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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically focused on the practical aspects of research design, like recruitment and consent, adherence, and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from different geographical regions. This type of heterogeneity, which is essential for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. A high degree of heterogeneity, however could cause issues with the trial design.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policymakers to inform their decisions. They are also a good method to determine the causal relationship between an intervention and its results. However, they should not be used to replace explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study, including recruitment, design and delivery of the intervention, as well as monitoring.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary care settings.