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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, including the recruitment process and consent in adherence, as well as the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and participants from various geographical areas. This type 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 can result in problems with the trial design.
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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 help inform their decisions. They can also be used to determine the causality of an intervention and its results. However, they should not be used to replace explanatory 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 serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic study that include recruitment, design and delivery of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary care settings.