Sur la Croix 189, 1020 Renens, Switzerland.
J Clin Epidemiol. 2011 Dec;64(12):1331-40. doi: 10.1016/j.jclinepi.2011.04.006. Epub 2011 Jul 20.
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.
描述 2004 年至 2010 年期间发表的儿童整群随机试验（cluster randomized trials，CRTs）的特征和报告质量。
在四个数据库中搜索了关于儿童 CRTs 的报告（0-18 岁）。总结了研究特征，并使用 CONSORT-CRT（CONsolidated Standards of Reporting Trials-CRT）评估报告质量。
在 1949 篇确定的参考文献中，有 106 篇被纳入。自 2004 年以来，发表的儿童 CRTs 数量有所增加。CRTs 最大比例来自欧洲（29%），而 40%来自中低收入国家。大多数研究为复杂干预而非简单干预（83%）；为预防干预而非治疗干预（76%）；最常涉及传染病（21%）、饮食/体育活动干预（19%）、健康风险行为（15%）和营养不足（13%）。大多数研究以学校为随机分组单位（72%），每研究纳入 1000-10000 名儿童（51%）。报告总体较差，34%的 CRTs 对 CONSORT-CRT 标准的一半以上标准报告不足。尽管 85%的 CRTs 报告他们的研究已获得伦理批准，但大多数研究并未获得儿童的同意或同意。
需要针对 CRTs 的报告制定儿童特定的要素，以提高 CRTs 的报告质量，从而改善其规划和实施。
