A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol.

Schoenthaler M, Fichtner UA, Boeker M, Zoeller D, Binder H, Prokosch HU, Praus F, Walther T, Glienke M, Horki P, Gratzke C, Farin-Glattacker E (2022)

Publication Type: Journal article

Publication year: 2022


Book Volume: 22

Journal Issue: 1

DOI: 10.1186/s12913-022-08375-7


BACKGROUND: Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries". METHODS: RECUR builds on the technical infrastructure of Germany's Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. DISCUSSION: The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry's technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. TRIAL REGISTRATION: This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11th 2022.

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Schoenthaler, M., Fichtner, U.A., Boeker, M., Zoeller, D., Binder, H., Prokosch, H.-U.,... Farin-Glattacker, E. (2022). A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol. BMC Health Services Research, 22(1). https://doi.org/10.1186/s12913-022-08375-7


Schoenthaler, Martin, et al. "A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol." BMC Health Services Research 22.1 (2022).

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