• 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 shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological research studies to compare treatment effects estimates across trials that employ different levels of pragmatism and other design features.

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 measurement require clarification. Pragmatic trials are intended to guide clinical practices and policy decisions rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should also aim to be as similar to actual clinical practice as possible, including in its recruitment of participants, setting up and design, the delivery and implementation of the intervention, determination and analysis of outcomes as well as primary analysis. This is a major difference between explanatory trials, as described by Schwartz & Lellouch1 that are designed to prove the hypothesis in a more thorough manner.

The trials that are truly pragmatic should not attempt to blind participants or the clinicians as this could lead to bias in the estimation of the effects of treatment. Practical trials should also aim to enroll patients from a wide range of health care settings so that their results can be applied to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are crucial to patients, like quality of life or functional recovery. This is especially important in trials that involve surgical procedures that are invasive or have potential dangerous adverse events. The CRASH trial29, for instance was focused on functional outcomes to compare a two-page report with an electronic system to monitor the health of hospitalized patients with chronic heart failure. In addition, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these aspects pragmatic trials should also reduce the procedures for conducting trials and requirements for data collection to cut costs and time commitments. Furthermore pragmatic trials should strive to make their results as relevant to actual clinical practice as they can by making sure that their primary method of analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).

Despite these guidelines 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 could lead to false claims of pragmatism, and the term's use should be standardized. The development of the PRECIS-2 tool, which offers an objective standard for assessing pragmatic characteristics is a great first step.

Methods

In a practical study the aim is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine treatment in real-world contexts. Explanatory trials test hypotheses about the causal-effect relationship in idealized settings. In this way, 프라그마틱 불법 pragmatic trials can have a lower internal validity than explanatory studies and are more susceptible to biases in their design as well as analysis and conduct. Despite their limitations, pragmatic research can provide valuable information to make decisions in the healthcare context.

The PRECIS-2 tool measures the degree of pragmatism within an RCT by scoring it across 9 domains, ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruit-ment organization, flexibility in delivery and follow-up domains received high scores, however, the primary outcome and the procedure for missing data were below the limit of practicality. This suggests that a trial could be designed with well-thought-out pragmatic features, without harming the quality of the trial.

It is, however, difficult to assess how practical a particular trial is since pragmatism is not a binary attribute; some aspects of a trial can be more pragmatic than others. Moreover, protocol or logistic changes during the trial may alter its score on pragmatism. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to licensing. The majority of them were single-center. Thus, they are not as common and are only pragmatic when their sponsors are accepting of the lack of blinding in such trials.

Furthermore, a common feature of pragmatic trials is that researchers try to make their results more meaningful by analysing subgroups of the sample. However, this can lead to unbalanced comparisons with a lower statistical power, thereby increasing the chance of not or misinterpreting 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 corrected for covariates' differences at the time of baseline.

Furthermore, pragmatic studies can pose difficulties in the collection and interpretation of safety data. This is due to the fact that adverse events are typically self-reported, and are prone to delays, errors or coding errors. It is essential to improve the accuracy and quality of the results in these trials.

Results

While the definition of pragmatism does not mean that trials must be 100 100% pragmatic, there are advantages to incorporating pragmatic components into clinical trials. These include:

Enhancing sensitivity to issues in the real world, reducing study size and cost and allowing the study results to be faster transferred into real-world clinical practice (by including routine patients). However, pragmatic trials may have disadvantages. The right kind of heterogeneity, for example could help a study extend its findings to different patients or settings. However the wrong kind of heterogeneity can reduce the assay sensitivity and, consequently, lessen the power of a trial to detect even minor effects of treatment.

Many studies have attempted classify pragmatic trials using a variety of definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can distinguish between explanatory studies that support the physiological hypothesis or 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 evaluated on a scale of 1-5, with 1 being more informative and 5 was more pragmatic. The domains included recruitment and setting, delivery of intervention and follow-up, as well as flexible adherence and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal and colleagues10 developed an adaptation of this assessment called the Pragmascope that was easier to use in systematic reviews. They discovered that pragmatic systematic reviews had higher average scores across all domains, but lower scores in the primary analysis domain.

This distinction in the primary analysis domains could be explained by the way that most pragmatic trials approach data. Certain explanatory trials however, do not. The overall score was lower for pragmatic systematic reviews when the domains of the organization, flexibility of delivery and follow-up were merged.

It is important to remember that a pragmatic trial doesn't necessarily mean a poor quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, but this is not sensitive nor specific) that use the term "pragmatic" in their abstract or title. These terms may indicate an increased understanding of pragmatism in abstracts and titles, however it's unclear whether this is reflected in the content.

Conclusions

As the value of real-world evidence grows commonplace and pragmatic trials have gained popularity in research. They are randomized clinical trials that evaluate real-world alternatives to care instead of experimental treatments under development, they include patients that more closely mirror the patients who receive routine medical care, they utilize comparators which exist in routine practice (e.g. existing medications), and they depend on participants' self-reports of outcomes. This approach has the potential to overcome the limitations of observational studies that are prone to limitations of relying on volunteers, and the limited accessibility and coding flexibility in national registry systems.

Pragmatic trials offer other advantages, including the ability to draw on existing data sources, and a greater chance of detecting significant differences than traditional trials. However, these tests could have some limitations that limit their reliability and generalizability. Participation rates in some trials may be lower than expected due to 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. Practical trials aren't always equipped with controls to ensure that any observed differences aren't caused by biases during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described as pragmatic. The PRECIS-2 tool was employed to evaluate pragmatism. It covers areas like eligibility criteria and flexibility in recruitment and adherence to intervention and follow-up. They found 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or 프라그마틱 카지노 슬롯 프라그마틱 슬롯 무료체험 (read full article) more) in at least one of these domains.

Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs that have specific criteria that aren't likely to be present in the clinical setting, and include populations from a wide range of hospitals. These characteristics, according to the authors, can make pragmatic trials more relevant and useful in the daily practice. However, they don't ensure that a study is free of bias. Moreover, the pragmatism of the trial is not a fixed attribute; a pragmatic trial that does not possess all the characteristics of an explanatory trial can yield valuable and reliable results.