GOUTERGALLERY

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

Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that supports research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological studies to evaluate the effect of treatment on trials that have different levels of pragmatism as well as other design features.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. However, the usage of the term "pragmatic" is not uniform and its definition and evaluation requires further clarification. The purpose of pragmatic trials is to inform clinical practice and policy decisions, rather than confirm a physiological or clinical hypothesis. A pragmatic trial should try to be as close as possible to the real-world clinical practice which include the recruiting participants, setting, designing, delivery and execution of interventions, determination and analysis outcomes, and primary analysis. This is a key distinction from explanatory trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough confirmation of an idea.

Studies that are truly pragmatic should be careful not to blind patients or the clinicians, as this may cause bias in the estimation of the effects of treatment. Practical trials should also aim to enroll patients from a variety of health care settings to ensure that the results 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 involve surgical procedures that are invasive or have potentially dangerous adverse events. The CRASH trial29 compared a 2 page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The catheter trial28, on the other hand, 프라그마틱 슬롯 체험 used symptomatic catheter associated urinary tract infections as its primary outcome.

In addition to these features pragmatic trials should reduce trial procedures and data-collection requirements to reduce costs and time commitments. Finaly these trials should strive to make their findings as relevant to real-world clinical practices as possible. This can be accomplished by ensuring their primary analysis is based on the intention-to treat method (as described in CONSORT extensions).

Despite these requirements, a number of RCTs with features that challenge pragmatism have been incorrectly self-labeled pragmatic and published in journals of all kinds. This can lead to false claims of pragmaticity and the use of the term should be standardized. The development of a PRECIS-2 tool that can provide an objective, standardized assessment of pragmatic features is the first step.

Methods

In a pragmatic research study the aim is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine treatment in real-world situations. Explanatory trials test hypotheses about the cause-effect relationship within idealised settings. In this way, pragmatic trials can have a lower internal validity than studies that explain and are more susceptible to biases in their design as well as analysis and conduct. Despite their limitations, 프라그마틱 슬롯 하는법 pragmatic research can provide valuable information to make decisions in the healthcare context.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study, the recruit-ment, organization, flexibility in delivery and follow-up domains were awarded high scores, however, the primary outcome and the procedure for missing data fell below the pragmatic limit. This suggests that it is possible to design a trial with high-quality pragmatic features, without harming the quality of the results.

However, it is difficult to determine the degree of pragmatism a trial really is because the pragmatism score is not a binary quality; certain aspects of a study can be more pragmatic than others. Furthermore, logistical or protocol modifications during the course of a trial can change its score in pragmatism. Additionally, 36% of the 89 pragmatic trials discovered by Koppenaal et al were placebo-controlled, or conducted prior to licensing, and the majority were single-center. Therefore, they aren't quite as typical and can only be described as pragmatic in the event that their sponsors are supportive 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 within the trial. This can lead to unbalanced results and lower statistical power, thereby increasing the chance of not or incorrectly detecting differences in the primary outcome. This was the case in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not corrected for differences in covariates at the time of baseline.

Additionally, studies that are pragmatic may pose challenges to gathering and interpretation of safety data. This is due to the fact that adverse events are typically self-reported and are susceptible to delays, inaccuracies or coding variations. It is essential to improve the accuracy and quality of the outcomes in these trials.

Results

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

By incorporating routine patients, the trial results can be more quickly translated into clinical practice. But pragmatic trials can have disadvantages. The right type of heterogeneity for instance could allow a study to extend its findings to different patients or settings. However, the wrong type can reduce the sensitivity of an assay and, consequently, reduce a trial's power to detect minor treatment effects.

A variety of studies have attempted to categorize pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 created a framework to distinguish between research studies that prove the clinical or physiological hypothesis as well as pragmatic trials that aid in the choice of appropriate therapies in clinical practice. The framework consisted of nine domains that were scored on a 1-5 scale with 1 being more lucid while 5 was more pragmatic. The domains were recruitment, setting, intervention delivery, flexible adherence, 프라그마틱 무료 슬롯 follow-up and primary analysis.

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

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

It is important to understand that the term "pragmatic trial" does not necessarily mean a low-quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, but this is not specific nor sensitive) that employ the term "pragmatic" in their title or abstract. These terms may signal that there is a greater appreciation of pragmatism in abstracts and titles, however it's unclear if this is reflected in content.

Conclusions

As the value of evidence from the real world becomes more popular and pragmatic trials have gained momentum in research. They are randomized trials that compare real world care alternatives to new treatments that are being developed. They are conducted with populations of patients closer to those treated in regular care. This approach could help overcome the limitations of observational research, such as the biases associated with reliance on volunteers, and the limited accessibility and coding flexibility in national registry systems.

Other benefits of pragmatic trials include the ability to utilize existing data sources, and a greater likelihood of detecting meaningful changes than traditional trials. However, they may still have limitations which undermine their validity and generalizability. Participation rates in some trials could be lower than expected due to the healthy-volunteering effect, financial incentives or competition from other research studies. The need to recruit individuals in a timely fashion also restricts the sample size and the impact of many pragmatic trials. Additionally certain pragmatic trials do not have controls to ensure that the observed differences are not 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 from 2022. The PRECIS-2 tool was employed to determine the pragmatism of these trials. It covers areas such as eligibility criteria as well as recruitment flexibility, adherence to intervention, and follow-up. They found that 14 of these trials scored as highly or pragmatic sensible (i.e. scores of 5 or higher) in one or more of these domains, 프라그마틱 무료 and that the majority were single-center.

Trials with a high pragmatism rating tend to have broader eligibility criteria than traditional RCTs that have specific criteria that aren't likely to be present in the clinical environment, and they contain patients from a broad variety of hospitals. These characteristics, according to the authors, can make pragmatic trials more relevant and useful in everyday clinical. 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.