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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 collects and distributes clean trial data, ratings, 프라그마틱 불법 and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses to compare treatment effect estimates across trials with different levels of pragmatism.

Background

Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. The term "pragmatic" however, is used inconsistently and its definition and assessment require clarification. The purpose of pragmatic trials is to guide clinical practices and policy decisions, not to prove a physiological or clinical hypothesis. A pragmatic trial should aim to be as similar to the real-world clinical environment as possible, such as its selection of participants, setting up and design, the delivery and execution of the intervention, 프라그마틱 슈가러쉬 슬롯무료 (Letsbookmarkit.com) and the determination and analysis of outcomes as well as primary analysis. This is a major difference between explanatory trials as described by Schwartz and Lellouch1, which are designed to confirm a hypothesis in a more thorough way.

The trials that are truly pragmatic must be careful not to blind patients or clinicians, as this may result in distortions in estimates of the effect of treatment. The pragmatic trials also include patients from different healthcare settings to ensure that their results can be generalized to the real world.

Additionally, clinical trials should focus on outcomes that matter to patients, such as the quality of life and functional recovery. This is particularly relevant when trials involve invasive procedures or have potentially dangerous adverse consequences. The CRASH trial29, for instance, focused on functional outcomes to evaluate a two-page case report with an electronic system for the monitoring of hospitalized patients with chronic heart failure. In addition, the catheter trial28 used symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these features, pragmatic trials should minimize the procedures for conducting trials and data collection requirements in order to reduce costs. Additionally, pragmatic trials should aim to make their findings as applicable to current clinical practices as possible. This can be accomplished by ensuring that their analysis is based on the intention-to treat method (as described within CONSORT extensions).

Despite these guidelines however, a large number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all types. This could lead to misleading claims of pragmaticity, and the use of the term needs to be standardized. The creation of a PRECIS-2 tool that offers an objective, standardized assessment of pragmatic features is the first step.

Methods

In a pragmatic trial, the aim is to inform clinical or policy decisions by demonstrating how the intervention can be implemented into routine care. This differs from explanation trials that test hypotheses about the causal-effect relationship in idealized situations. Therefore, pragmatic trials might have less internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials may contribute valuable information to decision-making in the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study, the recruit-ment, organization, flexibility in delivery, flexible adherence and follow-up domains were awarded high scores, however, the primary outcome and the method of missing data were not at the limit of practicality. This suggests that it is possible to design a trial using excellent pragmatic features without damaging the quality of its outcomes.

It is, however, difficult to assess the degree of pragmatism a trial really is because pragmatism is not a binary attribute; some aspects of a study can be more pragmatic than others. Moreover, protocol or logistic modifications made during the trial may alter its pragmatism score. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. They also found that the majority were single-center. They are not in line with the standard practice and are only considered pragmatic if their sponsors agree that the trials are not blinded.

Furthermore, a common feature of pragmatic trials is that researchers try to make their results more meaningful by analysing subgroups of the trial sample. This can result in imbalanced analyses and less statistical power. This increases the chance of omitting or misinterpreting differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis this was a significant problem since the secondary outcomes weren't adjusted for variations in the baseline covariates.

In addition, pragmatic trials can also have challenges with respect to the gathering and interpretation of safety data. It is because adverse events tend to be self-reported, and therefore are prone to delays, inaccuracies or coding errors. It is important to increase the accuracy and quality of outcomes in these trials.

Results

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

Increased sensitivity to real-world issues which reduces the size of studies and their costs, and enabling the trial results to be more quickly transferred into real-world clinical practice (by including patients from routine care). However, pragmatic trials can also have drawbacks. The right type of heterogeneity, like, can help a study expand its findings to different settings or patients. However the wrong type of heterogeneity could reduce the sensitivity of an assay and thus reduce a trial's power to detect small treatment effects.

Many studies have attempted classify pragmatic trials using a variety of definitions and scoring methods. Schwartz and Lellouch1 created a framework to distinguish between explanatory studies that confirm a physiological hypothesis or clinical hypothesis and pragmatic studies that guide the choice for appropriate therapies in clinical practice. The framework was comprised of nine domains, 프라그마틱 정품 확인법 each scored on a scale of 1 to 5 with 1 being more informative and 5 indicating more practical. The domains covered recruitment of intervention, setting up, delivery of intervention, flexible adherence and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal et. al10 devised an adaptation of this assessment, known as the Pragmascope that was simpler 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.

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

It is crucial to keep in mind that a study that is pragmatic does not mean a low-quality trial. In fact, there are a growing number of clinical trials that employ the term 'pragmatic' either in their abstracts or titles (as defined by MEDLINE, but that is neither precise nor sensitive). The use of these terms in abstracts and titles could indicate a greater understanding of the importance of pragmatism however, it is not clear if this is evident in the contents of the articles.

Conclusions

As the value of real-world evidence becomes increasingly widespread and pragmatic trials have gained traction in research. They are randomized trials that evaluate real-world treatment options with new treatments that are being developed. They involve patient populations closer to those treated in regular medical care. This method has the potential to overcome limitations of observational studies, such as the biases that arise from relying on volunteers and the lack of availability and the variability of coding in national registry systems.

Other benefits of pragmatic trials include the possibility of using existing data sources, and a greater probability of detecting significant changes than traditional trials. However, pragmatic tests may still have limitations which undermine their effectiveness and generalizability. For instance, participation rates in some trials could be lower than anticipated due to the healthy-volunteer effect and financial incentives or competition for participants from other research studies (e.g. industry trials). A lot of pragmatic trials are restricted by the need to recruit participants on time. In addition certain pragmatic trials do not have controls to ensure that the observed differences are not due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described themselves as pragmatic. The PRECIS-2 tool was employed to evaluate the degree of pragmatism. It covers domains such as eligibility criteria as well as recruitment flexibility as well as adherence to interventions and follow-up. They discovered that 14 of these trials scored as highly or pragmatic practical (i.e. scoring 5 or more) in any one or more of these domains and that the majority of them were single-center.

Trials with a high pragmatism score tend to have broader eligibility criteria than traditional RCTs which have very specific criteria that are unlikely to be found in the clinical environment, and they contain patients from a broad variety of hospitals. The authors argue that these characteristics could make pragmatic trials more effective and applicable to everyday practice, but they do not guarantee that a pragmatic trial is free from bias. Furthermore, the pragmatism of a trial is not a predetermined characteristic and a pragmatic trial that doesn't have all the characteristics of an explanatory trial may yield valuable and reliable results.