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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 practical aspects of the research design, like the recruitment and consent process as well as adherence to the use of standard equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from various geographical areas. This type of heterogeneity is required for practical trials to be valid and helps reduce the chance of bias in the results. However excessive heterogeneity could result in 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 typically requested by practitioners and policymakers to help guide their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. They should, however, not be used to replace explanation studies.

The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a practical trial which includes the recruitment process, the design and implementation of the intervention, and follow-up.

There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary care settings.

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