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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial, open data platform and infrastructure that supports research on pragmatic trials. It collects and distributes cleaned trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological studies to compare treatment effect estimates across trials with different levels of pragmatism.

Background

Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the usage of the term "pragmatic" is not consistent and its definition and evaluation requires clarification. The purpose of pragmatic trials is to guide clinical practice and 무료 프라그마틱 플레이 (Going to king-wifi.win) policy decisions, not to confirm 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, including recruitment of participants, setting up, delivery and implementation of interventions, determining and analysis results, as well as primary analysis. This is a significant difference between explanatory trials, as described by Schwartz & Lellouch1 that are designed to test the hypothesis in a more thorough manner.

The trials that are truly pragmatic must avoid attempting to blind participants or clinicians in order to lead to bias in estimates of the effect of treatment. Practical trials also involve patients from different health care settings to ensure that the outcomes can be compared to the real world.

Furthermore the focus of pragmatic trials should be on outcomes that are important to patients, such as quality of life or functional recovery. This is particularly important in trials that require the use of invasive procedures or could have harmful adverse effects. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The catheter trial28, however was based on symptomatic catheter-related urinary tract infection as its primary outcome.

In addition to these aspects, pragmatic trials should minimize the procedures for conducting trials and requirements for data collection to cut down on costs and time commitments. Additionally, pragmatic trials should aim to make their results as relevant to real-world clinical practices as possible. This can be achieved by ensuring their primary analysis is based on the intention to treat approach (as described in CONSORT extensions).

Many RCTs that do not meet the criteria for pragmatism, however, they have characteristics that are in opposition to pragmatism, have been published in journals of various types and incorrectly labeled as pragmatic. This can lead to false claims about pragmatism, and the term's use should be standardised. The development of the PRECIS-2 tool, which offers a standard objective assessment of pragmatic features, is a good first step.

Methods

In a pragmatic trial it is the intention to inform clinical or policy decisions by demonstrating how the intervention can be incorporated into real-world routine care. Explanatory trials test hypotheses concerning the causal-effect relationship 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 their limitations, pragmatic studies can be a valuable source of information for decision-making within the healthcare context.

The PRECIS-2 tool evaluates the level of pragmatism that is present in an RCT by assessing it on 9 domains that range from 1 (very explanatory) to 5 (very pragmatic). In this study, 슬롯 (Going to king-wifi.win) the recruit-ment organization, flexibility in delivery and follow-up domains scored high scores, however, the primary outcome and the method of missing data fell below the pragmatic limit. This suggests that it is possible to design a trial that has good pragmatic features without compromising the quality of its outcomes.

However, it's difficult to determine how pragmatic a particular trial is, since the pragmatism score is not a binary attribute; some aspects of a study can be more pragmatic than others. Additionally, logistical or protocol modifications made during an experiment can alter its score on pragmatism. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. They also found that the majority were single-center. Therefore, they aren't as common and can only be described as pragmatic if their sponsors are tolerant of the absence of blinding in these trials.

Furthermore, a common feature of pragmatic trials is that researchers attempt to make their findings more meaningful by analysing subgroups of the trial. This can lead to unbalanced comparisons and lower statistical power, increasing the chance of not or incorrectly detecting differences in the primary outcome. In the case of the pragmatic trials that were included in this meta-analysis this was a serious issue since the secondary outcomes were not adjusted to account for differences in the baseline covariates.

In addition, pragmatic studies can pose difficulties in the collection and interpretation safety data. It is because adverse events are usually self-reported, and therefore are prone to delays, errors or coding errors. It is essential to improve the accuracy and quality of outcomes in these trials.

Results

While the definition of pragmatism doesn't require that all clinical trials be 100% pragmatic There are advantages when incorporating pragmatic components into trials. These include:

By including routine patients, the results of the trial can be translated more quickly into clinical practice. However, pragmatic trials may also have disadvantages. The right kind of heterogeneity for 프라그마틱 슬롯 체험 instance, can help a study extend its findings to different patients or settings. However, the wrong type can decrease the sensitivity of the test and thus reduce a trial's power to detect minor treatment effects.

A number of studies have attempted to categorize pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 created a framework for distinguishing between explanatory trials that confirm a clinical or physiological hypothesis as well as pragmatic trials that help in the choice of appropriate therapies in the real-world clinical setting. The framework was composed of nine domains assessed on a scale of 1-5 with 1 being more lucid while 5 being more pragmatic. The domains included recruitment, setting, intervention delivery with flexibility, follow-up and primary analysis.

The initial PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal et al10 created an adaptation to this assessment called the Pragmascope that was easier to use in systematic reviews. They found that pragmatic reviews scored higher on average in most domains, but scored lower in the primary analysis domain.

The difference in the main analysis domain could be explained by the fact that most pragmatic trials analyse their data in an intention to treat method while some explanation trials do not. The overall score for systematic reviews that were pragmatic was lower when the areas of management, flexible delivery and following-up were combined.

It is important to remember that the term "pragmatic trial" does not necessarily mean a low-quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, however this is not specific or sensitive) which use the word "pragmatic" in their abstracts or titles. These terms may indicate an increased appreciation of pragmatism in abstracts and titles, however it isn't clear whether this is reflected in the content.

Conclusions

As the importance of real-world evidence becomes increasingly commonplace the pragmatic trial has gained traction in research. They are randomized trials that compare real world care alternatives to clinical trials in development. They include patient populations closer to those treated in regular care. This method could help overcome the limitations of observational studies that are prone to biases associated with reliance on volunteers, and the limited availability and coding variability in national registry systems.

Pragmatic trials offer other advantages, such as the ability to draw on existing data sources, and a greater probability of detecting meaningful differences from traditional trials. However, pragmatic trials may be prone to limitations that compromise their credibility and generalizability. For example, participation rates in some trials could be lower than expected due to the healthy-volunteer effect as well as incentives to pay or compete for participants from other research studies (e.g., industry trials). Practical trials are often restricted by the need to recruit participants quickly. In addition, some pragmatic trials do not have controls to ensure that the observed differences aren't due to biases in trial conduct.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published up to 2022. They assessed pragmatism using the PRECIS-2 tool, which includes the domains eligibility criteria as well as recruitment, flexibility in intervention adherence, and follow-up. They discovered 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Studies with high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also contain patients from a variety of hospitals. According to the authors, may make pragmatic trials more useful and useful in everyday practice. However, they don't guarantee that a trial will be free of bias. Moreover, the pragmatism of the trial is not a definite characteristic; a pragmatic trial that does not possess all the characteristics of a explanatory trial can yield valid and useful results.