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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that allows research into pragmatic trials. It collects and distributes clean trial data, ratings and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses to compare treatment effect estimates across trials of different levels of pragmatism.

Background

Pragmatic trials are increasingly acknowledged as providing evidence from the real world to support clinical decision-making. However, the usage of the term "pragmatic" is not consistent and its definition as well as assessment requires further clarification. Pragmatic trials are designed to guide the practice of clinical medicine and policy choices, rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should aim to be as close as possible to real-world clinical practices which include the recruiting participants, setting, design, implementation and delivery of interventions, determination and analysis results, as well as primary analysis. This is a major distinction between explanatory trials as described by Schwartz and Lellouch1 that are designed to confirm the hypothesis in a more thorough manner.

Truely pragmatic trials should not be blind participants or clinicians. This could lead to bias in the estimations of the effect of treatment. Pragmatic trials should also seek to enroll patients from a variety of health care settings, to ensure that their findings are generalizable to the real world.

Furthermore, trials that are pragmatic must focus on outcomes that matter to patients, like the quality of life and functional recovery. This is particularly important for trials that involve surgical procedures that are invasive or may have dangerous adverse consequences. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals with chronic heart failure. The trial with a catheter, however utilized symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these characteristics pragmatic trials should also reduce the procedures for conducting trials and requirements for data collection to reduce costs and time commitments. Finally pragmatic trials should try to make their results as applicable to clinical practice as possible by ensuring that their primary analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs which do not meet the requirements for pragmatism but have features that are contrary to pragmatism, have been published in journals of different types and incorrectly labeled pragmatic. This could lead to false claims of pragmatism and the use of the term should be standardised. The creation of a PRECIS-2 tool that offers a standardized objective assessment of pragmatic features is a first step.

Methods

In a pragmatic study the goal is to inform policy or clinical decisions by demonstrating how the intervention can be incorporated into real-world routine care. This is distinct from explanation trials that test hypotheses regarding the causal-effect relationship in idealized situations. In this way, pragmatic trials may have lower internal validity than explanation studies and are more susceptible to biases in their design as well as analysis and conduct. Despite these limitations, pragmatic trials can provide valuable information to decision-making in the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study the domains of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the primary outcome and the method of missing data were scored below the practical limit. This indicates that a trial can be designed with effective practical features, yet not harming the quality of the trial.

It is difficult to determine the amount of pragmatism in a particular trial since pragmatism doesn't have a binary attribute. Certain aspects of a research study can be more pragmatic than others. Moreover, protocol or logistic changes during a trial can change its pragmatism score. Additionally 36% of 89 pragmatic trials identified by Koppenaal et al were placebo-controlled or conducted before licensing, and the majority were single-center. They are not in line with the norm and are only called pragmatic if their sponsors agree that the trials are not blinded.

Another common aspect of pragmatic trials is that the researchers try to make their results more relevant by analyzing subgroups of the sample. However, this can lead to unbalanced comparisons and 무료슬롯 프라그마틱 슬롯버프 (https://lovewiki.faith/wiki/How_Pragmatic_Was_Able_To_Become_The_No1_Trend_On_Social_Media) lower statistical power, increasing the risk of either not detecting or misinterpreting the results of the primary outcome. This was the case in the meta-analysis of pragmatic trials as secondary outcomes were not corrected for covariates' differences at baseline.

Additionally, studies that are pragmatic can pose difficulties in the collection and interpretation of safety data. This is because adverse events are typically reported by participants themselves and are prone to reporting delays, inaccuracies, or coding variations. It is essential to improve the quality and accuracy of the results in these trials.

Results

Although the definition of pragmatism doesn't require that all clinical trials be 100% pragmatist, there are benefits of including pragmatic elements in trials. These include:

Incorporating routine patients, the trial results are more easily translated into clinical practice. However, pragmatic trials may also have drawbacks. The right kind of heterogeneity, like could allow a study to generalise its findings to many different patients or settings. However, the wrong type can reduce the sensitivity of an assay, and therefore lessen the power of a trial to detect even minor effects of treatment.

Many studies have attempted classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 created a framework for distinguishing between explanatory trials that confirm a physiological or clinical hypothesis and pragmatic trials that aid in the choice of appropriate therapies in real-world clinical practice. The framework was comprised of nine domains scored on a 1-5 scale which indicated that 1 was more informative and 5 was more pragmatic. The domains included recruitment setting, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis.

The initial PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal and colleagues10 created an adaptation of the assessment, dubbed the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic systematic reviews had a higher average scores across all domains, but lower scores in the primary analysis domain.

This distinction in the primary analysis domain can be due to the way in which most pragmatic trials approach data. Certain explanatory trials however, do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organisation, flexible delivery and following-up were combined.

It is important to note that a pragmatic trial does not necessarily mean a poor quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, however this is not specific or sensitive) which use the word 'pragmatic' in their abstracts or titles. These terms may signal that there is a greater awareness of pragmatism within titles and abstracts, but it isn't clear whether this is evident in content.

Conclusions

As appreciation for the value of real-world evidence grows commonplace and pragmatic trials have gained traction in research. They are randomized studies that compare real-world alternatives to clinical trials in development. They include patient populations more closely resembling those treated in regular care. This method can help overcome the limitations of observational research like the biases that are associated with the use of volunteers and the limited availability and coding variations in national registries.

Pragmatic trials also have advantages, including the ability to leverage existing data sources and a greater chance of detecting significant differences than traditional trials. However, these tests could have some limitations that limit their effectiveness and generalizability. For instance, participation rates in some trials may be lower than expected due to the healthy-volunteer influence and financial incentives or competition for participants from other research studies (e.g. industry trials). The need to recruit individuals in a timely manner also reduces the size of the sample and the impact of many practical trials. Some pragmatic trials also lack controls to ensure that observed differences aren't caused by biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatic and were published from 2022. They assessed pragmatism using the PRECIS-2 tool, which consists of the eligibility criteria for domains and recruitment criteria, 프라그마틱 불법 as well as flexibility in intervention adherence, and follow-up. They discovered 14 trials scored highly pragmatic or 프라그마틱 pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials with a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs, which include very specific criteria that are unlikely to be present in the clinical environment, and they comprise patients from a wide variety of hospitals. According to the authors, could make pragmatic trials more useful and applicable in the daily practice. However they do not guarantee that a trial will be free of bias. The pragmatism characteristic is not a fixed attribute and a test that does not have all the characteristics of an explicative study can still produce reliable and beneficial results.