Table 6 Methodological issues that need evaluation in the context of an RCT
From: Questions asked and answered in pilot and feasibility randomized controlled trials
Issue | Needs to be evaluated in the context of a randomized pilot trial | Comments |
|---|---|---|
Sample size calculation | ✗ | The numbers in a pilot RCT are unlikely to be adequate to get accurate estimates of effect size of variances. |
Eligibility | ✗ | |
Recruitment | ✓ | Referrals from clinicians are likely to depend on the RCT context. |
Consent | ✓ | Consent rates in the RCT context are unlikely to be accurately estimated from asking about likely consent beforehand |
Randomization procedures | ✓ | |
Blinding procedures | ✓ | |
Compliance/adherence to intervention | ✗ | Though, this could potentially depend on preference amongst interventions offered in the main trial |
Acceptability of intervention | ✗ | Though, this could potentially depend on preference amongst interventions offered in the main trial |
Cost and duration of intervention | ✗ | |
Outcome assessment | ✗ | |
Selection of most appropriate outcomes | ✗ | |
Retention | ✓ | Retention may differ between experimental and control groups, and may depend on treatment preferences |
Logistics of multi-centre trial | ✓ | |
All components of the protocol work together | ✓ |