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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically focused on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of commonly available equipment.
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A pragmatic study that involves different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid, and it also reduces the chance of bias in the results. Too much heterogeneity, however can result in problems with the trial design.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are typically ordered by policymakers and practitioners to help guide their decisions. They can also be used to assess the causal relationship between an intervention with its outcomes. They should, however, not, be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and monitoring.
There is an encouraging increase in the number pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.