Sex as a Biologic Variable in Groin Hernia

PROJECT SUMMARY/ABSTRACT Females with groin hernia, the most common condition encountered by general surgeons in the US, receive inferior care. While male patients are offered a choice between surgery and watchful waiting (i.e., non- operative management), guidelines recommend surgery for all females regardless of symptoms or preference.

Moreover, females have been excluded from all major trials informing best practices for groin hernia. Importantly, watchful waiting has never been evaluated among females. As a result, nearly 100,000 females undergo potentially avoidable surgery every year, likely contributing to the high rates of chronic post-operative

pain and poor quality of life observed in this population. A clinical trial evaluating watchful waiting vs surgery among females would definitively answer whether watchful waiting is a safe and acceptable strategy for females with groin hernia. Unfortunately, most clinical trials ultimately fail or have minimal impact due to

common barriers including lack of adequate sample size to detect differences in outcomes, selection of outcome metrics that do not matter to patients, and insufficient enrollment. Prior to conducting a clinical trial to assess watchful waiting in females (the candidate’s future R01 application), we must address these barriers.

This proposal will address these key gaps and ultimately will lead to a patient-centered clinical trial studying surgery compared to watchful waiting in females with groin hernia. Leveraging the data and infrastructure from the Michigan Surgical Quality Collaborative Core Optimization Hernia Registry, a novel, population-based

hernia collaborative, we will explore patient-reported outcomes following groin hernia repair, elicit patient priorities around the most important outcome metrics to study in a clinical trial, and determine the feasibility and acceptability of a clinical trial. The aims of this research proposal are to 1) Evaluate patient reported

outcomes following groin hernia repair among female patients, 2) Elicit patient priorities surrounding research in groin hernia to inform outcome metrics for a clinical trial repair, and 3) Determine the feasibility and acceptability of a clinical trial for females with groin hernia. The research plan will develop the preliminary data

and infrastructure necessary for a future patient-centered clinical trial. The project, the multidisciplinary mentorship team, and educational plan are ideally suited to address the career goals of the candidate, Anne P. Ehlers, MD, MPH. Dr. Ehlers is board-certified in general surgery with a clinical and research interest in hernia

care. In additional to the innovative research plan described here, this proposal will provide Dr. Ehlers with methodologic training in real-world data analysis, advanced qualitative methodology, and clinical trial design. This project will lay the groundwork for Dr. Ehlers to become an independent health services researcher with

expertise in clinical trials.