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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 focused on the practical aspects of study design, such as the recruitment process and consent, adherence, and the use of commonly available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for a pragmatic trial to be valid and lessen the chance of bias is also essential. Too much heterogeneity, however can result in problems with the trial design.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an 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 explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including recruitment, design, implementation of the intervention and its follow-up.
There is a growing increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority of studies were conducted in primary-care settings.