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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are usually focused on the practical aspects of study design, including recruitment and consent, adherence, and the use of routinely available equipment.

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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for a pragmatic trial to be valid and reduce bias in results is also essential. However, too much heterogeneity, can cause problems with the design of the trial.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be a great method of determining the cause-effect relationship between an intervention and its outcomes. However, they should not be used as a substitute for the use of explanation studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis and pragmatic trials that inform the policy and practice of. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study that include recruitment, design and delivery of the intervention, and the follow-up.

There is a growing increase in the number pragmatic trials published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.