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Editors Selection IGR 10-3

Surgical Treatment: Reporting Surgical Harm

Comment by Luca Rossetti on:

78208 Reporting Harm in Glaucoma Surgical Trials: Systematic Review and a Consensus-Derived New Classification System, Sii S; Barton K; Pasquale LR et al., American Journal of Ophthalmology, 2018; 194: 153-162

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Assessment of safety of surgical procedures can be as important as efficacy evaluation. A comprehensive list of complications is mandatory in a surgical trial report although not sufficiently informative if not coupled with a quantification of harm severity. For example, general surgery trials usually adopt a standardized classification of severity to quantify degree of surgical harm. Are the standards of harm reporting for glaucoma surgical trials adequate to help ophthalmologists in the choice of a surgical procedure? This topic was the objective of a recently published meta-analysis. As a result of the systematic review, one further goal of the study was the development of a classification system for reporting surgical complications severity through a Delphi consensus approach.

This meta-analysis included 47 glaucoma surgery trials focusing on outcomes of trabeculectomy and aqueous shunts published in English approximately in the last decade. The authors found that the quality of harm reporting was generally poor - using the CONSORT checklist for reporting of harm - and none of the studies used a validated instrument to report severity of adverse events. Criteria that were infrequently reported included withdrawals owing to harm, subgroup analyses for harm, absolute risk of harm, severity of adverse events, definition and analysis of harm. And the few trials reporting the severity of complications did not use a standardized method for classification. To provide a standardized instrument to report harm according to severity, 43 glaucoma experts from the US, Asia-Pacific countries and Europe participated in a Delphi survey. All complications of glaucoma surgery were reviewed and graded according to a 1 to 10 severity scale and substantial consensus was achieved. Although with some limitations, e.g., results from a Delphi survey are not necessarily valid and in this case need to be validated with the patients' perspective, the proposed classification system of severity based on expert consensus might help to better compare risks and benefit of different surgical procedures for glaucoma.

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