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

Value in Health
April 2017 Volume 20, Issue 4, p519-726
http://www.valueinhealthjournal.com/current

Patient-Reported Outcomes
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
Saskia de Groot, Naomi van der Linden, Margreet G. Franken, Hedwig M. Blommestein, Brenda Leeneman, Ellen van Rooijen, J.J.M. (Koos) van der Hoeven, Michel W. Wouters, Hans M. Westgeest, Carin A. Uyl-de Groot
p627–636
Published online: April 6, 2016
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.