Journal Article

How traditional informed consent impairs inclusivity in a learning healthcare system: lessons learned from the Utrecht Cardiovascular Cohort

de Vries, Martine C., Haitjema, Saskia, Mostert, Menno, van Dijk, Wouter B., Bots, Michiel L., Grobbee, Diederick E., Lea, Nathan C., Asselbergs, Folkert W., van der Graaf, Rieke, Groenhof, T. Katrien J.

2022

Overview

[...]research into a new informed consent framework for LHS is needed. 1 Introduction In 2007, the Institute of Medicine called for the transition of healthcare systems into Learning Healthcare Systems (LHSs), where research and care are intertwined in such a way that daily healthcare practice is used as a source for continuous learning and that the knowledge that follows from these learning activities accordingly leads to an improvement of the healthcare practice [1]. A low informed consent rate is not the focus of this work rather it is the ethical and procedural issues raised when it is selective, that is, depends on patient characteristics that warrants consideration because it may reduce inclusivity, that is, representativeness of the population; this has wider implications for participation bias and undermines the premise of the LHS. [...]in this article we aimed to investigate whether inclusivity of the UCC-CVRM population was at stake with the traditional informed consent procedure as followed by the UCC-CVRM. To be able to explore solutions to the problem of a (potential) selective consent, insight is required into how the informed consent process in the UCC-CVRM was designed.2 The example 2.1 The Utrecht Cardiovascular Cohort The UCC-CVRM consists of (i) a collection of routine care data about a cardiovascular risk factor assessment based on the Dutch guidelines for cardiovascular risk assessment, (ii) linkage to other health data sources, and (iii) a biobank.2.2 Informed consent procedure Data-intensive LHSs may use various approaches to an informed consent. The UCC-CVRM cardiovascular intake is registered in the EHR, consisting of a questionnaire on medical history, intoxications, physical activity, family history, and measurements of blood pressure, height, and weight.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Bias / Blood pressure / Cardiovascular disease / Cardiovascular diseases / Electronic health records / Ethics / Feedback / Genetics / Health care / Health risks / Informed consent / Internal Medicine / Learning / Participation / Patients / Physical activity / Risk analysis / Risk assessment / Risk factors