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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically characterized by a focus on the practical aspects of the study design, such as recruitment and consent, adherence, and the use of standard equipment.
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A pragmatic trial that uses various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid, and it also reduces the chance of bias in the results. However, too much heterogeneity could cause issues with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can be used to determine the cause-effect relationship of an intervention and its results. However, they shouldn't be used as a substitute for the use of explanation trials.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, as well as the follow-up.
There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the words 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 has become more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.