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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that allows research into pragmatic trials. It shares clean trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological studies that compare treatment effects estimates across trials that have different levels of pragmatism, as well as other design features.

Background

Pragmatic trials are increasingly acknowledged as providing evidence from the real world for clinical decision-making. The term "pragmatic", however, is used inconsistently and its definition and assessment require clarification. Pragmatic trials are designed to guide the practice of clinical medicine and policy decisions, not to prove a physiological or clinical hypothesis. A pragmatic trial should aim to be as close as it is to actual clinical practices which include the recruiting participants, setting, design, implementation and delivery of interventions, determination and analysis outcomes, and primary analysis. This is a major difference between explanatory trials as defined by Schwartz & Lellouch1 that are designed to test a hypothesis in a more thorough manner.

The trials that are truly pragmatic must be careful not to blind patients or clinicians in order to result in bias in estimates of treatment effects. Practical trials also involve patients from different health care settings to ensure that the results can be generalized to the real world.

Additionally the focus of pragmatic trials should be on outcomes that are important for patients, such as quality of life or functional recovery. This is particularly important in trials that require surgical procedures that are invasive or may have serious adverse effects. The CRASH trial29, for example was focused on functional outcomes to compare a 2-page case-report with an electronic system for monitoring of hospitalized patients with chronic heart failure. Similarly, the catheter trial28 utilized urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these aspects pragmatic trials should also reduce trial procedures and data-collection requirements to reduce costs and time commitments. Additionally pragmatic trials should strive 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).

Many RCTs that do not meet the requirements for pragmatism but contain features contrary to pragmatism have been published in journals of various types and incorrectly labeled pragmatic. This can result in misleading claims of pragmaticity and the usage of the term should be standardized. The development of the PRECIS-2 tool, which offers a standard objective assessment of pragmatic features, is a good first step.

Methods

In a pragmatic study, the aim is to inform policy or clinical decisions by demonstrating how an intervention would be integrated into everyday routine care. This differs from explanation trials, which test hypotheses about the cause-effect relationship in idealised conditions. In this way, pragmatic trials could have less internal validity than explanation studies and be more susceptible to biases in their design analysis, conduct, and design. Despite their limitations, pragmatic studies can provide valuable information to make decisions in the healthcare context.

The PRECIS-2 tool evaluates the degree of pragmatism within an RCT by assessing it on 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the recruit-ment, organization, flexibility in delivery and follow-up domains were awarded high scores, but the primary outcome and the procedure for missing data were not at the practical limit. This suggests that it is possible to design a trial that has good pragmatic features without compromising the quality of its results.

It is hard to determine the degree of pragmatism in a particular trial because pragmatism does not have a binary characteristic. Some aspects of a study may be more pragmatic than other. Furthermore, logistical or protocol changes during a trial can change its score on pragmatism. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to the licensing. Most were also single-center. They are not in line with the usual practice, and can only be called pragmatic if their sponsors agree that the trials are not blinded.

Additionally, a typical feature of pragmatic trials is that researchers attempt to make their findings more meaningful by analysing subgroups of the trial. However, this often leads to unbalanced comparisons with a lower statistical power, thereby increasing the chance of not or misinterpreting differences in the primary outcome. This was the case in the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates' differences at the time of baseline.

In addition the pragmatic trials may be a challenge in the collection and interpretation of safety data. It is because adverse events are usually self-reported and are susceptible to errors, delays or coding errors. Therefore, it is crucial to enhance the quality of outcomes ascertainment in these trials, and ideally by using national registries rather than relying on participants to report adverse events in the trial's database.

Results

While the definition of pragmatism doesn't require that clinical trials be 100% pragmatist There are advantages when incorporating pragmatic components into trials. These include:

Increasing sensitivity to real-world issues as well as reducing cost and size of the study and allowing the study results to be more quickly translated into actual clinical practice (by including routine patients). However, pragmatic trials may be a challenge. The right type of heterogeneity, 프라그마틱 슬롯버프 무료체험 메타 [Setbookmarks.com] like, can 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, decrease the ability of a study to detect minor treatment effects.

Many studies have attempted categorize pragmatic trials using various definitions and 프라그마틱 슬롯 사이트 scoring methods. Schwartz and Lellouch1 developed a framework to distinguish between explanatory trials that confirm a physiological or clinical hypothesis as well as pragmatic trials that inform the selection of appropriate therapies in the real-world clinical setting. The framework consisted of nine domains that were assessed on a scale of 1-5, with 1 being more explanatory while 5 being more pragmatic. The domains were recruitment and setting, delivery of intervention with flexibility, follow-up and primary analysis.

The initial PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal and colleagues10 developed an adaptation of this assessment called the Pragmascope that was easier 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 primary analysis domains can be explained by the way most pragmatic trials approach data. Certain explanatory trials however don't. The overall score for pragmatic systematic reviews was lower when the areas of management, flexible delivery and follow-up were merged.

It is important to remember that a pragmatic trial doesn't necessarily mean a low quality trial, and there is an increasing number of clinical trials (as defined by MEDLINE search, 프라그마틱 but this is not sensitive nor specific) which use the word 'pragmatic' in their abstract or title. These terms could indicate a greater awareness of pragmatism within abstracts and titles, 프라그마틱 순위 but it's not clear whether this is reflected in the content.

Conclusions

In recent years, pragmatic trials have been gaining popularity in research as the value of real world evidence is increasingly recognized. They are randomized trials that evaluate real-world treatment options with new treatments that are being developed. They include patient populations more closely resembling those treated in regular care. This method is able to overcome the limitations of observational research, like the biases that come with the reliance on volunteers, as well as the insufficient availability and the coding differences in national registry.

Pragmatic trials have other advantages, like the ability to use existing data sources and a greater chance of detecting significant differences from traditional trials. However, these trials could have some limitations that limit their reliability and generalizability. For example the participation rates in certain trials may be lower than anticipated due to the healthy-volunteer effect as well as financial incentives or competition for participants from other research studies (e.g. industry trials). Many pragmatic trials are also limited by the need to enroll participants quickly. Certain pragmatic trials lack controls to ensure that any observed differences aren't caused by biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatic and were published until 2022. The PRECIS-2 tool was employed to evaluate pragmatism. It includes areas such as eligibility criteria as well as recruitment flexibility and adherence to intervention and follow-up. They found 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or higher) in at least one of these domains.

Trials with high pragmatism scores are likely to have more criteria for eligibility than traditional RCTs. They also include patients from a variety of hospitals. The authors argue that these characteristics can help make pragmatic trials more meaningful and relevant to daily practice, but they do not guarantee that a trial using a pragmatic approach is free from bias. Furthermore, the pragmatism of the trial is not a predetermined characteristic and a pragmatic trial that does not possess all the characteristics of a explanatory trial may yield reliable and relevant results.