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

Abstract

Abstract 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. Level of Evidence: 1