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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of standard equipment.

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A pragmatic study that involves a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be valid and helps to reduce bias in the results. However, too much heterogeneity can result in problems 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 commissioned by policy makers and practitioners to aid in their decision-making. They also provide a useful method to determine the causal relationship between the intervention and its effects. They should not, however, be used to replace explanation studies.

The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study, including recruitment, design, delivery of the intervention and its follow-up.

There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatics. It is important to note that the majority of these trials were conducted in primary care settings.