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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial, open data platform and infrastructure that facilitates research on pragmatic trials. It collects and distributes clean trial data, ratings, and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses that examine the effect 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 used inconsistently and its definition and evaluation require 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 trial should aim to be as similar to real-world clinical practice as is possible, including its participation of participants, setting up and design as well as the implementation of the intervention, determination and analysis of the outcomes, and primary analysis. This is a major difference between explanatory trials, as described by Schwartz and Lellouch1 that are designed to prove a hypothesis in a more thorough way.

Studies that are truly pragmatic should not attempt to blind participants or healthcare professionals in order to result in bias in estimates of the effect of treatment. Pragmatic trials will also recruit patients from different healthcare settings to ensure that their results can be generalized to the real world.

Finally, pragmatic trials must focus on outcomes that matter to patients, like quality of life and functional recovery. This is especially important in trials that involve the use of invasive procedures or potentially serious adverse events. The CRASH trial29 compared a 2-page report with an electronic monitoring system for patients in hospitals with chronic cardiac failure. The catheter trial28, on the other hand utilized symptomatic catheter-related urinary tract infections as its primary outcome.

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

Many RCTs that don't meet the criteria for pragmatism but contain features contrary to pragmatism have been published in journals of varying types and incorrectly labeled as pragmatic. 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 can provide a standardized objective evaluation of the pragmatic characteristics is a first step.

Methods

In a pragmatic trial it is the intention to inform clinical or policy decisions by showing how an intervention could be implemented into routine care. This is different from explanatory trials that test hypotheses regarding the causal-effect relationship in idealized situations. Therefore, pragmatic trials could have lower internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can be a valuable source of information for decision-making in the context of healthcare.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by scoring it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study, the recruit-ment organisation, flexibility: delivery, flexible adherence and follow-up domains were awarded high scores, however, the primary outcome and the method of missing data were below the limit of practicality. This indicates that a trial can be designed with well-thought-out practical features, but without compromising its quality.

However, 프라그마틱 이미지 it is difficult to judge how practical a particular trial is since pragmaticity is not a definite quality; certain aspects of a trial can be more pragmatic than others. Additionally, logistical or protocol modifications during the course of an experiment can alter its score on pragmatism. Additionally, 36% of the 89 pragmatic trials discovered by Koppenaal et al were placebo-controlled or conducted prior to approval and a majority of them were single-center. Therefore, they aren't quite as typical and can only be called pragmatic in the event that their sponsors are supportive of the lack of blinding in these trials.

A typical feature of pragmatic studies is that researchers try to make their findings more relevant by studying subgroups of the trial sample. This can result in unbalanced analyses with less statistical power. This increases the possibility of omitting or misinterpreting differences in the primary outcomes. This was a problem during the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates' differences at the time of baseline.

Furthermore, pragmatic studies may pose challenges to collection and interpretation safety data. This is because adverse events are typically reported by participants themselves and prone to reporting delays, inaccuracies, or coding variations. It is therefore important to enhance the quality of outcomes ascertainment in these trials, ideally by using national registry databases instead of relying on participants to report adverse events in a trial's own database.

Results

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

Enhancing sensitivity to issues in the real world as well as reducing study size and cost, and enabling the trial results to be faster implemented into clinical practice (by including patients who are routinely treated). However, pragmatic trials may be a challenge. For instance, the appropriate type of heterogeneity can help the trial to apply its results to many different patients and settings; however the wrong type of heterogeneity can reduce assay sensitivity, and thus lessen the ability of a study to detect small treatment effects.

Numerous studies have attempted to classify pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to discern between explanation-based studies that confirm the physiological hypothesis or clinical hypothesis, and pragmatic studies that inform the choice for appropriate therapies in real world clinical practice. The framework was composed of nine domains assessed on a scale of 1-5 which indicated that 1 was more informative and 5 being more pragmatic. The domains included recruitment setting, setting, intervention delivery and follow-up, 프라그마틱 as well as flexible adherence and 프라그마틱 슬롯 하는법 primary analysis.

The original PRECIS tool3 featured similar domains and a scale of 1 to 5. Koppenaal et al10 created an adaptation of this assessment called the Pragmascope which was more user-friendly to use in systematic reviews. They discovered that pragmatic reviews scored higher across all domains, however they scored lower in the primary analysis domain.

This distinction in the primary analysis domains can be due to the way in which most pragmatic trials approach data. Some explanatory trials, 프라그마틱 데모 however don't. The overall score for systematic reviews that were pragmatic was lower when the areas of management, flexible delivery and follow-up were merged.

It is crucial to keep in mind that a pragmatic study should not mean that a trial is of poor quality. In fact, there are increasing numbers of clinical trials which use the term "pragmatic" either in their title or abstract (as defined by MEDLINE but which is neither sensitive nor precise). These terms could indicate a greater understanding of pragmatism in abstracts and titles, but it's unclear whether this is reflected in content.

Conclusions

As the value of real-world evidence becomes increasingly popular and pragmatic trials have gained popularity in research. They are randomized clinical trials that compare real-world care alternatives instead of experimental treatments under development, they have populations of patients that are more similar to those treated in routine medical care, they utilize comparisons that are commonplace in practice (e.g., existing drugs) and rely on participant self-report of outcomes. This method is able to overcome the limitations of observational research such as the biases associated with the reliance on volunteers as well as the insufficient availability and codes that vary in national registers.

Pragmatic trials also have advantages, such as the ability to draw on existing data sources and a greater probability of detecting meaningful differences from traditional trials. However, they may still have limitations which undermine their reliability and generalizability. For example, participation rates in some trials might be lower than expected due to the healthy-volunteer effect and incentives to pay or compete for participants from other research studies (e.g., industry trials). The requirement to recruit participants in a timely manner also reduces the size of the sample and the impact of many pragmatic trials. Some pragmatic trials also lack controls to ensure that observed differences aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described as pragmatic. They assessed pragmatism by using the PRECIS-2 tool, which includes the eligibility criteria for domains, recruitment, flexibility in adherence to interventions and follow-up. They discovered that 14 of these trials scored as highly or pragmatic practical (i.e. scoring 5 or more) in any one or more of these domains, and that the majority of them were single-center.

Trials with high pragmatism scores are likely to have more lenient criteria for eligibility than conventional RCTs. They also have populations from many different hospitals. The authors claim that these traits can make the pragmatic trials more relevant and relevant to everyday clinical practice, however they do not guarantee that a trial using a pragmatic approach is free of bias. In addition, the pragmatism that is present in a trial is not a definite characteristic A pragmatic trial that does not have all the characteristics of a explanatory trial can produce valid and useful results.