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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, such as the recruitment process and consent in adherence, as well as 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 kind of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however, can cause problems with the trial design.
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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are typically ordered by policymakers and practitioners to guide their decisions. They can also be used to assess the causality of an intervention and its results. However, they should not be used to replace explanatory studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study that includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.