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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 focused on the practical aspects of the study design, such as the recruitment and consent process as well as adherence to the use of commonly available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographic areas. This kind of heterogeneity, that is crucial for pragmatic trials to be valid and lessen the chance of bias is also essential. However, too much heterogeneity can result in problems with the trial design.
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The goal of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are typically commissioned by policy makers and practitioners to inform their decision making. They are also a good method to determine the causal relationship between the intervention and its effects. They should not, however be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and the follow-up.
There is an encouraging increase in the number 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 suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.
