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Pragmatic trials are trials designed to inform the real-world practice of clinical. They are often characterized by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use 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 kind of heterogeneity is necessary for practical trials to be valid and reduces bias in the results. However too much heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They can also be used to assess the causal relationship between an intervention and its effects. They should not, however be used to replace explanation studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a practical study that includes the recruitment, design, and delivery of the intervention and follow-up.
There is an encouraging increase in the number of pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatics. It is important to keep in mind that the majority of these trials were conducted in primary care settings.