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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often described by their focus on practical aspects of study design which include recruitment and consent, adherence and the use of standard equipment.
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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be able to prove their validity and also helps to reduce the chance of bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are typically ordered by policymakers and practitioners to help inform their decisions. They are also a good way to identify the causal relationship between the intervention and its effects. They should not, however be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study, including the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.