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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial, open data platform and infrastructure that facilitates research on pragmatic trials. It collects and distributes clean trial data, ratings and evaluations using PRECIS-2. This permits a variety of meta-epidemiological analyses to evaluate the effects of treatment across trials of different levels of pragmatism.

Background

Pragmatic studies are increasingly acknowledged as providing evidence from the real world to support clinical decision-making. However, the usage of the term "pragmatic" is inconsistent and its definition as well as assessment requires clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, not to confirm the validity of a clinical or physiological hypothesis. A pragmatic study should strive to be as close as is possible to actual clinical practices that include recruitment of participants, 프라그마틱 데모 setting up, delivery and execution of interventions, determination and analysis outcomes, and primary analysis. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1) that are intended to provide a more complete confirmation of a hypothesis.

Truely pragmatic trials should not be blind participants or clinicians. This can result in an overestimation of the effects of treatment. Practical trials should also aim to enroll patients from a wide range of health care settings, to ensure that their findings can be compared to the real world.

Additionally, pragmatic trials should focus on outcomes that are vital for patients, such as quality of life or functional recovery. This is particularly important for trials that involve surgical procedures that are invasive or may have harmful adverse consequences. The CRASH trial29, for instance, focused on functional outcomes to compare a two-page report with an electronic system for monitoring of hospitalized patients with chronic heart failure, and the catheter trial28 used urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these characteristics pragmatic trials should reduce the trial procedures and requirements for data collection to reduce costs. Additionally pragmatic trials should try to make their findings as applicable to real-world clinical practice as they can by making sure 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 criteria for pragmatism but contain features contrary to pragmatism have been published in journals of various types and incorrectly labeled pragmatic. This could lead to misleading claims of pragmaticity, and the use of the term must be standardized. The creation of the PRECIS-2 tool, which offers an objective and standard assessment of pragmatic characteristics is a good initial step.

Methods

In a practical trial the goal is to inform clinical or policy decisions by showing how an intervention could be incorporated into real-world routine care. Explanatory trials test hypotheses about the cause-effect relationship within idealised environments. Therefore, pragmatic trials might have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials may provide valuable information to decision-making in healthcare.

The PRECIS-2 tool evaluates the degree of pragmatism in an RCT by assessing it across 9 domains, ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery, flexible adherence and 프라그마틱 follow-up domains scored high scores, but the primary outcome and the method of missing data fell below the practical limit. This indicates that a trial can be designed with good pragmatic features, without harming the quality of the trial.

However, it is difficult to determine how practical a particular trial is, since pragmaticity is not a definite attribute; some aspects of a trial can be more pragmatic than others. A trial's pragmatism could be affected by modifications to the protocol or the logistics during the trial. Additionally, 36% of the 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled, or conducted prior to approval and a majority of them were single-center. They are not in line with the norm and can only be referred to as pragmatic if their sponsors accept that such trials are not blinded.

Another common aspect of pragmatic trials is that researchers try to make their results more valuable by studying subgroups of the trial sample. However, this can lead to unbalanced results and lower statistical power, increasing the chance of not or incorrectly detecting differences in the primary outcome. In the case of the pragmatic trials included in this meta-analysis this was a major issue since the secondary outcomes were not adjusted for variations in the baseline covariates.

In addition, pragmatic studies can present challenges in the gathering and interpretation of safety data. It is because adverse events are usually self-reported, and therefore are prone to errors, delays or coding differences. It is therefore crucial to enhance the quality of outcomes for these trials, in particular by using national registry databases instead of relying on participants to report adverse events on a trial's own database.

Results

Although the definition of pragmatism may not mean that trials must be 100% pragmatic, there are some advantages to incorporating pragmatic components into clinical trials. These include:

Increased sensitivity to real-world issues, reducing study size and cost as well as allowing trial results to be more quickly implemented into clinical practice (by including patients who are routinely treated). But pragmatic trials can be a challenge. The right amount of heterogeneity, like could allow a study to expand its findings to different settings or patients. However the wrong type of heterogeneity could reduce the sensitivity of an assay and, consequently, reduce a trial's power to detect small treatment effects.

Many studies have attempted classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 have developed an approach to distinguish between explanation-based trials that support a physiological or clinical hypothesis and pragmatic trials that help in the selection of appropriate treatments in clinical practice. The framework was comprised of nine domains assessed on a scale of 1-5 which indicated that 1 was more lucid while 5 was more pragmatic. The domains included recruitment and setting, delivery of intervention and follow-up, as well as flexible adherence and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal et al10 developed an adaptation of the assessment, called the Pragmascope which was more user-friendly to use for systematic reviews. They found that pragmatic reviews scored higher across all domains, however they scored lower in the primary analysis domain.

This difference in the analysis domain that is primary could be explained by the fact that the majority of pragmatic trials process their data in an intention to treat manner however some explanation trials do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organization, flexible delivery, and following-up were combined.

It is crucial to keep in mind that a pragmatic study should not mean that a trial is of poor quality. In fact, there are a growing number of clinical trials that use the term 'pragmatic' either in their abstracts or titles (as defined by MEDLINE however it is not precise nor sensitive). These terms could indicate a greater appreciation of pragmatism in abstracts and titles, but it isn't clear whether this is evident in content.

Conclusions

In recent years, pragmatic trials have been increasing in popularity in research because the importance of real-world evidence is increasingly recognized. They are clinical trials that are randomized that compare real-world care alternatives rather than experimental treatments under development, they have patients that more closely mirror the patients who receive routine care, they employ comparators which exist in routine practice (e.g., existing drugs) and rely on participant self-report of outcomes. This approach can overcome the limitations of observational research such as the biases that are associated with the reliance on volunteers, and the lack of codes that vary in national registers.

Other benefits of pragmatic trials include 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 reliability and generalizability. For instance the participation rates in certain trials may be lower than expected due to the healthy-volunteer effect as well as financial incentives or competition for 프라그마틱 무료 슬롯버프 프라그마틱 무료체험 슬롯버프 (pragmatickorea81100.blogunok.com) participants from other research studies (e.g. industry trials). Practical trials are often limited by the need to enroll participants on time. Certain pragmatic trials lack controls to ensure that the observed variations aren't due to biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described as pragmatic. The PRECIS-2 tool was used to assess pragmatism. It includes areas like eligibility criteria and flexibility in recruitment and adherence to intervention and follow-up. They found 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Studies that have high pragmatism scores tend to have broader criteria for eligibility than traditional RCTs. They also contain populations from various hospitals. The authors claim that these characteristics could make the pragmatic trials more relevant and useful for daily practice, but they do not necessarily guarantee that a pragmatic trial is free of bias. In addition, the pragmatism that is present in a trial is not a fixed attribute and a pragmatic trial that doesn't have all the characteristics of an explanatory trial may yield valuable and reliable results.