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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often characterized by a focus on the practical aspects of study design, such as the recruitment and consent process in adherence, as well as the use of commonly available equipment.
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A practical trial that employs various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid and also helps reduce the chance of bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be a great method of determining the causal relationship between an intervention and its results. However, they should not be used to replace explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should replace tests for explanations or if they should be an addition to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.