Individually randomized group treatment trials: A critical appraisal of frequently used design and analytic approaches

American Journal of Public Health

Volumn 98, Issue 8, 2008, Pages 1418-1424

  Pals, Sherri L ^a,e   Murray, David M ^b   Alfano, Catherine M ^b   Shadish, William R ^c   Hannan, Peter J ^d   Baker, William L ^d  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b OHIO STATE UNIVERSITY   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BEHAVIOR CHANGE; CORRELATION COEFFICIENT; DATA ANALYSIS; GROUP THERAPY; HUMAN; PUBLIC HEALTH; REVIEW; SAMPLE SIZE;

BIOMETRY; DATA INTERPRETATION, STATISTICAL; HUMANS; INTERVENTION STUDIES; PUBLIC HEALTH PRACTICE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 48749124966     PISSN: 00900036     EISSN: 15410048     Source Type: Journal    
DOI: 10.2105/AJPH.2007.127027     Document Type: Review

References (67)

1. Cornfield J. Randomization by group: a formal analysis. Am J Epidemiol. 1978;108:100-102.
2. Donner A, Birkett N, Buck C. Randomization by cluster: sample size requirements and analysis. Am J Epidemiol. 1981;114:906-914.
3. Murray DM. Design and Analysis of Group-Randomized Trials. New York, NY: Oxford University Press Inc; 1998.
4. Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004;94:423-429.
5. Kenny DA, Judd CM. Consequences of violating the independence assumption in analysis of variance. Psychol Bull. 1986;99:422-431.
6. Wampold BE, Serlin RC. The consequences of ignoring a nested factor on measures of effect size in analysis of variance. Psychol Methods. 2000;5:425-433.
7. Zucker DM. An analysis of variance pitfall: the fixed effects analysis in a nested design. Educ Psychol Meas. 1990;50:731-738.
8. Kish L. Survey Sampling. New York, NY: John Wiley & Sons Inc; 1965.
9. Murray DM, Hannan PJ, Baker WL. A Monte Carlo study of alternative responses to intraclass correlation in community trials: is it ever possible to avoid Cornfield's penalties? Eval Rev. 1996;20:313-337.
10. Varnell SP, Murray DM, Baker WL. An evaluation of analysis options for the one-group-per-condition design: can any of the alternatives overcome the problems inherent in this design? Eval Rev. 2001;25:440-453.
11. Murray DM, Phillips GA, Birnbaum AS, Lytle LA. Intraclass correlation for measures from a middle school nutrition intervention study: estimates, correlates, and applications. Health Educ Behav. 2001;28:666-679.
12. Murray DM, Alfano CM, Zbikowski SM, Padgett LS, Robinson LA, Klesges R. Intraclass correlation among measures related to cigarette use by adolescents: estimates from an urban and largely African American cohort. Addict Behav. 2002;27:509-527.
13. Scheier LM, Griffin KW, Doyle MM, Botvin GJ. Estimates of intragroup dependence for drug use and skill measures in school-based drug abuse prevention trials: an empirical study of three independent samples. Health Educ Behav. 2002;29:85-103.
14. Murray DM, Catellier DJ, Hannan PJ, et al. School-level intraclass correlation for physical activity in adolescent girls. Phys Fitness Perform. 2004;36:876-882.
15. Parker DR, Evangelou E, Eaton CB. Intraclass correlation coefficients for cluster randomized trials in primary care: the Cholesterol Education and Research Trial (CEART). Contemp Clin Trials. 2005;26:260-267.
16. Murray DM, Blitstein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Eval Rev. 2003;27:79-103.
17. Creamer M, Morris P, Biddle D, Elliot P. Treatment outcome in Australian veterans with combat-related posttraumatic stress disorder: a cause for cautious optimism? J Trauma Stress. 1999;12:545-558.
18. Herzog TA, Lazev AB, Irvin JE, Juliano LM, Greenbaum PE, Brandon TH. Testing for group membership effects during and after treatment: the example of group therapy for smoking cessation. Behav Ther. 2002;33:29-43.
19. Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials. 2005;2:152-162.
20. Hoyle RH, Georgesen JC, Webster JM. Analyzing data from individuals in groups: the past, the present, and the future. Group Dyn. 2001;5:41-47.
