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Post-market mesh surveillance and automated prediction of outcome of ventral hernia surgery in 3 European countries
Background:Apart from data from RCTs, registry data are an important source for outcome measurement after surgical treatment. This is also true in hernia surgery, especially with the implementation of the European Medical Device Regulation in May 2021 and increased public awareness about possible deleterious outcomes of the use of some medical devices (breast implants, pelvic floor devices…). High quality registers may offer some important benchmarks but need to fulfill some key-criteria: measurement of clinical outcomes based on risk adjustment, peer-controlled, including consecutive patients, semi-automatic process based on available administrative data, on-site monitoring and source data verification, reporting of possible confounders, detailed multivariate analysis and continuous feedback to the individual participating surgeons. The most sophisticated high quality and validated registry for ventral hernias in the world is developed and used by the Danish Hernia Database (DHD https://www.danishhealthdata.com/find-health-data/Dansk-Herniedatabase). The DHD has published numerous papers in high ranking peer-reviewed journals and has internationally a very high scientific reputation, since it includes nearly all patients in the country and allows to track patients systematically in the whole country based on their unique patient identification number. The Ventral Hernia Database (VHD), as part of the DHD, covers nearly all ventral hernias (umbilical, epigastric, incisional and parastomal hernia…) treated in Denmark and evaluates systematically short-term outcome data (length of stay, 90d readmission rate, 90d reoperation rate for complications and 90d mortality) with automatic registration of administrative data, based on the Scandinavian version of ICD-10-CM and ICD-10-PCS coding. The VHD also allows to evaluate specific mesh materials since this is included recently as one of the independent variables. Based on the fact that this is a frequent pathology with often important medical consequences (eg high mortality after surgery for emergency parastomal hernia repair), the personal and socioeconomic implications are not to be underestimated. Since the Belgian health care system also uses a unique patient identification number all over the country, the Belgian Section of Abdominal Wall Surgery (BSAWS), which is also the Belgian Chapter of the European Hernia Society, decided to develop a comparable quality control mechanism, in close collaboration with the Danish Hernia Database and the Belgian health authorities (Sciensano). Starting in the summer of 2021 (protocol already approved by EC University Hospitals Leuven), 25 hospitals all over Belgium will, on a voluntary basis, use the same electronic health record for registering intraoperative surgical details. These hospitals represent a mix of university and non-university hospitals. Because of their specific interest in abdominal wall pathology, they will cover a substantial amount of ventral hernias in Belgium. Outcome will be evaluated in exactly the same way, until death or emigration out of Belgium, by using the comparable ICD-10-CM and ICD-10-PCS coding as in Denmark. Also comorbidity, present on admission for the index operation, will be registered. In this way, we will be able to compare our data not only within Belgium, but also benchmark our results versus Denmark.Objectives of the Horizon Europe project:WP 1. A standardized operation report template for ventral hernia repairThe purpose is to integrate the existing data capture reports of the index operations in the different countries of the EU. The templates in Denmark and Belgium are very similar. We want to integrate the plans of the British Hernia Society that is already far advanced in collaboration with Belgium and Denmark. Other potential partners are: Sweden (http://www.svensktbrackregister.se/en/), Germany/Austria (https://www.herniamed.de/) and France (https://www.club-hernie.com/). Also the input of the European Hernia Society Taskforces will be asked. It should also be possible to upload photos and video fragments. Crucial will be to include a screening log of the participating surgeons to avoid selective data input instead of consecutive patient inclusion. If possible we also aim at integrating this report in existing local/regional/national electronic health records. Important is also to integrate the UDI (unique device identificator) for every mesh used, which will become compulsory with the new Medical Device Regulation. This WP should ideally be lead by IT experts and engineers involved in European integration of health records.WP 2. Development of PROMS/PREMS for evaluation of patient satisfaction after ventral hernia repairSince some of the countries potentially involved have no unique patient ID to track patients on the long term, FU will be concentrated on obtaining pre- and postoperative PROMS/PREMS evaluation, obtained via digital questionnaires filled by the patient through a secure electronic link. The accent will be put on QoL, patient satisfaction and patient safety. For the latter, information of reoperations given by the patient will be cross checked by evaluating original operation reports. The Swedish Hernia Register has already a template for this questionnaires (Hero) that is now being tested and validated. The purpose is also, as in WP1, to integrate these data in existing local/regional/national electronic health records. We have already experience with such an automated system of PROMS evaluation in Vlaanderen for inguinal hernia surgery (FLIPR project of the VZN KULeuven). An important role is here for patient organisations, since patient empowerment in this WP will increase the motivation of patients to participate on the long term (preferably lifelong). This WP should ideally be led by surgeons and epidemiologists experienced in QoL, and psychologists.WP 3. Genetic profiling as another tool for personalised medicineSome patients are inherently at risk for developing a recurrence; this is most likely linked to a heterogenous pattern of inheritance. Based on pre- and intraoperative details (family history for hernias, number of hernias in one patient, microscopic quality of tissue intraoperatively), a subset of patients in the participating countries will be examined by an expert geneticist and a specific number of blood samples will be evaluated according to a standardized care path. This WP should ideally led by expert geneticists.WP 4. Application of machine learning to determine which pre- or intraoperative variables predict the need for reoperation postoperatively The analysis of all these data will be used in sophisticated machine learning analyses to evaluate mesh performance on one hand, and develop prediction models for patient reported outcome (QoL, SSO, SSOPI, SSI, reoperation for recurrence, reoperation for (mesh) complications) on the other hand. This WP should ideally led by methodologists, statisticians and computer scientists experienced in AI, with major input of surgeons.WP 5 Legal aspect, GDPR, FAIRificationThe integration of different modules (operation report of index surgery, questionnaires, operation reports of reoperations) and the integration in local/regional/national health records should improve its use by surgeons eg by allowing automatic generation of operation reports and allowing easy access for all health professsionals dealing with the care of this patient. For this reason we will include from the start the input of the scientific departments of the regional/national health authorities (eg Sciensano in Belgium). In addition, the legal/regulatory aspects on privacy/GDPR and the good governance of these databases (FAIRification) will be covered in this WP. It will be ideally led by legal counsellers and data managers experienced in large European health care projects. WP 6 Dissemination, exploitation and impact in EuropeWe believe that the result of this project will have an impact in many European MS on two levels: first of all we will provide a practical framework (including technical, logistic and legal aspects) for other European countries to embark with a national/regional register with full integration in the existing network. With this respect, the active collaboration of and promotion by the European Hernia Society is key for broader implementation. Secondly, we will also provide a more generic platform with modifieable independent and dependent variables to used by other surgical but also medical specialities for other comparable (frequently occurring) health care problems.
Date:15 May 2021 → Today
Keywords:ventral hernia, register, outcome, AI