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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 their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from different geographical regions. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and also helps reduce bias in the results. However too much heterogeneity could lead to problems with the design of the trial.
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Legality
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually commissioned by policymakers and practitioners to inform their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. They should, however, not be used to replace explanation studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic 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 terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority of studies were conducted in primary care settings.