Evaluating Patient-Reported Outcomes in Inguinal Hernia Clinical Trials

Patient-reported outcomes (PROs) are increasingly reported in the literature and are subsequently relied on for clinical decision-making. In 2013, CONSORT (Consolidated Standards of Reporting Trials) added 5 guidelines for reporting PROs in randomized controlled trials, the PRO extensions. Adherence to the extensions among inguinal hernia trials is unknown.

A comprehensive review of the literature was performed to find RCTs evaluating inguinal hernia repair. Inclusion criteria were RCTs evaluating surgical management of inguinal hernia that included PROs as primary or secondary outcomes, published from January, 2014 through July, 2018. Exclusion criteria were nonelective repairs, age <18 y, or articles unavailable in English. Two researchers graded the articles for compliance with the extensions.

We identified 1548 articles, 78 of which met inclusion criteria. Four articles (5%) met all 5 extensions, whereas five (6%) did not meet any of the extensions. The extension requiring "identification of the PROs in the abstract as a primary or secondary outcome" was most commonly satisfied (83%), whereas that requiring the article "reference PRO instrument validity" was least satisfied (23%). Pain was the most frequently studied PRO and a visual analog scale was the most frequently used instrument.

Inguinal hernia trials demonstrate poor adherence to the PRO extensions. PRO data from these trials have been published widely; however, the lack of standardization in reporting calls into question the generalizability of these findings. Further education about these guidelines is necessary to improve PRO reporting and ensure optimal patient-centered care based on high quality evidence.