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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are often characterized by a focus on the practical aspects of study design, including the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also reduces 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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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to aid in their decision-making. They also provide a useful way to identify the causal relationship between an intervention and its results. They should, however, not be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember, however, that the majority of studies were conducted in primary-care settings.