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

Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that allows research into pragmatic trials. It collects and shares cleaned trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological research studies to evaluate the effect of treatment on trials that have different levels of pragmatism as well as other design features.

Background

Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the use of the term "pragmatic" is not consistent and its definition as well as assessment requires further clarification. Pragmatic trials are intended to guide the practice of clinical medicine and policy decisions, not to verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as similar to the real-world clinical environment as possible, such as its participation of participants, setting up and design, the delivery and execution of the intervention, and the determination and analysis of outcomes as well as primary analyses. This is a key distinction from explanation trials (as described by Schwartz and Lellouch1) which are designed to provide more thorough proof of an idea.

Truly pragmatic trials should not conceal participants or clinicians. This could lead to an overestimation of the effect of treatment. Pragmatic trials should also seek to recruit patients from a variety of health care settings so that their results can be applied to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are crucial for 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 cardiac failure. The trial with a catheter, however utilized symptomatic catheter-related urinary tract infection as its primary outcome.

In addition to these characteristics pragmatic trials should also reduce trial procedures and data-collection requirements to reduce costs and time commitments. Additionally the aim of pragmatic trials is to make their findings as relevant to real-world clinical practice as is possible. This can be achieved by ensuring their primary analysis is based on an intention-to treat approach (as described within CONSORT extensions).

Many RCTs that do not meet the criteria for pragmatism, but have features that are contrary to pragmatism, have been published in journals of different types and incorrectly labeled as pragmatic. This can lead to misleading claims about pragmatism, and the usage of the term should be standardised. The creation of the PRECIS-2 tool, which offers an objective and standard assessment of practical features, is a good first step.

Methods

In a pragmatic research study the aim is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine treatment in real-world contexts. Explanatory trials test hypotheses about the cause-effect relation within idealized environments. In this way, pragmatic trials could have less internal validity than studies that explain and be more prone to biases in their design as well as analysis and conduct. Despite their limitations, pragmatic research can provide valuable information to make decisions in the healthcare context.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by assessing it on 9 domains that range from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruitment, organisation, flexibility: delivery, flexible adherence and follow-up domains received high scores, however, the primary outcome and the method of missing data fell below the limit of practicality. This suggests that it is possible to design a trial using excellent pragmatic features without damaging the quality of its outcomes.

It is, however, difficult to determine how pragmatic a particular trial is since pragmaticity is not a definite characteristic; certain aspects of a trial can be more pragmatic than others. The pragmatism of a trial can be affected by modifications to the protocol or logistics during the trial. Additionally 36% of the 89 pragmatic trials identified by Koppenaal and colleagues were placebo-controlled or conducted prior to licensing and most were single-center. Thus, they are not very close to usual practice and can only be described as pragmatic if their sponsors are tolerant of the lack of blinding in these trials.

Another common aspect of pragmatic trials is that researchers attempt to make their findings more meaningful by analysing subgroups of the trial. This can lead to imbalanced analyses and lower statistical power. This increases the risk of omitting or misinterpreting differences in the primary outcomes. This was a problem in the meta-analysis of pragmatic trials as secondary outcomes were not adjusted for covariates that differed at the baseline.

Additionally, studies that are pragmatic can present challenges in the collection and interpretation of safety data. This is due to the fact that adverse events are generally reported by the participants themselves and prone to delays in reporting, inaccuracies or coding deviations. It is important to improve the accuracy and quality of the results in these trials.

Results

While the definition of pragmatism may not mean that trials must be 100 100% pragmatic, there are some advantages of including pragmatic elements in clinical trials. These include:

By incorporating routine patients, the results of the trial can be more quickly translated into clinical practice. However, pragmatic trials may also have disadvantages. The right type of heterogeneity for instance could allow a study to generalise its findings to many different patients or settings. However the wrong type of heterogeneity could reduce the assay sensitivity and, consequently, lessen the power of a trial to detect even minor effects of treatment.

Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework to distinguish between explanation-based trials that support a clinical or physiological hypothesis and pragmatic trials that help in the choice of appropriate therapies in the real-world clinical setting. The framework was composed of nine domains evaluated on a scale of 1-5 with 1 being more lucid while 5 being more pragmatic. The domains were recruitment, setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 had similar domains and scales from 1 to 5. Koppenaal et al10 devised an adaptation of this assessment, dubbed the Pragmascope that was simpler to use in systematic reviews. They found 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 can be explained by the way most pragmatic trials analyse data. Some explanatory trials, however, do not. The overall score for 프라그마틱 체험 프라그마틱 슬롯 하는법체험 (https://thebookmarkfree.com/Story18213198/10-apps-that-can-help-you-manage-your-free-pragmatic) systematic reviews that were pragmatic was lower when the areas of organisation, flexible delivery and following-up were combined.

It is important to remember that a pragmatic trial does not necessarily mean a low-quality trial, and in fact there is a growing number of clinical trials (as defined by MEDLINE search, but this is not specific nor sensitive) that employ the term 'pragmatic' in their abstract or title. The use of these words in abstracts and titles may suggest a greater awareness of the importance of pragmatism, but it is unclear whether this is manifested in the contents 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 clinical trials which compare real-world treatment options instead of experimental treatments in development, they include patients which are more closely resembling the patients who receive routine care, they use comparators that are used in routine practice (e.g. existing medications) and depend on participants' self-reports of outcomes. This approach can overcome the limitations of observational research such as the biases associated with the use of volunteers and the lack of codes that vary in national registers.

Other advantages of pragmatic trials are the possibility of using existing data sources, and a greater chance of detecting meaningful changes than traditional trials. However, pragmatic tests may be prone to limitations that undermine their reliability 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. Practical trials are often limited by the need to recruit participants on time. Additionally, some pragmatic trials lack controls to ensure that the observed differences are not due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described themselves as pragmatic. They assessed pragmatism using the PRECIS-2 tool, which consists of the eligibility criteria for domains as well as recruitment, flexibility in adherence to interventions, and follow-up. They discovered that 14 of these trials scored pragmatic or highly practical (i.e. scoring 5 or more) in one or 프라그마틱 정품확인방법 more of these domains, and that the majority were single-center.

Trials with a high pragmatism rating tend to have higher eligibility criteria than traditional RCTs, which include very specific criteria that aren't likely to be used in the clinical setting, and contain patients from a broad range of hospitals. According to the authors, could make pragmatic trials more useful and relevant to the daily practice. However they do not 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 possess all the characteristics of a explanatory trial can yield valid and useful results.