Plint Amy C, Moher David, Morrison Andra, Schulz Kenneth, Altman Douglas G, Hill Catherine, Gaboury Isabelle
Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.
Med J Aust. 2006 Sep 4;185(5):263-7. doi: 10.5694/j.1326-5377.2006.tb00557.x.
To determine whether the adoption of the CONSORT checklist is associated with improvement in the quality of reporting of randomised controlled trials (RCTs).
MEDLINE, EMBASE, Cochrane CENTRAL, and reference lists of included studies and of experts were searched to identify eligible studies published between 1996 and 2005.
Studies were eligible if they (a) compared CONSORT-adopting and non-adopting journals after the publication of CONSORT, (b) compared CONSORT adopters before and after publication of CONSORT, or (c) a combination of (a) and (b). Outcomes examined included reports for any of the 22 items on the CONSORT checklist or overall trial quality.
1128 studies were retrieved, of which 248 were considered possibly relevant. Eight studies were included in the review. CONSORT adopters had significantly better reporting of the method of sequence generation (risk ratio [RR], 1.67; 95% CI, 1.19-2.33), allocation concealment (RR, 1.66; 95% CI, 1.37-2.00) and overall number of CONSORT items than non-adopters (standardised mean difference, 0.83; 95% CI, 0.46-1.19). CONSORT adoption had less effect on reporting of participant flow (RR, 1.14; 95% CI, 0.89-1.46) and blinding of participants (RR, 1.09; 95% CI, 0.84-1.43) or data analysts (RR, 5.44; 95% CI, 0.73-36.87). In studies examining CONSORT-adopting journals before and after the publication of CONSORT, description of the method of sequence generation (RR, 2.78; 95% CI, 1.78-4.33), participant flow (RR, 8.06; 95% CI, 4.10-15.83), and total CONSORT items (standardised mean difference, 3.67 items; 95% CI, 2.09-5.25) were improved after adoption of CONSORT by the journal.
Journal adoption of CONSORT is associated with improved reporting of RCTs.
确定采用CONSORT清单是否与随机对照试验（RCT）报告质量的提高相关。
检索MEDLINE、EMBASE、Cochrane CENTRAL以及纳入研究和专家的参考文献列表，以识别1996年至2005年期间发表的符合条件的研究。
如果研究符合以下条件则纳入：（a）在CONSORT发表后比较采用和未采用CONSORT的期刊；（b）比较CONSORT采用者在CONSORT发表前后的情况；或（c）（a）和（b）的组合。检查的结果包括CONSORT清单上22项中的任何一项的报告或总体试验质量。
检索到1128项研究，其中248项被认为可能相关。8项研究纳入综述。与未采用者相比，采用CONSORT的研究者在序列产生方法的报告方面显著更好（风险比[RR]，1.67；95%置信区间[CI]，1.19 - 2.33）、分配隐藏（RR，1.66；95%CI，1.37 - 2.00）以及CONSORT项目的总数（标准化均值差，0.83；95%CI，0.46 - 1.19）。采用CONSORT对参与者流程报告（RR，1.14；95%CI，0.89 - 1.46）、参与者设盲（RR，1.09；95%CI，0.84 - 1.43）或数据分析师设盲（RR，5.44；95%CI，0.73 - 36.87）的影响较小。在研究CONSORT发表前后采用CONSORT的期刊的研究中，期刊采用CONSORT后，序列产生方法的描述（RR，2.78；95%CI，1.78 - 4.33）、参与者流程（RR，8.06；95%CI，4.10 - 15.83）以及CONSORT项目总数（标准化均值差，3.67项；95%CI，2.09 - 5.25）均有所改善。
期刊采用CONSORT与RCT报告质量的提高相关。
