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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that facilitates research into pragmatic trials. It collects and distributes clean trial data, ratings and evaluations using PRECIS-2. This permits a variety of meta-epidemiological analyses that evaluate the effects of treatment across trials of various levels of pragmatism.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence for clinical decision-making. The term "pragmatic", however, is a word that is often used in contradiction and its definition and assessment require clarification. The purpose of pragmatic trials is to guide the practice of clinical medicine and policy decisions, not to prove a physiological or 프라그마틱 슬롯 추천 clinical hypothesis. A pragmatic study should strive to be as close as possible to actual clinical practices, including recruiting participants, setting, design, delivery and implementation of interventions, determination and analysis results, as well as primary analyses. This is a major distinction between explanatory trials, as described by Schwartz and Lellouch1 that are designed to test the hypothesis in a more thorough manner.

Studies that are truly pragmatic should be careful not to blind patients or 프라그마틱 무료스핀 healthcare professionals as this could cause bias in estimates of treatment effects. The trials that are pragmatic should also try to attract patients from a variety of health care settings, to ensure that their findings can be applied to the real world.

Finally, pragmatic trials must concentrate on outcomes that are important to patients, such as the quality of life and functional recovery. This is particularly relevant when it comes to trials that involve surgical procedures that are invasive or have potential serious adverse events. The CRASH trial29 compared a 2-page report with an electronic monitoring system for hospitalized patients suffering from chronic cardiac failure. The catheter trial28 however, used symptomatic catheter associated urinary tract infections as its primary outcome.

In addition to these aspects pragmatic trials should also reduce trial procedures and data-collection requirements to reduce costs and time commitments. Additionally pragmatic trials should try to make their results as applicable to clinical practice as possible by making sure that their primary analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).

Despite these requirements however, a large number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to misleading claims of pragmatism and the use of the term should be made more uniform. The creation of a PRECIS-2 tool that provides an objective and standardized assessment of pragmatic features is the first step.

Methods

In a practical trial, 프라그마틱 슬롯 팁 the aim is to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. Explanatory trials test hypotheses regarding the cause-effect relationship within idealised environments. Therefore, pragmatic trials could have less internal validity than explanatory trials and may be more susceptible to bias in their design, conduct and 프라그마틱 무료스핀 analysis. Despite their limitations, pragmatic research can provide valuable data for making decisions within the healthcare context.

The PRECIS-2 tool evaluates the degree of pragmatism within an RCT by assessing it on 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruit-ment organisation, flexibility: delivery and follow-up domains received high scores, however the primary outcome and the procedure for missing data fell below the pragmatic limit. This suggests that it is possible to design a trial with high-quality pragmatic features, without compromising the quality of its outcomes.

It is difficult to determine the degree of pragmatism that is present in a trial since pragmatism doesn't have a single characteristic. Some aspects of a study can be more pragmatic than other. A trial's pragmatism could be affected by modifications to the protocol or the logistics during the trial. In addition 36% of 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled, or conducted prior to licensing, and the majority were single-center. Therefore, they aren't as common and can only be described as pragmatic when their sponsors are accepting of the lack of blinding in these trials.

Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more valuable by studying subgroups of the sample. However, this often leads to unbalanced results and lower statistical power, which increases the chance of not or incorrectly detecting differences in the primary outcome. This was the case in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for covariates that differed at the time of baseline.

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

Results

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

Incorporating routine patients, the results of the trial are more easily translated into clinical practice. But pragmatic trials can be a challenge. For instance, the appropriate type of heterogeneity can help a trial to generalise its results to many different settings and patients. However, the wrong type of heterogeneity could reduce assay sensitiveness and consequently decrease the ability of a study to detect small 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 support a physiological hypothesis or clinical hypothesis, and pragmatic studies that inform the selection of appropriate treatments in the real-world clinical practice. The framework was composed of nine domains assessed on a scale of 1-5, with 1 being more lucid while 5 was more practical. The domains included recruitment setting, setting, intervention delivery with flexibility, follow-up and primary analysis.

The original PRECIS tool3 had similar domains and a scale of 1 to 5. Koppenaal et. al10 devised an adaptation of the assessment, known as the Pragmascope that was simpler to use for systematic reviews. They found that pragmatic systematic reviews had a higher average scores in the majority of domains, with lower scores in the primary analysis domain.

This distinction in the primary analysis domains can be explained by the way that most pragmatic trials analyse data. Certain explanatory trials however don't. The overall score was lower for systematic reviews that were pragmatic when the domains on organisation, flexible delivery, and follow-up were combined.

It is crucial to keep in mind that a pragmatic study should not necessarily mean a low-quality study. In fact, there is a growing number of clinical trials that use the term 'pragmatic' either in their abstracts or titles (as defined by MEDLINE, but that is neither sensitive nor precise). These terms could indicate that there is a greater understanding of pragmatism in abstracts and titles, but it isn't clear whether this is reflected in the content.

Conclusions

As the value of evidence from the real world becomes more commonplace the pragmatic trial has gained traction in research. They are clinical trials that are randomized that evaluate real-world alternatives to care rather than experimental treatments under development. They have patients that more closely mirror those treated in routine medical care, they utilize comparators which exist in routine practice (e.g. existing drugs) and depend on the self-reporting of participants about outcomes. This approach can overcome the limitations of observational research, like the biases associated with the use of volunteers and the lack of codes that vary in national registers.

Pragmatic trials offer other advantages, like the ability to use existing data sources and a greater chance of detecting significant distinctions from traditional trials. However, these trials could be prone to limitations that compromise their credibility and generalizability. The participation rates in certain trials may be lower than expected due to the health-promoting effect, financial incentives, or competition from other research studies. The need to recruit individuals in a timely manner also restricts the sample size and impact of many pragmatic trials. In addition, some pragmatic trials lack 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 RCTs published up to 2022 that self-described as pragmatic. The PRECIS-2 tool was used to evaluate pragmatism. It includes areas such as eligibility criteria, recruitment flexibility, adherence to intervention, and follow-up. They discovered 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) 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 have patients from a variety of hospitals. The authors claim that these traits can make pragmatic trials more meaningful and relevant to everyday clinical practice, however they do not guarantee that a trial conducted in a pragmatic manner is free of bias. Moreover, the pragmatism of the trial is not a fixed attribute and a pragmatic trial that does not possess all the characteristics of a explanatory trial can produce valid and useful results.