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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically focused on the practical aspects of study design, including the recruitment and consent process, 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 is required for practical trials to be valid, and it also helps to reduce the chance of bias in the results. However, too much heterogeneity can result in problems with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are typically ordered by policymakers and practitioners to help inform their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. They should not, however be used to replace the need for explanation studies.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, which 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 pragmatic study that includes recruitment, design, delivery of the intervention and follow-up.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to note, however, that the majority of studies were conducted in primary care settings.