0.51,
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Pain = 0.64
Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Pain: RE = -.28, MH = -0.40
Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. Skewness statistics range from -1 to +1.
2. Floor and ceiling effects are less than 20% 3. WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar subscale (physical function and bodily pain) scores derived from SF-36.
4. WOMAC index subscales are inadequately or weakly correlated with theoretically unrelated subscale (mental component subscales) scores derived from SF-36.
5. WOMAC total is highly correlated with Lequesne index.
Criterion Validity
Correlated with “gold standard” 279
Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Time 1 Pain = 0.75
α: Time 2 Pain = 0.81
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Group 1 ES: Pain = 0.88 SRM: : Pain = 1.0 Group 2 ES: Pain = 0.74 SRM: : Pain = 0.78
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 2 weeks
Descriptive Features
Age range of sample 61 ± 9 (41-80) Number: 72 Sex (table 1)
Male 10 Female 62
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
280
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic exercise).
Time 1: Baseline
Time 2: 3rd day after treatment period (2 WEEKS)
281
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Pain subscale Author’s Last Name Kersten Title of the Article The Visual Anologue WOMAC 3.0 scale – internal validity and
responsiveness of the VAS version Year 2010 PubMed ID: 20433732 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α Pain = 0.82
282
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Ordinal data (raw scores) SRM: Pain = 0.55 Interval data (Rasch transformed scores) SRM: Pain = 0.35
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 weeks
Descriptive Features
Age range of sample 66.8 ± 8.3 Number: 221 Sex
Male 42% Female 58%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 40% hip, 60% knee PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
283
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Pain subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.
Year 2010 PubMed ID: 20044494 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
284
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 6 mo. ICC 12 mo. ICC
Pain = 0.81 Pain = 0.85 Testing interval (time between repeated measures) 6 mo., 12 mo.
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s 6 mo. 12 mo.
ES SRM ES SRM
Pain = 0.98, Pain = 0.91, Pain = 1.14,
Pain = 0.94, = 1.13
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 mo. 12 mo.
MCD MCID MCD MCID
Pain = 16.2,
Pain = 17.5 (sens = .68, spec = .70), Pain = 14.4,
Pain = 7.5 (sens = .87, spec = .5),
Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months
Descriptive Features
Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 17 50
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2
285
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC Author’s Last Name Bellamy Title of the Article Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1 Year 2011 PubMed ID: 21546065 Reviewer’s Name Travis Hamilton Date of Review 1.2.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
286
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 27-104 Number: 7420 (respondents) Sex
Male 3707 (~50%) Female 3713 (~50%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General population 100%
Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1
Notes:
287
288
WOMAC FUNCTION SUBSCALE
Davies (1) Angst (2) Escobar (3)
Study Characteristics
Purpose Responsiveness Responsiveness Validity, Reliability of Spanish translation
Study Population/Sample (inclusion/exclusion)
Hip/Knee OA Hip/Knee OA Hip/Knee OA
Number Placebo group = 50, Ibuprofen group = 54 223 Hip Group = 100, Knee Group = 103
Age range (average ± SD, min-max)
Placebo group = 62.1 ± 7.2 (45-79), Ibuprofen group = 61 ± 9.3 (45 – 77)
65.1 ± 10.0 (37-86) Hip Group = 68.6 ± 10.3, Knee Group = 70.9 ±6
Sex (% female) Placebo group = 64% Ibuprofen group = 63% 71% Hip Group = 56% Knee Group = 70%
Reliability
Internal consistency NA NA α = 0.93
Test-retest reliability NA NA ICC = 0.81
Time interval NA NA 15 days
Validity
Correlation to similar scale NA NA NA
Correlation to general measures of Physical function
Moderate (100%) correlation to general measures of physical function
NA Little (100%) correlation to general measures of physical function
Correlation to general measures of mental function NA NA Little (100%) correlation to general
measures of mental function
Responsiveness
ES 7 day = 8.7, 14 day = 8.4, 28 day = 7.9 0.18 1.5
SRM NA 0.23 1.3
MDC NA NA NA
MCID NA NA NA
Guyatt NA 0.31 NA
Time Interval 7, 14, 28 days 3 months 6 months
Other
Floor/Ceiling Effect NA No NA
Normal Distribution NA NA NA
Normal Data NA NA NA
OA – Osteoarthritis
289
WOMAC FUNCTION SUBSCALE CONTINUED
Salaffi (4) Tuzun (5) Kersten (7)
Study Characteristics
Purpose Reliability, Validity Reliability, Validity, Responsiveness of Turkish translation
Validity, Responsiveness
Study Population/Sample (inclusion/exclusion)
OA OA Hip/Knee OA
Number 304 72 221
Age range (average ± SD, min-max) 65.7 ± 9.3 (50 – 82) 61 ± 9 (41-80) 66.8 ± 8.3
Sex (% female) 70% 86% 58%
Reliability
Internal consistency α = 0.84 α: Baseline = 0.94, Treatment = 0.96 α = 0.95
Test-retest reliability ICC = 0.89 NA NA
Time interval 10 days NA NA
Validity
Correlation to similar scale Moderate (100%) correlation to similar scales
Moderate (100%) correlation to similar scales NA
Correlation to general measures of Physical function
Little (100%) correlation to general measures of physical function
Little (100%) correlation to general measures of physical function
NA
Correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
NA
Responsiveness
ES NA Group 1 = 0.79, Group 2 = 0.50 NA
SRM NA Group 1 = 0.94, Group 2 = 0.69 Raw score = 0.49, Rasch score = 0.37
MDC 350.8 (calc) (1.96)*(sqrt(2)) *((381.6)*sqrt(1-.89)) NA NA
MCID NA NA NA
Guyatt NA NA NA
Time Interval NA 2 weeks 6 weeks
Other
Floor/Ceiling Effect No No NA
Normal Distribution No NA NA
Normal Data NA NA NA OA - Osteoarthritis
290
WOMAC FUNCTION SUBSCALE CONTINUED
Greco (8) Bellamy (9)
Study Characteristics
Purpose Reliability, Responsiveness Normative Data
Study Population/Sample (inclusion/exclusion)
Patient’s following articular cartilage surgery General Population
Number Reliability = 17, Responsiveness = 50 7420
Age range (average ± SD, min-max)
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56) 27-104
Sex (% female) Reliability = 39%, Responsiveness = 39.2% 50%
Reliability
Internal consistency NA NA
Test-retest reliability ICC: 6mo = 0.93, 12mo = 0.86 NA
Time interval 6 months, 12 months NA
Validity
Correlation to similar scale NA NA
Correlation to general measures of Physical function NA NA
Correlation to general measures of mental function NA NA
Responsiveness
ES 6mo = 0.88, 12mo = 1.20 NA
SRM 6mo = 0.86, 12mo = 1.13 NA
MDC 6mo = 10.6, 12mo = 15 NA
MCID 6mo = 8.1(sens = .79, spec = .52), 12mo = 5.89(sens = .94, spec = .50) NA
Guyatt NA NA
Time Interval 6, 12 months NA
Other
Floor/Ceiling Effect No NA
Normal Distribution NA NA
Normal Data NA Yes
OA - Osteoarthritis
291
WOMAC FUNCTION SUBSCALE CONSOLIDATION
REFERENCES
