Caring for brain AVM patients requires a pragmatic care research protocol

Darsaut, T.E.; Magro, Elsa; Gentric, Jean-Christophe; Raymond, Jean

doi:10.1007/s00234-020-02405-z

Cited by 2 publications

(1 citation statement)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…On the care side, without financial compensation few centers have participated. Frequent criticisms concerned "informativeness" and feasibility [17,49,50].…”

Section: Care Research Is a Work In Progressmentioning

confidence: 99%

Ethical care requires pragmatic care research to guide medical practice under uncertainty

Darsaut

Raymond

2021

Trials

Self Cite

View full text Add to dashboard Cite

Background The current research-care separation was introduced to protect patients from explanatory studies designed to gain knowledge for future patients. Care trials are all-inclusive pragmatic trials integrated into medical practice, with no extra tests, risks, or cost, and have been designed to guide practice under uncertainty in the best medical interest of the patient. Proposed revision Patients need a distinction between validated care, previously verified to provide better outcomes, and promising but unvalidated care, which may include unnecessary or even harmful interventions. While validated care can be practiced normally, unvalidated care should only be offered within declared pragmatic care research, designed to protect patients from harm. The validated/unvalidated care distinction is normative, necessary to the ethics of medical practice. Care trials, which mark the distinction and allow the tentative use of promising interventions necessarily involve patients, and thus the design and conduct of pragmatic care research must respect the overarching rule of care ethics “to always act in the best medical interest of the patient.” Yet, unvalidated interventions offered in contexts of medical uncertainty cannot be prescribed or practiced as if they were validated care. The medical interests of current patients are best protected when unvalidated practices are restricted to a care trial protocol, with 1:1 random allocation (or “hemi-prescription”) versus previously validated care, to optimize potential benefits and minimize risks for each patient. Conclusion Pragmatic trials can regulate medical practice by providing (i) a transparent demarcation between unvalidated and validated care; (ii) norms of medical conduct when using tests and interventions of yet unknown benefits in practice; and eventually (iii) a verdict regarding optimal care.

show abstract

“…On the care side, without financial compensation few centers have participated. Frequent criticisms concerned "informativeness" and feasibility [17,49,50].…”

Section: Care Research Is a Work In Progressmentioning

confidence: 99%

Ethical care requires pragmatic care research to guide medical practice under uncertainty

Darsaut

Raymond

2021

Trials

Self Cite

View full text Add to dashboard Cite

show abstract

Practicing outcome-based medical care using pragmatic care trials

Darsaut

Raymond

2020

Trials

Self Cite

View full text Add to dashboard Cite

The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions actually deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty. Pragmatic care trials have been designed to address these problems. Care trials are all-inclusive randomized trials integrated into care. Every item of trial design is selected in the best medical interest of participating patients. Care trials can eventually show what constitutes good medical practice based on patient outcomes. In the meantime, care trials give clinicians and patients the scientific methods necessary for optimization of medical care when no one really knows what to do. We report the progress of 9 randomized care trials that were used to guide the endovascular or surgical management of 1212 patients with acute stroke, intracranial aneurysms, and arteriovenous malformations in a single center in an elective or acute care context. Care trials were used to address long-standing dilemmas regarding rival medical, surgical, or endovascular management options or to offer innovative instead of standard treatments. The trial methodology, by replacing unrepeatable treatment decisions by 1:1 randomized allocation whenever reliable knowledge was not available, had an immediate impact, transforming unverifiable dogmatic medical practice into verifiable outcome-based medical care. We believe the approach is applicable to all medical or surgical domains, but widespread adoption may require the revision of many currently prevalent views regarding the role of research in clinical practice.

show abstract

Caring for brain AVM patients requires a pragmatic care research protocol

Cited by 2 publications

References 6 publications

Ethical care requires pragmatic care research to guide medical practice under uncertainty

Ethical care requires pragmatic care research to guide medical practice under uncertainty

Practicing outcome-based medical care using pragmatic care trials

Contact Info

Product

Resources

About