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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are usually focused on the practical aspects of the study design, including the recruitment process and consent, adherence, and the use of commonly available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is vital for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. Too much heterogeneity, however can result in problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners in order to inform their decisions. They are also a good method of determining the causal relationship between the intervention and its effects. However, they should not be used in lieu for explanatory studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy 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 which includes recruitment, design, delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.