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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of design that include 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 used a variety of investigators and participants from various geographical areas. This kind of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however can result in problems with the trial design.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. Usually, they are requested by practitioners and policymakers to help guide their decisions. They are also a good method to determine the causality between an intervention and its outcomes. However, they should not be used as a substitute for explanatory studies.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. simply click the next web page suggested a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a practical trial that include recruitment, design and delivery of the intervention, as well as monitoring.
The number of pragmatic trials is increasing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority were conducted in primary-care settings.