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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are usually focused on practical aspects of the research design, like the recruitment process and consent, adherence, and the use of standard equipment.

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A practical trial that employs various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps to reduce bias in the results. However too much heterogeneity could result in issues with the design of the trial.

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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are usually requested by practitioners and policymakers in order to inform their decisions. They can also be used to determine the causality of an intervention and its results. However, they shouldn't be used to substitute for the use of explanation studies.

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

There is a positive trend in the number of pragmatic trials published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatism. However, it is important to remember that the majority of these studies were conducted in primary care settings.