Care and research concepts should be revised to practice outcome-based medical care

Raymond, Jean; Darsaut, T.E.; Roy, David J.

doi:10.1016/j.jclinepi.2019.05.025

Cited by 20 publications

(8 citation statements)

References 10 publications

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“…The fundamental principle we propose is that physicians should provide validated care and reserve the use of unvalidated tests and interventions within declared care research [3]. This principle, in the spirit of the classical primum non nocere clause, has a number of consequences that remain to be studied in more detail by a new program.…”

Section: The Ethical Role Trial Methods Can Play In the Care Of Patientsmentioning

confidence: 99%

“…Equipoise (conceived as a condition to trial participation) should be replaced, in the case of care trials, by the notion that there must be good reasons to exempt clinicians from the general obligation of using unvalidated interventions only within the prudent context of declared care research. If care trials are designed as optimal care in the presence of uncertainty, they should not be obstructed by competition and bureaucracy or be conditioned on winning grants or funding streams, like other research endeavors [3]. They should be encouraged and promoted at all levels.…”

Section: The Ethical Role Trial Methods Can Play In the Care Of Patientsmentioning

confidence: 99%

“…Validated medical care is improvable, open to revision, and can be continuously challenged by rival or innovative options. The verdict regarding which action is best must take into account what is most valuable for most patients, but while the verdict may only come in the future, in the meantime the medical interests of current patients are best protected when unvalidated practices are restricted to an openly declared care trial protocol [2,3].…”

Section: The Notion Of Validated Care In Care Ethicsmentioning

confidence: 99%

“…While explanatory research must be regulated to protect vulnerable patients from being used to gain knowledge, other research methods, such as pragmatic care trials, are designed to protect patients from another threat, the unregulated use of unvalidated tests and interventions within medical care. Care trials also serve to guide medical practice under uncertainty and to eventually define good medical practice [3]. Unfortunately the current research regulation does not distinguish explanatory from pragmatic care research.…”

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confidence: 99%

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

Darsaut

Raymond

2021

Trials

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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.

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Section: The Ethical Role Trial Methods Can Play In the Care Of Patientsmentioning

confidence: 99%

Section: The Ethical Role Trial Methods Can Play In the Care Of Patientsmentioning

confidence: 99%

Section: The Notion Of Validated Care In Care Ethicsmentioning

confidence: 99%

mentioning

confidence: 99%

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

Darsaut

Raymond

2021

Trials

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“…This scenario would mean that blinding the test results at the time of HAPO deprived all participants from receiving the potential benefits. Study designers would claim that this was not known at the time, but that is exactly the problem: in the presence of uncertainty, the interests of research participants are best protected by balancing risks by using randomized allocation [16]. In our view, the evaluation of HAPO by research ethics committees was doubly erroneous: risks for participants were not minimized (the study did not use randomization to balance risks), and the knowledge to be gained was not worth the risk (since observational research findings ran the risk of misleading medical care for decades).…”

Section: Pragmatic Lessons From Gdmmentioning

confidence: 99%

Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes

Raymond

Long

Darsaut

2022

Trials

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Objective The aim of the paper is to discuss how a pragmatic definition could change our conception of diagnosis, using gestational diabetes mellitus (GDM) as an example. Study design We review the diagnostic controversy that followed an observational study showing a linear relationship between maternal glycaemia and adverse pregnancy outcomes and the resolution proposed 15 years later by a recent pragmatic trial comparing two screening approaches (one- vs two-step) with different diagnostic thresholds. Results The pragmatic trial involved approximately 24,000 women. The one-step screening strategy using lower GDM thresholds diagnosed twice as many women with GDM, but pregnancy outcomes were not different. We examine how the pragmatic approach integrates research into practice and defines the meaning of a diagnosis according to patient outcomes. The approach is ethically and scientifically sound as compared to the previous methodology, where observational research separated from care gave a theoretical definition of GDM that may have misled medical practice for two decades. Conclusion Pragmatic research integrated into practice can revolutionize our conception of medical diagnosis in the best medical interest of patients.

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Experience using pragmatic care trials to guide neurovascular practice under uncertainty

Darsaut

Raymond²

2020

Neurochirurgie

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Care and research concepts should be revised to practice outcome-based medical care

Cited by 20 publications

References 10 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

Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes

Experience using pragmatic care trials to guide neurovascular practice under uncertainty

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