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Trials designed to inform 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 and consent process, as well as adherence and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from different geographic areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and also helps to reduce bias in the results. A high degree of heterogeneity, however, can cause problems with the trial design.

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Legality

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The goal of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually ordered by policymakers and practitioners to inform their decisions. They can also be used to assess the cause-effect relationship of an intervention and its results. However, they shouldn't be used in lieu for explanatory trials.

The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and the follow-up.

The number of pragmatic trials is increasing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more acquaint to the subject of pragmatics. However, it is important to note that the majority of these trials were conducted in primary care settings.