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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically focused on the practical aspects of study design, such as recruitment and consent, adherence, and the use of commonly available equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and to reduce bias in the results is also essential. Too much heterogeneity, however can result in problems with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are typically requested by practitioners and policymakers to help guide their decisions. They are also a good way to identify the cause-effect relationship between an intervention and its outcomes. However, they should not be used in lieu for the use of explanation trials.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial, including the recruitment process, the design and implementation of the intervention, and monitoring.
There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.