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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often 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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A pragmatic study that involves various 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 excessive heterogeneity could lead to 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 usually commissioned by practitioners and policy makers to guide their decision-making. They are also a good method of determining the causality between the intervention and its effects. They should, however, not be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study that include the recruitment process, the design and delivery of the intervention, and follow-up.
There is an encouraging increase in the number pragmatic trials that have been published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.