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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically focused on the practical aspects of study design, including recruitment and consent in adherence, as well as the use of commonly available equipment.
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A pragmatic trial that uses 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 to reduce bias in the results, is also necessary. A high degree of heterogeneity, however can result in problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are usually ordered by policymakers and practitioners to guide their decisions. They can also be a great way to identify the causality between the intervention and its effects. They should not, however be used to replace the need for explanation studies.
view site… is controversial, and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis, and pragmatic trials, which inform the policy and practice of. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the subject of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.