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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described as a focus on the 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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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and had participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be valid and also helps to reduce bias in the results. However excessive heterogeneity could cause problems with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. Usually, they are requested by practitioners and policymakers in order to inform their decisions. They also provide a useful method of determining the causal relationship between the intervention and its effects. They should not, however, be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study which 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 query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health science community is becoming more sensitive to the subject of pragmatism. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.