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Comprehensive Assessment of Health Outcomes
K30 Course on Translational Research
Ron D. Hays, Ph.D. UCLA GIM & HSR
October 4, 2004 (3:30-5:00 pm)
Gonda Building Conference Room, 1357
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How do we know how the patient is doing?
Temperature
Respiration
Pulse
Weight
Blood pressure
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And by asking her or him about ...
Symptoms
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Have you had any of the following symptoms in the last 4 weeks?
Fever?
Loss of appetite?
Unintended weight loss?
Dizziness?
Trouble sleeping?
Headache?
Trouble swallowing?
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First RCT of Treatment for NewlyDiagnosed Prostate Cancer (NEJM, 2002)
* Watchful waiting
Versus
* Radical prostatectomy
- Trend to reduction in all-cause mortality
(18% versus 15%; RR 0.83, 0.57 to 1.2, p = 0.31)
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Impact on Symptoms
Reduction in urinary obstruction (weak stream)
- 44% waiting, 28% prostatectomy
Increase in urinary leakage and sexual dysfunction
- 49% prostatectomy vs. 21% waiting
- 80% prostatectomy vs. 45% waiting
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Also, by asking her or him about ...
What she or he is able to do
And how he or she feels about their life
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Does your health now limit you inwalking more than a mile?
(If so, how much?)
Yes, limited a lot
Yes, limited a little
No, not limited at all
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How much of the time during the past4 weeks have you been happy?
None of the time
A little of the time
Some of the time
Most of the time
All of the time
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In general, how would you rate your health?
Excellent
Very Good
Good
Fair
Poor
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Are self-reports reliable?
Reliability—extent to which you get the same score on repeated assessments
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Reliability is an issue in blood pressure measurement
• Do not place the blood pressure cuff over clothing or roll a tight fitting sleeve above the biceps when determining blood pressure as either can cause elevated readings.
• If you have a chance, obtain measurements on the same patient with both a large and small cuff.
• If the reading is surprisingly high or low, repeat the measurement towards the end of your exam.
• These exercises should give you an appreciation for the magnitude of error that can be introduced when improper technique is utilized.
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Range of reliability estimates
0.80-0.90 for blood pressure
0.70-0.90 for multi-item self-report scales
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Are self-reports valid?
Validity—score represents what you are trying to measure rather than something else
• If possible, measure the blood pressure of a patient who has an indwelling arterial catheter (these patients can be found in the ICU with the help of a preceptor). Arterial transducers are an extremely accurate tool for assessing blood pressure and therefore provide a method for checking your non-invasive technique.
• Make sure the patient has had an opportunity to rest before measuring their BP.
• Instruct her or him to avoid coffee, smoking or any other un-prescribed drug with sympathomimetic activity on the day of the measurement.
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Hospitalized Patients Report Worse General Health (n =
20,158)26
14
64 3
0
5
10
15
20
25
30
Poor Fair Good VeryGood
Excellent
% Hospitalized
in past 3 months
Kravitz, R. et al. (1992). Differences in the mix of patients among medical specialties and systems of care: Results from the Medical Outcomes Study. JAMA, 267, 1617-1623.
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6
2
17
5
0
2
4
6
8
10
12
14
16
18
<35 35-44 45-54 >55
%
Dead
(n=676) (n=754) (n=1181) (n=609)
SF-36 Physical Health Component Score (PCS)—T scoreSF-36 Physical Health Component Score (PCS)—T score
Ware et al. (1994). SF-36 Physical and Mental Health Summary Scales: A User’s Manual.
Self-Reports of Physical Health Predictive
of Five-Year Mortality Rates
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Mark D. Sprenke et al. (Chest, 2004)
“The Veterans Short Form 36 Questionnaire is predictive of mortality and health-care utilization in a population of veterans with a self-reported diagnosis of asthma or COPD”
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Health-Related Quality of Life is:
How the person FEELs (well-being)
• Emotional well-being
• Pain
• Energy
What the person can DO (functioning)
• Self-care
• Role
• Social
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HRQOL is Not
• Quality of environment
• Type of housing
• Level of income
• Social Support
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Profile: Generic vs. Targeted
Preference Measure
Types of HRQOL Measures
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SF-36 Generic Profile Measure
• Physical functioning (10 items)
• Role limitations/physical (4 items)
• Role limitations/emotional (3 items)
• Social functioning (2 items)
• Emotional well-being (5 items)
• Energy/fatigue (4 items)
• Pain (2 items)
• General health perceptions (5 items)
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Scoring Generic HRQOL Scales
Average or sum all items in the same scale.
