• 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 is a platform that collects and shares clean trial data and ratings using PRECIS-2, allowing for multiple and diverse meta-epidemiological research studies to evaluate the effect of treatment on trials with different levels of pragmatism and other design features.

Background

Pragmatic trials are increasingly acknowledged as providing evidence from the real world to support 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 policy and clinical practice decisions, rather than confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should try to be as close as it is to the real-world clinical practice that include recruitment of participants, setting up, delivery and execution of interventions, determination and analysis outcomes, and primary analysis. This is a significant difference between explanatory trials, as defined by Schwartz & Lellouch1 that are designed to test the hypothesis in a more thorough way.

The trials that are truly pragmatic must not attempt to blind participants or clinicians, as this may lead to bias in the estimation of the effect of treatment. Pragmatic trials will also recruit patients from different health care settings to ensure that their results can be generalized to the real world.

Furthermore, trials that are pragmatic must focus on outcomes that matter to patients, such as quality of life and functional recovery. This is particularly important for trials involving invasive procedures or those with potential serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The catheter trial28, on the other hand was based on symptomatic catheter-related urinary tract infection as the primary outcome.

In addition to these characteristics, pragmatic trials should minimize the procedures for conducting trials and requirements for data collection to cut down on costs and time commitments. Finaly these trials should strive to make their results as applicable to current 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, many RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all types. This can lead to false claims about pragmatism, and the term's use should be standardised. The development of the PRECIS-2 tool, 프라그마틱 무료스핀 which offers an objective and standard assessment of practical features is a good initial step.

Methods

In a practical study the aim is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine care in real-world contexts. This is distinct from explanation trials, which test hypotheses about the causal-effect relationship in idealized settings. Therefore, pragmatic trials might have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials may provide valuable information to decision-making in healthcare.

The PRECIS-2 tool measures the degree of pragmatism in an RCT by assessing it on 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruitment, organization, flexibility in delivery, flexible adherence and follow-up domains were awarded high scores, 프라그마틱 무료스핀 but the primary outcome and the method of missing data fell below the practical limit. This suggests that it is possible to design a trial that has high-quality pragmatic features, without harming the quality of the outcomes.

It is difficult to determine the level of pragmatism within a specific trial since pragmatism doesn't possess a specific characteristic. Some aspects of a research 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 89 pragmatic trials identified by Koppenaal and co. were placebo-controlled or conducted before approval and a majority of them were single-center. They are not close to the standard practice, and can only be referred to as pragmatic if the sponsors agree that these trials are not blinded.

A typical feature of pragmatic studies is that researchers attempt to make their findings more meaningful by analyzing subgroups within 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. This was the case in the meta-analysis of pragmatic trials because secondary outcomes were not corrected for covariates that differed at baseline.

Additionally, pragmatic trials can also be a challenge in the collection and interpretation of safety data. This is because adverse events are generally reported by the participants themselves and are prone to reporting delays, inaccuracies or coding deviations. It is therefore crucial to enhance the quality of outcomes ascertainment in these trials, and ideally by using national registries rather than relying on participants to report adverse events in the trial's database.

Results

While the definition of pragmatism does not mean that trials must be 100 percent pragmatic, there are advantages of including pragmatic elements in clinical trials. These include:

By incorporating routine patients, the results of trials can be more quickly translated into clinical practice. However, pragmatic trials have their disadvantages. The right amount of heterogeneity for instance could help a study expand its findings to different settings or patients. However the wrong kind of heterogeneity can reduce the sensitivity of an assay, and therefore reduce a trial's power to detect small treatment effects.

A variety of studies have attempted to classify pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework for distinguishing between research studies that prove a clinical or physiological hypothesis, and pragmatic trials that inform the selection of appropriate therapies in the real-world clinical setting. The framework was comprised of nine domains assessed on a scale of 1-5 with 1 being more lucid while 5 being more pragmatic. The domains included recruitment of intervention, setting up, delivery of intervention, flexible adherence and primary analysis.

The original PRECIS tool3 included similar domains and an assessment scale ranging from 1 to 5. Koppenaal et al10 devised an adaptation to this assessment called the Pragmascope that was simpler to use in systematic reviews. They found that pragmatic reviews scored higher on average across all domains, however they scored lower in the primary analysis domain.

This difference in the main analysis domain could be explained by the fact that the majority of pragmatic trials process their data in the intention to treat method, whereas some explanatory trials do not. The overall score for pragmatic systematic reviews was lower when the domains of organization, flexible delivery, and following-up were combined.

It is important to understand that a pragmatic trial does not necessarily mean a low quality trial, and indeed there is an increasing number of clinical trials (as defined by MEDLINE search, however this is neither sensitive nor specific) that employ the term 'pragmatic' in their abstracts or titles. These terms could indicate that there is a greater awareness of pragmatism within titles and abstracts, but it's not clear whether this is evident in content.

Conclusions

In recent years, pragmatic trials are becoming more popular in research as the importance of real-world evidence is increasingly recognized. They are randomized studies that compare real-world alternatives to new treatments that are being developed. They involve patient populations more closely resembling those treated in regular medical care. This approach can overcome the limitations of observational research, like the biases that are associated with the reliance on volunteers and the limited availability and codes that vary in national registers.

Pragmatic trials offer other advantages, such as the ability to leverage existing data sources and a greater probability of detecting meaningful differences from traditional trials. However, 프라그마틱 슬롯 추천 they may have some limitations that limit their validity and generalizability. The participation rates in certain trials may be lower than anticipated because of the healthy-volunteering effect, financial incentives, or competition from other research studies. The necessity to recruit people quickly restricts the sample size and the impact of many pragmatic trials. Practical trials aren't always equipped with controls to ensure that observed differences aren't caused by biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described themselves as pragmatic. They assessed pragmatism by using the PRECIS-2 tool, which includes the eligibility criteria for domains, recruitment, flexibility in adherence to interventions, and follow-up. They discovered that 14 trials scored highly pragmatic or 프라그마틱 슬롯 하는법 pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Studies with high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also contain patients from a variety of hospitals. The authors suggest that these characteristics could make pragmatic trials more meaningful and useful for daily practice, but they don't necessarily mean that a trial using a pragmatic approach is free from bias. The pragmatism is not a definite characteristic; a pragmatic test that does not possess all the characteristics of an explanatory study could still yield valuable and valid results.