Power calculations for cluster randomized trials (CRTs) with right-truncated Poisson-distributed outcomes: a motivating example from a malaria vector control trial
Power calculations for cluster randomized trials (CRTs) with right-truncated Poisson-distributed outcomes: a motivating example from a malaria vector control trial
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DOI：
10.1093/ije/dyz277
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发表时间：
2020-06-01
影响因子：
7.7
通讯作者：
Ghani, Azra C.
中科院分区：
文献类型：
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作者：
Mwandigha, Lazaro M.;Fraser, Keith J.;Ghani, Azra C.
背景：聚类随机试验（CRTs）越来越多地用于研究针对人群水平的干预措施的有效性。存在计算crt样本量的公式，但它们假设所考虑的结果域涵盖所考虑分布的全部值范围。这一假设在流行病学试验中往往是不正确的，在流行病学试验中，由于对一个人可进行检测的次数的实际限制，感染发作数被右截断。方法：以一项泊松分布结果为右截断的疟疾病媒控制试验为动力，利用蒙特卡罗模拟研究了右截断对功率的影响。结果：结果表明，右截断的不利影响与事件率（lambda）的大小成正比，在未考虑右截断的情况下，功率的计算被高估。当簇数为时，右侧截断对功率的不利影响的严重程度更为明显
Background: Cluster randomized trials (CRTs) are increasingly used to study the efficacy of interventions targeted at the population level. Formulae exist to calculate sample sizes for CRTs, but they assume that the domain of the outcomes being considered covers the full range of values of the considered distribution. This assumption is frequently incorrect in epidemiological trials in which counts of infection episodes are right-truncated due to practical constraints on the number of times a person can be tested.Methods: Motivated by a malaria vector control trial with right-truncated Poisson-distributed outcomes, we investigated the effect of right-truncation on power using Monte Carlo simulations.Results: The results demonstrate that the adverse impact of right-truncation is directly proportional to the magnitude of the event rate, lambda, with calculations of power being overestimated in instances where right-truncation was not accounted for. The severity of the adverse impact of right-truncation on power was more pronounced when the number of clusters was