Why The Pragmatic Free Trial Is Beneficial For COVID-19
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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of study design, including the recruitment process and consent, adhering 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 used various investigators and included participants from different geographical regions. This type of heterogeneity is required for pragmatic trials to be able to prove their validity and also helps reduce the chance of bias in the results. However too much heterogeneity could cause issues with the design of the trial.
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Legality
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are usually ordered by policymakers and practitioners in order to inform their decisions. They can also be a great method to determine the causal relationship between the intervention and its effects. However, they should not be used to substitute for explanation trials.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove 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 sought to define the features of a practical trial which includes the recruitment process, the design and delivery of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority were conducted in primary care settings.