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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and included participants from various geographical areas. This type of heterogeneity, that is crucial for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. However excessive heterogeneity could cause problems with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. They are usually requested by practitioners and policymakers in order to guide their decisions. They can also be used to determine the causality of an intervention and its effects. However, they shouldn't be used as a substitute for explanation studies.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a practical trial which includes the recruitment process, the design and delivery of the intervention, as well as the follow-up.
There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.