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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often characterized by a focus on practical aspects of the study design, such as the recruitment process and consent in adherence, as well as the use of commonly available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However excessive heterogeneity could result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are typically commissioned by policymakers and practitioners in order to guide their decisions. They are also a good way to identify the causality between an intervention and its outcomes. However, they should not be used to substitute for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatics. It is important to remember, however, that the majority of studies were conducted in primary-care settings.
