Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, Canada K1Y 4E9.
BMJ. 2011 May 11;342:d2496. doi: 10.1136/bmj.d2496.
To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.
Review of a random sample of published cluster randomised trials from an electronic search in Medline.
Cluster randomised trials in health research published in English language journals from 2000 to 2008. Study sample 300 cluster randomised trials published in 150 journals.
77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001).
Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.
调查群组随机试验的作者遵守世界医学协会赫尔辛基宣言和国际医学期刊编辑委员会统一要求（即报告研究伦理审查和知情同意）这两个基本要求的程度，确定报告的充分性是否随时间推移而有所改善，并确定与报告伦理实践相关的群组随机试验的特征。
对电子检索 Medline 中发表的群组随机试验的随机样本进行回顾。
2000 年至 2008 年期间在英语期刊上发表的健康研究中的群组随机试验。研究样本：150 种期刊上发表的 300 个群组随机试验。
77 项（26%，95%置信区间 21%至 31%）试验未报告伦理审查。报告伦理审查的比例随时间显著增加（P<0.001）。采用个体水平数据收集干预措施的试验比仅使用常规数据源的试验更有可能报告伦理审查（79%（n=151）比 55%（23）；P=0.008）。在设计和分析中考虑到聚类的试验更有可能报告伦理审查。发表期刊的中位影响因子对报告伦理审查的试验更高（3.4 比 2.3；P<0.001）。93 项（31%，26%至 36%）试验未报告同意。报告同意的比例随时间显著增加（P<0.001）。针对个体参与者的干预措施的试验比针对群组水平的干预措施的试验更有可能报告同意（87%（90）比 48%（41）；P<0.001）。采用个体水平数据收集干预措施的试验比仅使用常规数据源的试验更有可能报告同意（78%（146）比 29%（11）；P<0.001）。
群组随机试验中研究伦理保护的报告不充分。除了研究伦理批准外，作者还应报告是否寻求了知情同意、从谁那里寻求了同意以及同意的内容。
