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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often focused on practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and had participants from different geographic areas. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results, is also necessary. However too much heterogeneity could result in issues with the design of the trial.

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The goal of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are typically commissioned by policymakers and practitioners in order to inform their decisions. They also provide a useful method to determine the causal relationship between an intervention and its results. However, they should not be used in lieu for explanatory studies.

The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.

The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more acquaint to the issue of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.