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Pragmatic trials are those that are designed to provide information for real-world clinical practice. They are typically described as focusing on practical aspects of designing a study that include recruitment and consent, adherence and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and participants from different geographical regions. This type of heterogeneity is required for pragmatic trials to be valid and helps reduce bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. Usually, they are ordered by policymakers and practitioners to help inform their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used in lieu for the use of explanation trials.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study, including the recruitment, design, and delivery of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.