Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles.
Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles.
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DOI：
10.1136/bmj.d1828
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发表时间：
2011-04-05
期刊：
影响因子：
--
通讯作者：
von Elm E
中科院分区：
文献类型：
--
作者：
Blümle A;Meerpohl JJ;Rücker G;Antes G;Schumacher M;von Elm E
目的确定随机试验方案中预先规定的受试者资格标准是否以及如何在后续文章中报告。设计队列研究。提交给德国医学院伦理委员会的设定方案。数据来源：2000年至2006年期间发表的52项试验方案和78项后续出版物。主要结局指标试验方案和后续出版物之间匹配、缺失、修改或新增合格性标准的比例。结果所有52项试验的方案与后续出版物之间存在差异。所有52项试验（100%，95%置信区间93%-100%）的出版物中均缺失合格性标准信息，44项试验（85%，72%-93%）进行了修改，21项试验（41%，27%-55%）新增了合格性标准信息。每项试验的合格性标准的平均数量为25（范围7-43），每项试验匹配合格性标准的平均比例为50%（95%置信区间为44%-55%，范围13-93）。在方案中预先规定的1248项合格性标准中，606项（49%，46%-51%）在后续出版物中匹配，479项（38%，36%-41%）缺失，163项（13%，11%-15%）修改。在出版物中增加了51项合格标准。大多数预先规定的合格标准是关于合并症（42%，39%至45%），治疗（20%，18%至22%）或疾病类型或严重程度（17%，15%至19%）。大多数缺失的合格性标准（96%，94%-97%）和修改的合格性标准（54%，46%-62%）表明研究人群更广泛，大多数增加的合格性标准（86%，74%-94%）表明研究人群更狭窄。结论：许多试验信息的使用者依赖于已发表的期刊文章。这些文章通常不反映方案中预先规定的研究人群的确切定义。对合格标准的报告不完整或不充分会妨碍对试验结果的适用性进行适当评估。
Objective To determine whether and how eligibility criteria of participants prespecified in protocols of randomised trials are reported in subsequent articles. Design Cohort study. Setting Protocols submitted to the ethics committee of a German medical faculty. Data sources 52 trial protocols and 78 subsequent publications published between 2000 and 2006. Main outcome measure Proportion of matching, missing, modified, or newly added eligibility criteria between trial protocols and subsequent publications. Results Differences were found between protocols and subsequent publications for all 52 trials. Information on eligibility criteria was missing in the publications for all 52 trials (100%, 95% confidence interval 93% to 100%), modified for 44 (85%, 72% to 93%), and newly added for 21 (41%, 27% to 55%). The mean number of eligibility criteria for each trial was 25 (range 7-43) and the mean proportion of matching eligibility criteria per trial was 50% (95% confidence interval 44% to 55%, range 13-93). Of 1248 eligibility criteria prespecified in the protocols, 606 (49%, 46% to 51%) were matching in subsequent publications, 479 (38%, 36% to 41%) were missing, and 163 (13%, 11% to 15%) were modified. 51 eligibility criteria were added to publications. Most prespecified eligibility criteria were about comorbidity (42%, 39% to 45%), treatment (20%, 18% to 22%), or type or severity of illness (17%, 15% to 19%). Most of the missing eligibility criteria (96%, 94% to 97%) and modified eligibility criteria (54%, 46% to 62%) suggested broader study populations and most of the added eligibility criteria (86%, 74% to 94%) suggested narrower study populations. Conclusions Many users of trial information rely on published journal articles. These articles generally do not reflect the exact definition of the study population as prespecified in the protocol. Incomplete or inadequate reporting of eligibility criteria hampers a proper assessment of the applicability of trial results.
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15.8
作者：
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通讯作者：
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影响因子：
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