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Pragmatic trials are trials designed to inform the practice of clinical trials in real life. They are often characterized by their focus on practical aspects of design, including the recruitment and consent process, as well as adherence and the use of routinely available 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 is required for practical trials to be valid and reduces the chance of bias in the results. A high degree of heterogeneity, however can result in problems with the trial design.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They are also a good way to identify the causality between the intervention and its effects. They should not, however be used to replace explanatory studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study that includes recruitment, design, delivery of the intervention, and follow-up.
There is an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.