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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a free and non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It collects and shares cleaned trial data and ratings using PRECIS-2, allowing for multiple and diverse meta-epidemiological studies to examine the effects of treatment across trials that employ different levels of pragmatism as well as other design features.

Background

Pragmatic studies provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however, is used inconsistently and its definition and evaluation require clarification. The purpose of pragmatic trials is to guide clinical practices and policy choices, rather than prove a physiological or clinical hypothesis. A pragmatic trial should aim to be as close as it is to actual clinical practices, including recruiting participants, setting up, delivery and implementation of interventions, determination and analysis results, as well as primary analysis. This is a significant difference between explanation-based trials, as described by Schwartz and Lellouch1 which are designed to prove a hypothesis in a more thorough manner.

The trials that are truly pragmatic must not attempt to blind participants or the clinicians in order to lead to distortions in estimates of the effect of treatment. Pragmatic trials will also recruit patients from different health care settings to ensure that the results can be applied 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 especially important in trials that require the use of invasive procedures or could have dangerous adverse effects. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The catheter trial28, however, used symptomatic catheter associated urinary tract infection as the primary outcome.

In addition to these characteristics the pragmatic trial should also reduce the trial's procedures and requirements for data collection to reduce costs. Furthermore pragmatic trials should strive to make their results as relevant to actual clinical practice as possible by making sure that their primary method of analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs that do not meet the requirements for pragmatism but contain features contrary to pragmatism have been published in journals of varying types and incorrectly labeled as pragmatic. This can lead to misleading claims of pragmatism and the term's use should be made more uniform. The creation of the PRECIS-2 tool, which provides an objective and standard assessment of pragmatic characteristics 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 routine care in real-world settings. Explanatory trials test hypotheses about the cause-effect relationship within idealised settings. In this way, pragmatic trials can have less internal validity than explanatory studies and are more susceptible to biases in their design analysis, conduct, and 프라그마틱 슬롯 체험 design. Despite these limitations, pragmatic trials may be a valuable source of information for decision-making in the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatist). In this study, the recruitment, organization, flexibility in delivery, 프라그마틱 정품 사이트 flexible adherence and follow-up domains received high scores, but the primary outcome and the procedure for missing data were below the limit of practicality. This indicates that a trial can be designed with good pragmatic features, without compromising its quality.

It is hard to determine the amount of pragmatism within a specific trial because pragmatism does not have a single attribute. Certain aspects of a study can be more pragmatic than other. Additionally, logistical or protocol modifications during the course of the trial may alter its score in pragmatism. In addition, 36% of the 89 pragmatic trials identified by Koppenaal et al were placebo-controlled, or conducted prior to licensing and most were single-center. They are not close to the standard practice and are only referred to as pragmatic if their sponsors agree that the trials aren't blinded.

Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more valuable by studying subgroups of the sample. This can result in unbalanced analyses with less statistical power. This increases the chance of missing or misdetecting differences in the primary outcomes. This was a problem during the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not corrected for covariates' differences at the baseline.

Additionally, pragmatic trials can also be a challenge in the gathering and interpretation of safety data. This is due to the fact that adverse events tend to be self-reported, and therefore are prone to errors, delays or coding differences. It is essential to improve the quality and accuracy of the results in these trials.

Results

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

Increased sensitivity to real-world issues which reduces cost and size of the study and allowing the study results to be faster implemented into clinical practice (by including patients from routine care). However, pragmatic trials can also have disadvantages. The right type of heterogeneity, like could help a study extend 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 even minor effects of treatment.

A variety of studies have attempted to categorize pragmatic trials, with various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework for distinguishing between explanatory trials that confirm a physiological or clinical hypothesis and pragmatic trials that help in the selection of appropriate therapies in the real-world clinical setting. The framework consisted of nine domains scored on a 1-5 scale which indicated that 1 was more lucid while 5 was more practical. The domains included recruitment and setting, delivery of intervention, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 was based on a similar scale and domains. Koppenaal et al10 created an adaptation of this assessment called the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic systematic reviews had higher average score in most domains, but lower scores in the primary analysis domain.

This distinction in the primary analysis domain 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 organisation, flexible delivery and follow-up were merged.

It is important to remember that a pragmatic study does not mean that a trial is of poor quality. In fact, there is an increasing number of clinical trials that use the term 'pragmatic' either in their abstract or title (as defined by MEDLINE however it is not precise nor sensitive). The use of these words in abstracts and titles could indicate a greater understanding of the importance of pragmatism, but it is unclear whether this is evident in the content of the articles.

Conclusions

As the value of real-world evidence becomes increasingly commonplace and pragmatic trials have gained traction in research. They are randomized trials that evaluate real-world care alternatives to new treatments that are being developed. They include patient populations more closely resembling those treated in regular care. This method has the potential to overcome the limitations of observational studies, such as the biases that arise from relying on volunteers and the lack of availability and coding variability in national registries.

Pragmatic trials also have advantages, like the ability to draw on existing data sources, and a greater likelihood of detecting meaningful differences from traditional trials. However, they may still have limitations that undermine their validity and generalizability. Participation rates in some trials may be lower than expected due to the healthy-volunteering effect, financial incentives or competition from other research studies. The necessity to recruit people in a timely fashion also reduces the size of the sample and impact of many pragmatic trials. Additionally some pragmatic trials do not have controls to ensure that the observed differences aren't due to biases in trial conduct.

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 employed to assess pragmatism. It covers areas like eligibility criteria, recruitment flexibility and adherence to intervention and 프라그마틱 정품확인 공식홈페이지 (websites) follow-up. They discovered that 14 trials scored highly pragmatic or 프라그마틱 무료스핀 pragmatic (i.e. scoring 5 or above) in at least one of these domains.

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. The authors argue that these characteristics can help make pragmatic trials more effective and applicable to everyday clinical practice, however they do not guarantee that a pragmatic trial is free of bias. Furthermore, the pragmatism of the trial is not a definite characteristic A pragmatic trial that does not possess all the characteristics of a explanatory trial may yield reliable and relevant results.