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1 04/20/23
Course materials copyrighted 2003 by Ron D. Hays
A Comprehensive Approach to theMeasurement of Health Outcomes
Ron D. Hays, Ph.D. UCLA GIM & HSR
October 22, 2003 (4:00-5:30 pm)
MacDonald Research Building, 1-441
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2 04/20/23
First RCT of Treatment for NewlyDiagnosed Prostate Cancer
Radical prostatectomy vs. watchful waiting
- Concealed randomization; blinded adjudication of outcomes
Prostatectomy
- trend to reduced all-cause mortality
(18% versus 15%; RR 0.83, 0.57 to 1.2, p = 0.31)
NEJM, 2002, 347
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3 04/20/23
Impact of Treatment
Sexual dysfunction
- 45% waiting, 80% prostatectomy
Urinary leakage
- 21% waiting, 49% prostatectomy
Urinary obstruction (weak stream)
- 44% waiting, 28% prostatectomy
No differences in bowel function, anxiety, depression, and well being.
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4 04/20/23
With more doctors and better technology,
we are able to detect more diseaseNumber of cardiologists has doubled; number of radiologists increased 5-fold in past 2 decades
New spiral CT scans can detect hepatic lesions of 2mm. In 1982, only 20mm lesions could be detected.
MRI can …
detect abnormalities of the knee in 25% of healthy young men.
find lumbar disc bulge in 50% of adults, many who report no back pain.
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5 04/20/23
Access to Cost-Effective Care
Cost
Effectiveness
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6 04/20/23
How is the Patient Doing
Biological indicators
• Blood pressure
• Hematocrit
Self-report indicators
• Symptoms
• Functioning
• Well-being
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7 04/20/23
Health-Related Quality of Life is:
What the person can DO (functioning)
• Self-care
• Role
• Social
How the person FEELs (well-being)
• Emotional well-being
• Pain
• Energy
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8 04/20/23
HRQOL is Not
• Quality of environment
• Type of housing
• Level of income
• Social Support
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9 04/20/23
Generic
- Profile
- Preference
Targeted
Types of HRQOL Measures
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10 04/20/23
Example Generic HRQOL Item
In general, would you say your health is:
Excellent
Very Good
Good
Fair
Poor
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11 04/20/23
SF-36 Generic HRQOL Scales
• 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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12 04/20/23
Physical Functioning Item
Does your health now limit you in bathing or dressing yourself?
Yes, limited a lot
Yes, limited a little
No, not limited at all
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13 04/20/23
Emotional Well-Being Item
How much of the time during the past 4 weeks have you been very nervous?
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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14 04/20/23
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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15 04/20/23
Physical Health
Physical functionPhysical function
Role function-physical
Role function-physical
PainPain General Health
General Health
Physical Health
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16 04/20/23
Mental Health
Emotional Well-Being
Emotional Well-Being
Role function-emotional
Role function-emotional
EnergyEnergy Social functionSocial
function
Mental Health
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17 04/20/23
Example Uses of Generic HRQOL Measures
Cross-Sectional
• Comparison of Different Samples
• Profiles of Different Diseases
Longitudinal
• Profiles of Different Disease
• Exploring HRQOL Antecedents
• Predicting Future Health-Related Events
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18 04/20/23
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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19 04/20/23
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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20 04/20/23
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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21 04/20/23
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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22 04/20/23
Generic Health Ratings Associated with
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.
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23 04/20/23
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 Ratesby Levels of Physical Health
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24 04/20/23
Targeted HRQOL Measures
• Designed to be relevant to particular group.
• Sensitive to small, clinically-important changes.
• Important for respondent cooperation.
• More familiar and actionable.
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25 04/20/23
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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26 04/20/23
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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27 04/20/23
Cross-sectional study of managed care pop.
214 men with prostate cancer
– 98 radical prostatectomy
– 56 primary pelvic irradiation
– 60 observation alone
273 age/zip matched pts. without cancer
Litwin et al. (1995, JAMA)
HRQOL in Men Treated for Localized Prostate Cancer
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28 04/20/23
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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29 04/20/23
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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30 04/20/23
Marathoner and person in coma = 1.0
Do a Survival Analysis?
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31 04/20/23
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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32 04/20/23
Health State 111111
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33 04/20/23
This lecture was supported in part by the UCLA/DREW Project EXPORT, National Institutes of Health, National Center on Minority Health & Health Disparities, (P20-MD00148-01) and the UCLA Center for Health Improvement in Minority Elders/Resource Centers for Minority Aging Research, National Institutes of Health, National Institute of Aging, (AG-02-004).
Questions?
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34 04/20/23
X =(original score - minimum) *100
(maximum - minimum)
Y = (target SD * Zx) + target mean
ZX = SDX
(X - X)
Appendix: Transforming Scores
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35 04/20/23
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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36 04/20/23
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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37 04/20/23
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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38 04/20/23
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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39 04/20/23
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