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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described as a focus on the practical aspects of design, including the recruitment process and consent, adhering and the use of routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be reliable and reduce bias in results is also essential. Too much heterogeneity, however, can cause problems with the trial design.
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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are usually ordered by policymakers and practitioners to inform their decisions. They also provide a useful method of determining the causality between an intervention and its results. They should, however, not be used to replace explanation studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study that include recruitment, design and delivery of the intervention, and the follow-up.
There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatism. However, it is important to remember that the majority of these studies were conducted in primary care settings.