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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often focused on practical aspects of the study design, including the recruitment and consent process as well as adherence to the use of commonly available 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 that is crucial for pragmatic trials to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity can cause problems with the design of the trial.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. Usually, they are commissioned by policymakers and practitioners to help guide their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. They should, however, not, be used to replace explanation studies.

The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they are an addition 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 inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study, including the recruitment, design, and delivery of the intervention and follow-up.

There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatics. It is important to note that the majority of these trials were conducted in primary care settings.