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Purpose:  To develop a prospective non-muscle-invasive bladder cancer (NMIBC) data registry by generating NMIBC-specific electronic case report forms (eCRFs) in our institution's electronic patient file system, and to report on the development and implementation of a prospective multicentric registry.   Methods:  Templates for data collection, including clinical outcome parameters and quality indicators, were developed in InfoPath™ as an eCRF and were incorporated in our hospital's electronic patient file system. Quality parameters for managing NMIBC patients that were identified by comprehensive literature review were included in the eCRFs. Three separate eCRFs were developed for the management of NMIBC patients: surgery report, bladder instillation form, and multidisciplinary team form.   Results:  In August 2013, we started a Flemish prospective clinical and pathological data registry for all patients undergoing transurethral resection of bladder tumor (TURBT) for NMIBC in four participating hospitals, three of which continued using this to date. Three more hospitals started enrolling in 2017, 2018, and 2019, respectively. Written reports of the registered clinical actions are automatically generated within the electronic medical file. When urologists complete these eCRFs, an automated ready-to-send letter to the general practitioner is generated. Up till May 2019, 2,756 TURBTs in 2,419 patients are included in the dataset. Currently, we are recruiting over 600 TURBTs every year.   Conclusions:  Easy-to-use eCRFs were developed and included in the electronic patient file system. This registration tool was implemented in 7 hospitals, 6 of which are still using it today. The register harvests important clinical data, while performing routine clinical practice. The data will be used to analyze real-life data of NMIBC patients, to challenge the existing guidelines, to create novel risk stratification tools, and to develop, monitor and validate quality parameters for NMIBC management.

Development of a Prospective Data Registry System for Non-muscle-Invasive Bladder Cancer Patients Incorporated in the Electronic Patient File System