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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be valid and helps to 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 are designed to replicate real-life situations and attain maximum external validity. They are typically requested by practitioners and policymakers to inform their decisions. They can be used to determine the causal relationship between an intervention and its effects. They should not, however be used to replace explanation studies.

The idea of pragmatism is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a pragmatic study which includes recruitment, design and delivery of the intervention, as well as the follow-up.

There is a growing trend in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatism. It is important to note, however, that the majority of these studies were conducted in primary-care settings.