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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus on the practical aspects of study design, such as recruitment and consent as well as adherence to the use of standard equipment.
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A practical trial that employs various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. However too much heterogeneity could result in issues with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners to help inform their decisions. They can be used to determine the cause-effect relationship of an intervention and its results. However, they should not be used to substitute for explanatory trials.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a practical trial which includes recruitment, design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to keep in mind that the majority were conducted in primary-care settings.