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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are often characterized by a focus on practical aspects of the study design, including recruitment and consent, adherence, and the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from different geographic areas. This kind of heterogeneity is required for pragmatic trials to be valid and helps reduce bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be used to determine the causal relationship between an intervention and its effects. However, they should not, be used to replace explanation studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic research study, including recruitment, design, implementation of the intervention and follow-up.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic,
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Read Significantly more, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority were conducted in primary care settings.