Defining clinically meaningful change in health-related quality of life

Journal of Clinical Epidemiology

Volumn 56, Issue 5, 2003, Pages 395-407

  Crosby, Ross D ^a,b   Kolotkin, Ronette L ^c   Williams, G Rhys ^d  

^a NEUROPSYCHIATRIC RESEARCH INSTITUTE   (United States)

^b UND School of Medicine & Health Sciences Southeast Campus   (United States)

^c Obesity and Quality of Life Consulting   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

Author keywords

Anchor based methods; Clinically meaningful change; Criterion referenced change; Distribution based methods; Health related quality of life; Minimally important difference; Precision referenced change

Indexed keywords

ACCURACY; ARTICLE; CALCULATION; CLINICAL RESEARCH; HEALTH CARE; INTERMETHOD COMPARISON; METHODOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSYCHOMETRY; QUALITY OF LIFE; RATING SCALE; STATISTICAL ANALYSIS;

EID: 0037567512     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0895-4356(03)00044-1     Document Type: Article

References (110)

1. Gotay C.C., Moore T.D. Assessing quality of life in head and neck cancer. Qual Life Res. 1:1992;5-17.
2. Berzon R. Understanding and using health-related quality of life instruments within clinical research studies. Staquet M.J., Hays R.D., Fayers P.M. Quality of life assessment in clinical trials: methods and practice. 2000;3-15 Oxford University Press, Oxford, England.
3. Fayers P.M., Machin D. Quality of life: assessment, analysis and interpretation. 2000;John Wiley&Sons, Chichester.
4. Ware J.E., Sherbourne C.D. The MOS 36-item short-form health survey (SF-36). Med Care. 30:1992;473-483.
5. Bergner M., Bobbit R.A., Carter W.B., et al. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 19:1981;787-805.
6. Hunt S.M., McKenna S.P., McEwen J., et al. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med. 15A:1981;221-229.
7. Brooks R., with the EuroQol group. EuroQol: the current state of play. Health Policy. 37:1996;53-72.
8. Mathias S.D., Williamson C.L., Colwell H.H., et al. Assessing health-related quality-of-life and health state preference in persons with obesity: a validation study. Qual Life Res. 6:1997;311-322.
9. Kolotkin R.L., Head S., Brookhart A., et al. Assessing impact of weight on quality of life. Obes Res. 3:1995;49-56.
10. Kolotkin R.L., Crosby R.D., Kosloski K.D., et al. Development of a brief measure to assess quality of life in obesity. Obes Res. 9:2001;102-111.
11. Le Pen C., Levy E., Loos F.M., et al. 'Specific' scale compared with 'generic' scale: a double measurement of the quality of life in a French community sample of obese subjects. J Epidemiol Commun Health. 52:1998;445-450.
12. Mannucci E., Ricca V., Bariculli E., et al. Quality of life and overweight: the obesity related well-being (ORWELL 97) questionnaire. Addict Behav. 24:1999;345-357.
13. Fries J.F., Spitz P., Kraines G., et al. Measurement of patient outcome in arthritis. Arthritis Rheum. 23:1980;137-145.
14. Meenan R.F., Mason J.H., Anderson J.J., et al. The content and properties of a revised and expanded Arthritis Impact Measurement Scale Health Status Questionnaire. Arthritis Rheum. 35:1992;1-10.
15. Hammond G.S., Aoki T.T. Measurement of health status in diabetic patients: diabetes impact measurement scales. Diabetes Care. 15:1992;469-477.
16. Fitzgerald J.T., Davis W.K., Connell C.M., et al. Development and validation of the Diabetes Care Profile. Eval Health Prof. 19:1996;208-230.
17. Meadows K., Steen N., McColl E., et al. The Diabetes Health Profile (DHP): a new instrument for assessing the psychosocial profile of insulin requiring patients-development and psychometric evaluation. Qual Life Res. 5:1996;242-254.
18. The DCCT Research Group. Reliability and validity of a Diabetes Quality of Life Measure (DQOL) for the Diabetes Control and Complications Trial (DCCT). Diabetes Care. 11:1988;725-732.
19. Juniper E.F., Guyatt G.H., Epstein R.S., et al. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 47:1992;76-83.
20. Marks G.B., Dunn S.M., Woolcock A.J. An evaluation of an asthma quality of life questionnaire as a measure of change in adults with asthma. J Clin Epidemiol. 46:1993;1103-1111.
21. Jones P.W., Quirk F.H., Baveystock C.M., et al. A self-complete measure of health status for chronic airflow limitation. Am Rev Respir Dis. 145:1992;1321-1327.
22. Guyatt G.H., Berman L.B., Townsend M., et al. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 42:1987;773-778.
