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Pragmatic trials are trials designed to inform real-world clinical practice. They are often described as a focus on the practical aspects of study design, including recruitment and consent, adherence and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from various geographical areas. This type of heterogeneity is necessary for practical trials to be valid and also helps to reduce the chance of bias in the results. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are typically ordered by policymakers and practitioners to guide their decisions. They can be used to determine the causality of an intervention with its outcomes. They should not, however, be used to replace explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also proposed an approach to pragmatic trials, which they called 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.
There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests 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 studies were conducted in primary care settings.