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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described as a focus on the practical aspects of designing a study that include the recruitment process and consent, adhering and 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 necessary for practical trials to be valid and also helps to reduce bias in the results. However, too much heterogeneity can cause problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great way to identify the cause-effect relationship between the intervention and its effects. However, they shouldn't be used to substitute for the use of explanation trials.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool sought to define the features of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and monitoring.
The number of pragmatic trials is increasing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.