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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of study design which include recruitment and consent, adherence and the use of standard equipment.
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A practical trial that employs various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They can also be used to determine the causal relationship between an intervention and its results. However, they should not, be used to replace explanatory studies.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the features of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as monitoring.
There is a growing trend in the number of pragmatic trials that have been 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 sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.