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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are usually focused on the practical aspects of the research design, like the recruitment process and consent, adherence, and the use of commonly available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from different geographic areas. This type of heterogeneity which is vital for a pragmatic trial to be reliable and to reduce bias in the results is also essential. Too much heterogeneity, however could cause issues with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They can also be used to assess the causal relationship between an intervention with its outcomes. They should not, however be used to replace the need for explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a practical trial which includes the recruitment process, the design and delivery of the intervention, and follow-up.
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 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 remember, however, that the majority of studies were conducted in primary care settings.