• 목록
• 답변
• 글쓰기
• 게시판 리스트 옵션
  • 수정
  • 삭제

Pragmatic Free Trial Meta

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

Background

Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the use of the term "pragmatic" is inconsistent and its definition and 프라그마틱 무료체험 메타 evaluation requires clarification. Pragmatic trials are intended to inform clinical practices and policy decisions rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as similar to actual clinical practice as possible, such as its selection of participants, setting up and design, the delivery and execution of the intervention, and the determination and analysis of outcomes and primary analyses. This is a key distinction from explanation trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough proof of a hypothesis.

Trials that are truly practical should be careful not to blind patients or 프라그마틱 슈가러쉬 healthcare professionals as this could cause bias in estimates of treatment effects. Practical trials should also aim to recruit patients from a variety of health care settings, to ensure that their findings can be applied to the real world.

Furthermore studies that are pragmatic should focus on outcomes that are important to patients, like quality of life or functional recovery. This is particularly important in trials that require the use of invasive procedures or could have harmful adverse impacts. The CRASH trial29, for instance focused on the functional outcome to compare a two-page report with an electronic system for monitoring of hospitalized patients with chronic heart failure. Similarly, the catheter trial28 focused on symptomatic catheter-associated urinary tract infections as the primary outcome.

In addition to these characteristics pragmatic trials should reduce trial procedures and data-collection requirements to cut costs and time commitments. In the end these trials should strive to make their findings as relevant to real-world clinical practices as possible. This can be accomplished by ensuring that their primary analysis is based on the intention to treat method (as defined in CONSORT extensions).

Many RCTs that do not meet the requirements for pragmatism however, they have characteristics that are contrary to pragmatism, have been published in journals of various kinds and incorrectly labeled pragmatic. This can lead to false claims about pragmatism, and the use of the term should be standardized. The development of the PRECIS-2 tool, which provides an objective standard for assessing pragmatic features, is a good first step.

Methods

In a practical trial it is the intention to inform policy or clinical decisions by demonstrating how an intervention would be implemented into routine care. This differs from explanation trials, which test hypotheses about the causal-effect relationship in idealized conditions. Consequently, pragmatic trials may 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 information for decision-making within the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study the domains of recruitment, organisation as well as flexibility in delivery flexibility in adherence, and follow-up received high scores. However, the principal outcome and the method for missing data were scored below the practical limit. This suggests that a trial could be designed with effective practical features, but without damaging the quality.

It is difficult to determine the degree of pragmatism that is present in a trial since pragmatism doesn't possess a specific characteristic. Some aspects of a research study can be more pragmatic than others. The pragmatism of a trial can be affected by changes to the protocol or logistics during the trial. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. Most were also single-center. Thus, they are not quite as typical and can only be called pragmatic when their sponsors are accepting of the absence of blinding in these trials.

Furthermore, a common feature of pragmatic trials is that researchers try to make their results more relevant by analyzing subgroups of the trial sample. However, this can lead to unbalanced comparisons and lower statistical power, thereby increasing the chance of not or misinterpreting differences in the primary outcome. In the case of the pragmatic trials included in this meta-analysis, this was a serious issue because the secondary outcomes weren't adjusted for variations in baseline covariates.

Additionally, studies that are pragmatic can pose difficulties in the collection and interpretation of safety data. This is because adverse events are usually self-reported and are susceptible to reporting errors, delays or coding deviations. It is crucial to improve the quality and accuracy of the results in these trials.

Results

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

Increased sensitivity to real-world issues as well as reducing study size and cost and allowing the study results to be faster transferred into real-world clinical practice (by including routine patients). However, pragmatic trials be a challenge. The right kind of heterogeneity, like could allow a study to extend its findings to different settings or patients. However the wrong kind of heterogeneity can decrease the sensitivity of the test and, consequently, lessen the power of a trial to detect even minor effects of treatment.

Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 created a framework for distinguishing between explanation-based trials that support a physiological or 프라그마틱 슬롯 조작 환수율 (Maps.Google.Mw) clinical hypothesis, and pragmatic trials that aid in the selection of appropriate treatments in the real-world clinical setting. The framework was comprised of nine domains that were evaluated on a scale of 1-5 with 1 being more informative and 5 being more pragmatic. The domains were recruitment and setting, delivery of intervention, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 included similar domains and an assessment scale ranging from 1 to 5. Koppenaal and colleagues10 created an adaptation of this assessment, known as the Pragmascope, that was easier to use for systematic reviews. They found that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.

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

It is important to note that a pragmatic trial does not necessarily mean a poor quality trial, and indeed there is an increasing rate of clinical trials (as defined by MEDLINE search, however it is neither specific nor sensitive) that use the term "pragmatic" in their title or abstract. These terms may signal an increased awareness of pragmatism within abstracts and titles, but it isn't clear whether this is reflected in the content.

Conclusions

As appreciation for the value of evidence from the real world becomes more popular and pragmatic trials have gained popularity in research. They are randomized trials that evaluate real-world alternatives to clinical trials in development. They include patient populations that are more similar to those who receive treatment in regular medical care. This approach can help overcome the limitations of observational research which include the limitations of relying on volunteers and limited accessibility and coding flexibility in national registry systems.

Other advantages of pragmatic trials are the ability to utilize existing data sources, as well as a higher chance of detecting meaningful changes than traditional trials. However, these trials could be prone to limitations that compromise their validity and generalizability. The participation rates in certain trials could be lower than expected because of the healthy-volunteering effect, financial incentives, or competition from other research studies. A lot of pragmatic trials are limited by the need to enroll participants on time. In addition certain pragmatic trials don't have controls to ensure that the observed differences are not due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and that were published up to 2022. The PRECIS-2 tool was used to determine the pragmatism of these trials. It includes areas such as eligibility criteria as well as recruitment flexibility as well as adherence to interventions and follow-up. They discovered that 14 of these trials scored pragmatic or highly pragmatic (i.e., scoring 5 or more) in one or more of these domains, and that the majority were single-center.

Trials that have a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs which have very specific criteria that are not likely to be present in the clinical setting, and include populations from a wide variety of hospitals. The authors claim that these characteristics could make pragmatic trials more meaningful and useful for everyday clinical practice, however they don't necessarily mean that a trial using a pragmatic approach is free of bias. Moreover, the pragmatism of trials is not a predetermined characteristic and a pragmatic trial that doesn't possess all the characteristics of a explanatory trial can produce reliable and relevant results.