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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often focused on the practical aspects of the study design, including the recruitment process and consent as well as adherence to the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from various geographical areas. This type of heterogeneity is necessary for practical trials to be valid and also helps to reduce the chance of bias in the results. However, too much heterogeneity can result in problems with the trial design.
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The aim of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are typically requested by practitioners and policymakers in order to inform their decisions. They are also a good method of determining the cause-effect relationship between an intervention and its outcomes. 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 be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic study, including the recruitment process, the design and implementation of the intervention, as well as monitoring.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using 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 science community is becoming more acquaint to the subject of pragmatic thinking. It is important to note that the majority were conducted in primary care settings.