• 목록
• 답변
• 글쓰기
• 게시판 리스트 옵션
  • 수정
  • 삭제

Pragmatic Free Trial Meta

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

Background

Pragmatic trials are increasingly acknowledged as providing evidence from the real world for clinical decision-making. However, the usage of the term "pragmatic" is not uniform and its definition and assessment requires clarification. Pragmatic trials must be designed to guide clinical practice and policy decisions, rather than to prove an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should aim to be as close as is possible to the real-world clinical practice, including recruiting participants, setting, design, delivery and implementation of interventions, determination and analysis outcomes, and primary analysis. This is a major distinction from explanatory trials (as described by Schwartz and Lellouch1) which are intended to provide a more complete confirmation of a hypothesis.

Truly pragmatic trials should not be blind participants or the clinicians. This can lead to bias in the estimations of the effects of treatment. Practical trials also involve patients from various health care settings to ensure that their outcomes can be compared to the real world.

Finally studies that are pragmatic should focus on outcomes that are vital for patients, such as quality of life or functional recovery. This is especially important when trials involve the use of invasive procedures or could have harmful adverse consequences. The CRASH trial29 compared a 2-page report with an electronic monitoring system for hospitalized patients suffering from chronic cardiac failure. The catheter trial28 however was based on symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these characteristics, pragmatic trials should minimize the procedures for conducting trials and requirements for data collection to reduce costs. Finally pragmatic trials should strive to make their findings as relevant to actual clinical practice as is possible by making sure that their primary method of analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

Despite these requirements, a number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and 프라그마틱 데모 published in journals of all kinds. This can lead to false claims of pragmatism, and the use of the term must be standardized. The creation of a PRECIS-2 tool that can provide an objective, standardized evaluation of pragmatic aspects is a first step.

Methods

In a pragmatic trial, the aim is to inform clinical or policy decisions by showing how an intervention could be incorporated into real-world routine care. Explanatory trials test hypotheses about the cause-effect relation within idealized conditions. Consequently, pragmatic trials may be less reliable than explanatory trials and may be more susceptible to bias in their design, conduct, and analysis. Despite their limitations, pragmatic research can provide valuable information for 프라그마틱 슬롯 무료 decision-making within the context of healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study, the recruitment, organization, flexibility in delivery and follow-up domains received high scores, however, the primary outcome and the method of missing data were not at the pragmatic limit. This suggests that it is possible to design a trial using excellent pragmatic features without harming the quality of the results.

It is hard to determine the level of pragmatism in a particular trial because pragmatism does not possess a specific characteristic. Certain aspects of a study may be more pragmatic than others. Moreover, protocol or logistic modifications made during an experiment can alter its score in pragmatism. Koppenaal and colleagues found that 36% of the 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. Most were also single-center. They are not close to the norm, and can only be called pragmatic if the sponsors agree that these trials are not blinded.

A common feature of pragmatic studies is that researchers try to make their findings more meaningful by studying subgroups within the trial. This can lead to unbalanced analyses that have less statistical power. This increases the chance of omitting or misinterpreting differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis, this was a major issue since the secondary outcomes were not adjusted to account for variations in the baseline covariates.

In addition, pragmatic studies can present challenges in the collection and interpretation safety data. This is due to the fact that adverse events are usually self-reported, and are prone to delays, errors or coding variations. Therefore, it is crucial to improve the quality of outcomes ascertainment in these trials, in particular by using national registries rather than relying on participants to report adverse events in the trial's own database.

Results

While the definition of pragmatism may not require that all clinical trials are 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 study size and cost, and enabling the trial results to be more quickly implemented into clinical practice (by including patients from routine care). However, pragmatic studies can also have drawbacks. The right amount of heterogeneity for instance could allow a study to extend its findings to different patients or settings. However the wrong kind of heterogeneity can reduce the sensitivity of an assay and thus reduce a trial's power to detect even minor effects of treatment.

A number of studies have attempted to categorize pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 developed a framework for distinguishing between explanatory trials that confirm a physiological or clinical hypothesis, and pragmatic trials that aid in the selection of appropriate treatments in real-world clinical practice. Their framework included nine domains that were scored on a scale of 1-5, with 1 indicating more lucid and 5 indicating more practical. The domains included recruitment setting, setting, intervention delivery and 무료슬롯 프라그마틱 follow-up, as well as flexible adherence and primary analysis.

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

This difference in the analysis domain that is primary could be due to the fact that the majority of pragmatic trials process their data in the intention to treat way however some explanation trials do not. The overall score was lower for pragmatic systematic reviews when the domains of organisation, flexible delivery, and follow-up were combined.

It is important to remember that a study that is pragmatic does not mean a low-quality trial. In fact, there are increasing numbers of clinical trials which use the word 'pragmatic,' either in their abstracts or titles (as defined by MEDLINE but which is neither sensitive nor precise). The use of these words in abstracts and titles may suggest a greater awareness of the importance of pragmatism, but it is unclear whether this is evident in the content of the articles.

Conclusions

In recent years, pragmatic trials have been becoming more popular in research as the value of real-world evidence is becoming increasingly acknowledged. They are randomized trials that evaluate real-world treatment options with experimental treatments in development. They include patient populations closer to those treated in regular care. This method can help overcome the limitations of observational research like the biases that are associated with the reliance on volunteers as well as the insufficient availability and the coding differences in national registry.

Other advantages of pragmatic trials include the ability to use existing data sources, as well as a higher chance of detecting meaningful changes than traditional trials. However, they may have some limitations that limit their validity and generalizability. The participation rates in certain trials could be lower than anticipated due to the health-promoting effect, financial incentives or competition from other research studies. The need to recruit individuals in a timely manner also limits the sample size and impact of many pragmatic trials. Practical trials aren't always equipped with controls to ensure that the observed differences aren't caused by biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatist and published up to 2022. The PRECIS-2 tool was used to assess the degree of pragmatism. It covers areas like eligibility criteria and flexibility in recruitment as well as adherence to interventions and follow-up. They found that 14 of these trials scored as highly or 프라그마틱 불법 pragmatic sensible (i.e., scoring 5 or more) in one or more of these domains and that the majority of these were single-center.

Studies with high pragmatism scores tend to have more lenient criteria for eligibility than conventional RCTs. They also have patients from a variety of hospitals. The authors argue that these characteristics could make the pragmatic trials more relevant and applicable to everyday clinical practice, however they do not necessarily guarantee that a trial using a pragmatic approach is free of bias. The pragmatism is not a definite characteristic and a test that doesn't have all the characteristics of an explanation study may still yield valuable and valid results.