Transcript American Association of Pharmaceutical Scientistsneral

Health-Related Quality of
Life Assessment
Ron D. Hays, Ph.D. ([email protected])
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 Problem
Everyone in health care wants
reimbursement for their services
Options range from acute surgery,
prevention, to long term care
But there is a limited amount of money
How do we spend limited resources to
enhance population health?
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Cost Effective Care
Cost 
Effectiveness 
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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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HRQOL is Multidimensional
HRQOL
Physical
Mental
Social
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HRQOL is Not
• Quality of
environment
• Type of housing
• Level of income
• Social Support
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Types of HRQOL Measures
•Profile
– Generic
– Targeted
•Preference-based
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Generic HRQOL Item
In general, would you say
your health is:
Excellent
Very Good
Good
Fair
Poor
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General Health vs.Quality of Life
In general, would you say your health is …?
How would you rate your overall health during
the past week? (EORTC QLQ-C30)
==================================
General health rating reflects physical health
more than mental health.
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Quality of Life vs. General Health
Overall, how would you rate your quality of
life?
How would you rate your overall quality of
life during the past week? (EORTC QLQC30)
==================================
Global quality of life reflects mental health
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SF-36 Generic Profile Scales (Items)
• Physical functioning (10 items)
• Role limitations/physical (4 items)
• Pain (2 items)
• General health perceptions (5 items)
• Emotional well-being (5 items)
• Role limitations/emotional (3 items)
• Energy/fatigue (4 items)
• Social functioning (2 items)
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Physical Health
Physical Health
Physical
function
Role
functionphysical
Pain
General
Health
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Mental Health
Mental Health
Emotional
WellBeing
Role
functionemotional
Energy
Social
function
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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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Emotional Well-Being Item
How much of the time
during the past 4 weeks
have you been a very
nervous person?
None of the time
A little of the time
Some of the time
A Good bit of the time
Most of the time
All of the time
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Scoring Generic HRQOL Scales
Average or sum all items in the same
scale.
Transform raw average or sum linearly to
• 0-100 possible range
• T-score metric
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Generic Measures Allow
• Comparisons of different people
 Profiles of diseases
• Examination of HRQOL antecedents
• Detection of unexpected effects
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Emotional Well-Being and Physical Functioning
of Those with HIV Compared with Other
Chronic Illnesses and General Population
Mental
Physical
MS
ESRD
Diabetes
Depression
Prostate disease
GERD
Epilepsy
General Pop
AIDS
Symptomatic
Asymptomatic
0
10
20
Hays, et al. (2000), American Journal of Medicine
30
40
50
60
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SF-36 Scores of Patients with
Neck or Low Back Pain
90
80
70
60
50
Saw MD
Saw chiro
40
30
20
10
0
PF
Role- Pain Gen. EWB RoleP
H
E
EF
SF
Cote, P. et al., Med Care, 2001
167 adults from Saskatchewan
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Association of Exercise at Baseline with
Physical Functioning 2-years Later (MOS)
Hypertension
84
82
80
Diabetes
78
76
Current Depression
74
Subthreshold
Depression
72
70
68
66
64
62
Low
High
Total Time Spent Exercising
Stewart, A.L., Hays, R.D., Wells, K.B., Rogers, W.H., Spritzer, K.L., & Greenfield, S. (1994). Long-term
functioning and well-being outcomes associated with physical activity and exercise in patients with
chronic conditions in the Medical Outcomes Study. Journal of Clinical Epidemiology, 47, 719-730.
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Treatment Impact on Physical Health
12
Duodenal Ulcer
Medication
Shoulder Surgery
10
8
Impact on
6
SF-36 PCS
Asthma Medication
4
2
0
Treatment Outcomes
Coronary
Revascularization
Heart Value
Replacement
Total Hip
Replacement
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Treatment Impact on Mental Health
12
Stayed the same
10
Low back pain
therapy
Hip replacement
8
Impact on
6
SF-36 MCS
4
Ulcer maintenance
2
Recovery from
Depression
0
Treatment Outcomes
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Targeted HRQOL Measures
• Designed to be relevant to particular group.
• Sensitive to small, clinically-important changes.
• More familiar and actionable.
• Important for 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?
 Feeling washed out or drained?
(Not at all to Extremely)
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 Item
How much difficulty do you have judging
distances, like walking downstairs or parking
a car?
No difficulty at all
A little difficulty
Moderate difficulty
A 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 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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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
combo
chemo
0
-2
-4
-6
-8
-10
8 weeks
20 weeks
32 weeks
44 weeks
56 weeks
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Correlations between EORTC and SF-12
PCS
Global PF
RF
Fatig.
Pain
0.65
0.65
0.61
0.61
0.63
MCS
Emot
0.59
Correlations >0.50 are shown.
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Breast Cancer Module
EORTC QLQ-BR23
Patients sometimes report that they have the following symptoms or problems. Please indicate
the extent to which you have experienced these symptoms or problems during the past week.
Not at
all
A
little
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 attractive
as a result of your disease or treatment?
1
2
3
4
10. Have you been feeling less feminine as a
result 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
all
A
little
14. To what extent were you interested in sex?
1
2
3
4
15. To what extent were you sexually active?
(with or without intercourse)
1
2
3
4
1
2
3
4
During the past week:
During the past four weeks:
16. Answer this question only if you have been sexually
active. To what extent was sex enjoyable for you?
Quite Very
a bit much
Quite Very
a bit much
Please go on to the next page
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Is Intervention, X, Better
Than Standard Care,O?
100
90
80
70
X
60
50
0
0
X
40
30
20
10
0
Physical
Health
Mental
Health
X>0
0>X
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Is Being a Musician Related to Worse HRQOL?
ID
Musician?
1
2
3
4
5
6
7
8
9
10
Group
Not musician
Yes, musician
HRQOL (0-100 scale)
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
dead
dead
50
75
100
0
25
50
75
100
n
HRQOL
3
5
75
50
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EQ-5D
Mobility
Self-care
Usual activities
Pain/discomfort
Anxiety/depression
 243 states, 3 levels per attribute
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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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Five-Year Mortality Rates
by Levels of Physical Health
18
17
16
14
%
Dead
12
10
8
6
6
5
4
2
2
0
(n=676)
(n=754)
(n=1181)
(n=609)
<35
35-44
45-54
>55
SF-36 Physical Health Component Score (PCS)—T score
Ware et al. (1994). SF-36 Physical and Mental Health Summary Scales: A User’s Manual.
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