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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of design which include the recruitment process and consent, adhering and the use of standard 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 type of heterogeneity is required for practical trials to be valid and also helps to reduce bias in the results. However, too much heterogeneity can result in issues 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 requested by policy makers and practitioners to inform their decision making. They are also a good method to determine the causality between the intervention and its effects. However, they should not be used to substitute for explanatory studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.