Abstract
A clinical practice guideline (CPG) from the American Society of Plastic Surgeons recommended not to use drains in breast reduction. This CPG was based on 3 randomized controlled trials (RCTs). The objective of this review was to double-check the methodological quality of the 3 RCTs. These RCTs were critically appraised using: (1) the "User's Guide to the Surgical Literature" checklist to critically appraise the methodological quality, (2) the CONSORT guidelines for reporting quality, and (3) the Cochrane risk-of-bias tool 2 (RoB 2) for risk of bias. Weaknesses were identified in all assessments for the 3 RCTs. Items with the poorest adherence in the "User's Guide" included: "Were patients stratified?," "Was follow-up complete?," and "Were all clinically important outcomes considered?" The overall adherence to the CONSORT reporting checklist across all 3 studies was moderate with 40.0%, 62.1%, and 48.3% adherence. All 3 RCTs had a similar low to moderate risk of bias, with no areas with a high risk of bias. None of the studies took into consideration a single critical outcome (such as major hematoma) and the outcome's minimally important difference as the basis for the sample size and power calculation of the study. All 3 RCTs additionally lacked clear reporting of treatment effect sizes or precision of estimates. Our re-examination of the evidence questions the recommendation of the CPG. We believe that the recommendation should have been: "We remain uncertain whether drains in breast reduction have a salutary effect." As such, we recommend that a methodologically robust RCT be conducted to resolve the question of whether drains should be used in breast reduction.