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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often characterized as focusing on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. However, too much heterogeneity could cause issues with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually commissioned by practitioners and policy makers to inform their decision making. They can also be used to assess the causal relationship between an intervention and its effects. They should, however, not, be used to replace explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the elements of a pragmatic study that include recruitment, design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the subject of pragmatism. It is important to note, however, that the majority were conducted in primary-care settings.
