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

Table 1.

Definitions of some care and research terms and concepts

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