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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 the practical aspects of the study design, such as the recruitment and consent process, adherence, and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. However, too much heterogeneity can cause issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They can be used to determine the causality of an intervention with its outcomes. They should not, however, be used to replace explanation studies.
The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate a physiological or clinical hypothesis, and pragmatic trials, which guide the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study that includes recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, 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 sensitive to the issue of pragmatics. It is important to note that the majority of these trials were conducted in primary care settings.