• 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 facilitates research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological research studies to examine the effects of treatment across trials that have different levels of pragmatism, 프라그마틱 환수율 (google.bt) as well as other design features.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence to support clinical decision-making. The term "pragmatic", however, is a word that is often used in contradiction and its definition and measurement need further clarification. Pragmatic trials should be designed to guide clinical practice and 프라그마틱 슬롯 팁 환수율 (Read the Full Document) policy decisions, not to confirm a physiological or clinical hypothesis. A pragmatic trial should also try to be as similar to real-world clinical practice as possible, such as its recruitment of participants, setting up and design of the intervention, its delivery and implementation of the intervention, as well as the determination and analysis of the outcomes, and primary analyses. This is a key distinction from explanation trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough proof of an idea.

Truely pragmatic trials should not blind participants or clinicians. This can lead to bias in the estimations of treatment effects. Practical trials should also aim to recruit patients from a variety of health care settings, so that their results are generalizable to the real world.

Finally, pragmatic trials should focus on outcomes that are vital to patients, such as quality of life or functional recovery. This is particularly relevant in trials that involve invasive procedures or those with potential dangerous adverse events. The CRASH trial29, for example was focused on functional outcomes to evaluate a two-page case report with an electronic system to monitor the health of patients in hospitals suffering from chronic heart failure. In addition, the catheter trial28 used symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these features, 무료슬롯 프라그마틱 pragmatic trials should minimize the requirements for data collection and trial procedures to cut costs and time commitments. Finally, pragmatic trials should seek to make their findings as applicable to real-world clinical practice as possible by making sure that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).

Despite these criteria, a number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all types. This could lead to misleading claims of pragmatism and the usage 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 practical study the aim is to inform policy or clinical decisions by showing how an intervention could be integrated into routine care in real-world contexts. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised conditions. In this way, pragmatic trials could have lower internal validity than studies that explain and be more prone to biases in their design as well as analysis and conduct. Despite these limitations, pragmatic trials may provide valuable information to decision-making in healthcare.

The PRECIS-2 tool assesses the level of pragmatism that is present in an RCT by scoring it across 9 domains that range from 1 (very explicative) to 5 (very pragmatic). In this study, the areas of recruitment, organization, flexibility in delivery, flexibility in adherence, and follow-up received high scores. However, the main outcome and the method for missing data scored below the pragmatic limit. This indicates that a trial can be designed with good practical features, but without compromising its quality.

It is hard to determine the degree of pragmatism within a specific trial because pragmatism does not have a binary characteristic. Certain aspects of a research study can be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or the logistics during the trial. Koppenaal and colleagues found that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to licensing. Most were also 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 these trials.

A common aspect of pragmatic research is that researchers try to make their findings more relevant by studying subgroups of the trial sample. However, this often leads to unbalanced comparisons with a lower statistical power, increasing the risk of either not detecting or incorrectly detecting differences in the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not corrected for covariates' differences at the time of baseline.

Additionally practical trials can present challenges in the gathering and interpretation of safety data. It is because adverse events are typically self-reported and are susceptible to delays, inaccuracies or coding variations. It is important to improve the accuracy and quality of the outcomes in these trials.

Results

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

Increased sensitivity to real-world issues, reducing study size and cost and allowing the study results to be faster transferred into real-world clinical practice (by including patients who are routinely treated). However, pragmatic trials may have disadvantages. The right amount of heterogeneity, for example could allow a study to expand its findings to different settings or patients. However the wrong type of heterogeneity could reduce the assay sensitivity, and therefore lessen the power of a trial to detect even minor effects of treatment.

A number of studies have attempted to categorize pragmatic trials with a variety of definitions and scoring systems. Schwartz and Lellouch1 have developed a framework that can distinguish between explanatory studies that confirm the physiological hypothesis or clinical hypothesis, and pragmatic studies that guide the choice for appropriate therapies in clinical practice. Their framework included nine domains that were scored on a scale of 1-5, with 1 indicating more lucid and 5 suggesting more pragmatic. The domains were recruitment, setting, intervention delivery with flexibility, follow-up and primary analysis.

The original PRECIS tool3 was based on a similar scale and domains. Koppenaal and colleagues10 created an adaptation of this assessment, known as the Pragmascope that was simpler to use for systematic reviews. They found that pragmatic reviews scored higher on average in most domains, but scored lower in the primary analysis domain.

The difference in the primary analysis domain can be explained by the way most pragmatic trials approach data. Some explanatory trials, however do not. The overall score for pragmatic systematic reviews was lower when the areas of organization, flexible delivery, and following-up were combined.

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

Conclusions

As the importance of evidence from the real world becomes more widespread and pragmatic trials have gained popularity in research. They are clinical trials that are randomized which compare real-world treatment options instead of experimental treatments in development, they include patients which are more closely resembling the patients who receive routine care, they use comparisons that are commonplace in practice (e.g. existing medications) and depend on the self-reporting of participants about outcomes. This approach can overcome the limitations of observational research, such as the biases associated with the reliance on volunteers and the limited availability and codes that vary in national registers.

Pragmatic trials also have advantages, including the ability to use existing data sources and a higher chance of detecting significant differences from traditional trials. However, they may have some limitations that limit their validity and generalizability. The participation rates in certain trials could be lower than expected due to the healthy-volunteering effect, financial incentives, or competition from other research studies. The need to recruit individuals in a timely manner also restricts the sample size and the impact of many practical trials. Practical trials aren't always equipped with controls to ensure that any observed differences aren't caused by biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs that were published between 2022 and 2022 that self-described as pragmatism. The PRECIS-2 tool was used to assess the degree of pragmatism. It includes areas such as eligibility criteria and flexibility in recruitment and adherence to intervention and follow-up. They discovered that 14 of the trials scored highly or pragmatic practical (i.e. scores of 5 or more) in any one or more of these domains, and that the majority of these were single-center.

Studies with high pragmatism scores tend to have more lenient criteria for eligibility than conventional RCTs. They also have patients from a variety of hospitals. These characteristics, according to the authors, can make pragmatic trials more relevant and useful in everyday clinical. However they do not guarantee that a trial is free of bias. Moreover, the pragmatism of a trial is not a fixed attribute and a pragmatic trial that doesn't have all the characteristics of a explanatory trial can yield valid and useful results.