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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It gathers and distributes clean trial data, ratings and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses to compare treatment effect estimates across trials of 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 not used in a consistent manner and its definition and evaluation require further clarification. Pragmatic trials are designed to guide the practice of clinical medicine and policy decisions rather than prove a physiological or clinical hypothesis. A pragmatic study should aim to be as similar to real-world clinical practice as possible, such as its selection of participants, setting and design, the delivery and execution of the intervention, and the determination and analysis of outcomes as well as primary analysis. This is a major difference from explanatory trials (as described by Schwartz and Lellouch1) which are designed to provide more thorough confirmation of an idea.

Trials that are truly pragmatic should not attempt to blind participants or the clinicians, as this may result in distortions in estimates of the effects of treatment. Pragmatic trials should also seek to attract patients from a wide range of health care settings to ensure that their findings can be applied to the real world.

Additionally, clinical trials should concentrate on outcomes that are important to patients, like the quality of life and functional recovery. This is particularly relevant in trials that involve the use of invasive procedures or potential dangerous adverse events. 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 utilized urinary tract infections that are symptomatic of catheters as its primary outcome.

In addition to these characteristics pragmatic trials should reduce the trial's procedures and requirements for data collection to reduce costs. Additionally, pragmatic trials should seek to make their findings as applicable to real-world clinical practice as they can by making sure that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

Many RCTs which do not meet the criteria for pragmatism however, they have characteristics that are in opposition to pragmatism, have been published in journals of different types and incorrectly labeled pragmatic. This could lead to false claims of pragmatism and the use of the term should be standardised. The creation of a PRECIS-2 tool that can provide a standardized objective evaluation of the pragmatic characteristics is the first step.

Methods

In a pragmatic trial the goal is to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. Explanatory trials test hypotheses about the causal-effect relationship in idealized conditions. Therefore, pragmatic trials might have lower 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 the context of healthcare.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by assessing it across 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery and follow-up domains were awarded high scores, but the primary outcome and the method of missing data were not at the pragmatic limit. This suggests that it is possible to design a trial that has good pragmatic features without compromising the quality of its outcomes.

It is hard to determine the level of pragmatism within a specific trial since pragmatism doesn't have a binary characteristic. Some aspects of a study may be more pragmatic than other. A trial's pragmatism could be affected by changes to the protocol or logistics during the trial. In addition 36% of the 89 pragmatic trials identified by Koppenaal and colleagues were placebo-controlled or conducted prior to licensing and most were single-center. They are not in line with the usual practice and can only be considered pragmatic if their sponsors agree that the trials are not blinded.

A common feature of pragmatic research is that researchers attempt to make their findings more meaningful by studying 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. This was a problem during the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates' differences at the baseline.

Furthermore, pragmatic studies can pose difficulties in the collection and interpretation safety data. It is because adverse events are usually self-reported, and are prone to errors, delays or coding differences. Therefore, it is crucial to enhance the quality of outcomes for these trials, in particular by using national registries instead of relying on participants to report adverse events on the trial's own database.

Results

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

Increased sensitivity to real-world issues which reduces cost and size of the study, and enabling the trial results to be more quickly implemented into clinical practice (by including patients from routine care). But pragmatic trials can have their disadvantages. The right type of heterogeneity, like could allow a study to generalise its findings to many 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 even minor effects of treatment.

A number of studies have attempted to categorize pragmatic trials, using various definitions and scoring systems. Schwartz and Lellouch1 created an approach to distinguish between explanation-based trials that support a clinical or physiological hypothesis as well as pragmatic trials that aid in the selection of appropriate treatments in clinical practice. The framework was comprised of nine domains that were assessed on a scale of 1-5, with 1 being more informative and 5 was more practical. The domains included recruitment, setting up, delivery of intervention, flexible adhering to the program and primary analysis.

The initial PRECIS tool3 featured similar domains and a scale of 1 to 5. Koppenaal and colleagues10 created an adaptation of this assessment, called the Pragmascope, that was easier 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 main analysis domain could be explained by the fact that most pragmatic trials process their data in an intention to treat manner however some explanation trials do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organisation, flexible delivery and follow-up were merged.

It is important to remember that the term "pragmatic trial" does not necessarily mean a poor quality trial, and in fact there is a growing number of clinical trials (as defined by MEDLINE search, but it is neither sensitive nor specific) that use the term 'pragmatic' in their abstracts or titles. The use of these terms in abstracts and 프라그마틱 불법 무료 프라그마틱 (understanding) titles could suggest a greater awareness of the importance of pragmatism but it is unclear whether this is manifested in the contents of the articles.

Conclusions

As the importance of evidence from the real world becomes more commonplace and pragmatic trials have gained popularity in research. They are randomized studies that compare real-world care alternatives to new treatments that are being developed. They are conducted with populations of patients closer to those treated in regular care. This method can help overcome the limitations of observational research such as the biases that are associated with the use of volunteers as well as the insufficient availability and codes that vary in national registers.

Pragmatic trials also have advantages, such as the ability to draw on existing data sources, and a greater likelihood of detecting meaningful distinctions from traditional trials. However, 프라그마틱 슈가러쉬 무료체험 슬롯버프 (brewwiki.win) they may be prone to limitations that compromise their credibility and generalizability. For example the rates of participation in some trials might be lower than expected due to the healthy-volunteer effect as well as incentives to pay or compete for participants from other research studies (e.g., industry trials). Many pragmatic trials are also restricted by the necessity to enroll participants quickly. In addition, some pragmatic trials don't have controls to ensure that the observed differences aren't due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs self-labeled as pragmatic and that were published until 2022. They assessed pragmatism by using the PRECIS-2 tool that includes the domains eligibility criteria, recruitment, flexibility in adherence to interventions and follow-up. They discovered that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials that have a high pragmatism score tend to have higher eligibility criteria than traditional RCTs that have specific criteria that aren't likely to be used in clinical practice, and they contain patients from a broad variety of hospitals. The authors argue that these characteristics can help make the pragmatic trials more relevant and applicable to everyday clinical practice, however they do not guarantee that a trial using a pragmatic approach is free of bias. In addition, the pragmatism that is present in trials is not a fixed attribute A pragmatic trial that doesn't have all the characteristics of an explanatory trial can yield valuable and reliable results.