1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a randomized, clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis 2001;60:834-840
3) Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clin Rheumatol. 2001 Nov;21(6):466-71
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
7. Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80
8. Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
292
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Function subscale Author’s Last Name Davies Title of the Article Comparison of the Responsiveness and Relative Effect Size of
the WOMAC and Short-Form Medical Outcomes Study Survey in a Randomized, Clinical Trial of Osteoarthritis Patients
Year 1999 PubMed ID: 10513507 Reviewer’s Name Travis Hamilton Date of Review 7.26.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 0.75 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
293
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES Function; 7day = 8.7, 14 day = 8.4, 28 day = 7.9 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
TABLE 3
Time interval between baseline and follow-up assessments 7, 14, 28 DAYS
Descriptive Features
Placebo Ibuprofen Age range of sample 62.1 ± 7.2 (45-79) 61 ± 9.3 (45 – 77) Number: 50 54 Sex
Male 36% 37% Female 64% 63%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA Hip = 12%, Knee = 70%, Both = 18%
Hip = 5.6%, Knee = 66.7%, Both = 27.8%
PF General knee pain
Combined injury Sport related
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2 Notes:
Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.
294
295
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – function subscale Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the leg undergoing a comprehensive rehabilitation intervention
Year 2001 PubMed ID: 11502609 Reviewer’s Name Travis Hamilton Date of Review 7.27.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60)
296
Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s 3 month: ES: Function = .18 SRM Function = .23 Guyatt: Function = .31
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
End of rehabilitation(3-4 weeks): ES Function = .42 SRM Function = .62 Guyatt Function = .73
Time interval between baseline and follow-up assessments 1 month, 3 month
Descriptive Features
Age range of sample 65.1 ± 10.0 (37-86) Number: 223 Sex
Male 64 Female 159
Diagnosis Hip 93
Knee 130 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
Notes:
297
298
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Function subscale Author’s Last Name Escobar Title of the Article Validation of the Spanish Version of the WOMAC
Questionnaire for Patients with Hip or Knee Osteoarthritis Year 2002 PubMed ID: 12447629 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 Table 3.
FUNCTION: BP = -0.63, PF = -0.52, RP = -0.43 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36
FUNCTION RE = -0.31, MH = -0.43
Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Function = 0.93
299
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC
Function = 0.81
Testing interval (time between repeated measures) 15 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES Function = 1.5 SRM Function = 1.3
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 months
Descriptive Features
Hip Replacement Knee Replacement Age range of sample 68.6 ± 10.3 70.9 ±6 Number: Sex
Male 44 30 Female 56 73
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report Spanish Is this the first or primary report about this instrument? 2
Notes:
300
The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related Quality of Life
301
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Function subscale Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with osteoarthritis of the knee
Year 2003 PubMed ID: 12880577 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Function: BP = -0.59, PS = -0.70, SF-36 overall = -.65
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Function = 0.75
Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: MCS
Function = -0.56
Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
302
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Function = 0.84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC
Function = 0.89
Testing interval (time between repeated measures) 10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 65.7 ± 9.3 (50 – 82) Number: 304 Sex
Male 30% Female 70%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2
303
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Function subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index Year 2005 PubMed ID: 15639634 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Function: PS = -0.72, RP = -0.48, BP = -0.54 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Function = 0.68
Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Function: RE = -.40, MH = -0.37
Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 6. Skewness statistics range from -1 to +1.
7. Floor and ceiling effects are less than 20% 8. WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar subscale (physical function and bodily pain) scores derived from SF-36.
9. WOMAC index subscales are inadequately or weakly correlated with theoretically unrelated subscale (mental component subscales) scores derived from SF-36.
10. WOMAC total is highly correlated with Lequesne index.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
304
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Time 1 Function = 0.94
α: Time 2 Function = 0.96
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Group 1 ES: Function = 0.79 SRM: : Function = 0.94 Group 2 ES: Function = 0.50 SRM: : Function = 0.69
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 2 weeks
Descriptive Features
Age range of sample 61 ± 9 (41-80) Number: 72 Sex (table 1)
Male 10 Female 62
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA
305
Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic exercise).
Time 1: Baseline
Time 2: 3rd day after treatment period (2 WEEKS)
306
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Function subscale Author’s Last Name Kersten Title of the Article The Visual Analogue WOMAC 3.0 scale – internal validity and
responsiveness of the VAS version Year 2010 PubMed ID: 20433732 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α Function = 0.95
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
307
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Ordinal data (raw scores) SRMFunction = 0.49 Interval data (Rasch transformed scores) SRM: Function = 0.37
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 weeks
Descriptive Features
Age range of sample 66.8 ± 8.3 Number: 221 Sex
Male 42% Female 58%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 40% hip, 60% knee PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
308
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Function subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.
Year 2010 PubMed ID: 20044494 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 6 mo. ICC 12 mo. ICC
Function = 0.93 Function = 0.86 Testing interval (time between repeated measures) 6 mo., 12 mo.
309
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s 6 mo. 12 mo.
ES SRM ES SRM Function = 0.88
Function = 0.86
Function = 1.20
Function = 1.13
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 mo. 12 mo.
