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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of designing a study which include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for pragmatic trials to be valid and lessen the chance of bias is also essential. However too much heterogeneity could lead to issues with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They can be used to determine the cause-effect relationship of an intervention with its outcomes. However, they should not be used to substitute for the use of explanation trials.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more acquaint to the subject of pragmatic thinking. It is important to remember that the majority of these trials were conducted in primary care settings.