Five Pragmatic Free Trial Lessons From The Pros

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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are typically described as focusing on practical aspects of designing a study which include recruitment and consent, adherence and the use of routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for pragmatic trials to be reliable and reduce bias in results, is also necessary. However too much heterogeneity could result in issues with the design of the trial.
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Legality
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used to substitute for explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic study, including recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary care settings.