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Pragmatic trials are studies designed to inform real-world clinical practice. They are often described as a focus on the practical aspects of designing a study, including the recruitment process and consent, adhering and the use of standard equipment.
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A practical trial that employs 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 necessary. However excessive heterogeneity could cause problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are typically requested by practitioners and policymakers in order to inform their decisions. They are also a good method of determining the causality between an intervention and its results. However, they should not be used to replace explanatory studies.
The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could replace explanatory tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes recruitment, design, implementation of the intervention and its follow-up.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become 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.