A. R. Wilcox1,2, S. W. Trooboff1,2,3,4, S. L. Wong1,2,3 1Dartmouth-Hitchcock Medical Center,Department Of Surgery,Lebanon, NH, USA 2Dartmouth Medical School,Lebanon, NH, USA 3The Dartmouth Institute for Health Policy and Clinical Practice,Lebanon, NH, USA 4Veterans Health Administration,VA National Quality Scholars Program,White River Junction, VT, USA
Introduction: Patient-reported outcomes (PRO) data are increasingly reported in the surgical literature and are subsequently relied upon for clinical decision making. Adherence to the CONSORT (Consolidated Standards of Reporting Trials) statement is required by major journals for randomized controlled trials (RCTs). In 2013, CONSORT added 5 guidelines for reporting PROs in RCTs, known as the PRO extensions. Although PROs are frequently reported in the inguinal hernia literature as a main outcome of interest, adherence to the PRO extensions is unknown.
Methods: In consultation with a medical librarian, a systematic review of the literature was performed to find RCTs evaluating inguinal hernia repair via Ovid MEDLINE. Our inclusion criteria were RCTs evaluating surgical management of inguinal hernia that included PROs as primary or secondary outcomes, published January 2014-July 2018. Exclusion criteria were non-elective repairs, age < 18, or articles unavailable in English. If a trial’s results were published more than once, we only included the most recent publication. Two researchers graded the articles for compliance with the PRO extensions.
Results: We identified 1548 papers in our initial review, 78 of which met criteria for inclusion in this study. Most RCTs (43/78, 55%) compared different types of mesh or techniques to secure mesh. Only 1 paper (1.3%) met all 5 CONSORT PRO extensions, while 11 (14%) did not meet any of the extensions. The PRO extension requiring “identification of the PROs in the abstract as a primary or secondary outcome” was the most commonly satisfied extension (82%), while the extension requiring “statistical approaches for dealing with missing data are explicitly stated” was the least satisfied (18%) (FIGURE). Pain was the most frequently studied PRO, and a Visual Analog Scale was the most frequently used assessment tool. Of note, only 12 papers (15%) referenced the CONSORT statement and none of these demonstrated full adherence to the extensions.
Conclusion: RCTs evaluating elective inguinal hernia repair demonstrate poor adherence to CONSORT PRO guidelines. PRO data from inguinal hernia trials have been published in numerous studies and meta-analyses; however, the lack of standardization in PRO reporting calls into question the generalizability of these findings. It is also noteworthy that very few studies referenced the CONSORT statement in the design of their RCT. If few studies are following CONSORT, it is unsurprising that there was such poor compliance with the PRO extensions. Further education about and dissemination of these guidelines is necessary to improve PRO reporting and ensure optimal patient-centered care based on high quality evidence.
