TY - JOUR
T1 - Learning healthcare systems in cardiology
T2 - A qualitative interview study on ethical dilemmas of a learning healthcare system
AU - Laurijssen, Sara
AU - van der Graaf, Rieke
AU - Schuit, Ewoud
AU - den Haan, Melina
AU - van Dijk, Wouter
AU - Groenwold, Rolf
AU - le Sessie, Saskia
AU - Grobbee, Diederick
AU - de Vries, Martine
N1 - Funding Information:
All authors are funded by the Netherlands Organization for Health Research and Development (ZonMW) (grant number 91217027).
Publisher Copyright:
© 2023 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.
PY - 2024/1
Y1 - 2024/1
N2 - Background: Implementation of an LHS in cardiology departments presents itself with ethical challenges, including ethical review and informed consent. In this qualitative study, we investigated stakeholders' attitudes toward ethical issues regarding the implementation of an LHS in the cardiology department. Methods: We conducted a qualitative study using 35 semi-structured interviews and 5 focus group interviews with 34 individuals. We interviewed cardiologists, research nurses, cardiovascular patients, ethicists, health lawyers, epidemiologists/statisticians and insurance spokespersons. Results: Respondents identified different ethical obstacles for the implementation of an LHS within the cardiology department. These obstacles were mainly on ethical oversight in LHSs; in particular, informed con sent and data ownership were discussed. In addition, respondents reported on the role of patients in LHS. Respondents described the LHS as a possibility for patients to engage in both research and care. While the LHS can promote patient engagement, patients might also be reduced to their data and are therefore at risk, according to respondents. Conclusions: Views on the ethical dilemmas of a LHSs within cardiology are diverse. Similar to the literary debate on oversight, there are different views on how ethical oversight should be regulated. This study adds to the literary debate on oversight by highlighting that patients wish to be informed about the learning activities within the LHS they participate in, and that they wish to actively contribute by sharing their data and identifying learning goals, provided that informed consent is obtained.
AB - Background: Implementation of an LHS in cardiology departments presents itself with ethical challenges, including ethical review and informed consent. In this qualitative study, we investigated stakeholders' attitudes toward ethical issues regarding the implementation of an LHS in the cardiology department. Methods: We conducted a qualitative study using 35 semi-structured interviews and 5 focus group interviews with 34 individuals. We interviewed cardiologists, research nurses, cardiovascular patients, ethicists, health lawyers, epidemiologists/statisticians and insurance spokespersons. Results: Respondents identified different ethical obstacles for the implementation of an LHS within the cardiology department. These obstacles were mainly on ethical oversight in LHSs; in particular, informed con sent and data ownership were discussed. In addition, respondents reported on the role of patients in LHS. Respondents described the LHS as a possibility for patients to engage in both research and care. While the LHS can promote patient engagement, patients might also be reduced to their data and are therefore at risk, according to respondents. Conclusions: Views on the ethical dilemmas of a LHSs within cardiology are diverse. Similar to the literary debate on oversight, there are different views on how ethical oversight should be regulated. This study adds to the literary debate on oversight by highlighting that patients wish to be informed about the learning activities within the LHS they participate in, and that they wish to actively contribute by sharing their data and identifying learning goals, provided that informed consent is obtained.
KW - cardiology
KW - ethics
KW - learning healthcare system
KW - qualitative research
UR - http://www.scopus.com/inward/record.url?scp=85165288270&partnerID=8YFLogxK
U2 - 10.1002/lrh2.10379
DO - 10.1002/lrh2.10379
M3 - Article
C2 - 38249849
AN - SCOPUS:85165288270
VL - 8
JO - Learning Health Systems
JF - Learning Health Systems
IS - 1
M1 - e10379
ER -