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1 Health-Related Quality of Life - 11 John E. Ware, Jr., PhD, Professor and Chief Measurement Sciences Division, Department of Quantitative Health Sciences University of Massachusetts Medical School, Worcester, MA Introduction to the Principles and Practice of Clinical Research National Institutes of Health - Warren G. Magnuson Clinical Center Building 10 Lipsett Amphitheater, Bethesda, MD, January 31, 11 What Are The Advances? Standardization (concepts & metrics) Better measures Adaptive (dynamic) survey administration Internet and other technologies 2 Quality of Life Community Education Family Life Friendships Health Housing Marriage Nation Neighborhood Self Standard of Living Work Source: Campbell,
2 World Health Organization Definition of Health Health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity WHO, Health is Measured in Terms of: Bodily structure & function Specific symptoms What you do/are able to do functioning How you feel subjective ill- and well-being (+ and -) What you say it is personal evaluation Sources: Understanding Health Outcomes Educational Series 5 Continuum of Disease-specific and Generic Health Measures - Arthritis X-ray, Disease Progression Arthritis Symptoms Arthritis Impact Generic Health Have you had the following symptoms: Joint pain, swelling, burning sensation: Almost every day Several days a week A few days a month Not at all How much does your arthritis limit your usual activities or enjoyment of everyday life? Not at all A little Moderately Extremely In general, would you say your health is: Excellent Very good Good Fair Poor Clinical Markers Specific Symptoms Impact of Diseasespecific Problems Generic Functioning, Well-being and Evaluation (1) (2) (3) (4) Adapted from: Wilson and Cleary, JAMA, 1995 Ware, Annual Rev. Pub. Health, 1995 Health-related QOL (HR-QOL) 6 6 2
3 Summary of Content/Concepts for Widely-Used Generic Health Surveys Psychometric Utility Concepts and Characteristics SIP HIE NHP QLI COOP DUKE MOS MOS PROMIS QWB EURO HUI SF-6D FWBP SF-36 -QOL CONCEPTS Physical functioning (-) Social functioning (-) Role functioning (-) Psychological distress (-) Health perception (gen l) Pain (-) Vitality (-) Psychological well-being Sleep Cognitive functioning Quality of life Reported health transition SIP = Sickness Impact Profile (1976) MOS SF-36 = MOS 36-Item Short-Form Health Survey (1992) HIE = Health Insurance Experiment surveys (1979) PROMIS = Patient Reported Outcomes Measurement NHP = Nottingham Health Profile (1980) Information System (08) QLI = Quality of Life Index (1981) QWB = Quality of Well-Being Scale (1973) COOP = Dartmouth Function Charts (1987) EUROQOL = European Quality of Life Index (1990) DUKE = Duke Health Profile (1990) HUI = Health Utility Index (1996) MOS FWBP = MOS Functioning & Well-Being Profile SF-6D= SF-36 Utility Index (02) (1992) 7 Source: Adapted from Ware, 1995 Visit the PROMIS Website 8 Anatomy of a Survey Item Recall period Item stem During the past 4 weeks, how often did your health ATTRIBUTION heart problem limit your ability to do your everyday activities such as work, school or chores? Attribution Domain/concept Never Rarely Sometimes Often Very often Response categories 9 3
4 SF-36 Health Survey Measurement Model Physical Mental 10 SF-36 Health Survey Utility Index (SF-6D) Physical Utility Index (Brazier et al., 02) (Lam, Brazier, McGhee 08) Mental 11 There is More to the Continuum Clinical Markers Specific Symptoms Impact of Diseasespecific Problems Generic Functioning, Well-being and Evaluation (1) (2) (3) (4) 12 4
5 Predictive Validity: HR-QOL is one of the Best Predictors Impact of Diseasespecific Problems Generic Functioning, Well-being and Evaluation (3) (4) Health-Related QOL (HR-QOL) Future health Inpatient expenditures Outpatient expenditures Job loss Response to treatment Return to work Work productivity Mortality 13 Methods: Standardization (norm-based scoring Item response theory (IRT) Computerized adaptive testing (CAT) Internet and handhelds 14 Improving the Physical Function Ruler 1980 Old Ruler > Ceiling NEW Ruler > Ceiling Vigorous Activities, Not limited 50 Norm Climbing several flights of stairs Walk one hundred yards 1,0 Limited 0,8 a lot Bathing or dressing, Limited a little 08 BETTER Ruler < 3 Ceiling Limited a little Not.76 Limited 0,6 0,4.24 0,2 0 a b Mean = 50 SD =
