随机对照临床试验中韩国医学干预措施的脱落率：系统评价和荟萃分析。
Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis.
机构信息
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Department of Korea8n Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, 23 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
出版信息
Trials. 2021 Mar 1;22(1):176. doi: 10.1186/s13063-021-05114-x.
BACKGROUND
The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (KM) interventions by systematic evaluation of RCTs conducted in the past 10 years.
METHODS
Three clinical trial registries (Clinical Research Information Service, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform) were searched to identify RCT protocols for KM interventions, such as acupuncture, herbal medicine, moxibustion, or cupping, and studies of mixed interventions, registered in Korea from 2009 to 2019. The PubMed, Embase, and OASIS databases were searched for the full reports of these RCTs, including published journal articles and theses. Dropout rates and the reasons for dropping out were analyzed in each report. The risk of bias in each of the included studies was assessed using the Cochrane risk of bias tool. The risk difference for dropping out between the treatment and control groups was calculated with the 95% confidence interval in a random effects model.
RESULTS
Forty-nine published studies were included in the review. The median dropout rate was 10% in the treatment group (interquartile range 6.7%, 17.0%) and 14% in the control group (interquartile range 5.4%, 16.3%) and was highest in acupuncture studies (12%), followed by herbal medicine (10%), moxibustion (8%), and cupping (7%). Loss to follow-up was the most common reason for dropping out. The risk difference for dropping out between the intervention and control groups was estimated to be 0.01 (95% confidence interval - 0.02, 0.03) in KM intervention studies.
CONCLUSIONS
This review found no significant difference in the dropout rate between studies according to the type of KM intervention. We recommend allowance for a minimum dropout rate of 15% in future RCTs of KM interventions.
REVIEW PROTOCOL REGISTRATION
PROSPERO CRD42020141011.
背景
失访率是随机对照试验（RCT）结果的重要决定因素，应谨慎控制。本研究通过系统评价过去 10 年进行的 RCT，探讨了韩国医学（KM）干预研究的当前失访率。
方法
检索了三个临床试验注册机构（临床研究信息服务、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台），以确定 2009 年至 2019 年在韩国注册的 KM 干预措施（如针灸、草药、艾灸或拔罐）和混合干预措施的 RCT 方案。还检索了 PubMed、Embase 和 OASIS 数据库，以获取这些 RCT 的完整报告，包括已发表的期刊文章和论文。分析了每份报告中的失访率和失访原因。使用 Cochrane 偏倚风险工具评估纳入研究的偏倚风险。采用随机效应模型计算治疗组和对照组之间的脱落差异风险，并计算 95%置信区间。
结果
本综述纳入了 49 项已发表的研究。治疗组的中位失访率为 10%（四分位距 6.7%，17.0%），对照组为 14%（四分位距 5.4%，16.3%），其中针灸研究的失访率最高（12%），其次是草药（10%）、艾灸（8%）和拔罐（7%）。失访是最常见的失访原因。KM 干预研究中，干预组和对照组之间的脱落差异风险估计为 0.01（95%置信区间 -0.02，0.03）。
结论
本综述未发现 KM 干预类型与失访率之间存在显著差异。我们建议在未来的 KM 干预 RCT 中允许最低 15%的失访率。
综述方案注册
PROSPERO CRD42020141011。
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