TY - JOUR
T1 - Assessing the Reporting of Harms in Systematic Reviews Focused on the Therapeutic and Cosmetic Uses of Botulinum Toxin
AU - Cox, Katherine
AU - Ghebrehiwet, Merhawit
AU - Kee, Micah
AU - Rucker, Brayden
AU - Flores, Holly
AU - Ottwell, Ryan
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 Nature Switzerland AG.
PY - 2023/2
Y1 - 2023/2
N2 - Background and Objective: The expanding use of botulinum toxin (BoNT) in medical practice demonstrates the need to highlight whether there is adequate information regarding its safety profile. The aim of our study was to identify completeness of harms reporting for BoNT treatment within systematic reviews (SRs), assess quality of SRs using the AMSTAR-2 tool, and determine the degree of overlap among primary studies within each SR. Methods: On May 31, 2022, we searched Embase, Epistemonikos, MEDLINE, and the Cochrane Database of Systematic Reviews for SRs on BoNT therapy. Screening and data extraction were performed in a masked, duplicate fashion. AMSTAR-2 was used to evaluate the methodological quality of included SRs. Corrected covered area (CCA) was calculated for SR dyads. Results: Of the 90 included SRs, we found that 70 completed less than 50% of harms items. The most reported items were BoNT as a favorable intervention (73/90, 81.1%) and harms as a primary outcome (72/90, 80.0%). The least reported items were grades and severity scales used to classify harms (8/90, 8.9%) and number of treatment discontinuations in each arm (10/90, 11.1%). Eighty-three SRs were rated “critically low” (83/90, 92.2%), while 5 SRs were rated “high” (5/90, 5.6%) via AMSTAR-2 tool. Significant associations were found between completion of harms reporting and: (1) a “critically low” appraisal on AMSTAR-2 tool (p = 0.0060) and (2) whether harms was reported as a primary outcome (p = 0.0001). The total CCA overlap was determined to be 0.8%. Conclusion: Our results demonstrate that harms are underreported within BoNT SRs. Because healthcare professionals often refer to SRs to guide clinical decision making, it is important to continue to explore shortcomings among BoNT literature in future studies.
AB - Background and Objective: The expanding use of botulinum toxin (BoNT) in medical practice demonstrates the need to highlight whether there is adequate information regarding its safety profile. The aim of our study was to identify completeness of harms reporting for BoNT treatment within systematic reviews (SRs), assess quality of SRs using the AMSTAR-2 tool, and determine the degree of overlap among primary studies within each SR. Methods: On May 31, 2022, we searched Embase, Epistemonikos, MEDLINE, and the Cochrane Database of Systematic Reviews for SRs on BoNT therapy. Screening and data extraction were performed in a masked, duplicate fashion. AMSTAR-2 was used to evaluate the methodological quality of included SRs. Corrected covered area (CCA) was calculated for SR dyads. Results: Of the 90 included SRs, we found that 70 completed less than 50% of harms items. The most reported items were BoNT as a favorable intervention (73/90, 81.1%) and harms as a primary outcome (72/90, 80.0%). The least reported items were grades and severity scales used to classify harms (8/90, 8.9%) and number of treatment discontinuations in each arm (10/90, 11.1%). Eighty-three SRs were rated “critically low” (83/90, 92.2%), while 5 SRs were rated “high” (5/90, 5.6%) via AMSTAR-2 tool. Significant associations were found between completion of harms reporting and: (1) a “critically low” appraisal on AMSTAR-2 tool (p = 0.0060) and (2) whether harms was reported as a primary outcome (p = 0.0001). The total CCA overlap was determined to be 0.8%. Conclusion: Our results demonstrate that harms are underreported within BoNT SRs. Because healthcare professionals often refer to SRs to guide clinical decision making, it is important to continue to explore shortcomings among BoNT literature in future studies.
UR - http://www.scopus.com/inward/record.url?scp=85145923250&partnerID=8YFLogxK
U2 - 10.1007/s40261-022-01235-6
DO - 10.1007/s40261-022-01235-6
M3 - Review article
AN - SCOPUS:85145923250
SN - 1173-2563
VL - 43
SP - 85
EP - 95
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
IS - 2
ER -