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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that supports research on pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2, which allows for multiple and varied meta-epidemiological research studies to examine the effects of treatment across trials that have different levels of pragmatism and other design features.

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 assessment require 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 try to be as close as is possible to actual clinical practices that include recruiting participants, setting up, delivery and implementation of interventions, determining and analysis outcomes, and primary analyses. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more thorough confirmation of a hypothesis.

Studies that are truly pragmatic must not attempt to blind participants or the clinicians, as this may result in distortions in estimates of the effects of treatment. The pragmatic trials also include patients from different health care settings to ensure that the results can be applied to the real world.

Finally, 프라그마틱 홈페이지 pragmatic trials should focus on outcomes that are crucial to patients, such as quality of life or functional recovery. This is particularly important in trials that involve the use of invasive procedures or potentially dangerous adverse events. The CRASH trial29 compared a 2-page report with an electronic monitoring system for hospitalized patients with chronic heart failure. The catheter trial28, however, used symptomatic catheter associated urinary tract infections as its primary outcome.

In addition to these aspects pragmatic trials should reduce the procedures for conducting trials and requirements for data collection to reduce costs and time commitments. Additionally, pragmatic trials should aim to make their results as applicable to current clinical practices as possible. This can be accomplished by ensuring that their analysis is based on the intention-to treat approach (as described within CONSORT extensions).

Despite these requirements, many RCTs with features that defy the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all types. This can lead to false claims of pragmatism, and 프라그마틱 슬롯 사이트 the usage of the term should be standardized. The creation of the PRECIS-2 tool, which provides an objective standard for assessing pragmatic characteristics, is a good first step.

Methods

In a pragmatic trial, the aim is to inform policy or clinical decisions by demonstrating how the intervention can be integrated into everyday routine care. This differs from explanation trials, which test hypotheses about the causal-effect relationship in idealized situations. Therefore, pragmatic trials might have less internal validity than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can provide valuable information to decision-making in the context of healthcare.

The PRECIS-2 tool measures the degree of pragmatism in an RCT by scoring it across 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study the domains of recruitment, organisation and flexibility in delivery, flexibility in adherence, and follow-up were awarded high scores. However, the primary outcome and the method of missing data was scored below the pragmatic limit. This suggests that a trial can be designed with well-thought-out practical features, but without harming the quality of the trial.

However, it's difficult to judge how pragmatic a particular trial is, since the pragmatism score is not a binary characteristic; certain aspects of a trial can be more pragmatic than others. Furthermore, logistical or protocol changes during the trial may alter its score in pragmatism. Additionally 36% of the 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled or conducted prior to licensing and most were single-center. They are not in line with the usual practice and can only be referred to as pragmatic if their sponsors accept that such trials aren't blinded.

Furthermore, a common feature of pragmatic trials is that researchers attempt to make their findings more valuable by studying subgroups of the trial. This can lead to unbalanced results and lower statistical power, increasing the likelihood of missing or misinterpreting the results of the primary outcome. In the case of the pragmatic trials included in this meta-analysis this was a major issue since the secondary outcomes weren't adjusted for variations in the baseline covariates.

Furthermore practical trials can be a challenge in the gathering and interpretation of safety data. This is due to the fact that adverse events tend to be self-reported, 프라그마틱 환수율 and therefore are prone to errors, delays or coding errors. It is important to improve the quality and accuracy of the outcomes in these trials.

Results

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

Enhancing sensitivity to issues in the real world as well as reducing cost and 프라그마틱 슬롯 size of the study and allowing the study results to be more quickly translated into actual clinical practice (by including patients from routine care). However, pragmatic trials may have disadvantages. The right amount of heterogeneity, for example could help a study generalise its findings to many different patients or settings. However the wrong kind of heterogeneity can reduce the assay sensitivity and thus lessen the power of a trial to detect small treatment effects.

A variety of studies have attempted to categorize pragmatic trials, with a variety of definitions and scoring systems. Schwartz and Lellouch1 created an approach to distinguish between explanatory trials that confirm the clinical or physiological hypothesis and pragmatic trials that inform the choice of appropriate therapies in real-world clinical practice. Their framework comprised nine domains, each scored on a scale ranging from 1 to 5, with 1 being more informative and 5 suggesting more pragmatic. The domains were recruitment, setting, intervention delivery with flexibility, follow-up and primary analysis.

The original PRECIS tool3 was based on a similar scale and domains. Koppenaal et al10 created an adaptation to this assessment called the Pragmascope which was more user-friendly to use in systematic reviews. They found that pragmatic systematic reviews had higher average scores across all domains but lower scores in the primary analysis domain.

This distinction in the primary analysis domain could be due to the fact that most pragmatic trials analyze their data in an intention to treat way while some explanation trials do not. 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 study that is pragmatic does not mean that a trial is of poor quality. In fact, there are a growing number of clinical trials which use the term "pragmatic" either in their abstract or title (as defined by MEDLINE, but that is neither precise nor sensitive). These terms may indicate a greater appreciation of pragmatism in titles and abstracts, but it isn't clear if this is reflected in the content.

Conclusions

In recent years, pragmatic trials have been becoming more popular in research as the value of real-world evidence is increasingly recognized. They are randomized studies that compare real-world alternatives to new treatments that are being developed. They include patient populations that are more similar to those who receive treatment in regular care. This method can help overcome the limitations of observational research such as the biases that are associated with the reliance on volunteers, and the limited availability and the coding differences in national registry.

Pragmatic trials also have advantages, such as the ability to use existing data sources and a greater probability of detecting meaningful differences from traditional trials. However, they may still have limitations that undermine their validity and generalizability. Participation rates in some trials could be lower than expected due to the health-promoting effect, financial incentives, or competition from other research studies. Many pragmatic trials are also limited by the need to enroll participants in a timely manner. Additionally certain pragmatic trials don't have controls to ensure that the observed differences aren't due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and that were published up to 2022. They assessed pragmatism using the PRECIS-2 tool that includes the domains eligibility criteria as well as recruitment, flexibility in intervention adherence and follow-up. They found that 14 of these trials scored pragmatic or highly practical (i.e. scoring 5 or more) in one or more of these domains, and that the majority of them were single-center.

Trials that have high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also have patients from a variety of hospitals. According to the authors, could make pragmatic trials more relevant and relevant to everyday practice. However they do not guarantee that a trial will be free of bias. The pragmatism is not a fixed attribute and a test that does not possess all the characteristics of an explicative study could still yield valuable and valid results.