Course materials copyrighted 2003 by Ron D. Hays

Measurement of Health-Related Measurement of Health-Related Quality of Life OutcomesQuality of Life Outcomes

Ron D. Hays, Ph.D. (hays@rand.org)

January 29, 2002 (3:00-6:00 pm)

Main conference room

Health Care System ConcernsHealth Care System Concerns

AccessAccess

AffordabilityAffordability

AccountabilityAccountability

Resource Allocation ProblemResource Allocation Problem

Everyone in health care wants Everyone in health care wants reimbursement for their servicesreimbursement for their services

Options range from acute surgery, Options range from acute surgery, prevention, to long term careprevention, to long term care

But there is a limited amount of moneyBut there is a limited amount of money

How do we spend limited resources to How do we spend limited resources to enhance population health?enhance population health?

Cost Effective CareCost Effective Care

Cost Cost

Effectiveness Effectiveness

““Outcomes”Outcomes”How is the Patient Doing?How is the Patient Doing?

PhysiologicalPhysiological

• HematocritHematocrit

• AlbuminAlbumin

Physician observation Physician observation

• Physical performancePhysical performance

Self-report indicatorsSelf-report indicators

• Functioning and well-beingFunctioning and well-being

Health-Related Quality of Life is:Health-Related Quality of Life is:

What the person can DO (functioning)What the person can DO (functioning)

• Self-care Self-care

• Role Role

• Social Social

How the person FEELS (well-being)How the person FEELS (well-being)

• Emotional well-beingEmotional well-being

• PainPain

• EnergyEnergy

HRQOL is Multi-HRQOL is Multi-DimensionalDimensional

HRQOL

Physical Mental Social

HRQOL is NotHRQOL is Not

• Quality of Quality of environmentenvironment

• Type of housingType of housing

• Level of incomeLevel of income

• Social SupportSocial Support

HRQOL OutcomesHRQOL Outcomes

More important to patients than physiological More important to patients than physiological measures or physician observations.measures or physician observations.

Summarize overall results of health care:Summarize overall results of health care:

CostCost

HRQOLHRQOL

•ProfileProfile

– GenericGeneric

– TargetedTargeted

•Preference-basedPreference-based

Types of HRQOL MeasuresTypes of HRQOL Measures

Advantages of Generic Advantages of Generic MeasuresMeasures

Allow comparisons across different peopleAllow comparisons across different people

• Across disease groupsAcross disease groups

• Sick versus wellSick versus well

• Young versus oldYoung versus old

Can detect unexpected side effectsCan detect unexpected side effects

Generic HRQOL ItemGeneric HRQOL Item

In general, would you say In general, would you say your health is:your health is:

ExcellentExcellent

Very GoodVery Good

Good Good

FairFair

PoorPoor

Overall Health Rating Item

Overall, how would you rate your current health?(Circle One Number)

0 1 2 3 4 5 6 7 8 9 10

Worst possible health (as bad or worse than being dead)

Half-waybetween worst

and best

Best possible

health

Overall Quality of Life Item

Overall, how would you rate your quality of life?

0 1 2 3 4 5 6 7 8 9 10

Worst possible quality of life(as bad or worse than being dead)

Half-waybetween worst

and best

Best possible quality of life

HealthHealth versus versus Quality of LifeQuality of Life

““In general, how would you rate your In general, how would you rate your health?”health?”

““Overall, how would you rate your quality Overall, how would you rate your quality of life?”of life?”

Generic HRQOL: 8 SF-36 Scales Generic HRQOL: 8 SF-36 Scales

• Physical functioning Physical functioning

• Role limitations/physical Role limitations/physical

• Pain Pain

• General health perceptions General health perceptions

• Social functioningSocial functioning

• Energy/fatigueEnergy/fatigue

• Role limitations/emotionalRole limitations/emotional

• Emotional well-being Emotional well-being

Physical HealthPhysical Health

Physical Physical functionfunctionPhysical Physical functionfunction

Role Role function-function-physicalphysical

Role Role function-function-physicalphysical

PainPainPainPain General General HealthHealth

General General HealthHealth

SF-36 Physical HealthSF-36 Physical Health

SF-36 Mental Health

Mental HealthMental Health

Emotional Emotional Well-Well-BeingBeing

Emotional Emotional Well-Well-BeingBeing

Role Role function-function-emotionalemotional

Role Role function-function-emotionalemotional

EnergyEnergyEnergyEnergy Social Social functionfunctionSocial Social

functionfunction

Physical Functioning ItemPhysical Functioning Item

Does your health now Does your health now limit you in bathing or limit you in bathing or dressing yourself?dressing yourself?