6 International Quality of Life Assessment (IQOLA) Project Standardized questionnaires and scoring methods Culturally sensitive questionnaires 16 Item Response Model Calibrations for Physical Function Items, Seven Countries Denmark (82) Italy (82) UK (81) Netherlands (79) Sweden (82) US (80) Germany (79) Vigorous activities raw Scoring Denmark (32) Italy (25) UK (24) Netherlands (22) 10 Sweden (31) Germany (29) US (24) Bathing Source: Raczek, Ware, Bjorner et al, JCE, Short-Form Surveys and Ceiling Effects Measuring Too Low - Ceiling Effect
7 IRT-Based Item Bank Combining HAQ and MOS Items Yielded a Better Scale + = Source: Business Week 11/26/01 MHAQ MOS Better Scale Physical Functioning (PF) Reference: M Martin, M Kosinski, J Bjorner, J Ware, R Maclean and T Li. Item Response Theory Methods Can Improve the Measurement of Physical Function by Combining the Modified Health Assessment Questionnaire and the SF-36 Physical Function Scale. Quality of Life Research, 07; 16: Some Thermometers Focus on a Very Narrow Range F C Cooking Thermometer Example: Cross-Calibrating Celsius and Fahrenheit Normal Human Blood Temperature F = 98.6 C = 37.0 Shirt Sleeve Weather Water Freezes 21 7
8 Cross-Calibration Makes Scores Comparable and Interpretable Theta (θ) [Best Possible Estimate] Scales HDI HIMQ MIDAS MSQ DYNHA-5 (+) Note: Direction of scoring shown with arrows Source: Ware, Bjorner & Kosinski, Medical Care, Standardization: Scoring = = = Scoring Software Static Short Forms Dynamic Short Forms Improvements in Short Form Measures of Health Status, J. Clinical Epidemiology, Solution: Assess Health Dynamically Patient scores here CAT CAT = Computerized Adaptive Testing 24 8
9 Logic of Computerized Adaptive Testing (CAT) 1. Begin with initial score estimate 2. Select & present optimal survey item No 5. Is stopping rule satisfied 3. Score response 4. Re- estimate health score and confidence interval Yes 6. End scale assessment 7. End of battery? No 8. Administer next scale Yes Source: Adapted from Wainer et al. (00) 9. Stop 25 Dynamic Assessments Match Questions to Each Patient s Level 80 Severe Moderate 50 Mild First Question Noisy Score Estimate (+/- 15) 80 Severe Moderate First Item Score = 62 +/- 15 Mild
10 Second Question: Standard Error Reduced by One Third 80 Severe Moderate Second Item Score = 64 +/- 10 Mild Third Question: Standard Error Cut in Half 80 Severe Moderate Third Item Score = 63 +/- 7 Mild Fourth Question: Standard Error Cut by Two Thirds 80 Severe Moderate Fourth Item Score = 62 +/- 5 Mild 10 10
11 A Promising Solution in 1999: CAT-Based Health Assessment Ceiling Effect r = N = 1016 r = N = 1016 Criterion Score 3 SD units Criterion Score No Disability Static 5-Item Headache Pain Measure Dynamic 5-Item Headache Pain Measure Reference: Ware JE, Jr., Bjorner JB, Kosinski M: Practical implications of item response theory and computerized adaptive testing: A brief summary of ongoing studies of widely used headache impact scales. Medical Care 00;38:II Practical Implications of CAT in Health Assessment 32 Performance of 5-item CAT Scores Confirmed in NIH-Sponsored Studies r = 0.98 N = 2,753 r = 0.94 N = 1, r = 0.96 N = Mental Health Headache Disability Pediatric Disability 2 r = N = 1, Chronic Kidney Disease r = N = Diabetes Impact 50 r = N = Post Acute Rehabilitation 33 11
12 What are the Advantages of Dynamic Assessments? More accurate risk screening Reliable enough to monitor individual outcomes Brevity of a short form 90% reduction in respondent burden Elimination of ceiling & floor effects Can be administered using various data collection technologies Markedly reduced data collection costs Monitor data quality in real time 34 Matching Methods to Applications Population Surveys 7 Group-Level Studies 7 6 Patient-Level Assessments Noisy Individual Classification Very 4Accurate Individual 3 Classification 2 2 Most 1 Functionally 1 Impaired 1 Single-Item Multi-Item Scale Item Bank (CAT Dynamic) 35 Dynamic Short-Forms are More Precise Difference Missed Difference Detected Norm Static Short Forms Dynamic Short Forms Norm Improvements in Short Form Measures of Health Status, J. Clinical Epidemiology,
