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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are usually focused on practical aspects of the study design, such as recruitment and consent, adherence, and the use of commonly available equipment.
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A pragmatic study that involves different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and helps reduce the chance of bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to determine the causality of an intervention with its outcomes. However, they shouldn't be used in lieu for the use of explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis and pragmatic trials, which guide the policy and practice of. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the features of a practical trial which includes the recruitment process, the design and implementation of the intervention, and monitoring.
The number of pragmatic trials is increasing. A recent Medline query that used 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 is a sign that the health science community is becoming more acquaint to the subject of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.