• 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, which allows for multiple and varied meta-epidemiological studies to evaluate the effect of treatment on trials that have different levels of pragmatism and 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 and assessment requires further clarification. The purpose of pragmatic trials is to guide clinical practices and policy choices, rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic study should strive to be as close as possible to real-world clinical practices that include recruiting participants, setting, designing, delivery and implementation of interventions, determining and analysis outcomes, and primary analysis. This is a major distinction between explanatory trials as described by Schwartz & Lellouch1 that are designed to test a hypothesis in a more thorough way.

The most pragmatic trials should not be blind participants or clinicians. This could lead to bias in the estimations of treatment effects. Pragmatic trials will also recruit patients from different healthcare settings to ensure that their results can be generalized to the real world.

Finally, pragmatic trials must focus on outcomes that matter to patients, like the quality of life and functional recovery. This is especially important 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 hospitalized patients with chronic cardiac failure. The catheter trial28, however was based on symptomatic catheter-related urinary tract infection as its primary outcome.

In addition to these features pragmatic trials should reduce the requirements for data collection and trial procedures to cut down on costs and time commitments. Finaly, pragmatic trials should aim to make their results as applicable to current clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on the intention to treat approach (as described within CONSORT extensions).

Despite these criteria, a number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and 프라그마틱 슈가러쉬 published in journals of all kinds. This could lead to false claims of pragmatism and the term's use should be standardized. The creation of a PRECIS-2 tool that offers an objective, standardized evaluation of pragmatic aspects is a first step.

Methods

In a pragmatic trial it is the intention to inform clinical or policy decisions by showing how an intervention could be incorporated into real-world routine care. This is distinct from explanation trials that test hypotheses about the causal-effect relationship in idealized settings. Therefore, pragmatic trials might have less internal validity than explanatory trials, 프라그마틱 무료 and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in the context of healthcare.

The PRECIS-2 tool evaluates the level of pragmatism that is present in an RCT by scoring it across 9 domains, 슬롯 ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruitment, organization, flexibility in delivery, flexible adherence and follow-up domains scored high scores, but the primary outcome and the method of missing data were not at the pragmatic limit. This suggests that a trial can be designed with effective pragmatic features, without compromising its quality.

It is, 프라그마틱 정품확인방법 however, difficult to assess the degree of pragmatism a trial is, since the pragmatism score is not a binary attribute; some aspects of a study can be more pragmatic than others. The pragmatism of a trial can be affected by changes to the protocol or logistics during the trial. Additionally, 36% of the 89 pragmatic trials identified by Koppenaal et al were placebo-controlled, or conducted prior to approval and a majority of them were single-center. They are not in line with the norm and are only considered pragmatic if their sponsors accept that these trials aren't blinded.

Furthermore, a common feature 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 and lower statistical power, which increases the chance of not or misinterpreting the results of the primary outcome. In the case of the pragmatic trials included in this meta-analysis, this was a major issue because the secondary outcomes weren't adjusted for variations in baseline covariates.

In addition the pragmatic trials may present challenges in the collection and 프라그마틱 정품 확인법 interpretation of safety data. This is due to the fact that adverse events are usually self-reported, and therefore are prone to delays, inaccuracies or coding errors. It is essential to improve the accuracy and quality of outcomes in these trials.

Results

While the definition of pragmatism may not require that all clinical trials be 100% pragmatist there are benefits to including pragmatic components in 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 faster implemented into clinical practice (by including patients from routine care). However, pragmatic trials may be a challenge. For instance, the right type of heterogeneity can help a trial to generalise its findings to a variety of patients and settings; however the wrong type of heterogeneity can reduce assay sensitivity and therefore reduce the power of a trial to detect minor treatment effects.

A variety of studies have attempted to categorize pragmatic trials, with various definitions and scoring systems. Schwartz and Lellouch1 created a framework for distinguishing between explanatory trials that confirm the clinical or physiological hypothesis as well as pragmatic trials that inform the choice of appropriate therapies in real-world clinical practice. The framework was comprised of nine domains that were evaluated on a scale of 1-5 which indicated that 1 was more explanatory while 5 was more pragmatic. The domains were recruitment, setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The initial PRECIS tool3 had similar domains and a scale of 1 to 5. Koppenaal and colleagues10 created an adaptation of this assessment, known as the Pragmascope which was more user-friendly to use for systematic reviews. They found that pragmatic systematic reviews had a higher average scores across all domains, with lower scores in the primary analysis domain.

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

It is important to understand that a pragmatic trial doesn't necessarily mean a low quality trial, and there is a growing number of clinical trials (as defined by MEDLINE search, however this is neither sensitive nor specific) that use the term 'pragmatic' in their title or abstract. The use of these terms in titles and abstracts may suggest a greater awareness of the importance of pragmatism, but it is unclear whether this is manifested in the contents of the articles.

Conclusions

In recent years, pragmatic trials are increasing in popularity in research because the value of real-world evidence is increasingly recognized. They are randomized clinical trials that compare real-world care alternatives rather than experimental treatments under development. They involve patients which are more closely resembling the patients who receive routine care, they use comparisons that are commonplace in practice (e.g. existing drugs), and they depend on participants' self-reports of outcomes. This method can help overcome the limitations of observational research, such as the biases that are associated with the reliance on volunteers, and the lack of the coding differences in national registry.

Other benefits of pragmatic trials include the possibility of using existing data sources, and a greater chance of detecting meaningful changes than traditional trials. However, they may have some limitations that limit their effectiveness and generalizability. The participation rates in certain trials may be lower than expected due to the health-promoting effect, financial incentives or competition from other research studies. The need to recruit individuals quickly limits the sample size and impact of many pragmatic trials. In addition certain pragmatic trials don't 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 that self-described themselves as pragmatic and were published from 2022. The PRECIS-2 tool was used to evaluate pragmatism. 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 pragmatic or highly sensible (i.e., scoring 5 or higher) in any one or more of these domains, and that the majority were single-center.

Trials that have high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also have populations from many different hospitals. These characteristics, according to the authors, can make pragmatic trials more useful and applicable in the daily practice. However, they cannot guarantee that a trial will be free of bias. Moreover, the pragmatism of trials is not a predetermined characteristic; a pragmatic trial that does not have all the characteristics of a explanatory trial can produce valuable and reliable results.