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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 distributes clean trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses to examine the effect of treatment across trials of various levels of pragmatism.

Background

Pragmatic trials are becoming more widely recognized as providing real-world evidence to support clinical decision-making. However, the usage of the term "pragmatic" is not consistent and its definition as well as assessment requires further clarification. Pragmatic trials should be designed to inform clinical practice and policy decisions, rather than confirm a physiological or clinical hypothesis. A pragmatic study should try to be as similar to actual clinical practice as is possible, including the selection of participants, setting and design, the delivery and implementation of the intervention, determination and analysis of outcomes and primary analyses. This is a significant difference between explanatory trials, as described by Schwartz & Lellouch1 that are designed to test the hypothesis in a more thorough manner.

Trials that are truly practical should not attempt to blind participants or clinicians in order to cause bias in estimates of the effect of treatment. Practical trials also involve patients from different healthcare settings to ensure that their results can be applied to the real world.

Finally studies that are pragmatic should focus on outcomes that are crucial to patients, such as quality of life or functional recovery. This is especially important in trials that involve invasive procedures or those with potential serious adverse events. The CRASH trial29, for example was 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, and the catheter trial28 used symptomatic catheter-associated urinary tract infections as its primary outcome.

In addition to these aspects, pragmatic trials should minimize the procedures for conducting trials and data collection requirements in order to reduce costs. Additionally the aim of pragmatic trials is to make their results as applicable to current clinical practice as is possible. This can be achieved by ensuring their primary analysis is based on an intention-to treat approach (as described within CONSORT extensions).

Many RCTs which do not meet the requirements for pragmatism but contain features contrary to pragmatism, have been published in journals of varying kinds and incorrectly labeled pragmatic. This can result in misleading claims of pragmatism, and the use of the term must be standardized. The development of a PRECIS-2 tool that offers an objective and standardized evaluation of the pragmatic characteristics is the first step.

Methods

In a practical trial it is the intention to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. This differs from explanation trials, which test hypotheses about the causal-effect relationship in idealized conditions. Therefore, pragmatic trials could have lower internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials may be a valuable source of information for decision-making in the context of healthcare.

The PRECIS-2 tool assesses the level of pragmatism that is present in an RCT by assessing it on 9 domains that range from 1 (very explicative) to 5 (very pragmatic). In this study the areas of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the primary outcome and method of missing data scored below the pragmatic limit. This suggests that it is possible to design a trial with good pragmatic features without damaging the quality of its results.

However, it's difficult to judge how pragmatic a particular trial is since pragmatism is not a binary quality; certain aspects of a study can be more pragmatic than others. A trial's pragmatism could be affected by changes to the protocol or logistics during the trial. Additionally 36% of 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled, or conducted prior to licensing and most were single-center. They aren't in line with the usual practice and are only referred to as pragmatic if their sponsors agree that the trials are not blinded.

A common aspect of pragmatic research is that researchers attempt to make their findings more meaningful by analyzing subgroups of the trial sample. This can result in unbalanced analyses that have less statistical power. This increases the risk of omitting or misinterpreting differences in the primary outcomes. In the instance of the pragmatic trials included in this meta-analysis, this was a serious issue because the secondary outcomes were not adjusted for variations in baseline covariates.

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 prone to reporting errors, delays or 프라그마틱 체험 coding deviations. It is therefore important to improve the quality of outcomes for these trials, in particular by using national registries instead of relying on participants to report adverse events on the trial's own database.

Results

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

By incorporating routine patients, the trial results are more easily translated into clinical practice. However, pragmatic trials may also have drawbacks. For example, the right kind of heterogeneity can allow a trial to generalise its findings to a variety of settings and patients. However the wrong kind of heterogeneity may reduce the assay's sensitiveness and consequently reduce the power of a study to detect minor treatment effects.

A variety of studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 created a framework to differentiate between explanation studies that confirm a physiological or clinical hypothesis, and pragmatic studies that guide the selection of appropriate therapies in real world clinical practice. The framework was composed of nine domains that were assessed on a scale of 1-5 with 1 being more informative and 5 was more practical. The domains included recruitment setting, setting, intervention delivery and 프라그마틱 슬롯무료 프라그마틱 슬롯 무료체험 무료 (navigate to this web-site) follow-up, 슬롯 as well as flexible adherence and primary analysis.

The original PRECIS tool3 had similar domains and scales from 1 to 5. Koppenaal et al10 developed an adaptation of this assessment, called the Pragmascope, that was easier to use for systematic reviews. They found that pragmatic reviews scored higher on average in all domains, but scored lower in the primary analysis domain.

The difference in the primary analysis domains could be explained by the way most pragmatic trials approach data. Some explanatory trials, however do not. The overall score was lower for pragmatic systematic reviews when the domains of the organization, flexibility of delivery and follow-up were combined.

It is important to understand 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, but this is neither specific or sensitive) that employ the term 'pragmatic' in their abstract or title. These terms may indicate that there is a greater awareness of pragmatism within titles and abstracts, but it's unclear if this is reflected in content.

Conclusions

As the importance of real-world evidence grows commonplace the pragmatic trial has gained traction in research. They are randomized trials that evaluate real-world care alternatives to clinical trials in development. They involve patient populations more closely resembling those treated in regular medical care. This method is able to overcome the limitations of observational research, such as the biases that come with the use of volunteers and the limited availability and the coding differences in national registry.

Pragmatic trials offer other advantages, such as the ability to draw on existing data sources and a higher chance of detecting significant differences than traditional trials. However, they may have some limitations that limit their reliability and generalizability. For example the rates of participation in some trials might be lower than anticipated due to the healthy-volunteer influence and incentives to pay or compete for participants from other research studies (e.g., industry trials). The necessity to recruit people in a timely fashion also reduces the size of the sample and the impact of many practical trials. 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 48 RCTs that self-described themselves as pragmatist and published up to 2022. They assessed pragmatism using the PRECIS-2 tool, which consists of the eligibility criteria for domains as well as recruitment, flexibility in intervention adherence, and follow-up. They found that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials with high pragmatism scores tend to have more criteria for eligibility than conventional RCTs. They also have populations from many different hospitals. According to the authors, could make pragmatic trials more useful and useful in the daily practice. However, they cannot guarantee that a trial will be free of bias. The pragmatism is not a fixed characteristic and a test that does not have all the characteristics of an explanatory study may still yield reliable and beneficial results.