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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as a focus on the practical aspects of study design, including the recruitment and consent process, as well as adherence and the use routinely available 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 various geographical areas. This type of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. Usually, they are requested by practitioners and policymakers in order to guide their decisions. They are also a good method of determining the causality between an intervention and its outcomes. However, they shouldn't be used as a substitute for explanatory studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which inform the policy and practice of. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study, including recruitment, design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words 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 has become more aware of the importance of pragmatism. It is important to remember, however, 프라그마틱 that the majority of studies were conducted in primary care settings.