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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of the study design, such as the recruitment and consent process as well as adherence to the use of routinely available 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 type of heterogeneity, which is essential for a pragmatic trial to be valid and reduce bias in results, is also necessary. However excessive heterogeneity could lead to problems with the design of the trial.

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Legality

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The purpose of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are typically ordered by policymakers and practitioners to help inform their decisions. They are also a good method of determining the causal relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for explanation studies.

The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as follow-up.

The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to note that the majority were conducted in primary care settings.