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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often described as a focus on the practical aspects of design, including recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also reduces bias in the results. Too much heterogeneity, however, can cause problems with the trial design.
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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used to substitute for the use of explanation studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study that includes recruitment, design, implementation of the intervention and follow-up.
There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary care settings.