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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are often characterized as a focus on the practical aspects of design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and included participants from different geographical regions. This type of heterogeneity is required 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 aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They are also a good way to identify the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for explanatory trials.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study that includes the recruitment, design, and delivery of the intervention and its follow-up.
There is a positive increase in the number of pragmatic trials that have been published. 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 indicates that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these trials were conducted in primary care settings.