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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 focused on the practical aspects of research design, like the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and helps to reduce the chance of bias in the results. However too much heterogeneity could lead to problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an intervention and its effects. They should, however, not, be used to replace the need for explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic research study, including the recruitment, design, and delivery of the intervention and its follow-up.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary care settings.