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Trials designed to inform clinical practice in the real world are called 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, that is crucial for pragmatic trials to be reliable and to reduce bias in the results is also essential. Too much heterogeneity, however, can cause problems with the design of the trial.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically commissioned by practitioners and policy makers to inform their decision making. They are also a good method of determining the cause-effect relationship between an intervention and its results. They should not, however be used to replace explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study, including the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary-care settings.