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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, including the recruitment process and consent, adhering and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from different geographic areas. This type of heterogeneity is required for pragmatic trials to be valid and helps to reduce bias in the results. However excessive heterogeneity could cause issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. Usually, they are commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great method to determine the causality between an intervention and its results. They should, however, not, be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis and pragmatic trials that inform 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 study, including recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.