Measures Preference-Based Measures Ron D. Hays, Ph.D. ([email protected]) February 9, 2004.
1 1/5/2016 Course materials copyrighted 2002 by Ron D. Hays Health-Related Quality of Life...
Transcript of 1 1/5/2016 Course materials copyrighted 2002 by Ron D. Hays Health-Related Quality of Life...
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Course materials copyrighted 2002 by Ron D. Hays
Health-Related Quality of Life Assessment
Ron D. Hays, Ph.D. ([email protected])
February 13, 2002 (3:00-6:00 pm)
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Problems with US Health Care
Health costs increasing despite managed care
Number of cardiologists has doubled and number of radiologists increased 5-fold in past 2 decades
Despite much greater growth in costs of health care in the US, no evidence that health has improved more than other G7 countries
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With more doctors and better technology,
we have found that more people are sick
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.
MRI can find lumbar disc bulge in 50% of adults, many who have no back pain.
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Health Care System Concerns
Access
Affordability
Accountability
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Cost Effective Care
Cost
Effectiveness
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What is Effective Care?
• Maximizes desired outcomes
• Outcomes serve as markers of effective care.
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How is the Patient Doing
Biological indicators
• Hematocrit
• Albumin
Self-report indicators
• Functioning
• Well-being (including symptoms)
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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
Physical Mental Social
HRQOL is Multi-Dimensional
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HRQOL is Not
• Quality of environment
• Type of housing
• Level of income
• Social Support
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HRQOL Outcomes
Matter more to patients than biological indicators.
Can summarize overall effects:
Cost
HRQOL
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Profile
- Generic
- Targeted
Preference-based
Types of HRQOL Measures
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Has your child had difficulty running?
NeverSometimesOften
Example Generic Item
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Generic HRQOL Item
In general, would you say Bob Brook’s health is:
Excellent
Very Good
Good
Fair
Poor
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Generic HRQOL Scales (Items)
• 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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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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Advantages of Generic Measures
Allow comparisons across different people
• Across disease groups
• Sick versus well
• Young versus old
Can detect unexpected side effects
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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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X =(original score - minimum) *100
(maximum - minimum)
Y = (target SD * Zx) + target mean
ZX = SDX
(X - X)
Formula for Transforming Scores
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Some Uses of Generic Measures
Cross-Sectional
• Profiles of Different Diseases
• Comparison of Different Samples
• Profiles by Medical Group
Longitudinal
• Profiles of Different Disease
• Examining Antecedents of HRQOL
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Comparison of SF-36 Scoresfor Different Patient Populations
0
1020
3040
50
6070
8090
100
Ph
ys
ica
lF
un
ctio
nin
g
Ro
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Ph
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ica
l
Pa
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Ge
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He
alth
Em
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ell-B
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Ro
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So
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En
erg
y/
Fa
tigu
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SF-36 Scales
ESRD
Gen Pop
Diabetes
COPD
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HRQOL of HIV Infected Adults
0 20 40 60 80 100
CDC A
CDC B
CDC C
General Pop
Epilepsy
GERD
Prostate disease
Depression
Diabetes
ESRD
MSEmotional
Physical
Hays, Cunningham, Sherbourne, et al (2000, AJ Medicine)
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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
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HRQOL Scores of Patients with HIV Infection
in Clinical Trial and Non-Clinical Trial Samples
0
10
20
30
40
50
60
70
80
90
100
Adjusted Scale Scores
Health Index
CurrentHealth
PhysicalFunction
Energy/Fatigue
Low Pain EmotionalWell-being
SocialFunction
RoleFunction
CognitiveFunction
Trial Non-trial
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WHAT THIS FIGURE SHOWS: X’s denote average SF-36 score for a sample of 200 members from your medical group. Average score across all 48 medical groups is 50 (standard deviation is 10).
