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

Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that facilitates research into pragmatic trials. It collects and distributes clean trial data, ratings, and evaluations using PRECIS-2. This allows for diverse meta-epidemiological studies to evaluate the effects of treatment across trials of various levels of pragmatism.

Background

Pragmatic trials are increasingly acknowledged as providing evidence from the real world for clinical decision-making. However, the use of the term "pragmatic" is not consistent and its definition and evaluation requires clarification. Pragmatic trials should be designed to inform clinical practice and policy decisions, rather than to prove a physiological or clinical hypothesis. A pragmatic study should strive to be as close as it is to real-world clinical practices which include the recruiting participants, 프라그마틱 정품인증 setting, designing, delivery and execution of interventions, determination and analysis outcomes, and primary analyses. This is a major distinction from explanatory trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough confirmation of an idea.

Truely pragmatic trials should not conceal participants or the clinicians. This could lead to a bias in the estimates of the effect of treatment. Practical trials should also aim to enroll patients from a wide range of health care settings, to ensure that their findings can be applied to the real world.

Finally studies that are pragmatic should focus on outcomes that are important to patients, such as quality of life or functional recovery. This is especially important when it comes to trials that involve invasive procedures or those with potential dangerous adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals with chronic heart failure. The catheter trial28 however utilized symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these characteristics pragmatic trials should also reduce the procedures for conducting trials and requirements for data collection to cut down on costs and time commitments. Additionally the aim of pragmatic trials is to make their findings as applicable to current clinical practices as they can. This can be accomplished by ensuring that their primary analysis is based on the intention to treat approach (as described within CONSORT extensions).

Despite these criteria however, a large number of RCTs with features that challenge the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all types. This can result in misleading claims of pragmatism, and the use of the term needs to be standardized. The creation of a PRECIS-2 tool that offers an objective, standardized evaluation of the pragmatic characteristics is a first step.

Methods

In a practical study, the goal is to inform policy or clinical decisions by showing how an intervention can be integrated into routine treatment in real-world settings. Explanatory trials test hypotheses about the cause-effect relation within idealized conditions. Consequently, pragmatic trials may be less reliable than explanatory trials and may be more susceptible to bias in their design, conduct, and analysis. Despite their limitations, pragmatic studies can provide valuable information for 프라그마틱 환수율 decision-making within the context of healthcare.

The PRECIS-2 tool assesses the degree of pragmatism in an RCT by assessing it on 9 domains, ranging from 1 (very explicative) to 5 (very pragmatic). In this study the areas of recruitment, organization as well as flexibility in delivery flexible adherence, and follow-up scored high. However, the main outcome and method of missing data was scored below the pragmatic limit. This suggests that a trial can be designed with good practical features, but without harming the quality of the trial.

However, it's difficult to determine how practical a particular trial is, since pragmaticity is not a definite attribute; some aspects of a study can be more pragmatic than others. Additionally, logistical or protocol changes during an experiment can alter its pragmatism score. In addition 36% of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or conducted prior to licensing and most were single-center. They are not in line with the usual practice, and can only be referred to as pragmatic if the sponsors agree that the trials are not blinded.

Additionally, a typical feature of pragmatic trials is that researchers attempt to make their findings more valuable by studying subgroups of the trial. This can lead to unbalanced analyses that have lower statistical power. This increases the risk of omitting or ignoring differences in the primary outcomes. In the case of the pragmatic trials that were included in this meta-analysis this was a major issue since the secondary outcomes weren't adjusted for the differences in baseline covariates.

Additionally, studies that are pragmatic can pose difficulties in the collection and interpretation safety data. This is because adverse events are usually self-reported and prone to delays in reporting, inaccuracies or coding errors. It is important to increase the accuracy and quality of outcomes in these trials.

Results

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

Increasing sensitivity to real-world issues, reducing study size and cost, and enabling the trial results to be more quickly transferred into real-world clinical practice (by including patients who are routinely treated). However, pragmatic trials have disadvantages. For example, the right type of heterogeneity can help a trial to generalise its results to different settings and patients. However the wrong type of heterogeneity can reduce assay sensitivity, and thus decrease the ability of a study to detect minor treatment effects.

A variety of studies have attempted to classify pragmatic trials with a variety of definitions and scoring systems. Schwartz and Lellouch1 created a framework to differentiate between explanation studies that support a physiological or clinical hypothesis, and pragmatic studies that help inform the choice for appropriate therapies in real world clinical practice. The framework was comprised of nine domains, each scored on a scale ranging from 1 to 5, with 1 indicating more lucid and 5 suggesting more pragmatic. The domains covered recruitment, setting up, delivery of intervention, flex adherence and primary analysis.

The initial PRECIS tool3 had similar domains and a scale of 1 to 5. Koppenaal and colleagues10 developed 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 on average in all domains, but scored lower in the primary analysis domain.

This distinction in the primary analysis domains can be explained by the way that most pragmatic trials approach data. Some explanatory trials, however do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery, and follow-up were combined.

It is important to note that a pragmatic trial does not necessarily mean a low quality trial, and there is an increasing number of clinical trials (as defined by MEDLINE search, but this is neither sensitive nor specific) which use the word 'pragmatic' in their abstracts or titles. These terms may indicate that there is a greater understanding of pragmatism in abstracts and titles, however it's unclear if this is reflected in the content.

Conclusions

In recent years, pragmatic trials are gaining popularity in research as the value of real-world evidence is becoming increasingly acknowledged. They are randomized clinical trials that compare real-world care alternatives instead of experimental treatments under development. They involve patients that more closely mirror the patients who receive routine care, they use comparisons that are commonplace in practice (e.g., existing medications) and 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 coding variations in national registries.

Pragmatic trials also have advantages, like the ability to leverage existing data sources and a higher likelihood of detecting meaningful distinctions from traditional trials. However, these trials could be prone to limitations that compromise their reliability and generalizability. The participation rates in certain trials could be lower than expected due to the health-promoting effect, financial incentives, or competition from other research studies. The necessity to recruit people in a timely fashion also reduces the size of the sample and the impact of many practical trials. Some pragmatic trials also lack controls to ensure that observed variations aren't due to biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs self-labeled as pragmatist and published from 2022. They assessed pragmatism by using the PRECIS-2 tool, 프라그마틱 정품 사이트 프라그마틱 정품 확인법확인방법 (i was reading this) which includes the domains eligibility criteria, recruitment, flexibility in 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.

Studies that have high pragmatism scores tend to have more lenient criteria for eligibility than conventional RCTs. They also contain patients from a variety of hospitals. These characteristics, according to the authors, could make pragmatic trials more relevant and applicable in the daily clinical. However they do not guarantee that a trial will be free of bias. The pragmatism is not a fixed attribute and a test that does not have all the characteristics of an explanation study could still yield valid and useful outcomes.