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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are usually characterized by a focus on the practical aspects of research design, like the recruitment and consent process, adherence, and the use of standard 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 participants from different geographical regions. This type of heterogeneity which is essential for a pragmatic trial to be valid and to reduce bias in the results is also essential. However excessive heterogeneity could cause 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 commissioned by policy makers and practitioners to guide their decision-making. They can be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used in lieu for the use of explanation studies.

The pragmatism idea is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study, including recruitment, design, implementation of the intervention and follow-up.

There is a positive increase in the number of pragmatic trials that are 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 indicates that the health science community is becoming more acquaint to the issue of pragmatics. It is important to keep in mind, however, that the majority of these studies were conducted in primary-care settings.