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Reporting of Complications in Retinal Detachment Surgical Trials: A Systematic Review Using the CONSORT Extension for Harms

Lookup NU author(s): Professor David SteelORCiD


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© 2021 American Medical Association. All rights reserved.Importance: Knowledge on the frequency and severity of complications in surgical trials for rhegmatogenous retinal detachment (RRD) is essential to determine whether surgical procedures are developed and compared adequately, taking into account not only efficacy but also harms. Objective: To review standards of reporting of complications in recent randomized clinical trials of RRD surgery. Evidence Review: This systematic review included randomized clinical trials on RRD surgery published between January 2008 and January 2021 in Embase, MEDLINE, and Web of Science Core Collection databases. Titles, abstracts, and full-text articles retrieved were reviewed for eligibility by 2 independent authors. Eligible studies were evaluated against checklist items from the Consolidated Standards of Reporting Trials Extension for Harms criteria by 2 independent authors, and discrepancies were resolved by discussion with a third author. Findings: Fifty studies were included. The median number of checklist items fulfilled was 8 (range, 0-15), of a possible total of 18. Frequently reported items were discussions balanced with regard to efficacy and adverse events (42 studies [84%]) and inclusions of harm-associated timing of data collection (41 studies [82%]). The least frequently reported items were distinctions between expected and unexpected adverse events (1 study [2%]) and mentions of the use of a validated instrument to report adverse event severity (4 studies [8%]). Frequency of complications was commonly reported (29 studies [58%]) in contrast with complication severity (10 studies [20%]). Conclusions and Relevance: This review suggests that severity of complications of RRD surgery has been infrequently quantified and reported in randomized clinical trials and potentially represents an important area of improvement in future RRD surgical trials..

Publication metadata

Author(s): Xu ZY, Azuara-Blanco A, Kadonosono K, Murray T, Natarajan S, Sii S, Smiddy W, Steel DH, Wolfensberger TJ, Lois N

Publication type: Review

Publication status: Published

Journal: JAMA Ophthalmology

Year: 2021

Volume: 139

Issue: 8

Pages: 898-905

Online publication date: 17/06/2021

Acceptance date: 23/03/2021

ISSN (print): 2168-6165

ISSN (electronic): 2168-6173

Publisher: American Medical Association


DOI: 10.1001/jamaophthalmol.2021.1836

PubMed id: 34137800