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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 usually characterized by a focus on practical aspects of the research design, like recruitment and consent as well as adherence to the use of standard equipment.
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A pragmatic trial that uses various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for pragmatic trials to be valid and reduce bias in results is also essential. A high degree of heterogeneity, however can result in problems with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. They are typically ordered by policymakers and practitioners to help guide their decisions. They are also a good method to determine the cause-effect relationship between the intervention and its effects. They should not, however be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a practical trial, including the recruitment process, the design and implementation of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatic thinking. It is important to remember that the majority of these trials were conducted in primary care settings.