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. 2021 Feb 15;22(1):143.
doi: 10.1186/s13063-021-05084-0.

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

Tim E Darsaut  1 , Jean Raymond  2
Affiliations

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

Tim E Darsaut et al. Trials. .

Abstract

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.

Keywords: Clinical trials; Equipoise; Evidence based medicine; Medical care; Research ethics; Therapeutic obligation.

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Conflict of interest statement

The authors declare that they have no competing interests.

All authors declare that they have no significant financial, professional, or personal interests that might have influenced the performance or presentation of the work described in this manuscript.

Figures

Fig. 1
Fig. 1
Reconstructing the care research demarcation. a According to the prevailing view, research must be cleanly separated from care. Consequently, unvalidated tests and interventions are admitted as care, and explanatory research may use patients as research subjects. In the new program (b), optimal care includes validated (but revisable) care and pragmatic care research, but unvalidated tests and interventions are only offered within care research
See this image and copyright information in PMC

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