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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often characterized as focusing on practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and had participants from different geographic areas. This type of heterogeneity that is crucial for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However excessive heterogeneity could result in 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 typically ordered by policymakers and practitioners to inform their decisions. They can also be a great method of determining the causality between an intervention and its results. However, they shouldn't be used in lieu for the use of explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including recruitment, design, delivery of the intervention, and follow-up.
There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to remember that the majority of these studies were conducted in primary care settings.