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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often focused on the practical aspects of research design, like recruitment and consent, adherence, and the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and lessen the chance of bias is also essential. related , however can result in problems with the design of the trial.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are usually requested by practitioners and policy makers to inform their decision making. They can be used to determine the causal relationship between an intervention and its effects. However, they should not be used to replace explanatory studies.
The concept 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 a physiological or clinical hypothesis and pragmatic trials, which inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the traits 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 search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming increasingly sensitized to the subject of pragmatics. It is important to note that the majority of these studies were conducted in primary care settings.