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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and included participants from various geographical areas. This type of heterogeneity that is crucial for a pragmatic trial to be valid and reduce bias in results is also essential. However too much heterogeneity could result in problems with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be a great method to determine the cause-effect relationship between an intervention and its results. However, they shouldn't be used as a substitute for explanation studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study, including recruitment, design, implementation of the intervention and follow-up.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on 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 trials were conducted in primary care settings.