Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.

ABSTRACT:

Background

Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by th

SUBMITTER: Nicholls SG 

PROVIDER: S-EPMC6247737 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature