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Pragmatic trials are those that are designed to inform real-world clinical practice. They are often focused on practical aspects of the study design, such as recruitment and consent, adherence, and the use of routinely available equipment.Free spins
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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 kind of heterogeneity, which is vital for pragmatic trials to be valid and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however could cause issues with the trial design.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They can also be used to determine the cause-effect relationship of an intervention and its results. However, they shouldn't be used to substitute for explanatory studies.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a practical trial that include recruitment, design and delivery of the intervention, as well as the follow-up.
There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority were conducted in primary care settings.
