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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are typically characterized by a focus on practical aspects of the research design, like the recruitment and consent process as well as adherence to the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and participants from various geographical areas. This type of heterogeneity which is vital for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However excessive heterogeneity could result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They also provide a useful method to determine the causality between an intervention and its results. However, they shouldn't be used in lieu for the use of explanation trials.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which guide the policy and practice of. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a practical trial that include the recruitment process, the design and implementation of the intervention, and follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the words naturalistic and pragmatic, 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. However, it is important to remember that the majority of these trials were conducted in primary care settings.