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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often characterized by their focus on practical aspects of design that include recruitment and consent, adherence and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographic areas. This type of heterogeneity is essential for pragmatic trials to be valid and helps to reduce the chance of bias in the results. However, too much heterogeneity can lead to problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. Usually, they are ordered by policymakers and practitioners to help inform their decisions. They also provide a useful method to determine the causality between the intervention and its effects. However, they should not, be used to replace explanatory studies.
The concept of pragmatism 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 trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study that includes recruitment, design, implementation of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, 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 remember that the majority of these studies were conducted in primary care settings.