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Results from patient-reported outcome measures are inconsistently reported in inguinal hernia trials: a systematic
A Gram-Hanssen1, C Christophersen2, J Rosenberg2
1Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark. anders@gram-hanssen.dk.
Insights
Patient-reported outcome measures in inguinal hernia repair studies show varied results and reporting methods, hindering evidence synthesis. Standardizing reporting is crucial for better utilization of these valuable patient insights.
Area of Science:
- Surgical research
- Patient-reported outcomes
- Hernia repair
Background:
- Patient-reported outcome measures (PROMs) are increasingly vital in surgical research.
- Standardized reporting of PROMs is essential for robust evidence synthesis.
Purpose of the Study:
- To evaluate the use, results, and reporting of PROMs in inguinal hernia repair.
- To identify common PROMs and their application in clinical trials.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) adhering to PRISMA 2020 guidelines.
- Searches conducted in PubMed and EMBASE, including only RCTs with postoperative hernia-specific PROMs.
- Risk of bias assessed using Cochrane risk of bias tool 2.0.
Main Results:
- Twenty trials utilized four PROMs: Carolinas Comfort Scale, Activities Assessment Scale, Inguinal Pain Questionnaire, and Surgical Pain Scales.
- PROMs were used to compare surgical approaches, mesh/fixation types, and anesthesia/analgesia.
- Significant heterogeneity observed in results reporting (means, medians, proportions), with only 7/20 studies designating PROMs as a primary outcome.
Conclusions:
- Heterogeneous reporting of PROM results in inguinal hernia research impedes evidence synthesis.
- Lack of standardized PROM reporting is a significant methodological issue.
- Improved reporting standards are needed to fully leverage PROMs in hernia repair research.
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.
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