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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, which allows for multiple and varied meta-epidemiological studies to examine the effects of treatment across trials with different levels of pragmatism as well as other design features.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence for clinical decision-making. The term "pragmatic" however, is used inconsistently and its definition and 프라그마틱 정품 확인법 evaluation require clarification. Pragmatic trials must be designed to guide clinical practice and policy decisions, 프라그마틱 슬롯 하는법 [Pattern-wiki.Win] rather than confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic study should strive to be as close to actual clinical practice as possible, including in its participation of participants, setting up and design of the intervention, its delivery and execution of the intervention, and the determination and analysis of outcomes as well as primary analyses. This is a major distinction between explanatory trials, as defined by Schwartz & Lellouch1 which are designed to prove a hypothesis in a more thorough way.

Truely pragmatic trials should not conceal participants or clinicians. This could lead to an overestimation of treatment effects. Pragmatic trials should also seek to enroll patients from a wide range of health care settings, to ensure that the results are generalizable to the real world.

Additionally, clinical trials should be focused on outcomes that matter to patients, like quality of life and functional recovery. This is particularly relevant when trials involve the use of invasive procedures or could have harmful adverse impacts. The CRASH trial29, for instance focused on the functional outcome to compare a 2-page case-report with an electronic system to monitor the health of hospitalized patients with chronic heart failure. In addition, the catheter trial28 used urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these features pragmatic trials should reduce trial procedures and data-collection requirements to cut down on costs and time commitments. Additionally the aim of pragmatic trials is to make their findings as applicable to current clinical practice as is possible. This can be accomplished by ensuring that their primary analysis is based on the intention-to treat approach (as described in CONSORT extensions).

Despite these guidelines, a number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all kinds. This could lead to misleading claims of pragmatism, and the usage of the term needs to be standardized. The creation of the PRECIS-2 tool, which provides an objective and standard assessment of pragmatic features is a great first step.

Methods

In a practical trial, the aim is to inform policy or clinical decisions by showing how an intervention could be integrated into everyday routine care. This is distinct from explanation trials that test hypotheses about the causal-effect relationship in idealized conditions. Therefore, pragmatic trials could be less reliable than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic research can be a valuable source of data for making decisions within the healthcare context.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study, the areas of recruitment, organisation and flexibility in delivery, flexible adherence, 프라그마틱 플레이 and follow-up received high scores. However, the principal outcome and method of missing data scored below the pragmatic limit. This indicates that a trial can be designed with effective practical features, yet not compromising its quality.

However, it is difficult to determine how practical a particular trial is, since pragmaticity is not a definite quality; certain aspects of a trial may be more pragmatic than others. The pragmatism of a trial can be affected by changes 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 the licensing. They also found that the majority were single-center. This means that they are not as common and can only be described as pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.

Additionally, a typical feature of pragmatic trials is that researchers attempt to make their findings more meaningful by analysing 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. This was a problem in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for covariates that differed at baseline.

Additionally practical trials can be a challenge in the gathering and interpretation of safety data. This is because adverse events are generally reported by the participants themselves and are susceptible to reporting errors, delays or coding errors. It is therefore crucial to improve the quality of outcome assessment in these trials, ideally by using national registries instead of relying on participants to report adverse events in the trial's database.

Results

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

Increased sensitivity to real-world issues as well as reducing study size and cost, and enabling the trial results to be more quickly translated into actual clinical practice (by including routine patients). But pragmatic trials can have disadvantages. The right kind of heterogeneity for instance, can help a study expand its findings to different settings or patients. However the wrong type of heterogeneity could decrease the sensitivity of the test and, consequently, lessen the power of a trial to detect even minor effects of treatment.

A number of studies have attempted to classify pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework for distinguishing between explanation-based trials that support a physiological or clinical hypothesis and pragmatic trials that aid in the choice of appropriate therapies in real-world clinical practice. The framework consisted of nine domains scored on a 1-5 scale, with 1 being more lucid while 5 was more pragmatic. The domains covered recruitment of intervention, setting up, delivery of intervention, flexible adherence and primary analysis.

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

This difference in primary analysis domains can be explained by the way most pragmatic trials analyze data. Some explanatory trials, however do not. The overall score for systematic reviews that were pragmatic was lower when the areas of management, flexible delivery and follow-up were merged.

It is important to remember that a pragmatic study does not mean a low-quality trial. In fact, there is increasing numbers of clinical trials which use the word 'pragmatic,' either in their abstracts or titles (as defined by MEDLINE but which is not precise nor sensitive). These terms may signal an increased appreciation of pragmatism in abstracts and titles, however it's unclear whether this is reflected in the content.

Conclusions

In recent years, pragmatic trials are increasing in popularity in research because the value of real world evidence is becoming increasingly acknowledged. They are randomized trials that evaluate real-world alternatives to new treatments that are being developed. They involve patient populations more closely resembling those treated in regular care. This method could help overcome the limitations of observational research that are prone to limitations of relying on volunteers and the lack of availability and coding variability in national registries.

Pragmatic trials also have advantages, like the ability to leverage existing data sources, and a greater chance of detecting significant differences than traditional trials. However, pragmatic tests may still have limitations which undermine their reliability and generalizability. For instance, participation rates in some trials could be lower than expected due to the healthy-volunteer effect as well as financial incentives or competition for participants from other research studies (e.g., 프라그마틱 무료게임 industry trials). The necessity to recruit people in a timely manner also restricts the sample size and the impact of many pragmatic trials. Some pragmatic trials also 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 self-labeled as pragmatic and were published until 2022. They assessed pragmatism by using the PRECIS-2 tool, which consists of the eligibility criteria for domains, recruitment, flexibility in adherence to intervention and follow-up. They discovered that 14 of these trials scored as highly or pragmatic pragmatic (i.e. scores of 5 or more) in one or more of these domains, and that the majority were single-center.

Trials with high pragmatism scores are likely to have more criteria for eligibility than conventional RCTs. They also have populations from many different hospitals. These characteristics, according to the authors, could make pragmatic trials more useful and applicable in the daily practice. However they do not ensure that a study is free of bias. In addition, the pragmatism that is present in trials is not a predetermined characteristic A pragmatic trial that doesn't contain all the characteristics of a explanatory trial can yield reliable and relevant results.