Transform average or sum to
• 0 (worse) to 100 (best) possible range
• z-score (mean = 0, SD = 1)
• T-score (mean = 50, SD = 10)
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Physical Health
Physical functionPhysical function
Role function-physical
Role function-physical
PainPain General Health
General Health
Physical Health
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Mental Health
Emotional Well-Being
Emotional Well-Being
Role function-emotional
Role function-emotional
EnergyEnergy Social functionSocial
function
Mental Health
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Example Uses of Generic HRQOL Measures
Cross-Sectional
• Comparison of Same Disease in Different Samples
• Profiles of Different Diseases
Longitudinal
• Profiles of Different Disease
• Identifying Antecedents/Causes of HRQOL
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HRQOL of Patients in ACTG versus
Public Hospital Samples
0
10
20
30
40
50
60
70
80
90
100
Adjusted Scale Scores (Cunningham et al., 1995)
Health Index
CurrentHealth
PhysicalFunction
Energy/Fatigue
Low Pain EmotionalWell-being
SocialFunction
RoleFunction
CognitiveFunction
Trial Non-trial
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HRQOL for HIV Compared to otherHRQOL for HIV Compared to otherChronic Illnesses and General PopulationChronic Illnesses and General Population
0 10 20 30 40 50 60
Asymptomatic
Symptomatic
AIDS
General Pop
Epilepsy
GERD
Prostate disease
Depression
Diabetes
ESRD
MSMental
Physical
Hays et al. (2000), American Journal of Medicine
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Hays, R.D., Wells, K.B., Sherbourne, C.D., Rogers, W., & Spritzer, K. (1995).Functioning and well-being outcomes of patients with depression comparedto chronic medical illnesses. Archives of General Psychiatry, 52, 11-19.
Course of Emotional Well-being Over 2-years
for Patients in the MOS General Medical Sector
5557596163656769717375777981
Baseline 2-Years
Major Depression
Diabetes
Hypertension
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Hypertension
Diabetes
Current Depression
Stewart, A.L., Hays, R.D., Wells, K.B., Rogers, W.H., Spritzer, K.L., & Greenfield, S. (1994). Long-termfunctioning and well-being outcomes associated with physical activity and exercise in patients withchronic conditions in the Medical Outcomes Study. Journal of Clinical Epidemiology, 47, 719-730.
Physical Functioning in Relation toTime Spent Exercising 2-years Before
Low High
Total Time Spent Exercising
84
82
80
78
76
74
72
70
68
66
64
62
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Targeted HRQOL Measures
• Designed to be relevant to particular group.
• Sensitive to small, but clinically-important changes.
• More familiar and actionable for clinicians.
• Enhance respondent cooperation.
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Kidney-Disease Targeted Items
During the last 30 days, to what extent were you bothered by each of the following?
Cramps during dialysis
Washed out or drained
Not at all bothered
Somewhat bothered
Moderately bothered
Very much bothered
Extremely bothered
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IBS-Targeted Item
During the last 4 weeks, how often were you angry about your irritable bowel syndrome?
None of the time
A little of the time
Some of the time
Most of the time
All of the time
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Cross-sectional study of 214 men with prostate cancer
- 98 radical prostatectomy
- 56 primary pelvic irradiation
– 60 observation alone
273 age/zip matched pts. without cancer
JAMA, 1995
Litwin et al. Study of HRQOL in Men Treated for Localized Prostate Cancer
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Sexual, Urinary and Bowel Function
0
10
20
30
40
50
60
70
80
90
Sexual Urinary Bowel
Surgery
Radiation
Observ.
