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 article reports on the outcomes of the Teens Eating for Energy and Nutrition at School (TEENS) study, a 2-year intervention study conducted in 16 middle schools with a goal of increasing students' intakes of fruits, vegetables, and lower fat foods. Despite positive interim results for students randomized to intervention schools, the positive effects of the intervention were not seen for the primary outcomes at the end of the 2nd year. Positive effects were seen only for a food choice score (suggesting that the students usually choose lower versus higher fat foods) and not for measures of food intake. Future studies may need to take a step back toward more controlled efficacy studies in working with this age-group. In addition, future work may consider the use of peer leaders, more intensive teacher training, ongoing formative assessment, and the testing of more powerful environmental change intervention strategies.
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.
This article compares four mixed-model analyses valid for group-randomized trials (GRTs) involving a nested cohort design with a single pretest and posttest. This study makes estimates of intraclass correlations (ICCs) available to investigators planning GRTs addressing dietary outcomes. It also provides formulae demonstrating the potential benefits to the standard error of the intervention effect (sigma(delta)) from adjustments for both fixed and time-varying covariates and correlations over time. These estimates will allow other researchers using these variables to plan their studies by estimating a priori detectable differences and sample size requirements for any of the four analytic options. These methods are demonstrated using data from the Teens Eating for Energy and Nutrition at School study. Mixed-model analyses of covariance proved to be the most powerful analysis in that data set. The formulae may be applied to any dependent variable in any GRT given corresponding information for those variables on the parameters that define the formulae.
Within Rothstein's ego-psychological framework, the pursuit of perfection is central to self-esteem regulation along a narcissistic spectrum of self-functioning [1]. In a test of this perspective, the Multidimensional Perfectionism Scale, the Narcissistic Personality Inventory (NPI), and other measures of narcissism were administered to 400 undergraduates. Self-and Other-Oriented Perfectionism predicted greater self-esteem, but this effect was mediated by the apparently more adaptive NPI factors. Selffunctioning variables displayed systematic linkages with perfectionism; and a rough "spectrum" of functioning was evident in the effects of partial correlations controlling for healthy self-esteem, for more adaptive narcissism, or for more maladaptive narcissism. These data supported a previously articulated hypothesis that at least some conscious representations of the self may vary along a continuum of self-esteem regulation.
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