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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 by their focus on practical aspects of design which include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be valid and also helps to reduce bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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Legality
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The aim of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They can be used to determine the causal relationship between an intervention and its results. However, they should not be used to substitute for explanatory studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic study which includes recruitment, design and delivery of the intervention, and monitoring.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.