From: Ethical care requires pragmatic care research to guide medical practice under uncertainty
Current definitions | Proposed revisions | |
---|---|---|
Practice | “Interventions designed solely to enhance the well-being of an individual patient and that have a reasonable expectation of success.” [1] | Practice includes validated care which can be prescribed, and unvalidated care, which is restricted to care research |
Research | “An activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.” | Care research guides care in the presence of uncertainty in the best medical interest of current patients |
Boundary in theory | “The general rule is that if there is any element of research in an activity, that activity should undergo review.” | The crucial distinction is between validated and unvalidated care |
Boundary in practice | Inexistent; experimental interventions can be used as care | Unvalidated care should only be offered within a care trial |
Experimental interventions | “The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category of research.” [1, 2] | Experimental procedures are by definition unvalidated care; they can be offered, but within a care trial. |
Validated care | No definition exists | Care that has previously been shown to improve patient outcomes in pragmatic trials |
Unvalidated care | Tests and interventions that can and are used in practice but that have never been convincingly shown to improve patient outcomes | Unvalidated care is promising but experimental care offered within a care trial. |
Unverifiable care | Tests and interventions are practiced in such a fashion that no conclusion regarding their relative merit or resulting patient outcomes can be drawn | Unverifiable care is not practiced. |
Optimal medical care | Impossible to define | Optimal care is validated care continuously revised by care research |