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Reporting of randomised controlled trials: Before and after the advent of the CONSORT statement

机译：随机对照试验的报告：CONSORT声明出现之前和之后

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摘要

Poorly conducted randomised controlled trials and inadequate reporting are susceptible to different forms of bias, which can have a detrimental effect?on the?interpretation and application?of?clinical evidence. This study examines the effect of Consolidated Standards of Reporting Trials (CONSORT) statement on the quality of the reporting of randomised controlled trials by comparing those published before and after the advent of the CONSORT. A systematic review was performed using a MEDLINE search to find all randomised controlled trials published in JAMA and the Lancet in the years 1995, 1997 and 2002. For each trial, the quality of reporting of sample size calculation, trial period, randomisation, and blinding was assessed. There was a substantial increase in the proportion of trials reporting sample size calculation, event rates, randomisation, and blinding in the RCTs post-CONSORT. However, the improvement in the quality of those reporting appears to be slow. This increase in quantity in the post-CONSORT period may be due to reporting and publication bias, where authors are trying to comply with the CONSORT guidelines and increasingly reporting favourable results, while at the same time not clearly explaining their methodology clearly. Authors and journal editors should strictly adhere with the CONSORT guidelines to ensure transparent, unbiased, and complete reporting so that we can reap the maximum benefit from clinical trials.
机译：随机对照试验开展不善和报告不充分容易受到不同形式的偏见的影响，这可能会对临床证据的解释和应用产生不利影响。这项研究通过比较CONSORT出现之前和之后发表的研究结果，检验了合并报告标准（CONSORT）声明对随机对照试验报告质量的影响。使用MEDLINE搜索进行了系统评价，以查找1995年，1997年和2002年在JAMA和Lancet上发表的所有随机对照试验。对于每个试验，样本量计算，试验期，随机化和盲法报告的质量被评估。在CONSORT之后，RCT中报告样本量计算，事件发生率，随机化和致盲性的试验比例显着增加。但是，这些报告质量的改善似乎很缓慢。 CONSORT后时期数量的增加可能是由于报告和出版物的偏见，作者试图遵守CONSORT指南并越来越多地报告良好的结果，而同时又没有清楚地说明其方法。作者和期刊编辑应严格遵守CONSORT指南，以确保透明，公正和完整的报告，以便我们可以从临床试验中获得最大的收益。

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