MCD MCID MCD MCID
Function = 10.6
Function = 8.1(sens = .79, spec = .52)
Function = 15.0
Function = 5.89(sens = .94, spec = .50)
Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months
Descriptive Features
Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 17 50
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2
310
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC Author’s Last Name Bellamy Title of the Article Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1 Year 2011 PubMed ID: 21546065 Reviewer’s Name Travis Hamilton Date of Review 1.2.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
311
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 27-104 Number: 7420 (respondents) Sex
Male 3707 (~50%) Female 3713 (~50%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General population 100%
Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1
Notes:
312
313
WOMAC STIFFNESS SUBSCALE
Angst (2) Escobar (3) Salaffi (4)
Study
Purpose Responsiveness Validity, Reliability of Spanish translation Reliability, Validity
Study Population/Sample (inclusion/exclusion)
Hip/Knee OA Hip/Knee OA OA
Number 223 Hip Group = 100, Knee Group = 103 304
Age range (average ± SD, min-max) 65.1 ± 10.0 (37-86) Hip Group = 68.6 ± 10.3, Knee
Group = 70.9 ±6 65.7 ± 9.3 (50 – 82)
Sex (% female) 71% Hip Group = 56% Knee Group = 70% 70%
Reliability
Internal consistency NA α = 0.81 α = 0.84
Test-retest reliability NA ICC = 0.67 ICC = 0.68
Time interval NA 15 days 10 days
Validity
Correlation to similar scale NA NA Moderate (100%) correlation to similar scales
Correlation to general measures of Physical function NA
Little (100%) correlation to general measures of physical function
Little (100%) correlation to general measures of physical function
Correlation to general measures of mental function NA
Little (100%) correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
Responsiveness
ES 0.07 1 NA
SRM 0.08 0.8 NA
MDC NA NA 80.2 (calc)
MCID NA NA NA
Guyatt 0.1 NA NA
Time Interval 3 months 6 months NA
Other
Floor/Ceiling Effect No NA No
Normal Distribution NA NA No
Normal Data NA NA NA
OA – Osteoarthritis
314
WOMAC STIFFNESS SUBSCALE CONTINUED Tuzun (5) Kersten (7) Greco (8)
Study Characteristics
Purpose Reliability, Validity, Responsiveness of Turkish translation
Validity, Responsiveness Reliability, Responsiveness
Study Population/Sample (inclusion/exclusion)
OA Hip/knee OA Patients following articular cartilage surgery
Number 72 221 Reliability = 17, Responsiveness = 50
Age range (average ± SD, min-max) 61 ± 9 (41-80) 66.8 ± 8.3
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56)
Sex (% female) 86% 58% Reliability = 39%, Responsiveness = 39.2%
Reliability
Internal consistency α: Baseline = 0.71, Treatment = 0.76 α = 0.80 NA
Test-retest reliability NA NA ICC: 6mo = 0.86, 12mo = 0.75
Time interval NA NA 6 mo, 12 mo
Validity
Correlation to similar scale Moderate (100%) correlation to similar scales NA NA
Correlation to general measures of Physical function
Little (100%) correlation to general measures of physical function
NA NA
Correlation to general measures of mental function
Little (100%) correlation to general measures of mental function
NA NA
Responsiveness
ES Group 1 = 0.44, Group 2 = 0.32 NA 6mo = 0.51, 12mo = 0.72
SRM Group 1 = 0.52, Group 2 = 0.29 6mo = 0.40, 12mo = 0.64
MDC NA NA 6mo = 22.9, 12mo = 30.6
MCID NA NA 6mo = 6.3(sens = .68, spec = .48) , 12mo =18.8(sens = .55, spec = .65)
Guyatt NA NA NA
Time Interval 2 weeks 6 weeks 6, 12 months
Other
Floor/Ceiling Effect No NA No
Normal Distribution NA NA NA
Normal Data NA NA NA
OA – Osteoarthritis
315
WOMAC STIFFNESS SUBSCALE CONTINUED
Bellamy (9)
Study Characteristics
Purpose Normative Data
Study Population/Sample (inclusion/exclusion)
General Population
Number 7420
Age range (average ± SD, min-max) 27-104
Sex (% female) 50%
Reliability
Internal consistency NA
Test-retest reliability NA
Time interval NA
Validity
Correlation to similar scale NA
Correlation to general measures of Physical function NA
Correlation to general measures of mental function NA
Responsiveness
ES NA
SRM NA
MDC NA
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution NA
Normal Data Yes
316
WOMAC STIFFNESS SUBSCALE CONSOLIDATION
REFERENCES
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis 2001;60:834-840
3) Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clin Rheumatol. 2001 Nov;21(6):466-71
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
7) Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80
8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
317
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the leg undergoing a comprehensive rehabilitation intervention
Year 2001 PubMed ID: 11502609 Reviewer’s Name Travis Hamilton Date of Review 7.27.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
318
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s 3 month: ES:Stiffness = .07 SRM Stiffness = .08, Guyatt: Stiffness = .10
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
End of rehabilitation(3-4 weeks): ES: Stiffness = .34, SRM Stiffness = .38 Guyatt: Stiffness = .45
Time interval between baseline and follow-up assessments 1 month, 3 month
Descriptive Features
Age range of sample 65.1 ± 10.0 (37-86) Number: 223 Sex
Male 64 Female 159
Diagnosis Hip 93
Knee 130 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
Notes:
319
320
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – stiffness subscale Author’s Last Name Escobar Title of the Article Validation of the Spanish Version of the WOMAC
Questionnaire for Patients with Hip or Knee Osteoarthritis Year 2002 PubMed ID: 12447629 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36 Table 3.
