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

• 페이스북 공유
• 트위터 공유
• 

Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a free and 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 diverse meta-epidemiological analyses to 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 not used in a consistent manner and its definition and measurement require clarification. Pragmatic trials are designed to guide the practice of clinical medicine and policy choices, rather than prove a physiological or clinical hypothesis. A pragmatic trial should strive to be as close to real-world clinical practice as possible, such as its selection of participants, setting up and design as well as the implementation of the intervention, determination and analysis of outcomes and primary analyses. This is a major difference from explanatory 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 could cause bias in the estimation of the effects of treatment. Pragmatic trials should also seek to enroll patients from a wide range of health care settings, to ensure that the results are generalizable to the real world.

Additionally, clinical trials should concentrate on outcomes that are important to patients, like the quality of life and functional recovery. This is especially important in trials that require surgical procedures that are invasive or may have serious adverse impacts. The CRASH trial29, for instance, focused on functional outcomes to compare a two-page report with an electronic system for monitoring of patients in hospitals suffering from chronic heart failure. Similarly, the catheter trial28 utilized urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these features the pragmatic trial should also reduce the trial procedures and data collection requirements in order to reduce costs. Additionally, pragmatic trials should aim to make their results as applicable to current clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on an intention-to treat method (as defined in CONSORT extensions).

Despite these criteria, many RCTs with features that challenge pragmatism have been incorrectly self-labeled pragmatic and published in journals of all types. This can result in misleading claims of pragmatism and the usage of the term must be standardized. The development of the PRECIS-2 tool, which provides a standard objective assessment of pragmatic features is a good initial step.

Methods

In a practical trial the goal is to inform policy or clinical decisions by demonstrating how an intervention would be integrated into everyday routine care. This is different from explanatory trials that test hypotheses regarding the cause-effect connection in idealized conditions. Consequently, pragmatic trials may have lower internal validity than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can be a valuable source of information for decision-making within the healthcare context.

The PRECIS-2 tool assesses the level of pragmatism that is present in an RCT by scoring it across 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruit-ment organization, flexibility in delivery and follow-up domains were awarded high scores, however, the primary outcome and the method for missing data were not at the limit of practicality. This suggests that a trial could be designed with effective pragmatic features, without damaging the quality.

It is difficult to determine the degree of pragmatism that is present in a trial since pragmatism doesn't have a single characteristic. Certain aspects of a study can be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or logistics during the trial. Additionally, 36% of the 89 pragmatic trials identified by Koppenaal et al were placebo-controlled or conducted before licensing and most were single-center. Thus, they are not very close to usual practice 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 studies is that researchers attempt to make their findings more meaningful by analyzing subgroups within the trial sample. This can lead to unbalanced results and lower statistical power, thereby increasing the risk of either not detecting or incorrectly detecting differences in the primary outcome. In the case of the pragmatic studies included in this meta-analysis this was a major issue because the secondary outcomes weren't adjusted for differences in baseline covariates.

Furthermore the pragmatic trials may be a challenge in the gathering and interpretation of safety data. This is because adverse events are typically reported by participants themselves and are prone to reporting errors, delays or coding deviations. It is therefore crucial to improve the quality of outcome ascertainment in these trials, ideally by using national registries instead of relying on participants to report adverse events on a trial's own database.

Results

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

Enhancing sensitivity to issues in the real world as well as reducing the size of studies and their costs, and enabling the trial results to be faster implemented into clinical practice (by including routine patients). But pragmatic trials can be a challenge. The right type of heterogeneity, for example, can help a study extend its findings to different settings or patients. However, the wrong type can reduce the sensitivity of an assay, 프라그마틱 무료게임 and therefore reduce a trial's power to detect small treatment effects.

A variety of studies have attempted to classify pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework for distinguishing between research studies that prove a clinical or physiological hypothesis and pragmatic trials that aid 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 explanatory while 5 was more practical. The domains included recruitment and setting, 프라그마틱 정품인증 delivery of intervention, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 had similar domains and an assessment scale ranging from 1 to 5. Koppenaal and colleagues10 developed an adaptation to this assessment called the Pragmascope that was easier to use in systematic reviews. They found that pragmatic systematic reviews had higher average scores in the majority of domains, but lower scores in the primary analysis domain.

This distinction in the analysis domain that is primary could be explained by the fact that most pragmatic trials analyse their data in the intention to treat method, whereas some explanatory trials do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organization, flexible delivery, and follow-up were merged.

It is important to remember that a pragmatic study does not necessarily mean a low-quality study. In fact, there are an increasing number of clinical trials which use the term 'pragmatic' either in their abstract or title (as defined by MEDLINE but which is neither precise nor sensitive). These terms may indicate a greater understanding of pragmatism in titles and abstracts, but it isn't clear whether this is reflected in content.

Conclusions

In recent years, pragmatic trials have been gaining popularity in research as the value of real-world evidence is increasingly recognized. They are randomized trials that evaluate real-world care alternatives to clinical trials in development. They involve patient populations closer to those treated in regular care. This method is able to overcome the limitations of observational research for example, the biases that are associated with the reliance on volunteers, and the limited availability and coding variations in national registries.

Pragmatic trials have other advantages, including the ability to leverage existing data sources, and a greater likelihood of detecting meaningful differences than traditional trials. However, they may be prone to limitations that compromise their reliability and generalizability. The participation rates in certain 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 restricted by the necessity to recruit participants quickly. Certain pragmatic trials lack controls to ensure that the observed variations aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs that were published between 2022 and 2022 that self-described themselves as pragmatic. The PRECIS-2 tool was used to evaluate the degree of pragmatism. It covers domains such as eligibility criteria as well as recruitment flexibility and 프라그마틱 무료 슬롯 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.

Studies with high pragmatism scores are likely to have broader criteria for 프라그마틱 슬롯 무료 eligibility than traditional RCTs. They also have populations from many different hospitals. According to the authors, can make pragmatic trials more useful and relevant to the daily practice. However, 프라그마틱 정품확인방법 they don't guarantee that a trial is free of bias. The pragmatism principle is not a fixed attribute and a test that doesn't have all the characteristics of an explanation study may still yield reliable and beneficial results.