TY - JOUR
T1 - Calculating the power of a planned individual participant data meta‐analysis of randomised trials to examine a treatment‐covariate interaction with a time‐to‐event outcome
AU - Riley, Richard D.
AU - Collins, Gary S.
AU - Hattle, Miriam
AU - Whittle, Rebecca
AU - Ensor, Joie
PY - 2023/6/29
Y1 - 2023/6/29
N2 - Before embarking on an individual participant data meta‐analysis (IPDMA) project, researchers should consider the power of their planned IPDMA conditional on the studies promising their IPD and their characteristics. Such power estimates help inform whether the IPDMA project is worth the time and funding investment, before IPD are collected. Here, we suggest how to estimate the power of a planned IPDMA of randomised trials aiming to examine treatment‐covariate interactions at the participant‐level (i.e., treatment effect modifiers). We focus on a time‐to‐event (survival) outcome with a binary or continuous covariate, and propose an approximate analytic power calculation that conditions on the actual characteristics of trials, for example, in terms of sample sizes and covariate distributions. The proposed method has five steps: (i) extracting the following aggregate data for each group in each trial—the number of participants and events, the mean and SD for each continuous covariate, and the proportion of participants in each category for each binary covariate; (ii) specifying a minimally important interaction size; (iii) deriving an approximate estimate of Fisher's information matrix for each trial and the corresponding variance of the interaction estimate per trial, based on assuming an exponential survival distribution; (iv) deriving the estimated variance of the summary interaction estimate from the planned IPDMA, under a common‐effect assumption, and (v) calculating the power of the IPDMA based on a two‐sided Wald test. Stata and R code are provided and a real example provided for illustration. Further evaluation in real examples and simulations is needed.
AB - Before embarking on an individual participant data meta‐analysis (IPDMA) project, researchers should consider the power of their planned IPDMA conditional on the studies promising their IPD and their characteristics. Such power estimates help inform whether the IPDMA project is worth the time and funding investment, before IPD are collected. Here, we suggest how to estimate the power of a planned IPDMA of randomised trials aiming to examine treatment‐covariate interactions at the participant‐level (i.e., treatment effect modifiers). We focus on a time‐to‐event (survival) outcome with a binary or continuous covariate, and propose an approximate analytic power calculation that conditions on the actual characteristics of trials, for example, in terms of sample sizes and covariate distributions. The proposed method has five steps: (i) extracting the following aggregate data for each group in each trial—the number of participants and events, the mean and SD for each continuous covariate, and the proportion of participants in each category for each binary covariate; (ii) specifying a minimally important interaction size; (iii) deriving an approximate estimate of Fisher's information matrix for each trial and the corresponding variance of the interaction estimate per trial, based on assuming an exponential survival distribution; (iv) deriving the estimated variance of the summary interaction estimate from the planned IPDMA, under a common‐effect assumption, and (v) calculating the power of the IPDMA based on a two‐sided Wald test. Stata and R code are provided and a real example provided for illustration. Further evaluation in real examples and simulations is needed.
KW - sample size
KW - power
KW - individual participant data (IPD) meta‐analysis
KW - treatment‐covariate interactions
KW - treatment effect modifiers
U2 - 10.1002/jrsm.1650
DO - 10.1002/jrsm.1650
M3 - Article
C2 - 37386750
SN - 1759-2879
JO - Research Synthesis Methods
JF - Research Synthesis Methods
ER -