STIFFNESS: BP = -0.5, PF = -0.38, RP = -0.33
Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36
STIFFNESS RE = -0.27, MH = -0.33 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Stiffness = 0.81
321
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC
Stiffness = 0.67 Testing interval (time between repeated measures) 15 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES Stiffness = 1 SRM Stiffness = 0.8
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 months
Descriptive Features
Hip Replacement Knee Replacement Age range of sample 68.6 ± 10.3 70.9 ±6 Number: Sex
Male 44 30 Female 56 73
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report Spanish Is this the first or primary report about this instrument? 2
Notes:
The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related Quality of Life
322
323
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with osteoarthritis of the knee
Year 2003 PubMed ID: 12880577 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Stiffness: BP = -0.46, PS = -0.54, SF-36 overall = -.51
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Stiffness = 0.58
Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: MCS
Stiffness = -0.40
Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
324
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Stiffness = 0.84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC
Stiffness = 0.68 Testing interval (time between repeated measures) 10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value: Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments Descriptive Features
Age range of sample 65.7 ± 9.3 (50 – 82) Number: 304 Sex
Male 30% Female 70%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2
325
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index Year 2005 PubMed ID: 15639634 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Stiffness: PS = -0.38, RP = -0.47, BP = -0.40
Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Stiffness = 0.50
Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Stiffness: RE = -.34, MH = -0.31
Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 11. Skewness statistics range from -1 to +1.
12. Floor and ceiling effects are less than 20% 13. WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar subscale (physical function and bodily pain) scores derived from SF-36.
14. WOMAC index subscales are inadequately or weakly correlated with theoretically unrelated subscale (mental component subscales) scores derived from SF-36.
15. WOMAC total is highly correlated with Lequesne index.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
326
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α: Time 1 Stiffness = 0.71
α: Time 2 Stiffness = 0.76
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Group 1 ES: Stiffness = 0.44 SRM: : Stiffness = 0.52 Group 2 ES: Stiffness = 0.32 SRM: : Stiffness = 0.29
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 2 weeks
Descriptive Features
Age range of sample 61 ± 9 (41-80) Number: 72 Sex (table 1)
Male 10 Female 62
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
327
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic exercise).
Time 1: Baseline
Time 2: 3rd day after treatment period (2 WEEKS)
328
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Kersten Title of the Article The Visual Analogue WOMAC 3.0 scale – internal validity and
responsiveness of the VAS version Year 2010 PubMed ID: 20433732 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint NA Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α Stiffness = 0.80
329
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Ordinal data (raw scores) SRM: Stiffness = 0.34 Interval data (Rasch transformed scores) SRM: Stiffness = 0.43
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 6 weeks
Descriptive Features
Age range of sample 66.8 ± 8.3 Number: 221 Sex
Male 42% Female 58%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 40% hip, 60% knee PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
330
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Stiffness subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.
Year 2010 PubMed ID: 20044494 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
331
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 6 mo. ICC 12 mo. ICC
Stiffness = 0.86 Stiffness = 0.75 Testing interval (time between repeated measures) 6 mo., 12 mo. Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value: Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s 6 mo. 12 mo.
ES SRM ES SRM Stiffness = 0.51,
Stiffness = 0.40,
Stiffness = 0.72
Stiffness = 0.64
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 mo. 12 mo.
MCD MCID MCD MCID
Stiffness = 22.9
Stiffness = 6.3(sens = .68, spec = .48)
Stiffness = 30.6
Stiffness = 18.8(sens = .55, spec = .65)
Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months Descriptive Features
Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 17 50
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2
332
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC Author’s Last Name Bellamy Title of the Article Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1 Year 2011 PubMed ID: 21546065 Reviewer’s Name Travis Hamilton Date of Review 1.2.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
333
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 27-104 Number: 7420 (respondents) Sex
Male 3707 (~50%) Female 3713 (~50%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General population 100%
Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1
Notes:
334
335
WOMAC OVERALL SUBSCALE
Davies (1) Angst (2) Salaffi (4)
Study Characteristics
Purpose Reliability, Validity, Responsiveness Reliability, Responsiveness Reliability, Validity
Study Population/Sample (inclusion/exclusion)
OA Patients following articular cartilage surgery OA
Number 72 Reliability = 17, Responsiveness = 50 304
Age range (average ± SD, min-max) 61 ± 9 (41-80)
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56)
65.7 ± 9.3 (50 – 82)
Sex (% female) Placebo group = 64% Ibuprofen group = 63%
Reliability = 39%, Responsiveness = 39.2% 70%
Reliability
Internal consistency NA NA α = 0.84
Test-retest reliability NA NA ICC = 0.89
Time interval NA NA 10 days
Validity
Correlation to similar scale NA NA Moderate (100%) correlation to similar scales
Correlation to general measures of Physical function
Moderate (100%) correlation to general measures of physical function
NA Little (100%) correlation to general measures of physical function
Correlation to general measures of mental function NA NA Little (100%) correlation to general
measures of mental function
Responsiveness
ES 7 day = 10.0, 14 day = 9.6, 28 day = 9.5 0.18 NA
SRM NA 0.24 NA
MDC NA NA 477.8 (calc) (
MCID NA NA NA
Guyatt NA 0.34 NA
Time Interval 7, 14, 28 days 3 months NA
Other
Floor/Ceiling Effect NA No No
Normal Distribution NA NA No
Normal Data NA NA NA
OA – Osteoarthritis 336
WOMAC – Overall Subscale
Tuzun (5) Greco (8) Bellamy (9)
Study Characteristics
Purpose Reliability, Validity, Responsiveness of Turkish translation Reliability, Responsiveness Normative Data
Study Population/Sample (inclusion/exclusion)
OA Patients following articular cartilage surgery General Population
Number 72 Reliability = 17, Responsiveness = 50 7420
Age range (average ± SD, min-max) 61 ± 9 (41-80)
Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56)
27-104
Sex (% female) 86% Reliability = 39%, Responsiveness = 39.2% 50%
Reliability
Internal consistency α: Baseline = 0.94, Treatment = 0.96 NA NA
Test-retest reliability NA ICC: 6mo = 0.93, 12mo = 0.86 NA
Time interval NA 6 mo, 12 mo NA
Validity
Correlation to similar scale Moderate (100%) correlation to similar scales NA NA
Correlation to general measures of Physical function
Little (100%) correlation to general measures of physical function NA NA
Correlation to general measures of mental function
Little (100%) correlation to general measures of mental function NA NA
Responsiveness
ES Group 1 = 0.79, Group 2 = 0.50 6mo = 0.96, 12mo = 1.19 NA
SRM Group 1 = 0.94, Group 2 = 0.69 6mo = 0.91, 12mo = 1.13 NA
MDC NA 6mo = 10.9, 12mo = 15.3 NA
MCID NA 6mo =11.5 (sens = .79, spec = .57), 12mo = 11.5 (sens = .84, spec = .55) NA
Guyatt NA NA NA
Time Interval 2 weeks 6, 12 months NA
Other
Floor/Ceiling Effect No No NA
Normal Distribution NA NA NA
Normal Data NA NA Yes
OA - Osteoarthritis
337
WOMAC OVERALL SUBSCALE CONSOLIDATION
REFERENCES
1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a randomized, clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared
with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis 2001;60:834-840
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of
life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33 8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee
Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster
WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
338
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Overall subscale Author’s Last Name Davies Title of the Article Comparison of the Responsiveness and Relative Effect Size of
the WOMAC and Short-Form Medical Outcomes Study Survey in a Randomized, Clinical Trial of Osteoarthritis Patients
Year 1999 PubMed ID: 10513507 Reviewer’s Name Travis Hamilton Date of Review 7.26.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 075 Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
339
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES overall; 7day = 10.0, 14 day = 9.6, 28 day = 9.5 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
TABLE 3
Time interval between baseline and follow-up assessments 7, 14, 28 DAYS
Descriptive Features
Placebo Ibuprofen Age range of sample 62.1 ± 7.2 (45-79) 61 ± 9.3 (45 – 77) Number: 50 54 Sex
Male 36% 37% Female 64% 63%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA Hip = 12%, Knee = 70%, Both = 18%
Hip = 5.6%, Knee = 66.7%, Both = 27.8%
PF General knee pain
Combined injury Sport related
Cartilage degeneration or surgery Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2 Notes:
Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.
