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

Abstract

Importance\nKnowledge 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.\n\n\nObjective\nTo review standards of reporting of complications in recent randomized clinical trials of RRD surgery.\n\n\nEvidence Review\nThis 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.\n\n\nFindings\nFifty 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%]).\n\n\nConclusions and Relevance\nThis 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.