• 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 permitting multiple and varied meta-epidemiological research studies to compare treatment effects estimates across trials that employ different levels of pragmatism as well as other design features.

Background

Pragmatic trials are becoming more widely recognized as providing real-world evidence to support clinical decision-making. The term "pragmatic", however, is a word that is often used in contradiction and its definition and measurement require further clarification. The purpose of pragmatic trials is to inform clinical practices and policy choices, rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should aim to be as close as is possible to real-world clinical practices that include recruitment of participants, setting, designing, delivery and 프라그마틱 무료체험 메타 execution of interventions, determination and analysis results, as well as primary analyses. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1), which are intended to provide a more thorough proof of a hypothesis.

The trials that are truly practical should be careful not to blind patients or the clinicians, as this may result in distortions in estimates of treatment effects. Pragmatic trials should also seek to enroll patients from a variety of health care settings, so that their results can be compared to the real world.

Additionally, clinical trials should be focused on outcomes that matter to patients, such as quality of life and functional recovery. This is especially important for trials that involve the use of invasive procedures or could have harmful adverse effects. The CRASH trial29, for example was focused on functional outcomes to compare a two-page report with an electronic system for the monitoring of patients in hospitals suffering from chronic heart failure. In addition, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these characteristics, pragmatic trials should minimize the trial procedures and data collection requirements to reduce costs. Finaly the aim of pragmatic trials is to make their results as applicable to current clinical practice as is possible. This can be accomplished by ensuring that their analysis is based on the intention to treat approach (as defined in CONSORT extensions).

Many RCTs that do not meet the criteria for pragmatism, but contain features contrary to pragmatism have been published in journals of various types and incorrectly labeled pragmatic. This can result in misleading claims of pragmaticity, and the usage of the term should be standardized. The development of the PRECIS-2 tool, which offers an objective and standard assessment of practical features is a good initial step.

Methods

In a practical study it is the intention to inform clinical or policy decisions by showing how an intervention could be integrated into routine care in real-world contexts. This is different from explanatory trials that test hypotheses about the causal-effect relationship in idealized situations. Therefore, pragmatic trials might have lower internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, ranging from 1 to 5 (very pragmatist). In this study, the areas of recruitment, organisation, flexibility in delivery, flexibility in adherence, and follow-up scored high. However, the main outcome and method of missing data scored below the pragmatic limit. This suggests that it is possible to design a trial that has high-quality pragmatic features, without damaging the quality of its outcomes.

It is difficult to determine the amount of pragmatism in a particular trial since pragmatism doesn't possess a specific characteristic. Some aspects of a study can be more pragmatic than others. Moreover, protocol or logistic modifications made during an experiment can alter its score in pragmatism. Additionally, 36% of the 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled or conducted prior to licensing, and the majority were single-center. This means that they are not very close to usual practice and can only be described as pragmatic when their sponsors are accepting of the lack of blinding in such trials.

A typical feature of pragmatic research is that researchers try to make their findings more meaningful by analyzing subgroups within the trial sample. However, this often leads to unbalanced comparisons with a lower statistical power, thereby increasing the chance of not or incorrectly detecting differences in the primary outcome. This was a problem during the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for covariates' differences at the baseline.

In addition the pragmatic trials may present challenges in the gathering and interpretation of safety data. It is because adverse events are usually self-reported, and therefore are prone to errors, delays or coding errors. It is crucial to improve the accuracy and quality of the outcomes in these trials.

Results

While the definition of pragmatism doesn't require that all clinical trials are 100% pragmatic There are advantages of including pragmatic elements in trials. These include:

By including routine patients, the results of the trial can be more quickly translated into clinical practice. However, pragmatic trials may also have disadvantages. For instance, the appropriate type of heterogeneity could help a trial to generalise its results to many different patients and settings; however the wrong type of heterogeneity can reduce assay sensitivity and therefore decrease the ability of a trial to detect small treatment effects.

A variety of studies have attempted to classify pragmatic trials using a variety of definitions and scoring methods. Schwartz and 프라그마틱 플레이 Lellouch1 developed an approach to distinguish between explanation-based trials that support a physiological or clinical hypothesis as well as pragmatic trials that help in the choice of appropriate therapies in clinical practice. The framework was comprised of nine domains, each scoring on a scale ranging from 1-5, with 1 indicating more explanatory and 5 indicating more pragmatic. The domains included recruitment and setting, delivery of intervention and follow-up, as well as flexible adherence and primary analysis.

The original PRECIS tool3 was an adapted version of the PRECIS tool3 that was based on the same scale and domains. Koppenaal and colleagues10 created an adaptation of the assessment, dubbed the Pragmascope which was more user-friendly to use for systematic reviews. They discovered that pragmatic reviews scored higher on average across all domains, however they scored lower in the primary analysis domain.

This difference in primary analysis domains could be explained by the way most pragmatic trials analyse data. Some explanatory trials, however, do not. The overall score was lower for 프라그마틱 게임 pragmatic systematic reviews when the domains on the organization, flexibility of delivery and follow-up were combined.

It is important to remember that the term "pragmatic trial" does not necessarily mean a low quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, however this is neither specific or sensitive) which use the word "pragmatic" in their abstracts or titles. These terms may signal an increased understanding of pragmatism in abstracts and titles, but it's unclear whether this is reflected in content.

Conclusions

As the value of evidence from the real world becomes more commonplace the pragmatic trial has gained popularity in research. They are randomized trials that compare real world treatment options with clinical trials in development. They are conducted with populations of patients more closely resembling those treated in regular care. This approach can overcome the limitations of observational research, for example, the biases associated with the use of volunteers and the lack of codes that vary in national registers.

Pragmatic trials offer other advantages, including the ability to use existing data sources and a greater chance of detecting significant differences than traditional trials. However, these tests could have some limitations that limit their validity and generalizability. Participation rates in some trials could be lower than anticipated due to the health-promoting effect, financial incentives or competition from other research studies. The need to recruit individuals in a timely manner also limits the sample size and impact of many pragmatic trials. Practical trials aren't always equipped with controls to ensure that any observed variations aren't due to biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published up to 2022. They assessed pragmatism by using the PRECIS-2 tool, which includes the eligibility criteria for domains as well as recruitment, 프라그마틱 공식홈페이지 무료 (kredit-1500000.mosgorkredit.ru) flexibility in adherence to interventions, and follow-up. They found that 14 of these trials scored pragmatic or highly pragmatic (i.e. scores of 5 or more) in one or more of these domains, and that the majority of these were single-center.

Trials with a high pragmatism rating tend to have more expansive eligibility criteria than traditional RCTs which have very specific criteria that are not likely to be found in clinical practice, and they include populations from a wide range of hospitals. According to the authors, can make pragmatic trials more relevant and useful in everyday practice. However, they cannot guarantee that a trial is free of bias. Furthermore, the pragmatism of a trial is not a fixed attribute; a pragmatic trial that doesn't contain all the characteristics of a explanatory trial can produce valid and useful results.