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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 by their focus on practical aspects of design, including recruitment and consent, adherence and the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for a pragmatic trial to be reliable and reduce bias in results is also essential. However too much heterogeneity could 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 usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an intervention and its effects. They should not, however be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic research study that includes recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.