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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually focused on practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from different geographical regions. This type of heterogeneity that is crucial for a pragmatic trial 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 replicate real-life situations and achieve maximum validity externally. They are typically requested by practitioners and policymakers to help inform their decisions. They are also a good method of determining 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 doubts about whether pragmatic trials can be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis and pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study which includes recruitment, design, implementation of the intervention and its follow-up.
There is an encouraging increase in the number pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited 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 keep in mind that the majority of these trials were conducted in primary care settings.