340
341
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall Subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC Author’s Last Name Angst Title of the Article Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the leg undergoing a comprehensive rehabilitation intervention
Year 2001 PubMed ID: 11502609 Reviewer’s Name Travis Hamilton Date of Review 7.27.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
342
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s 3 month: ES: global = .18; SRM : global = .24; Guyatt:, global = .34
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
End of rehabilitation(3-4 weeks): ES: global = .47; SRM : global = .67; Guyatt: global = .82
Time interval between baseline and follow-up assessments 1 month, 3 month
Descriptive Features
Age range of sample 65.1 ± 10.0 (37-86) Number: 223 Sex
Male 64 Female 159
Diagnosis Hip 93
Knee 130 ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 2
Notes:
343
344
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Overall Subscale Author’s Last Name Salaffi Title of the Article Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with osteoarthritis of the knee
Year 2003 PubMed ID: 12880577 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2 Was the document translated using standard procedure? 1 If yes. How? Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Overall: BP = -0.60, PS = -0.70, SF-36 overall = -.66 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Overall = 0.77 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient Overall = -0.57 Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
345
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 65.7 ± 9.3 (50 – 82) Number: 304 Sex
Male 30% Female 70%
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2
346
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Overall subscale Author’s Last Name Tuzun Title of the Article Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index Year 2005 PubMed ID: 15639634 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient Overall: PS = -0.63, RP = -0.52, BP = -0.55, Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lequesne algofunctional index
Overall = 0.70 Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36:
Overall: RE = -.40, MH = -0.42 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 16. Skewness statistics range from -1 to +1.
17. Floor and ceiling effects are less than 20% 18. WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar subscale (physical function and bodily pain) scores derived from SF-36.
19. WOMAC index subscales are inadequately or weakly correlated with theoretically unrelated subscale (mental component subscales) scores derived from SF-36.
20. WOMAC total is highly correlated with Lequesne index.
Criterion Validity
Correlated with “gold standard” Predictive of a future outcome If yes to either of above, report how this was demonstrated
347
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s Group 1 ES: Overall = 0.78 SRM: : Overall = 1.02 Group 2 ES: Overall = 0.60 SRM: Overall = 0.70
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 2 weeks
Descriptive Features
Age range of sample 61 ± 9 (41-80) Number: 72 Sex (table 1)
Male 10 Female 62
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: 1
348
Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic exercise).
Time 1: Baseline
Time 2: 3rd day after treatment period (2 WEEKS)
349
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC – Overall subscale Author’s Last Name Greco Title of the Article Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects.
Year 2010 PubMed ID: 20044494 Reviewer’s Name Travis Hamilton Date of Review 7.28.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
350
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 6 mo. ICC 12 mo. ICC
Overall = 0.93 Overall = 0.86 Testing interval (time between repeated measures) 6 mo., 12 mo.
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model) 1 Report statistics: ES. SRM. Guyatt’s 6 mo. 12 mo.
ES SRM ES SRM Overall = 0.96
Overall = 0.91
Overall = 1.19
Overall = 1.13
Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) 1 Report statistics: 6 mo. 12 mo.
MCD MCID MCD MCID
Overall = 10.9
Overall = 11.5 (sens = .79, spec = .57)
Overall = 15.3
Overall = 11.5 (sens = .84, spec = .55)
Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments 6 months and 12 months
Descriptive Features
Reliability (A) Responsiveness (B) Age range of sample 43.8 years ± 10.4 (21-60) 36.6 years±9.7 (15-56) Number: 17 50 Sex 61% male 60.8% male
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery 17 50
Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA NA Is this the first or primary report about this instrument? 2
351
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure WOMAC Author’s Last Name Bellamy Title of the Article Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1 Year 2011 PubMed ID: 21546065 Reviewer’s Name Travis Hamilton Date of Review 1.2.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
352
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 27-104 Number: 7420 (respondents) Sex
Male 3707 (~50%) Female 3713 (~50%)
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related General population 100%
Provide normative data 1 Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1
Notes:
353
354
355
WOMET
Kirkley (1) Sihvonen (2)
Study Characteristics
Purpose Validity, Reliability Validity, Reliability, Responsiveness
Study Population/Sample (inclusion/exclusion) Meniscus injury Meniscus injury
Number Reliability group = 78, Validity group = 61 485 (100 – validity; 385 – psychometric testing[40 test retest])
Age range (average ± SD, min-max) NA 53 (18 – 81)
Sex (% female) NA 44.7%
Reliability
Internal consistency α = 0.923 α = .917
Test-retest reliability ICC = .92 95% LOA = 20.10 and -20.11
Time interval 2 weeks 2 weeks
Validity
Correlation to similar scale Fair (50%), Moderate (50%) correlation to similar scales Moderate (100%)
Correlation to general measures of physical function NA Fair (100%)
Correlation to general measures of mental function NA NA
Responsiveness
ES NA 1.17
SRM 0.65 .90
MDC NA NA
MCID NA NA
Guyatt NA NA
Time Interval 6 months 6 months
Other
Floor/Ceiling Effect No No
Normal DIstribution NA Yes
Normal Data NA NA
WOMET SCALE CONSOLIDATION
REFERENCES
1) Kirkley A, Griffin S, Whelan D. The development and validation of a quality of life-measurement tool for patients
with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med. 2007 Sep; 17(5): 349-56
2) Sihvonen R, Järvelä T, Aho H, Järvinen TL. Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for Patients with a Degenerative Meniscal Tear: A Meniscal Pathology-Specific Quality-of-Life Index. J Bone Joint Surg Am. 2012 May 16;94(10):e651-8.
