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Health-Related Quality of Health-Related Quality of Life AssessmentLife Assessment

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

November 27, 2002 (8:30-9:30 am)

UCLA Center for East-West Medicine

2428 Santa Monica Blvd. Suite 208

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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 But there is a limited amount of moneymoney

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

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Cost Effective CareCost Effective Care

CostCost

EffectivenessEffectiveness

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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

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HRQOL is HRQOL is MultidimensionalMultidimensional

HRQOL

Physical Mental Social

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HRQOL is NotHRQOL is Not

•Quality of Quality of environmentenvironment

•Type of housingType of housing

•Level of incomeLevel of income

•Social SupportSocial Support

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•ProfileProfile

– GenericGeneric

– TargetedTargeted

•Preference-Preference-basedbased

Types of HRQOL MeasuresTypes of HRQOL Measures

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Generic HRQOL ItemGeneric HRQOL Item

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

ExcellentExcellent

Very GoodVery Good

Good Good

FairFair

PoorPoor

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General HealthGeneral Health vs. vs.Quality of Quality of LifeLife

In general, would you say your health is In general, would you say your health is …? …?

How would you rate your overall health How would you rate your overall health during the past week? (EORTC QLQ-C30)during the past week? (EORTC QLQ-C30)

============================================================== General health rating reflects ====== General health rating reflects physical health more than mental health.physical health more than mental health.

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Quality of Life vs. General Quality of Life vs. General HealthHealth

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

How would you rate your overall How would you rate your overall quality of life during the past week? quality of life during the past week? (EORTC QLQ-C30)(EORTC QLQ-C30)

============================================================ Global quality of life ======== Global quality of life reflects mental healthreflects mental health

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SF-36 Generic Profile Scales (Items)SF-36 Generic Profile Scales (Items)

• Physical functioning (10 items)Physical functioning (10 items)

• Role limitations/physical (4 items)Role limitations/physical (4 items)

• Pain (2 items)Pain (2 items)

• General health perceptions (5 items)General health perceptions (5 items)

• Emotional well-being (5 items)Emotional well-being (5 items)

• Role limitations/emotional (3 items)Role limitations/emotional (3 items)

• Energy/fatigue (4 items)Energy/fatigue (4 items)

• Social functioning (2 items)Social functioning (2 items)

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Physical Health

Physical functionPhysical function

Role function-physical

Role function-physical

PainPain General Health

General Health

Physical HealthPhysical Health

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Mental Health

Emotional Well-Being

Emotional Well-Being

Role function-emotional

Role function-emotional

EnergyEnergy Social functionSocial

function

Mental HealthMental Health

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Physical Functioning ItemPhysical Functioning Item

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

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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 a very have you been a very nervous person?nervous person?

None of the timeNone of the time

A little of the timeA little of the time

Some of the timeSome of the time

A Good bit of the timeA Good bit of the time

Most of the timeMost of the time

All of the timeAll of the time

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Scoring Generic HRQOL ScalesScoring Generic HRQOL Scales

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

Transform raw average or sum linearly Transform raw average or sum linearly toto

•0-100 possible range0-100 possible range

•T-score metricT-score metric

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Generic Measures AllowGeneric Measures Allow

• Comparisons of different peopleComparisons of different people

Profiles of diseasesProfiles of diseases

• Examination of HRQOL antecedentsExamination of HRQOL antecedents

• Detection of unexpected effectsDetection of unexpected effects

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Emotional Well-Being and Physical Functioning Emotional Well-Being and Physical Functioning of Those with HIV Compared with Otherof Those with HIV Compared with Other

Chronic 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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SF-36 Scores of Patients with Neck or Low Back Pain

0

10

20

30

40

50

60

70

80

90

PF Role-P

Pain Gen.H

EWB Role-E

EF SF

Saw MD

Saw chiro

Cote, P. et al., Med Care, 2001167 adults from Saskatchewan

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Hypertension

Diabetes

Current Depression

Subthreshold 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 at Baseline Association of Exercise at Baseline with with

Physical Functioning 2-years Later Physical Functioning 2-years Later (MOS)(MOS)

Low High

Total Time Spent Exercising

84

82

80

78

76

74

72

70

68

66

64

62

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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

Treatment Impact on Physical HealthTreatment 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

Treatment Impact on Mental HealthTreatment Impact on Mental Health

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Targeted HRQOL MeasuresTargeted HRQOL Measures

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

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

• More familiar and actionable.More familiar and actionable.

