Results from patient-reported outcome measures are inconsistently reported in inguinal hernia trials: a systematic review.

Abstract

To evaluate the use, results, and reporting of patient-reported outcome measures specific to patients undergoing inguinal hernia repair. A systematic review was performed and reported according to the PRISMA 2020 statement. A protocol was registered at PROSPERO (CRD42021243468). Systematic searches were performed in PubMed and EMBASE. We only included randomized controlled trials that involved postoperative administration of a hernia-specific patient-reported outcome measure. Risk of bias was evaluated with the Cochrane risk of bias-tool 2.0. Twenty trials and four different instruments were included: the Carolinas Comfort Scale (nine studies), Activities Assessment Scale (six studies), Inguinal Pain Questionnaire (seven studies), and Surgical Pain Scales (one study). Included trials used patient-reported outcome measures and compared either different surgical approaches (11 studies), types of mesh/fixation (seven studies), or types of anesthesia/analgesia (two studies). Results were reported using several different methods including means, medians, or proportions of either overall results, results from subscales, or results from single questionnaire items. Seven of the 20 included studies specified a patient-reported outcome measure as a primary outcome and provided clear reporting of sample size calculation. Reporting of results from patient-reported outcome measures in inguinal hernia research was characterized by heterogeneity. The results were reported using several different methods, which impedes proper evidence synthesis. Only half of the included studies applied a patient-reported outcome measure as primary outcome. Ultimately, the heterogeneity in outcome reporting is an important methodological problem obstructing the full utilization of patient-reported outcome measures in inguinal hernia research.