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Clinical trials that are designed to help inform 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 recruitment and consent, adherence and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid and also helps reduce bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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The purpose 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 to guide their decisions. They can also be used to determine the causality of an intervention and its effects. They should, however, not, be used to replace explanation studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove a physiological or clinical hypothesis, and pragmatic trials that inform the policy and practice of. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the elements of a practical trial that include recruitment, design and delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary-care settings.
