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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of design which include the recruitment process and consent, adhering and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used various investigators and included participants from different geographical regions. This type of heterogeneity is necessary for practical trials to be valid and helps to reduce the chance of bias in the results. However too much heterogeneity could result in problems with the design of the trial.

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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. Usually, they are ordered by policymakers and practitioners to guide their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they should not be used to substitute for explanation trials.

The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study which includes recruitment, design, delivery of the intervention, and follow-up.

There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.