코엔원

• 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 that compare treatment effects estimates across trials with different levels of pragmatism, as well as other design features.

Background

Pragmatic trials are increasingly recognized as providing real-world evidence for clinical decision-making. The term "pragmatic", however, is not used in a consistent manner and its definition and measurement require further clarification. The purpose of pragmatic trials is to guide clinical practices and policy decisions, not to verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should also strive to be as close to the real-world clinical environment as possible, such as its recruitment of participants, setting and design of the intervention, its delivery and implementation of the intervention, and the determination and analysis of outcomes and primary analyses. This is a significant difference between explanatory trials as described by Schwartz and Lellouch1 which are designed to confirm a hypothesis in a more thorough manner.

Truly pragmatic trials should not conceal participants or the clinicians. This can lead to an overestimation of the effects of treatment. Practical trials also involve patients from various health care settings to ensure that the outcomes can be compared to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are important for patients, such as quality of life or functional recovery. This is particularly relevant when trials involve the use of invasive procedures or could have dangerous adverse consequences. The CRASH trial29, for instance was focused on functional outcomes to evaluate a two-page case report with an electronic system for monitoring of patients admitted to hospitals with chronic heart failure. In addition, the catheter trial28 utilized urinary tract infections caused by catheters as its primary outcome.

In addition to these aspects, pragmatic trials should minimize the requirements for data collection and trial procedures to cut down on costs and time commitments. Additionally 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 primary analysis is based on an intention-to treat method (as described within CONSORT extensions).

Many RCTs that don't meet the criteria for pragmatism however, they have characteristics that are contrary to pragmatism have been published in journals of different types and incorrectly labeled as pragmatic. This can result in misleading claims of pragmaticity and the use of the term should be standardized. The creation of a PRECIS-2 tool that offers a standardized objective evaluation of the pragmatic characteristics is a good start.

Methods

In a pragmatic trial the goal is to inform clinical or policy decisions by demonstrating how an intervention would be incorporated into real-world routine care. This is different from explanatory trials, which test hypotheses about the cause-effect relationship in idealised situations. Therefore, pragmatic trials could have lower internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct, and analysis. Despite their limitations, pragmatic studies can be a valuable source of information for decision-making within the context of healthcare.

The PRECIS-2 tool assesses the degree of pragmatism in an RCT by assessing it on 9 domains that range from 1 (very explanatory) to 5 (very pragmatic). In this study the areas of recruitment, organization and flexibility in delivery, flexible adherence, and follow-up received high scores. However, the primary outcome and the method for missing data scored below the pragmatic limit. This suggests that a trial can be designed with good practical features, but without compromising its quality.

It is hard to determine the level of pragmatism within a specific trial since pragmatism doesn't have a single attribute. Certain aspects of a study may be more pragmatic than others. Moreover, protocol or logistic modifications made during a trial can change its score on pragmatism. 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. Thus, they are not quite as typical and can only be described as pragmatic in the event that their sponsors are supportive of the absence of blinding in these trials.

A common aspect of pragmatic studies is that researchers attempt to make their findings more meaningful by studying subgroups within the trial. This can lead to unbalanced comparisons and lower statistical power, which increases the risk of either not detecting or misinterpreting differences in the primary outcome. This was the case in the meta-analysis of pragmatic trials as secondary outcomes were not corrected for covariates' differences at the baseline.

Additionally, studies that are pragmatic can pose difficulties in the collection and interpretation safety data. This is due to the fact that adverse events tend to be self-reported, and therefore are prone to errors, delays 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 trials are 100% pragmatic, there are advantages to incorporating pragmatic components into clinical trials. These include:

Enhancing sensitivity to issues in the real world which reduces the size of studies and their costs and allowing the study results to be faster translated into actual clinical practice (by including patients from routine care). However, 프라그마틱 정품인증 사이트 (vuf.Minagricultura.gov.Co) pragmatic trials may be a challenge. The right type of heterogeneity for instance could allow a study to expand its findings to different patients or settings. However the wrong type of heterogeneity could reduce the sensitivity of an assay and, consequently, decrease the ability of a study to detect minor treatment effects.

Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 created a framework to distinguish between explanation-based trials that support the clinical or physiological hypothesis, and pragmatic trials that help in the choice of appropriate therapies in the real-world clinical setting. Their framework comprised nine domains, each scoring on a scale ranging from 1-5, with 1 indicating more lucid and 5 indicating more practical. The domains covered recruitment, setting up, delivery of intervention, flex 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 et. al10 devised an adaptation of the assessment, called the Pragmascope which was more user-friendly to use for systematic reviews. They discovered that pragmatic reviews scored higher on average across all domains, however they scored lower in the primary analysis domain.

This difference in the primary analysis domain could be due to the fact that the majority of pragmatic trials analyse their data in an intention to treat method while some explanation trials do not. The overall score for systematic reviews that were pragmatic was lower when the domains of organization, flexible delivery, and following-up were combined.

It is important to note that the term "pragmatic trial" does not necessarily mean a poor quality trial, and indeed there is a growing number of clinical trials (as defined by MEDLINE search, but it is neither sensitive nor specific) that employ the term '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 manifested in the content of the articles.

Conclusions

As appreciation for the value of real-world evidence grows popular, pragmatic trials have gained momentum in research. They are randomized trials that evaluate real-world alternatives to experimental treatments in development. They involve patient populations closer to those treated in regular medical care. This approach can overcome the limitations of observational research such as the biases that are associated with the use of volunteers and the limited availability and codes that vary in national registers.

Other benefits of pragmatic trials include the possibility of using existing data sources, and a higher probability of detecting significant changes than traditional trials. However, pragmatic tests may be prone to limitations that undermine their effectiveness and generalizability. For instance, participation rates in some trials could be lower than anticipated due to the healthy-volunteer effect as well as incentives to pay or compete for participants from other research studies (e.g., industry trials). The requirement to recruit participants quickly limits the sample size and impact of many pragmatic trials. In addition some 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 published up to 2022 that self-described themselves as pragmatic. The PRECIS-2 tool was employed to evaluate the pragmatism of these trials. It covers areas such as eligibility criteria and flexibility in recruitment, adherence to intervention, and follow-up. They found 14 trials scored highly pragmatic or 프라그마틱 슬롯 하는법 pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs, which include very specific criteria that are unlikely to be found in clinical practice, and they include populations from a wide variety of hospitals. The authors suggest that these traits can make the pragmatic trials more relevant and 프라그마틱 useful for everyday clinical practice, however they don't necessarily mean that a trial using a pragmatic approach is free from bias. The pragmatism characteristic is not a fixed characteristic and a test that does not possess all the characteristics of an explanatory study can still produce valuable and valid results.