23. Spitzer W.O., Dobson A.J., Hall J., et al. Measuring the quality of life in cancer patients. J Chronic Dis. 14:1981;585-597.
24. Aaronson N.K., Ahmedzai S., Bergman B., et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 85:1993;365-376.
25. Cella D.F., Tulsky D.S., Gray G., et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 11:1993;570-579.
26. De Haes J.C.J.M., Olschewski M., Fayers P.M., et al. Measuring the quality of life of cancer patients: the Rotterdam Symptom Checklist (RSCL): a manual. 1996;Northern Centre for Healthcare Research, Groningen.
27. Devinsky O., Vickrey B.G., Cramer J., et al. Development of the quality of life in epilepsy inventory. Epilepsia. 36:1995;1089-1104.
28. Bozzette S.A., Hays R.D., Berry S.H., et al. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care. 32:1994;716-731.
29. Jaeschke R., Guyatt G.H., Cook D. Quality of life instruments in the evaluation of new drugs. Pharmacoeconomics. 1:1992;84-94.
30. Revicki D.A., Allen H., Bungay K., et al. Responsiveness and calibration of the general well-being adjustment scale in patients with hypertension. J Clin Epidemiol. 437:1994;1333-1342.
31. Testa M.A., Lenderking W.R. Interpreting pharmacoeconomic and quality-of-life clinical trial data for use in therapeutics. Pharmacoeconomics. 2:1992;107.
32. Patrick D.L., Erickson P. Health status and health policy: quality of life in health care evaluation and resource allocation. 1992;Oxford University Press, New York.
33. Constitution of the World Health Organization. 1946;World Health Organization, Geneva.
34. Karnofsky D., Burchenal J. The clinical evaluation of chemotherapeutic agents in cancer. Maclead C. Evaluation of chemotherapeutic agents. 1949;191-205 Columbia University Press, New York.
35. Revicki D.A., Osoba D., Fairclough D., et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res. 9:2000;887-900.
36. Bergner M. Qualify of life, health status, and clinical research. Med Care. 27:(Suppl):1989;S148-S156.
37. Leidy N.K. Using functional status to assess treatment outcomes. Chest. 106:1994;1645-1646.
38. Gill T.M., Feinstein A.R. A critical appraisal of the quality of quality-of-life measurements. JAMA. 272:1994;619-626.
39. Testa M.A., Simonson D.C. Assessment of quality-of-life outcomes. New Engl J Med. 28:1996;835-840.
40. Berzon R., Hays R.D., Shumaker S.A. International use, application, and performance of health-related quality of life instruments. Qual Life Res. 2:1993;367-368.
41. Juniper E.F., Guyatt G.H., Willan A., et al. Determining a minimal important change in a disease specific quality of life questionnaire. J Clin Epidemiol. 47:1994;81-87.
42. Samsa G., Edelman D., Rothman M.L., et al. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics. 15:1999;141-155.
43. Jaeschke R., Singer J., Guyatt G.H. Ascertaining the minimal clinically important difference. Control Clin Trials. 10:1989;407-415.
44. Osoba D., Rodrigues G., Myles J., et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 16:1998;139-144.
45. Streiner D.L., Norman G.R. Health measurement scales: a practical guide to their development and use. 2nd edition: 1995;Oxford University Press, Oxford, England.
46. Guyatt G.H., Osoba D., Wu A.W., et al. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 77:2002;371-383.
47. Hageman W.J., Arrindell W.A. Establishing clinically significant change: increment of precision and distinction between individual and group level of analysis. Behav Res Ther. 37:1999;1169-1193.
48. Beaton D.E., Bombardier C., Katz J.N., et al. Looking for important change/differences in studies of responsiveness. J Rheumatol. 28:2001;400-405.
49. Lydick F., Epstein R.S. Interpretation of quality of life changes. Qual Life Res. 2:1993;221-226.
50. Deyo R.A., Inui T.S., Leininger J., et al. Physical and psychosocial function in rheumatoid arthritis: clinical use of a self-administered health status instrument. Arch Intern Med. 142:1982;879.
51. Ware J.E., Kosinski M., Keller S.D. SF-36 physical and mental summary scales: a user's manual. 1994;The Health Institute New England Medical Center, Boston.
52. Johnson P.A., Goldman L., Orav E.J., et al. Comparison of the medical outcomes study short-form 36-item health survey in black patients and white patients with acute chest pain. Med Care. 33:1995;145-160.
