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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a free and non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological research studies to evaluate the effect of treatment on trials that employ different levels of pragmatism as well as other design features.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence for clinical decision-making. The term "pragmatic" however, is not used in a consistent manner and 프라그마틱 플레이 its definition and assessment need further clarification. The purpose of pragmatic trials is to guide clinical practice and policy decisions, not to confirm a physiological or clinical hypothesis. A pragmatic trial should strive to be as close to the real-world clinical environment as possible, including in the selection of participants, setting up and design of the intervention, its delivery and implementation of the intervention, as well as the determination and analysis of outcomes as well as primary analyses. This is a major difference between explanatory trials, as defined by Schwartz & Lellouch1, which are designed to confirm a hypothesis in a more thorough way.

Truly pragmatic trials should not blind participants or the clinicians. This could lead to bias in the estimations of the effect of treatment. Practical trials should also aim to attract patients from a wide range of health care settings, to ensure that their findings are generalizable to the real world.

Finally the focus of pragmatic trials should be on outcomes that are vital to patients, like quality of life or 프라그마틱 게임 functional recovery. This is especially important for trials involving surgical procedures that are invasive or have potential dangerous adverse events. The CRASH trial29, for example was focused on functional outcomes to compare a two-page report with an electronic system for the monitoring of patients in hospitals suffering from chronic heart failure, and the catheter trial28 focused on urinary tract infections caused by catheters as the primary outcome.

In addition to these features pragmatic trials should reduce trial procedures and data-collection requirements to cut down on costs and time commitments. Finally pragmatic trials should strive to make their findings as relevant to actual clinical practice as they can by ensuring that their primary analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Despite these requirements, a number of 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 of pragmatism and the usage of the term should be made more uniform. The creation of the PRECIS-2 tool, which offers a standard objective assessment of pragmatic characteristics, is a good first step.

Methods

In a pragmatic trial it is the intention to inform policy or 프라그마틱 사이트 clinical decisions by demonstrating how an intervention would be integrated into everyday routine care. Explanatory trials test hypotheses concerning the causal-effect relationship in idealized settings. In this way, pragmatic trials may have lower internal validity than explanation studies and be more susceptible to biases in their design as well as analysis and conduct. Despite these limitations, pragmatic trials may contribute valuable information to decisions in the context of healthcare.

The PRECIS-2 tool assesses the degree of pragmatism within an RCT by assessing it across 9 domains that range from 1 (very explicative) to 5 (very pragmatic). In this study, the recruit-ment organisation, flexibility: delivery, flexible adherence and follow-up domains were awarded high scores, however the primary outcome and the method for missing data fell below the pragmatic limit. This suggests that a trial could be designed with good pragmatic features, without compromising its quality.

It is hard to determine the degree of pragmatism within a specific trial since pragmatism doesn't have a single characteristic. Certain aspects of a study can be more pragmatic than others. A trial's pragmatism can be affected by changes to the protocol or logistics during the trial. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. Most were also single-center. Thus, they are not as common and are only pragmatic if their sponsors are tolerant of the lack of blinding in these trials.

Another common aspect of pragmatic trials is that the researchers try to make their results more valuable by studying subgroups of the trial sample. This can result in unbalanced analyses that have lower statistical power. This increases the possibility of omitting or ignoring differences in the primary outcomes. This was a problem during the meta-analysis of pragmatic trials as secondary outcomes were not adjusted for differences in covariates at the time of baseline.

In addition, pragmatic studies can pose difficulties in the collection and interpretation of safety data. This is due to the fact that adverse events are usually self-reported and prone to reporting delays, inaccuracies or coding errors. It is therefore crucial to enhance the quality of outcomes ascertainment in these trials, ideally by using national registries instead of relying on participants to report adverse events in the trial's own database.

Results

While the definition of pragmatism does not require that clinical trials be 100% pragmatic, there are benefits to including pragmatic components in trials. These include:

By incorporating routine patients, the results of trials can be more quickly translated into clinical practice. However, pragmatic trials can also have drawbacks. For instance, the appropriate type of heterogeneity can help a trial to generalise its results to different patients and settings; however the wrong kind of heterogeneity may reduce the assay's sensitivity, and thus reduce the power of a trial to detect even minor effects of treatment.

A number of studies have attempted to categorize pragmatic trials, using various definitions and 프라그마틱 scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that prove the physiological hypothesis or clinical hypothesis and pragmatic studies that inform the choice for appropriate therapies in the real-world clinical practice. Their framework included nine domains that were scored on a scale of 1 to 5, with 1 indicating more lucid and 5 suggesting more pragmatic. The domains included recruitment setting, setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et al10 devised an adaptation of this assessment dubbed the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic reviews scored higher in most domains, but scored lower in the primary analysis domain.

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

It is important to note that a pragmatic trial doesn't necessarily mean a poor quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, but it is neither sensitive nor specific) which use the word 'pragmatic' in their title or abstract. These terms could indicate an increased understanding of pragmatism in abstracts and titles, but it's unclear if this is reflected in content.

Conclusions

In recent years, pragmatic trials are increasing in popularity in research because the value of real-world evidence is becoming increasingly acknowledged. They are randomized studies that compare real-world alternatives to clinical trials in development. They involve patient populations that are more similar to those who receive treatment in regular care. This method is able to overcome the limitations of observational research like the biases associated with the use of volunteers and the lack of coding variations in national registries.

Other advantages of pragmatic trials include the ability to use existing data sources, and a higher probability of detecting significant changes than traditional trials. However, pragmatic tests may still have limitations which undermine their validity and generalizability. The participation rates in certain trials could be lower than anticipated due to the health-promoting effect, financial incentives, or competition from other research studies. The requirement to recruit participants in a timely manner also restricts the sample size and the impact of many pragmatic trials. Practical trials aren't always equipped with controls to ensure that any observed variations aren't due to biases in the trial.

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 using the PRECIS-2 tool that includes the domains eligibility criteria as well as recruitment, flexibility in adherence to interventions and follow-up. They discovered that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials that have high pragmatism scores tend to have more lenient criteria for eligibility than traditional RCTs. They also contain patients from a variety of hospitals. These characteristics, according to the authors, may make pragmatic trials more relevant and useful in the daily clinical. However they do not ensure that a study is free of bias. The pragmatism is not a fixed characteristic; a pragmatic test that doesn't have all the characteristics of an explanation study could still yield valuable and valid results.