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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, such as recruitment and consent, adherence, and the use of commonly available equipment.
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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be able to prove their validity and helps reduce bias in the results. However, too much heterogeneity could cause issues with the design of the trial.
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Legality
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The purpose of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. They are typically commissioned by policymakers and practitioners to inform their decisions. They can be used to determine the cause-effect relationship of an intervention and its effects. They should not, however be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, as well as monitoring.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary-care settings.