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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of study design which include the recruitment process and consent, adhering and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps to reduce the chance of bias in the results. However excessive heterogeneity could cause problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. Usually, they are requested by practitioners and policymakers in order to guide their decisions. They also provide a useful method to determine the causal relationship between an intervention and its results. They should, however, not be used to replace explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials, which guide the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study that includes the recruitment, design, and delivery of the intervention and its follow-up.
There is a growing trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to remember that the majority of these studies were conducted in primary care settings.