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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 as focusing on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for practical trials to be valid and helps reduce bias in the results. However too much heterogeneity could result in issues with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners to inform their decisions. They can be used to determine the causality of an intervention and its effects. However, they should not be used in lieu for explanatory studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a practical trial that include recruitment, design and delivery of the intervention, and follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming more acquaint to the subject of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.