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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A practical trial that employs different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for pragmatic trials to be valid and reduce bias in results is also essential. A high degree of heterogeneity, however could cause issues with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. Usually, they are requested by practitioners and policymakers to help inform their decisions. They can also be used to determine the causal relationship between an intervention and its results. They should not, however be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which guide the policy and practice of. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, and the follow-up.
There is a positive increase in the number of pragmatic trials that are published. 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 is an indication that the health science community is becoming more acquaint to the subject of pragmatism. It is important to keep in mind, however, that the majority of these studies were conducted in primary-care settings.