TY - JOUR
T1 - Harms reporting by systematic reviews for functional endoscopic sinus surgery
T2 - a cross-sectional analysis
AU - Jones, Garrett
AU - Hemmerich, Christian
AU - Rucker, Brayden
AU - Wise, Audrey
AU - Kee, Micah
AU - Johnson, Austin
AU - Brame, Lacy
AU - Hamilton, Tom
AU - Vassar, Matt
N1 - Funding Information:
No financial or other sources of support were provided during the development of this manuscript. Dr. Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences—all outside of the present work. All other authors have nothing to report.
Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2023/6
Y1 - 2023/6
N2 - Objectives: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). Methods: 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. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, 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. Results: Fifty-five SR’s 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 and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs 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 (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. Conclusions: 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 the 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.
AB - Objectives: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS). Methods: 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. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, 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. Results: Fifty-five SR’s 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 and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs 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 (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms. Conclusions: 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 the 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.
KW - Adverse events
KW - Complications
KW - Functional endoscopic sinus surgery
KW - Harms
KW - Rhinology
KW - Systematic reviews
UR - http://www.scopus.com/inward/record.url?scp=85145506026&partnerID=8YFLogxK
U2 - 10.1007/s00405-022-07803-y
DO - 10.1007/s00405-022-07803-y
M3 - Article
C2 - 36595047
AN - SCOPUS:85145506026
SN - 0937-4477
VL - 280
SP - 2805
EP - 2819
JO - European Archives of Oto-Rhino-Laryngology
JF - European Archives of Oto-Rhino-Laryngology
IS - 6
ER -