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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of designing a study, including recruitment and consent, adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and had participants from different geographic areas. This kind of heterogeneity is necessary for pragmatic trials to be valid, and it also helps reduce bias in the results. A high degree of heterogeneity, however, can cause problems with the trial design.
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The purpose of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They can be used to determine the causal relationship between an intervention and its results. had me going should, however, not be used to replace explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study that includes recruitment, design, delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. 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 sciences community is becoming more acquaint to the subject of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.