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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus on the practical aspects of the study design, including the recruitment and consent process as well as adherence to the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid and reduces the chance of bias in the results. However, too much heterogeneity, can cause problems with the trial design.
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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to determine the causality of an intervention and its results. However, they should not be used as a substitute for the use of explanation trials.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial, including recruitment, design and delivery of the intervention, and monitoring.
There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in Figure 2. This is a sign that the health science community is becoming more sensitive to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary care settings.