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

Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that allows research into pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological studies to compare treatment effects estimates across trials with 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. However, the use of the term "pragmatic" is inconsistent and its definition as well as assessment requires further clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, rather than confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should also try to be as similar to actual clinical practice as possible, such as its participation of participants, setting and design as well as the implementation of the intervention, and the determination and analysis of outcomes as well as primary analysis. This is a major distinction between explanatory trials, as described by Schwartz and Lellouch1, which are designed to confirm a hypothesis in a more thorough manner.

The most pragmatic trials should not blind participants or clinicians. This can lead to bias in the estimations of the effects of treatment. Practical trials should also aim to attract patients from a variety of health care settings, to ensure that the results can be compared to the real world.

Finally studies that are pragmatic should focus on outcomes that are important for patients, such as quality of life or 프라그마틱 슬롯 환수율 functional recovery. This is especially important for trials involving invasive procedures or those with potentially serious adverse events. The CRASH trial29, for instance focused on the functional outcome to evaluate a two-page case report with an electronic system for monitoring of patients in hospitals suffering from chronic heart failure. Similarly, the catheter trial28 used urinary tract infections caused by catheters as the primary outcome.

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

Despite these guidelines, many RCTs with features that challenge the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all kinds. 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 can provide an objective, standardized assessment of pragmatic features is a first step.

Methods

In a pragmatic research study it is the intention to inform clinical or policy decisions by demonstrating how an intervention can be integrated into routine care in real-world settings. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised conditions. In this way, pragmatic trials could have lower internal validity than explanatory studies and be more susceptible to biases in their design as well as analysis and conduct. Despite their limitations, pragmatic research can provide valuable information for decision-making within the context of 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, organisation and flexibility in delivery, flexible adherence, and follow-up scored high. However, the principal outcome and the method for missing data scored below the pragmatic limit. This suggests that a trial can be designed with good practical features, yet not compromising its quality.

It is difficult to determine the amount of pragmatism within a specific trial since pragmatism doesn't have a binary characteristic. Some aspects of a study can be more pragmatic than other. A trial's pragmatism could be affected by modifications to the protocol or the logistics during the trial. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. They also found that the majority were single-center. They are not close to the standard practice and are only referred to as pragmatic if their sponsors accept that such trials aren't blinded.

A common aspect of pragmatic studies is that researchers try to make their findings more relevant by studying subgroups within the trial sample. This can lead to unbalanced analyses with less statistical power. This increases the risk of omitting or misinterpreting differences in the primary outcomes. This was a problem during the meta-analysis of pragmatic trials as secondary outcomes were not adjusted for covariates' differences at the baseline.

Additionally, pragmatic trials can also have challenges with respect to the collection and interpretation of safety data. This is because adverse events are usually self-reported and are prone to reporting errors, delays or coding deviations. It is therefore important to improve the quality of outcome for these trials, in particular by using national registries instead of relying on participants to report adverse events in the trial's own database.

Results

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

Incorporating routine patients, the results of trials are more easily translated into clinical practice. However, pragmatic studies can also have drawbacks. For example, the right kind of heterogeneity can allow a trial to generalise its findings to a variety of patients and settings; however, the wrong type of heterogeneity could reduce assay sensitiveness and consequently reduce the power of a study to detect even minor effects of treatment.

A variety of studies have attempted to categorize pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that prove a physiological or clinical hypothesis, and pragmatic studies that guide the choice for appropriate therapies in clinical practice. The framework was composed of nine domains scored on a 1-5 scale with 1 being more lucid while 5 being more pragmatic. The domains included recruitment of intervention, setting up, delivery of intervention, flexible compliance and primary analysis.

The original PRECIS tool3 was based on a similar scale and domains. Koppenaal et al10 devised an adaptation to this assessment dubbed the Pragmascope which was more user-friendly to use in systematic reviews. They discovered that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.

This difference in the primary analysis domain could be due to the fact that most pragmatic trials process their data in the intention to treat way however some explanation trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains on organisation, flexible delivery, and follow-up were combined.

It is important to remember that a pragmatic study does not necessarily mean a low-quality study. In fact, there is increasing numbers of clinical trials that employ the word 'pragmatic,' either in their title or abstract (as defined by MEDLINE but which is not precise nor sensitive). The use of these terms in abstracts and titles may suggest a greater awareness of the importance of pragmatism, however, it is not clear if this is manifested in the contents of the articles.

Conclusions

As the importance of evidence from the real world becomes more popular the pragmatic trial has gained popularity in research. They are clinical trials that are randomized that evaluate real-world alternatives to care instead of experimental treatments under development. They include populations of patients that more closely mirror 프라그마틱 환수율 the ones who are treated in routine medical care, 프라그마틱 추천 they utilize comparators that are used in routine practice (e.g., existing drugs) and depend on participants' self-reports of outcomes. This approach has the potential to overcome the limitations of observational studies, such as the limitations of relying on volunteers, and the limited accessibility and 프라그마틱 정품 확인법 coding flexibility in national registry systems.

Other advantages of pragmatic trials are the ability to utilize existing data sources, as well as a higher chance of detecting meaningful changes than traditional trials. However, pragmatic trials may have some limitations that limit 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. Many pragmatic trials are also restricted by the need to enroll participants quickly. Practical trials aren't always equipped with controls to ensure that observed variations aren't due to biases that occur during 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. The PRECIS-2 tool was employed to determine pragmatism. It covers areas like eligibility criteria, recruitment flexibility as well as adherence to interventions and follow-up. They discovered that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs which have very specific criteria that are unlikely to be found in the clinical environment, and they contain patients from a broad variety of hospitals. The authors suggest that these characteristics can help make the pragmatic trials more relevant and useful for daily practice, but they do not guarantee that a pragmatic trial is free of bias. The pragmatism characteristic is not a fixed characteristic; a pragmatic test that doesn't have all the characteristics of an explicative study can still produce valid and useful outcomes.