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

Pragmatic Free Trial Meta

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

Background

Pragmatic trials are increasingly recognized as providing real-world evidence to support clinical decision-making. However, the use of the term "pragmatic" is not uniform and its definition as well as assessment requires further clarification. The purpose of pragmatic trials is 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 similar to the real-world clinical environment as possible, such as its recruitment of participants, setting up and design of the intervention, its delivery and execution of the intervention, as well as the determination and analysis of the outcomes, and primary analysis. This is a major difference between explanatory trials, as described by Schwartz & Lellouch1, which are designed to confirm a hypothesis in a more thorough manner.

Trials that are truly pragmatic should avoid attempting to blind participants or clinicians in order to cause bias in the estimation of treatment effects. The trials that are pragmatic should also try to enroll patients from a wide range of health care settings, to ensure that their findings can be compared to the real world.

Finally the focus of pragmatic trials should be on outcomes that are crucial for 프라그마틱 정품확인방법 patients, such as quality of life or functional recovery. This is especially important for trials involving invasive procedures or those with potentially dangerous adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The catheter trial28, on the other hand, used symptomatic catheter associated urinary tract infection as its primary outcome.

In addition to these aspects pragmatic trials should also reduce the procedures for conducting trials and requirements for data collection to cut costs and time commitments. Additionally, pragmatic trials should aim to make their results as relevant to real-world clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on the intention-to treat method (as defined in CONSORT extensions).

Despite these requirements, a number of RCTs with features that defy the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all kinds. This can lead to false claims of pragmatism and the usage of the term must be standardized. The development of a PRECIS-2 tool that provides an objective, standardized evaluation of pragmatic aspects is a first step.

Methods

In a pragmatic study, the goal is to inform policy or clinical decisions by demonstrating how an intervention could be integrated into routine treatment in real-world settings. This differs from explanation trials that test hypotheses about the cause-effect connection in idealized conditions. In this way, pragmatic trials can have a lower internal validity than explanation studies and are more susceptible to biases in their design as well as analysis and conduct. Despite their limitations, pragmatic studies can be a valuable source of information for decision-making within the healthcare context.

The PRECIS-2 tool assesses the degree of pragmatism in an RCT by scoring it across 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study the domains of recruitment, organisation, flexibility in delivery, flexible adherence and 프라그마틱 슬롯체험 follow-up scored high. However, the main outcome and the method for missing data were scored below the practical limit. This suggests that it is possible to design a trial that has good pragmatic features without harming the quality of the outcomes.

However, it is difficult to determine the degree of pragmatism a trial is, since the pragmatism score is not a binary characteristic; certain aspects of a study can be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or the logistics during the trial. In addition, 36% of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled, 프라그마틱 슬롯 사이트 or conducted prior to approval and a majority of them were single-center. Thus, they are not as common and can only be called pragmatic if their sponsors are tolerant of the lack of blinding in such trials.

A typical feature of pragmatic studies is that researchers attempt to make their findings more meaningful by studying subgroups of the trial sample. This can result in unbalanced analyses that have less statistical power. This increases the chance of omitting or misinterpreting differences in the primary outcomes. In the instance of the pragmatic trials that were included in this meta-analysis this was a major issue since the secondary outcomes were not adjusted for the differences in baseline covariates.

Additionally practical trials can present challenges in the collection and interpretation of safety data. This is due to the fact that adverse events are usually self-reported, and are prone to delays, inaccuracies or coding errors. It is essential to improve the quality and accuracy of the outcomes in these trials.

Results

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

Enhancing sensitivity to issues in the real world, reducing cost and size of the study as well as allowing trial results to be faster transferred into real-world clinical practice (by including patients who are routinely treated). However, pragmatic studies can also have drawbacks. 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 assay sensitivity and, consequently, lessen the power of a trial to detect small treatment effects.

A number of studies have attempted to categorize pragmatic trials with a variety of definitions and scoring systems. Schwartz and Lellouch1 have developed an approach to distinguish between explanation-based trials that support a physiological or clinical hypothesis, and pragmatic trials that help in the selection of appropriate therapies in clinical practice. The framework was comprised of nine domains, each scoring on a scale ranging from 1 to 5, with 1 indicating more explanatory and 5 indicating more pragmatic. The domains covered recruitment and setting up, the delivery of intervention, flex compliance and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal et. al10 devised an adaptation of the assessment, dubbed the Pragmascope which was more user-friendly to use for systematic reviews. They discovered that pragmatic reviews scored higher across all domains, however they scored lower in the primary analysis domain.

This distinction in the analysis domain that is primary could be explained by the fact that the majority of pragmatic trials process their data in the intention to treat manner however some explanation trials 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 low quality trial, and in fact there is an increasing number of clinical trials (as defined by MEDLINE search, however this is not specific or sensitive) which use the word "pragmatic" in their abstract or title. The use of these terms in abstracts and titles may suggest a greater awareness of the importance of pragmatism, but it isn't clear if this is reflected in the contents of the articles.

Conclusions

In recent years, pragmatic trials have been increasing in popularity in research because the importance of real-world evidence is increasingly recognized. They are randomized studies that compare real-world alternatives to new treatments that are being developed. They involve patient populations more closely resembling those treated in regular care. This method has the potential to overcome the limitations of observational studies that are prone to biases that arise from relying on volunteers, and the limited availability and the variability of coding in national registry systems.

Other benefits of pragmatic trials include the possibility of using existing data sources, as well as a higher probability of detecting significant changes than traditional trials. However, pragmatic trials may have some limitations that limit their credibility and generalizability. For instance the participation rates in certain trials may be lower than expected due to the healthy-volunteer effect and financial incentives or competition for participants from other research studies (e.g. industry trials). A lot of pragmatic trials are limited by the need to recruit participants on time. Certain pragmatic trials lack controls to ensure that observed differences aren't due to biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described themselves as pragmatic. The PRECIS-2 tool was used to determine the degree of pragmatism. It covers areas such as eligibility criteria as well as recruitment flexibility as well as adherence to interventions and follow-up. They discovered that 14 of the trials scored pragmatic or highly practical (i.e., 프라그마틱 공식홈페이지 scoring 5 or higher) in one or more of these domains, and that the majority of them were single-center.

Trials that have a high pragmatism score tend to have higher eligibility criteria than traditional RCTs, which include very specific criteria that aren't likely to be present in the clinical setting, and contain patients from a broad variety of hospitals. The authors argue that these characteristics can help make the pragmatic trials more relevant and relevant to daily practice, but they don't necessarily mean that a trial conducted in a pragmatic manner is completely free of bias. The pragmatism is not a definite characteristic the test that does not possess all the characteristics of an explanatory study can still produce valuable and valid results.