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Pragmatic trials are trials designed to provide information for the practice of clinical trials in real life. They are usually characterized by a focus on the practical aspects of research design, like recruitment and consent as well as adherence to the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and participants from different geographic areas. This kind of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the results is also essential. Too much heterogeneity, however could cause issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can also be a great way to identify the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for the use of explanation studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.