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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often focused on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity, and it also reduces the chance of bias in the results. However excessive heterogeneity could result in problems with the design of the trial.

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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to aid in their decision-making. They also provide a useful method of determining the causality between an intervention and its outcomes. However, they shouldn't be used in lieu for explanatory trials.

The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study, including recruitment, design, delivery of the intervention and its follow-up.

There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming more acquaint to the issue of pragmatism. It is important to note, however, that the majority were conducted in primary care settings.