关键词: Orthopaedics Randomised clinical trials State of evidence Transparency

来  源:   DOI:10.1016/j.ocarto.2021.100215   PDF(Pubmed)

Abstract:
UNASSIGNED: To assess the extent and trends in registration of Orthopaedic randomized clinical trials (RCTs) between 2015 and 2020.
UNASSIGNED: Epidemiological study. Primary publications of RCTs published in top Orthopaedic journals (ISI Journal Citation Reports 2019 rankings) between 2015 and 2020 were included in this meta-epidemiological study with no restrictions on patient population, intervention/control groups or outcome type. Independent reviewers in pairs were involved in RCT selection and data extraction. The proportion of RCTs published that were registered (prospectively or retrospectively) or not registered were reported using counts and percentages stratified by years for each journal.
UNASSIGNED: A total of 474 primary RCTs were considered eligible. We identified 157 out of 474 RCTs (33% of RCTs across journals) that were reported to have been registered prospectively.The proportion of prospective RCT registrations had increased by 40% (10%-50%) between 2015 and 2020. On the other hand, the proportion of RCTs with no registrations were reduced by 29% (50%-21%) between 2015 and 2020.
UNASSIGNED: Prospective RCT registration in the past 5 years in the field of orthopaedic has increased, but 2/3 of published RCTs still failed to report prospective registration.
摘要:
UNASSIGNED:评估2015年至2020年骨科随机临床试验(RCT)注册的程度和趋势。
未经评估:流行病学研究。2015年至2020年在顶级骨科期刊上发表的RCTs的主要出版物(ISIJournalCitationReports2019排名)被纳入该元流行病学研究,对患者人群没有限制。干预/对照组或结果类型。成对的独立审阅者参与了RCT选择和数据提取。已注册(前瞻性或回顾性)或未注册的已发表RCT的比例使用计数和百分比进行报告,每个期刊按年份分层。
UNASSIGNED:总共474个主要随机对照试验被认为是合格的。我们确定了474个RCT中的157个(占期刊RCT的33%),据报道已前瞻性注册。在2015年至2020年期间,预期RCT注册的比例增加了40%(10%-50%)。另一方面,在2015年至2020年期间,没有注册的RCT比例减少了29%(50%-21%).
UNASSIGNED:在过去5年中,骨科领域的前瞻性RCT注册有所增加,但2/3已发表的RCT仍未报告预期注册.
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