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Pragmatic trials are trials designed to provide information for the real-world practice of clinical. They are usually focused on practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and reduces bias in the results. However too much heterogeneity could cause problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great method of determining the causality between an intervention and its results. They should, however, not be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study which includes the recruitment, design, and delivery of the intervention and its follow-up.
There is an encouraging increase in the number pragmatic trials that are published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note, however, that the majority of these studies were conducted in primary-care settings.