• 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 cleaned trial data, ratings and evaluations using PRECIS-2. This permits a variety of meta-epidemiological analyses that 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. The term "pragmatic", however, is used inconsistently and its definition and evaluation require clarification. Pragmatic trials are designed to guide clinical practices and policy choices, rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic study should strive to be as close to actual clinical practice as is possible, including the selection of participants, setting and design, the delivery and implementation of the intervention, determination and analysis of outcomes as well as primary analyses. This is a major 프라그마틱 무료슬롯 distinction between explanation-based trials, as defined by Schwartz & Lellouch1, which are designed to prove the hypothesis in a more thorough way.

The most pragmatic trials should not blind participants or clinicians. This can lead to a bias in the estimates of the effect of treatment. Practical trials should also aim to recruit patients from a variety of health care settings to ensure that the results are generalizable to the real world.

Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, like quality of life and 프라그마틱 공식홈페이지 플레이 (Nyborg-hinson-4.technetbloggers.De) functional recovery. This is particularly important in trials that involve invasive procedures or those with potentially 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 on the other hand was based on symptomatic catheter-related urinary tract infection as its primary outcome.

In addition to these aspects pragmatic trials should reduce the procedures for conducting trials and data collection requirements in order to reduce costs. In the end, pragmatic trials should aim to make their results as relevant to real-world clinical practices as possible. This can be accomplished by ensuring their primary analysis is based on the intention-to treat approach (as described within CONSORT extensions).

Despite these guidelines, a number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This could lead to misleading claims of pragmatism and the usage of the term should be standardized. The development of a PRECIS-2 tool that offers an objective and standardized evaluation of pragmatic aspects is the first step.

Methods

In a pragmatic trial the goal is to inform policy or 프라그마틱 무료체험 clinical decisions by demonstrating how an intervention would be integrated into everyday routine care. Explanatory trials test hypotheses about the cause-effect relation within idealized conditions. Therefore, pragmatic trials could have less internal validity than explanatory trials and may be more susceptible to bias in their design, conduct, and analysis. Despite their limitations, pragmatic studies can provide valuable data for making decisions within the healthcare context.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by assessing it across 9 domains, ranging from 1 (very explicative) to 5 (very pragmatic). In this study the areas of recruitment, organization and flexibility in delivery, flexible adherence and 프라그마틱 플레이 follow-up scored high. However, the primary outcome and the method for missing data scored below the pragmatic limit. This suggests that it is possible to design a trial with excellent pragmatic features without damaging the quality of its outcomes.

It is, however, difficult to judge the degree of pragmatism a trial really is because pragmatism is not a binary quality; certain aspects of a study can be more pragmatic than others. Additionally, logistical or protocol modifications made during the trial may alter its score in pragmatism. In addition 36% of 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled or conducted prior to approval and a majority of them were single-center. They are not in line with the standard practice and are only called pragmatic if their sponsors agree that these trials are not blinded.

Furthermore, a common feature of pragmatic trials is that researchers try to make their results more valuable by studying subgroups of the trial sample. However, this can lead to unbalanced comparisons and lower statistical power, increasing the chance of not or incorrectly detecting differences in the primary outcome. This was a problem during the meta-analysis of pragmatic trials as secondary outcomes were not adjusted for covariates that differed at the time of baseline.

In addition practical trials can be a challenge in the collection and interpretation of safety data. This is due to the fact that adverse events are usually self-reported, and therefore are prone to delays, errors or coding variations. It is essential to improve the accuracy and quality of outcomes in these trials.

Results

While the definition of pragmatism does not require that all trials be 100 percent pragmatic, there are benefits of including pragmatic elements in clinical trials. These include:

Incorporating routine patients, the results of trials can be more quickly translated into clinical practice. However, pragmatic trials may also have disadvantages. For example, the right type of heterogeneity could help a trial to generalise its findings to a variety of settings and patients. However the wrong type of heterogeneity may reduce the assay's sensitivity and therefore reduce the power of a trial to detect minor treatment effects.

A number of studies have attempted to classify pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 developed a framework for distinguishing between explanation-based trials that support the clinical or physiological hypothesis, and pragmatic trials that inform the selection of appropriate treatments in real-world clinical practice. The framework was comprised of nine domains that were scored on a 1-5 scale with 1 being more lucid while 5 was more pragmatic. The domains were recruitment setting, setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 featured similar domains and a scale of 1 to 5. Koppenaal and colleagues10 created an adaptation of the assessment, known as the Pragmascope that was simpler to use for systematic reviews. They found that pragmatic systematic reviews had a higher average score in most domains, with lower scores in the primary analysis domain.

This distinction in the analysis domain that is primary could be explained by the fact that the majority of pragmatic trials analyze their data in the intention to treat method however some explanation trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains on the organization, flexibility of delivery and follow-up were combined.

It is important to remember that a pragmatic trial does not necessarily mean a poor quality trial, and indeed there is an increasing rate of clinical trials (as defined by MEDLINE search, however this is not specific or sensitive) which use the word "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 isn't clear if this is manifested in the contents 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 compare real-world care alternatives rather than experimental treatments under development. They include patient populations that are more similar to the patients who receive routine care, they use comparators which exist in routine practice (e.g. existing medications), and they depend on the self-reporting of participants about outcomes. This approach can help overcome limitations of observational studies, such as the biases that arise from relying on volunteers and the lack of accessibility and coding flexibility in national registry systems.

Pragmatic trials offer other advantages, such as the ability to draw on existing data sources and a greater likelihood of detecting meaningful differences than traditional trials. However, these trials could be prone to limitations that compromise their validity and generalizability. The participation rates in certain trials may be lower than expected because of the healthy-volunteering effect, financial incentives or competition from other research studies. The requirement to recruit participants in a timely fashion also limits the sample size and the impact of many practical trials. Certain pragmatic trials lack controls to ensure that observed differences aren't caused by biases that occur 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 using the PRECIS-2 tool, which includes the eligibility criteria for domains, recruitment, flexibility in adherence to interventions 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.

Trials with a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs, which include very specific criteria that are not likely to be used in clinical practice, and they comprise patients from a wide range of hospitals. The authors suggest that these characteristics could make pragmatic trials more meaningful and applicable to everyday clinical practice, however they do not guarantee that a pragmatic trial is free from bias. The pragmatism principle is not a fixed attribute the test that does not have all the characteristics of an explanatory study can still produce valuable and valid results.