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

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...

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Bibliographic Details
Published in:Value in health 2017-04, Vol.20 (4), p.627-636
Main Authors: de Groot, Saskia, MSc, van der Linden, Naomi, PhD, Franken, Margreet G., PhD, Blommestein, Hedwig M., MSc, Leeneman, Brenda, MSc, van Rooijen, Ellen, MD, (Koos) van der Hoeven, J.J.M., MD, PhD, Wouters, Michel W., MD, PhD, Westgeest, Hans M., MD, Uyl-de Groot, Carin A., PhD
Format: Article
Language:English
Subjects:
Clinical trials
Confidentiality
Data Accuracy
Data collection
Data Collection - economics
Data Collection - methods
Data Collection - standards
Decision Making
Feasibility
Guideline Adherence
Guidelines as Topic
Health care
Health Services Research - economics
Health Services Research - methods
Health Services Research - standards
Humans
Internal Medicine
Medical Oncology - economics
Medical Oncology - methods
Medical Oncology - standards
Medical records
Netherlands
observational studies
Oncology
Organizational Objectives
Patients
Pharmacovigilance
Policy Making
Privacy
real-world data
Recruitment
registries
Registries - standards
Reliability
Reproducibility of Results
Research Support as Topic
Safety regulations
Stakeholders
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Summary: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.
ISSN:1098-3015
1524-4733
DOI:10.1016/j.jval.2016.02.007