Harms reporting by systematic reviews for functional endoscopic sinus surgery: a cross-sectional analysis

Area of Science:

• Otolaryngology
• Evidence-Based Medicine
• Medical Research Methodology

Background:

• Systematic reviews (SRs) are crucial for synthesizing medical evidence.
• Accurate reporting of harms is essential for patient safety and informed decision-making.
• Functional endoscopic sinus surgery (FESS) is a common procedure, necessitating thorough risk assessment.

Purpose of the Study:

• To evaluate the completeness of harms reporting in systematic reviews (SRs) concerning functional endoscopic sinus surgery (FESS).
• To identify deficiencies in how adverse events are documented in FESS-related SRs.

Main Methods:

• A cross-sectional study design was employed.
• A comprehensive search of multiple databases (MEDLINE, EMBASE, Epistemonikos, Cochrane) was conducted up to May 15th, 2022.
• Data extraction included study characteristics, harms items, methodological quality (AMSTAR-2), and corrected covered area (CCA) for SR dyads.

Main Results:

• Of 55 included SRs, 34.5% did not report harms, and 70.9% reported half or fewer harms items.
• Only 41.8% of SRs detailed harms data collection methods, and 47.3% included patient data for harms analysis.
• A significant association was found between harms reporting completeness and harms being a primary outcome; 90.7% of SRs were rated as "critically low" quality by AMSTAR-2.

Conclusions:

• Significant gaps exist in the reporting of harms within systematic reviews on FESS.
• Adherence to reporting guidelines such as STROCCS or PRISMA harms extension is recommended.
• Improved harms reporting can enhance patient safety and facilitate objective risk-benefit assessments for FESS.