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ETHical and MethodologIcal evaluation of knowledge geneRation in cardiology: introducing thE learning health care system as a fundamental new approach - ETHMIRE

Projectomschrijving

De traditioneel strikte scheiding tussen zorg en onderzoek belemmert volgens velen verbeteringen en innovaties in de geneeskunde. Een alternatief is een continu lerend systeem waarin onderzoek en zorg zijn geïntegreerd - een zogeheten ‘Learning Healthcare System’ (LHS). Een LHS kent echter veel uitdagingen, zoals ethische toetsing, informed consent en het verkrijgen van bewijs uit routinematig verzamelde gegevens. Tot nu toe zijn kennis genererende activiteiten in de zorg maar sporadisch hervormd tot LHS. In onze studie willen we deze transformatie op unieke wijze bewerkstelligen door ethiek, recht, methodologie en patiëntbetrokkenheid systematisch te integreren, leidend tot voor de patiënt betekenisvolle vernieuwingen. We transformeren daartoe alle kennis genererende activiteiten in de cardiologie in het UMC Utrecht en het LUMC tot LHS. De cardiologie fungeert zo als proeftuin voor andere gebieden waar zorg en onderzoek samen gaan.

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Samenvatting van de aanvraag

The generation of evidence is integral to the work of academic health care institutions and health service providers. At the same time, there is a growing recognition that the distinction between research and other evidence-generating activities in the context of care is artificial and leads to ethical-legal and methodological problems. Many research activities in cardiology are perceived as overregulated in terms of ethical review and informed consent procedures. Evaluation of data generated within highly protocolized clinical care tracks may require approval each time a single objective is evaluated. Moreover, research in cardiology typically takes the form of large-scale studies, for instance based on information stored in electronic patient files, with full conventional ethical governance. In many of those studies researchers experience that ethical review and a conventional informed consent procedure can overburden researchers and institutions when the risks are relatively low and patients receive care as usual. Other practices in cardiology are underregulated. In cardiology, the use of innovative medical techniques, usually does not fall under ethical research oversight when this use is labeled as “innovative care”. However, these care activities may generate highly relevant new knowledge for evidence based treatments while exposing patients to added risks over those they encounter in the “ideal” practice of care. The current distinction between research and care also faces methodological problems. This paradigm is not easily applicable to innovative forms of care that may already be outdated before formal evaluation has ended. Since new interventions are predominantly applied in those who are expected to benefit most a straightforward comparison of health outcomes among different intervention groups is ill-advised and clinical data does not directly allow valid clinical research. Randomized trials may overcome selective ‘prescribing’ of new interventions by random allocation of treatment, yet such studies are expensive and results may be hard to generalize. An alternative may be registry-based trials, which use existing data (e.g., electronic health record (EHR) databases) for patient recruitment and follow-up, while the experimental intervention is randomly assigned, as in a conventional RCT. Since these studies are executed in routine clinical practice, their results tend to better reflect the effectiveness of interventions in clinical practice. Furthermore, available observational routinely collected healthcare data may be used to reduce the sample size of trials, increase the generalizability of the results and tailor dosing based on certain patient characteristics. However, since EHR databases have primarily been designed to support clinical care rather than research, data quality may be a concern. At the same time, some measures of health status may be recorded with more detail in EHRs. Authorities do acknowledge the ethical and methodological problems but without a fundamental solution. Ten years ago, the Institute of Medicine already called on health care leaders to transform their health systems into “learning health care systems,” in which care of patients is integrated with medical research so that the health care practices offered in the system are continuously studied, learned from and improved. In this research proposal, we will transform all evidence-generating activities in the Departments of Cardiology in the UMC Utrecht and the LUMC into an LHS. We will focus on two clinical care pathways (acute myocardial infarctions and atrium fibrillation) and routinely collected cardiovascular data (via the Utrecht Cardiovascular Cohort). We will develop an ethical-legal review system for research in cardiology as an LHS, focusing on the introduction of new (non-pharmacological) interventions in clinical practice, and epidemiological studies that use large patient data-sets. We will design an informed consent process for cardiology as an LHS that includes an appropriate level of patient engagement. As regards the methodology, we will (1) assess the value of routinely collected health data for prospective assessment of the effects of (new) interventions; (2) investigate requirements for reusing existing data; and (3) develop methods for testing which intervention works in whom in a context of targeted use of interventions. ETHMIRE is one of the first attempts to realize this transformation. Our project is unique in that it systematically integrates ethics, law, methodology and patient engagement with regard to innovations and data collection in cardiology. The results of this project should be generalizable to other fields where similar ethical-legal and methodological problems are experienced and similar opportunities for transformation exist.

Onderwerpen

Kenmerken

Projectnummer:
91217027
Looptijd: 100%
Looptijd: 100 %
2018
2023
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
prof. dr. D.E. Grobbee
Verantwoordelijke organisatie:
Universitair Medisch Centrum Utrecht