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

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 gathers and distributes clean trial data, ratings, and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses that examine the effect of treatment across trials with different levels of pragmatism.

Background

Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. The term "pragmatic", however, is used inconsistently and its definition and measurement require clarification. Pragmatic trials must be designed to guide clinical practice and policy decisions, not to confirm the validity of a clinical or physiological hypothesis. A pragmatic trial should aim to be as similar to real-world clinical practice as is possible, including the participation of participants, setting and design, the delivery and implementation of the intervention, and the determination and analysis of outcomes and primary analyses. This is a key distinction from explanation trials (as described by Schwartz and 프라그마틱 슬롯 Lellouch1) which are designed to provide more thorough proof of the hypothesis.

The most pragmatic trials should not be blind participants or clinicians. This could lead to a bias in the estimates of the effect of treatment. The pragmatic trials also include patients from different health care settings to ensure that their results can be generalized to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are important to patients, such as quality of life or functional recovery. This is particularly important when trials involve the use of invasive procedures or could have harmful adverse consequences. The CRASH trial29, for instance focused on the functional outcome to compare a two-page report with an electronic system for monitoring of patients admitted to hospitals with chronic heart failure, and the catheter trial28 focused on urinary tract infections caused by catheters as the primary outcome.

In addition to these features the pragmatic trial should also reduce the procedures for conducting trials and data collection requirements in order to reduce costs. Finaly the aim of pragmatic trials is to make their results as applicable to current clinical practices as they can. This can be achieved by ensuring that their primary analysis is based on the intention to treat method (as described within CONSORT extensions).

Despite these criteria, many RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to false claims of pragmatism and the use of the term should be made more uniform. The development of a PRECIS-2 tool that provides a standardized objective assessment of pragmatic features is a good start.

Methods

In a pragmatic trial the goal is to inform clinical or policy decisions by demonstrating how the intervention can be incorporated into real-world routine care. This is distinct from explanation trials that test hypotheses about the causal-effect relationship in idealized conditions. In this way, pragmatic trials could have a lower internal validity than explanatory studies and be more prone to biases in their design, analysis, 프라그마틱 무료체험 and conduct. Despite these limitations, pragmatic trials can be a valuable source of information for decision-making in healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study, the domains of recruitment, organisation and flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the principal outcome and the method of missing data scored below the pragmatic limit. This suggests that a trial can be designed with effective pragmatic features, without damaging the quality.

However, it's difficult to judge the degree of pragmatism a trial is, since the pragmatism score is not a binary characteristic; certain aspects of a study can be more pragmatic than others. Additionally, logistical or protocol modifications made during a trial can change its score on pragmatism. Koppenaal and 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. This means that they are not quite as typical and are only pragmatic in the event that their sponsors are supportive of the lack of blinding in these trials.

Furthermore, a common feature of pragmatic trials is that researchers attempt to make their findings more relevant by analyzing subgroups of the trial. This can lead to unbalanced analyses with lower statistical power. This increases the possibility of omitting or ignoring differences in the primary outcomes. This was a problem during the meta-analysis of pragmatic trials as secondary outcomes were not adjusted for differences in covariates at 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 tend to be self-reported and are susceptible to errors, delays or coding variations. It is therefore crucial to improve the quality of outcome for these trials, ideally by using national registry databases instead of relying on participants to report adverse events on the trial's own database.

Results

Although the definition of pragmatism doesn't require that all clinical trials are 100% pragmatic there are benefits to including pragmatic components in trials. These include:

By including routine patients, the results of the trial can be more quickly translated into clinical practice. However, pragmatic trials can also have disadvantages. For example, the right type of heterogeneity can help the trial to apply its results to different settings and patients. However the wrong type of heterogeneity can reduce assay sensitivity and therefore reduce the power of a trial to detect small treatment effects.

Numerous studies have attempted to classify pragmatic trials with a variety of definitions and scoring systems. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that support a physiological hypothesis or clinical hypothesis, and pragmatic studies that inform the selection of appropriate treatments in the real-world clinical practice. The framework was comprised of nine domains evaluated on a scale of 1-5, with 1 being more explanatory while 5 was more pragmatic. The domains included recruitment setting, setting, intervention delivery with flexibility, 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 called the Pragmascope that was easier to use in systematic reviews. They discovered that pragmatic systematic reviews had a higher average score in most domains, with lower scores in the primary analysis domain.

The difference in the primary analysis domains could be due to the way in which most pragmatic trials analyse data. Certain explanatory trials however do not. The overall score was lower for pragmatic systematic reviews when the domains of the organization, flexibility of delivery and follow-up were merged.

It is crucial to keep in mind that a study that is pragmatic does not mean a low-quality trial. In fact, there is increasing numbers of clinical trials that employ the term "pragmatic" either in their title or abstract (as defined by MEDLINE but which is neither precise nor sensitive). These terms may indicate a greater appreciation of pragmatism in abstracts and titles, however it's unclear whether this is reflected in the content.

Conclusions

As the importance of real-world evidence grows popular, pragmatic trials have gained momentum in research. They are randomized trials that compare real world care alternatives to new treatments that are being developed. They include patient populations more closely resembling those treated in regular care. This method has the potential to overcome the limitations of observational studies which include the limitations of relying on volunteers and limited availability and the variability of coding in national registries.

Pragmatic trials offer other advantages, including the ability to leverage existing data sources, and a greater likelihood of detecting meaningful distinctions from traditional trials. However, pragmatic trials may be prone to limitations that compromise their credibility and generalizability. Participation rates in some trials could be lower than expected due to the health-promoting effect, financial incentives or competition from other research studies. The need to recruit individuals quickly limits the sample size and 프라그마틱 홈페이지 the impact of many practical trials. Some pragmatic trials also lack controls to ensure that the observed differences aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and that were published until 2022. They assessed pragmatism by using the PRECIS-2 tool, which includes the domains eligibility criteria as well as recruitment, flexibility in adherence to intervention and follow-up. They found that 14 of these trials scored as highly or pragmatic practical (i.e. scores of 5 or higher) in one or more of these domains and that the majority were single-center.

Trials that have a high pragmatism score tend to have higher eligibility criteria than traditional RCTs, which include very specific criteria that are not likely to be present in the clinical setting, and comprise patients from a wide variety of hospitals. According to the authors, could make pragmatic trials more relevant and useful in everyday practice. However, they don't guarantee that a trial will be free of bias. In addition, 프라그마틱 환수율 - Agency-social.com, the pragmatism that is present in a trial is not a definite characteristic and a pragmatic trial that doesn't have all the characteristics of an explanatory trial can yield valid and useful results.