10 Pragmatic Free Trial Tips All Experts Recommend
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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often described by their focus on practical aspects of design, including recruitment and consent, adherence and the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for pragmatic trials to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They are also a good method to determine the cause-effect relationship between an intervention and its results. They should not, however, be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study, including recruitment, design, delivery of the intervention, and 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. These are shown in red on Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.