Access to unpublished protocols and statistical analysis plans of randomised trials.
Access to unpublished protocols and statistical analysis plans of randomised trials.
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作者：
访问协议和统计分析计划（SAP）增加了随机试验的透明度，允许读者识别和解释研究方法的计划外变化，但它们通常不公开。我们试图确定研究者应要求共享不可用文件的频率。我们使用了来自两个先前确定的队列的试验（队列1：2018年1月至4月期间在高影响因子期刊上发表的101项试验;队列2：2018年6月在PubMed索引的期刊上发表的100项试验），以确定研究人员是否会根据要求共享不可用的方案/SAP。我们给没有公开协议或SAP的试验的通讯作者发了四次电子邮件。总体而言，两个队列的201项试验中有96项（48%）没有公开的方案或SAP（11/101高影响队列，85/100 PubMed队列）。总共有8/96名作者（8%）共享了一些试验文件（仅方案[n = 5];方案和SAP [n = 1];方案摘录[n = 1];研究伦理申请表[n = 1]）。我们收到了6/96项试验的方案（6%）和1/96项试验的SAP（1%）。73名作者（76%）没有回复，7名作者（7%）回复但拒绝分享方案或SAP，8名电子邮件地址无效（8%）。共发送了329封电子邮件（平均每项试验发送41封电子邮件）。在给作者发电子邮件后，有可用方案的试验总数仅增加了3%，从52%增加到55%。大多数研究者没有在直接要求时分享其未发表的方案或SAP。需要采取其他战略来提高随机试验的透明度，并确保获得方案和SAP。在线版本包含补充材料，可通过10.1186/s13063-022-06641-x获得。
Access to protocols and statistical analysis plans (SAPs) increases the transparency of randomised trial by allowing readers to identify and interpret unplanned changes to study methods, however they are often not made publicly available. We sought to determine how often study investigators would share unavailable documents upon request. We used trials from two previously identified cohorts (cohort 1: 101 trials published in high impact factor journals between January and April of 2018; cohort 2: 100 trials published in June 2018 in journals indexed in PubMed) to determine whether study investigators would share unavailable protocols/SAPs upon request. We emailed corresponding authors of trials with no publicly available protocol or SAP up to four times. Overall, 96 of 201 trials (48%) across the two cohorts had no publicly available protocol or SAP (11/101 high-impact cohort, 85/100 PubMed cohort). In total, 8/96 authors (8%) shared some trial documentation (protocol only [n = 5]; protocol and SAP [n = 1]; excerpt from protocol [n = 1]; research ethics application form [n = 1]). We received protocols for 6/96 trials (6%), and a SAP for 1/96 trial (1%). Seventy-three authors (76%) did not respond, 7 authors responded (7%) but declined to share a protocol or SAP, and eight email addresses were invalid (8%). A total of 329 emails were sent (an average of 41 emails for every trial which sent documentation). After emailing authors, the total number of trials with an available protocol increased by only 3%, from 52% in to 55%. Most study investigators did not share their unpublished protocols or SAPs upon direct request. Alternative strategies are needed to increase transparency of randomised trials and ensure access to protocols and SAPs. The online version contains supplementary material available at 10.1186/s13063-022-06641-x.
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DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David
影响因子：
9.3
作者：
Kahan, Brennan C.;Forbes, Gordon;Cro, Suzie
通讯作者：
Cro, Suzie
影响因子：
7.2
作者：
Greenberg, Lauren;Jairath, Vipul;Kahan, Brennan C.
通讯作者：
Kahan, Brennan C.
影响因子：
105.7
作者：
Chan, AW;Altman, DG
通讯作者：
Altman, DG
影响因子：
3.7
作者：
Dwan, Kerry;Altman, Douglas G.;Williamson, Paula R.
通讯作者：
Williamson, Paula R.