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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized by their focus on practical aspects of design which include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for practical trials to be valid, and it also helps reduce the chance of bias in the results. A high degree of heterogeneity, however can result in problems with the design of the trial.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can also be a great method of determining the cause-effect relationship between an intervention and its outcomes. However, they should not be used to replace the need for explanation studies.
The pragmatism concept is controversial, and there are concerns 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 that inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study, including recruitment, design, implementation of the intervention, and follow-up.
There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more acquaint to the subject of pragmatic thinking. It is important to remember that the majority were conducted in primary care settings.