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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