We have recently completed a qualitative study in which we interviewed key stakeholders in the arena of pragmatic RCTs (Nicholls et al. 2019). Based on these findings we note that terminology such as “routine care” or “standard of care” were used interchangeably with usual care. Within our work it was noted that varied terminology may generate confusion with the terms used in both a medical-legal sense (such that the term standard may be used to describe a threshold of acceptable practice) as well as a more epidemiological use (where the term standard tended to be used to describe the care most frequently used for a particular clinical condition).

Any description of “routine” or “usual” delivery of care is both geographically and chronologically bound; healthcare systems and the delivery of care will differ across jurisdictions but also within a jurisdiction over time. Providing a detailed justification for the choice of trial design with specific reference to the decision that the trial is intended to inform, as well as current usual care practices, would provide the contextual information to evaluate the appropriateness of the study design. This is in fact a minimal extension to existing reporting guidelines such as the CONSORT extension for pragmatic trials (Zwarenstein et al. 2008), which explicitly states that: the clinical problem that the intervention is targeting should be clearly articulated; that usual alternatives to the intervention in relevant settings are described; that describing interventions or comparators as “usual care” is not sufficient; and that usual care should be described with the same level of detail as any novel intervention would (Zwarenstein et al. 2008).

Nicholls, S. G., K. Carroll, M. Zwarenstein, J. C. Brehaut, C. Weijer, S. P. Hey, C. E. Goldstein, I. D. Graham, J. M. Grimshaw, J. E. McKenzie, D. A. Fergusson, M. Taljaard and Ethics of Pragmatic Trials project (2019). "The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders." Trials 20(1): 765.

Nicholls, S., M. Zwarenstein and M. Taljaard (2020). "The importance of describing as well as defining usual care." The American Journal of Bioethics 20(1): 56-58.

Zwarenstein, M., S. Treweek, J. J. Gagnier, et al. 2008. Improving the reporting of pragmatic trials: An extension of the CONSORT statement. BMJ 337: A2390. doi: 10. 1136/bmj.a2390.
Stuart Nicholls
Ottawa Hospital Research Institute
Researcher, health/medical
Representing my own views