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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 often characterized by their focus on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and had participants from different geographical regions. This type of heterogeneity, which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity, can cause problems with the trial design.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are usually ordered by policymakers and practitioners to help guide their decisions. 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 trials.
The pragmatism idea 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 prove a physiological or clinical hypothesis, and pragmatic trials, which inform the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study that includes recruitment, design, implementation of the intervention and follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority of studies were conducted in primary-care settings.