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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described by their focus on practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use routinely available 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 kind of heterogeneity is required for pragmatic trials to be able to prove their validity and reduces bias in the results. However too much heterogeneity could result in problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually requested by policy makers and practitioners to guide their decision-making. They also provide a useful method of determining the causal relationship between an intervention and its results. However, they should not, be used to replace explanation studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study which includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become 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.