Otolaryngol Head Neck Surg. 2024 Apr 12. doi: 10.1002/ohn.765. Online ahead of print.
ABSTRACT
OBJECTIVE: This study aimed to assess the completeness of adverse event (AE) reporting in randomized control trials (RCTs) focused on rhinoplasty, using the Consolidated Standards for Reporting (CONSORT) Extension for Harms checklist.
STUDY DESIGN: A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022.
SETTING: The study analyzed clinical trials on rhinoplasty retrieved from PubMed.
METHODS: We performed a comprehension search on PubMed, blind and duplicate screening, and data extraction. Adherence to the 18 recommendations of the CONSORT Extension for Harms was evaluated, with 1 point assigned for each adhered item. Percent adherence was calculated based on the 18 points, taking into account the multiple subcategories within some recommendations. Descriptive statistics were used to summarize adherence-including frequencies, percentages, and 95% confidence intervals.
RESULTS: Our search returned 240 articles, of which 56 met inclusion criteria. No RCTs adhered to all 18 CONSORT Extension for Harms items. Twenty-six (26/56, 46.4%) adhered to ≥50% of the items, and 30 (30/56, 53.6%) adhered to ≥33.3% of the items. Seven (7/56, 12.5%) RCTs adhered to no items. Across all RCTs, the average number of CONSORT-Harms items adhered to was 7.2 (7.2/18, 40.0%). The most adhered to item was item 10. Discussion balanced with regard to efficacy and AEs (80.4%, [70.0-90.8]).
CONCLUSION: This study highlights the inadequacy of AE reporting in rhinoplasty RCTs according to CONSORT-Harms guidelines. Urgent efforts are required to bridge this reporting gap and enhance transparency in surgical research, ultimately safeguarding patient well-being.
PMID:38613190 | DOI:10.1002/ohn.765
