Pragmatic Free Trial 101: A Complete Guide For Beginners
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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, including recruitment and consent, adherence, and the use of commonly available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from various geographical areas. This type of heterogeneity which is vital for a pragmatic trial to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They can also be used to assess the causality of an intervention and its results. They should, however, not, be used to replace explanation studies.
The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study that includes recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is increasing. 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 suggests that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.