Yes, limited a lotYes, limited a lot

Yes, limited a littleYes, limited a little

No, not limited at allNo, not limited at all

Emotional Well-Being ItemEmotional Well-Being Item

How much of the time How much of the time during the past 4 weeks during the past 4 weeks have you been very have you been very nervous?nervous?

None of the timeNone of the time

A little of the timeA little of the time

Some of the timeSome of the time

Most of the timeMost of the time

All of the timeAll of the time

Scoring Generic HRQOL ScalesScoring Generic HRQOL Scales

Average or sum all items in the same scale.Average or sum all items in the same scale.

Transform average or sum linearly toTransform average or sum linearly to

• 0-100 possible range0-100 possible range

• T-score metricT-score metric

X =(original score - minimum) *100

(maximum - minimum)

Y = target mean + (target SD * Zx)

ZX = SDX

(X - X)

Formula for Transforming Formula for Transforming ScoresScores

Uses of Generic MeasuresUses of Generic Measures

Cross-SectionalCross-Sectional

• Profiles of Different DiseasesProfiles of Different Diseases

• Comparison of Different SamplesComparison of Different Samples

LongitudinalLongitudinal

• Profiles of Different DiseasesProfiles of Different Diseases

• Examining Antecedents Examining Antecedents

• Predicting utilization or mortalityPredicting utilization or mortality

HRQOL of Those with Chronic Illness HRQOL of Those with Chronic Illness Compared to General PopulationCompared to 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

HRQOL Scores of Clinical Trial and HRQOL Scores of Clinical Trial and

Non-Clinical Trial HIV PatientsNon-Clinical Trial HIV PatientsCunningham et al. (1995)

0

10

20

30

40

50

60

70

80

90

100

Health Index

CurrentHealth

PhysicalFunction

Energy/Fatigue

Low Pain EmotionalWell-being

SocialFunction

RoleFunction

CognitiveFunction

Trial Non-trial

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-Course of Emotional Well-being Over 2-yearsyears

for Patients in the MOS General Medical for Patients in the MOS General Medical SectorSector

5557596163656769717375777981

Baseline 2-Years

X

X

Subthreshold Depression

Major Depression

Diabetes

Hypertension

Hypertension

Diabetes

Current DepressionSubthreshold 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.

Association of Exercise with Physical Association of Exercise with Physical FunctioningFunctioning

2-years After Baseline in the MOS2-years After Baseline in the MOS

Low High

Total Time Spent Exercising

84

82

80

78

76

74

72

70

68

66

64

62

Generic Health Ratings Generic Health Ratings Associated with Associated with

Hospitalizations (N = 20,158)Hospitalizations (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.

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.

Five-Year Mortality RatesFive-Year Mortality Ratesby Levels of Physical Healthby Levels of Physical Health

Targeted HRQOL MeasuresTargeted HRQOL Measures

• Designed to be relevant to particular group.Designed to be relevant to particular group.

• Sensitive to small, clinically-important changes.Sensitive to small, clinically-important changes.

• Important for respondent cooperation.Important for respondent cooperation.

• More familiar and actionable.More familiar and actionable.

Persons with mobility Persons with mobility impairments object to SF-36 impairments object to SF-36 physical functioning items:physical functioning items:

Does Does your health now limit youyour health now limit you in (if so, how much) … in (if so, how much) …

climbing several flights of stairsclimbing several flights of stairs

climbing one flight of stairsclimbing one flight of stairs

walking more than a milewalking more than a mile

walking several hundred yardswalking several hundred yards

walking one hundred yardswalking one hundred yards

Andresen & Meyers (2000, Andresen & Meyers (2000, Archives ofArchives of Physical Medicine and Physical Medicine and RehabilitationRehabilitation))

Mattson-Prince (1997)Mattson-Prince (1997)

Dropped 10 physical functioning items Dropped 10 physical functioning items because of perception that they were because of perception that they were demeaning to people with SCIdemeaning to people with SCI

Spinal CordSpinal Cord, , 3535, 326-331, 326-331

Kidney-Disease Targeted ItemsKidney-Disease Targeted Items

During the last 30 days, to what extent were you During the last 30 days, to what extent were you bothered by each of the following? bothered by each of the following?

