Reliability, effect size, and responsiveness of health status measures in the design of randomized and cluster-randomized trials

Contemporary Clinical Trials

Volumn 26, Issue 1, 2005, Pages 45-58

  Diehr, Paula ^a   Chen, Lu ^a   Patrick, Donald ^a   Feng, Ziding ^a,b   Yasui, Yutaka ^c  

^a UNIVERSITY OF WASHINGTON   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c UNIVERSITY OF ALBERTA   (Canada)

Author keywords

Effect Size; Intraclass Correlation; Power; Reliability; Responsiveness; Sample size

Indexed keywords

ARTICLE; CLINICAL TRIAL; CLUSTER ANALYSIS; CONTROLLED CLINICAL TRIAL; CORRELATION ANALYSIS; COST EFFECTIVENESS ANALYSIS; HEALTH STATUS; HEALTH SURVEY; INSTRUMENT; MATHEMATICAL MODEL; MENTAL HEALTH CARE; PSYCHOMETRY; RANDOMIZED CONTROLLED TRIAL; RELIABILITY; SAMPLE SIZE; STATISTICAL ANALYSIS; VALIDATION PROCESS; COST BENEFIT ANALYSIS; DEPRESSION; ECONOMICS; EPIDEMIOLOGY; HUMAN; MENTAL HEALTH; METHODOLOGY; PSYCHOLOGIC TEST; REPRODUCIBILITY;

COST-BENEFIT ANALYSIS; DEPRESSIVE DISORDER; EPIDEMIOLOGIC FACTORS; HEALTH SURVEYS; HUMANS; INTERVIEW, PSYCHOLOGICAL; MENTAL HEALTH; PSYCHOLOGICAL TESTS; RANDOMIZED CONTROLLED TRIALS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SAMPLE SIZE;

EID: 17844406898     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2004.11.014     Document Type: Article

References (32)

1. J.C. Nunnally Psychometric theory 1967 McGraw-Hill Book New York
2. D.L. Streiner, and G.R. Norman Health measurement scales: a practical guide to their development and use Second edition 1995 Oxford University Press New York
3. Scientific Advisory Committee of the Medical Outcomes Trust Assessing health status and quality-of-life instruments: attributes and review criteria Qual. Life Res. 11 2002 193 205
4. D.L. Patrick, and P. Erickson Health status and health policy: allocating resources to health care 1993 Oxford University Press New York
5. E.H. Wagner, T.M. Wickizer, A. Cheadle, B.M. Psaty, T.D. Koepsell, and P. Diehr The Kaiser Family Foundation Community Health Promotion Grants Program: findings from an outcome evaluation Health Serv. Res. 35 3 2000 (Aug) 561 589
6. S.A. Beresford, B. Thompson, Z. Feng, A. Christianson, D. McLerran, and D.L. Patrick Seattle 5 a Day worksite program to increase fruit and vegetable consumption Prev. Med. 32 2001 230 238
7. S.B. Green, D.K. Carle, M.H. Gail, S.D. Mark, D. Pee, and L.S. Freedman Interplay between design and analysis for behavioral intervention trials with the community as the unit of randomization Am. J. Epidemiol. 142 1995 587 593
8. T. Koepsell, D. Martin, P. Diehr, B. Psaty, E. Wagner, and E. Perrin Data analysis and sample size issues in evaluations of community-based health promotion and disease prevention programs: a mixed-model analysis of variance approach J. Clin. Epidemiol. 44 1991 701 713
9. T. Koepsell, E. Wagner, A. Cheadle, D. Patrick, A. Kristal, and C.H. Allan-Andrilla Selected methodological issues in evaluating community-based health promotion and disease prevention programs Annu. Rev. Public Health 13 1992 31 57
10. T. Koepsell, P. Diehr, A. Cheadle, and A. Kristal Commentary: symposium on community preventive trials Am. J. Epidemiol. 142 1995 594 599
11. Z. Feng, P. Diehr, Y. Yasui, B. Evans, and T.D. Koepsell Explaining community-level variance in group randomized trials Stat. Med. 18 1999 539 556
12. Z. Feng, P. Diehr, A. Peterson, and D. McLerran Selected statistical issues in group randomized trials Annu. Rev. Public Health 22 2001 167 187
13. G. Guyatt, S. Walter, and G. Norman Measuring change over time: assessing the usefulness of evaluative instruments J. Chronic. Dis. 40 1987 171 178
14. D.L. Fairclough Design and analysis of quality of life studies in clinical trials 2002 Chapman and Hall New York
15. P.M. Fayers, and D. Machin Quality of life: assessment, analysis, and interpretation 2000 John Wiley and Sons West Sussex (England)
16. M.J. Staquet, R.D. Hays, and P.M. Fayers Quality of life assessment in clinical trials: methods and practice 1998 Oxford University Press New York
17. J.J. Bartko The intraclass correlation coefficient as a measure of reliability Psychol. Rep. 19 1966 3 11
18. J.L. Fleiss Reliability of measurement J.L. Fleiss The design and analysis of clinical experiments 1986 Wiley New York 1 32
19. R. Deyo, P. Diehr, and D. Patrick Reproducibility and responsiveness of health status measures: statistics and strategies for evaluation Control. Clin. Trials 12 1991 142S 158S
20. A.R. Kristal, S.A. Beresford, and D. Lazovich Assessing change in diet-intervention research Am. J. Clin. Nutr. 59 1994 185S 189S [Suppl.]
21. J. Cohen Statistical power analysis for the behavioral sciences Second edition 1988 Lawrence Erlbaum Associates Hillsdale (NJ)
22. P. Diehr, D.L. Patrick, G. Burke, and J. Williamson Survival versus years of healthy life: which is more powerful as a study outcome? Control. Clin. Trials 20 1999 267 279
23. A. Donner, and A. Klar Design and analysis of cluster randomization trials in health research 2000 Arnold London
24. M.H. Gail, D.P. Byar, T.F. Pechacek, and D.K. Corle Aspects of statistical design for the Community Intervention Trial for Smoking Cessation (COMMIT) Control. Clin. Trials 13 1992 6 21
25. D.M. Murray Design and analysis of group-randomized trials 1998 Oxford University Press New York
26. K. Campbell, J. Mollison, and J.M. Grimshaw Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size Stat. Med. 20 2001 391 399
27. Z. Feng, and J. Grizzle Correlated binomial variates: properties of estimator of intraclass correlation and its effect on sample size calculations Stat. Med. 11 1992 1607 1614
28. O.J. Dunn, and V. Clark Applied statistics: analysis of variance and regression 1974 John Wiley and Sons New York
29. C.M. Moinpour Costs of quality-of-life research in southwest oncology group trials J. Natl. Cancer Inst. Monogr. 20 1996 11 16
30. S. Yusuf, R. Collins, and R. Peto Why do we need some large, simple trials? Stat. Med. 3 1984 409 422
31. H. Herrman, D.L. Patrick, P. Diehr, M. Martin, M. Fleck, G. Simon the LIDO group Longitudinal investigation of depression outcomes in primary care in six countries: the LIDO study. Functional status, health service use and treatment of people with depressive symptoms Psychol. Med. 32 2002 889 902
32. R.C. Kessler, G. Andrews, D. Mroczek, B. Ustun, and H.U. Wittchen The World Health Organization Composite International Diagnostic Interview Short-Form (CIDI-SF) Int. J. Methods Psychiatr. Res. 7 1998 171 185