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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are usually focused on the practical aspects of study design, such as recruitment and consent as well as adherence to 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 a variety of investigators and participants from different geographical regions. This type of heterogeneity, which is vital for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners in order to inform their decisions. They can also be used to determine the causal relationship between an intervention with its outcomes. However, they shouldn't be used in lieu for explanation studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials should replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a practical trial which includes the recruitment process, the design and delivery of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to note that the majority of studies were conducted in primary-care settings.