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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus 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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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. However, too much heterogeneity, can cause problems with the design of the trial.

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The aim of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually commissioned by policymakers and practitioners to help inform their decisions. They can be used to determine the causality of an intervention and its effects. However, they should not, be used to replace explanatory studies.

The idea of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis and 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, including recruitment, design, delivery of the intervention and follow-up.

There is an encouraging increase in the number of pragmatic trials published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.