Why Pragmatic Free Trial Is So Helpful When COVID-19 Is In Session
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Pragmatic trials are trials designed to inform the practice of clinical trials in real life. They are often characterized as focusing on practical aspects of study design that include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results is also essential. Too much heterogeneity, however, can cause problems with the design of the trial.
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Legality
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They also provide a useful method to determine the causality between an intervention and its outcomes. However, they shouldn't be used to substitute for explanation trials.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials, which inform policy and practice decisions. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a practical trial, including the recruitment process, the design and delivery of the intervention, as well as the follow-up.
There is a growing increase in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.