Institute for Research in Operative Medicine, Chair of Surgical Research, Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany.
Institute for Research in Operative Medicine, Chair of Surgical Research, Faculty of Health, School of Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109 Cologne, Germany.
J Clin Epidemiol. 2018 Jan;93:120-127. doi: 10.1016/j.jclinepi.2017.09.017. Epub 2017 Sep 22.
The objective of this study was to analyze the features of registry-based randomized trials (rRCTs).
We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics.
The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%.
rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis.
本研究旨在分析基于注册的随机对照试验（rRCT）的特征。
我们系统地在 PubMed 中搜索 rRCT。由两名评审员独立进行研究选择。我们将所有数据提取到标准化表格中，并准备描述性汇总统计数据。
搜索结果有 1202 个结果。我们纳入了 71 项 rRCT。大多数 rRCT 来自丹麦和瑞典。考虑了 82.2%的慢性疾病。45.1%的研究检验了预防干预措施。纳入患者的中位数为 2000 例（范围：69-246079 例）。研究人群的定义大多较为宽泛。研究程序通常没有标准化。82.1%的 rRCT 纳入和分析的患者数量相同。在一半的 rRCT 中，使用了多个登记处。使用了各种链接技术。中位数从登记处收集了两个结果。rRCT 的中位随访时间为 5.3 年（范围：6 周至 27 年）。11.3%的研究报告了登记数据的质量信息。
rRCT 可以为相对较少的努力提供有效的（随机化、低失访率、可推广性）患者重要的长期比较效果数据。计划进行 RCT 的研究人员应始终检查是否可以使用现有登记处来收集数据。为了用于证据综合，必须改进数据质量报告。