Cramps during dialysis Cramps during dialysis

Washed out or drained Washed out or drained

((Not at all Not at all to to ExtremelyExtremely))

IBS-Targeted ItemIBS-Targeted Item

During the last 4 weeks, how often were you angry about During the last 4 weeks, how often were you angry about your irritable bowel syndrome?your irritable bowel syndrome?

None of the timeNone of the time

A little of the timeA little of the time

Some of the timeSome of the time

Most of the timeMost of the time

All of theAll of the timetime

NEI-RQL-42 Far Vision ItemNEI-RQL-42 Far Vision Item

How much difficulty do you have judging How much difficulty do you have judging distances, like walking downstairs or distances, like walking downstairs or parking a car?parking a car?

No difficulty at allNo difficulty at all

A little difficultyA little difficulty

Moderate difficultyModerate difficulty

A lot of difficultyA lot of difficulty

Spinal Cord Independence Spinal Cord Independence MeasureMeasure

Self care (feeding, bathing, dressing, grooming)Self care (feeding, bathing, dressing, grooming)

Respiration and sphincter managementRespiration and sphincter management

Mobility (in bed and preventing pressure ulcers, Mobility (in bed and preventing pressure ulcers, bed-wheel chair, wheelchair-toilet-tub transfers)bed-wheel chair, wheelchair-toilet-tub transfers)

Kidney Disease-Targeted ScalesKidney Disease-Targeted Scales

• Symptoms/problems (12 items)Symptoms/problems (12 items)

• Effects of kidney disease (8 items)Effects of kidney disease (8 items)

• Burden of kidney disease (4 items)Burden of kidney disease (4 items)

• Work status (2 items)Work status (2 items)

• Cognitive function (3 items)Cognitive function (3 items)

• Quality of social interaction (3 items)Quality of social interaction (3 items)

• Sexual function (2 items)Sexual function (2 items)

• Sleep (4 items)Sleep (4 items)

Cross-sectional study of managed care pop.Cross-sectional study of managed care pop.

Sexual, urinary and bowel function and distressSexual, urinary and bowel function and distress

214 men with prostate cancer 214 men with prostate cancer

98 radical prostatectomy98 radical prostatectomy

56 primary pelvic irradiation56 primary pelvic irradiation

60 observation alone60 observation alone

273 age/zip matched pts. without cancer273 age/zip matched pts. without cancer

HRQOL in Men Treated for HRQOL in Men Treated for Localized Prostate CancerLocalized Prostate Cancer

19

3541

47

65

82 86 9082 81 84 86

0102030405060708090

100

Surgery Radiation Observ. Control

(c)

(c)

(a,b)

(b,c)

(b) (b)

(b)

(a,b)

(a)

(a)(a)(a)

Sexual, Urinary, and Sexual, Urinary, and Bowel Function OutcomesBowel Function Outcomes

Sexual Function

Urinary Function

Bowel Function

Litwin, et al. (1995, JAMA)

Check-in PointCheck-in Point

Generic Profile MeasuresGeneric Profile Measures

Targeted Profile MeasuresTargeted Profile Measures

-> Summarizing Profile Information-> Summarizing Profile Information

Physical Health

Physical functionPhysical function

Role function-physical

Role function-physical

PainPain General Health

General Health

Physical HealthPhysical Health

Mental Health

Emotional Well-Being

Emotional Well-Being

Role function-emotional

Role function-emotional

EnergyEnergy Social functionSocial

function

Mental HealthMental Health

SF-36 PCS and MCS

PCS = (PF_Z * .42402) + (RP_Z * .35119) + (BP_Z * .31754) + (GH_Z * .24954) + (EF_Z * .02877) + (SF_Z * -.00753) + (RE_Z * -.19206) + (EW_Z * -.22069)

MCS = (PF_Z * -.22999) + (RP_Z * -.12329) + (BP_Z * -.09731) + (GH_Z * -.01571) + (EF_Z * .23534) + (SF_Z * .26876) + (RE_Z * .43407) + (EW_Z * .48581)

0

2

4

6

8

10

12

Impact on SF-36 PCS

Treatment Outcomes

Duodenal UlcerMedicationShoulder Surgery

Asthma Medication

CoronaryRevascularizationHeart ValueReplacementTotal HipReplacement

Treatment Impact on Physical HealthTreatment Impact on Physical Health

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

Treatment Impact on Mental HealthTreatment Impact on Mental Health

Is New Treatment (X) Better Is New Treatment (X) Better Than Standard Care (O)?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

35%35% 84%84% at least 1 moderate symptomat least 1 moderate symptom

7%7% 70%70% at least 1 disability dayat least 1 disability day

1%1% 11%11% hospital admissionhospital admission

2%2% 14%14% performance of invasiveperformance of invasivediagnostic procedurediagnostic procedure

Perceived Health Index (n = 1,862; reliability = 0.94)Perceived Health Index (n = 1,862; reliability = 0.94)

Highest Lowest Quartile on Index Highest Lowest Quartile on Index

Perceived Health Index = 0.20 Physical functioning + 0.15 Pain + 0.41 Energy +0.10 Emotional well-being + 0.05 Social functioning + 0.09 Role functioning.

