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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are usually characterized by a focus on the practical aspects of research design, like recruitment and consent, adherence, and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and had participants from different geographical regions. This type of heterogeneity that is crucial for a pragmatic trial to be valid and reduce bias in results is also essential. However too much heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They can also be a great way to identify the cause-effect relationship between an intervention and its results. 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 should be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and monitoring.
The number of pragmatic trials is increasing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of studies were conducted in primary-care settings.