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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 typically focused on practical aspects of the research design, like the recruitment process and consent, adherence, and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and participants from different geographic areas. This kind of heterogeneity is essential for practical trials to be valid, and it also reduces bias in the results. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually commissioned by policy makers and practitioners to inform their decision making. They also provide a useful method of determining the cause-effect relationship between an intervention and its results. However, they should not, be used to replace explanatory studies.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should be used to 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 that inform the policy and practice of. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as the follow-up.
The number of pragmatic trials is increasing. 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 suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of these trials were conducted in primary care settings.