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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often described by their focus on practical aspects of study design, including recruitment and consent, adherence and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from various geographical areas. This type of heterogeneity, which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in problems with the trial design.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually commissioned by practitioners and policy makers to inform their decision making. They are also a good method to determine the cause-effect relationship between an intervention and its results. They should, however, not be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the elements of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.
