Medicine A, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel; Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel.
Medicine A, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel.
Clin Microbiol Infect. 2018 Nov;24(11):1211.e9-1211.e14. doi: 10.1016/j.cmi.2018.02.010. Epub 2018 Feb 15.
Discrepancies between ClinicalTrials.gov entries and matching publications were previously described in general medicine. We aimed to evaluate the consistency of reporting in trials addressing systemic antibiotic therapy.
We searched ClinicalTrials.gov for completed phase III trials comparing antibiotic regimens until May 2017. Matched publications were identified in PubMed. Two independent reviewers extracted data and identified inconsistencies. Reporting was assessed among studies started before and after 1 July 2005, when the International Committee of Medical Journal Editors (ICMJE) required mandatory registration as a prerequisite for considering a trial for publication.
Matching publications were identified for 75 (70%) of 107 ClinicalTrials.gov entries. Median time from study completion to publication was 26 months (interquartile range 19-42). Primary outcome definition was inconsistent between ClinicalTrials.gov and publications in seven trials (7/72, 10%) and reporting of the primary outcome timeframe was inconsistent in 14 (14/71, 20%). Secondary outcomes definitions were inconsistent in 36 trials (36/66, 55%). Reporting of inclusion criteria and study timeline were inconsistent in 17% (13/65) and 3% (2/65), respectively. Trials started after July 2005 were significantly less likely to have reporting inconsistencies and were published in higher impact factor journals.
We found a lower inconsistency rate of outcome reporting compared with other medical disciplines. Reporting completeness and consistency were significantly better after July 2005. The ICMJE requirement for mandatory registration was associated with significant improvement in reporting quality in infectious diseases trials. Prolonged time lag to publication and missing data from unpublished trials should raise a discussion on current reporting and publishing procedures.
此前在普通医学领域已描述过 ClinicalTrials.gov 条目与匹配出版物之间的差异。我们旨在评估针对全身抗生素治疗的试验报告的一致性。
我们在 ClinicalTrials.gov 上搜索了截至 2017 年 5 月完成的比较抗生素方案的 III 期试验。在 PubMed 中确定了匹配的出版物。两名独立的审查员提取数据并识别出不一致之处。评估了 2005 年 7 月 1 日之前和之后开始的研究的报告，当时国际医学期刊编辑委员会（ICMJE）要求强制性注册是考虑发表试验的前提。
75 项（70％）ClinicalTrials.gov 条目匹配到了出版物。从研究完成到出版的中位数时间为 26 个月（四分位距 19-42）。7 项试验（7/72，10％）的主要结局定义在 ClinicalTrials.gov 和出版物之间不一致，14 项试验（14/71，20％）的主要结局时间框架报告不一致。36 项试验（36/66，55％）的次要结局定义不一致。纳入标准和研究时间线的报告分别在 17％（13/65）和 3％（2/65）的试验中不一致。2005 年 7 月以后开始的试验报告不一致的发生率明显较低，并且发表在影响因子较高的期刊上。
我们发现与其他医学学科相比，结局报告的不一致率较低。2005 年 7 月以后，报告的完整性和一致性明显提高。ICMJE 强制性注册的要求与传染病试验报告质量的显著提高有关。从研究完成到发表的时间过长以及未发表试验中缺少数据，应就当前的报告和发表程序展开讨论。
