The methodologic quality of clinical trials on regional anesthesia for cataract surgery

Objective: To assess the methodologic quality of published randomized trials of regional anesthesia management strategies for cataract surgery. Design: Literature review and analysis. Method: We performed a systematic search of the literature to identify all articles pertaining to regional anesthesia for cataract surgery on adults. Overall quality scores and scores for individual methodologic domains were based on the evaluations of two investigators experienced in methodologic research who independently reviewed all relevant articles using a quality abstraction form. Main Outcome Measures: Study quality in each of five domains: representativeness, bias and confounding, intervention description, outcomes and follow-up, and statistical quality and interpretation. Results: Eighty-two randomized clinical trials were identified with a mean overall quality score of 44%, The mean domain scores ranged from 37% for representativeness to 58% for outcomes and follow-up. Forty percent or fewer studies received the maximum score for reporting the setting, the population, and the start and end dates; describing the inclusion and exclusion criteria; adequately randomizing subjects; and adequately masking individuals participating in the study. Key outcomes were often inadequately reported, including the distribution of patient-reported pain scores and the mean surgical time. Conclusions: Greater attention to methodologic quality and detailed reporting of study results will improve the ability of readers to interpret the results of clinical trials assessing regional anesthesia for cataract surgery. (C) 2001 by the American Academy of Ophthalmology.