Characteristics and quality of reporting of cluster randomized trials in children: Reporting needs improvement

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Journal of clinical epidemiology (Impact Factor: 3.42). 07/2011; 64(12):1331-40. DOI: 10.1016/j.jclinepi.2011.04.006
Source: PubMed


To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010.
Four databases were searched for reports of CRTs in children (0-18 years). Characteristics of the studies were summarized and the quality of reporting assessed using consolidated standards of reporting trial-CRT (CONSORT-CRT).
Of 1,949 identified references, 106 were included. The number of published CRTs in children increased since 2004. The greatest proportion of CRTs was undertaken in Europe (29%), whereas 40% was conducted in low- and middle-income countries. Most studies were of complex rather than simple interventions (83%); were preventive rather than treatment interventions (76%); and most frequently addressed infectious disease (21%), diet/physical activity interventions (19%), health-risk behaviors (15%), and undernutrition (13%). The majority used schools as units of randomization (72%) and enrolled 1,000-10,000 children per study (51%). Reporting was generally poor, with 34% of CRTs inadequately reporting on more than half of the CONSORT-CRT criteria. Although 85% of CRTs reported that they had ethics approval for the study, consent or assent was not obtained from children in most studies.
Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation.

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    • "The 2012 revision additionally recommends specification of whether equal or unequal cluster sizes are assumed. Adherence to all the reporting items provided in the 2004 CONSORT extension for CRTs has been reviewed in 23 trials in oral health [16], 300 randomly sampled trials [17], 106 trials in children [18], and 73 trials in residential facilities [19]. The presence of a sample size calculation in a trial report is considered an initial indication of reporting quality in the area of sample size. "
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    ABSTRACT: Objectives: To assess the quality of reporting and accuracy of a priori estimates used in sample size calculations for cluster randomized trials (CRTs). Study design and setting: We reviewed 300 CRTs published between 2000 and 2008. The prevalence of reporting sample size elements from the 2004 CONSORT recommendations was evaluated and a priori estimates compared with those observed in the trial. Results: Of the 300 trials, 166 (55%) reported a sample size calculation. Only 36 of 166 (22%) reported all recommended descriptive elements. Elements specific to CRTs were the worst reported: a measure of within-cluster correlation was specified in only 58 of 166 (35%). Only 18 of 166 articles (11%) reported both a priori and observed within-cluster correlation values. Except in two cases, observed within-cluster correlation values were either close to or less than a priori values. Conclusion: Even with the CONSORT extension for cluster randomization, the reporting of sample size elements specific to these trials remains below that necessary for transparent reporting. Journal editors and peer reviewers should implement stricter requirements for authors to follow CONSORT recommendations. Authors should report observed and a priori within-cluster correlation values to enable comparisons between these over a wider range of trials.
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