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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, including recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and included participants from different geographical regions. This kind of heterogeneity is necessary for practical trials to be valid and helps to reduce the chance of bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life situations and achieve maximum credibility externally. They are typically requested by practitioners and policymakers to help inform their decisions. They can be used to determine the causality of an intervention and its effects. However, they should not be used in lieu for explanatory trials.
The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study that includes recruitment, design, implementation of the intervention, and follow-up.
There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these studies were conducted in primary-care settings.