• 목록
• 답변
• 글쓰기
• 게시판 리스트 옵션
  • 수정
  • 삭제

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 shares cleaned trial data and ratings using PRECIS-2 which allows for multiple and varied meta-epidemiological studies that evaluate the effect of treatment on trials with different levels of pragmatism as well as other design features.

Background

Pragmatic studies are increasingly acknowledged as providing evidence from the real world to support clinical decision-making. The term "pragmatic" however, is a word that is often used in contradiction and its definition and measurement require clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, rather than to prove the validity of a clinical or physiological hypothesis. A pragmatic trial should aim to be as close as is possible to the real-world clinical practice which include the recruitment of participants, setting, design, delivery and implementation of interventions, determining and analysis results, as well as primary analysis. This is a key distinction from explanatory trials (as described by Schwartz and 프라그마틱 무료체험 슬롯버프 Lellouch1), which are intended to provide a more thorough proof of an idea.

The most pragmatic trials should not be blind participants or the clinicians. This can lead to an overestimation of the effect of treatment. Pragmatic trials will also recruit patients from different healthcare settings to ensure that their results can be applied to the real world.

Additionally the focus of pragmatic trials should be on outcomes that are important for patients, such as quality of life or functional recovery. This is especially important when trials involve surgical procedures that are invasive or may have harmful adverse consequences. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients suffering from chronic cardiac failure. The catheter trial28 on the other hand utilized symptomatic catheter-related urinary tract infection as the primary outcome.

In addition to these aspects pragmatic trials should reduce the requirements for data collection and trial procedures to reduce costs and time commitments. Additionally, pragmatic trials should aim 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 that don't meet the criteria for pragmatism however, they have characteristics that are contrary to pragmatism, have been published in journals of varying types and incorrectly labeled pragmatic. This could lead to misleading claims of pragmaticity, and the usage of the term needs to be standardized. The development of the PRECIS-2 tool, which offers an objective and standard assessment of practical features, is a good first step.

Methods

In a practical trial, the aim is to inform clinical or policy decisions by demonstrating how an intervention would be incorporated into real-world routine care. Explanatory trials test hypotheses regarding the cause-effect relationship within idealised conditions. Therefore, pragmatic trials might be less reliable than explanatory trials, and could be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials may contribute valuable information to decision-making in healthcare.

The PRECIS-2 tool evaluates the degree of pragmatism within an RCT by scoring it across 9 domains, ranging from 1 (very explicative) to 5 (very pragmatic). In this study the areas of recruitment, organisation as well as flexibility in delivery flexible adherence, and follow-up were awarded high scores. However, the primary outcome and method of missing data was scored below the pragmatic limit. This suggests that a trial can be designed with well-thought-out practical features, but without compromising its quality.

It is hard to determine the degree of pragmatism that is present in a trial since pragmatism doesn't possess a specific attribute. Some aspects of a research study can be more pragmatic than others. A trial's pragmatism could be affected by modifications to the protocol or the logistics during the trial. Additionally, 36% of the 89 pragmatic trials identified by Koppenaal and colleagues were placebo-controlled or conducted before licensing and most were single-center. This means that they are not quite as typical and can only be described as pragmatic when their sponsors are accepting of the lack of blinding in these trials.

A typical feature of pragmatic research is that researchers attempt to make their findings more meaningful by analyzing subgroups of the trial sample. However, this can lead to unbalanced results and lower statistical power, which increases the chance of not or misinterpreting the results of the primary outcome. In the case of the pragmatic trials included in this meta-analysis, this was a significant problem since the secondary outcomes weren't adjusted for variations in the baseline covariates.

Furthermore, pragmatic trials can also have challenges with respect to the collection and interpretation of safety data. This is due to the fact that adverse events are usually self-reported and are susceptible to delays, inaccuracies or 프라그마틱 체험 coding differences. It is essential to increase the accuracy and quality of outcomes in these trials.

Results

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

By incorporating routine patients, the trial results can be more quickly translated into clinical practice. However, pragmatic trials can also have disadvantages. The right amount of heterogeneity, like could help a study expand its findings to different settings or patients. However the wrong type of heterogeneity could reduce the sensitivity of an assay and thus reduce a trial's power to detect even minor effects of treatment.

Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 created a framework for distinguishing between explanatory trials that confirm a clinical or 프라그마틱 정품 physiological hypothesis, and pragmatic trials that aid in the selection of appropriate therapies in real-world clinical practice. The framework consisted of nine domains that were evaluated on a scale of 1-5 which indicated that 1 was more informative and 5 was more practical. The domains covered recruitment, setting up, delivery of intervention, flexible adhering to the program and primary analysis.

The original PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et al10 devised an adaptation to this assessment, dubbed the Pragmascope which was more user-friendly to use in systematic reviews. They discovered that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.

This distinction in the analysis domain that is primary could be due to the fact that most pragmatic trials process their data in an intention to treat manner while some explanation trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains on organisation, flexible delivery, and follow-up were combined.

It is important to understand that a pragmatic trial doesn't 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 sensitive nor specific) which use the word 'pragmatic' in their abstract or title. These terms may signal that there is a greater appreciation of pragmatism in abstracts and titles, but it isn't clear whether this is evident in the content.

Conclusions

In recent years, pragmatic trials have been becoming more popular in research as the value of real world evidence is increasingly recognized. They are randomized clinical trials which compare real-world treatment options instead of experimental treatments in development, they involve patients which are more closely resembling those treated in routine care, they employ comparisons that are commonplace in practice (e.g. existing drugs), and they rely on participant self-report of outcomes. This method is able to overcome the limitations of observational research for example, the biases that come with the use of volunteers and the limited availability and 프라그마틱 무료체험 메타 codes that vary in national registers.

Pragmatic trials also have advantages, like the ability to use existing data sources and a higher probability of detecting meaningful differences than traditional trials. However, these tests could be prone to limitations that undermine their validity and generalizability. Participation rates in some trials may be lower than expected due to the health-promoting effect, financial incentives or competition from other research studies. Practical trials are often restricted by the need to recruit participants on time. In addition certain pragmatic trials lack controls to ensure that the observed differences aren't due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described as pragmatic. The PRECIS-2 tool was employed to evaluate the degree of pragmatism. It includes areas like eligibility criteria, recruitment flexibility and adherence to intervention 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 tend to have more criteria for eligibility than conventional RCTs. They also include populations from many different hospitals. These characteristics, according to the authors, may make pragmatic trials more relevant and useful in everyday practice. However, they cannot ensure that a study is free of bias. In addition, the pragmatism that is present in a trial is not a definite characteristic and a pragmatic trial that doesn't have all the characteristics of an explanatory trial can yield valid and useful results.