Power calculation for cross-sectional stepped wedge cluster randomized trials with a time-to-event endpoint
| Autor: | Ryan, Mary M., Esserman, Denise, Taljaard, Monica, Li, Fan |
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| Rok vydání: | 2023 |
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| Druh dokumentu: | Working Paper |
| Popis: | Stepped wedge cluster randomized trials (SW-CRTs) are a form of randomized trial whereby clusters are progressively transitioned from control to intervention, with the timing of transition randomized for each cluster. An important task at the design stage is to ensure that the planned trial has sufficient power to observe a clinically meaningful effect size. While methods for determining study power have been well-developed for SW-CRTs with continuous and binary outcomes, limited methods for power calculation are available for SW-CRTs with censored time-to-event outcomes. In this article, we propose a stratified marginal Cox model to account for secular trend in cross-sectional SW-CRTs, and derive an explicit expression of the robust sandwich variance to facilitate power calculations without the need for computationally intensive simulations. Power formulas based on both the Wald and robust score tests are developed and validated via simulation under different finite-sample scenarios. Finally, we illustrate our methods in the context of a SW-CRT testing the effect of a new electronic reminder system on time to catheter removal in hospital settings. We also offer an R Shiny application to facilitate sample size and power calculations using our proposed methods. Comment: v2: under review; 49 pgs (main text - 19, supporting information - 30); 16 figures (main text - 4, supporting information - 12); 2 tables (main text - 2, supporting information - 0); 7 appendices v1: under review; 45 pgs (main text - 22, supporting information - 23); 18 figures (main text - 4, supporting information - 14); 2 tables (main text - 2, supporting information - 0); 5 appendices |
| Databáze: | arXiv |
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