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Pragmatic trials are studies designed to provide information for real-world clinical practice. They are often characterized by a focus on the practical aspects of the study design, including recruitment and consent, adherence, and 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 is essential for pragmatic trials to be able to prove their validity and also reduces bias in the results. However, too much heterogeneity could cause issues with the trial design.
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The goal of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be a great method of determining the cause-effect relationship between an intervention and its outcomes. However, they shouldn’t be used in lieu for the use of explanation studies.
The pragmatism concept is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study, including recruitment, design, delivery of the intervention and its follow-up.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.