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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, such as recruitment and consent in adherence, as well as the use of standard 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 type of heterogeneity which is essential for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however can result in problems with the trial design.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically ordered by policymakers and practitioners in order to guide their decisions. They are also a good method to determine the causal relationship between an intervention and its outcomes. They should not, however, be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which inform the policy and practice of. 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, delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming more acquaint to the subject of pragmatic thinking. It is important to keep in mind, however, that the majority of these studies were conducted in primary-care settings.