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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 the practical aspects of research design, like the recruitment and consent process in adherence, as well as the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from different geographic areas. This type of heterogeneity that is crucial for pragmatic trials to be valid and lessen the chance of bias, is also necessary. However too much heterogeneity could result in issues with the design of the trial.

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The aim 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 guide their decision-making. They are also a good method to determine the causal relationship between an intervention and its outcomes. However, they should not, be used to replace explanation studies.

The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic study that include recruitment, design and delivery of the intervention, as well as monitoring.

The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatics. However, it is important to remember that the majority of these trials were conducted in primary care settings.