Design and Analysis of Group-Randomized Trials: A Review of Recent Methodological Developments
David M. Murray, PhD,
Sherri P. Varnell, PhD, MS and
Jonathan L. Blitstein, MS
David M. Murray and Jonathan L. Blitstein are with the Department of Psychology, College of Arts and Sciences, University of Memphis, Memphis, Tenn. Sherri P. Varnell is with Northrop-Grumman Mission Systems, Atlanta, Ga.
Correspondence: Requests for reprints should be sent to David M. Murray, PhD, 3693 Norriswood, 202 Psychology Bldg, Memphis, TN 38134 (e-mail: d.murray{at}mail.psyc.memphis.edu).
We review recent developments in the design and analysis ofgroup-randomized trials (GRTs). Regarding design, we summarizedevelopments in estimates of intraclass correlation, power analysis,matched designs, designs involving one group per condition,and designs in which individuals are randomized to receive treatmentsin groups. Regarding analysis, we summarize developments inmarginal and conditional models, the sandwich estimator, model-basedestimators, binary data, survival analysis, randomization tests,survey methods, latent variable methods and nonlinear mixedmodels, time series methods, global tests for multiple endpoints,mediation effects, missing data, trial reporting, and software.
We encourage investigators who conduct GRTs to become familiarwith these developments and to collaborate with methodologistswho can strengthen the design and analysis of their trials.
This article has been cited by other articles:
E. S. Anderson, R. A. Winett, J. R. Wojcik, and D. M. Williams Social Cognitive Mediators of Change in a Group Randomized Nutrition and Physical Activity Intervention: Social Support, Self-efficacy, Outcome Expectations and Self-regulation in the Guide-to-Health Trial
J Health Psychol,
January 1, 2010;
15(1):
21 - 32.
[Abstract][PDF]
L. V. Hedges Adjusting a Significance Test for Clustering in Designs With Two Levels of Nesting
Journal of Educational and Behavioral Statistics,
December 1, 2009;
34(4):
464 - 490.
[Abstract][Full Text][PDF]
T. E. Hanlon, B. D. Simon, K. E. O'Grady, S. B. Carswell, and J. M. Callaman The Effectiveness of an After-school Program Targeting Urban African American Youth
Education and Urban Society,
November 1, 2009;
42(1):
96 - 118.
[Abstract][PDF]
M. E. Waring, M. B. Roberts, D. R. Parker, and C. B. Eaton Documentation and Management of Overweight and Obesity in Primary Care
J Am Board Fam Med,
September 1, 2009;
22(5):
544 - 552.
[Abstract][Full Text][PDF]
F Vigna-Taglianti, S Vadrucci, F Faggiano, G Burkhart, R Siliquini, M R Galanti, and t. E.-D. S. Group Is universal prevention against youths' substance misuse really universal? Gender-specific effects in the EU-Dap school-based prevention trial
J Epidemiol Community Health,
September 1, 2009;
63(9):
722 - 728.
[Abstract][Full Text][PDF]
S. Konstantopoulos Incorporating Cost in Power Analysis for Three-Level Cluster-Randomized Designs
Eval Rev,
August 1, 2009;
33(4):
335 - 357.
[Abstract][PDF]
B. T. Levy, A. Hartz, G. Woodworth, Y. Xu, and S. Sinift Interventions to Improving Osteoporosis Screening: An Iowa Research Network (IRENE) Study
J Am Board Fam Med,
July 1, 2009;
22(4):
360 - 367.
[Abstract][Full Text][PDF]
D. A. Dzewaltowski, P. A. Estabrooks, G. Welk, J. Hill, G. Milliken, K. Karteroliotis, and J. A. Johnston Healthy Youth Places: A Randomized Controlled Trial to Determine the Effectiveness of Facilitating Adult and Youth Leaders to Promote Physical Activity and Fruit and Vegetable Consumption in Middle Schools
Health Educ Behav,
June 1, 2009;
36(3):
583 - 600.
[Abstract][PDF]
D. Prabhakaran, P. Jeemon, S. Goenka, R. Lakshmy, K.R. Thankappan, F. Ahmed, P. P. Joshi, B.V. M. Mohan, R. Meera, M. S. Das, et al. Impact of a worksite intervention program on cardiovascular risk factors: a demonstration project in an Indian industrial population.
J. Am. Coll. Cardiol.,
May 5, 2009;
53(18):
1718 - 1728.
[Full Text][PDF]
I. Bulte and P. Onghena Randomization tests for multiple-baseline designs: An extension of the SCRT-R package
Behav Res Methods,
May 1, 2009;
41(2):
477 - 485.
[Abstract][PDF]
R. Goud, N. F de Keizer, G. ter Riet, J. C Wyatt, A. Hasman, I. M Hellemans, and N. Peek Effect of guideline based computerised decision support on decision making of multidisciplinary teams: cluster randomised trial in cardiac rehabilitation
BMJ,
April 27, 2009;
338(apr27_2):
b1440 - b1440.
[Abstract][Full Text][PDF]
S. J Dobbinson, V. White, M. A Wakefield, K. M Jamsen, V. White, P. M Livingston, D. R English, and J. A Simpson Adolescents' use of purpose built shade in secondary schools: cluster randomised controlled trial
BMJ,
February 17, 2009;
338(feb17_1):
b95 - b95.
[Abstract][Full Text][PDF]
S. L. Pals, B. L. Beaty, S. F. Posner, and S. S. Bull Estimates of Intraclass Correlation for Variables Related to Behavioral HIV/STD Prevention in a Predominantly African American and Hispanic Sample of Young Women
Health Educ Behav,
February 1, 2009;
36(1):
182 - 194.
