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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, such as recruitment and consent, adherence, and the use of commonly available equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for a pragmatic trial to be valid and lessen the chance of bias is also essential. Too much heterogeneity, however could cause issues with the trial design.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policymakers in order to inform their decisions. They are also a good method of determining the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used in lieu for explanatory trials.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which inform the policy and practice of. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.
There is a growing trend in the number of pragmatic trials that are published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.