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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often described by their focus on practical aspects of study design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be valid and also helps to reduce the chance of bias in the results. However excessive heterogeneity could lead to problems with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually requested by policy makers and practitioners to inform their decision making. They are also a good method to determine the causality between an intervention and its results. They should, however, not be used to replace explanatory studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a practical trial, including the recruitment process, the design and delivery of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on 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 trials were conducted in primary care settings.