Pscheidl Tamara, Weber Florencia, Sydenham Emma, Meybohm Patrick, Weibel Stephanie
Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany.
Cochrane Central Editorial Service, Cochrane, London, UK.
BMJ Open. 2025 May 11;15(5):e092243. doi: 10.1136/bmjopen-2024-092243.
Prospective registration of randomised controlled trials (RCTs) is an international standard of good clinical practice but is often neglected by evidence synthesis producers. This study aims to assess prospective registration of RCTs included in evidence syntheses as part of a research integrity assessment and examine its impact on the study pool.
Meta-epidemiological study.
COVID-19 Cochrane reviews (CRs) and non-Cochrane systematic reviews (SRs) in MEDLINE via PubMed up to 9 June 2022.
RCTs from CRs and SRs evaluating 13 investigational medicinal products for SARS-CoV-2 and COVID-19.
We assessed prospective trial registration in RCTs according to domain 2 of the research integrity assessment tool. Prospective registration is defined as registration before participant enrolment. We extracted the trial registration number, registration date, study start date and inconsistencies in dates between study report and registration. RCTs were categorised as 'no concern', 'awaiting classification' and 'exclude'. We also analysed the relationship between study settings, publishing journals and prospective registration.
We included 188 RCTs. In the primary study report, 91% reported a trial registration number. In 84 RCTs, either not or retrospectively registered or with missing or inconsistent dates, we searched and/or contacted study authors for prospective registrations, resolving 17 RCTs. Ultimately, 58% of RCTs were prospectively registered and considered 'no concern', 15% were 'awaiting classification' due to inconsistent or missing information and 27% were either not registered or retrospectively registered and categorised as 'exclude'. Prospective registration was higher in larger or international multicentre RCTs and in RCTs conducted in Europe.
If prospective trial registration is required for inclusion in evidence syntheses, only 6 out of 10 COVID-19 RCTs would be eligible. Restricting eligibility to prospectively registered RCTs would include most large and international multicentre RCTs but exclude many smaller and non-European RCTs.
The protocol is available on OSF (https://osf.io/3bzeg).
随机对照试验（RCT）的前瞻性注册是良好临床实践的国际标准，但证据综合分析的生产者常常忽视这一点。本研究旨在评估作为研究完整性评估一部分的证据综合分析中纳入的RCT的前瞻性注册情况，并考察其对研究库的影响。
Meta流行病学研究。
截至2022年6月9日，通过PubMed检索MEDLINE中的COVID-19考克兰系统评价（CR）和非考克兰系统评价（SR）。
来自CR和SR的RCT，评估13种用于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）和COVID-19的研究用药品。
我们根据研究完整性评估工具的第2个领域评估RCT中的前瞻性试验注册情况。前瞻性注册定义为在参与者入组前进行注册。我们提取了试验注册号、注册日期、研究开始日期以及研究报告与注册之间日期的不一致之处。RCT被分类为“无问题”、“待分类”和“排除”。我们还分析了研究背景、发表期刊与前瞻性注册之间的关系。
我们纳入了188项RCT。在主要研究报告中，91%报告了试验注册号。在84项RCT中，要么未进行前瞻性注册或进行了回顾性注册（即入组后注册），要么日期缺失或不一致，我们搜索和/或联系了研究作者以获取前瞻性注册信息，解决了17项RCT的问题。最终，58%的RCT进行了前瞻性注册并被视为“无问题”，15%因信息不一致或缺失而“待分类”，27%要么未注册要么进行了回顾性注册并被分类为“排除”。在规模较大或国际多中心的RCT以及在欧洲进行的RCT中，前瞻性注册的比例更高。
如果证据综合分析要求纳入前瞻性试验注册的研究，那么每10项COVID-19 RCT中只有6项符合条件。将纳入标准限制为前瞻性注册的RCT将包括大多数大型和国际多中心的RCT，但会排除许多规模较小的和非欧洲的RCT。
该方案可在开放科学框架（OSF，https://osf.io/3bzeg）上获取。