Western Ontario Meniscal Evaluation Tool (WOMET)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Western Ontario Meniscal Evaluation Tool (WOMET) Author’s Last Name Kirkley Title of the Article The Development and Validation of a Quality of Life
Measurement Tool for Patients with Meniscal Pathology: The Western Ontario Meniscal Evaluation Tool WOMET
Year 2007 PubMed ID: 17873546 Reviewer’s Name Travis Hamilton Date of Review 7.26.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient ACL-QOL, Lysholm TABLE 3 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. WOMET would have positive correlations with both
the Lysholm and ACL-QOL. 2. Because the ACL-QOL was specifically designed assess
HRQOL, the correlation between it and the WOMET was anticipated to be slightly stronger than the correlation between the Lysholm and the WOMET.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.923
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.78 Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s SRM = 0.65 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments 6 months
Descriptive Features
Reliability Validity Age range of sample Number: 78 61 Sex
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 3 9
OA Subtotal Menisectomy 1
General knee pain Subtotal menisectomy
No surgery 2 Isolated Meniscal Debridement/Partial menisectomy 9 8
Repaired (meniscus pathology) 22 23 Meniscus pathology 36 34
Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 1
Western Ontario Meniscal Evaluation Tool (WOMET)
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Western Ontario Meniscal Evaluation Tool (WOMET) Author’s Last Name Sihvonen Title of the Article Validation of the Western Ontario Meniscal Evaluation Tool
(WOMET) for Patients with a Degenerative Meniscal Tear Year 2012 PubMed ID: Reviewer’s Name Travis Date of Review 6.14.2012
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 Used standard forward and reverse translation process? 1
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient 15-D = .311 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Lysholm = .558 Uncorrelated with theoretically distinct scale If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? Table 2 (all were significant and the one discriminate
hypothesis showed no significant difference between the two groups of patients)
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
W/o OA = .913; w/ OA = .931 Overall = .917
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 95% limits of agreement = 20.10 and -20.11 (fig 1) Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES = 1.17; SRM = .90 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
WOMET score was greater for patients who reported knee was better after surgery (31 ± 21) vs same/worse (-3 ± 16) (p < 0.001)
Time interval between baseline and follow-up assessments 6 months
Descriptive Features
Age range of sample 53 (18 – 81) Number: 485 (100 – validity; 385 – psychometric testing[40 test retset]) Sex
Male 268 Female 217
Diagnosis Arthroscopically verified meniscal tear 100%
Provide normative data NA Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Finnish/Swedish? Is this the first or primary report about this instrument? 2
Notes:
MOHTADI QOL
Mohtadi(1) Tanner(2)
Study Characteristics
Purpose Development and validation Development and validation
Study Population/Sample (inclusion/exclusion) ACL injury ACL injury, Meniscal tears, Osteoarthritis
Number Responsiveness = 25, Construct Validity = 50, Test re-test = 25 153
Age range (average ± SD, min-max) Responsiveness = 27.6 years (16-43),
Construct Validity = 27.14 years± (16-43), Test Re-test = NA
44.6 (14-82)
Sex (% female) Responsiveness= 48%, Construct Validity = 40%, Test Re-test = NA 51%
Reliability
Internal consistency NA NA
Test-retest reliability Average Error = 6% NA
Time interval 2 weeks NA
Validity
Correlation to similar scale NA NA
Correlation to general measures of Physical function NA NA
Correlation to general measures of mental function NA NA
Responsiveness
ES NA NA
SRM NA NA
MDC NA NA
MCID NA NA
Guyatt NA NA
Time interval NA NA
Other
Floor/Ceiling effect No NA
Normal Distribution NA NA
Normal Data NA NA
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MOHTADI QOL CONSOLIDATION QUESTIONNAIRE
REFERENCES
1) Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9.
2) Tanner SM, Dainty KN, Marx RG, Kirkley A. Knee-specific quality-of-life instruments: which ones measure symptoms
and disabilities most important to patients? Am J Sports Med. 2007 5(9):1450-8. Epub 2007 May 14
362
Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Mohtadi QOL measure for ACL deficiency Author’s Last Name Mohtadi Title of the Article Development and Validation of the Quality of Life Outcome
Measure (Questionnaire) for Chronic Anterior Cruciate Ligament Deficiency
Year 1998 PubMed ID: 9617395 Reviewer’s Name Travis Hamilton Date of Review 7.26.2011
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. The ACL-QOL outcome measure should reflect all
severity of chronic ACL deficiency and therefore cover the spectrum of score from 0 – 100.
