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Pragmatic trials are studies designed to provide information for real-world clinical practice. They are often described as focusing on practical aspects of designing a study that include the recruitment process and consent, adhering and the use routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and had participants from different geographic areas. This type of heterogeneity, which is essential for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity could cause issues with the trial design.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are typically requested by practitioners and policymakers to inform their decisions. They are also a good method of determining the cause-effect relationship between the intervention and its effects. However, they should not be used as a substitute for explanation studies.
The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis and pragmatic trials that inform the policy and practice of. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic trial that include the recruitment process, the design and implementation of the intervention, and monitoring.
There is a positive increase in the number pragmatic trials that are published. 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 suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority were conducted in primary-care settings.