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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of standard 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 valid and reduce bias in results is also essential. Too much heterogeneity, however can result in problems with the design of the trial.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are usually ordered by policymakers and practitioners to help inform their decisions. They are also a good way to identify the causal relationship between an intervention and its results. However, they should not be used to substitute for explanation trials.
The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis and pragmatic trials, which guide the policy and practice of. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study, including the recruitment, design, and delivery of the intervention, and follow-up.
There is a positive increase in the number pragmatic trials that have been published. 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 is an indication that the health science community is becoming more acquaint to the subject of pragmatic thinking. It is important to keep in mind, however, that the majority of these studies were conducted in primary-care settings.