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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of design, including the recruitment process and consent, adhering and the use of routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for practical trials to be valid, and it also helps to reduce bias in the results. However excessive heterogeneity could lead to problems with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They are also a good method of determining the causal relationship between the intervention and its effects. However, they should not be used in lieu for explanation trials.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study that includes recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.