2. Those patients who were booked for surgery based on clinical evaluation only, independently of the results of the ACL-QOL measure, should have scores lower than 50 and should score lower, on average, than patients not requiring surgery.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA
363
(eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Average error = 6% Testing interval (time between repeated measures) 2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA (NOTES)
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments Over a 6 month period
Descriptive Features
Responsiveness Construct Validity Test Retest Age range of sample 27.6 (16 – 43) 27.14 (16-43) Number: 25 50 25 Sex
Male 13 30 Female 12 20
Diagnosis ACL injury/surgery 1 1 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) PRESNENT Language(s) of instrument used in this report NA Is this the first or primary report about this instrument? 1
364
Notes:
Responsiveness: 21 out of 25 (84%) had appropriate overall scores on the repeat administration of the ACL-QOL questionnaire based on the clinical changes that had occurred. Of these 21 patients, 9 had clinically improved, 10 remained unchanged, and 2 had deteriorated. Three of the four patients who did not correctly match their overall clinical impression on the second ACL-QOL questionnaire were in the postoperative period after their knee surgery.
365
Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Mohtadi QOL measure for ACL deficiency Author’s Last Name Tanner Title of the Article Knee-specific Quality-of-Life Instruments Which Ones
Measure Symptoms and Disabilities Most Important to Patients
Year 2007 PubMed ID:
17502427 Reviewer’s Name Travis Hamilton Date of Review 7.28.2011
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA
366
(eg.. Cronbach’s α > .60) Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) NA Indicate value: Testing interval (time between repeated measures) NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 44.6 (14-82) Number: 153 Sex
Male 75 Female 78
Diagnosis Table 3 ACL injury/surgery 1 PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL 1
OA 1 PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
Notes:
153 patients with ACL, Isolated meniscal tears, or OA were polled to complete a questionnaire of 111 items by combining 222 patient directed questions from 11 knee specific quality of life instruments. The groups were broken down by the type of injury, then group statistics including the mean importance ranking and the frequency importance product (FIP = frequency x mean importance) were calculated. For the population
367
with ACL deficiency, patients endorsed 87 % (27/31) questions on the Mohtadi QOL. The endorsement statistic for the Mohtadi QOL was not reported for patients with Osteoarthritis and Meniscal tears.
368
Marx Activity
Marx (1)
Study Characteristics
Purpose Validity, Reliability
Study Population/Sample (inclusion/exclusion)
Normal/Sports active
Number 40
Age range (average ± SD, min-max) 33.7 (18-50)
Sex (% female) 32%
Reliability
Internal consistency NA
Test-retest reliability ICC = .97
Time interval 1 year
Validity
Correlation to similar scale Moderate (100%) correlation to similar scales
Correlation to general measures of Physical function NA
Correlation to general measures of mental function NA
Responsiveness
ES NA
SRM NA
MDC 9.9 (calc) (1.96)*(sqrt(2))*((20.8)*sqrt(1-.97))
MCID NA
Guyatt NA
Time Interval NA
Other
Floor/Ceiling Effect NA
Normal Distribution NA
Normal Data NA
369
MARX ACTIVITY SCALE CONSOLIDATON
REFERENCES
1) Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am. J Sports Med 2001; 29: 21.3-218
370
MARX ACTIVITY LEVEL
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Marx Activity Level Author’s Last Name Marx Title of the Article Development and Evaluation of an Activity Rating Scale for
Disorders of the Knee Year 2001 PubMed ID:
11292048 Reviewer’s Name Travis Hamilton Date of Review 7.25.11
Content Validity
Reported that items were generated by team of experts 1 Reported that items were developed from patient input 1 Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Tegner = 0.66, Cincinnati = 0.67,Daniel scale = 0.52 ( Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency NA (eg.. Cronbach’s α > .60) Indicate value:
371
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: 0.97 Testing interval (time between repeated measures) 1 week
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments NA
Descriptive Features
Age range of sample 33.7 (18-50) Number: 40 Sex
Male 27 Female 13
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Participates in sports on a regular basis 28 Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Present Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 1
Notes:
Items of importance were generated by interviewing 10 orthopaedic surgeons who specialize in sports medicine, 5 physical therapists and athletic trainers who specialize in sports medicine and 10 athletic patients with disorders of the knee. Nine relevant items were generated: getting out of a low chair, going up stairs, going down stairs, running, cutting, pivoting, jumping, decelerating, and doing a deep knee bend/squat. The top 4 items were selected for the scale (Running, cutting, decelerating, and pivoting) depicted in table 1.
372
373
Kujala Activity Level
Paxton (1) Kuru (2)
Study Characteristics
Purpose Validity, Reliability Validity, Reliability of Turkish translation
Study Population/Sample (inclusion/exclusion)
Acute patellar dislocation Patellar femoral disorder
Number Validity = 110, Test-retest = 81 40
Age range (average ± SD, min-max)
Validity =First dislocation: 16 (9-67), Prior dislocation: 18 (8-65) Test-retest= First dislocation: 16 (9-48), Prior dislocation: 22 (8-65)
33 ±12 (17 – 54)
Sex (% female) NA NA
Reliability
Internal consistency α = .82 α = 0.84
Test-retest reliability ICC = .86 MCC** = .94
Time interval 21 days NA
Validity
Correlation to similar scale Demonstrate Little (20%), moderate (20%), excellent (60%) correlation to similar scales
NA
Correlation to general measures of Physical function
Demonstrates excellent (100%) correlations to similar scales NA
Correlation to general measures of mental function NA NA
Responsiveness
ES NA NA
SRM NA NA
MDC NA NA
MCID NA NA
Guyatt NA NA
Time Interval NA NA
Other
Floor/Ceiling Effect No NA
Normal Distribution No NA
Normal Data NA NA ** MCC = Mean Correlation Coefficient
374
KUJALA CONSOLIDATION
REFERENCES
1) Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee-specific and general health instruments in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003 Jul-Aug;31(4):487-92.
