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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized by a focus on the practical aspects of the study design, such as the recruitment and consent process, adherence, and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically ordered by policymakers and practitioners in order to inform their decisions. They can also be a great way to identify the causality between an intervention and its results. They should, however, not, be used to replace explanatory studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic study that includes the recruitment, design, and delivery of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the subject of pragmatism. It is important to remember that the majority of studies were conducted in primary-care settings.