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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are typically characterized by a focus on the practical aspects of research design, like recruitment and consent in adherence, as well as the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and included participants from different geographical regions. This type of heterogeneity is necessary for practical trials to be valid, and it also helps to reduce the chance of bias in the results. However,
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The goal of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They also provide a useful method of determining the cause-effect relationship between an intervention and its results. However, they should not be used to replace explanatory studies.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials, which inform policy and practice decisions. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a pragmatic study, including the recruitment process, the design and delivery of the intervention, as well as follow-up.
There is a growing increase in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to remember that the majority of studies were conducted in primary-care settings.