• 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 is a platform that collects and shares clean trial data and ratings using PRECIS-2 allowing for multiple and diverse meta-epidemiological studies that evaluate the effect of treatment on trials that employ different levels of pragmatism and other design features.

Background

Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world to support clinical decision-making. However, the use of the term "pragmatic" is not uniform and its definition and evaluation requires clarification. Pragmatic trials are designed to guide the practice of clinical medicine and policy decisions, not to confirm a physiological hypothesis or clinical hypothesis. A pragmatic study should aim 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, and the determination and analysis of the outcomes, and primary analyses. This is a major 프라그마틱 무료슬롯 distinction between explanation-based trials, as described by Schwartz and Lellouch1 that are designed to confirm a hypothesis in a more thorough manner.

Truly pragmatic trials should not conceal participants or the clinicians. This can result in a bias in the estimates of the effects of treatment. The trials that are pragmatic should also try to attract patients from a variety of health care settings, so that their results 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 particularly important when trials involve invasive procedures or have potentially serious adverse consequences. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients with chronic heart failure. The catheter trial28, on the other hand utilized symptomatic catheter-related urinary tract infection as the primary outcome.

In addition to these features, 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 applicable to current clinical practice as is possible. This can be achieved by ensuring that their primary analysis is based on an intention-to treat method (as described in CONSORT extensions).

Despite these requirements, a number of RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all types. This can lead to misleading claims about pragmatism, and the usage of the term should be standardized. The creation of the PRECIS-2 tool, which provides an objective standard for 프라그마틱 데모 assessing practical features, is a good first step.

Methods

In a pragmatic trial the goal is to inform policy or clinical decisions by demonstrating how an intervention would be integrated into everyday routine care. Explanatory trials test hypotheses regarding the cause-effect relation within idealized environments. Therefore, pragmatic trials might 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 be a valuable source of data for making decisions within the healthcare context.

The PRECIS-2 tool evaluates an RCT on 9 domains, ranging between 1 and 5 (very pragmatic). In this study, the recruit-ment, organization, flexibility in delivery, flexible adherence and follow-up domains received high scores, however, the primary outcome and the procedure for missing data were below the practical limit. This suggests that it is possible to design a trial with high-quality pragmatic features, without compromising the quality of its outcomes.

However, it is difficult to determine how pragmatic a particular trial is, since the pragmatism score is not a binary attribute; some aspects of a trial can be more pragmatic than others. Furthermore, logistical or protocol modifications during the course of the trial may alter its pragmatism score. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to licensing. The majority of them were single-center. Therefore, they aren't very close to usual practice and can only be called pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.

Another common aspect of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the sample. However, this often leads to unbalanced comparisons with a lower statistical power, which increases the likelihood of missing or misinterpreting differences in the primary outcome. In the case of the pragmatic trials included in this meta-analysis, this was a serious issue because the secondary outcomes were not adjusted to account for the differences in the baseline covariates.

Furthermore the pragmatic trials may have challenges with respect to the gathering and interpretation of safety data. This is due to the fact that adverse events are typically reported by participants themselves and are prone to reporting delays, inaccuracies or coding errors. It is therefore important to improve the quality of outcomes ascertainment in these trials, and ideally by using national registry databases instead of relying on participants to report adverse events in the trial's database.

Results

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

By incorporating routine patients, the results of trials are more easily translated into clinical practice. But pragmatic trials can be a challenge. For instance, the right type of heterogeneity can help a trial to generalise its results to different settings and patients. However the wrong type of heterogeneity may reduce the assay's sensitivity and therefore decrease the ability of a study to detect small treatment effects.

A number of studies have attempted to classify pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that confirm a physiological or clinical hypothesis, and pragmatic studies that guide the choice for appropriate therapies in the real-world clinical practice. The framework was composed of nine domains evaluated on a scale of 1-5 with 1 being more explanatory while 5 being more pragmatic. The domains covered recruitment of intervention, 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 of the assessment, called the Pragmascope, that was easier to use for systematic reviews. They found that pragmatic reviews scored higher on average across all domains, however they scored lower in the primary analysis domain.

The difference in the primary analysis domain could be explained by the fact that most pragmatic trials process their data in an intention to treat way however some explanation trials do not. The overall score for pragmatic systematic reviews was lower when the domains of management, flexible delivery and following-up were combined.

It is important to understand that a pragmatic trial does not necessarily mean a low quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, 프라그마틱 이미지 but it is neither sensitive nor specific) that use the term "pragmatic" in their abstract or title. The use of these terms in titles and abstracts could indicate a greater understanding of the importance of pragmatism however, it is not clear if this is manifested in the contents of the articles.

Conclusions

As the importance of real-world evidence becomes increasingly popular, pragmatic trials have gained momentum in research. They are randomized studies that compare real-world treatment options with experimental treatments in development. They are conducted with populations of patients that are more similar to those who receive treatment in regular medical care. This approach can help overcome limitations of observational studies which include the limitations of relying on volunteers and limited availability and coding variability in national registries.

Other benefits of pragmatic trials include the ability to utilize 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 effectiveness and generalizability. For instance the rates of participation in some trials could be lower than expected due to the healthy-volunteer effect as well as incentives to pay or compete for participants from other research studies (e.g. industry trials). Many pragmatic trials are also restricted by the need to recruit participants quickly. Practical trials aren't always equipped with controls to ensure that any observed variations aren't due to biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and that were published from 2022. The PRECIS-2 tool was employed to assess the pragmatism of these trials. It covers areas like eligibility criteria, recruitment flexibility, adherence to intervention, and 프라그마틱 정품 확인법 follow-up. They found that 14 of these trials scored highly or pragmatic sensible (i.e. scoring 5 or higher) in any one or more of these domains, and that the majority were single-center.

Trials with high pragmatism scores tend to have broader criteria for eligibility than conventional RCTs. They also have populations from many different hospitals. The authors suggest that these traits can make pragmatic trials more effective and relevant to daily practice, but they do not guarantee that a trial conducted in a pragmatic manner is free from bias. The pragmatism characteristic is not a fixed attribute and a test that does not possess all the characteristics of an explanatory study can still produce valuable and valid results.