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Pragmatic trials are those that are designed to provide information for real-world clinical practice. They are often characterized by their focus on practical aspects of design which include the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from different geographical regions. This type of heterogeneity, which is vital for a pragmatic trial to be valid and lessen the chance of bias is also essential. A high degree of heterogeneity, however can result in problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They also provide a useful method of determining the causality between an intervention and its outcomes. However, they shouldn't be used as a substitute for explanatory studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.
