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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, such as the recruitment process and consent in adherence, as well as 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 employed a variety of investigators and included participants from different geographical regions. This type of heterogeneity which is vital for pragmatic trials to be reliable and reduce bias in results is also essential. However excessive heterogeneity could cause problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. They are typically commissioned by policymakers and practitioners to help guide their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they should not be used to substitute for the use of explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for 프라그마틱 사이트 policy and practice. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, as well as monitoring.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatics. It is important to note that the majority of these studies were conducted in primary care settings.