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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 the research design, like the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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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 guide their decisions. They can be used to determine the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study, including recruitment, design, delivery of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.