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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often described as a focus on the practical aspects of design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographic areas. This type of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However, too much heterogeneity can 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. Usually, they are requested by practitioners and policymakers in order to inform their decisions. They can be used to determine the causality of an intervention and its results. However, they should not be used to substitute for the use of explanation studies.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords 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 subject of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.