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Pragmatic trials are those that are designed to inform real-world clinical practice. They are often characterized as focusing on practical aspects of design which include the recruitment process and consent, adhering and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographic areas. This type of heterogeneity is essential for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity, can cause problems with the trial design.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically ordered by policymakers and practitioners to guide their decisions. They are also a good method of determining the cause-effect relationship between an intervention and its results. They should not, however be used to replace the need for explanation studies.
The pragmatism concept is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study that includes recruitment, design, implementation of the intervention and its follow-up.
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), yielded 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.