21. Kenny DA, Mannetti L, Pierro A, Livi S, Kashy DA. The statistical analysis of data from small groups. J Pers Soc Psychol. 2002;83:126-137.
22. Baldwin SA, Murray DM, Shadish WR. Empirically supported treatments or type I errors? Problems with the analysis of data from group-administered treatments. J Consult Clin Psychol. 2005;73:924-935.
23. Crits-Cristoph P, Mintz J. Implications of therapist effects for the design and analysis of comparative studies of psychotherapies. J Consult Clin Psychol. 1991;59:20-26.
24. Martindale C. The therapist-as-fixed-effect fallacy in psychotherapy research. J Consult Clin Psychol. 1978;46:1526-1530.
25. Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London, England: Edward Arnold; 2000.
26. Hoover DR. Clinical trials of behavioural interventions with heterogeneous teaching subgroup effects. Stat Med. 2002;21:1351-1364.
27. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13-22.
28. Lee KJ, Thompson SG. The use of random effects models to allow for clustering in individually randomized trials. Clin Trials. 2005;2:163-173.
29. Varnell SP, Murray DM, Janega JB, Blitstein JL. Design and analysis of group-randomized trials: a review of recent practices. Am J Public Health. 2004;94:393-399.
30. Lipsitz SR, Fitzmaurice GM, Orav EJ, Laird NM. Performance of generalized estimating equations in practical situations. Biometrics. 1994;50:270-278.
31. Wyatt GE, Longshore D, Chin D, et al. The efficacy of an integrated risk reduction intervention for HIV-positive women with child sexual abuse histories. AIDS Behav. 2004;8:453-462.
32. Wing RR. Prescribed "breaks" as a means to disrupt weight control efforts. Obes Res. 2003;11:287-291.
33. Gurka MJ, Wolf AM, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Lifestyle intervention in obese patients with type 2 diabetes: impact of the patient's educational background. Obesity. 2006;14:1085-1092.
34. Harvey-Berino J, Pintauro S, Buzzell P, Gold EC. Effect of Internet support on the long-term maintenance of weight loss. Obes Res. 2004;12:320-329.
35. Harvey-Berino J, Gold BC, Lauber R, Starinski A. The impact of calcium and dairy product consumption on weight loss. Obes Res. 2005;13:1720-1726.
36. Jeffery RW, Linde JA, Finch EA, Rothman AJ, King CM. A satisfaction enhancement intervention for long-term weight loss. Obesity. 2006;14:863-869.
37. Miller GD, Nicklas BJ, Davis C, Loeser RF, Lenchik L, Messier SP. Intensive weight loss program improves physical function in older obese adults with knee osteoarthritis. Obesity. 2006;14:1219-1230.
38. Stice E, Presnell K, Groesz L, Shaw H. Effects of a weight maintenance diet on bulimic symptoms in adolescent girls: An experimental test of the dietary restraint theory. Health Psychol. 2005;24:402-412.
39. Sikkema KJ, Hansen NB, Ghebremichael M, et al. A randomized controlled trial of a coping group intervention for adults with HIV who are AIDS bereaved: longitudinal effects on grief. Health Psychol. 2006;25:563-570.
40. Epstein LH. The effect of reinforcement or stimulus control to reduce sedentary behavior in the treatment of pediatric obesity. Health Psychol. 2004;23:371-380.
41. Herman S, Blumenthal JA, Babyak M, et al. Exercise therapy for depression in middle-aged and older adults: predictors of early dropout and treatment failure. Health Psychol. 2002;21:553-563.
42. Jackson K, Aiken LS. Evaluation of a multicomponent appearance-based sun-protective intervention for young women: uncovering the mechanisms of program efficacy. Health Psychol. 2006;25:34-46.
43. Lepore SJ, Helgeson VS, Eton DT, Schulz R. Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions. Health Psychol. 2003;22:443-452.
44. Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003;22:223-228.
45. Taylor KL, Lamdan RM, Siegel JE, Shelby R, Moran-Klimi K, Hrywna M. Psychological adjustment among African American breast cancer patients: one-year follow-up results of a randomized psychoeducational group intervention. Health Psychol. 2003;22:316-323.
