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Table 1 Glossary of terms

From: Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol

Term

Definition assumed in this manuscript

Pragmatic trial

A trial whose purpose is to evaluate the effectiveness of an intervention with the view to informing a decision about a healthcare policy or practice; key characteristics are broad eligibility criteria and patient-centered outcomes to maximize generalizability and applicability.

Intervention

Includes diagnostic, preventive, therapeutic, and delivery system interventions.

Randomized controlled trial

A research study in which, using a random mechanism, human participants are prospectively assigned (whether as individuals or in groups) to one or more interventions (which may include usual care or other competing interventions), to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Usual care interventions

Treatments or procedures that have been accepted by medical experts as appropriate treatments or procedures for a given type of disease or condition and are commonly used by healthcare professionals.

Knowledge translation interventions

An intervention designed to improve the uptake of research evidence in practice and reducing barriers and facilitators inherent in this process.

Gatekeepers

Individuals or bodies that represent the interests of community members, communities, or organizations participating in pragmatic trials.