Transporting monovalent rotavirus vaccine efficacy estimates to an external target population: a secondary analysis of data from a randomised controlled trial in Malawi.
Transporting monovalent rotavirus vaccine efficacy estimates to an external target population: a secondary analysis of data from a randomised controlled trial in Malawi.
复制标题
DOI：
10.1017/s0950268823000286
复制
发表时间：
2023-02-27
影响因子：
4.2
通讯作者：
Becker-Dreps, Sylvia
中科院分区：
文献类型：
--
作者：
St Jean, Denise T. T.;Edwards, Jessie K. K.;McQuade, Elizabeth T. Rogawski T.;Thompson, Peyton;Thomas, James C. C.;Becker-Dreps, Sylvia
来自随机对照试验的口服轮状病毒疫苗效力估计在不同环境下差异很大。尽管随机研究设计增加了研究结果内部有效性的可能性，但由于试验参与者和目标人群之间的差异，试验结果可能并不总是适用于研究背景之外。在这里，我们使用基于权重的方法将2005年至2008年在马拉维进行的单价轮状病毒疫苗临床试验的结果传递到马拉维所有符合试验条件的儿童的目标人群，这些儿童由2015-2016年马拉维人口与健康调查（DHS）的数据代表。我们对试验参与者进行了重新加权，以反映马拉维国土安全部所描述的人口特征。在应用这些权重后，估计了1008名试验参与者的疫苗效力，以便他们代表马拉维符合试验条件的儿童。我们还进行了亚组分析，通过入组时的发育迟缓和结核病疫苗接种状况来检查异质性治疗效果。在最初的试验中，马拉维一年疫苗对严重轮状病毒胃肠炎和任何严重轮状病毒胃肠炎的有效性估计分别为49.2% （95% CI 15.6%-70.3%）和32.1% （95% CI 2.5%-53.1%）。在对马拉维所有符合试验条件的儿童进行加权后，疫苗对严重轮状病毒胃肠炎的有效性提高到62.2% (95% CI 35.5%-79.0%)，对任何严重轮状病毒胃肠炎的有效性提高到38.9% （95% CI 11.4%-58.5%）。当试验参与者和目标人群不同时，轮状病毒疫苗的效力可能不同。试验样本和国土安全部人群之间结核病疫苗接种状况的差异导致了试验和目标人群疫苗有效性的不同估计。
Oral rotavirus vaccine efficacy estimates from randomised controlled trials are highly variable across settings. Although the randomised study design increases the likelihood of internal validity of findings, results from trials may not always apply outside the context of the study due to differences between trial participants and the target population. Here, we used a weight-based method to transport results from a monovalent rotavirus vaccine clinical trial conducted in Malawi between 2005 and 2008 to a target population of all trial-eligible children in Malawi, represented by data from the 2015–2016 Malawi Demographic and Health Survey (DHS). We reweighted trial participants to reflect the population characteristics described by the Malawi DHS. Vaccine efficacy was estimated for 1008 trial participants after applying these weights such that they represented trial-eligible children in Malawi. We also conducted subgroup analyses to examine the heterogeneous treatment effects by stunting and tuberculosis vaccination status at enrolment. In the original trial, the estimates of one-year vaccine efficacy against severe rotavirus gastroenteritis and any-severity rotavirus gastroenteritis in Malawi were 49.2% (95% CI 15.6%–70.3%) and 32.1% (95% CI 2.5%–53.1%), respectively. After weighting trial participants to represent all trial-eligible children in Malawi, vaccine efficacy increased to 62.2% (95% CI 35.5%–79.0%) against severe rotavirus gastroenteritis and 38.9% (95% CI 11.4%–58.5%) against any-severity rotavirus gastroenteritis. Rotavirus vaccine efficacy may differ between trial participants and target populations when these two populations differ. Differences in tuberculosis vaccination status between the trial sample and DHS population contributed to varying trial and target population vaccine efficacy estimates.
影响因子：
5.5
作者：
St Jean, Denise T.;McQuade, Elizabeth T. Rogawski;Edwards, Jessie K.;Thompson, Peyton;Thomas, James;Becker-Dreps, Sylvia
通讯作者：
Becker-Dreps, Sylvia