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작성자 Lynda 작성일 24-12-31 16:14 조회 3 댓글 0

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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 is a platform that collects and shares clean trial data and ratings using PRECIS-2, which allows for multiple and varied meta-epidemiological studies to compare treatment effects estimates across trials that employ different levels of pragmatism as well as other design features.

Background

Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world for clinical decision making. However, the usage of the term "pragmatic" is not consistent and its definition as well as assessment requires clarification. Pragmatic trials are designed to guide clinical practices and policy decisions rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should aim to be as close as it is to actual clinical practices that include recruiting participants, setting up, delivery and execution of interventions, determination and analysis results, as well as primary analyses. This is a key difference from explanatory trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough proof of a hypothesis.

Truly pragmatic trials should not be blind participants or clinicians. This can result in a bias in the estimates of treatment effects. The pragmatic trials also include patients from different health care settings to ensure that their results can be generalized to the real world.

Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, such as quality of life and functional recovery. This is especially important in trials that involve the use of invasive procedures or potential dangerous 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 infections as its primary outcome.

In addition to these aspects the pragmatic trial should also reduce the trial procedures and data collection requirements to reduce costs. Additionally the aim of pragmatic trials is to make their results as applicable to current clinical practices as they can. This can be accomplished by ensuring their primary analysis is based on an intention-to treat approach (as defined in CONSORT extensions).

Despite these guidelines however, a large number of RCTs with features that challenge pragmatism have been incorrectly self-labeled pragmatic and published in journals of all kinds. This can lead to false claims about pragmatism, and the use of the term should be standardised. The creation of the PRECIS-2 tool, which provides an objective standard for assessing practical features is a good initial step.

Methods

In a pragmatic trial it is the intention to inform clinical or policy decisions by demonstrating how the intervention can be implemented into routine care. This is distinct from explanation trials that test hypotheses regarding the cause-effect connection in idealized conditions. Therefore, pragmatic trials might be less reliable than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can be a valuable source of information for decisions in the context of healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatic). In this study, the domains of recruitment, organisation as well as flexibility in delivery flexible adherence, and follow-up were awarded high scores. However, the principal outcome and the method for missing data was scored below the pragmatic limit. This suggests that a trial can be designed with effective pragmatic features, without harming the quality of the trial.

It is difficult to determine the amount of pragmatism in a particular study because pragmatism is not a possess a specific characteristic. Certain aspects of a study can be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or the logistics during the trial. In addition 36% of the 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled or conducted prior to licensing, and the majority were single-center. Therefore, they aren't as common and can only be called pragmatic in the event that their sponsors are supportive of the absence of blinding in these trials.

Another common aspect of pragmatic trials is that the researchers try to make their results more meaningful by analysing subgroups of the trial sample. However, this often leads to unbalanced results and lower statistical power, thereby increasing the risk of either not detecting or misinterpreting the results of the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not corrected for differences in covariates at baseline.

Furthermore, pragmatic studies can present challenges in the collection and interpretation safety data. This is due to the fact that adverse events are usually self-reported and are susceptible to errors, delays or coding differences. It is therefore important to improve the quality of outcome ascertainment in these trials, and ideally by using national registries instead of relying on participants to report adverse events in a trial's own database.

Results

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

Increased sensitivity to real-world issues as well as reducing study size and cost as well as allowing trial results to be more quickly transferred into real-world clinical practice (by including patients from routine care). However, pragmatic trials may be a challenge. For example, the right type of heterogeneity can help a study to generalize its results to different patients and settings; however, the wrong type of heterogeneity may reduce the assay's sensitivity, and thus decrease the ability of a study to detect small treatment effects.

Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that confirm a physiological hypothesis or 라이브 카지노; linked resource site, 프라그마틱 정품인증 공식홈페이지 (sneak a peek at this website) clinical hypothesis and pragmatic studies that guide the selection of appropriate therapies in real world clinical practice. The framework was composed of nine domains that were scored on a 1-5 scale, with 1 being more informative and 5 was more pragmatic. The domains were recruitment, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis.

The initial PRECIS tool3 featured similar domains and scales from 1 to 5. Koppenaal and colleagues10 developed an adaptation to this assessment dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic systematic reviews had a higher average scores across all domains, with lower scores in the primary analysis domain.

This distinction in the analysis domain that is primary could be explained by the fact that the majority of pragmatic trials analyse their data in the intention to treat method, whereas some explanatory trials do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery and follow-up were combined.

It is important to understand that a pragmatic trial doesn't necessarily mean a low quality trial, and in fact there is an increasing rate of clinical trials (as defined by MEDLINE search, however this is not specific nor sensitive) that use the term 'pragmatic' in their abstract or title. These terms could indicate that there is a greater understanding of pragmatism in abstracts and titles, but it isn't clear if this is reflected in content.

Conclusions

As appreciation for the value of evidence from the real world becomes more widespread the pragmatic trial has gained traction in research. They are randomized studies that compare real-world alternatives to experimental treatments in development. They include patient populations more closely resembling those treated in regular care. This approach can help overcome the limitations of observational research, such as the limitations of relying on volunteers, and the limited availability and the variability of coding in national registry systems.

Pragmatic trials have other advantages, such as the ability to draw on existing data sources and a greater probability of detecting meaningful differences than traditional trials. However, they may be prone to limitations that undermine their effectiveness and generalizability. For example, participation rates in some trials could be lower than expected due to the healthy-volunteer influence and financial incentives or competition for participants from other research studies (e.g. industry trials). The need to recruit individuals in a timely fashion also reduces the size of the sample and the impact of many practical trials. Some pragmatic trials also lack controls to ensure that the observed differences aren't caused by biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatic and were published until 2022. The PRECIS-2 tool was employed to determine the degree of pragmatism. It includes domains such as eligibility criteria as well as recruitment flexibility and adherence to intervention and follow-up. They found 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 which have very specific criteria that aren't likely to be used in the clinical environment, and they comprise patients from a wide range of hospitals. The authors claim that these characteristics can help make pragmatic trials more meaningful and applicable to everyday clinical practice, however they do not necessarily guarantee that a pragmatic trial is free from bias. Furthermore, the pragmatism of trials is not a predetermined characteristic and 프라그마틱 슬롯 추천 (153.126.169.73) a pragmatic trial that does not possess all the characteristics of a explanatory trial can yield valid and useful results.

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