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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that enables research into pragmatic trials. It gathers and distributes clean trial data, ratings, and evaluations using PRECIS-2. This permits a variety of meta-epidemiological analyses to examine the effect of treatment across trials with different levels of pragmatism.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. However, the usage of the term "pragmatic" is inconsistent and its definition and assessment requires further clarification. Pragmatic trials are designed to guide clinical practices and policy choices, rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should strive to be as close to real-world clinical practice as is possible, including the recruitment of participants, setting up and design, the delivery and execution of the intervention, and the determination and analysis of outcomes and primary analyses. This is a key difference from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more thorough proof of an idea.

The most pragmatic trials should not conceal participants or the clinicians. This can lead to a bias in the estimates of the effect of treatment. The trials that are pragmatic should also try to recruit patients from a wide range of health care settings to ensure that their findings can be compared to the real world.

Additionally, pragmatic trials should focus on outcomes that are important to patients, such as quality of life or functional recovery. This is particularly relevant when trials involve invasive procedures or have potentially dangerous adverse impacts. The CRASH trial29, for example, focused on functional outcomes to compare a 2-page case-report with an electronic system to monitor the health of patients admitted to hospitals with chronic heart failure. Similarly, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these aspects, pragmatic trials should minimize the requirements for data collection and trial procedures to cut costs and time commitments. Additionally the aim of pragmatic trials is to make their results as relevant to real-world clinical practices as possible. This can be achieved by ensuring their primary analysis is based on an intention-to treat method (as described in CONSORT extensions).

Despite these criteria however, a large number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all types. This can lead to misleading claims of pragmatism, and the term's use should be standardised. The creation of the PRECIS-2 tool, which offers a standard objective assessment of practical features is a good initial step.

Methods

In a practical trial, the aim is to inform policy or clinical decisions by demonstrating how an intervention would be integrated into everyday routine care. This is different from explanatory trials that test hypotheses regarding the cause-effect relationship in idealised situations. Consequently, pragmatic trials may be less reliable than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic research can be a valuable source of information to make decisions in the context of healthcare.

The PRECIS-2 tool evaluates the degree of pragmatism within an RCT by scoring it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study, the domains of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up received high scores. However, the main outcome and the method for missing data was scored below the pragmatic limit. This suggests that it is possible to design a trial with high-quality pragmatic features, without harming the quality of the outcomes.

It is difficult to determine the level of pragmatism in a particular trial since pragmatism doesn't have a single attribute. Certain aspects of a research study can be more pragmatic than other. Moreover, protocol or logistic modifications made during a trial can change its score on pragmatism. Additionally, 36% of the 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled or conducted prior to licensing and most were single-center. They aren't in line with the usual practice, and can only be referred to as pragmatic if their sponsors agree that such trials are not blinded.

Furthermore, a common feature of pragmatic trials is that researchers attempt to make their findings more relevant by analyzing subgroups of the trial sample. However, this often leads to unbalanced comparisons with a lower statistical power, thereby increasing the likelihood of missing or incorrectly detecting differences in the primary outcome. In the case of the pragmatic studies included in this meta-analysis, this was a major issue since the secondary outcomes were not adjusted for differences in baseline covariates.

Furthermore the pragmatic trials may have challenges with respect to the gathering and interpretation of safety data. It is because adverse events are usually self-reported, and are prone to errors, delays or coding errors. It is therefore crucial to improve the quality of outcomes for these trials, in particular by using national registry databases instead of relying on participants to report adverse events in a trial's own database.

Results

While the definition of pragmatism does not require that all clinical trials be 100% pragmatic, there are benefits when incorporating pragmatic components into trials. These include:

By including routine patients, the results of trials can be translated more quickly into clinical practice. However, pragmatic trials may have disadvantages. The right kind of heterogeneity for instance could help a study extend its findings to different settings or patients. However the wrong kind of heterogeneity can decrease the sensitivity of the test and thus lessen the power of a trial to detect minor treatment effects.

Several studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 developed a framework to discern between explanation-based studies that support a physiological or clinical hypothesis and 프라그마틱 무료 슬롯버프 pragmatic studies that inform the choice for appropriate therapies in clinical practice. The framework consisted of nine domains assessed on a scale of 1-5 which indicated that 1 was more informative and 프라그마틱 슈가러쉬 5 was more practical. The domains were recruitment setting, setting, intervention delivery with flexibility, follow-up and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal and colleagues10 developed an adaptation to this assessment dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic systematic reviews had higher average scores in the majority of domains but lower scores in the primary analysis domain.

This distinction in the main analysis domain could be due to the fact that the majority of pragmatic trials process their data in the intention to treat way, whereas some explanatory trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains of the organization, 프라그마틱 게임 정품 확인법 (just click the following web page) flexibility of delivery and follow-up were merged.

It is important to note that a pragmatic trial doesn't necessarily mean a low-quality trial, and there is a growing number of clinical trials (as defined by MEDLINE search, but it is neither specific or sensitive) that employ the term "pragmatic" in their abstracts or titles. These terms may indicate that there is a greater appreciation of pragmatism in abstracts and titles, however it's not clear whether this is evident in content.

Conclusions

In recent times, pragmatic trials are becoming more popular in research as the value 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 under development, they include patients which are more closely resembling those treated in routine care, they employ comparators which exist in routine practice (e.g. existing drugs) and depend on the self-reporting of participants about outcomes. This method could help overcome the limitations of observational research that are prone to limitations of relying on volunteers and the lack of accessibility and coding flexibility in national registry systems.

Pragmatic trials also have advantages, like the ability to draw on existing data sources and a higher probability of detecting meaningful differences than traditional trials. However, pragmatic trials may still have limitations that undermine their reliability and generalizability. For instance the participation rates in certain trials may 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). A lot of pragmatic trials are restricted by the need to enroll participants quickly. Additionally some 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 48 RCTs that self-described themselves as pragmatist and published from 2022. They assessed pragmatism by using the PRECIS-2 tool, which includes the domains eligibility criteria and recruitment criteria, as well as flexibility in adherence to interventions and follow-up. They found that 14 of these trials scored as highly or pragmatic sensible (i.e. scoring 5 or more) in any one or more of these domains, and that the majority were single-center.

Trials that have high pragmatism scores tend to have more criteria for eligibility than conventional RCTs. They also have populations from many different hospitals. The authors suggest that these characteristics could make pragmatic trials more meaningful and useful for daily practice, but they don't necessarily mean that a pragmatic trial is free of bias. Furthermore, the pragmatism of trials is not a predetermined characteristic A pragmatic trial that does not possess all the characteristics of an explanatory trial may yield reliable and relevant results.