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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of standard equipment.
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A practical trial that employs different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for practical trials to be valid and helps to reduce bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They are also a good method of determining the causal relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should serve as an addition to 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 proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic study which includes recruitment, design, delivery of the intervention and follow-up.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the words 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 note that the majority were conducted in primary-care settings.