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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically focused on the practical aspects of research design, like the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from various geographical areas. This type of heterogeneity which is vital for pragmatic trials to be valid and reduce bias in results is also essential. However, too much heterogeneity, can cause problems with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually requested by practitioners and policymakers to guide their decisions. They also provide a useful method to determine the causality between an intervention and its outcomes. However, they should not be used to replace explanation studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study which includes recruitment, design, implementation of the intervention and follow-up.
There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the subject of pragmatism. It is important to note that the majority of these studies were conducted in primary-care settings.