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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, including the recruitment and consent process, adherence, and the use of standard equipment.
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A pragmatic study that involves different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for pragmatic trials to be valid and to reduce bias in the results is also essential. Too much heterogeneity, however can result in problems with the trial design.
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Legality
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually requested by practitioners and policymakers to help guide their decisions. They can also be a great method to determine the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used as a substitute for explanatory studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove a physiological or clinical hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial that include recruitment, design and delivery of the intervention, as well as follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatics. It is important to remember that the majority of these studies were conducted in primary care settings.