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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often described as focusing on practical aspects of designing a study which include the recruitment process and consent, adhering and the use routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and lessen the chance of bias is also essential. However excessive heterogeneity could result in issues with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually ordered by policymakers and practitioners to guide their decisions. They can also be used to assess the causality of an intervention with its outcomes. However, they shouldn't be used in lieu for the use of explanation trials.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic study, including the recruitment process, the design and delivery of the intervention, and monitoring.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the subject of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.