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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a free and non-commercial open data platform and infrastructure that supports research on pragmatic trials. It gathers and distributes clean trial data, ratings, 프라그마틱 체험 이미지 (Www.ddhszz.Com) and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses to examine the effect of treatment across trials of different levels of pragmatism.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. However, the usage of the term "pragmatic" is inconsistent and its definition as well as assessment requires further clarification. The purpose of pragmatic trials is to guide clinical practice and policy decisions, rather than confirm a physiological or clinical hypothesis. A pragmatic trial should aim to be as close as it is to actual clinical practices which include the recruitment of participants, setting up, delivery and execution of interventions, determining and analysis results, as well as primary analyses. This is a major difference between explanatory trials, as defined by Schwartz & Lellouch1, which are designed to prove the hypothesis in a more thorough way.

Truly pragmatic trials should not be blind participants or the clinicians. This could lead to bias in the estimations of treatment effects. Pragmatic trials will also recruit patients from various healthcare settings to ensure that their results can be generalized to the real world.

Finally, pragmatic trials must be focused on outcomes that matter to patients, such as quality of life and functional recovery. This is particularly relevant in trials that involve invasive procedures or those with potentially dangerous adverse events. The CRASH trial29, for example, focused on functional outcomes to evaluate a two-page case report with an electronic system for the monitoring of patients admitted to hospitals with chronic heart failure, and the catheter trial28 used symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these characteristics pragmatic trials should reduce trial procedures and data-collection requirements to reduce costs and time commitments. Finally pragmatic trials should try to make their results as applicable to clinical practice as they can by ensuring 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 but have features that are in opposition to pragmatism, have been published in journals of varying types and incorrectly labeled pragmatic. This can lead to misleading claims about pragmatism, and the use of the term should be standardized. The development of the PRECIS-2 tool, which offers an objective and standard assessment of practical features, is a good first step.

Methods

In a pragmatic study, the aim is to inform policy or clinical decisions by showing how an intervention could be incorporated into real-world routine care. Explanatory trials test hypotheses concerning the causal-effect relationship in idealized environments. 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 decision-making in the context of healthcare.

The PRECIS-2 tool assesses the degree of pragmatism within an RCT by assessing it on 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery and follow-up domains were awarded high scores, however the primary outcome and the procedure for missing data fell below the limit of practicality. This indicates that a trial can be designed with well-thought-out practical features, yet not compromising its quality.

It is difficult to determine the degree of pragmatism in a particular trial because pragmatism does not have a single attribute. Some aspects of a study may 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 the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or conducted prior to licensing and most were single-center. They are not in line with the norm, and can only be considered pragmatic if their sponsors agree that the trials are not blinded.

A typical feature of pragmatic research is that researchers attempt to make their findings more meaningful by analyzing subgroups within 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 trials included in this meta-analysis, this was a major issue because the secondary outcomes weren't adjusted for the differences in the baseline covariates.

In addition, pragmatic studies can pose difficulties in the collection and interpretation safety data. This is due to the fact that adverse events are generally reported by the participants themselves and are susceptible to reporting delays, inaccuracies, or coding variations. Therefore, it is 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 on a trial's own database.

Results

Although the definition of pragmatism may not require that all trials are 100% pragmatic, there are advantages of including pragmatic elements in clinical trials. These include:

Increasing sensitivity to real-world issues as well as reducing the size of studies and their costs as well as allowing trial results to be more quickly translated into actual clinical practice (by including patients who are routinely treated). However, pragmatic trials may also have disadvantages. The right kind of heterogeneity, for example, can help a study expand its findings to different settings or patients. However the wrong kind of heterogeneity can decrease the sensitivity of the test and thus lessen the power of a trial to detect minor treatment effects.

A variety of studies have attempted to categorize pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework that can distinguish between explanatory studies that confirm a physiological or clinical hypothesis and pragmatic studies that help inform the selection of appropriate treatments in clinical practice. Their framework comprised 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 프라그마틱 슬롯 환수율 무료체험 슬롯버프 (Recommended Browsing) primary analysis.

The original PRECIS tool3 was an adapted version of the PRECIS tool3 that was based on the same scale and domains. Koppenaal et al10 devised an adaptation of this assessment, dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.

This distinction in the primary analysis domain could be explained by the fact that most pragmatic trials process their data in an intention to treat way however some explanation trials do not. The overall score for pragmatic systematic reviews was lower when the domains of management, flexible delivery and follow-up were merged.

It is important to remember that a pragmatic trial does not necessarily mean a low-quality trial, and in fact there is a growing number of clinical trials (as defined by MEDLINE search, but this is not specific or sensitive) which use the word "pragmatic" in their abstracts or titles. The use of these terms in titles and abstracts may suggest a greater awareness of the importance of pragmatism however, it is not clear if this is manifested in the content of the articles.

Conclusions

As the importance of evidence from the real world becomes more commonplace and pragmatic trials have gained traction in research. They are randomized trials that evaluate real-world care alternatives to experimental treatments in development. They are conducted with populations of patients closer to those treated in regular medical care. This approach can overcome the limitations of observational research such as the biases that come with the use of volunteers as well as the insufficient availability and coding variations in national registries.

Pragmatic trials offer other advantages, such as the ability to leverage existing data sources and a greater likelihood of detecting meaningful differences from traditional trials. However, these tests could be prone to limitations that undermine their effectiveness and generalizability. The participation rates in certain trials may be lower than expected because of the healthy-volunteering effect, financial incentives, or competition from other research studies. The need to recruit individuals in a timely manner also reduces the size of the sample and the impact of many pragmatic trials. In addition, some pragmatic trials lack 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 48 RCTs that self-described themselves as pragmatic and were published from 2022. They evaluated pragmatism using the PRECIS-2 tool that includes the domains eligibility criteria and recruitment criteria, as well as flexibility in adherence to interventions and follow-up. They found that 14 of these trials scored pragmatic or highly sensible (i.e. scores of 5 or higher) in one or more of these domains, and that the majority of them were single-center.

Trials with a high pragmatism rating tend to have higher eligibility criteria than traditional RCTs that have specific criteria that are not likely to be present in the clinical environment, and they include populations from a wide range of hospitals. The authors argue that these characteristics could make pragmatic trials more meaningful and useful for everyday clinical practice, however they do not guarantee that a pragmatic trial is free of bias. The pragmatism characteristic is not a fixed attribute; a pragmatic test that does not have all the characteristics of an explicative study could still yield valid and useful outcomes.