• 목록
• 답변
• 글쓰기
• 게시판 리스트 옵션
  • 수정
  • 삭제

Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that allows research into pragmatic trials. It collects and distributes clean trial data, ratings, and evaluations using PRECIS-2. This allows for diverse meta-epidemiological studies to evaluate the effects of treatment across trials with different levels of pragmatism.

Background

Pragmatic trials are becoming more widely recognized as providing real-world evidence for clinical decision-making. However, the use of the term "pragmatic" is inconsistent and its definition and assessment requires further clarification. The purpose of pragmatic trials is to inform policy and clinical practice decisions, rather than to prove the validity of a clinical or physiological hypothesis. A pragmatic trial should try to be as close as possible to the real-world clinical practice which include the recruiting participants, setting, designing, delivery and implementation of interventions, determination and analysis results, as well as primary analyses. This is a significant difference between explanation-based trials, as described by Schwartz and Lellouch1, which are designed to prove a hypothesis in a more thorough way.

Trials that are truly pragmatic should not attempt to blind participants or clinicians in order to cause bias in the estimation of the effect of treatment. Pragmatic trials should also seek to attract patients from a variety of health care settings to ensure that the results are generalizable to the real world.

Furthermore, trials that are pragmatic must focus on outcomes that matter to patients, like the quality of life and functional recovery. This is especially important when it comes to trials that involve invasive procedures or those with potential serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The trial with a catheter, on the other hand utilized symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these characteristics the pragmatic trial should also reduce the trial's procedures and data collection requirements in order to reduce costs. Finally pragmatic trials should strive to make their findings as relevant to actual clinical practice as possible by ensuring that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

Despite these criteria, a number of RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to false claims of pragmaticity, and the use of the term should be standardized. The creation of the PRECIS-2 tool, which provides an objective standard for assessing practical features, is a good first step.

Methods

In a practical study the aim is to inform clinical or policy decisions by demonstrating how an intervention could be integrated into routine treatment in real-world settings. This is distinct from explanation trials that test hypotheses about the cause-effect connection in idealized conditions. Therefore, pragmatic trials might be less reliable than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic research can provide valuable data for making decisions within the healthcare context.

The PRECIS-2 tool evaluates an RCT on 9 domains, ranging from 1 to 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 method of missing data was scored below the pragmatic limit. This indicates that a trial can be designed with effective pragmatic features, without harming the quality of the trial.

It is difficult to determine the level of pragmatism that is present in a trial since pragmatism doesn't have a single attribute. Certain aspects of a research study can be more pragmatic than others. Additionally, logistical or protocol modifications made during an experiment can alter its pragmatism score. In addition 36% of the 89 pragmatic trials identified by Koppenaal and co. were placebo-controlled or conducted prior to licensing, and the majority were single-center. They are not in line with the usual practice and can only be called pragmatic if their sponsors accept that the trials aren't blinded.

Furthermore, a common feature of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the trial sample. However, this can lead to unbalanced results and lower statistical power, thereby increasing the risk of either not detecting or misinterpreting the results of the primary outcome. In the case of the pragmatic studies included in this meta-analysis this was a significant problem because the secondary outcomes weren't adjusted for the differences in the baseline covariates.

Furthermore the pragmatic trials may be a challenge in the gathering and interpretation of safety data. This is due to the fact that adverse events are usually self-reported, and are prone to errors, delays or coding errors. It is therefore important to improve the quality of outcome assessment in these trials, and ideally by using national registries rather than relying on participants to report adverse events in the trial's own database.

Results

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

Increasing sensitivity to real-world issues, reducing cost and size of the study, and enabling the trial results to be more quickly implemented into clinical practice (by including patients who are routinely treated). However, pragmatic trials can also have drawbacks. For instance, the right kind of heterogeneity can allow the trial to apply its results to different settings and patients. However the wrong kind 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, using various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework that can discern between explanation-based studies that support the physiological hypothesis or clinical hypothesis, and pragmatic studies that guide the selection of appropriate therapies in real world clinical practice. Their framework comprised nine domains that were scored on a scale of 1-5, with 1 indicating more lucid and 5 indicating more pragmatic. The domains included recruitment of intervention, setting up, delivery of intervention, flex adherence and primary analysis.

The original PRECIS tool3 was based on a similar scale and 프라그마틱 슬롯버프 슬롯 팁 (click this link now) domains. Koppenaal and colleagues10 created an adaptation of the assessment, called the Pragmascope that was simpler to use for systematic reviews. They found that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.

This difference in the primary analysis domain could be due to the fact that the majority of pragmatic trials process their data in an intention to treat way while some explanation trials do not. 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 mean a low-quality trial. In fact, there are increasing numbers of clinical trials that use the term 'pragmatic' either in their title or abstract (as defined by MEDLINE but which is not precise nor sensitive). The use of these terms in abstracts and titles could indicate a greater understanding of the importance of pragmatism but it isn't clear if this is reflected in the content of the articles.

Conclusions

In recent years, pragmatic trials have been gaining popularity in research as the value of real world evidence is increasingly recognized. They are clinical trials that are randomized which compare real-world treatment options instead of experimental treatments under development, they have populations of patients that more closely mirror the patients who receive routine care, they use comparators which exist in routine practice (e.g. existing drugs), and they depend on participants' self-reports of outcomes. This method is able to overcome the limitations of observational research like the biases that are associated with the reliance on volunteers, and the lack of the coding differences in national registry.

Pragmatic trials offer other advantages, like the ability to leverage existing data sources and a greater probability of detecting meaningful distinctions from traditional trials. However, these trials could still have limitations that undermine their credibility and generalizability. The participation rates in certain trials could be lower than anticipated due to the health-promoting 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 impact of many pragmatic trials. In addition some pragmatic trials don't 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 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 as well as recruitment, flexibility in adherence to intervention, and follow-up. They discovered that 14 trials scored highly pragmatic or 프라그마틱 슬롯버프 슬롯 사이트 (pragmatickr65318.ziblogs.Com) pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials with high pragmatism scores are likely to have broader criteria for eligibility than conventional RCTs. They also have populations from various hospitals. According to the authors, may make pragmatic trials more useful and applicable in the daily clinical. However they do not guarantee that a trial is free of bias. The pragmatism characteristic is not a fixed characteristic; a pragmatic test that does not possess all the characteristics of an explanatory study could still yield valid and useful outcomes.