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

Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that supports research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2 which allows for multiple and varied meta-epidemiological studies that compare treatment effects estimates across trials that have different levels of pragmatism as well as other design features.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. The term "pragmatic" however, is used inconsistently and its definition and assessment need further clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, rather than confirm the validity of a clinical or physiological hypothesis. A pragmatic trial should try to be as similar to the real-world clinical environment as possible, such as the recruitment of participants, setting and design of the intervention, its delivery and execution of the intervention, as well as the determination and analysis of outcomes as well as primary analyses. This is a major difference from explanatory trials (as described by Schwartz and Lellouch1) which are intended to provide a more complete confirmation of an idea.

The trials that are truly pragmatic must not attempt to blind participants or clinicians in order to cause distortions in estimates of treatment effects. Practical trials should also aim to enroll patients from a wide range of health care settings so that their results are generalizable to the real world.

Additionally studies that are pragmatic should focus on outcomes that are crucial to patients, such as quality of life or functional recovery. This is particularly relevant when trials involve surgical procedures that are invasive or may have serious adverse consequences. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals with chronic heart failure. The trial with a catheter, however, used symptomatic catheter associated urinary tract infections as its 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. Finally, pragmatic trials should seek to make their results as relevant to actual clinical practice as possible by ensuring that their primary analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs that do not meet the requirements for pragmatism however, they have characteristics that are contrary to pragmatism, have been published in journals of varying kinds and incorrectly labeled pragmatic. This can lead to false claims of pragmaticity, and the use of the term should be standardized. The creation of a PRECIS-2 tool that offers an objective and standardized assessment of pragmatic features is a good start.

Methods

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

The PRECIS-2 tool measures the degree of pragmatism within an RCT by assessing it on 9 domains ranging from 1 (very explicit) to 5 (very pragmatic). In this study, the recruitment, organization, flexibility in delivery and follow-up domains received high scores, but the primary outcome and the method for missing data were below the practical limit. This suggests that a trial can be designed with good practical features, yet not compromising its quality.

However, it's difficult to judge how pragmatic a particular trial really is because pragmatism is not a binary characteristic; certain aspects of a study can be more pragmatic than others. Moreover, protocol or logistic modifications made during the trial may alter its score on pragmatism. Koppenaal and colleagues discovered that 36% of 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 very close to usual practice and can only be described as pragmatic if their sponsors are tolerant of the lack of blinding in such trials.

A common aspect 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 analyses that have lower statistical power. This increases the chance of missing or misdetecting differences in the primary outcomes. In the case of the pragmatic trials included in this meta-analysis this was a significant problem because the secondary outcomes weren't adjusted for the differences in 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 errors, delays or coding errors. It is important to increase the accuracy and quality of outcomes in these trials.

Results

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

Increased sensitivity to real-world issues which reduces study size and cost and allowing the study results to be faster transferred into real-world clinical practice (by including routine patients). However, pragmatic trials may have disadvantages. For instance, the appropriate type of heterogeneity could help the trial to apply its results to many different patients and settings; however the wrong type of heterogeneity could reduce assay sensitiveness and consequently lessen the ability of a study to detect small treatment effects.

Several studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 created a framework to discern between explanation-based studies that confirm a physiological or clinical hypothesis, and pragmatic studies that help inform the selection of appropriate treatments in the real-world clinical practice. Their framework included nine domains, each scoring on a scale of 1 to 5, with 1 being more informative and 5 indicating more practical. The domains included recruitment of intervention, setting up, delivery of intervention, flexible compliance 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 devised an adaptation of the assessment, dubbed the Pragmascope that was simpler to use for systematic reviews. They found 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 domain can be explained by the way that most pragmatic trials analyze data. Some explanatory trials, however, do not. The overall score was lower for systematic reviews that were pragmatic when the domains of the organization, flexibility of delivery and follow-up were combined.

It is important to remember that a pragmatic study does not mean a low-quality trial. In fact, there is an increasing number of clinical trials which use the word 'pragmatic,' either in their title or abstract (as defined by MEDLINE, but that is neither sensitive nor precise). These terms could indicate a greater appreciation of pragmatism in abstracts and titles, 프라그마틱 슬롯 사이트 but it's not clear if this is reflected in the content.

Conclusions

In recent years, 프라그마틱 공식홈페이지 pragmatic trials have been gaining popularity in research as the value of real world evidence is increasingly recognized. They are clinical trials randomized that compare real-world care alternatives instead of experimental treatments under development. They include populations of patients that more closely mirror 프라그마틱 불법 무료 (Pragmatickr64208.Theblogfairy.Com) those treated in routine care, they employ comparators that are used in routine practice (e.g., existing medications), and they depend on participants' self-reports of outcomes. This method can help overcome the limitations of observational research like the biases that are associated with the reliance on volunteers, and the limited availability and codes that vary in national registers.

Other advantages of pragmatic trials are the possibility of using existing data sources, and a higher probability of detecting significant changes than traditional trials. However, pragmatic tests may have some limitations that limit their effectiveness and generalizability. For example, participation rates in some trials might be lower than expected due to the healthy-volunteer influence and financial incentives or competition for participants from other research studies (e.g. industry trials). The necessity to recruit people in a timely manner also limits the sample size and impact of many pragmatic trials. Certain pragmatic trials lack controls to ensure that the observed differences aren't caused by biases in the trial.

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

Studies with high pragmatism scores tend to have broader criteria for eligibility than traditional RCTs. They also contain patients from a variety of hospitals. These characteristics, according to the authors, may make pragmatic trials more useful and useful in the daily clinical. However, they cannot ensure that a study is free of bias. Furthermore, the pragmatism of trials is not a definite characteristic A pragmatic trial that doesn't contain all the characteristics of a explanatory trial can yield valuable and reliable results.