Balancing the Optimal and the Feasible

A Practical Guide for Setting Up Patient Registries for the Collection of Real-World Data for Health Care Decision Making Based on Dutch Experiences

Journal article (2017)

Authors

Saskia de Groot Erasmus Universiteit Rotterdam
N. van der Linden Erasmus Universiteit Rotterdam
Margreet G. Franken Erasmus Universiteit Rotterdam
Hedwig M. Blommestein Erasmus Universiteit Rotterdam, Integraal Kankercentrum Nederland (IKNL)
Brenda Leeneman Erasmus Universiteit Rotterdam
Ellen van Rooijen Erasmus Universiteit Rotterdam
J. J.M. Koos van der Hoeven Radboud University Medical Center
M.W.J.M. Wouters Nederlands Kanker Instituut - Antoni van Leeuwenhoek ziekenhuis, Dutch Institute for Clinical Auditing
Hans M. Westgeest Amphia Hospital, Erasmus Universiteit Rotterdam
C. A. Uyl-de Groot Erasmus Universiteit Rotterdam, Integraal Kankercentrum Nederland (IKNL)
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Published Date

2017

Language

English

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Abstract

Objectives The aim of this article was to provide practical guidance in setting up patient registries to facilitate real-world data collection for health care decision making. Methods This guidance was based on our experiences and involvement in setting up patient registries in oncology in the Netherlands. All aspects were structured according to 1) mission and goals (“the Why”), 2) stakeholders and funding (“the Who”), 3) type and content (“the What”), and 4) identification and recruitment of patients, data handling, and pharmacovigilance (“the How”). Results The mission of most patient registries is improving patient health by improving the quality of patient care; monitoring and evaluating patient care is often the primary goal (“the Why”). It is important to align the objectives of the registry and agree on a clear and functional governance structure with all stakeholders (“the Who”). There is often a trade off between reliability, validity, and specificity of data elements and feasibility of data collection (“the What”). Patient privacy should be carefully protected, and address (inter-)national and local regulations. Patient registries can reveal unique safety information, but it can be challenging to comply with pharmacovigilance guidelines (“the How”). Conclusions It is crucial to set up an efficient patient registry that serves its aims by collecting the right data of the right patient in the right way. It can be expected that patient registries will become the new standard alongside randomized controlled trials due to their unique value.