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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for pragmatic trials to be reliable and reduce bias in results is also essential. However too much heterogeneity could result in problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They also provide a useful way to identify the causality between an intervention and its results. However, they should not be used as a substitute for explanation studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic trial, including recruitment, design and delivery of the intervention, and follow-up.
There is a positive increase in the number pragmatic trials published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatics. However, it is important to note that the majority of these trials were conducted in primary care settings.