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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be valid and also helps to reduce the chance of bias in the results. However, too much heterogeneity, can cause problems with the trial design.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to assess 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 concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic trial, including recruitment, design and delivery of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.