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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically focused on the practical aspects of study design, such as recruitment and consent in adherence, as well as the use of commonly available equipment.
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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for a pragmatic trial to be reliable and reduce bias in results is also essential. However too much heterogeneity could result in issues with the design of the trial.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They can also be used to assess the causality of an intervention with its outcomes. However, they should not, be used to replace the need for explanation studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which inform the policy and practice of. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a practical trial which includes the recruitment process, the design and delivery of the intervention, as well as the follow-up.
There is a growing increase in the number pragmatic trials published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember that the majority were conducted in primary care settings.