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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of design which include recruitment and consent, adherence and the use of routinely available equipment.
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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for pragmatic trials to be valid and lessen the chance of bias is also essential. However, too much heterogeneity can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to assess the causal relationship between an intervention with its outcomes. However, they should not be used in lieu for the use of explanation studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic study, including the recruitment, design, and delivery of the intervention and follow-up.
There is a growing increase in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatics. It is important to remember that the majority of these trials were conducted in primary care settings.