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Pragmatic trials are trials designed to inform the practice of clinical trials in real life. They are often described by their focus on practical aspects of study design, including the recruitment process and consent, adhering and the use 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 various investigators and had participants from different geographical regions. This kind of heterogeneity, that is crucial for a pragmatic trial to be valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however could cause issues with the trial design.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used to replace explanation studies.
The pragmatism idea is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and the follow-up.
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 science community is becoming increasingly sensitized to the subject of pragmatism. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.