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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for a pragmatic trial to be reliable and lessen the chance of bias is also essential. However too much heterogeneity could cause issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can be used to determine the causality of an intervention and its results. However, they shouldn't be used in lieu for the use of explanation trials.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study, including recruitment, design and delivery of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.