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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of study design that include recruitment and consent, adherence and the use of standard equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. However too much heterogeneity could result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. Usually, they are ordered 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. However, they shouldn't be used to substitute for explanatory trials.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate a physiological or clinical hypothesis and pragmatic trials, which inform the policy and practice of. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind that the majority of these trials were conducted in primary care settings.