• Important for respondent cooperation.Important for respondent cooperation.

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Kidney-Disease Targeted ItemsKidney-Disease Targeted Items

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

Cramps during dialysis? Cramps during dialysis? Feeling washed out or drained? Feeling washed out or drained?

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

Hays, R. et al. (1994). Development of the Kidney Disease Quality of Life (KDQOL) Instrument. Quality of Life Research, 3, 329-338.

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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

Hays, R. D. et al. (in press). Psychometric properties of the National Eye Institute--Refractive Error Quality of Life (NEI-RQL) Instrument. Ophthalmology.

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IBS-Targeted ItemIBS-Targeted Item

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

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Combined Trastuzumab and Chemotherapy in

Women with Metastatic Breast Cancer

400 women randomized: chemo only or chemo + transtuzumab

Treatment repeated every 3 weeks for total of six cycles unless toxicity or disease progression.

Main clinical trial efficacy study (Slamon et al., NEJM, 2001) found:

- decreases in tumor mass, longer maintenance of tumor response, and longer time to disease progression

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Osoba et al. (J Clin Oncology, 2002)

EORTC QLQ-C30 (http://www.eortc.be/home/qol/)

• Physical, role, cognitive, emotional, and social functioning

• Fatigue, pain, and nausea/vomiting symptom scales

• Dyspnea, insomnia, anorexia, constipation, and diarrhea symptom items

- Administered at baseline, weeks 8, 20 and every 12 weeks after; cessation of therapy at 20 weeks

- Completed in clinic before administration of treatment

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Change in Fatigue Score

-10

-8

-6

-4

-2

0

2

4

6

8

10

8 weeks 20 weeks 32 weeks 44 weeks 56 weeks

combo

chemo

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Correlations between EORTC and SF-12

Global PF RF Fatig. Pain Emot

PCS 0.65 0.63 0.65 0.61 0.61

MCS 0.59

Correlations >0.50 are shown.

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Breast Cancer Module

Please go on to the next page

EORTC QLQ-BR23

Patients sometimes report that they have the following symptoms or problems. Please indicatethe extent to which you have experienced these symptoms or problems during the past week.

Not at A Quite VeryDuring the past week: all little a bit much

1. Did you have a dry mouth? 1 2 3 4

2. Did food and drink taste different than usual? 1 2 3 4

3. Were your eyes painful, irritated or watery? 1 2 3 4

4. Have you lost any hair? 1 2 3 4

5. Answer this question only if you had any hair loss:Were you upset by the loss of hair? 1 2 3 4

6. Did you feel ill or unwell? 1 2 3 4

7. Did you have hot flushes? 1 2 3 4

8. Did you have headaches? 1 2 3 4

9. Have you felt physically less attractiveas a result of your disease or treatment? 1 2 3 4

10. Have you been feeling less feminine as aresult of your disease or treatment? 1 2 3 4

11. Did you find it difficult to look at yourself naked? 1 2 3 4

12. Have you been dissatisfied with your body? 1 2 3 4

13. Were you worried about your health in the future? 1 2 3 4

Not at A Quite VeryDuring the past four weeks: all little a bit much

14. To what extent were you interested in sex? 1 2 3 4

15. To what extent were you sexually active? 1 2 3 4(with or without intercourse)

16. Answer this question only if you have been sexuallyactive. To what extent was sex enjoyable for you? 1 2 3 4

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Is Intervention, X, Better Is Intervention, 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

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Is Being a Musician Related to Worse Is Being a Musician Related to Worse HRQOL?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

ID Musician? HRQOL (0-100 scale)

Not musician 3 75Yes, musician 5 50

Group n HRQOL

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EQ-5DEQ-5D

MobilityMobility

Self-careSelf-care

Usual activitiesUsual activities

Pain/discomfortPain/discomfort

Anxiety/depressionAnxiety/depression

243 states, 3 levels per 243 states, 3 levels per attributeattribute

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Questions?

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Appendix: URLs

www.rand.org/health/surveys.html

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

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

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Targeted Areas of Interest to You

Breast cancer undergoing chemotherapy

Chronic low back and neck pain

Musicians

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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.

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