• 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 distributes cleaned trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses that compare treatment effect estimates across trials of different levels of pragmatism.

Background

Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world for clinical decision-making. The term "pragmatic", however, is not used in a consistent manner and its definition and measurement need further clarification. Pragmatic trials should be designed to inform clinical practice and policy decisions, not to confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic study should strive to be as close to real-world clinical practice as is possible, including the recruitment of participants, setting and design, the delivery and execution of the intervention, as well as the determination and analysis of outcomes and primary analysis. This is a major difference from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more thorough confirmation of the hypothesis.

Truely pragmatic trials should not conceal participants or clinicians. This can result in bias in the estimations of the effects of treatment. Practical trials should also aim to recruit patients from a wide range of health care settings, to ensure that their findings are generalizable to the real world.

Additionally, clinical trials should concentrate on outcomes that are important to patients, such as the quality of life and 프라그마틱 홈페이지 정품인증, wikimapia.Org, functional recovery. This is especially important when it comes to trials that involve invasive procedures or those with potential serious adverse events. The CRASH trial29, for example was focused on functional outcomes to evaluate a two-page case report with an electronic system for monitoring of hospitalized patients with chronic heart failure. Similarly, the catheter trial28 utilized urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these characteristics, pragmatic trials should minimize the requirements for data collection and trial procedures to cut down on costs and time commitments. Finally pragmatic trials should strive to make their findings as applicable to clinical practice as they can by making sure that their primary method of analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs which do not meet the criteria for pragmatism, but have features that are in opposition to pragmatism, have been published in journals of different types and incorrectly labeled as pragmatic. This could lead to misleading claims of pragmaticity and the usage of the term must be standardized. The development of the PRECIS-2 tool, which provides a standard objective assessment of practical features is a good initial step.

Methods

In a pragmatic trial, the aim is to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. This differs from explanation trials that test hypotheses regarding the cause-effect connection in idealized settings. In this way, 프라그마틱 pragmatic trials may have a lower internal validity than explanation studies and are more susceptible to biases in their design as well as analysis and conduct. Despite these limitations, pragmatic trials may provide valuable information to decisions in the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatic). In this study, the recruitment, 슬롯 organization, flexibility in delivery, flexible adherence and follow-up domains were awarded high scores, but the primary outcome and the method for missing data were below the practical limit. This suggests that a trial can be designed with effective pragmatic features, without damaging the quality.

It is, however, difficult to assess how practical a particular trial is since pragmatism is not a binary quality; certain aspects of a trial can be more pragmatic than others. A trial's pragmatism can be affected by changes to the protocol or the logistics during the trial. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. They also found that the majority were single-center. This means that they are not as common and are only pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.

A common aspect of pragmatic studies is that researchers try to make their findings more relevant by studying subgroups within the trial. This can result in unbalanced analyses that have less statistical power. This increases the chance of omitting or ignoring differences in the primary outcomes. In the instance of the pragmatic trials that were included in this meta-analysis this was a significant problem because the secondary outcomes were not adjusted to account for the differences in the baseline covariates.

Furthermore, pragmatic studies may pose challenges to collection and interpretation of safety data. This is due to the fact that adverse events tend to be self-reported, and are prone to errors, delays or coding differences. Therefore, it is crucial to improve the quality of outcome for these trials, ideally by using national registry databases instead of relying on participants to report adverse events in the trial's database.

Results

Although the definition of pragmatism doesn't require that clinical trials be 100% pragmatist there are benefits of including pragmatic elements in trials. These include:

Incorporating routine patients, the trial results can be more quickly translated into clinical practice. However, pragmatic trials may also have drawbacks. The right amount of heterogeneity for instance could help a study generalise its findings to many different settings or patients. However the wrong type of heterogeneity could reduce the sensitivity of an assay, and therefore decrease the ability of a study to detect even minor effects of treatment.

Numerous studies have attempted to categorize pragmatic trials, using various definitions and scoring systems. Schwartz and Lellouch1 created a framework to discern between explanation-based studies that prove the physiological hypothesis or clinical hypothesis and pragmatic studies that inform the selection of appropriate therapies in the real-world clinical practice. Their framework included nine domains, each scored on a scale ranging from 1 to 5, with 1 indicating more explanatory and 5 indicating more practical. The domains included recruitment, setting up, delivery of intervention, flexible adherence and primary analysis.

The original PRECIS tool3 was an adapted version of the PRECIS tool3 that was based on the same scale and domains. Koppenaal and colleagues10 developed an adaptation to this assessment, dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic systematic reviews had higher average score in most domains, but lower scores in the primary analysis domain.

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

It is important to note that a pragmatic trial doesn't necessarily mean a low-quality trial, and in fact there is a growing number of clinical trials (as defined by MEDLINE search, but this is neither specific nor sensitive) that employ the term 'pragmatic' in their title or abstract. The use of these words in abstracts and titles could suggest a greater awareness of the importance of pragmatism, but it isn't clear if this is reflected in the content of the articles.

Conclusions

As the importance of real-world evidence grows commonplace, pragmatic trials have gained momentum in research. They are randomized trials that compare real world treatment options with experimental treatments in development. They include patient populations closer to those treated in regular medical care. This approach can overcome the limitations of observational research like the biases that come with the reliance on volunteers, as well as the insufficient availability and coding variations in national registries.

Pragmatic trials have other advantages, including the ability to use existing data sources, and a greater chance of detecting significant differences from traditional trials. However, they may still have limitations which undermine their reliability and generalizability. Participation rates in some trials could be lower than anticipated due to the healthy-volunteering effect, financial incentives or competition from other research studies. Practical trials are often restricted by the need to enroll participants quickly. 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 pragmatist and published up to 2022. The PRECIS-2 tool was employed to determine the degree of pragmatism. It includes areas like eligibility criteria as well as recruitment flexibility, adherence to intervention, and follow-up. They found that 14 of these trials scored pragmatic or highly practical (i.e., scoring 5 or higher) in any one or more of these domains and that the majority of them were single-center.

Studies with high pragmatism scores tend to have more criteria for eligibility than conventional RCTs. They also have patients from a variety of hospitals. The authors claim that these traits can make pragmatic trials more effective and relevant to everyday practice, but they don't necessarily mean that a trial using a pragmatic approach is free from bias. Furthermore, the pragmatism of the trial is not a predetermined characteristic and a pragmatic trial that does not have all the characteristics of a explanatory trial may yield valid and useful results.