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

Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a free and non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2 allowing for multiple and diverse meta-epidemiological studies to examine the effects of treatment across trials with 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 usage of the term "pragmatic" is inconsistent and its definition and assessment requires further clarification. Pragmatic trials are intended to guide the practice of clinical medicine and policy decisions rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should also strive to be as close to the real-world clinical environment as possible, such as its participation of participants, setting up and design, the delivery and execution of the intervention, and the determination and analysis of outcomes and primary analysis. This is a major distinction between explanatory trials as described by Schwartz & Lellouch1 that are designed to confirm a hypothesis in a more thorough manner.

The trials that are truly pragmatic should avoid attempting to blind participants or healthcare professionals, as this may lead to distortions in estimates of treatment effects. 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 focus on outcomes that matter to patients, like quality of life and functional recovery. This is especially important in trials that involve surgical procedures that are invasive or 프라그마틱 플레이 이미지 (Artkaoji blog entry) have potential for dangerous adverse events. The CRASH trial29, for example, focused on functional outcomes to evaluate a two-page case report with an electronic system for the monitoring of patients admitted to hospitals with chronic heart failure, and the catheter trial28 focused on 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 to reduce costs. Additionally pragmatic trials should strive to make their findings as applicable to clinical practice as is possible by making sure that their primary analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Many RCTs that do not meet the criteria for pragmatism, but have features that are in opposition 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 should be standardized. The creation of the PRECIS-2 tool, which provides an objective and standard assessment of practical features is a great first step.

Methods

In a pragmatic study the aim is to inform policy or 프라그마틱 추천 플레이; Link-fry-2.Mdwrite.net, clinical decisions by showing how an intervention can be integrated into routine care in real-world settings. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised settings. Therefore, pragmatic trials might have lower internal validity than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can be a valuable source of information for decision-making within the healthcare context.

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

It is hard to determine the degree of pragmatism in a particular study because pragmatism is not a have a binary characteristic. Certain aspects of a study may be more pragmatic than others. A trial's pragmatism could be affected by modifications to the protocol or logistics during the trial. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. They also found that the majority were single-center. They are not in line with the usual practice and are only called pragmatic if their sponsors accept that the trials are not blinded.

Another common aspect of pragmatic trials is that researchers attempt to make their findings more relevant by analyzing subgroups of the trial sample. This can result in unbalanced analyses that have lower statistical power. This increases the risk of omitting or ignoring differences in the primary outcomes. In the instance of the pragmatic trials that were included in this meta-analysis this was a major issue since the secondary outcomes weren't adjusted for differences in the baseline covariates.

Furthermore the pragmatic trials may have challenges with respect to the gathering and interpretation of safety data. This is due to the fact that adverse events tend to be self-reported, and are prone to errors, delays or coding variations. It is therefore crucial to improve the quality of outcomes for these trials, in particular by using national registry databases instead of relying on participants to report adverse events in a trial's own database.

Results

Although the definition of pragmatism may not require that all clinical trials be 100% pragmatic, 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 as well as allowing trial results to be faster transferred into real-world clinical practice (by including routine patients). However, pragmatic trials can also have disadvantages. For instance, the right type of heterogeneity can help the trial to apply its findings to a variety of patients and settings; however, 프라그마틱 정품확인 the wrong type of heterogeneity may reduce the assay's sensitivity, and thus reduce 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 an approach to distinguish between explanation-based trials that support a physiological or clinical hypothesis as well as pragmatic trials that inform the selection of appropriate therapies in clinical practice. The framework consisted of nine domains that were scored on a 1-5 scale which indicated that 1 was more informative and 5 was more pragmatic. The domains included recruitment and setting, delivery of intervention with flexibility, follow-up and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal et. al10 devised an adaptation of this assessment, called the Pragmascope, that was easier to use for systematic reviews. They found that pragmatic systematic reviews had higher average scores in the majority of domains, but lower scores in the primary analysis domain.

This difference in the main analysis domain could be explained by the fact that the majority of pragmatic trials process their data in an intention to treat way while some explanation trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains on the organization, flexibility of delivery and follow-up were merged.

It is important to remember that a pragmatic trial does not necessarily mean a low-quality trial, and there is an increasing number of clinical trials (as defined by MEDLINE search, however it is neither specific or sensitive) that use the term "pragmatic" in their abstracts or titles. These terms could indicate a greater awareness of pragmatism within titles and abstracts, but it's unclear whether this is reflected in content.

Conclusions

As the value of real-world evidence grows popular the pragmatic trial has gained momentum in research. They are clinical trials that are randomized that evaluate real-world alternatives to care instead of experimental treatments under development, they have patients that are more similar to the ones who are treated in routine care, they employ comparators that are used in routine practice (e.g. existing medications) and rely on participant self-report of outcomes. This method can help overcome the limitations of observational research, for example, the biases that are associated with the reliance on volunteers and the limited availability and codes that vary in national registers.

Other advantages of pragmatic trials include the ability to utilize existing data sources, as well as a higher probability of detecting significant changes than traditional trials. However, these trials could have some limitations that limit their credibility 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). The necessity to recruit people quickly reduces the size of the sample and the impact of many pragmatic trials. Some pragmatic trials also lack controls to ensure that any observed differences aren't due to biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatist and published until 2022. The PRECIS-2 tool was employed to assess the degree of pragmatism. It covers areas like eligibility criteria as well as recruitment flexibility and adherence to intervention 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 of these were single-center.

Trials with high pragmatism scores tend to have more criteria for eligibility than conventional RCTs. They also have populations from various hospitals. The authors suggest that these traits can make the pragmatic trials more relevant and applicable to everyday clinical practice, however they don't necessarily mean that a trial conducted in a pragmatic manner is free of bias. The pragmatism is not a fixed attribute; a pragmatic test that does not have all the characteristics of an explanation study can still produce valid and useful outcomes.