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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used various investigators and included participants from different geographic areas. This type of heterogeneity is necessary for pragmatic trials to be valid and helps reduce the chance of bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great method to determine the causality between an intervention and its outcomes. They should, however, not be used to replace explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials can be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the elements of a practical trial which includes recruitment, design and delivery of the intervention, as well as follow-up.
There is an encouraging increase in the number pragmatic trials that are published. A recent Medline query that used 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 suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority were conducted in primary-care settings.