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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are usually characterized by a focus on the practical aspects of study design, including the recruitment and consent process, adherence, and the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and participants from different geographical regions. This type of heterogeneity which is vital for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. 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 scenarios and gain maximum validity externally. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to assess the causality of an intervention and its effects. However, they shouldn't be used as a substitute for explanatory trials.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which inform the policy and practice of. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study, including recruitment, design, 프라그마틱 순위 delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health sciences community is becoming more acquaint to the issue of pragmatic thinking. It is important to note that the majority were conducted in primary-care settings.