ABDOMINAL CORE HEALTH
Coordinated Registry Network
Tens of millions of hernia operations are performed worldwide every year to improve patients’ abdominal core health. Many products (e.g., meshes, fixation devices, and adhesives) are used in the care of these patients. These products and techniques are designed to last decades but their real-world durability requires large-scale research. Comprehensive surveillance of these products will help address effectiveness and safety in the general population and subpopulations. To address these needs, the Americas Hernia Society Quality Collaborative (AHSQC) was established in 2013. Surgeons in private practice and academic settings created the registry to maximize quality and value of hernia patient care.
The AHSQC mission is to utilize the concepts of continuous quality improvement through patient-centered data collection, ongoing performance feedback to clinicians, and improvement based on analysis of collected data and collaborative learning. In 2018, the AHSQC partnered with MDEpiNet to establish a CRN capable of addressing key questions through research and surveillance of techniques and devices. The AHSQC has taken the lead on the Abdominal Core Health CRN, with aims to fill the knowledge gap related to post market surveillance system in the US and plans to expand globally in partnership with international registries.
The CRN was initiated with two main objectives. Its first objective is to establish a CRN capable of addressing clinical questions and long-term surveillance of techniques and devices important to the maintenance of abdominal core health. The CRN’s second objective is to harmonize the collection of abdominal core health data by identifying and maintaining the common key variables important to patients and patient outcomes.
The CRN is guided by the AHSQC Foundation, with input from its collaboration partners, including its Executive Council and MDEpiNet leadership. The CRN is supported by several collaborating agencies, foundations, and hospital organizations involved in managing abdominal wall hernia disease.
In addition to MDEpiNet, lead agencies supporting the CRN and the AHSQC include: the Cleveland Clinic Foundation (AHSQC Center of Innovation), The Ohio State University Wexner Medical Center (AHSQC Data Coordination Center), Vanderbilt University Medical Center, and Weill Cornell Medicine (MDEpiNet Coordinating Center). CRN leadership includes Benjamin Poulose (Ohio State and AHSQC) AHSQC, Michael Rosen (Cleveland Clinic and AHSQC), Danica Marinac-Dabic (U.S. FDA), and Art Sedrakyan (Weill Cornell Medicine).
MDEpiNet Coordinating Center has an existing Data Use Agreement (DUA) with the AHSQC and collaborates with the lead institutions for data analytics. The AHSQC has agreements with each of its analytic sites including the Cleveland Clinic Foundation, Ohio State University Wexner Medical Center, and Vanderbilt University Medical Center.
International efforts relevant to the CRN
International efforts relevant to the Abdominal Core CRN include several registries with representatives from France Club Hernie, Denmark (Danish Groin Hernia Database (DGHD), Belgium (EuraHS), Spain (Registro Español de Eventraciones), Germany/Austria/Switzerland (Herniamed), and Sweden (Swedish Hernia Registry (SGHR)2. In 1992, prospective data collection on hernia surgeries began with the SGHR. Then in 1998, the DGHD was established which and later expanded to include ventral hernias in 2007 (DGHD). These registries were followed by the German Herniamed Registry in 2009; the French Club Hernie in 2011; EuraHS as well as the Spanish Registro Español de Eventraciones in 2012; and the AHSQC Registry in 2013.
The AHSQC registry includes patients aged 18 years and older who have had an inguinal or ventral hernia repair operation including umbilical, epigastric, Spiegelian, lumbar, incisional, and parastomal hernias, at a US-based hospital, academic health center, or surgery center. The registry collects demographics and pre-operative, intra-operative, post-operative, and long-term clinical data. As of September 2019, the AHSQC registry includes 54,129 patients treated by 354 participating surgeons in academic and private practice locations across the United States with long term follow up data as long as 5 years for cases conducted early in the registry’s history.
Aside from registry data, current data sources for linkage include New York State all payer data from the Statewide Planning and Research Cooperative System (SPARCS) as well as Medicare l data. The AHSQC facilitates data management through its web-based proprietary data platform. A main goal of the AHSQC and Abdominal Core Health CRN is to merge data sources to create an effective model for answering critical clinical questions and enabling post-market surveillance.
Current Projects and Plans
There are two major ongoing projects for Abdominal Core CRN that include 1) collection of patient perspective reported outcomes for short and long term follow up and, 2) conducting data linkages with the New York State and Medicare claims data.
Patient reported outcome (PRO)
The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications. The plan is to decouple the assessment of highly impactful patient events (that patients are very likely to recall) from a clinical visit with a provider to enhance the efficiency of surveillance.
In this effort, the CRN prioritizes the evaluation of outcomes such as readmission, reoperation, surgical site infection, and mesh-related complications, developing PROs sensitive to long-term, low rate, serious complications after hernia repair, and developing a common set of core variables in concert with international partners.
Data linkage projects
The project focus is an assessment of medical device performance through the linkage of AHSQC registry data to claims data. A pilot study was initiated in 2019 to link AHSQC registry data with New York State discharge claims and examine data completeness as well as the potential to determine short and long-term outcomes following ventral hernia repair. After the pilot study is completed and evaluated, the analytic center will link Center for Medicare and Medicaid Services (CMS) claims data to the registry. The CRN anticipates the completion of the first linkage project in January 2020.