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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 characterized by a focus on practical aspects of the study design, such as recruitment and consent, adherence, and the use of standard equipment.
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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind 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 could cause issues with the trial design.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. Usually, they are requested by practitioners and policymakers 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 to substitute for the use of explanation trials.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study which includes the recruitment, design, and delivery of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatic thinking. It is important to note that the majority were conducted in primary-care settings.