Bozzette, S.A., Hays, R.D., Berry, S.H., & Kanouse, D.E. (1994). A perceived health index for use in persons with advanced HIV disease: Derivation, reliability, and validity. Medical Care, 32, 716-731.

Single Weighted Combination of ScoresSingle Weighted Combination of Scores

Is Use of Medicine Related to Worse HRQOL?Is Use of 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

Marathoner 1.0Marathoner 1.0

Person in coma 1.0Person in coma 1.0

Survival AnalysisSurvival Analysis

Profile + MortalityProfile + MortalityOutcomes for Acute MI (n = 133)Outcomes 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

• Summarize HRQOL in QALYsSummarize HRQOL in QALYs

-- 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

Preference-Based Measure--Preference-Based Measure--Quality of Well-Being ScaleQuality of Well-Being Scale

Dead Well-Being

0 1

Each page in this booklet tells how an imaginary person is affected by a health problem on one day of his or her life. I want you to look at each health situation and rate it on a ladder with steps numbered from zero to ten. The information on each page tells 1) the person's age group, 2) whether the person could drive or use public transportation, 3) how well the person could walk, 4) how well the person could perform the activities usual for his or her age, and 5) what symptom or problem was bothering the person.

Example Case #1

Adult (18-65)Drove car or used public transportation without helpWalked without physical problemsLimited in amount or kind of work, school, or houseworkProblem with being overweight or underweight

Quality of Well-Being Weighting Quality of Well-Being Weighting ProcedureProcedure

012

43

5

78

6

910 Perfect Health

Death

EQ-5DEQ-5D

MobilityMobility

Self-careSelf-care

Usual activitiesUsual activities

Pain/discomfortPain/discomfort

Anxiety/depressionAnxiety/depression

243 states, 3 levels per attribute243 states, 3 levels per attribute

On each dimension, respondent gets three choices of level.

HUI-3HUI-3VisionVision

HearingHearing

SpeechSpeech

AmbulationAmbulation

DexterityDexterity

CognitionCognition

Pain and discomfortPain and discomfort

EmotionEmotion

972,000 states, 5-6 levels per attribute972,000 states, 5-6 levels per attribute

SF-6D Summary MeasureSF-6D Summary Measure

Brazier et al. (1998, 2002)Brazier et al. (1998, 2002)——6-dimensional classification6-dimensional classification Collapsed role scales, dropped Collapsed role scales, dropped

general healthgeneral health

Uses 11 SF-36 items (8 SF-12 and 3 Uses 11 SF-36 items (8 SF-12 and 3 additional physical functioning items)additional physical functioning items)

——18,000 possible states18,000 possible states

——249 states rated by sample of 836 249 states rated by sample of 836 from UK general populationfrom UK general population

Quality-adjusted life-years (QALYs)

1.0

0.5

0

Age80 85

Smoker

Non-smoker

Tengs, T. Presented at Health Services Research Seminar,

VA Hospital, San Diego, July, 2000

Cost/QALY (1993 US dollars)Cost/QALY (1993 US dollars)

•$0 Seat belt laws

•$2k Pneumonococcal vaccine

•$6k Smoking cessation counseling

•$12k Oral gold for rheumatoid arthritis

•$40k CABG, 2-vessel disease; hemodialysis

•$167k Mammography screening

•$293k Hip replacement

•$663k CABG, 1-vessel disease

Questions?

www.rand.org/health/surveys.html

http://gim.med.ucla.edu/kdqol/

http://gim.med.ucla.edu/facultypages/hays

Next Week’s Reading

  Hays, R. D., Anderson, R. T., & Revicki, D. (1998). Assessing reliability and validity of measurement in clinical trials. In M. Staquet, R. Hays, & P. Fayers (eds.), Quality of Life Assessment in Clinical Trials: Methods and Practice (pp. 169-182). Oxford: Oxford University Press.