Health Systems Based on Primary Health Care, Pan American Health Organization, Washington, DC 20037, USA.
Cad Saude Publica. 2013 Jun;29(6):1095-100.
The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.
本研究旨在确定拉丁美洲和加勒比生物医学期刊在多大程度上认可并遵守临床试验注册和报告指南。使用 LILACS 数据库对随机临床试验进行了检索。对通过检索确定的随机临床试验进行评估，以确定是否提及了试验注册和 CONSORT 指南。从研究中纳入的期刊的在线作者指南中提取了关于 ICMJE、试验注册和其他报告指南的认可信息。检索共确定了 477 篇参考文献。我们评估了随机抽取的 240 个标题，其中 101 个是发表在 56 种期刊上的随机临床试验。19.8%的随机临床试验报告了试验注册情况，6.9%是前瞻性注册，3%提到了 CONSORT。68%的期刊提到了 ICMJE，36%的期刊要求进行试验注册。提供报告指南建议的期刊较少：CONSORT（13%）、PRISMA（1.8%）、STROBE（1.8%）和 EQUATOR 网络（3.6%）。在拉丁美洲和加勒比地区进行的临床试验中，需要更广泛地认可试验注册并遵守报告指南。
