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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are usually characterized by a focus on practical aspects of the research design, like recruitment and consent, adherence, and the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and reduce bias in results is also essential. However excessive heterogeneity could result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can be used to determine the causality of an intervention with its outcomes. However, they should not, be used to replace explanatory studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study that includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.
