Assessment of Harms Reporting Quality in Randomized Controlled Trials of Aesthetic Rhinoplasty: A Systematic Review.

Background: Rhinoplasty is one of the most common aesthetic plastic surgery procedures. Complications can lead to both aesthetic and functional impairments. The Consolidated Standards of Reporting Trials (CONSORT) Harms statement was developed to promote improved reporting of harm across randomized controlled trials (RCTs). Objectives: The aim of this systematic review is to assess harms reporting quality across RCTs on aesthetic rhinoplasty. Methods: A literature search was conducted in Ovid MEDLINE and Embase databases (January 1, 2005 to August 4, 2023). RCTs which compared 2 or more interventions in rhinoplasty with primarily aesthetic indications and assessed patient-important outcomes were included. The reporting quality was assessed by following a 40-item checklist endorsed by the 2022 CONSORT Harms Extension update. Results: A total of 58 RCTs met the inclusion criteria. Fifteen RCTs addressed harms of treatment in some capacity. Overall, the reporting quality across RCTs was poor, with a median CONSORT Harms score of 33% (range, 16%-83%). A reporting adherence of ≥50% was met by only 8 studies. There was no significant difference in reporting adherence between studies based on journal endorsement of CONSORT or industry vs nonindustry funding sources (P > .05). A high journal impact factor was significantly associated with a higher reporting quality (P = .044). Conclusions: CONSORT Harms reporting adherence was poor across the majority of included RCTs. Future trials on aesthetic rhinoplasty should aim to follow the reporting recommendations endorsed by the CONSORT Harms statement to increase transparency and minimize heterogeneity in harms reporting across studies.

Drains in Breast Reduction: How Good is the Recommendation Not to Use Them?

A clinical practice guideline (CPG) 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 three RCTs. These RCTs were critically appraised using a) the Users' guide to RCT assessment for methodological quality, b) the CONSORT guideline for reporting quality, and c) the Cochrane risk of bias tool 2 (RoB 2) for risk of bias. Weaknesses were identified in all assessments for the three RCTs. Items with the poorest adherence in the User's guide to RCT 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 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 three 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 RCTs be conducted to answer this question.

Patient-reported experience with the use of Mepitel Film for prevention of acute radiation dermatitis in breast cancer.

BACKGROUND AND PURPOSE: Mepitel Film (MF) has been demonstrated to reduce the severity of radiation dermatitis (RD) in patients receiving breast cancer radiotherapy (RT). The objective of this study was to characterize patient-reported experience with MF use, including its impact on daily activities and wellbeing. MATERIALS AND METHODS: This single-institution study analyzed anonymized responses to a questionnaire completed by patients who used MF for the prevention of RD during breast cancer RT. RESULTS: Of the 254 patients contacted, 192 patients completed the survey. Most patients disagreed or strongly disagreed that MF limited their ability to perform their daily activities, including household chores (88%, n = 169/191), their ability to work (83%, n = 157/189), or their ability to sleep (85%, n = 163/191). Furthermore, patients agreed or strongly agreed MF was comfortable on their skin (67%, n = 126/189) and protected their skin from rubbing against clothing (86%, n = 161/188). Some patients agreed or strongly agreed that MF affected their ability to shower (31%, n = 50/162), wear bras (28%, n = 51/185), and impacted their level of pruritus (35%, n = 67/189). However, most patients agreed or strongly agreed that their overall experience with MF was positive (92%, n = 173/189) and would recommend MF to a friend undergoing breast cancer RT (88%, n = 166/188). CONCLUSION: MF use is associated with positive patient-reported experience during breast RT with minimal impact on daily activities.