OBJECTIVE: To propose a tool to assist trialists in making design decisions that are
consistent with their trial's stated purpose. STUDY DESIGN AND SETTING: Randomized …

Theconceptofa “pragmatic” clinicaltrialwasfirstproposednearly 50 years ago as a study
design philosophy that emphasizes answering questions of most interest to decision …

Methodologists have traditionally categorized randomized controlled trials (RCTs) as
explanatory (representing the ideal setting) and pragmatic (representing the real-world …

This is the introductory paper in a series of eight papers. In this series, we integrate the
theoretical design options with the practice of conducting pragmatic trials. For most new …

The discussion about the optimal design of clinical trials reflects the perspectives of theory-
based scientists and practice-based clinicians. Scientists compare the theory with published …

Randomised controlled trials are the best research design for decisions about the effect of
different interventions but randomisation does not, of itself, promote the applicability of a …

Decision makers in health care are increasingly interested in using high-quality scientific
evidence to support clinical and health policy choices; however, the quality of available …

The need for high-quality evidence to support decision making about health and health care
by patients, physicians, care providers, and policy-makers is well documented. However …

Randomized clinical trials often serve the purpose of assessing the efficacy and safety of a
compound. By combining real-world evidence and randomization, pragmatic randomized …

Background Pragmatic randomized, controlled trials (PCTs) test the effectiveness of
interventions implemented in routine clinical practice. Because PCT findings are …