Control
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Ultimate Use of HRQOL Measures--
Helping to Ensure Access to Cost-Effective Care
Cost
Effectiveness
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Is New Treatment (X) Better Than Standard Care (O)?
0
10
20
30
40
50
60
70
80
90
100
XX
00XX
00
PhysicalPhysicalHealthHealth
X > 0X > 0
Mental Mental HealthHealth
0 > X0 > X
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Marathoner and person in coma = 1.0
Do a Survival Analysis?
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51 7/25/2004
• Summarize HRQOL in Summarize HRQOL in QALYsQALYs
---- Physical activity (PAC)Physical activity (PAC)
–– Mobility (MOB)Mobility (MOB)
–– Social activity (SAC)Social activity (SAC)
-- Symptom/problem complexes (SPC)Symptom/problem complexes (SPC)
• Well-Being Formula w = 1 + PAC + MOB + SAC + SPC
PreferencePreference-- Based MeasureBased Measure- -- -Quality of WellQuality of Well-- Being ScaleBeing Scale
Dead Well-Being
0 1
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Health State 111111
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EQ-5D in UK by age and gender
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For further information
http://gim.med.ucla.edu/FacultyPages/Hays/
http://www.rand.org/health/surveys.html
http://www.qolid.org/
www.sf-36.com
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X =(original score - minimum) *100
(maximum - minimum)
Y = (target SD * Zx) + target mean
ZX = SDX
(X - X)
Appendix: Transforming Scores
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Appendix: Is Medicine Related to Worse HRQOL?
1 No deaddead2 No deaddead
3 No 50 4 No 75 5 No 100 6 Yes 0 7 Yes 25 8 Yes 50 9 Yes 75 10 Yes 100
MedicationPerson Use HRQOL (0-100 scale)
No Medicine 3 75Yes Medicine 5 50
Group n HRQOL
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Appendix: Profile + MortalityOutcomes for Acute MI (n = 133)
25
81
25
63 66
27
81
15
49
64
31
83
12
7585
0102030405060708090
Total HospitalCharges
Satisfactionwith Care
Mortality PhysicalFunction
EmotionalWell-Being
A B C
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Appendix: Generic Child Health Measures
Landgraf, J. M., & Abetz, L. N. (1996). Measuring health outcomes in pediatric populations: Issues in psychometrics and application. In B. Spilker (ed.), Quality of life and pharmacoeconomics in clinical trials, Second edition. Lippincott-Raven Publishers.
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0
2
4
6
8
10
12
Impact on SF-36 PCS
Treatment Outcomes
Duodenal UlcerMedicationShoulder Surgery
Asthma Medication
CoronaryRevascularizationHeart ValueReplacementTotal HipReplacement
Appendix: Impact on Physical Health
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0
2
4
6
8
10
12
Impact on SF-36 MCS
Treatment Outcomes
Stayed the same
Low back paintherapy
Hip replacement
Ulcer maintenance
Recovery fromDepression
Appendix: Impact on Mental Health
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53 7/25/2004
EQEQ-- 5D5D
MobilityMobility
SelfSelf--carecare
Usual activitiesUsual activities
Pain/discomfortPain/discomfort
Anxiety/depressionAnxiety/depression
243 states, 3 levels per attribute243 states, 3 levels per attribute
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Brazier et al. SF-6D
Brazier et al. (1998, 2002)Brazier et al. (1998, 2002) 6-dimensional classification6-dimensional classification
Collapsed role scales, dropped general healthCollapsed role scales, dropped general health Uses 11 SF-36 items (8 SF-12 and 3 additional Uses 11 SF-36 items (8 SF-12 and 3 additional
physical functioning items)physical functioning items) 18,000 possible states18,000 possible states 249 states rated by sample of 836 from UK 249 states rated by sample of 836 from UK
general populationgeneral population
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54 7/25/2004
HUIHUI -- 33VisionVision
HearingHearing
SpeechSpeech
AmbulationAmbulation
DexterityDexterity
CognitionCognition
Pain and discomfortPain and discomfort
EmotionEmotion
972,000 states, 5972,000 states, 5--6 levels per attribute6 levels per attribute