Pragmatic Free Trial Meta
Pragmatic Free Trial Meta is a free and non-commercial open data platform and infrastructure that supports research on pragmatic trials. It collects and shares cleaned trial data and ratings using PRECIS-2, allowing for
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Background
Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. The term "pragmatic" however, is used inconsistently and its definition and measurement need further clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than to prove an hypothesis that is based on a clinical or physiological basis. A pragmatic study should try to be as similar to real-world clinical practice as possible, including in its participation of participants, setting up and design, the delivery and implementation of the intervention, and the determination and
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프라그마틱 이미지 primary analysis. This is a major distinction between explanation-based trials, as defined by Schwartz & Lellouch1 that are designed to test the hypothesis in a more thorough manner.
Truely pragmatic trials should not blind participants or clinicians. This can lead to an overestimation of the effect of treatment. Practical trials should also aim to attract patients from a wide range of health care settings, to ensure that the results can be compared to the real world.
Finally, pragmatic trials must focus on outcomes that matter to patients, such as the quality of life and functional recovery. This is especially important in trials that involve invasive procedures or those with potential serious adverse events. The CRASH trial29, for instance, focused on functional outcomes to evaluate a two-page case report with an electronic system to monitor the health of hospitalized patients with chronic heart failure. In addition, the catheter trial28 used urinary tract infections that are symptomatic of catheters as the primary outcome.
In addition to these aspects, pragmatic trials should minimize the requirements for data collection and trial procedures to reduce costs and time commitments. Additionally, pragmatic trials should aim to make their results as relevant to real-world clinical practices as they can. This can be accomplished by ensuring that their primary analysis is based on the intention-to treat method (as described in CONSORT extensions).
Many RCTs that don't meet the requirements for pragmatism but contain features contrary to pragmatism have been published in journals of different kinds and incorrectly labeled pragmatic. This could lead to misleading claims of pragmaticity, and the use of the term should be standardized. The creation of the PRECIS-2 tool, which offers an objective standard for assessing pragmatic features, is a good first step.
Methods
In a practical trial it is the intention to inform policy or clinical decisions by showing how an intervention could be implemented into routine care. This is different from explanatory trials that test hypotheses regarding the causal-effect relationship in idealized conditions. Consequently, pragmatic trials may have lower internal validity than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can be a valuable source of information for decisions in the context of healthcare.
The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study, the recruit-ment, organisation, flexibility: delivery, flexible adherence and follow-up domains scored high scores, but the primary outcome and the method for missing data were not at the limit of practicality. This suggests that a trial could be designed with well-thought-out pragmatic features, without damaging the quality.
It is, however, difficult to judge how pragmatic a particular trial is since pragmaticity is not a definite characteristic; certain aspects of a study can be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or logistics during the trial. In addition 36% of the 89 pragmatic trials identified by Koppenaal and co. were placebo-controlled or conducted prior to licensing, and the majority were single-center. They are not close to the norm and are only considered pragmatic if their sponsors agree that such trials are not blinded.
A typical feature of pragmatic studies is that researchers try to make their findings more meaningful by analyzing subgroups within the trial. However, this often leads to unbalanced results and lower statistical power, thereby increasing the likelihood of missing or misinterpreting differences in the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for
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In addition, pragmatic trials can also present challenges in the gathering and interpretation of safety data. This is because adverse events are generally reported by the participants themselves and prone to reporting errors, delays or coding errors. It is therefore important to improve the quality of outcomes assessment in these trials, and ideally by using national registries rather than relying on participants to report adverse events on a trial's own database.
Results
While the definition of pragmatism doesn't require that all clinical trials be 100% pragmatic, there are benefits of including pragmatic elements in trials. These include:
Increasing sensitivity to real-world issues as well as reducing study size and cost and allowing the study results to be faster transferred into real-world clinical practice (by including patients who are routinely treated). However, pragmatic trials have their disadvantages. For instance, the appropriate type of heterogeneity can help a study to generalize its findings to a variety of settings and patients. However, the wrong type of heterogeneity may reduce the assay's sensitivity, and thus lessen the ability of a study to detect small treatment effects.
A variety of studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 created a framework to discern between explanation-based studies that support a physiological or clinical hypothesis and pragmatic studies that help inform the selection of appropriate therapies in real world clinical practice. The framework was composed of nine domains evaluated on a scale of 1-5 which indicated that 1 was more lucid while 5 was more pragmatic. The domains included recruitment of intervention, setting up, delivery of intervention, flexible adhering to the program and primary analysis.
The original PRECIS tool3 featured similar domains and a scale of 1 to 5. Koppenaal et al10 created an adaptation to this assessment, dubbed the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic systematic reviews had a higher average score in most domains, with lower scores in the primary analysis domain.
This difference in primary analysis domains could be explained by the way most pragmatic trials approach data. Certain explanatory trials however don't. The overall score was lower for systematic reviews that were pragmatic when the domains of organisation, flexible delivery, and follow-up were combined.
It is crucial to keep in mind that a pragmatic study should not mean a low-quality trial.