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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of designing a study, including the recruitment process and consent, adhering and the use of standard equipment.
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A pragmatic trial that uses various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for practical trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity, can cause problems with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are typically requested by practitioners and policymakers to inform their decisions. They also provide a useful method of determining the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used in lieu for the use of explanation trials.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study, including recruitment, design, delivery of the intervention and its follow-up.
There is a positive trend 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 shown in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of studies were conducted in primary-care settings.