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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are usually characterized by a focus on the practical aspects of study design, such as the recruitment process and consent as well as adherence to the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from different geographic areas. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also reduces the chance of bias in the results. A high degree of heterogeneity, however can result in problems with the design of the trial.

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Legality

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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an intervention and its results. However, they shouldn't be used as a substitute for explanatory studies.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they should serve as an addition to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the traits of a practical study which includes recruitment, design, delivery of the intervention, and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more acquaint to the issue of pragmatics. However, it is important to note that the majority of these studies were conducted in primary care settings.