Public Policies and Research, Health Systems Based on Primary Health Care, Pan American Health Organization, Washington DC 20037, USA.
J Clin Epidemiol. 2012 May;65(5):482-7. doi: 10.1016/j.jclinepi.2011.09.003. Epub 2012 Jan 29.
To determine the prevalence of trial registration in randomized controlled trials (RCTs) published in 2010 (PUBMED/LILACS) from Latin America and the Caribbean's (LAC) and to compare methodological characteristics between registered and nonregistered RCTs.
A search for detecting RCTs in which at least the first/contact author had a LAC's affiliation was made. We determined if RCTs were registered in the International Clinical Trial Registry Platform (ICTRP). Data were independently extracted by two authors. The risk of bias (RoB) was assessed in all registered RCTs (n=89) and in a sample of nonregistered RCTs (n=237).
The search identified 1,695 references; 526 RCTs from 19 countries were included. 16.9% (89/526) of RCTs were registered in the ICTRP; however, only 21 (4.0%) were prospectively registered. A significant difference was found in the overall assessment of the RoB between registered and nonregistered RCTs. Overall, registered RCTs were multinational, had larger sample size and longer follow-up, and reported more frequently information on funding, conflict of interests, and ethic issues. No significant differences were found when analyzing prospectively registered RCTs.
This study shows that trial registration rates are still low in LAC and the quality of reporting needs to be improved.
确定 2010 年（PUBMED/LILACS）发表的拉丁美洲和加勒比地区（LAC）随机对照试验（RCT）的试验注册率，并比较已注册和未注册 RCT 的方法学特征。
搜索至少第一/联系作者具有 LAC 隶属关系的 RCT。我们确定 RCT 是否在国际临床试验注册平台（ICTRP）上进行了注册。两名作者独立提取数据。对所有已注册 RCT（n=89）和非注册 RCT 样本（n=237）进行了偏倚风险（RoB）评估。
搜索共确定了 1695 篇参考文献；纳入了来自 19 个国家的 526 项 RCT。16.9%（89/526）的 RCT 在 ICTRP 上进行了注册；然而，只有 21 项（4.0%）是前瞻性注册的。已注册和未注册 RCT 之间的 RoB 总体评估存在显著差异。总体而言，已注册 RCT 为多中心研究，样本量较大，随访时间较长，并且更频繁地报告了资金、利益冲突和伦理问题的信息。当分析前瞻性注册 RCT 时，未发现显著差异。
本研究表明，LAC 的试验注册率仍然较低，报告质量需要提高。
