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Pragmatic trials are trials designed to provide information for the practice of clinical trials in real life. They are often characterized by their focus on practical aspects of study 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 employed various investigators and participants from various geographical areas. This type of heterogeneity is necessary for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However too much heterogeneity could cause problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. Usually, they are ordered by policymakers and practitioners to guide their decisions. They are also a good method of determining the causal relationship between the intervention and its effects. They should, however, not be used to replace explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study which includes recruitment, design, delivery of the intervention and follow-up.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline query that used 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 more acquaint to the subject of pragmatic thinking. It is important to note, however, that the majority of studies were conducted in primary-care settings.