• 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 research studies to examine the effects of treatment across trials that have different levels of pragmatism and other design features.

Background

Pragmatic studies provide real-world evidence that can be used to make clinical decisions. However, the use of the term "pragmatic" is not consistent and its definition and assessment requires clarification. Pragmatic trials are intended to inform clinical practices and policy choices, rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should aim to be as close as is possible to real-world clinical practices, including recruitment of participants, setting, design, implementation and delivery of interventions, determining and analysis outcomes, and primary analyses. This is a major difference between explanation-based trials, as defined by Schwartz & Lellouch1 which are designed to confirm the hypothesis in a more thorough manner.

Trials that are truly pragmatic should be careful not to blind patients or the clinicians, as this may result in bias in the estimation of the effect of treatment. The trials that are pragmatic should also try to enroll patients from a variety of health care settings to ensure that their findings are generalizable to the real world.

Additionally the focus of pragmatic trials should be on outcomes that are important to patients, like quality of life or functional recovery. This is particularly important in trials that involve surgical procedures that are invasive or have potential serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals with chronic cardiac failure. The catheter trial28 however, used symptomatic catheter associated urinary tract infections as its primary outcome.

In addition to these features, pragmatic trials should minimize the trial procedures and data collection requirements to reduce costs. Furthermore pragmatic trials should strive to make their findings as relevant to actual clinical practice as they can by making sure that their primary method of analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

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 result in misleading claims of pragmatism and the use of the term should be standardized. The creation of a PRECIS-2 tool that offers a standardized objective evaluation of the pragmatic characteristics is a good start.

Methods

In a practical study the aim is to inform policy or clinical decisions by demonstrating how an intervention could be integrated into routine treatment in real-world settings. This is different from explanatory trials that test hypotheses regarding the causal-effect relationship in idealized conditions. In this way, pragmatic trials can have less internal validity than explanatory studies and be more susceptible to biases in their design, analysis, and conduct. Despite these limitations, pragmatic trials may contribute valuable information to decisions in the context of healthcare.

The PRECIS-2 tool assesses the degree of pragmatism within an RCT by scoring it across 9 domains, ranging from 1 (very explicit) to 5 (very pragmatic). In this study, the areas of recruitment, organisation and flexibility in delivery, flexible adherence and follow-up scored high. However, the main outcome and the method of missing data were scored below the practical limit. This suggests that it is possible to design a trial with good pragmatic features without compromising the quality of its outcomes.

However, it's difficult to determine how practical a particular trial is, since the pragmatism score is not a binary attribute; some aspects of a study can be more pragmatic than others. A trial's pragmatism could be affected by changes to the protocol or logistics during the trial. Koppenaal and colleagues found that 36% of the 89 pragmatic studies were placebo-controlled or conducted prior to licensing. The majority of them were single-center. Therefore, they aren't as common and can only be described as pragmatic in the event that their sponsors are supportive of the absence of blinding in these trials.

A typical feature of pragmatic research is that researchers attempt to make their findings more meaningful by analyzing subgroups of the trial sample. This can result in unbalanced analyses with less statistical power. This increases the possibility of omitting or ignoring differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis this was a significant problem since the secondary outcomes were not adjusted for the differences in the baseline covariates.

Furthermore, pragmatic studies can pose difficulties in the collection and interpretation safety data. This is because adverse events are typically reported by participants themselves and prone to reporting delays, inaccuracies or coding errors. It is crucial to increase the accuracy and quality of the results in these trials.

Results

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

By incorporating routine patients, the results of trials can be more quickly translated into clinical practice. But pragmatic trials can have disadvantages. For instance, the right kind of heterogeneity can allow the trial to apply its results to many different settings and patients. However, the wrong type of heterogeneity may reduce the assay's sensitivity, and thus reduce the power of a study to detect even minor effects of treatment.

Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 created a framework to distinguish between explanatory studies that confirm a physiological or clinical hypothesis, and pragmatic studies that help inform the choice for appropriate therapies in the real-world clinical practice. The framework consisted of nine domains assessed on a scale of 1-5 which indicated that 1 was more explanatory while 5 was more pragmatic. The domains were recruitment, 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 and colleagues10 developed 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 analysis domain that is primary could be due to the fact that the majority of pragmatic trials analyse their data in the intention to treat manner, whereas some explanatory trials do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery, 프라그마틱 슬롯 추천 and follow-up were merged.

It is crucial to keep in mind that a pragmatic study does not mean that a trial is of poor quality. In fact, 프라그마틱 홈페이지 there are increasing numbers of clinical trials that use the word 'pragmatic,' either in their title or abstract (as defined by MEDLINE but which is neither precise nor sensitive). The use of these terms in abstracts and titles could suggest a greater awareness of the importance of pragmatism, however, it is not clear if this is manifested in the contents of the articles.

Conclusions

In recent years, pragmatic trials have been becoming more popular in research as the value of real world evidence is becoming increasingly acknowledged. They are randomized studies that compare real-world alternatives to experimental treatments in development. They involve patient populations closer to those treated in regular medical care. This method can help overcome the limitations of observational research such as the biases that come with the use of volunteers as well as the insufficient availability and the coding differences in national registry.

Other advantages of pragmatic trials include the possibility of using existing data sources, and a greater likelihood of detecting meaningful changes than traditional trials. However, these tests could be prone to limitations that undermine their effectiveness and generalizability. Participation rates in some trials could be lower than expected due to the healthy-volunteering effect, financial incentives or competition from other research studies. The necessity to recruit people quickly reduces the size of the sample and the impact of many practical trials. Additionally, some pragmatic trials do not have controls to ensure that the observed differences aren't due to biases in trial conduct.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatic and that were published from 2022. They evaluated pragmatism using the PRECIS-2 tool that includes the eligibility criteria for domains and recruitment criteria, as well as flexibility in intervention adherence and follow-up. They discovered that 14 of the trials scored highly or pragmatic sensible (i.e. scores of 5 or more) in one or more of these domains, 프라그마틱 무료스핀 이미지, Http://Delphi.Larsbo.Org, and that the majority of them were single-center.

Trials with high pragmatism scores are likely to have broader criteria for eligibility than traditional RCTs. They also contain populations from various hospitals. The authors suggest that these characteristics can help make pragmatic trials more effective and relevant to daily practice, but they do not necessarily guarantee that a pragmatic trial is free from bias. Furthermore, the pragmatism of the trial is not a definite characteristic; a pragmatic trial that does not have all the characteristics of a explanatory trial can produce valuable and reliable results.