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Studies designed to provide insight into 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, adherence, and the use of routinely available equipment.

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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for practical trials to be valid and reduces bias in the results. However, too much heterogeneity can cause issues with the design of the trial.

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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They are also a good way to identify the cause-effect relationship between the intervention and its effects. However, they shouldn't be used to substitute for explanatory trials.

The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study, including recruitment, design, 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 an indication that the health science community is becoming more sensitive to the subject of pragmatic thinking. It is important to note that the majority were conducted in primary-care settings.