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

PURPOSE: To evaluate the use, results, and reporting of patient-reported outcome measures specific to patients undergoing inguinal hernia repair. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Trends in the use of patient-reported outcome measures for inguinal hernia repair: a quantitative systematic review.

PURPOSE: To quantitatively assess the use of patient-reported outcome measures in studies involving patients undergoing inguinal hernia repair. METHODS: We performed a systematic literature search in Medline and EMBASE. We included all studies published between 2000 and 2019 that involved > 5 patients receiving inguinal hernia repair and evaluated a postoperative patient-reported outcome measure. Studies were stratified in 5-year intervals. We extracted data on which patient-reported outcome measure was used, its time of administration, study design, and the size and composition of the study population. Data were presented using descriptive statistics. RESULTS: We included 929 studies that covered 81 different patient-reported outcome measures. Of these, the Short-Form 36 was the most commonly used generic instrument (14%), the Carolinas Comfort Scale was the most commonly used hernia-specific instrument (5%), and the Visual Analogue Scale was the most commonly used domain-specific instrument (70%). There was a proportional decrease in the use of generic instruments, from 24% of studies in 2000-2004 to only 14% of studies in 2015-2019. Conversely, there was an increase in the use of hernia-specific instruments, from 0% in 2000-2004 to 18% in 2015-2019. CONCLUSIONS: There is heterogeneity in the use of patient-reported outcome measures in the field of inguinal hernia research. The use of hernia-specific instruments is increasing, the use of generic instruments is decreasing, and the use of domain-specific instruments remains consistently high. This study serves as a repository of all available patient-reported outcome measures relevant to patients undergoing inguinal hernia repair.