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Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome

Before embarking on an individual participant data meta‐analysis (IPDMA) project, researchers and funders need assurance it is worth their time and cost. This should include consideration of how many studies are promising their IPD and, given the characteristics of these studies, the power of an IPD...

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Autores principales: Riley, Richard D., Hattle, Miriam, Collins, Gary S., Whittle, Rebecca, Ensor, Joie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9805219/
https://www.ncbi.nlm.nih.gov/pubmed/35932153
http://dx.doi.org/10.1002/sim.9538
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author Riley, Richard D.
Hattle, Miriam
Collins, Gary S.
Whittle, Rebecca
Ensor, Joie
author_facet Riley, Richard D.
Hattle, Miriam
Collins, Gary S.
Whittle, Rebecca
Ensor, Joie
author_sort Riley, Richard D.
collection PubMed
description Before embarking on an individual participant data meta‐analysis (IPDMA) project, researchers and funders need assurance it is worth their time and cost. This should include consideration of how many studies are promising their IPD and, given the characteristics of these studies, the power of an IPDMA including them. Here, we show how to estimate the power of a planned IPDMA of randomized trials to examine treatment‐covariate interactions at the participant level (ie, treatment effect modifiers). We focus on a binary outcome with binary or continuous covariates, and propose a three‐step approach, which assumes the true interaction size is common to all trials. In step one, the user must specify a minimally important interaction size and, for each trial separately (eg, as obtained from trial publications), the following aggregate data: the number of participants and events in control and treatment groups, the mean and SD for each continuous covariate, and the proportion of participants in each category for each binary covariate. This allows the variance of the interaction estimate to be calculated for each trial, using an analytic solution for Fisher's information matrix from a logistic regression model. Step 2 calculates the variance of the summary interaction estimate from the planned IPDMA (equal to the inverse of the sum of the inverse trial variances from step 1), and step 3 calculates the corresponding power based on a two‐sided Wald test. Stata and R code are provided, and two examples given for illustration. Extension to allow for between‐study heterogeneity is also considered.
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spelling pubmed-98052192023-01-06 Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome Riley, Richard D. Hattle, Miriam Collins, Gary S. Whittle, Rebecca Ensor, Joie Stat Med Research Articles Before embarking on an individual participant data meta‐analysis (IPDMA) project, researchers and funders need assurance it is worth their time and cost. This should include consideration of how many studies are promising their IPD and, given the characteristics of these studies, the power of an IPDMA including them. Here, we show how to estimate the power of a planned IPDMA of randomized trials to examine treatment‐covariate interactions at the participant level (ie, treatment effect modifiers). We focus on a binary outcome with binary or continuous covariates, and propose a three‐step approach, which assumes the true interaction size is common to all trials. In step one, the user must specify a minimally important interaction size and, for each trial separately (eg, as obtained from trial publications), the following aggregate data: the number of participants and events in control and treatment groups, the mean and SD for each continuous covariate, and the proportion of participants in each category for each binary covariate. This allows the variance of the interaction estimate to be calculated for each trial, using an analytic solution for Fisher's information matrix from a logistic regression model. Step 2 calculates the variance of the summary interaction estimate from the planned IPDMA (equal to the inverse of the sum of the inverse trial variances from step 1), and step 3 calculates the corresponding power based on a two‐sided Wald test. Stata and R code are provided, and two examples given for illustration. Extension to allow for between‐study heterogeneity is also considered. John Wiley & Sons, Inc. 2022-08-05 2022-10-30 /pmc/articles/PMC9805219/ /pubmed/35932153 http://dx.doi.org/10.1002/sim.9538 Text en © 2022 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Articles
Riley, Richard D.
Hattle, Miriam
Collins, Gary S.
Whittle, Rebecca
Ensor, Joie
Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
title Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
title_full Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
title_fullStr Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
title_full_unstemmed Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
title_short Calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
title_sort calculating the power to examine treatment‐covariate interactions when planning an individual participant data meta‐analysis of randomized trials with a binary outcome
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9805219/
https://www.ncbi.nlm.nih.gov/pubmed/35932153
http://dx.doi.org/10.1002/sim.9538
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