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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of designing a study, including the recruitment process and consent, adhering and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from different geographical regions. This type of heterogeneity is necessary for practical trials to be valid and also helps reduce the chance of bias in the results. However excessive heterogeneity could result in issues with the design of the trial.

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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can be used to determine the causal relationship between an intervention and its results. They should not, however, be used to replace explanation studies.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove a physiological or clinical hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study which includes the recruitment, design, and delivery of the intervention and its follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority were conducted in primary care settings.