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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often described as a focus on the practical aspects of design which include the recruitment process and consent, adhering and the use of routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for practical trials to be valid, and it also helps to reduce bias in the results. However excessive heterogeneity could cause problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. 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 the intervention and its effects. They should, however, not be used to replace the need for explanation studies.
The pragmatism concept is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a pragmatic trial, including recruitment, design and delivery of the intervention, and monitoring.
There is a growing increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatics. It is important to keep in mind, however, that the majority of studies were conducted in primary care settings.