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Pragmatic trials are trials designed to inform real-world clinical practice. They are often characterized by a focus on the practical aspects of research design, like the recruitment process and consent as well as adherence to the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and included participants from different geographic areas. This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps reduce bias in the results. However too much heterogeneity could cause problems with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can also be used to determine the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used in lieu for explanatory studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which inform the policy and practice of. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a practical trial, including recruitment, design and delivery of the intervention, as well as the follow-up.
There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the subject of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.