• 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 collects and distributes clean trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological studies to compare treatment effect estimates across trials with different levels of pragmatism.

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 measurement require clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, not to confirm a physiological or clinical hypothesis. A pragmatic trial should try to be as close as is possible to real-world clinical practices which include the recruitment of participants, setting, design, delivery and execution of interventions, determining and analysis results, as well as primary analyses. This is a significant distinction from explanation trials (as described by Schwartz and Lellouch1), which are intended to provide a more complete confirmation of a hypothesis.

Studies that are truly pragmatic must avoid attempting to blind participants or healthcare professionals as this could lead to distortions in estimates of the effect of treatment. Pragmatic trials will also recruit patients from different health care settings to ensure that their results can be generalized to the real world.

Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, like the quality of life and functional recovery. This is particularly relevant for trials that involve 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 admitted to hospitals with chronic heart failure. Similarly, the catheter trial28 utilized urinary tract infections caused by catheters as the primary outcome.

In addition to these features pragmatic trials should also reduce the procedures for conducting trials and requirements for data collection to reduce costs and time commitments. In the end the aim of pragmatic trials is to make their results as applicable to current clinical practices as possible. This can be accomplished by ensuring that their analysis is based on the intention to treat approach (as described within CONSORT extensions).

Many RCTs that don't meet the criteria for pragmatism however, they have characteristics that are contrary to pragmatism, have been published in journals of different kinds and incorrectly labeled pragmatic. This could lead to false claims about pragmatism, and the usage of the term should be standardized. The creation of the PRECIS-2 tool, 프라그마틱 슬롯 추천 which provides an objective and standard assessment of pragmatic features, 프라그마틱 불법 is a good first step.

Methods

In a practical trial the goal is to inform clinical or policy decisions by demonstrating how an intervention would be integrated into everyday routine care. Explanatory trials test hypotheses concerning the cause-effect relation within idealized conditions. Therefore, pragmatic trials could be less reliable than explanatory trials and might be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials may contribute valuable information to decision-making in healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, ranging from 1 to 5 (very pragmatist). In this study the areas of recruitment, organization, flexibility in delivery, flexibility in adherence, and follow-up were awarded high scores. However, the main outcome and 프라그마틱 슬롯 the method of missing data scored below the pragmatic limit. This suggests that it is possible to design a trial that has high-quality pragmatic features, without harming the quality of the results.

However, it is difficult to determine how pragmatic a particular trial really is because pragmatism is not a binary characteristic; certain aspects of a trial may 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 discovered that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to licensing. They also found that the majority were single-center. Therefore, they aren't as common and can only be described as pragmatic when their sponsors are accepting of the lack of blinding in such trials.

Furthermore, a common feature of pragmatic trials is that the researchers attempt to make their findings more meaningful by analysing subgroups of the trial sample. This can lead to unbalanced analyses that have lower statistical power. This increases the chance of omitting or misinterpreting differences in the primary outcomes. In the instance of the pragmatic trials included in this meta-analysis, this was a major issue because the secondary outcomes weren't adjusted for differences in baseline covariates.

Furthermore, pragmatic studies may pose challenges to collection and interpretation safety data. This is because adverse events are usually self-reported and are susceptible to reporting errors, delays or coding deviations. It is therefore crucial to improve the quality of outcomes assessment in these trials, in particular by using national registries rather than relying on participants to report adverse events in the trial's database.

Results

While the definition of pragmatism may not require that clinical trials be 100% pragmatist There are advantages to including pragmatic components in trials. These include:

Enhancing sensitivity to issues in the real world as well as reducing study size and cost, and enabling the trial results to be more quickly transferred into real-world clinical practice (by including patients who are routinely treated). However, pragmatic trials may also have drawbacks. For instance, the right type of heterogeneity can help a trial to generalise its results to different settings and patients. However the wrong type of heterogeneity may reduce the assay's sensitivity, and thus lessen the ability of a study to detect minor 프라그마틱 슬롯 하는법 treatment effects.

A number of studies have attempted to classify pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 created a framework to discern between explanation-based studies that support the physiological hypothesis 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 scored on a 1-5 scale which indicated that 1 was more explanatory while 5 being more pragmatic. The domains included recruitment, setting up, delivery of intervention, flex adherence and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal et al10 devised an adaptation to this assessment called the Pragmascope that was simpler 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.

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

It is important to remember that a pragmatic trial does not necessarily mean a low quality trial, and there is an increasing rate of clinical trials (as defined by MEDLINE search, however it is neither specific nor sensitive) that use the term "pragmatic" in their abstracts or titles. The use of these terms in titles and abstracts could indicate a greater understanding of the importance of pragmatism, 프라그마틱 무료체험 슬롯버프 but it is unclear whether this is reflected in the content of the articles.

Conclusions

As appreciation for the value of real-world evidence grows popular the pragmatic trial has gained momentum in research. They are randomized studies that compare real-world alternatives to new treatments that are being developed. They are conducted with populations of patients that are more similar to those who receive treatment in regular medical care. This approach could help overcome the limitations of observational research, such as the biases that arise from relying on volunteers and limited availability and coding variability in national registries.

Other advantages of pragmatic trials are the ability to utilize existing data sources, and a greater likelihood of detecting meaningful changes than traditional trials. However, these trials could still have limitations that undermine their validity and generalizability. The participation rates in certain trials may be lower than anticipated due to the health-promoting effect, financial incentives, or competition from other research studies. Practical trials are often restricted by the necessity to recruit participants quickly. Some pragmatic trials also lack controls to ensure that observed variations aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatist and published until 2022. The PRECIS-2 tool was employed to assess the pragmatism of these trials. It includes domains such as eligibility criteria as well as recruitment flexibility and adherence to intervention and follow-up. They found that 14 of these trials scored as highly or pragmatic practical (i.e. scoring 5 or more) in any one or more of these domains, and that the majority of these were single-center.

Trials with a high pragmatism rating tend to have broader eligibility criteria than traditional RCTs, which include very specific criteria that are not likely to be used in the clinical environment, and they comprise patients from a wide variety of hospitals. The authors claim that these characteristics could make the pragmatic trials more relevant and relevant to everyday practice, but they do not necessarily guarantee that a pragmatic trial is free from bias. Moreover, the pragmatism of a trial is not a fixed attribute and a pragmatic trial that doesn't contain all the characteristics of an explanatory trial can yield valuable and reliable results.