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Pragmatic trials are studies designed to inform real-world clinical practice. They are typically characterized by a focus on practical aspects of the study design, including the recruitment and consent process as well as adherence to the use of commonly available equipment.
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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for a pragmatic trial to be reliable and to reduce bias in the results is also essential. A high degree of heterogeneity, however, can cause problems 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 validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to determine the causality of an intervention and its results. They should, however, not be used to replace the need for explanation studies.
The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis, and pragmatic trials, which guide the policy and practice of. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic study that include the recruitment process, the design and delivery of the intervention, as well as follow-up.
The number of pragmatic trials is growing. 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 is a sign that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to note, however, that the majority were conducted in primary-care settings.