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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 with different levels of pragmatism.

Background

Pragmatic studies provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however, is not used in a consistent manner and its definition and measurement need further clarification. Pragmatic trials must be designed to inform clinical practice and policy decisions, not to confirm a physiological or clinical hypothesis. A pragmatic trial should try to be as similar to the real-world clinical environment as is possible, including its selection of participants, setting up and design as well as the execution of the intervention, determination and analysis of outcomes as well as primary analysis. This is a major difference between explanation-based trials, as defined by Schwartz and Lellouch1 which are designed to confirm a hypothesis in a more thorough manner.

The most pragmatic trials should not be blind participants or the clinicians. This can result in a bias in the estimates of treatment effects. Pragmatic trials should also seek to enroll patients from a variety of health care settings, so that their results are generalizable to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are important to patients, like quality of life or functional recovery. This is particularly relevant for trials involving invasive procedures or those with potential dangerous adverse events. The CRASH trial29, for example was focused on functional outcomes to evaluate a two-page case report with an electronic system for monitoring of hospitalized patients with chronic heart failure, and the catheter trial28 focused on urinary tract infections caused by catheters as its primary outcome.

In addition to these characteristics pragmatic trials should also reduce the requirements for data collection and trial procedures to cut costs and time commitments. Finaly these trials should strive to make their findings as applicable to current clinical practices as they can. This can be achieved by ensuring their primary analysis is based on the intention-to treat approach (as described in CONSORT extensions).

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 can result in misleading claims of pragmatism, and the use of the term should be standardized. The development of the PRECIS-2 tool, which provides an objective standard for assessing pragmatic features is a great first step.

Methods

In a practical trial it is the intention to inform policy or clinical decisions by demonstrating how the intervention can be implemented into routine care. Explanatory trials test hypotheses about the cause-effect relation within idealized environments. Therefore, pragmatic trials could have less internal validity than explanatory trials and 프라그마틱 슬롯무료 may be more susceptible to bias in their design, 프라그마틱 슬롯무료 conduct, and analysis. Despite these limitations, pragmatic trials can contribute valuable information to decisions in the context of healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, ranging from 1 to 5 (very pragmatist). In this study, the recruit-ment, organisation, flexibility: delivery, flexible adherence 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 suggests that it is possible to design a trial with high-quality pragmatic features, without damaging the quality of its results.

It is difficult to determine the degree of pragmatism within a specific trial because pragmatism does not have a single characteristic. Some aspects of a study may be more pragmatic than other. A trial's pragmatism can be affected by changes to the protocol or the logistics during the trial. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to licensing. The majority of them were single-center. This means that 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 try to make their results more relevant by analyzing subgroups of the trial sample. This can result in unbalanced analyses that have lower statistical power. This increases the risk of omitting or 프라그마틱 무료게임 ignoring differences in the primary outcomes. This was a problem during the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not corrected for covariates' differences at baseline.

Additionally, studies that are pragmatic may pose challenges to collection and interpretation safety data. This is due to the fact that adverse events are usually self-reported, and therefore are prone to delays, errors or coding differences. It is therefore crucial to improve the quality of outcome ascertainment in these trials, in particular by using national registries rather than relying on participants to report adverse events on a trial's own database.

Results

While the definition of pragmatism may not require that clinical trials be 100% pragmatist There are advantages when incorporating pragmatic components into trials. These include:

Increasing sensitivity to real-world issues, reducing cost and size of the study, and enabling the trial results to be more quickly translated into actual clinical practice (by including routine patients). However, pragmatic trials may have disadvantages. The right type of heterogeneity, for example could help a study generalise its findings to many different patients or settings. However the wrong type of heterogeneity could reduce the assay sensitivity and, consequently, lessen the power of a trial to detect minor treatment effects.

Numerous studies have attempted to categorize pragmatic trials, using various definitions and scoring systems. Schwartz and Lellouch1 created a framework for distinguishing between explanation-based trials that support a clinical or physiological hypothesis as well as pragmatic trials that inform the selection of appropriate therapies in clinical practice. Their framework included nine domains that were scored on a scale ranging from 1 to 5, with 1 indicating more explanatory and 5 suggesting more pragmatic. The domains included recruitment and setting, delivery of intervention with flexibility, follow-up and primary analysis.

The original PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal et. al10 devised an adaptation of the assessment, dubbed the Pragmascope, 프라그마틱 정품확인방법 that was easier to use for 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 explained by the way that most pragmatic trials analyze data. Some explanatory trials, however, do not. The overall score was lower for systematic reviews that were pragmatic when the domains on the organization, 프라그마틱 슬롯 하는법 flexibility of delivery and follow-up were combined.

It is important to note that the term "pragmatic trial" does not necessarily mean a poor quality trial, and in fact there is an increasing number of clinical trials (as defined by MEDLINE search, but this is not specific or sensitive) that use the term "pragmatic" in their abstracts or titles. These terms could indicate an increased appreciation of pragmatism in titles and abstracts, 프라그마틱 공식홈페이지 but it's unclear whether this is evident in the content.

Conclusions

As the value of evidence from the real world becomes more widespread, pragmatic trials have gained traction in research. They are clinical trials that are randomized which compare real-world treatment options instead of experimental treatments in development. They have patients which are more closely resembling those treated in routine medical care, they utilize comparisons that are commonplace in practice (e.g., existing medications), and they rely on participant self-report of outcomes. This approach can overcome the limitations of observational research such as the biases that are associated with the reliance on volunteers as well as the insufficient availability and the coding differences in national registry.

Other advantages of pragmatic trials are the possibility of using existing data sources, and a higher likelihood of detecting meaningful changes than traditional trials. However, these trials could still have limitations that undermine their validity and generalizability. Participation rates in some trials could be lower than anticipated 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 quickly. Additionally certain 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 RCTs that were published between 2022 and 2022 that self-described as pragmatism. They assessed pragmatism using the PRECIS-2 tool, which includes the eligibility criteria for domains and recruitment criteria, as well as flexibility in adherence to interventions 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.

Trials with high pragmatism scores are likely to have more lenient criteria for eligibility than traditional RCTs. They also contain populations from many different hospitals. The authors argue that these traits can make pragmatic trials more effective and applicable to everyday practice, but they do not necessarily guarantee that a trial using a pragmatic approach is free of bias. The pragmatism principle is not a definite characteristic; a pragmatic test that does not possess all the characteristics of an explanation study could still yield reliable and beneficial results.