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Pragmatic trials are those that are designed to provide information for the real-world practice of clinical. They are usually characterized by a focus on practical aspects of the research design, like the recruitment process and consent, adherence, and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and participants from different geographic areas. This kind of heterogeneity, which is vital for a pragmatic trial to be valid and to reduce bias in the results is also essential. However, too much heterogeneity, can cause problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. They are typically 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 substitute for explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they are an addition to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study that includes recruitment, design, implementation of the intervention and its follow-up.
There is a growing 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 that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority of these trials were conducted in primary care settings.