Completeness of harms reporting in systematic reviews of functional endoscopic sinus surgery: a cross-sectional analysis

To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. In a masked, duplicate manner we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables. Fifty-five SRs were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms, 23 (23/55, 41.8%) demonstrated a method of harms data collection, and 25 (25/55, 45.5%) had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as ‘critically low’ quality using AMSTAR-2. A significant association was found between completeness of harms reporting and whether harms were listed as a primary outcome. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.