We review recent developments in the design and analysis of group-randomized trials (GRTs). Regarding design, we summarize developments in estimates of intraclass correlation, power analysis, matched designs, designs involving one group per condition, and designs in which individuals are randomized to receive treatments in groups. Regarding analysis, we summarize developments in marginal and conditional models, the sandwich estimator, model-based estimators, binary data, survival analysis, randomization tests, survey methods, latent variable methods and nonlinear mixed models, time series methods, global tests for multiple endpoints, mediation effects, missing data, trial reporting, and software. We encourage investigators who conduct GRTs to become familiar with these developments and to collaborate with methodologists who can strengthen the design and analysis of their trials.
This study reports intraclass correlation (ICC) for dependent variables used in group-randomized trials (GRTs). The authors also document the effect of two methods suggested to reduce the impact of ICC in GRTs; these two methods are modeling time and regression adjustment for covariates. They coded and analyzed 1,188 ICC estimates from 17 published, in press, and unpublished articles representing 21 studies. Findings confirm that both methods can improve the efficiency of analyses shown to be valid across conditions common in GRTs. Investigators planning GRTs should obtain ICC estimates matched to their planned analysis so that they can size their studies properly.
Objective To determine the effectiveness of a sanitation campaign that combines "shaming" (i.e. emotional motivators) with subsidies for poor households in rural Orissa, an Indian state with a disproportionately high share of India's child mortality. Methods Using a cluster-randomized design, we selected 20 treatment and 20 control villages in the coastal district of Bhadrak, rural Orissa, for a total sample of 1050 households. We collected sanitation and health data before and after a community-led sanitation project, and we used a difference-in-difference estimator to determine the extent to which the campaign influenced the number of households building and using a latrine. Findings Latrine ownership did not increase in control villages, but in treatment villages it rose from 6% to 32% in the overall sample, from 5% to 36% in households below the poverty line (eligible for a government subsidy) and from 7% to 26% in households above the poverty line (not eligible for a government subsidy). Conclusion Subsidies can overcome serious budget constraints but are not necessary to spur action, for shaming can be very effective by harnessing the power of social pressure and peer monitoring. Through a combination of shaming and subsidies, social marketing can improve sanitation worldwide.Une traduction en français de ce résumé figure à la fin de l'article. Al final del artículo se facilita una traducción al español. املقالة. لهذه الكامل النص نهاية يف الخالصة لهذه العربية الرتجمة
We reviewed group-randomized trials (GRTs) published in the American Journal of Public Health and Preventive Medicine from 1998 through 2002 and estimated the proportion of GRTs that employ appropriate methods for design and analysis. Of 60 articles, 9 (15.0%) reported evidence of using appropriate methods for sample size estimation. Of 59 articles in the analytic review, 27 (45.8%) reported at least 1 inappropriate analysis and 12 (20.3%) reported only inappropriate analyses. Nineteen (32.2%) reported analyses at an individual or subgroup level, ignoring group, or included group as a fixed effect. Hence increased vigilance is needed to ensure that appropriate methods for GRTs are employed and that results based on inappropriate methods are not published.
Many investigators who use group-randomized trials in cancer research do not adequately attend to the special design and analytic challenges associated with these trials. Failure to do so can lead to reporting type I errors as real effects, mislead investigators and policy-makers, and slow progress toward control and prevention of cancer. A collaborative effort by investigators, statisticians, and others will be required to ensure that group-randomized trials are planned and analyzed using appropriate methods so that the scientific community can have confidence in the published results.
Objective: The present study examined whether characteristics such as quality, selection and convenience are associated with dietary intake of fruits and vegetables independent of perceived costs in an inner-city, low-income population.
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