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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of study design, such as recruitment 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 utilized a variety of investigators and had participants from different geographical regions. This type of heterogeneity, which is vital for pragmatic trials to be reliable and lessen the chance of bias is also essential. A high degree of heterogeneity, however, can cause problems with the trial design.
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The aim 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 guide their decision-making. They can also be a great method of determining the causal relationship between an intervention and its results. They should, however, not be used to replace explanatory studies.
The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, and monitoring.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted 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.