Power analysis for YouControl-AFib
Based on Elliott et al. (2023):
- Control group: 6-month AF-free probability = 0.52; hazard rate: 0.11 per person-month;
- Exercise group: 6-month AF-free probability = 0.8; hazard rate: 0.04 per person-month.
- Hazard ratio: 0.34.
Aim 3: Prospective, multi-site clinical trial of YouControl-AFib in secondary prevention of AF
- Control group: Assume the same AF-free probability as in the control group of the Elliott et al. (2023) study.
- Exercise group: To be conservative, assume a 25% reduction in log-HR:
- HR: 0.45.
- Loss to follow-up: Assume a 6-month attrition rate of 20%.
- Randomization ratio: 1:1
| HR | 80% power | 90% power |
|---|---|---|
| 0.35 | 40 (17) | 48 (20) |
| 0.40 | 52 (22) | 62 (27) |
| 0.45 | 68 (29) | 80 (35) |
| 0.50 | 88 (38) | 106 (46) |
| 0.55 | 118 (51) | 142 (62) |
| 0.60 | 162 (70) | 194 (85) |
| 0.65 | 226 (99) | 272 (119) |
| 0.70 | 330 (144) | 398 (173) |
| 0.75 | 506 (220) | 610 (266) |
| 0.80 | 840 (366) | 1012 (441) |
References
Elliott, Adrian D., Christian V. Verdicchio, Rajiv Mahajan, Melissa E. Middeldorp, Celine Gallagher, Ricardo S. Mishima, Jeroen M. L. Hendriks, et al. 2023. “An Exercise and Physical Activity Program in Patients With Atrial Fibrillation.” JACC: Clinical Electrophysiology 9 (4): 455–65. https://doi.org/10.1016/j.jacep.2022.12.002.