T-Score706560555045403530
XX
XX
XXXX
Physical Role- Pain General Emotional Role- Social EnergyFunctioning Physical Health Well-Being Emotional Function
SF-36 Health Profiles for Medical Group
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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
X
X
Subthreshold Depression
Major Depression
Diabetes
Hypertension
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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 with Physical Functioning
2-years After Baseline in the MOS
Low High
Total Time Spent Exercising
84
82
80
78
76
74
72
70
68
66
64
62
X
X
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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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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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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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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 to Extremely)
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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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KDQOL-SFTM (80 items)
Generic core: SF-36TM health survey
Kidney disease-targeted items (43 items)
One overall health item
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KDQOL-SFTM Kidney Disease-Targeted Scales
• Symptoms/problems (12 items)
• Effects of kidney disease (8 items)
• Burden of kidney disease (4 items)
• Work status (2 items)
• Cognitive function (3 items)
• Quality of social interaction (3 items)
• Sexual function (2 items)
• Sleep (4 items)
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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
HRQOL in Men Treated for Localized Prostate Cancer
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GenericSF-36
IntermediateCancer Rehabilitation Evaluation System (CARES)Functional Assessment of Cancer Therapy (FACT)
Disease-TargetedSexual, Urinary, Bowel Function/Distress
HRQOL Measures for Prostate Cancer Study
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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 Bowel Function Outcomes
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How do you summarize HRQOL?
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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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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 PCS
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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 MCS
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• SF-36 PCS & MCS SF-36 PCS & MCS ununcorrelated (r = correlated (r = 0.000.00))
• RAND-36 Physical Health & Mental Health RAND-36 Physical Health & Mental Health Composites correlated (r = Composites correlated (r = 0.660.66))
Hays, R. et al. (1998), RAND-36 Health Status Inventory.
Physical and Mental HealthSummary Scores
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• 3-month improvements in physical functioning, role—physical, pain, and general health perceptions ranging from 0.28 to 0.49 SDs.
• Yet SF-36 PCS did not improve.
Simon et al. (Med Care, 1998)
536 Primary Care Patients536 Primary Care PatientsInitiating Antidepressant TxInitiating Antidepressant Tx
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• Lower scores than general population on Lower scores than general population on
– Emotional well-being (Emotional well-being ( 0.3 SD) 0.3 SD)
– Role—emotional (Role—emotional ( 0.7 SD) 0.7 SD)
– Energy (Energy (1.0 SD)1.0 SD)
– Social functioning (Social functioning (1.0 SD) 1.0 SD)
• Yet SF-36 MCS was only Yet SF-36 MCS was only 0.20.2 SD lower. SD lower.
• RAND-36 mental health was RAND-36 mental health was 0.90.9 SD lower. SD lower.
Nortvedt et al. (Nortvedt et al. (Med CareMed Care, 2000), 2000)
n = 194 with Multiple Sclerosis
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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 XX
00
PhysicalPhysicalHealthHealth
X > 0X > 0
Mental Mental HealthHealth
0 > X0 > X
Social Social HealthHealth
0 >X0 >X
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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
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HRQOL Summary Options
Ignore mortality
• Single score--weighted combination
Profile and mortality information
Preference score
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35% 84% at least 1 moderate symptom
7% 70% at least 1 disability day
1% 11% hospital admission
2% 14% performance of invasivediagnostic procedure
Quartile on Perceived Health Index (reliability = 0.94)
Highest Lowest (n = 1,862)
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 Scores
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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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Marathoner 1.0
Person in coma 1.0
Problem with Survival Analysis
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• Societal Preferences (Multi-attribute Utility)
–QWB–HUI–EQ-5D
• Individual Preferences
–Standard Gamble–Time Tradeoff
Types of Preference Measures
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• 15 Minute Structured Interview
– Physical activity (PAC)
– Mobility (MOB)
– Social activity (SAC)
- Symptom/problem complexes (SPC)
• Summarizes Health in Quality-adjusted Life Years
Death Well-Being
0 1
• Well-Being Formula w = 1 + PAC + MOB + SAC + SPC
Quality of Well-Being Scale
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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 Procedure
012
43
5
78
6
910 Perfect Health
Death
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1) Dead2) In bed, chair, couch, or wheelchair*3) In wheelchair** or had difficulty
liftingstoopingusing stairswalking, etc.
4) None of the above
* Did not move oneself** Moved oneself
QWB Physical Activity Levels
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1) Dead
2) In hospital, nursing home, or hospice
3) Did not drive car or use public transportation
4) None of the above
QWB Mobility Levels
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1) Dead
2) Did not feed, bath, dress, or toilet oneself
3) Limited or did not perform role activities
4) None of the above
QWB Social Activity Levels
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Worst Symptom/problem complex experienced
Loss of consciousness –> breathing smog
QWB Symptom/Problem Complexes
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Component Measures States Weights
Physical activity Physical function In bed, chair, couch, or wheelchair* -.077In wheelchair* or had difficulty lifting, -.060
stooping, using stairs, walking, etc.
