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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized as a focus on the practical aspects of designing a study, including recruitment and consent, adherence and the use of standard equipment.
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A practical trial that employs various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for practical trials to be valid, and it also helps reduce the chance of bias in the results. However excessive heterogeneity could result in issues with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are typically requested by practitioners and policymakers in order to guide their decisions. They also provide a useful method of determining the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for explanatory trials.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study, including recruitment, design, implementation of the intervention, and follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of studies were conducted in primary care settings.