46. Duncan GE, Perri MG, Anton SD, et al. Effects of exercise on emerging and traditional cardiovascular risk factors. Prev Med. 2004;39:894-902.
47. Fitzgibbon ML, Stolley MR, Schiffer L, Sanchez-Johnson LAP, Wells AM, Dyer A. A combined breast health/weight loss intervention for black women. Prev Med. 2005;40:373-383.
48. Korhonen M, Kastarinen M, Uusitupa M, Puska P, Nissinen A. The effect of intensified diet counseling on the diet of hypertensive subjects in primary health care: a 2-year open randomized controlled trial of lifestyle intervention against hypertension in eastern Finland. Prev Med. 2003;36:8-16.
49. Kukkonen-Harjula K, Borg PT, Nenonen AM, Fogelholm MG. Effects of a weight maintenance program with or without exercise on the metabolic syndrome: a randomized trial in obese men. Prev Med. 2005;41:784-790.
50. Lalonde L, Gray-Donald K, Lowensteyn I, et al. Comparing the benefits of diet and exercise in the treatment of dyslipidemia. Prev Med. 2002;35:16-24.
51. Winzenberg TM, Oldenburg B, Frendin S, De Wit L, Jones G. A mother-based intervention trial for osteoporosis prevention in children. Prev Med. 2006;42:21-26.
52. Mayer-Davis EJ, D'Antonio AM, Smith SM, et al. Pounds off with empowerment (POWER): a clinical trial of weight management strategies for black and white adults with diabetes who live in medically underserved rural communities. Am J Public Health. 2004;94:1736-1742.
53. Bier ID, Wilson J, Studt P, Shakleton M. Auricular acupuncture, education, and smoking cessation: a randomized, sham-controlled trial. Am J Public Health. 2002;92:1642-1647.
54. Van Devanter N, Gonzales V, Merzel C, Parikh NS, Celentano D, Greenberg J. Effect of an STD/HIV behavioral intervention on women's use of the female condom. Am J Public Health. 2002;92:109-115.
55. Wingood GM, DiClemente RJ, Harrington KF, et al. Efficacy of an HIV prevention program among female adolescents experiencing gender-based violence. Am J Public Health. 2006;96:1085-1090.
56. Clark MM, Hays JT, Vickers KS, et al. Body image treatment for weight concerned smokers: a pilot study. Addict Behav. 2005;30:1236-1240.
57. Hoff CC, Pals SL, Purcell DW, et al. Examining the role of partner status in an HIV prevention trial targeting HIV-positive gay and bisexual men: the Seropositive Urban Men's Intervention Trial (SUMIT). AIDS Behav. 2006;10:637-648.
58. Marlowe DB, Kirby KC, Festinger DS, Merikle EP, Tran GQ, Platt JJ. Day treatment for cocaine dependence: incremental utility over outpatient counseling and voucher incentives. Addict Behav. 2003;28:387-398.
59. van den Bosch LMC, Verheul R, Schippers GM, van den Brink W. Dialectical behavior therapy of borderline patients with and without substance use problems: implementation and long-term effects. Addict Behav. 2002;27:911-923.
60. Thorndike FP, Friedman-Wheeler DG, Haaga DAF. Effect of cognitive behavior therapy on smokers' compensatory coping skills. Addict Behav. 2006;31:1705-1710.
61. Wiers RW, Kummeling RHC. An experimental test of an alcohol expectancy challenge in mixed gender groups of young heavy drinkers. Addict Behav. 2004;29:215-220.
62. Copeland AL, Martin PD, Geiselman PJ, Rash CJ, Kendzor DE. Smoking cessation for weight-concerned women: group vs. individually tailored, dietary, and weight-control follow-up sessions. Addict Behav. 2006;31:115-127.
63. Davis CL, Tkacz J, Gregoski M, Boyle CA, Lovrekovic G. Aerobic exercise and snoring in overweight children: a randomized controlled trial. Obesity. 2006;14:1985-1991.
64. Schroeder JR, Epstein DH, Umbricht A, Preston KL. Changes in HIV risk behaviors among patients receiving combined pharmacological and behavioral interventions for heroin and cocaine dependence. Addict Behav. 2006;31:868-879.
65. Davison AC, Hinkley DV. Bootstrap Methods and Their Application. Cambridge, England: Cambridge University Press; 1997.
66. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-662.
67. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;20:702-708.