TY - JOUR
T1 - Embedding routine health care data in clinical trials
T2 - with great power comes great responsibility
AU - Handoko, M Louis
AU - de Man, Frances S
AU - Brugts, Jasper J
AU - van der Meer, Peter
AU - Rhodius-Meester, Hanneke F M
AU - Schaap, Jeroen
AU - van de Kamp, H J Rik
AU - Houterman, Saskia
AU - van Veghel, Dennis
AU - Uijl, Alicia
AU - Asselbergs, Folkert W
N1 - Publisher Copyright: © The Author(s) 2024.
PY - 2024/3
Y1 - 2024/3
N2 - Randomised clinical trials (RCTs) are vital for medical progress. Unfortunately, 'traditional' RCTs are expensive and inherently slow. Moreover, their generalisability has been questioned. There is considerable overlap in routine health care data (RHCD) and trial-specific data. Therefore, integration of RHCD in an RCT has great potential, as it would reduce the effort and costs required to collect data, thereby overcoming some of the major downsides of a traditional RCT. However, use of RHCD comes with other challenges, such as privacy issues, as well as technical and practical barriers. Here, we give a current overview of related initiatives on national cardiovascular registries (Netherlands Heart Registration, Heart4Data), showcasing the interrelationships between and the relevance of the different registries for the practicing physician. We then discuss the benefits and limitations of RHCD use in the setting of a pragmatic RCT from a cardiovascular perspective, illustrated by a case study in heart failure.
AB - Randomised clinical trials (RCTs) are vital for medical progress. Unfortunately, 'traditional' RCTs are expensive and inherently slow. Moreover, their generalisability has been questioned. There is considerable overlap in routine health care data (RHCD) and trial-specific data. Therefore, integration of RHCD in an RCT has great potential, as it would reduce the effort and costs required to collect data, thereby overcoming some of the major downsides of a traditional RCT. However, use of RHCD comes with other challenges, such as privacy issues, as well as technical and practical barriers. Here, we give a current overview of related initiatives on national cardiovascular registries (Netherlands Heart Registration, Heart4Data), showcasing the interrelationships between and the relevance of the different registries for the practicing physician. We then discuss the benefits and limitations of RHCD use in the setting of a pragmatic RCT from a cardiovascular perspective, illustrated by a case study in heart failure.
KW - Big data
KW - Cardiovascular diseases
KW - Heart failure
KW - Pragmatic clinical trials
KW - Randomised controlled trials
UR - http://www.scopus.com/inward/record.url?scp=85182472124&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s12471-023-01837-5
DO - https://doi.org/10.1007/s12471-023-01837-5
M3 - Article
C2 - 38224411
SN - 1568-5888
VL - 32
SP - 106
EP - 115
JO - Netherlands heart journal
JF - Netherlands heart journal
IS - 3
ER -