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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from different geographical regions. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results, is also necessary. However excessive heterogeneity could result in problems with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are usually ordered by policymakers and practitioners to help guide their decisions. They can also be a great method to determine the causal relationship between an intervention and its results. However, they should not be used in lieu for explanation studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool sought to define the features of a practical trial that include recruitment, design and delivery of the intervention, as well as follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.