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Pragmatic clinical trials (PCTs) seek to improve the generalizability and increase the statistical power of traditional explanatory trials.
Pragmatic trials test the effectiveness of interventions in real-world conditions; explanatory trials test for efficacy under ideal conditions.
To propose and test a simple instrument based on seven criteria of study design to distinguish effectiveness (pragmatic) from efficacy (explanatory) trials.
A recently published instrument (PRECIS) was designed to assist investigative teams in understanding the various design decisions that need to be made regarding pragmatic vs. explanatory trials.
Although pragmatic outcome measures are easier to achieve explanatory trials are needed.
Explanatory trials concentrate on compliant patients in order to study the biological effect of the treatment.
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To illustrate how pragmatic trial design elements or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision, and operational feasibility.
For this question, an explanatory trial design would be appropriate.
This trial has features of both a pragmatic and an explanatory trial [ 29].
This explanatory trial is a two-arm cluster randomised controlled trial, with clustering by GP practice.
In pragmatic trials, consent is rarely the same issue as it is in an explanatory trial.
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