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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of design, including the recruitment process and consent, adhering and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from different geographical regions. This type of heterogeneity which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.

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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are usually commissioned by policymakers and practitioners to inform their decisions. They can also be used to determine the causality of an intervention and its effects. They should not, however, be used to replace explanatory studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study, including recruitment, design, delivery of the intervention, and follow-up.

There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatics. However, it is important to note that the majority of these studies were conducted in primary care settings.