53. Brook R.H., Ware J.E., Davies-Avery A., et al. Conceptualization and measurement of health for adults in the health insurance study, vol. 8: overview. 1979;Rand Corporation, Santa Monica (CA).
54. Llewellyn-Thomas H.A., Williams J.I., Levy L., et al. Using a trade-off techniques to assess patients' treatment preferences for benign prostatic hyperplasia. Med Decis Making. 16:1996;262-272.
55. Jacobson N.S., Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 59:1991;12-19.
56. Hsu L.M. On the identification of clinically significant client changes: reinterpretation of Jacobson's cut scores. J Psychopathol Behav Assess. 18:1996;371-385.
57. Liang M.H. Evaluating measurement responsiveness. J Rheumatol. 22:1995;1191-1192.
58. Stucki G., Liang M.H., Fossel A.H., et al. Relative responsiveness of condition specific and health status measures in degenerative lumbar spinal stenosis. J Clin Epidemiol. 48:1995;1369-1378.
59. Bessette L., Sangha O., Kuntz K.M., et al. Comparative responsiveness of generic versus disease-specific and weighted versus unweighted health status measures in carpal tunnel syndrome. Med Care. 36:1998;491-502.
60. Deyo R.A., Inui T.S. Toward clinical application of health status measures: sensitivity of scales to clinically important changes. Health Serv Res. 19:1984;275-289.
61. Steinbroker O., Traeger G.H., Batterman R.C. Therapeutic criteria in rheumatoid arthritis. JAMA. 140:1949;659.
62. Mossey J.M., Shapiro E. Self-rated health: a predictor of mortality among the elderly. Am J Public Health. 72:1982;800-808.
63. Idler E.L., Angel R.J. Self-rate health and mortality in the NHANES-I epidemiology follow-up study. Am J Public Health. 80:1990;446-452.
64. Ware J.E., Manning W.G., Duan N., et al. Health status and the use of outpatient mental health services. Am Psychol. 39:1984;1090-1100.
65. Kolotkin R.L., Crosby R.D., Williams G.R. Integrating anchor-based and distribution-based methods to determine clinically meaningful change in obesity-specific quality of life. Qual Life Res. 11:2002;670.
66. Schwartz N., Sudman S. Autobiographical memory and the validity of retrospective reports. 1994;Springer-Verlag, New York.
67. Wyrwich K.W., Metz S., Babu A.N., et al. The reliability of retrospective change assessments. Qual Life Res. 11:2002;636.
68. Mozes B., Maor Y., Shmueli A. Do we know what global ratings of health-related quality of life measure? Qual Life Res. 8:1999;269-273.
69. Kirwan J.R., Chaput de Saintonge D.M., Joyce C.R.B., et al. Clinical judgment in rheumatoid arthritis III. British rheumatologists' judgments of 'change in response to therapy.' . Ann Rheum Dis. 43:1984;686-694.
70. Cella D.F., Hahn E.A., Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 11:2002;207-221.
71. Guyatt G.H., Jaeschke R.J. Reassessing quality of life instruments in the evaluation of new drugs. Pharmacoeconomics. 12:1997;616-626.
72. Lydick F., Yawn B.P. Clinical interpretation of health-related quality of life data. Staquet M.J., Hays R.D., Fayers P.M. Quality of life assessment in clinical trials: methods and practice. 1998;299-314 Oxford University Press, Oxford.
73. Hudgens S.A., Yost K., Cella D., et al. Comparing retrospective and prospective anchors for identifying minimally important differences. Qual Life Res. 11:2002;629.
74. Husted J.A., Cook R.J., Farewll V.T., et al. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 53:2000;459-468.
75. Liang M.H., Larson M.G., Cullen K.E., et al. Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Arthritis Rheum. 28:1985;542-547.
76. Deyo R.A., Diehr P., Patrick D.L. Reproducibility and responsiveness of health status measures: statistics and strategies for evaluation. Control Clin Trial. 12:1991;142S-158S.
77. Speer D.C., Greenbaum P.D. Five methods for computing significant individual client change and improvement rates: support for an individual growth curve approach. J Consult Clin Psychol. 63:1995;1044-1048.
78. Byrk A.S., Raudenbush S.W. Hierarchical linear models: applications and data analysis methods. 1992;Newbury Park (CA), Sage.
79. Schafer J.L., Graham J.W. Missing data: our view of the state of the art. Psychol Methods. 7:2002;147-177.
80. Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition: 1988;Academic Press, New York.
81. Kazis L.E., Anderson J.J., Meenan R.S. Effect sizes for interpreting changes in health status. Med Care. 27:(Suppl 3):1989;S178-S189.
82. Norman G.R., Stratford P., Regehr G. Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J Clin Epidemiol. 50:1997;869-879.
