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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of study design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic trial that uses a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also reduces 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 replicate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They also provide a useful method to determine the cause-effect relationship between an intervention and its results. They should not, however be used to replace explanatory studies.

The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study that includes recruitment, design, implementation of the intervention, and follow-up.

The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to remember that the majority of these studies were conducted in primary-care settings.