A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research.
A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research.
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DOI：
10.1186/s12874-017-0465-7
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发表时间：
2018-01-11
影响因子：
4
通讯作者：
Thabane L
中科院分区：
文献类型：
--
作者：
Li G;Abbade LPF;Nwosu I;Jin Y;Leenus A;Maaz M;Wang M;Bhatt M;Zielinski L;Sanger N;Bantoto B;Luo C;Shams I;Shahid H;Chang Y;Sun G;Mbuagbaw L;Samaan Z;Levine MAH;Adachi JD;Thabane L
前瞻性研究方案和登记可在减少初级生物医学研究的不完整或选择性报告方面发挥重要作用，因为它们是预先规定的蓝图，可用于评估和比较完整的报告。然而，方案或注册与完整报告之间的不一致经常被记录在案。在这篇系统性综述中，作为我们关于初级生物医学报告状态系列的一部分，我们旨在调查方案或注册之间不一致的现有证据（即，计划做什么和/或实际做了什么）和完整的报告（即，文献中报告的内容）;这是基于文献中的系统综述和调查结果。检索电子数据库，包括CINAHL、MEDLINE、Web of Science和EMBASE，以确定合格的调查和系统评价。我们的主要结果是方案或注册与完整报告之间的不一致性水平（以百分比表示，百分比越高表示不一致性越大）。我们对纳入的系统评价和调查结果进行了定性总结。共有37项研究（33项调查和4项系统评价）纳入我们的分析。大多数研究（n = 36）比较了临床试验中的方案或注册与完整报告，而一项调查侧重于临床试验的初步研究和观察性研究。在结果报告（范围从14%到100%）、亚组报告（从12%到100%）、统计分析（从9%到47%）和其他测量比较中发现了高不一致性水平。一些因素，如具有显著结果的结局、申办者、结局类型和疾病特异性与报告不一致显著相关。我们发现，协议或注册和主要生物医学研究的完整报告之间的不一致的报告是频繁的，普遍的和次优的。我们还确定了方法学问题，例如需要就测量试验报告来源之间的不一致性达成共识，以及更多的研究评估报告研究设计和分析各个方面的透明度和再现性。要解决这个问题，需要作者、期刊、赞助商、监管机构和研究伦理委员会的共同努力。
Prospective study protocols and registrations can play a significant role in reducing incomplete or selective reporting of primary biomedical research, because they are pre-specified blueprints which are available for the evaluation of, and comparison with, full reports. However, inconsistencies between protocols or registrations and full reports have been frequently documented. In this systematic review, which forms part of our series on the state of reporting of primary biomedical, we aimed to survey the existing evidence of inconsistencies between protocols or registrations (i.e., what was planned to be done and/or what was actually done) and full reports (i.e., what was reported in the literature); this was based on findings from systematic reviews and surveys in the literature. Electronic databases, including CINAHL, MEDLINE, Web of Science, and EMBASE, were searched to identify eligible surveys and systematic reviews. Our primary outcome was the level of inconsistency (expressed as a percentage, with higher percentages indicating greater inconsistency) between protocols or registration and full reports. We summarized the findings from the included systematic reviews and surveys qualitatively. There were 37 studies (33 surveys and 4 systematic reviews) included in our analyses. Most studies (n = 36) compared protocols or registrations with full reports in clinical trials, while a single survey focused on primary studies of clinical trials and observational research. High inconsistency levels were found in outcome reporting (ranging from 14% to 100%), subgroup reporting (from 12% to 100%), statistical analyses (from 9% to 47%), and other measure comparisons. Some factors, such as outcomes with significant results, sponsorship, type of outcome and disease speciality were reported to be significantly related to inconsistent reporting. We found that inconsistent reporting between protocols or registrations and full reports of primary biomedical research is frequent, prevalent and suboptimal. We also identified methodological issues such as the need for consensus on measuring inconsistency across sources for trial reports, and more studies evaluating transparency and reproducibility in reporting all aspects of study design and analysis. A joint effort involving authors, journals, sponsors, regulators and research ethics committees is required to solve this problem.
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影响因子：
4.8
作者：
Hernández, AV;Steyerberg, EW;Maas, AIR
通讯作者：
Maas, AIR
影响因子：
5
作者：
Boonacker, Chantal W. B.;Hoes, Arno W.;Rovers, Maroeska M.
通讯作者：
Rovers, Maroeska M.
影响因子：
9
作者：
Killeen, Shane;Sourallous, Panos;Grady, Helen L. O.
通讯作者：
Grady, Helen L. O.
影响因子：
9.3
作者：
Korevaar, Daniel A.;Ochodo, Eleanor A.;Hooft, Lotty
通讯作者：
Hooft, Lotty
DOI：
10.1136/bmj.c723
发表时间：
2010-03-23
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Hopewell S;Dutton S;Yu LM;Chan AW;Altman DG
通讯作者：
Altman DG