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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that enables research into pragmatic trials. It collects and shares cleaned trial data and ratings using PRECIS-2 which allows for multiple and varied meta-epidemiological studies to examine the effects of treatment across trials with different levels of pragmatism as well as other design features.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence for clinical decision-making. However, the use of the term "pragmatic" is inconsistent and its definition as well as assessment requires clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than to prove a physiological or clinical hypothesis. A pragmatic trial should aim to be as similar to the real-world clinical environment as is possible, 무료 프라그마틱 including the recruitment of participants, setting up and design, the delivery and implementation of the intervention, as well as the determination and analysis of the outcomes, and 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.

Studies that are truly pragmatic should avoid attempting to blind participants or the clinicians as this could cause bias in the estimation of the effects of treatment. Pragmatic trials should also seek to recruit patients from a wide range of health care settings so that their results can be compared to the real world.

Furthermore the focus of pragmatic trials should be on outcomes that are vital to patients, such as quality of life or functional recovery. This is particularly relevant for trials involving invasive procedures or those with potential for serious adverse events. The CRASH trial29, for instance was focused on functional outcomes to compare a 2-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 symptomatic catheter-associated urinary tract infections as its primary outcome.

In addition to these aspects pragmatic trials should reduce the trial procedures and data collection requirements to reduce costs. Furthermore, pragmatic trials should seek to make their results as applicable to real-world clinical practice as possible by making sure that their primary method of analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

Despite these requirements, many RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all kinds. This can lead to false claims of pragmaticity, and 무료 프라그마틱 the usage of the term must be standardized. The creation of the PRECIS-2 tool, which provides an objective standard for assessing practical features is a great first step.

Methods

In a practical study it is the intention to inform clinical or policy decisions by demonstrating how an intervention can be integrated into routine treatment in real-world contexts. Explanatory trials test hypotheses about the cause-effect relationship within idealised environments. Therefore, pragmatic trials might have lower internal validity than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can be a valuable source of data for making decisions within the healthcare context.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by assessing it across 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruit-ment organisation, flexibility: delivery and follow-up domains received high scores, however the primary outcome and the method of missing data were not at the limit of practicality. This indicates that a trial can be designed with good practical features, but without damaging the quality.

It is hard to determine the level of pragmatism within a specific study because pragmatism is not a possess a specific characteristic. Some aspects of a study may be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or the logistics during the trial. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled or conducted prior to licensing. The majority of them were single-center. Thus, they are not very close to usual practice and can only be called pragmatic when their sponsors are accepting of the absence of blinding in these trials.

Another common aspect of pragmatic trials is that the researchers attempt to make their findings more meaningful by analysing subgroups of the trial sample. However, this can lead to unbalanced results and lower statistical power, thereby increasing the likelihood of missing or misinterpreting differences in the primary outcome. This was a problem 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.

In addition, pragmatic trials can also present challenges in the collection and interpretation of safety data. This is due to the fact that adverse events are typically self-reported, and therefore are prone to errors, 프라그마틱 무료체험 delays or coding differences. It is therefore important to improve the quality of outcomes ascertainment in these trials, ideally by using national registries instead of relying on participants to report adverse events in a trial's own database.

Results

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

Incorporating routine patients, the results of the trial are more easily translated into clinical practice. However, pragmatic trials may be a challenge. For instance, the appropriate type of heterogeneity can help the trial to apply its results to different patients and settings; however the wrong kind of heterogeneity can reduce assay sensitivity, and 슬롯 thus reduce the power of a study to detect even minor effects of treatment.

Many studies have attempted classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 have developed an approach to distinguish between research studies that prove a physiological or clinical hypothesis as well as pragmatic trials that inform the selection of appropriate therapies in clinical practice. The framework consisted of nine domains evaluated on a scale of 1-5 which indicated that 1 was more informative and 5 was more pragmatic. The domains were recruitment and setting, delivery of intervention and follow-up, as well as flexible adherence and primary analysis.

The initial PRECIS tool3 had similar domains and an assessment scale ranging from 1 to 5. Koppenaal et al10 devised an adaptation of this assessment dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic systematic reviews had higher average score in most domains, but lower scores in the primary analysis domain.

This distinction in the primary analysis domain can be due to the way in which most pragmatic trials analyse data. Some explanatory trials, however don't. The overall score was lower for 무료 프라그마틱 pragmatic systematic reviews when the domains on organisation, flexible delivery and follow-up were merged.

It is important to remember that a pragmatic study should 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 abstracts or titles (as defined by MEDLINE but which is neither sensitive nor precise). The use of these words in abstracts and titles could suggest a greater awareness of the importance of pragmatism, however, it is not clear if this is reflected in the content of the articles.

Conclusions

In recent years, pragmatic trials have been gaining popularity in research as the importance of real-world evidence is becoming increasingly acknowledged. They are clinical trials that are randomized that evaluate real-world alternatives to care instead of experimental treatments in development, they have patient populations that are more similar to the patients who receive routine care, they employ comparisons that are commonplace in practice (e.g. existing drugs), and they depend on participants' self-reports of outcomes. This approach can overcome the limitations of observational research for example, the biases that are associated with the reliance on volunteers, 프라그마틱 슬롯 추천 and the lack of coding variations in national registries.

Pragmatic trials offer other advantages, such as the ability to use existing data sources, and a greater chance of detecting significant differences from traditional trials. However, pragmatic trials may still have limitations that undermine their credibility and generalizability. The participation rates in certain trials could be lower than expected due to 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. In addition some pragmatic trials lack controls to ensure that the observed differences aren't due to biases in trial conduct.

The authors of the Pragmatic Free Trial Meta identified RCTs that were published between 2022 and 2022 that self-described as pragmatic. The PRECIS-2 tool was employed to assess pragmatism. It covers areas like eligibility criteria, recruitment flexibility and adherence to intervention and follow-up. They found that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or higher) 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 have patients from a variety of hospitals. These characteristics, according to the authors, could make pragmatic trials more relevant and applicable in everyday practice. However, they don't guarantee that a trial is free of bias. The pragmatism characteristic is not a fixed characteristic; a pragmatic test that does not have all the characteristics of an explicative study may still yield valuable and valid results.