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Embedding routine health care data in clinical trials: with great power comes great responsibility.
Handoko, M Louis; de Man, Frances S; Brugts, Jasper J; van der Meer, Peter; Rhodius-Meester, Hanneke F M; Schaap, Jeroen; van de Kamp, H J Rik; Houterman, Saskia; van Veghel, Dennis; Uijl, Alicia; Asselbergs, Folkert W.
Afiliación
  • Handoko ML; Department of Cardiology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. ml.handoko@amsterdamumc.nl.
  • de Man FS; Heart Failure and Arrhythmias, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. ml.handoko@amsterdamumc.nl.
  • Brugts JJ; Department of Pulmonary Medicine, Amsterdam University Medical Centres, Amsterdam, The Netherlands.
  • van der Meer P; Amsterdam Cardiovascular Sciences, Pulmonary Hypertension and Thrombosis, Amsterdam, The Netherlands.
  • Rhodius-Meester HFM; Department of Cardiology, Thorax Centre, Erasmus Medical Centre, University Medical Centre Rotterdam, Rotterdam, The Netherlands.
  • Schaap J; Department of Cardiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
  • van de Kamp HJR; Department of Internal Medicine, Geriatrics Section, Amsterdam University Medical Centres, Amsterdam, The Netherlands.
  • Houterman S; Department of Neurology, Alzheimer Centre Amsterdam, Amsterdam University Medical Centres, Amsterdam, The Netherlands.
  • van Veghel D; Department of Geriatric Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.
  • Uijl A; Department of Cardiology, Amphia Hospital, Breda, The Netherlands.
  • Asselbergs FW; Dutch Network for Cardiovascular Research, Utrecht, The Netherlands.
Neth Heart J ; 32(3): 106-115, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38224411
ABSTRACT
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Neth Heart J Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Neth Heart J Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Países Bajos