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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually 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 practical trial that employs various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for pragmatic trials to be valid and reduce bias in results is also essential. However, too much heterogeneity can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to aid in their decision-making. They are also a good way to identify the causal relationship between an intervention and its outcomes. However, they should not be used to substitute for the use of explanation studies.
The pragmatism concept is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis as well as pragmatic trials that 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 pragmatic research study that includes recruitment, design, delivery of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.