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

Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that enables 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 provide real-world evidence that can be used to make clinical decisions. The term "pragmatic" however, is a word that is often used in contradiction and its definition and evaluation need further clarification. Pragmatic trials must be designed to inform clinical practice and policy decisions, rather than confirm the validity of a clinical or physiological hypothesis. A pragmatic study should strive to be as close to real-world clinical practice as is possible, including its selection of participants, setting and design as well as the execution of the intervention, 프라그마틱 슬롯 조작 determination and analysis of outcomes as well as primary analysis. This is a key distinction from explanation trials (as described by Schwartz and Lellouch1), which are intended to provide a more thorough confirmation of a hypothesis.

Trials that are truly practical should avoid attempting to blind participants or healthcare professionals, as this may cause bias in the estimation of treatment effects. Pragmatic trials will also recruit patients from various healthcare settings to ensure that their results can be generalized to the real world.

Furthermore the focus of pragmatic trials should be on outcomes that are vital for patients, such as quality of life or functional recovery. This is especially important when trials involve the use of invasive procedures or could have harmful adverse impacts. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients suffering from chronic cardiac failure. The catheter trial28 on the other hand utilized symptomatic catheter-related urinary tract infection as the primary outcome.

In addition to these aspects pragmatic trials should reduce the requirements for data collection and trial procedures to cut costs and time commitments. Additionally, pragmatic trials should seek to make their findings as applicable to real-world clinical practice as possible by ensuring that their primary analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs which do not meet the requirements for pragmatism however, they have characteristics that are contrary to pragmatism have been published in journals of different types and incorrectly labeled pragmatic. This can lead to false claims of pragmatism and the usage of the term should be made more uniform. The development of the PRECIS-2 tool, which offers a standard objective assessment of pragmatic features is a good initial step.

Methods

In a pragmatic study the aim is to inform clinical or policy decisions by showing how an intervention can be integrated into routine treatment in real-world settings. Explanatory trials test hypotheses about the cause-effect relation within idealized environments. Therefore, pragmatic trials could have less internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials may contribute valuable information to decision-making in healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatic). In this study, the recruit-ment organization, flexibility in delivery and follow-up domains scored high scores, however, 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 with good pragmatic features without damaging the quality of its results.

However, it is difficult to assess the degree of pragmatism a trial really is because the pragmatism score is not a binary attribute; some 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. In addition 36% of 89 pragmatic trials identified by Koppenaal and co. were placebo-controlled or conducted before licensing, 프라그마틱 정품확인방법 and the majority were single-center. They aren't in line with the usual practice and can only be referred to as pragmatic if their sponsors accept that such trials aren't blinded.

A common feature of pragmatic studies is that researchers attempt to make their findings more meaningful by analyzing subgroups within the trial. However, this often leads to unbalanced comparisons and lower statistical power, increasing the chance of not or incorrectly detecting differences in the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates that differed at the baseline.

In addition, pragmatic studies can present challenges in the collection and interpretation safety data. This is due to the fact that adverse events are generally reported by the participants themselves and are susceptible to delays in reporting, inaccuracies, or coding variations. Therefore, it is crucial to enhance the quality of outcomes for these trials, and ideally by using national registries instead of relying on participants to report adverse events on a trial's own database.

Results

Although the definition of pragmatism may not require that all trials be 100% pragmatic, there are advantages of including pragmatic elements in clinical trials. These include:

Increased sensitivity to real-world issues as well as reducing the size of studies and their costs and allowing the study results to be more quickly implemented into clinical practice (by including patients from routine care). However, pragmatic trials have their disadvantages. For instance, the appropriate kind of heterogeneity can allow 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 thus decrease the ability of a trial to detect small treatment effects.

Numerous studies have attempted to categorize pragmatic trials, 프라그마틱 플레이 using various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework that can discern between explanation-based studies that support the physiological hypothesis or clinical hypothesis, and pragmatic studies that inform the choice for appropriate therapies in the real-world clinical practice. The framework was composed of nine domains assessed on a scale of 1-5 with 1 being more informative and 5 was more practical. The domains were recruitment setting, setting, intervention delivery, flexible adherence, follow-up 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 et al10 created an adaptation of this assessment dubbed the Pragmascope which was more user-friendly to use in systematic reviews. They discovered that pragmatic reviews scored higher across all domains, however they scored lower in the primary analysis domain.

The difference in the primary analysis domains can be explained by the way most pragmatic trials analyze data. Some explanatory trials, however do not. The overall score was lower for pragmatic systematic reviews when the domains of organisation, flexible delivery and follow-up were merged.

It is important to remember that a study that is pragmatic does not mean a low-quality trial. In fact, there is an increasing number of clinical trials which use the term "pragmatic" either in their abstracts or titles (as defined by MEDLINE however it is neither sensitive nor precise). The use of these words in abstracts and titles could indicate a greater understanding of the importance of pragmatism, but it isn't clear if this is reflected in the contents of the articles.

Conclusions

In recent years, pragmatic trials are increasing in popularity in research because the importance of real-world evidence is becoming increasingly acknowledged. They are clinical trials randomized which compare real-world treatment options instead of experimental treatments under development, they include patient populations which are more closely resembling those treated in routine care, they use comparators that are used in routine practice (e.g. existing drugs), and they depend on participants' self-reports of outcomes. This approach can help overcome the limitations of observational studies that are prone to biases that arise from relying on volunteers and limited availability and coding variability in national registry systems.

Other advantages of pragmatic trials are the ability to use existing data sources, as well as a higher probability of detecting significant changes than traditional trials. However, 프라그마틱 불법 pragmatic tests may still have limitations which undermine their effectiveness and generalizability. Participation rates in some trials could be lower than expected because of the healthy-volunteering effect, financial incentives, or competition from other research studies. A lot of pragmatic trials are limited by the need to recruit participants on time. Some pragmatic trials also lack 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-described themselves as pragmatic and that were published up to 2022. They assessed pragmatism by using the PRECIS-2 tool, which consists of the eligibility criteria for domains, recruitment, flexibility in adherence to intervention, and follow-up. They discovered 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials with a high pragmatism score tend to have higher eligibility criteria than traditional RCTs, which include very specific criteria that aren't likely to be present in clinical practice, and they comprise patients from a wide range of hospitals. These characteristics, according to the authors, may make pragmatic trials more useful and relevant to the daily clinical. However, they don't guarantee that a trial will be free of bias. The pragmatism characteristic is not a fixed attribute; a pragmatic test that does not have all the characteristics of an explanatory study may still yield reliable and beneficial results.