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Progression of Pilot Trials to Completed Randomized Controlled Trials in Plastic Surgery: A Systematic Review
Andrew T Chen1, Tara Behroozian2, Tal Levit2
1From the Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Annals of Plastic Surgery
|December 9, 2024
Summary
Few plastic surgery pilot studies advance to definitive randomized controlled trials (RCTs). Most lack feasibility statements, hindering clinical practice implementation.
Area of Science:
- Surgical Research
- Clinical Trial Design
- Evidence-Based Medicine
Background:
- Pilot trials are crucial for assessing feasibility before large-scale randomized controlled trials (RCTs).
- Successful implementation of new surgical techniques relies on robust pilot data.
- Plastic surgery research requires well-designed feasibility studies to guide definitive trials.
Purpose of the Study:
- To determine the progression rate of plastic surgery pilot studies to definitive randomized controlled trials (RCTs).
- To assess the reporting of feasibility statements and outcomes in plastic surgery pilot studies.
- To evaluate the reporting quality of pilot and feasibility studies in plastic surgery.
Main Methods:
- Searched MEDLINE, Embase, Web of Science, and clinicaltrials.gov for pilot and definitive RCTs in plastic surgery (2012-2023).
- Matched pilot trials to definitive RCTs using keywords, authors, and citation reports.
- Analyzed feasibility outcome reporting and evaluated reporting quality using the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot and feasibility trials.
Main Results:
- Only 5.8% of included pilot studies progressed to a completed definitive RCT; 2.3% were in progress, and 1.2% were stopped.
- Inadequate funding (41.4%) and insufficient efficacy (17.3%) were primary reasons for pilot studies not progressing.
- Average adherence to CONSORT reporting standards was 65.6%; only 29.2% reported feasibility statements and 17.5% reported feasibility outcomes.
Conclusions:
- A small proportion of plastic surgery pilot trials transition to definitive RCTs.
- Most pilot studies lack essential feasibility statements and outcome reporting, limiting their utility.
- Future pilot studies in plastic surgery must include clear feasibility objectives and outcomes to inform definitive trial design and clinical practice.
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