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Pragmatic trials are studies designed to inform real-world clinical practice. published here are typically described as focusing on practical aspects of designing a study which include recruitment and consent, adherence and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However too much heterogeneity could cause issues with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can be used to determine the causal relationship between an intervention with its outcomes. They should not, however, be used to replace explanation studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. 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 is an indication that the health science community is becoming more acquaint to the subject of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.