83. Anderson J.J., Chernoff M.C. Sensitivity to change of rheumatoid arthritis clinical trial outcome measures. J Rheumatol. 20:1993;535-537.
84. Liang M.H., Fossel A.H., Katz J.N. Comparisons of five health status instruments for orthopedic evaluation. Med Care. 28:1990;632-642.
85. Beaton D.E., Hogg-Johnson S., Bombardier C. Evaluating changes in health status: reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders. J Clin Epidemiol. 50:1997;79-93.
86. Garratt A.M., Ruta D.A., Abdalla M.I., et al. SF-36 Health Survey Questionnaire: II. responsiveness to changes in health status in four common clinical conditions . Qual Health Care. 3:1994;186-192.
87. Guyatt G.H., Bombardier C., Tugwell P.X. Measuring disease-specific quality of life in clinical trials. CMAJ. 134:1986;889-895.
88. Wyrwich K., Nienaber N., Tierney W., et al. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol. 52:1999;861-873.
89. Wolinsky F., Wan G., Tierney W. Changes in the SF-36 in 12 months in a sample of disadvantaged older adults. Med Care. 36:1998;1589-1598.
90. McHorney C.A., Tarlov A. Individual-patient monitoring in clinical practice: are available health status surveys adequate. Qual Life Res. 4:1995;293-307.
91. Speer D.C. Can treatment research inform decision makers? Nonexperimental method issues and examples among older adults. J Consult Clin Psychol. 62:1994;560-568.
92. Stratford P.W., Binkley J., Solomon P., et al. Defining the minimum level of detectable change for the Roland-Morris Questionnaire. Phys Ther. 76:1996;359-365.
93. Jacobson N.S., Follette W.C., Revenstorf D. Psychotherapy outcomes research: methods for reporting variability and evaluating clinical significance. Behav Therapy. 15:1984;336-352.
94. Jacobson N.S., Follette W.C., Revenstorf D. Toward a standard definition of clinically significant change. Behav Therapy. 17:1986;308-311.
95. Christensen L., Mendoza J.L. A method of assessing change in a single subject: an alteration of the RC index. Behav Therapy. 17:1986;305-308.
96. Deyo R.A., Patrick D.T. The significance of treatment effects: the clinical perspective. Med Care. 33:(Suppl):1995;AS286-AS291.
97. Norman G.R., Sridhar F.G., Guyatt G.H., et al. Relation of distribution- and anchor-based approaches in interpretation of changes in health-related quality of life. Med Care. 39:2001;1039-1047.
98. Cella D., Eton D.T., Fairchough D.L., et al. What is clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol. 55:2002;285-295.
99. st century. Ann Intern Med. 127:1997;743-750.
100. Stucki G., Daltroy L., Katz J.N., et al. Interpretation of change scores in ordinal clinical scales and health status measures: the whole may not equal the sum of the parts. J Clin Epidemiol. 49:1996;711-717.
101. Baker D.W., Hays R.D., Brook R.H. Understanding changes in health status: is the floor phenomenon merely the last step or the staircase? Med Care. 35:1997;1-15.
102. Hays R.D., Woolley J.M. The concept of clinically meaningful difference in health-related quality-of-life research: how meaningful is it? Pharmacoeconomics. 18:2000;419-423.
103. Stratford P.W., Binkley J.M., Riddle D.L., et al. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 1 . Phys Ther. 78:1998;1186-1196.
104. Kolotkin R.L., Crosby R.D. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite): user's manual. 2002;Obesity and Quality of Life Consulting, Durham (NC).
105. Moser M.T., Weis J., Bartsch H.H. How does regression to the mean affect thresholds of reliable change statistics? Simulations and examples for estimation of true change in cancer-related quality of life. Qual Life Res. 11:2002;669.
106. Speer D.C. Clinically significant change: Jacobson and Truax (1991) revisited. J Consult Clin Psychol. 60:1992;402-408.
107. Hsu L.M. Regression toward the mean associated with measurement error and the identification of improvement and deterioration in psychotherapy. J Consult Clin Psychol. 63:1995;141-144.
108. Ware J.E., Snow K., Kosinski M., et al. SF-36 Health Survey: manual and interpretation guide. 1993;The Health Institute, Boston.
109. Hays R.D., Anderson R., Revicki D. Psychometric considerations in evaluating health-related quality of life measures. Qual Life Res. 2:1993;441-449.
110. Lohr K.N., Aaronson N.K., Alonso J., et al. Evaluating quality-of-life and health status instruments: development of scientific review criteria. Clin Ther. 18:1996;979-991.