Faculty of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.
Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.
J Epidemiol Community Health. 2018 Feb;72(2):173-178. doi: 10.1136/jech-2017-209976. Epub 2017 Nov 28.
Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China.
Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of -3%.
In the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, -5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were -2.6% (95% CI, -14.2 to 8.9) and 2.7% (95% CI, -10.7 to 16.2), with both approaches also not establishing non-inferiority.
Conducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up.
NCT02248558.
研究人员越来越多地使用在线方法招募随机对照试验(RCT)的参与者。然而,在线招募的参与者在多大程度上代表了感兴趣的人群尚不清楚。我们评估了在线 RCT 样本在中国男男性行为者中的代表性。
使用逆概率抽样权重(IPSW)和 G 公式,通过基于模型的方法来评估在线 RCT 的可推广性。分析了在线 RCT 数据和中国全国性横断面研究数据,以说明定量评估可推广性的过程。该 RCT(标识符 NCT02248558)随机分配参与者接受众包或健康营销视频以促进 HIV 检测。主要结局是在 4 周内自我报告 HIV 检测,非劣效性边界为-3%。
在原始的在线 RCT 分析中,两个手臂(众包和健康营销)之间 HIV 检测比例的估计差异为 2.1%(95%CI,-5.4%至 9.7%)。众包视频在促进 HIV 检测方面不劣于健康营销视频的假设未得到证明。IPS 和 G 公式估计的差异分别为-2.6%(95%CI,-14.2 至 8.9)和 2.7%(95%CI,-10.7 至 16.2),两种方法均未确定非劣效性。
对在线 RCT 进行可推广性分析是可行的。在干预措施扩大规模之前,检查在线 RCT 的可推广性是一个重要步骤。
NCT02248558。