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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that facilitates research into pragmatic trials. It shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological research studies to evaluate the effect of treatment on trials that employ different levels of pragmatism as well as other design features.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence for clinical decision making. The term "pragmatic" however, is a word that is often used in contradiction and its definition and assessment need further clarification. Pragmatic trials should be designed to inform clinical practice and policy decisions, 프라그마틱 정품확인방법 not to confirm a physiological or clinical hypothesis. A pragmatic trial should try to be as close as it is to actual clinical practices which include the recruiting participants, setting, designing, delivery and implementation of interventions, determination and analysis results, as well as primary analyses. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1), which are intended to provide a more complete confirmation of the hypothesis.

The most pragmatic trials should not be blind participants or clinicians. This could lead to bias in the estimations of the effect of treatment. The trials that are pragmatic should also try to recruit patients from a variety of health care settings, so that their results can be compared to the real world.

Finally, pragmatic trials must concentrate on outcomes that are important to patients, like the quality of life and functional recovery. This is particularly relevant when it comes to trials that involve surgical procedures that are invasive or have potential serious adverse events. The CRASH trial29 compared a 2 page report with an electronic monitoring system for patients in hospitals with chronic cardiac failure. The catheter trial28 however utilized symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these characteristics pragmatic trials should reduce the trial's procedures and data collection requirements to reduce costs. Furthermore pragmatic trials should try to make their findings as applicable to real-world 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 that don't meet the criteria for pragmatism, however, they have characteristics that are in opposition to pragmatism, have been published in journals of different types and incorrectly labeled as pragmatic. This can lead to false claims of pragmatism, and the usage of the term should be standardised. The creation of a PRECIS-2 tool that offers an objective, standardized evaluation of pragmatic aspects is a good start.

Methods

In a pragmatic study, the goal is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine care in real-world settings. This is distinct from explanation trials, which test hypotheses about the cause-effect relationship in idealised settings. In this way, pragmatic trials may have a lower internal validity than studies that explain and are more susceptible to biases in their design analysis, conduct, and design. Despite their limitations, pragmatic research can provide valuable information for decision-making within the context of healthcare.

The PRECIS-2 tool assesses the level of pragmatism that is present in an RCT by assessing it across 9 domains, ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruitment, organisation, flexibility: delivery, 슬롯 flexible adherence and 프라그마틱 체험 follow-up domains received high scores, but the primary outcome and the procedure for missing data were below the practical limit. This suggests that a trial could be designed with effective pragmatic features, without harming the quality of the trial.

It is, however, difficult to judge the degree of pragmatism a trial is, since pragmaticity is not a definite characteristic; certain aspects of a trial can be more pragmatic than others. The pragmatism of a trial can be affected by changes to the protocol or the logistics during the trial. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. Most were also single-center. Thus, they are not as common and can only be described as pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.

A common feature of pragmatic studies is that researchers try to make their findings more relevant by studying subgroups of the trial sample. This can result in imbalanced analyses and less statistical power. This increases the possibility of omitting or misinterpreting differences in the primary outcomes. This was the case in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for differences in covariates at the time of baseline.

Additionally, studies that are pragmatic may pose challenges to collection and interpretation of safety data. It is because adverse events tend to be self-reported and are susceptible to delays, inaccuracies or coding errors. It is essential to increase the accuracy and quality of the results in these trials.

Results

Although the definition of pragmatism does not require that clinical trials be 100% pragmatist there are benefits when incorporating pragmatic components into trials. These include:

By including routine patients, the trial results can be translated more quickly into clinical practice. However, pragmatic trials may also have disadvantages. The right amount of heterogeneity, like could help a study extend its findings to different settings or patients. However, the wrong type can reduce the sensitivity of an assay, and therefore reduce a trial's power to detect even minor effects of treatment.

Several studies have attempted to classify pragmatic trials using a variety of definitions and scoring methods. Schwartz and Lellouch1 have developed a framework for distinguishing between explanation-based trials that support a physiological or clinical hypothesis, and pragmatic trials that help in the selection of appropriate treatments in real-world clinical practice. The framework was comprised of nine domains assessed on a scale of 1-5, with 1 being more informative and 5 was more pragmatic. The domains included recruitment, setting up, delivery of intervention, flexible compliance and primary analysis.

The original PRECIS tool3 included similar domains and an assessment scale ranging from 1 to 5. Koppenaal and colleagues10 developed an adaptation to this assessment dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic reviews scored higher on average in most domains, but scored lower in the primary analysis domain.

This distinction in the primary analysis domains can be explained by the way most pragmatic trials approach data. Some explanatory trials, however don't. The overall score was lower for systematic reviews that were pragmatic when the domains on organisation, flexible delivery, and follow-up were combined.

It is important to note that the term "pragmatic trial" does not necessarily mean a low quality trial, and 프라그마틱 이미지 (Http://3.13.251.167/Home.Php?Mod=Space&Uid=1265311) there is an increasing rate of clinical trials (as defined by MEDLINE search, 프라그마틱 홈페이지 but this is neither specific nor sensitive) that employ the term "pragmatic" in their abstracts or titles. The use of these terms in titles and abstracts could suggest a greater awareness of the importance of pragmatism but it is unclear whether this is reflected in the contents of the articles.

Conclusions

In recent years, pragmatic trials have been increasing in popularity in research because the value of real-world evidence is becoming increasingly acknowledged. They are clinical trials randomized that compare real-world care alternatives instead of experimental treatments in development, they involve patients that are more similar to the patients who receive routine care, they employ comparisons that are commonplace in practice (e.g., existing medications) and depend on participants' self-reports of outcomes. This approach has the potential to overcome the limitations of observational studies, such as the limitations of relying on volunteers and the lack of accessibility and coding flexibility in national registries.

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, they may have some limitations that limit their reliability and generalizability. For example the participation rates in certain trials could be lower than expected due to the healthy-volunteer effect as well as financial incentives or competition for 프라그마틱 플레이 participants from other research studies (e.g. industry trials). The necessity to recruit people in a timely fashion also limits the sample size and the impact of many practical trials. In addition certain pragmatic trials do not have controls to ensure that the observed differences aren't due to biases in trial conduct.

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

Studies with high pragmatism scores are likely to have more lenient criteria for eligibility than conventional RCTs. They also have patients from a variety of hospitals. According to the authors, can make pragmatic trials more useful and applicable in everyday practice. However they do not guarantee that a trial is free of bias. Moreover, the pragmatism of a trial is not a predetermined characteristic and a pragmatic trial that doesn't contain all the characteristics of a explanatory trial can yield valuable and reliable results.