• 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 distributes cleaned trial data, ratings, and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological studies to evaluate the effects of treatment across trials of various levels of pragmatism.

Background

Pragmatic studies provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however, is used inconsistently and its definition and evaluation need further clarification. The purpose of pragmatic trials is to guide the practice of clinical medicine and policy choices, rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should aim to be as close as is possible to the real-world clinical practice that include recruiting participants, setting, designing, implementation and delivery of interventions, determination and analysis results, as well as primary analysis. This is a significant difference between explanatory trials as defined by Schwartz & Lellouch1, which are designed to test a hypothesis in a more thorough way.

The trials that are truly practical should avoid attempting to blind participants or healthcare professionals in order to result in bias in the estimation of the effect of treatment. Pragmatic trials should also seek to recruit patients from a wide range of health care settings so that their results are generalizable to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are vital for patients, such as quality of life or functional recovery. This is particularly relevant when it comes to trials that involve invasive procedures or those with potentially serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The catheter trial28, however, used symptomatic catheter associated urinary tract infection as its primary outcome.

In addition to these features pragmatic trials should also reduce the requirements for data collection and trial procedures to reduce costs and time commitments. Furthermore pragmatic trials should strive to make their findings as applicable to real-world clinical practice as they can by ensuring that their primary analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Despite these guidelines, many RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can result in misleading claims of pragmaticity, and the usage of the term must be standardized. The development of a PRECIS-2 tool that offers a standardized objective evaluation of the pragmatic characteristics is the first step.

Methods

In a pragmatic research study the aim is to inform policy or clinical decisions by showing how an intervention can be integrated into routine treatment in real-world settings. This differs from explanation trials that test hypotheses about the cause-effect relationship in idealised situations. In this way, pragmatic trials could have less internal validity than studies that explain and be more prone to biases in their design, analysis, and conduct. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study, the recruitment, organization, flexibility in delivery and follow-up domains were awarded high scores, but the primary outcome and the method of missing data were below the limit of practicality. This suggests that it is possible to design a trial that has good pragmatic features without compromising the quality of its outcomes.

However, it's difficult to determine how practical a particular trial really is because pragmatism is not a binary quality; certain aspects of a trial may be more pragmatic than others. A trial's pragmatism could be affected by modifications to the protocol or the logistics during the trial. Koppenaal and 프라그마틱 슬롯 무료 프라그마틱 슬롯 조작 (https://Xarakter.kz) colleagues found that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to licensing. They also found that the majority were single-center. Thus, they are not quite as typical and can only be called pragmatic if their sponsors are tolerant of the lack of blinding in these trials.

Additionally, a typical feature of pragmatic trials is that researchers attempt to make their findings more valuable by studying subgroups of the sample. However, this often leads to unbalanced comparisons with a lower statistical power, thereby increasing the chance of not or misinterpreting the results of 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 that differed at the time of baseline.

In addition the pragmatic trials may be a challenge in the gathering and interpretation of safety data. This is due to the fact that adverse events tend to be self-reported, and therefore are prone to delays, errors or coding errors. Therefore, it is crucial to improve the quality of outcomes for these trials, and ideally by using national registries rather than relying on participants to report adverse events in the trial's database.

Results

While 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:

Increased sensitivity to real-world issues which reduces cost and size of the study as well as allowing trial results to be more quickly transferred into real-world clinical practice (by including patients from routine care). But pragmatic trials can have disadvantages. For instance, the right type of heterogeneity can help the trial to apply its findings to a variety of patients and settings; 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.

Several studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that prove a physiological or clinical hypothesis, and pragmatic studies that inform the choice for appropriate therapies in clinical practice. Their framework included nine domains that were scored on a scale ranging from 1 to 5, with 1 indicating more lucid and 5 indicating more pragmatic. The domains were recruitment setting, setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 was based on a similar scale and domains. Koppenaal et al10 created an adaptation to this assessment dubbed the Pragmascope that was easier to use in systematic reviews. They found that pragmatic systematic reviews had a higher average score in most domains but lower scores in the primary analysis domain.

The difference in the main analysis domain could be explained by the fact that the majority of pragmatic trials analyze their data in an intention to treat manner however some explanation trials do not. The overall score for systematic reviews that were pragmatic was lower when the areas of management, flexible delivery and follow-up were merged.

It is important to understand that the term "pragmatic trial" does not necessarily mean a low-quality trial, and in fact there is an increasing rate of clinical trials (as defined by MEDLINE search, but this is neither specific nor sensitive) that employ the term "pragmatic" in their title or abstract. The use of these terms in titles and abstracts could suggest a greater awareness of the importance of pragmatism but it isn't clear if this is reflected in the content of the articles.

Conclusions

In recent years, pragmatic trials are becoming more popular in research as the value of real-world evidence is increasingly recognized. They are randomized trials that compare real world care alternatives to clinical trials 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 overcome the limitations of observational research, like the biases that come with the reliance on volunteers as well as the insufficient availability and coding variations in national registries.

Pragmatic trials have other advantages, such as the ability to draw on existing data sources and a greater chance of detecting significant differences than traditional trials. However, they may have some limitations that limit their reliability and generalizability. Participation rates in some trials may be lower than anticipated because of the healthy-volunteering 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 impact of many pragmatic trials. In addition some pragmatic trials don't have controls to ensure that the observed differences are not due to biases in trial conduct.

The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described as pragmatic. They evaluated pragmatism using the PRECIS-2 tool that includes the eligibility criteria for domains as well as recruitment, flexibility in intervention adherence, 프라그마틱 슬롯 무료체험 and follow-up. They discovered that 14 of the trials scored highly or pragmatic pragmatic (i.e., scoring 5 or more) in any one or more of these domains and that the majority of them were single-center.

Trials with high pragmatism scores are likely to have more criteria for eligibility than traditional RCTs. They also include patients from a variety of hospitals. According to the authors, can make pragmatic trials more relevant and 프라그마틱 데모 applicable in the daily clinical. However, they cannot ensure that a study is free of bias. The pragmatism principle is not a fixed characteristic the test that does not have all the characteristics of an explicative study may still yield valid and useful outcomes.