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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 shares cleaned trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological studies that compare treatment effects estimates across trials that employ different levels of pragmatism, as well as other design features.

Background

Pragmatic trials are increasingly recognized as providing real-world evidence for clinical decision making. The term "pragmatic" however, is not used in a consistent manner and its definition and evaluation require further clarification. The purpose of pragmatic trials is to guide clinical practice and policy decisions, rather than confirm the validity of a clinical or physiological hypothesis. A pragmatic trial should also aim to be as similar to the real-world clinical environment as possible, including in the recruitment of participants, setting and design as well as the execution of the intervention, as well as the determination and analysis of the outcomes, and primary analysis. This is a major distinction between explanatory trials, as described by Schwartz & Lellouch1, which are designed to prove a hypothesis in a more thorough way.

Truly pragmatic trials should not be blind participants or clinicians. This could lead to bias in the estimations of the effect of treatment. Practical trials also involve patients from different health care settings to ensure that the outcomes can be compared 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 especially important when trials involve surgical procedures that are invasive or may have serious adverse consequences. The CRASH trial29, for instance, focused on functional outcomes to compare a two-page report with an electronic system for monitoring of patients in hospitals suffering from chronic heart failure, and the catheter trial28 focused on urinary tract infections caused by catheters as its primary outcome.

In addition to these aspects pragmatic trials should also reduce the requirements for data collection and trial procedures to cut down on costs and 프라그마틱 정품확인 time commitments. Finally, pragmatic trials should seek to make their findings as relevant to actual clinical practice as they can by making sure that their primary analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).

Despite these criteria, a number of RCTs with features that challenge 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 needs to be standardized. The development of the PRECIS-2 tool, which provides an objective and standard assessment of pragmatic features is a good initial step.

Methods

In a pragmatic study it is the intention to inform clinical or policy decisions by showing how an intervention could be integrated into everyday routine care. This differs from explanation trials that test hypotheses regarding the cause-effect relationship in idealised settings. In this way, pragmatic trials may have lower internal validity than studies that explain and be more prone to biases in their design, analysis, and conduct. Despite their limitations, pragmatic research can be a valuable source of data for making decisions within the healthcare context.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery, flexible adherence and follow-up domains were awarded high scores, but the primary outcome and the method of missing data were not at the pragmatic limit. This suggests that it is possible to design a trial using excellent pragmatic features without harming the quality of the results.

However, it is difficult to determine the degree of pragmatism a trial is since the pragmatism score is not a binary attribute; some aspects of a trial can be more pragmatic than others. Furthermore, logistical or protocol changes during a trial can change its score on pragmatism. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to licensing. The majority of them were single-center. Therefore, they aren't as common and can only be described as pragmatic if their sponsors are tolerant of the lack of blinding in such trials.

A common feature of pragmatic studies is that researchers try to make their findings more meaningful by studying subgroups within the trial sample. However, this can lead to unbalanced comparisons and lower statistical power, increasing the likelihood of missing 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 baseline.

Additionally practical trials can be a challenge in the gathering and interpretation of safety data. It is because adverse events are typically self-reported, and therefore are prone to delays, inaccuracies or coding differences. It is crucial to improve the quality and accuracy of the outcomes in these trials.

Results

Although the definition of pragmatism does not mean that trials must be 100% pragmatic, there are benefits of including pragmatic elements in clinical trials. These include:

Incorporating routine patients, the results of trials can be translated more quickly into clinical practice. However, pragmatic trials may also have disadvantages. The right kind of heterogeneity, for example, can help a study expand its findings to different settings or patients. However the wrong kind of heterogeneity can reduce the sensitivity of an assay, and therefore reduce a trial's power to detect small treatment effects.

Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can discern between explanation-based studies that confirm a physiological or clinical hypothesis, and pragmatic studies that guide the choice for appropriate therapies in the real-world clinical practice. The framework was composed of nine domains assessed on a scale of 1-5 with 1 being more explanatory while 5 being more pragmatic. The domains included recruitment and setting up, the delivery of intervention, flex compliance and primary analysis.

The original PRECIS tool3 featured similar domains and an assessment scale ranging from 1 to 5. Koppenaal and colleagues10 developed an adaptation of this assessment, dubbed the Pragmascope that was simpler to use in systematic reviews. They found that pragmatic systematic reviews had a higher average scores across all domains, but lower scores in the primary analysis domain.

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

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

Conclusions

In recent years, pragmatic trials have been gaining popularity in research as the value of real-world evidence is becoming increasingly acknowledged. They are randomized trials that compare real world treatment options with clinical trials in development. They involve patient populations more closely resembling those treated in regular medical care. This method can help overcome the limitations of observational research such as the biases that come with the reliance on volunteers, 프라그마틱 무료체험 as well as the insufficient availability and codes that vary in national registers.

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, they may have some limitations that limit their effectiveness and generalizability. Participation rates in some trials could be lower than anticipated due to the healthy-volunteering effect, financial incentives or competition from other research studies. A lot of pragmatic trials are restricted by the necessity to enroll participants quickly. Certain pragmatic trials lack controls to ensure that any 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-described themselves as pragmatic and were published until 2022. They evaluated pragmatism using the PRECIS-2 tool, which consists of the eligibility criteria for domains, recruitment, 프라그마틱 데모 flexibility in adherence to intervention, and follow-up. They found that 14 of these trials scored as highly or 프라그마틱 게임 pragmatic sensible (i.e. scores of 5 or more) in one or more of these domains, and that the majority were single-center.

Trials with a high pragmatism rating tend to have broader eligibility criteria than traditional RCTs that have specific criteria that are not likely to be used in the clinical setting, and comprise patients from a wide range of hospitals. The authors suggest that these characteristics can help make pragmatic trials more meaningful and useful for everyday practice, but they do not necessarily guarantee that a trial using a pragmatic approach is free of bias. The pragmatism is not a fixed attribute and a test that does not possess all the characteristics of an explanation study may still yield valid and useful outcomes.