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Pragmatic Free Trial Meta

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

Background

Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the use of the term "pragmatic" is not uniform and its definition and assessment requires clarification. Pragmatic trials are intended to inform clinical practices and policy choices, rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should aim to be as similar to the real-world clinical environment as is possible, including its participation of participants, setting and design as well as the execution of the intervention, as well as the determination and analysis of outcomes as well as primary analyses. This is a significant distinction from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more thorough confirmation of a hypothesis.

The most pragmatic trials should not conceal participants or the clinicians. This can result in bias in the estimations of the effects of treatment. The pragmatic trials also include patients from various healthcare settings to ensure that the outcomes can be compared to the real world.

Finally, pragmatic trials must focus on outcomes that matter to patients, like quality of life and functional recovery. This is particularly relevant in trials that require surgical procedures that are invasive or may have dangerous adverse consequences. The CRASH trial29, for example, focused on functional outcomes to compare a 2-page case-report with an electronic system to monitor the health of hospitalized patients with chronic heart failure, and the catheter trial28 used urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these aspects the pragmatic trial should also reduce the procedures for conducting trials and requirements for data collection to reduce costs. Additionally, pragmatic trials should seek to make their results as relevant to actual clinical practice as is possible by making sure that their primary method of 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 however, they have characteristics that are contrary to pragmatism have been published in journals of different types and incorrectly labeled as pragmatic. This can lead to false claims about pragmatism, and the term's use should be standardized. The development of the PRECIS-2 tool, which provides an objective and standard assessment of pragmatic characteristics, is a good first step.

Methods

In a pragmatic trial it is the intention to inform policy or clinical decisions by demonstrating how an intervention would be incorporated into real-world routine care. Explanatory trials test hypotheses concerning the causal-effect relationship in idealized environments. Consequently, pragmatic trials may have lower internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can provide valuable information for decision-making within the healthcare context.

The PRECIS-2 tool measures the level of pragmatism that is present in an RCT by scoring it across 9 domains, 프라그마틱 무료스핀 무료슬롯 (mouse click on Kingranks) ranging from 1 (very explicit) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery and follow-up domains were awarded high scores, however the primary outcome and the method of missing data were not at the limit of practicality. This suggests that it is possible to design a trial that has good pragmatic features without compromising the quality of its outcomes.

However, it is difficult to judge how pragmatic a particular trial is since pragmaticity is not a definite quality; certain aspects of a trial can be more pragmatic than others. A trial's pragmatism could be affected by modifications to the protocol or logistics during the trial. In addition 36% of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or conducted before approval and a majority of them were single-center. They are not close to the norm and can only be considered pragmatic if the sponsors agree that the trials aren't blinded.

Another common aspect of pragmatic trials is that the researchers try to make their results more valuable by studying subgroups of the trial. However, this can lead to unbalanced comparisons with a lower statistical power, which increases the likelihood of missing or misinterpreting the results of the primary outcome. In the case of the pragmatic studies that were included in this meta-analysis this was a significant problem because the secondary outcomes weren't adjusted for variations in the baseline covariates.

Additionally, pragmatic trials can also present challenges in the collection and interpretation of safety data. It is because adverse events tend to be self-reported, and are prone to delays, errors or coding errors. It is important to improve the accuracy and quality of outcomes in these trials.

Results

Although the definition of pragmatism doesn't require that clinical trials be 100% pragmatic, there are benefits when incorporating pragmatic components into trials. These include:

Enhancing sensitivity to issues in the real world as well as reducing the size of studies and their costs and allowing the study results to be more quickly translated into actual clinical practice (by including routine patients). However, pragmatic trials may be a challenge. The right kind of heterogeneity, for example, can help a study expand its findings to different settings or patients. However, the wrong type can reduce the sensitivity of an assay and, consequently, lessen the power of a trial to detect minor treatment effects.

Several studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 created a framework to distinguish between explanatory trials that confirm the clinical or 프라그마틱 슬롯 추천 무료 프라그마틱 슬롯버프 (kingranks.com explains) physiological hypothesis, and pragmatic trials that help in the choice of appropriate therapies in the real-world clinical setting. The framework was comprised of nine domains that were scored on a scale ranging from 1-5, with 1 indicating more explanatory and 5 suggesting more pragmatic. The domains included recruitment and setting up, the delivery of intervention, flexible adhering to the program and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal and colleagues10 developed an adaptation of this assessment, dubbed the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic systematic reviews had a higher average scores across all domains, with lower scores in the primary analysis domain.

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

It is important to remember that a study that is pragmatic does not necessarily mean a low-quality study. In fact, there are increasing numbers 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 signal a greater understanding of pragmatism in abstracts and titles, but it's unclear if this is reflected in content.

Conclusions

In recent times, pragmatic trials are becoming more popular in research as the value of real world evidence is becoming increasingly acknowledged. They are clinical trials that are randomized that compare real-world care alternatives instead of experimental treatments in development, they have patient populations that more closely mirror the ones who are treated in routine care, they employ comparators that are used in routine practice (e.g. existing drugs), and they depend on participants' self-reports of outcomes. This approach can overcome the limitations of observational research, such as the biases that come with the reliance on volunteers, and the lack of codes that vary in national registers.

Other benefits of pragmatic trials include the ability to use existing data sources, and a higher likelihood of detecting meaningful changes than traditional trials. However, these trials could be prone to limitations that compromise their credibility and generalizability. For instance the rates of participation in some trials might be lower than anticipated due to the healthy-volunteer effect and incentives to pay or compete for participants from other research studies (e.g., industry trials). The necessity to recruit people in a timely manner also limits the sample size and impact of many pragmatic trials. Additionally, some pragmatic trials do not have controls to ensure that the observed differences are not due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatist and published until 2022. The PRECIS-2 tool was used to evaluate the pragmatism of these trials. It covers areas like eligibility criteria and flexibility in recruitment, adherence to intervention, and follow-up. They found 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials with a high pragmatism rating tend to have more expansive eligibility criteria than traditional RCTs that have specific criteria that are not likely to be found in the clinical setting, and comprise patients from a wide range of hospitals. The authors argue that these characteristics could make pragmatic trials more effective and applicable to daily practice, but they do not necessarily guarantee that a trial using a pragmatic approach is free of bias. The pragmatism characteristic is not a fixed characteristic the test that doesn't have all the characteristics of an explanation study could still yield valid and useful outcomes.