13 HR-QOL Validation Strategies Gold Standard Diagnosis Disease severity Responders Treatments HR-QOL Work productivity Costs of care Mortality Self- evaluated health Other Measures & Methods Adapted from: Ware JE, Jr. and Keller SD: Interpreting general health measures, in: Quality of Life and Pharmacoeconomics in Clinical Trials. Philadelphia, PA: Lippincott-Raven Publishers; 1995: Chapter Rheumatoid Using Comprehensive ArthritisItem Banks as Criteria in Validating Physical Function Measures Reliable 0.90 PF-10 Range Reliable 0.90 CAT Range PF-2 ( Static ) 0.75 Standard Error 4.0 Reliable 0.95 CAT Range Rheumatoid Arthritis (RA) General Population PF-10 ( Static ) PF CAT Physical Function (PF), Mean = Reliability Gold Standard (136-Item Bank, N=17,726) Source: Rose M, Bjorner JB, Becker J, Fries JF and Ware JE. Evaluation of a preliminary physical function item bank supported expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). Journal of Clinical Epidemiology, 08, 61, HR-QOL Validation Strategies Clinical Causes Diagnosis Disease severity Responders Clinical endpoint Treatments Gold Standard HR-QOL Economic & Social Consequences Work productivity Costs of care Mortality Self-evaluated evaluated health Other Measures & Methods Adapted from: Ware JE, Jr. and Keller SD: Interpreting general health measures, in: Quality of Life and Pharmacoeconomics in Clinical Trials. Philadelphia, PA: Lippincott-Raven Publishers; 1995: Chapter
14 Standardizing Metrics Across Applications General Population Health Surveys Chronic Disease Registry Chronic Disease Registry Population Health Surveys Congestive Heart Failure Chronic Lung Disease Chronic Kidney Disease Diabetes Type II Asthma Average Adult Average Well Adult MOS Physical Component Summary (PCS) (Mean = 50, SD = 10) 55 Standardizing Metrics Across Applications General Chronic Population Clinical Disease Trials Health Registry Surveys RA RA Before Chronic After Rx Lung Rx Disease Congestive Heart Failure Chronic Treatment Kidney Effect (net) Disease Strand etal Arth & Rheum, 1999;42(9): Content of questionnaire items Statistically significant change Chronic Clinical Disease Population Trials Registry Important reduction in disease Health burden Surveys Reduction in subsequent expenditures Substantial increase in work productivity Diabetes Type II Asthma Average Adult Average Well Adult MOS Physical Component Summary (PCS) (Mean = 50, SD = 10) Are Generic HR-QOL Measures Responsive? X-ray, Disease Progression Arthritis SF-36 agreed with primary Arthritis Symptoms endpoint (across Rx): Impact Have you had the following symptoms: Joint pain, swelling, burning sensation: 219 of 253 RCTs 86.6% How much does your arthritis limit your usual activities or enjoyment of everyday life? Almost every day Not at all Several days a week A little A few days a month Moderately Not at all Extremely Generic Health In general, would you say your health is: Excellent Very good Good Fair Poor Clinical Markers Specific Symptoms Impact of Diseasespecific Problems Generic Functioning, Well-being and Evaluation (1) (2) (3) (4) Reference: Ware JE and Frendl D Systematic review of the responsiveness of SF-36 Health Survey measures to efficacious pharmaceutical therapies in published double-blind randomized controlled trials. Presentation at the 13th Annual European ISPOR Congress, Prague Czech Republic, November 6-9, 10 SF-36 RCTs 42 14
15 Internet: Sampling, Data Collection and Reporting Reference Headache Impact: MS Bayliss, JE Dewey, R Cady etal., A.Study of the Feasibility of Internet Administration of a computerized health survey: The Headache Impact Test (HIT), Quality of Life Research, 03, 12: References Asthma Control: Nathan RA, Sorkness CA, Kosinski M et al., Development of the Asthma Control Test: A survey for assessing asthma control. Journal of Allergy and Clinical Immunology. 04;113: Health Outcomes Research Using Handhelds Final Comments Continuum of outcomes (specific-generic) Standardization of concepts and metrics Advances in psychometric methods Advances in data collection methods Comprehensive validation 45 15
16 Thank You! 16
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