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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that facilitates research into pragmatic trials. It collects and distributes clean trial data, ratings and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses that compare treatment effect estimates 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 inconsistent and its definition and assessment requires clarification. Pragmatic trials are intended to guide clinical practices and policy decisions, not to prove a physiological or clinical hypothesis. A pragmatic study should strive to be as close as possible to actual clinical practices, 프라그마틱 슬롯 조작 including recruitment of participants, setting, designing, implementation and delivery of interventions, determining and analysis results, as well as primary analyses. This is a major distinction from explanation trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough proof of the hypothesis.

Trials that are truly pragmatic must be careful not to blind patients or healthcare professionals, as this may lead to bias in estimates of the effect of treatment. Practical trials should also aim to recruit patients from a wide range of health care settings, to ensure that the results can be applied to the real world.

Additionally, clinical trials should concentrate on outcomes that are important to patients, like the quality of life and functional recovery. This is particularly relevant when trials involve the use of invasive procedures or could have harmful adverse consequences. The CRASH trial29, for example focused on the functional outcome to compare a 2-page case-report with an electronic system for monitoring of patients in hospitals suffering from chronic heart failure. Similarly, the catheter trial28 utilized urinary tract infections that are symptomatic of catheters as its primary outcome.

In addition to these characteristics the pragmatic trial should also reduce the trial's procedures and data collection requirements to reduce costs. In the end the aim of pragmatic trials is to make their findings as relevant to real-world clinical practices as possible. This can be accomplished 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 criteria for pragmatism however, they have characteristics that are in opposition to pragmatism, have been published in journals of different types and incorrectly labeled as pragmatic. This can lead to misleading claims of pragmatism, and 프라그마틱 환수율 the term's use should be made more uniform. The development of the PRECIS-2 tool, 프라그마틱 슬롯 환수율 which offers an objective standard for assessing practical features is a good initial step.

Methods

In a pragmatic research study the aim is to inform clinical or policy decisions by showing how an intervention could be integrated into routine treatment in real-world situations. Explanatory trials test hypotheses concerning the cause-effect relation within idealized environments. Therefore, pragmatic trials could have lower internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic research can be a valuable source of information to make decisions in the healthcare context.

The PRECIS-2 tool evaluates an RCT on 9 domains, ranging between 1 and 5 (very pragmatist). In this study, the recruit-ment organisation, flexibility: delivery and follow-up domains received high scores, however the primary outcome and the method of missing data were below the pragmatic limit. This suggests that it is possible to design a trial that has good pragmatic features without damaging the quality of its results.

It is hard to determine the amount of pragmatism that is present in a trial since pragmatism doesn't have a binary attribute. Certain aspects of a study can be more pragmatic than others. A trial's pragmatism can be affected by modifications to the protocol or the logistics during the trial. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled, or conducted prior to licensing. Most were also single-center. This means that they are not quite as typical and are only pragmatic when their sponsors are accepting of the lack of blinding in these trials.

A common feature of pragmatic research is that researchers attempt to make their findings more relevant by studying subgroups within the trial sample. This can lead to unbalanced comparisons with a lower statistical power, which increases the risk of either not detecting or misinterpreting differences in the primary outcome. In the instance of the pragmatic trials that were included in this meta-analysis this was a serious issue since the secondary outcomes were not adjusted for differences in baseline covariates.

Furthermore, pragmatic studies can present challenges in the collection and interpretation safety data. This is due to the fact that adverse events are typically reported by participants themselves and prone to delays in reporting, inaccuracies, or coding variations. It is essential to improve the accuracy and quality of the outcomes in these trials.

Results

While the definition of pragmatism may not require that all trials be 100 percent pragmatic, there are benefits to including pragmatic components in 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 have their disadvantages. For instance, the appropriate type of heterogeneity could help a trial to generalise its findings to a variety of settings and patients. However, the wrong type of heterogeneity could reduce assay sensitivity and therefore lessen the ability of a trial to detect even minor effects of treatment.

A number of studies have attempted to categorize pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 created a framework for distinguishing between research studies that prove a physiological or clinical hypothesis, and pragmatic trials that inform the selection of appropriate therapies in the real-world clinical setting. The framework consisted of nine domains assessed on a scale of 1-5 with 1 being more informative and 5 being more pragmatic. The domains covered recruitment, setting up, delivery of intervention, flex adherence 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 found that pragmatic systematic reviews had higher average score in most domains, but lower scores in the primary analysis domain.

This difference in primary analysis domain can be due to the way in which most pragmatic trials analyze data. Certain explanatory trials however do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organisation, flexible delivery and follow-up were merged.

It is important to remember that a pragmatic study should not necessarily mean a low-quality study. In fact, there are an increasing number of clinical trials that employ the term "pragmatic" either in their title or abstract (as defined by MEDLINE but which is not precise nor sensitive). These terms may indicate an increased appreciation of pragmatism in titles and abstracts, but it's not clear whether this is evident in content.

Conclusions

In recent years, pragmatic trials are gaining popularity in research as the importance of real-world evidence is becoming increasingly acknowledged. They are randomized studies that compare real-world care alternatives to experimental treatments in development. They are conducted with populations of patients that are more similar to those who receive treatment in regular medical care. This method can help overcome the limitations of observational research, such as the biases that are associated with the reliance on volunteers, and the lack of the coding differences in national registry.

Pragmatic trials have other advantages, including the ability to draw on existing data sources and a higher likelihood of detecting meaningful differences from traditional trials. However, they may be prone to limitations that undermine their validity and generalizability. For example the participation rates in certain trials may be lower than expected due to the healthy-volunteer effect and incentives to pay or compete for participants from other research studies (e.g., industry trials). Many pragmatic trials are also restricted by the necessity to enroll participants quickly. Certain pragmatic trials lack controls to ensure that observed variations aren't due to biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described themselves as pragmatic. They assessed pragmatism by using the PRECIS-2 tool that includes the eligibility criteria for 프라그마틱 슬롯체험 domains and recruitment criteria, as well as flexibility in adherence to intervention and follow-up. They discovered that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials with high pragmatism scores are likely to have more lenient criteria for eligibility than traditional RCTs. They also include patients from a variety of hospitals. The authors argue that these traits can make pragmatic trials more effective and useful for everyday practice, but they don't necessarily mean that a pragmatic trial is free of bias. In addition, the pragmatism that is present in a trial is not a definite characteristic; a pragmatic trial that doesn't contain all the characteristics of a explanatory trial can yield valuable and reliable results.