Methodological issues | Findings | Evidence |
---|---|---|
1. Did the feasibility study allow a sample size calculation for the main trial? | ||
2. What factors influenced eligibility and what proportion of those approached were eligible? | ||
3. Was recruitment successful? | ||
4. Did eligible participants consent? | ||
5. Were participants successfully randomized and did randomization yield equality in groups? | ||
6. Were blinding procedures adequate? | ||
7. Did participants adhere to the intervention? | ||
8. Was the intervention acceptable to the participants? | ||
9. Was it possible to calculate intervention costs and duration? | ||
10. Were outcome assessments completed? | ||
11. Were outcomes measured those that were the most appropriate outcomes? | ||
12. Was retention to the study good? | ||
13. Were the logistics of running a multicenter trial assessed? | ||
14. Did all components of the protocol work together? |