2) Kuru T, Dereli EE, Yaliman A. Validity of the Turkish version of the Kujala patellofemoral score in patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2010;44(2):152-6
375
Kujala Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Kujala Knee Score Author’s Last Name Paxton Title of the Article The reliability and validity of knee-specific and general health
instruments in assessing acute patellar dislocation outcomes Year 2003 PubMed ID: 12860533 Reviewer’s Name Travis Hamilton Date of Review 9.12.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF – 36: PF = .64, RP = .44, BP = .45
MFA: Total = -.52, Mobility = -.1, Leisure = -.51 Correlated with theoretically similar scale 1 If yes. Indicate instrument/scale and correlation coefficient Tegner = .33, Fulkerson = .85, Lysholm = .86, IKDC
(modified) = -.54 Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1
376
(eg.. Cronbach’s α > .60) Indicate value:
α = .82
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: .86 Testing interval (time between repeated measures) 21 days (13-42)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample Table 1. Number: Sex
Male Female
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA Acute Patellar Dislocation 1
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2
Notes:
377
378
Kujala Knee Score
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure Kujala Knee Score Author’s Last Name Kuru Title of the Article Validity of the Turkish version of the Kujala patellofemoral
score in patellofemoral pain syndrome Year 2010 PubMed ID: Reviewer’s Name Travis Hamilton Date of Review 9.12.11
Content Validity
Reported that items were generated by team of experts NA (Standard forward and reverse translation) Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect NA If yes. <30% of sample scored at endpoint Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale NA If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale NA If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? NA If yes. What is found?
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome NA If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.84
379
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: Mean correlation coefficient = 0.94 Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
NA
Report statistics: ES. SRM. Guyatt’s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
Descriptive Features
Age range of sample 33 ±12 (17 – 54) Number: 40 Sex
Male 8 Female 32
Diagnosis ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF 1
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) Language(s) of instrument used in this report Turkish Is this the first or primary report about this instrument? 2
380
INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SUBJECTIVE KNEE FORM – PEDIATRIC VERSION
Kocher (1)
Study Characteristics
Purpose Validity, Reliability, Responsiveness
Study Population/Sample Inclusion/exclusion)
Variety of knee injuries
Number 589
Age range (average ± SD, min-max)
14.6 ± 2.5 (10.0 - 18.9)
Sex (% female) 51%
Reliability
Internal consistency α = 0.91
Test-re-test reliability ICC = .91
Time interval 17 days
Validity Correlation to similar scale NA
Correlation to general measures of physical function
Fair (33%) to Moderate (66%) correlation to physical function
Correlation to general measures of mental function Fair (100%), correlation to mental function
Responsiveness
ES 1.39 SRM 1.35 MDC 18.3 (calc) (1.96)*(sqrt(2))*((22)*sqrt(1-.91)) MCID NA Time interval 7.5 weeks Other Floor/Ceiling effect No Normal Distribution NA
Normal Data NA
381
International Knee Documentation Committee (IKDC) Subjective Knee Form – Pediatric Version
REFERENCES
1) Kocher MS, Smith JT, Iversen MD, Brustowicz K, Ogunwole O, Andersen J, Yoo WJ, McFeely ED, Anderson AF, Zurakowski D. Reliability, validity, and responsiveness of a modified International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) in children with knee disorders. Am J Sports Med. 2011 May;39(5):933-9. Epub 2010 Nov 10. PubMed PMID: 21068443
382
IKDC SUBJECTIVE KNEE FORM – PEDIATRIC VERSION
Ratings
1 Yes 2 No 3 Not evaluated or not reported NA Not applicable
Outcome Measure IKDC pediatric version Author’s Last Name Kocher Title of the Article Reliability, Validity, and Responsiveness of a Modified
International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) in Children With Knee Disorders
Year 2011 PubMed ID: Reviewer’s Name Travis Hamilton Date of Review 9.12.11
Content Validity
Reported that items were generated by team of experts NA Reported that items were developed from patient input NA Reported that content was developed from statistical modeling NA Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed NA
Construct Validity
Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient **CHQ; PF = .65, RL = .35, BL = .20, PL = .45, BP = .61, GH =
.20, FA = .37, overall = .15, family cohesion = .05 (Bold = used for validity comparisons)
Correlated with theoretically similar scale NA If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient CHQ: EL = .35, MH = .30, SE = .32 Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? All hypotheses were confirmed:
1. Patients with greater difficulty walking several blocks or climbing several flights of stairs would have lower pedi-IKDC scores.
2. Patients with greater difficulty getting around their school, neighborhood, or playground would have lower pedi-IKDC scores.
3. Patients with greater difficulty walking 1 block or climbing 1 flight of stairs would have lower pedi-IKDC scores.
4. Patients with greater difficulty doing their tasks around the ouse would have lower pedi-IKDC scores.
5. Patients with greater difficulty bending, lifting, or stooping would have lower pedi-IKDC scores.
6. Patients with greater difficulty doing certain kinds of schoolwork or activities with friends would have lower pedi-IKDC scores.
7. Patients with more severe bodily pain or 383
discomfort during the past 4 weeks would have lower pedi-IKDC scores.
8. Patients with more frequent bodily pain or discomfort would have lower pedi-IKDC scores.
9. Patients who felt worse about their ability to play sports would have lower pedi-IKDC scores.
10. Patients who felt worse about the things they can do would have lower pedi-IKDC scores.
11. Patients whose health or behavior has more regularly limited types of activities that they could do as a family during the past 4 weeks would have lower pedi-IKDC scores.
Criterion Validity
Correlated with “gold standard” NA Predictive of a future outcome If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency 1 (eg.. Cronbach’s α > .60) Indicate value:
α = 0.91
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value: ICC = 0.91 Testing interval (time between repeated measures) 17 days (3-67)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60) NA Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt’s responsiveness index. Regression model)
1
Report statistics: ES. SRM. Guyatt’s ES = 1.39, SRM = 1.35 Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change)
NA
Report statistics: Change in measure related to change in external standard NA Measure demonstrated change for patients who received known efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments 7.5 weeks (.4 – 29.1)
384
Descriptive Features
Age range of sample 14.6 ± 2.5 (10.0 – 18.9) Number: 589 Sex
Male 288 (48.9%) Female 301 (51.1%)
Diagnosis Table 1. ACL injury/surgery PCL injury/surgery
Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL
OA PF
General knee pain Combined injury
Sport related Cartilage degeneration or surgery
Provide normative data NA Provide information about scoring and weighting of items: NA Provided information about calculating with missing values: NA Recall period (eg. “in the last month”) NA Language(s) of instrument used in this report ENGLISH Is this the first or primary report about this instrument? 2
Notes:
Physical functioning (PF), emotional limitations (EM), behavioral limitations (BL), physical limitations (PL), bodily pain (BP), mental health (MH), self esteem (SE), general health perceptions (GHP), and family activities (FA),
385
top related