• 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 gathers and distributes clean trial data, ratings and 프라그마틱 무료체험 메타 evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses to compare treatment effect estimates across trials of different levels of pragmatism.

Background

Pragmatic studies provide real-world evidence that can be used to make clinical decisions. However, the usage of the term "pragmatic" is inconsistent and its definition and evaluation requires clarification. The purpose of pragmatic trials is to guide clinical practices and policy decisions rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as similar to actual clinical practice as is possible, including the selection of participants, setting and design, the delivery and execution of the intervention, as well as the determination and analysis of the outcomes, and primary analyses. This is a key difference from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more complete confirmation of a hypothesis.

Truely pragmatic trials should not be blind participants or the clinicians. This could lead to a bias in the estimates of the effect of treatment. Practical trials also involve patients from different health care settings to ensure that the results can be applied 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 especially important when it comes to trials that involve the use of invasive procedures or potential dangerous adverse events. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The trial with a catheter, on the other hand was based on symptomatic catheter-related urinary tract infection as its primary outcome.

In addition to these aspects pragmatic trials should reduce the requirements for data collection and trial procedures to cut costs and time commitments. In the end the aim of pragmatic trials is to make their results as relevant to actual clinical practice as is possible. This can be accomplished by ensuring that their analysis is based on the intention-to treat approach (as defined in CONSORT extensions).

Despite these guidelines, a number of RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to false claims about pragmatism, and the usage of the term should be standardized. The creation of a PRECIS-2 tool that offers an objective, standardized evaluation of pragmatic aspects is a good start.

Methods

In a practical trial it is the intention to inform clinical or policy decisions by showing how an intervention could be integrated into everyday routine care. This is different from explanatory trials that test hypotheses about the cause-effect connection in idealized situations. Therefore, pragmatic trials might be less reliable than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can provide valuable information to decision-making in 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 explanatory) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: 프라그마틱 무료체험 delivery and follow-up domains scored high scores, however, the primary outcome and the method of missing data were below the practical limit. This suggests that it is possible to design a trial using excellent pragmatic features without harming the quality of the results.

However, it's difficult to determine how pragmatic a particular trial is since pragmatism is not a binary characteristic; certain aspects of a trial may be more pragmatic than others. Moreover, protocol or logistic changes during the trial may alter its score in pragmatism. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to licensing. They also found that the majority were single-center. Thus, they are not as common and can only be described as pragmatic if their sponsors are tolerant of the absence of blinding in these trials.

A typical feature of pragmatic studies is that researchers attempt to make their findings more meaningful by analyzing subgroups of the trial sample. This can lead to unbalanced analyses with less statistical power. This increases the chance of omitting or ignoring differences in the primary outcomes. In the case of the pragmatic trials included in this meta-analysis, this was a serious issue because the secondary outcomes were not adjusted to account for variations in the baseline covariates.

Furthermore, pragmatic trials can also have challenges with respect to 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. Therefore, it is crucial to improve the quality of outcomes assessment in these trials, ideally by using national registry databases instead of relying on participants to report adverse events on the trial's database.

Results

Although the definition of pragmatism may not require that all trials be 100 100% pragmatic, there are some advantages to incorporating pragmatic components into clinical trials. These include:

Enhancing sensitivity to issues in the real world, reducing the size of studies and their costs and allowing the study results to be faster transferred into real-world clinical practice (by including routine patients). But pragmatic trials can be a challenge. For instance, the appropriate type of heterogeneity could help a study to generalize its results to different settings and patients. However the wrong kind of heterogeneity could reduce assay sensitiveness and consequently lessen the ability of a trial to detect minor treatment effects.

A variety of 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 the clinical or physiological hypothesis, and pragmatic trials that inform the selection of appropriate treatments in clinical practice. The framework consisted of nine domains that were evaluated on a scale of 1-5 with 1 being more explanatory while 5 was more practical. The domains were recruitment setting, setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The initial 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 simpler to use in systematic reviews. They found that pragmatic reviews scored higher in all domains, 프라그마틱 무료게임 but scored lower in the primary analysis domain.

This difference in the primary analysis domain could be explained by the fact that the majority of pragmatic trials analyze their data in an intention to treat method however some explanation trials do not. The overall score was lower for pragmatic systematic reviews when the domains on the organization, flexibility of delivery and follow-up were merged.

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, 프라그마틱 무료 however it is neither sensitive nor specific) that employ the term "pragmatic" in their abstracts or titles. These terms may indicate an increased understanding of pragmatism in abstracts and titles, but it's not clear whether this is evident in content.

Conclusions

As appreciation for the value of evidence from the real world becomes more widespread the pragmatic trial has gained popularity in research. They are clinical trials that are randomized that evaluate real-world alternatives to care instead of experimental treatments under development. They have patient populations that are more similar to the ones who are treated in routine medical care, they utilize comparators that are used in routine practice (e.g., existing medications) and depend on participants' self-reports of outcomes. This approach can overcome the limitations of observational research such as the biases that come with the use of volunteers as well as the insufficient availability and coding variations in national registries.

Other advantages of pragmatic trials are the ability to use existing data sources, as well as a higher chance of detecting meaningful changes than traditional trials. However, these tests could have some limitations that limit their effectiveness and generalizability. Participation rates in some trials may be lower than expected because of the healthy-volunteering effect, financial incentives or competition from other research studies. The need to recruit individuals quickly restricts the sample size and 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 RCTs that were published between 2022 and 2022 that self-described as pragmatism. They assessed pragmatism by using the PRECIS-2 tool, which includes the domains eligibility criteria as well as recruitment, flexibility in intervention adherence and follow-up. They discovered 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials with high pragmatism scores are likely to have more lenient criteria for 프라그마틱 슬롯 무료체험 eligibility than traditional RCTs. They also contain patients from a variety of hospitals. The authors claim that these characteristics can help make the pragmatic trials more relevant and relevant to everyday clinical practice, however they do not guarantee that a pragmatic trial is free of bias. The pragmatism is not a fixed characteristic and a test that doesn't have all the characteristics of an explanatory study can still produce valid and useful outcomes.