Ambiguity in Care Delivery Terminology: Implications that Affect Pragmatic Clinical Trials Using Non-Pharmacological Interventions - BMJ Evidence-Based Medicine

rhon d, Davis A, Ali J, Brandt C, Burns A, Lucio W, Vining R, Young-mccaughan S

Pragmatic clinical trials (PCTs) often study interventions delivered within the context of standard clinical encounters with the overall goal of producing generalisable knowledge to inform implementation strategies and health policy. In reality, however, PCTs have a gradient of pragmatic and explanatory features, as described by the PRagmatic Explanatory Continuum Indicator Summary, 2nd edition (PRECIS-2) framework. To facilitate the process of iterative learning, PCTs and comparative effectiveness trials frequently test interventions shown to be effective in explanatory trials, the latter having more stringent entry criteria. PCTs are particularly valuable for assessing use of non-pharmacological interventions, such as those designed to manage pain. Conducted in settings involving a broad range of patients and delivered by a range of qualified clinicians that may or may not have a research background, PCTs can illuminate implementation barriers and practice variations affecting the delivery of clinical interventions that may or may not be widely supported by institutional culture.

The purpose of this manuscript is to clearly define and differentiate usual care and validated care, such that these terms can be considered generically as part of regulatory activities that affect PCTs.

Rhon DI, Davis AF, Ali J, et alAmbiguity in care delivery terminology: implications that affect pragmatic clinical trials using non-pharmacological interventionsBMJ Evidence-Based Medicine Published Online First: 21 November 2023. doi: 10.1136/bmjebm-2023-112547