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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 cleaned trial data, ratings and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses that evaluate the effects of treatment across trials with different levels of pragmatism.

Background

Pragmatic trials are increasingly recognized as providing real-world evidence to support clinical decision-making. However, the use of the term "pragmatic" is not consistent and its definition and assessment requires further clarification. The purpose of pragmatic trials is to guide clinical practices and policy decisions, not to confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as close as possible to actual clinical practices, including recruitment of participants, setting, design, delivery and implementation of interventions, determination and analysis results, as well as primary analysis. This is a major distinction between explanatory trials as described by Schwartz & Lellouch1 which are designed to test 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 result in bias in the estimation of treatment effects. The pragmatic trials also include patients from various health care settings to ensure that the results can be applied to the real world.

Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, such as quality of life and functional recovery. This is particularly relevant in trials that require surgical procedures that are invasive or may have dangerous adverse effects. 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, however utilized symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these characteristics pragmatic trials should reduce the trial procedures and requirements for data collection to reduce costs. Additionally pragmatic trials should strive to make their findings as applicable to clinical practice as possible by making sure that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for 프라그마틱 슬롯무료 프라그마틱 무료 슬롯버프 프라그마틱 무료체험 슬롯버프 (https://pukkabookmarks.com) pragmatic trials).

Despite these guidelines, a number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all types. This can lead to misleading claims of pragmatism, and the usage of the term should be made more uniform. The development of the PRECIS-2 tool, which provides an objective standard for assessing practical features is a great first step.

Methods

In a pragmatic study, the goal is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine care in real-world contexts. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised conditions. Therefore, pragmatic trials might have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and 프라그마틱 무료 슬롯버프 analysis. Despite their limitations, pragmatic research can be a valuable source of data for making decisions within the context of healthcare.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by assessing it across 9 domains, ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruitment, organization, flexibility in delivery, flexible adherence and follow-up domains were awarded high scores, however the primary outcome and the method of missing data were not at the pragmatic limit. This suggests that it is possible to design a trial that has excellent pragmatic features without harming the quality of the outcomes.

It is, however, difficult to determine how pragmatic a particular trial is since the pragmatism score is not a binary attribute; some aspects of a trial can be more pragmatic than others. Moreover, protocol or logistic modifications made during a trial can change its score in pragmatism. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. The majority of them were single-center. Thus, they are not quite as typical and can only be described as pragmatic if their sponsors are tolerant of the lack of blinding in these trials.

Additionally, a typical feature of pragmatic trials is that researchers attempt to make their findings more valuable by studying subgroups of the trial sample. However, this can lead to unbalanced comparisons and lower statistical power, which increases the risk of either not detecting or misinterpreting the results of the primary outcome. In the case of the pragmatic studies that were included in this meta-analysis this was a major issue because the secondary outcomes were not adjusted to account for the 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 errors, delays or coding variations. Therefore, it is crucial to enhance the quality of outcomes for these trials, ideally by using national registries instead of relying on participants to report adverse events on the trial's database.

Results

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

Incorporating routine patients, the trial results are more easily translated into clinical practice. However, pragmatic trials can also have drawbacks. For instance, the appropriate kind of heterogeneity can allow a trial to generalise its results to different settings and patients. However the wrong type of heterogeneity can reduce assay sensitivity, and thus reduce the power of a trial to detect even minor effects of treatment.

Several studies have attempted to classify pragmatic trials using a variety of definitions and scoring methods. Schwartz and Lellouch1 developed an approach to distinguish between explanatory trials that confirm a clinical or physiological hypothesis and pragmatic trials that aid in the selection of appropriate therapies in clinical practice. The framework was comprised of nine domains that were scored on a scale of 1 to 5 with 1 indicating more explanatory and 5 indicating more practical. The domains covered recruitment and setting up, the delivery of intervention, flex adhering to the program and primary analysis.

The original PRECIS tool3 featured similar domains and an assessment scale ranging from 1 to 5. Koppenaal et al10 devised an adaptation to this assessment, dubbed the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic reviews scored higher on average across all domains, however they scored lower in the primary analysis domain.

This distinction in the main analysis domain could be explained by the fact that the majority of pragmatic trials analyze their data in an intention to treat way however some explanation trials do not. 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 important to remember that a pragmatic study does not mean that a trial is of poor quality. In fact, there are increasing numbers of clinical trials that use the term "pragmatic" either in their title or abstract (as defined by MEDLINE however it is neither precise nor sensitive). These terms may signal an increased understanding of pragmatism in titles and abstracts, but it's not clear whether this is reflected in content.

Conclusions

As the value of evidence from the real world becomes more popular and pragmatic trials have gained momentum in research. They are randomized trials that evaluate real-world treatment options with clinical trials in development. They involve patient populations more closely resembling those treated in regular medical care. This method can help overcome the limitations of observational research, for example, the biases that are associated with the use of volunteers and the lack of the coding differences in national registry.

Pragmatic trials offer other advantages, including the ability to use existing data sources, and a greater probability of detecting meaningful differences from traditional trials. However, pragmatic tests may still have limitations which undermine their validity and generalizability. The participation rates in certain trials may be lower than anticipated because of the healthy-volunteering effect, financial incentives or competition from other research studies. A lot of pragmatic trials are restricted by the necessity to enroll participants on time. Some pragmatic trials also lack controls to ensure that the observed variations aren't due to biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs self-labeled as pragmatic and were published up to 2022. The PRECIS-2 tool was used to determine pragmatism. It includes areas such as eligibility criteria, recruitment flexibility as well as adherence to interventions and follow-up. They found that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials that have high pragmatism scores tend to have more lenient criteria for eligibility than conventional RCTs. They also include patients from a variety of hospitals. According to the authors, can make pragmatic trials more relevant and applicable in everyday clinical. However, they don't guarantee that a trial will be free of bias. The pragmatism characteristic is not a definite characteristic the test that doesn't have all the characteristics of an explicative study could still yield reliable and beneficial results.