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Open Access Study protocol

In-vivo-validation of a cardiovascular risk prediction tool: the arriba-pro study

Annette Diener1*, Salomé Celemín-Heinrich2, Karl Wegscheider3, Kai Kolpatzik4, Katrin Tomaschko5, Attila Altiner1, Norbert Donner-Banzhoff2 and Jörg Haasenritter2

Author Affiliations

1 Institute of General Practice, Rostock University Medical Center, 18055, Rostock, Germany

2 Department of General Practice/Family Medicine, Medical Faculty, Philipps University Marburg, 35043, Marburg, Germany

3 Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, 20246, Hamburg, Germany

4 Federal Association of the AOK, 10178, Berlin, Germany

5 AOK Baden-Württemberg, 70191, Stuttgart, Germany

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BMC Family Practice 2013, 14:13  doi:10.1186/1471-2296-14-13

Published: 22 January 2013

Abstract

Background

Calculation of individual risk is the cornerstone of effective cardiovascular prevention. arriba is a software to estimate the individual risk to suffer a cardiovascular event in 10 years. Prognosis and the absolute effects of pharmacological and lifestyle interventions help the patient make a well-informed decision. The risk calculation algorithm currently used in arriba is based on the Framingham risk algorithm calibrated to the German setting. The objective of this study is to evaluate and adapt the algorithm for the target population in primary care in Germany.

Methods/design

arriba-pro will be conducted within the primary care scheme provided by a large health care insurer in Baden-Württemberg, Germany. Patients who are counseled with arriba by their general practitioners (GPs) will be included in the arriba-pro cohort. Exposure data from the consultation with arriba such as demographic data and risk factors will be recorded automatically by the practice software and transferred to the study centre. Information on relevant prescription drugs (effect modifiers) and cardiovascular events (outcomes) will be derived from administrative sources.

Discussion

The study is unique in simulating a therapy naïve cohort, matching exactly research and application setting, using a robust administrative data base, and, finally, including patients with known cardiovascular disease who have been excluded from previous studies.

Trial registration

The study is registered with Deutsches Register Klinischer Studien (DRKS00004633).