Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials
Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials
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同行评审对主要结局报告和随机试验统计分析的影响
作者：
S. Hopewell;C. Witt;K. Linde;K. Icke;Olubusola Adedire;S. Kirtley;D. Altman
临床试验结果的选择性报告是一个严重的问题。我们的目的是调查的影响，在生物医学期刊的同行评议过程中的主要成果（S）和随机试验的报告内的统计分析。MethodsEvery month，PubMed（2014年5月至2015年4月）进行了搜索，以确定主要报告的随机试验发表在6个高影响力的一般和12个高影响力的专业期刊。每项试验的通讯作者都被邀请完成一项在线调查，询问作者对他们的手稿所做的修改，作为同行评议过程的一部分。我们的主要结果是评估：（1）作为同行评审过程的一部分，与主要结果和/或主要统计分析的报告有关的变化的性质和程度;（2）作者遵循这些要求的频率;以及（3）结果在893名被邀请参加在线调查的通讯作者中，（29%）回答。大多数试验为多中心试验（n = 191; 74%）;中位样本量为325（IQR 138 - 1010）。92%（n = 238）的主要结局明确，其中49%的治疗效果方向具有统计学意义。大多数人回答（1-10 Likert量表），他们对稿件的整体处理（平均值8.6，SD 1.5）和同行评审质量（平均值8.5，SD 1.5）感到满意。只有3%（n = 8）的人说编辑或同行评审员要求他们改变或澄清试验的主要结局。然而，27%（n = 69）报告称，他们被要求改变或澄清主要结局的统计分析;大多数人满足了要求，主要动机是改进统计方法（n = 38; 55%）或避免拒绝（n = 30; 44%）。总的来说，要求作者做出这种改变与期刊类型、干预措施、主要结局的重要性或资金来源之间几乎没有关联。36%（n = 94）的作者被要求纳入原始手稿中未包含的其他分析; 77%（n = 72）的作者未在方案中预先规定。百分之二十三（n = 60）已被要求修改他们的总体结论，通常（n = 53; 88%），以提供一个更谨慎的conclusionOverall，大多数变化，作为同行评议过程的结果，导致改进发表的手稿，有很少的证据表明，在事后的主要结果的变化方面的负面影响。但是，有些建议的更改可能被认为是不适当的，例如计划外的额外分析，应予以劝阻。
BackgroundSelective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials.MethodsEach month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics.ResultsOf 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1–10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial’s primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the primary outcome, or funding source. Thirty-six percent (n = 94) of authors had been asked to include additional analyses that had not been included in the original manuscript; in 77% (n = 72) these were not pre-specified in the protocol. Twenty-three percent (n = 60) had been asked to modify their overall conclusion, usually (n = 53; 88%) to provide a more cautious conclusion.ConclusionOverall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged.
影响因子：
120.7
作者：
Cho, MK;Justice, AC;Rennie, D
通讯作者：
Rennie, D