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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of design, including recruitment and consent, adherence and the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for pragmatic trials to be reliable and lessen the chance of bias is also essential. However, too much heterogeneity can result in problems with the trial design.
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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. Usually, they are commissioned by policymakers and practitioners to help guide their decisions. They are also a good method of determining the causality between an intervention and its results. However, they should not be used in lieu for explanation trials.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and the follow-up.
There is a growing trend in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more acquaint to the issue of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.