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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often focused on the practical aspects of research design, like the recruitment and consent process, adherence, and the use of commonly available equipment.

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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps reduce bias in the results. A high degree of heterogeneity, however, can cause problems with the design of the trial.

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The aim of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its results. They should not, however, be used to replace explanation studies.

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

There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority of these trials were conducted in primary care settings.