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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of study design, including recruitment and consent, adherence and the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is vital for pragmatic trials to be valid and to reduce bias in the results is also essential. However excessive heterogeneity could 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 in order to inform their decisions. They are also a good method of determining the causality between an intervention and its results. They should not, however be used to replace explanation studies.
The concept of pragmatism is controversial, and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health science community is becoming more acquaint to the issue of pragmatics. It is important to keep in mind, however, that the majority were conducted in primary-care settings.