10 Pragmatic Free Trial Tips All Experts Recommend
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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually focused on practical aspects of the study design, including the recruitment and consent process in adherence, as well as the use of commonly available equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. Too much heterogeneity, however can result in problems with the design of the trial.
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Legality
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The goal of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually requested by practitioners and policymakers in order to guide their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. They should not, however, be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study, including the recruitment, design, and delivery of the intervention, and follow-up.
There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.