Mobility Ability to get around or In hospital, nursing home, or hospice. -.090 transport oneself Did not drive car or use public -.062
transportation
Social activity Role function and self-care Did not feed, bath, dress, or toilet f -.106Limited or did not perform role -.061
Symptom/problem Physical symptoms and Worst symptom from loss of -.407 complexes problems consciousness to breathing -.101
smog or unpleasant air
* moved vs. did not move oneself in wheelchair
Quality of Well-Being States and Weights
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HUI-3 (5-6 levels/attribute, 972,000 unique states)
Vision
Hearing
Speech
Ambulation
Dexterity
Cognition
Pain and discomfort
Emotion
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EQ-5D(3 levels/dimension, 243 states)
Mobility
Self-care
Usual activities
Pain/discomfort
Anxiety/depression
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Ad Hoc Preference Score Ad Hoc Preference Score EstimatesEstimates
Comprehensive Geriatric Assessment (n = 363 Comprehensive Geriatric Assessment (n = 363 community-dwelling older persons) lead to community-dwelling older persons) lead to improvements in SF-36 energy, social functioning, andimprovements in SF-36 energy, social functioning, and
Physical functioning (4.69 points) in 64 weeksPhysical functioning (4.69 points) in 64 weeks
Cost of $746 over 5 years beyond control groupCost of $746 over 5 years beyond control group
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Is CGA worth paying for?Is CGA worth paying for?
Change in QALYs associated with 4.69 change in SF-Change in QALYs associated with 4.69 change in SF-36 physical functioning36 physical functioning
r = 0.69 -> b = .003 x 4.69 =.014 ( r = 0.69 -> b = .003 x 4.69 =.014 ( QWB)QWB)
.014 x 5 yrs. = .014 x 5 yrs. = 0.07 QALYs0.07 QALYs
Cost/QALY: $10,600+Cost/QALY: $10,600+
<$20,000 per QALY worthwhile<$20,000 per QALY worthwhile
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Latest Preference ScoreLatest Preference Score
Brazier et al. (1998, in press)Brazier et al. (1998, in press)
6-dimensional classification6-dimensional classification
Collapsed role scales, dropped general Collapsed role scales, dropped general healthhealth
9000 possible states9000 possible states
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Health state 424421 (0.59)• Your health limits you a lot in moderate activities (such as
moving a table, pushing a vacuum cleaner, bowling or playing golf)
• You are limited in the kind of work or other activities as a result of your physical health
• Your health limits your social activities (like visiting friends, relatives etc.) most of the time.
• You have pain that interferes with your normal work (both outside the home and housework) moderately
• You feel tense or downhearted and low a little of the time.• You have a lot of energy all of the time
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Classical method of assessing preferences
• Choose between certain outcome and a gamble
• Conformity to axioms of expected utility theory
• Incorporates uncertainty (thus, more reflective of treatment decisions).
Standard Gamble
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Choice #1: Your present state (e.g., paralysis)
Choice #2: X probability of complete mobility1-X probability of death
Preference Value: Point at which indifferent between choices, varying X
[ X = QUALY ]
Standard Gamble (SG)
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• Choice between two certain outcomes
• Years of life traded for quality of life
• Simple to administer alternative to SG
Time Tradeoff (TTO)
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Choice #1: Your present state (e.g., paralysis)
Life Expectancy: 10 years
Choice #2: Complete mobility
How many years would you give up in your current state to be able to have complete mobility?
[ 1 - X = QUALY ]10
Time Tradeoff
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Limitations of Preference Measures
Sensitivity to Method
Societal• Coarseness of health states
Individual• Complexity of task
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Physical Health
P3 0.00 High P2 -0.20 Medium P1 -0.50 Low
Mental Health
M3 0.00 High M2 -0.30 Medium M1 -0.40 Low
Hypothetical Health States
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Perfect QOL
Dead
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
Exists MeasuredP3, M3
P2, M3
P3, M2
P3, M1
P1, M2
P1, M1
P1, M3
P2, M2
P2, M1
Mapping Health States into Quality of Life
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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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Child Measures
Child Health and Illness Profile (CHIP)
Starfield et al., Medical Care, 1995
COOP Charts
Baribeau, P. et al., 1991 (final report)
Functional Status II-R
Stein & Jessop, Medical Care, 1990
Child Health Questionnaire
Landgraf, Abetz, & Ware (2000)
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Summary
Optimal HRQOL Assessment
• Generic Profile
• Targeted Profile
• Preference-Based Summary Measure