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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are usually focused on the practical aspects of the study design, such as recruitment and consent in adherence, as well as the use of routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for practical trials to be valid, and it also helps reduce bias in the results. However, too much heterogeneity can cause issues with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can be used to determine the cause-effect relationship of an intervention and its effects. They should not, however be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study, including recruitment, design, implementation of the intervention and follow-up.
There is an encouraging increase in the number pragmatic trials that are published. A recent Medline query that used 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 sciences community is becoming more acquaint to the subject of pragmatics. It is important to note, however, that the majority of these studies were conducted in primary care settings.