Characteristics and quality of reporting of cluster randomized trials in children: Reporting needs improvement
Sur la Croix 189, 1020 Renens, Switzerland. Journal of clinical epidemiology
(Impact Factor: 3.42).
07/2011; 64(12):1331-40. DOI: 10.1016/j.jclinepi.2011.04.006
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.
Available from: peerj.com
- "In a further analysis, we included only " explicit RCTs " (i.e., randomized trials that were explicitly defined in the text as " randomized controlled trial " or trials registered in a repository) because we hypothesized that such RCTs would have been conducted with a special focus on high methodological standards. In the final analyses, we excluded all the cross-over RCTs and cluster RCTs because these trial designs have also been associated with poor reporting (Walleser, Hill & Bero, 2011;Straube, Werny & Friede, 2015). Results of sensitivity analyses were reported with forest plots generated with RevMan (5.3; Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). "
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ABSTRACT: The validity of studies that assess the effectiveness of an intervention (EoI) depends on variables such as the type of study design, the quality of their methodology, and the participants enrolled. Five leading veterinary journals and 5 leading human medical journals were hand-searched for EoI studies for the year 2013. We assessed (1) the prevalence of randomized controlled trials (RCTs) among EoI studies, (2) the type of participants enrolled, and (3) the methodological quality of the selected studies. Of 1707 eligible articles, 590 were EoI articles and 435 RCTs. Random allocation to the intervention was performed in 52% (114/219; 95%CI:45.2–58.8%) of veterinary EoI articles, against 87% (321/371; 82.5–89.7%) of human EoI articles (adjusted OR:9.2; 3.4–24.8). Veterinary RCTs were smaller (median: 26 animals versus 465 humans) and less likely to enroll real patients, compared with human RCTs (OR:331; 45–2441). Only 2% of the veterinary RCTs, versus 77% of the human RCTs, reported power calculations, primary outcomes, random sequence generation, allocation concealment and estimation methods. Currently, internal and external validity of veterinary EoI studies is limited compared to human medical ones. To address these issues, veterinary interventional research needs to improve its methodology, increase the number of published RCTs and enroll real clinical patients.
Available from: Clare Rutterford
- "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 , 300 randomly sampled trials , 106 trials in children , and 73 trials in residential facilities . 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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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.
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.
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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ABSTRACT: Abstract Objective. To assess the impact of oral health promotion integrated with a health promoting school (HPS) initiative on the oral health outcomes of secondary school students. Materials and method. Using an urban-rural stratified cluster randomized approach, the intervention was applied to secondary school students in Arusha, Tanzania. In the urban, three control (n = 315) and two intervention (n = 214) schools performed oral clinical examination and questionnaires at baseline. In rural the corresponding figures at baseline were two (n = 188) and three (n = 360) schools. After 2 years, 374 and 358 students remained in the intervention and control arms. Results. Mean number of decayed teeth (DT) increased in the intervention (mean score 1.0 vs 1.7, p < 0.001) and control schools (mean score 1.2 vs 1.7, p < 0.001). Mean number of teeth with plaque decreased significantly in intervention and control schools. No significant difference in caries increment and plaque decline scores was observed between groups. Mean number of teeth with bleeding decreased (0.5 vs 0.3, p < 0.05) in intervention schools, whereas no change was observed in the control schools (0.4 vs 0.5, p = 0.051). Increment in mean number of DT between baseline and follow-up was largest and smallest in students who, respectively, deteriorated and improved their plaque and bleeding scores. Conclusion. The intervention activities did not show any effect with respect to dental caries, calculus and plaque status among the students investigated. Compared with the control group, more favorable changes in the intervention group occurred with respect to bleeding on probing, suggesting a weak but positive effect on students' oral hygiene status.
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