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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as a focus on the practical aspects of study design, including the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and also reduces bias in the results. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are usually ordered by policymakers and practitioners in order to guide their decisions. They also provide a useful method of determining the causal relationship between the intervention and its effects. They should, however, not be used to replace explanatory studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a practical study which includes recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.