[Abstract][PDF]
P. M. Johansson, A. P. de Leon, S. Sadigh, P. E. Tillgren, and C. Rehnberg Statistical modelling needed to find the effects from a community-based elderly safety promotion program
Eur J Public Health,
January 1, 2009;
19(1):
100 - 105.
[Abstract][Full Text][PDF]
L. Zeng, Y. Cheng, S. Dang, H. Yan, M. J Dibley, S. Chang, and L. Kong Impact of micronutrient supplementation during pregnancy on birth weight, duration of gestation, and perinatal mortality in rural western China: double blind cluster randomised controlled trial
BMJ,
November 7, 2008;
337(nov07_4):
a2001 - a2001.
[Abstract][Full Text][PDF]
S. L. Pals, D. M. Murray, C. M. Alfano, W. R. Shadish, P. J. Hannan, and W. L. Baker Individually Randomized Group Treatment Trials: A Critical Appraisal of Frequently Used Design and Analytic Approaches
Am J Public Health,
August 1, 2008;
98(8):
1418 - 1424.
[Abstract][Full Text][PDF]
I. BULTE and P. ONGHENA An R package for single-case randomization tests
Behav Res Methods,
May 1, 2008;
40(2):
467 - 478.
[Abstract][PDF]
D. M. Murray, S. L. Pals, J. L. Blitstein, C. M. Alfano, and J. Lehman Design and Analysis of Group-Randomized Trials in Cancer: A Review of Current Practices
J Natl Cancer Inst,
April 2, 2008;
100(7):
483 - 491.
[Abstract][Full Text][PDF]
B Roudsari, C Field, and R Caetano Clustered and missing data in the US National Trauma Data Bank: implications for analysis
Inj. Prev.,
April 1, 2008;
14(2):
96 - 100.
[Abstract][Full Text][PDF]
P. Z. Schochet Statistical Power for Random Assignment Evaluations of Education Programs
Journal of Educational and Behavioral Statistics,
March 1, 2008;
33(1):
62 - 87.
[Abstract][Full Text][PDF]
L. V. Hedges Effect Sizes in Cluster-Randomized Designs
Journal of Educational and Behavioral Statistics,
December 1, 2007;
32(4):
341 - 370.
[Abstract][Full Text][PDF]
B. Roudsari, R. Fowler, and A. Nathens Intracluster correlation coefficient in multicenter childhood trauma studies
Inj. Prev.,
October 1, 2007;
13(5):
344 - 347.
[Abstract][Full Text][PDF]
L. V. Hedges Correcting a Significance Test for Clustering
Journal of Educational and Behavioral Statistics,
June 1, 2007;
32(2):
151 - 179.
[Abstract][Full Text][PDF]
C. DiIorio, F. McCarty, K. Resnicow, S. Lehr, and P. Denzmore REAL Men: A Group-Randomized Trial of an HIV Prevention Intervention for Adolescent Boys
Am J Public Health,
June 1, 2007;
97(6):
1084 - 1089.
[Abstract][Full Text][PDF]
E. Yorkston, C. Turner, P. J Schluter, and R. McClure Quantifying the effect of a community-based injury prevention program in Queensland using a generalized estimating equation approach
Inj. Prev.,
June 1, 2007;
13(3):
191 - 196.
[Abstract][Full Text][PDF]
L. V. Hedges and E. C. Hedberg Intraclass Correlation Values for Planning Group-Randomized Trials in Education
Educational Evaluation and Policy Analysis,
March 1, 2007;
29(1):
60 - 87.
[Abstract][Full Text][PDF]
M. D. Slater, K. J. Kelly, R. W. Edwards, P. J. Thurman, B. A. Plested, T. J. Keefe, F. R. Lawrence, and K. L. Henry Combining in-school and community-based media efforts: reducing marijuana and alcohol uptake among younger adolescents
Health Educ. Res.,
February 1, 2006;
21(1):
157 - 167.
[Abstract][Full Text][PDF]
M. H. Samore, K. Bateman, S. C. Alder, E. Hannah, S. Donnelly, G. J. Stoddard, B. Haddadin, M. A. Rubin, J. Williamson, B. Stults, et al. Clinical Decision Support and Appropriateness of Antimicrobial Prescribing: A Randomized Trial
JAMA,
November 9, 2005;
294(18):
2305 - 2314.
[Abstract][Full Text][PDF]
J. D. Huber, G. Kernell, and E. L. Leoni Institutional Context, Cognitive Resources and Party Attachments Across Democracies
Political Analysis,
October 1, 2005;
13(4):
365 - 386.
[Abstract][Full Text][PDF]
J. L. Blitstein, P. J. Hannan, D. M. Murray, and W. R. Shadish Increasing the Degrees of Freedom in Existing Group Randomized Trials: The df* Approach
Eval Rev,
June 1, 2005;
29(3):
241 - 267.
[Abstract][PDF]
J. L. Blitstein, D. M. Murray, P. J. Hannan, and W. R. Shadish Increasing the Degrees of Freedom in Future Group Randomized Trials: The df* Approach
Eval Rev,
June 1, 2005;
29(3):
268 - 286.
[Abstract][PDF]
M. K Campbell, P. M Fayers, and J. M Grimshaw Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research
Clinical Trials,
April 1, 2005;
2(2):
99 - 107.
[Abstract][PDF]
D. C. Des Jarlais, C. Lyles, N. Crepaz, and the TREND Group Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement
Am J Public Health,
March 1, 2004;
94(3):
361 - 366.
[Abstract][Full Text][PDF]
S. P. Varnell, D. M. Murray, J. B. Janega, and J. L. Blitstein Design and Analysis of Group-Randomized Trials: A Review of Recent Practices
Am J Public Health,
March 1, 2004;
94(3):
393 - 399.
[Abstract][Full Text][PDF]