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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 collects and distributes cleaned trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses to examine the effect of treatment across trials of various levels of pragmatism.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. However, 프라그마틱 슬롯 환수율 the usage of the term "pragmatic" is not uniform and its definition and evaluation requires clarification. Pragmatic trials are intended to guide the practice of clinical medicine and policy choices, rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic study should strive to be as close as possible to the real-world clinical practice, including recruiting participants, setting, designing, delivery and implementation of interventions, determining and analysis outcomes, and primary analysis. This is a significant difference between explanatory trials, as described by Schwartz and Lellouch1 that are designed to test the hypothesis in a more thorough manner.

The most pragmatic trials should not conceal participants or the clinicians. This could lead to a bias in the estimates of treatment effects. Practical trials should also aim to attract patients from a wide range of health care settings to ensure that their findings are generalizable to the real world.

Additionally, clinical trials should be focused on outcomes that matter to patients, such as the quality of life and functional recovery. This is especially important when trials involve invasive procedures or have potentially dangerous adverse impacts. The CRASH trial29, for example was focused on functional outcomes to evaluate a two-page case report with an electronic system to monitor the health of hospitalized patients with chronic heart failure. In addition, the catheter trial28 focused on urinary tract infections caused by catheters as the primary outcome.

In addition to these aspects, pragmatic trials should minimize the procedures for conducting trials and data collection requirements to reduce costs. Finally pragmatic trials should strive to make their results as relevant to actual clinical practice as possible by making sure that their primary method of analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs which do not meet the criteria for pragmatism, but have features that are contrary to pragmatism, have been published in journals of different types and incorrectly labeled pragmatic. This could lead to false claims of pragmatism, and the use of the term should be standardised. The development of a PRECIS-2 tool that can provide a standardized objective evaluation of the pragmatic characteristics is a good start.

Methods

In a pragmatic trial the goal is to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. Explanatory trials test hypotheses concerning the cause-effect relation within idealized settings. Therefore, pragmatic trials could be less reliable than explanatory trials, and could be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials may be a valuable source of information for decision-making in the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatist). In this study, the recruitment, organization, flexibility in delivery, flexible adherence and follow-up domains received high scores, however the primary outcome and the method for missing data were not at the pragmatic limit. This suggests that it is possible to design a trial using high-quality pragmatic features, without harming the quality of the results.

However, it is difficult to determine how pragmatic a particular trial really is because pragmaticity is not a definite quality; certain aspects of a 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 most were single-center. Thus, they are not quite as typical and can only be described as pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.

Another common aspect of pragmatic trials is that researchers try to make their results more relevant by analyzing subgroups of the sample. This can lead to unbalanced results and lower statistical power, which increases the risk of either not detecting or misinterpreting the results of the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not corrected for covariates that differed at baseline.

In addition the pragmatic trials may present challenges in the gathering and interpretation of safety data. This is due to the fact that adverse events are typically self-reported, and are prone to delays, inaccuracies or coding variations. Therefore, it is crucial to improve the quality of outcome for these trials, ideally by using national registries instead of relying on participants to report adverse events in the trial's own database.

Results

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

By incorporating routine patients, the trial results are more easily translated into clinical practice. However, pragmatic studies can also have drawbacks. The right type of heterogeneity for instance could allow a study to generalise its findings to many different patients or settings. However the wrong kind of heterogeneity can reduce the sensitivity of an assay and thus reduce a trial's power to detect small treatment effects.

Several studies have attempted to classify pragmatic trials using a variety of definitions and scoring methods. Schwartz and Lellouch1 created a framework to differentiate between explanation studies that support the physiological hypothesis or 프라그마틱 무료 슬롯버프 clinical hypothesis, and pragmatic studies that guide the selection of appropriate treatments in real world clinical practice. The framework was comprised of nine domains scored on a 1-5 scale which indicated that 1 was more informative and 5 being more pragmatic. The domains covered recruitment, setting up, delivery of intervention, flex compliance and primary analysis.

The original PRECIS tool3 included similar domains and an assessment scale ranging from 1 to 5. Koppenaal et al10 devised an adaptation of this assessment called the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic reviews scored higher in most domains, 프라그마틱 정품확인방법 but scored lower in the primary analysis domain.

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

It is crucial to keep in mind that a pragmatic study should not mean a low-quality trial. In fact, there is a growing number of clinical trials which use the term 'pragmatic' either in their abstract or title (as defined by MEDLINE however it is neither precise nor sensitive). The use of these terms in abstracts and titles could indicate a greater understanding of the importance of pragmatism however, it is not clear if this is evident in the content of the articles.

Conclusions

As the value of evidence from the real world becomes more popular the pragmatic trial has gained traction in research. They are randomized trials that evaluate real-world care alternatives to clinical trials in development. They are conducted with populations of patients that are more similar to those who receive treatment in regular care. This method has the potential to overcome the limitations of observational research, such as the limitations of relying on volunteers and the lack of availability and coding variability in national registry systems.

Other benefits of pragmatic trials include the ability to utilize existing data sources, and a higher probability of detecting significant changes than traditional trials. However, they may still have limitations that undermine their credibility and generalizability. For instance, participation rates in some trials may be lower than anticipated due to the healthy-volunteer effect and financial incentives or competition for participants from other research studies (e.g. industry trials). The need to recruit individuals in a timely manner also limits the sample size and impact of many pragmatic trials. Additionally certain 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-labeled themselves as pragmatic and were published up to 2022. They evaluated pragmatism using the PRECIS-2 tool, which includes the eligibility criteria for domains, recruitment, flexibility in intervention adherence and follow-up. They discovered that 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 lenient criteria for 프라그마틱 무료체험 메타 eligibility than traditional RCTs. They also include populations from various hospitals. These characteristics, according to the authors, can make pragmatic trials more useful and useful in the daily clinical. However, they don't guarantee that a trial is free of bias. Moreover, the pragmatism of a trial is not a fixed attribute and a pragmatic trial that doesn't contain all the characteristics of a explanatory trial can yield reliable and relevant results.