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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of design, including the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They can also be used to assess the causality of an intervention and its effects. However, they should not be used to substitute for the use of explanation trials.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which guide the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic research study that includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.