Abstract
Background Medical Research Council guidance for evaluating complex interventions like surgery, recommends that pilot work should precede randomised controlled trials (RCTs). Methodological considerations pilot work could address include intervention complexity and adherence, education of surgeons on research methodology and recruitment, logistics of co-ordination and feasibility of collaboration. Presented are findings of an ongoing literature review exploring how pilot work may optimally inform surgical RCTs.
Highlights
Medical Research Council guidance for evaluating complex interventions like surgery, recommends that pilot work should precede randomised controlled trials (RCTs)
Work, includes analyses of the NIHR database of trial protocols, and exploring perceptions of trialists and surgeons involved in pilot work
This seeks to identify designs and methodologies associated with successful progression to main trials and develop recommendations for the optimal design of pilot work for surgical trials
Summary
Medical Research Council guidance for evaluating complex interventions like surgery, recommends that pilot work should precede randomised controlled trials (RCTs). Methodological considerations pilot work could address include intervention complexity and adherence, education of surgeons on research methodology and recruitment, logistics of co-ordination and feasibility of collaboration. Presented are findings of an ongoing literature review exploring how pilot work may optimally inform surgical RCTs. work, includes analyses of the NIHR database of trial protocols, and exploring perceptions of trialists and surgeons involved in pilot work. Work, includes analyses of the NIHR database of trial protocols, and exploring perceptions of trialists and surgeons involved in pilot work This seeks to identify designs and methodologies associated with successful progression to main trials and develop recommendations for the optimal design of pilot work for surgical trials
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