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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are often described by their focus on practical aspects of designing a study 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 a variety of investigators and included participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be valid and helps to reduce the chance of bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They also provide a useful way to identify the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for the use of explanation studies.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study which includes recruitment, design, delivery of the intervention and follow-up.
There is a growing trend in the number of pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, which are 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 remember, however, that the majority of studies were conducted in primary-care settings.