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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use of standard equipment.

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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and reduces bias in the results. However, too much heterogeneity can lead to problems with the design of the trial.

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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are typically requested by practitioners and policymakers to inform their decisions. They are also a good method of determining the causality between an intervention and its results. However, they should not be used to substitute for explanation studies.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study that includes recruitment, design, implementation of the intervention and follow-up.

The number of pragmatic trials is increasing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.