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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of designing a study which include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid, and it also helps reduce bias in the results. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to inform their decision making. They can also be used to determine the causal relationship between an intervention and its results. They should, however, not be used to replace explanatory studies.
The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatics. It is important to remember that the majority of these trials were conducted in primary care settings.