Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.
Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.
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DOI：
10.1136/bmj.d5886
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发表时间：
2011-09-26
期刊：
影响因子：
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通讯作者：
Donner A
中科院分区：
文献类型：
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作者：
Ivers NM;Taljaard M;Dixon S;Bennett C;McRae A;Taleban J;Skea Z;Brehaut JC;Boruch RF;Eccles MP;Grimshaw JM;Weijer C;Zwarenstein M;Donner A
目的评估2004年CONSORT指南的扩展对整群随机试验报告和方法学质量的影响。设计方法学回顾300个随机抽样的整群随机试验。两名评价者独立地提取了14个与报告质量相关的标准和4个特定于集群随机试验的方法学标准。我们将CONSORT（2000-4）之前发表的手稿与CONSORT（2005-8）之后发表的手稿进行了比较。我们还调查了期刊影响因子，期刊类型和试验设置的差异。数据来源经验证的Medline检索策略。选择研究的合格标准2000-8年在英文期刊上发表的群集随机试验。结果14个报告标准中有5个有显著改善：确定为随机分组;随机分组的理由;报告结局评估是否盲法;报告随机分组的数量;报告失访的分组数量。在遵守方法标准方面没有发现重大改进。在临床而不是非临床环境中进行的试验以及在具有较高影响因子的医学期刊或一般医学期刊上发表的研究更有可能遵守推荐的报告和方法学标准，但没有证据表明，在临床环境下进行的试验或在普通医学杂志上发表的试验中，在发表了CONSORT扩展后，聚类试验的改善更有可能或者在影响因子更高的期刊中。结论自CONSORT扩展版发表以来，整群随机试验的报告质量仅在少数方面有所改善，在基本方法学特征方面没有任何改善。总体而言，对整群随机试验的报告和方法指南的遵守情况仍不理想，需要进一步努力改进报告和方法。
Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.