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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial, open data platform and infrastructure that supports research on pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2, allowing for multiple and diverse meta-epidemiological studies that compare treatment effects estimates across trials with different levels of pragmatism and other design features.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence to support clinical decision-making. However, the usage of the term "pragmatic" is not consistent and its definition and assessment requires clarification. The purpose of pragmatic trials is to guide clinical practice and policy decisions, rather than confirm the validity of a clinical or physiological hypothesis. A pragmatic trial should try to be as similar to the real-world clinical environment as possible, such as the recruitment of participants, setting and design of the intervention, its delivery and implementation of the intervention, determination and analysis of outcomes as well as primary analyses. This is a major difference from explanatory trials (as described by Schwartz and Lellouch1) which are designed to provide more thorough proof of an idea.

Studies that are truly pragmatic must avoid attempting to blind participants or the clinicians in order to cause bias in estimates of the effect of treatment. The pragmatic trials also include patients from various healthcare settings to ensure that their outcomes can be compared to the real world.

Furthermore the focus of pragmatic trials should be on outcomes that are important for patients, such as quality of life or functional recovery. This is particularly relevant for trials involving surgical procedures that are invasive or have potentially dangerous adverse events. The CRASH trial29, for example focused on the functional outcome to evaluate a two-page case report with an electronic system to monitor the health of hospitalized patients with chronic heart failure. Similarly, the catheter trial28 used urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these aspects, pragmatic trials should minimize the trial's procedures and data collection requirements in order to reduce costs. Additionally, pragmatic trials should seek to make their findings as relevant to actual clinical practice as is possible by ensuring that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

Many RCTs which do not meet the requirements for pragmatism but contain features contrary to pragmatism, have been published in journals of various types and incorrectly labeled as pragmatic. This can lead to false claims of pragmatism and the use of the term should be standardized. The development of the PRECIS-2 tool, which offers an objective standard for assessing practical features is a good initial step.

Methods

In a pragmatic trial it is the intention to inform clinical or policy decisions by demonstrating how an intervention would be implemented into routine care. This differs from explanation trials that test hypotheses regarding the causal-effect relationship in idealized conditions. Therefore, pragmatic trials could have less internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct, and analysis. Despite their limitations, pragmatic studies can be a valuable source of information to make decisions in the healthcare context.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study, the recruitment, organization, flexibility in delivery and follow-up domains were awarded high scores, however, the primary outcome and 프라그마틱 무료게임 the procedure for missing data were below the practical limit. This suggests that a trial can be designed with effective pragmatic features, without damaging the quality.

However, it is difficult to judge how practical a particular trial really is because pragmatism is not a binary characteristic; certain aspects of a study can be more pragmatic than others. Furthermore, logistical or protocol modifications during the course of a trial can change its score in pragmatism. Additionally, 36% of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or conducted before licensing and most were single-center. Therefore, they aren't as common and can only be described as pragmatic if their sponsors are tolerant of the lack of blinding in such trials.

A typical feature of pragmatic studies is that researchers try to make their findings more meaningful by studying subgroups of the trial sample. This can lead to imbalanced analyses and lower statistical power. This increases the possibility of omitting or ignoring differences in the primary outcomes. This was the case in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for differences in covariates at baseline.

In addition, pragmatic studies can present challenges in the collection and interpretation safety data. This is due to the fact that adverse events are usually self-reported and prone to reporting delays, inaccuracies or coding errors. It is crucial to increase the accuracy and quality of the outcomes in these trials.

Results

Although the definition of pragmatism does not require that all clinical trials are 100% pragmatic, there are benefits to including pragmatic components in trials. These include:

Enhancing sensitivity to issues in the real world, 프라그마틱 추천 [Www.Google.Co.Vi] reducing cost and size of the study, and enabling the trial results to be more quickly transferred into real-world clinical practice (by including routine patients). However, pragmatic trials may have disadvantages. For instance, the right type of heterogeneity could help a study to generalize its findings to a variety of settings and patients. However the wrong kind of heterogeneity may reduce the assay's sensitiveness and consequently reduce the power of a study to detect minor treatment effects.

Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 developed a framework to discern between explanation-based studies that support the physiological hypothesis or clinical hypothesis and 프라그마틱 무료 pragmatic studies that inform the selection of appropriate treatments in the real-world clinical practice. The framework was comprised of nine domains that were assessed on a scale of 1-5, with 1 being more informative and 5 was more pragmatic. The domains included recruitment, setting up, delivery of intervention, flex adherence and primary analysis.

The original PRECIS tool3 featured similar domains and a scale of 1 to 5. Koppenaal et al10 developed an adaptation of the assessment, 프라그마틱 무료게임 (https://bookmarkzones.trade/story.php?title=11-creative-methods-to-write-about-pragmatic-slots) called the Pragmascope that was simpler to use for systematic reviews. They found that pragmatic systematic reviews had a higher average scores across all domains, but lower scores in the primary analysis domain.

This distinction in the primary analysis domain could be due to the fact that most pragmatic trials analyse their data in an intention to treat method however some explanation trials do not. The overall score for pragmatic systematic reviews was lower when the domains of organization, flexible delivery, and follow-up were merged.

It is important to remember that a pragmatic trial doesn't necessarily mean a low quality trial, and indeed there is an increasing rate of clinical trials (as defined by MEDLINE search, however it is neither sensitive nor specific) that employ the term "pragmatic" in their abstract or title. The use of these words in abstracts and titles could suggest a greater awareness of the importance of pragmatism but it is unclear whether this is reflected in the content of the articles.

Conclusions

In recent years, pragmatic trials have been increasing in popularity in research because the value of real-world evidence is increasingly recognized. They are clinical trials randomized that evaluate real-world alternatives to care instead of experimental treatments under development. They have patient populations that are more similar to those treated in routine medical care, they utilize comparators which exist in routine practice (e.g. existing drugs) and depend on the self-reporting of participants about outcomes. This method is able to overcome the limitations of observational research, such as the biases associated with the reliance on volunteers and the limited availability and coding variations in national registries.

Other benefits of pragmatic trials include the ability to use existing data sources, as well as a higher probability of detecting significant changes than traditional trials. However, they may still have limitations which undermine their reliability and generalizability. For instance the rates of participation in some trials may be lower than expected due to the healthy-volunteer effect and financial incentives or competition for participants from other research studies (e.g. industry trials). A lot of pragmatic trials are restricted by the need to enroll participants in a timely manner. 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 48 RCTs self-labeled as pragmatic and were published up to 2022. The PRECIS-2 tool was used to determine the pragmatism of these trials. It includes areas such as eligibility criteria and flexibility in recruitment, adherence to intervention, and follow-up. They discovered 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or higher) in at least one of these domains.

Trials with a high pragmatism rating tend to have more expansive eligibility criteria than traditional RCTs, which include very specific criteria that aren't likely to be found in the clinical setting, and comprise patients from a wide range of hospitals. The authors suggest that these characteristics can help make pragmatic trials more effective and relevant to daily practice, but they do not necessarily guarantee that a pragmatic trial is free of bias. The pragmatism principle is not a definite characteristic the test that does not possess all the characteristics of an explanatory study could still yield valid and useful outcomes.