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泌尿学杂志会强制要求试验注册吗?一项已发表试验的横断面研究。

Do urology journals enforce trial registration? A cross-sectional study of published trials.

作者信息

Kunath Frank, Grobe Henrik R, Keck Bastian, Rücker Gerta, Wullich Bernd, Antes Gerd, Meerpohl Joerg J

机构信息

German Cochrane Centre, Institute of Medical Biometry & Medical Informatics, University Medical Centre Freiburg, Freiburg/Br., Germany.

出版信息

BMJ Open. 2011 Dec 6;1(2):e000430. doi: 10.1136/bmjopen-2011-000430. Print 2011.

Abstract

Objectives (1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered. Design Cross-sectional study of author instructions and published trials. Setting Journals publishing in the field of urology. Participants First, the authors analysed author instructions of 55 urology-related journals indexed in 'Journal Citation Reports 2009' (12/2010). The authors divided these journals in two groups: those requiring and those not mentioning trial registration as a precondition for publication. Second, the authors chose the five journals with the highest impact factor (IF) from each group. Intervention MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011); search of the clinical trials meta-search interface of WHO (International Clinical Trials Registry Platform) for RCTs that lacked information about registration (01-03/2011). Two authors independently assessed the information. Outcome measures Proportion of journals providing advice about trial registration and proportion of trials registered. Results Of 55 journals analysed, 26 (47.3%) provided some editorial advice about trial registration. Journals with higher IFs were more likely to mention trial registration explicitly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration explicitly were registered. This difference was statistically significant (p=0.04). Conclusions The existence of a statement about trial registration in author instructions resulted in a higher proportion of registered RCTs in those journals. Journals with higher IFs were more likely to mention trial registration.

摘要

目的 (1)评估泌尿学相关期刊作者指南中对试验注册的支持情况,以及(2)评估泌尿学领域的随机对照试验(RCT)是否有效注册。设计 对作者指南和已发表试验的横断面研究。地点 泌尿学领域的出版期刊。参与者 首先,作者分析了《期刊引证报告2009》(2010年12月)收录的55种泌尿学相关期刊的作者指南。作者将这些期刊分为两组:要求将试验注册作为发表前提条件的期刊和未提及试验注册的期刊。其次,作者从每组中选出影响因子(IF)最高的五种期刊。干预 通过医学主题词表(MEDLINE)检索,确定2009年(2011年1月)在这10种期刊上发表的RCT;在世界卫生组织的临床试验元搜索界面(国际临床试验注册平台)中搜索缺乏注册信息的RCT(2011年1月至3月)。两名作者独立评估信息。主要结局指标 提供试验注册建议的期刊比例和已注册试验的比例。结果 在分析的55种期刊中,26种(47.3%)提供了一些关于试验注册的编辑建议。IF较高的期刊更有可能明确提及试验注册(p=0.015)。在2009年发表的106项RCT中,63项(59.4%)已注册,2005年后有增加趋势(83.3%,p=0.035)。在提及并要求注册的期刊上发表的RCT中,71.4%(30/42)已注册,在未明确提及试验注册的期刊上发表的RCT中,51.6%(33/64)已注册。这种差异具有统计学意义(p=0.04)。结论 作者指南中存在关于试验注册的声明,使得这些期刊中已注册的RCT比例更高。IF较高的期刊更有可能提及试验注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a04d/3236819/87163cfce2e2/bmjopen-2011-000430fig1.jpg

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