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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of designing a study that include recruitment and consent, adherence and the use of routinely available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be valid and reduces the chance of bias in the results. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They can also be used to assess the causality of an intervention and its results. However, they shouldn't be used in lieu for explanation trials.
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 inform policy and practice decisions. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic study that include recruitment, design and delivery of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.