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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically characterized by a focus on practical aspects of the research design, like recruitment and consent as well as adherence to the use of routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps to reduce the chance of bias in the results. Too much heterogeneity, however can result in 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. Usually, they are commissioned by policymakers and practitioners to help inform their decisions. They can also be a great method to determine the causality between an intervention and its outcomes. They should not, however be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials, which guide the practice and policy decisions. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, and follow-up.
The number of pragmatic trials is growing. 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 is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatics. It is important to note that the majority of these studies were conducted in primary-care settings.