Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries.

Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries.
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DOI:
10.1371/journal.pone.0114023
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发表时间:
2014
期刊:
影响因子:
3.7
通讯作者:
OPEN consortium
OPEN consortium
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Schmucker C;Schell LK;Portalupi S;Oeller P;Cabrera L;Bassler D;Schwarzer G;Scherer RW;Antes G;von Elm E;Meerpohl JJ;OPEN consortium

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在为临床和卫生政策决策提供信息时,在系统评价中综合已发表的研究是必不可少的。然而,如果期刊出版物代表了对已进行的所有研究的有偏见的选择(传播偏见),则系统审查的有效性受到威胁。为了调查传播偏差的程度,我们进行了一项系统的审查,确定了以同行评议的期刊文章形式发表的研究的比例,并调查了与研究队列中完整发表相关的因素(I)研究伦理委员会(REC)批准的研究或(Ii)纳入试验登记的研究。在四个书目数据库中搜索无发表年份、语言或研究地点限制的方法学研究项目(MRP)。通过手工搜索纳入的MRP的参考文献来补充这些搜索。我们使用预测区间(PI)和随机效应荟萃分析估计了已发表研究的比例。合并优势比(OR)被用来表示研究特征和期刊发表之间的关联。17个MRP(23个出版物)对REC批准的研究队列进行了评估;已发表研究的比例PI在22%到72%之间,合并估计时加权合并比例为46.2%(95%CI 40.2%-52.4%,I2 = 94.4%)。22篇MRP(22篇出版物)评估了纳入试验登记的研究队列;发表的比例的PI从13%到90%,加权合并比例将为54.2%(95%CI 42.0%-65.9%,I2 = 98.9%)。REC批准的结果具有统计学意义的研究(与那些没有统计意义的结果相比)更有可能发表(合并OR 2.8;95%可信区间2.2-3.5)。III期试验也比II期试验更有可能公布(合并OR 2.0;95%可信区间1.6-2.5)。研究完成后两年内发表论文的概率从7%到30%不等。区域经济共同体批准的或纳入试验登记的大部分研究仍未发表。由于这种巨大的异质性,对未来研究发表概率的预测是非常不确定的。不发表研究不是一个随机的过程,例如,它与研究结果的方向有关。我们的发现表明,研究成果的传播是有偏见的。
The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries. Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%–52.4%, I2 = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%–65.9%, I2 = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2–3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6–2.5). The probability of publication within two years after study completion ranged from 7% to 30%. A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.
DOI: 10.1371/journal.pone.0068409
发表时间: 2013
期刊: PloS one
影响因子: 3.7
作者:
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影响因子: 105.7
作者:
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通讯作者: Chapuis, F