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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 study design that include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However, too much heterogeneity could cause issues with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They can also be a great method of determining the cause-effect relationship between an intervention and its outcomes. They should, however, not, be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 made the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a pragmatic study that include recruitment, design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary care settings.