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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of design which include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A practical trial that employs a variety investigators and includes 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 it also helps reduce the chance of bias in the results. However excessive heterogeneity could lead to issues with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually requested by policy makers and practitioners to aid in their decision-making. They also provide a useful way to identify the causal relationship between an intervention and its results. However, they should not,
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The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should 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 confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, as well as follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.