CYCLE pilot RCT variables, measures and methods of analysis for the four feasibility objectives
| Variable/outcome | Hypothesis | Outcome measure | Methods of analysis |
|---|---|---|---|
| Feasibility outcomes | |||
| 1. Accrual | The overall average accrual rate will be 1–2 patients per month per site. | Average monthly patient enrolment per site | Descriptive statistics (mean, SD) by site |
| 2. Protocol violations | The in-bed cycling protocol can be successfully implemented with <20% protocol violations. | (1) Patients with no cycling exemptions from box 1 who did not receive cycling, and(2) Patients with cycling exemptions from box 1 and did receive cycling | Descriptive statistics (n, %, 95% CI) |
| 3. Outcome measures | >80% of outcomes (described above) will be measured as scheduled at ICU awakening, ICU discharge, and hospital discharge. | Whether the measurement occurred, the result, and any barriers to data collection | Descriptive statistics (n, %, 95% CI) |
| 4. Blinded outcome assessments | >80% of physical strength and function outcomes at hospital discharge will be assessed by personnel blinded to group allocation. | Whether the measurement occurred, the result, and any barriers to data collection | Descriptive statistics (n, %, 95% CI) |
| Subgroup analysis | |||
| ≥65 years old and <65 years old | There is no difference in any of the above four feasibility objectives between those ≥65 years old and those <65 years old | As outlined above | χ2 test |
In this table, we outline the variables, measures and methods of analysis for the four feasibility outcomes in the CYCLE pilot RCT.
ICU, intensive care unit; RCT, randomised clinical trial.