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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of the research design, like the recruitment process and consent, adherence, and the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and participants from different geographical regions. This kind of heterogeneity is essential for pragmatic trials to be valid, and it also reduces the chance of bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and gain maximum validity externally. Usually, they are ordered by policymakers and practitioners in order to inform their decisions. They can also be used to determine the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used to substitute for explanatory trials.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study, including the recruitment, design, and delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.