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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are usually characterized by a focus on practical aspects of the study design, such as the recruitment process and consent as well as adherence to the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from various geographical areas. This kind of heterogeneity, that is crucial for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However excessive heterogeneity could result in 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. Usually, they are ordered by policymakers and practitioners to help inform their decisions. They also provide a useful method of determining the causal relationship between an intervention and its results. However, they should not, be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including the recruitment, design, and delivery of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of studies were conducted in primary-care settings.