• 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 supports research on pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2 which allows for multiple and varied meta-epidemiological research studies to examine the effects of treatment across trials with different levels of pragmatism as well as other design features.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. The term "pragmatic" however, is a word that is often used in contradiction and its definition and measurement require clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than confirm the validity of a clinical or physiological hypothesis. A pragmatic trial should also aim to be as similar to the real-world clinical environment as possible, such as its recruitment 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 analysis. This is a major distinction between explanatory trials, as described by Schwartz and Lellouch1 that are designed to prove the hypothesis in a more thorough manner.

The most pragmatic trials should not conceal participants or clinicians. This can lead to a bias in the estimates of the effects of treatment. Practical trials should also aim to attract patients from a wide range of health care settings, 프라그마틱 사이트 to ensure that the results can be compared to the real world.

Furthermore the focus of pragmatic trials should be on outcomes that are important for patients, such as quality of life or functional recovery. This is especially important for 프라그마틱 플레이 슬롯체험 (Discover More) trials that involve surgical procedures that are invasive or may have serious adverse impacts. The CRASH trial29 compared a 2-page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The trial with a catheter, however utilized symptomatic catheter-related urinary tract infections as its primary outcome.

In addition to these aspects pragmatic trials should reduce the requirements for data collection and trial procedures to cut down on costs and time commitments. Finaly the aim of pragmatic trials is to make their results as relevant to real-world clinical practice as is possible. This can be achieved by ensuring their primary analysis is based on an intention-to treat method (as described within CONSORT extensions).

Many RCTs which do not meet the requirements for pragmatism but have features that are contrary to pragmatism, have been published in journals of different types and incorrectly labeled pragmatic. This can lead to misleading claims of pragmatism and the usage of the term should be made more uniform. The creation of a PRECIS-2 tool that provides an objective, standardized evaluation of pragmatic aspects is a first step.

Methods

In a pragmatic research study the aim is to inform policy or clinical decisions by showing how an intervention can be integrated into routine care in real-world settings. This differs from explanation trials that test hypotheses regarding the causal-effect relationship in idealized situations. Consequently, 무료슬롯 프라그마틱 pragmatic trials may have lower internal validity than explanatory trials and might 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 context of healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, ranging between 1 and 5 (very pragmatist). In this study the areas of recruitment, organisation, flexibility in delivery, flexibility in adherence, and follow-up were awarded high scores. However, the principal outcome and method of missing data scored 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, however, difficult to judge how pragmatic a particular trial really is because pragmaticity is not a definite quality; 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 found that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to licensing. They also found that the majority were single-center. They aren't in line with the norm and can only be considered pragmatic if their sponsors agree that such trials are not blinded.

Furthermore, a common feature of pragmatic trials is that researchers attempt to make their findings more valuable by studying subgroups of the trial sample. However, this can lead to unbalanced comparisons with a lower statistical power, which increases the chance of not or misinterpreting differences in the primary outcome. In the instance of the pragmatic trials included in this meta-analysis this was a major issue since the secondary outcomes were not adjusted to account for differences in the baseline covariates.

Furthermore, pragmatic trials can also be a challenge in the collection and interpretation of safety data. It is because adverse events tend to be self-reported, and therefore are prone to errors, delays or coding differences. It is important to improve the accuracy and quality of outcomes in these trials.

Results

Although the definition of pragmatism does not require that all trials are 100% pragmatic, there are benefits of including pragmatic elements in clinical trials. These include:

Increasing sensitivity to real-world issues as well as reducing the size of studies and their costs as well as allowing trial results to be more quickly translated into actual clinical practice (by including routine patients). However, pragmatic trials may also have drawbacks. For example, the right type of heterogeneity could help a trial to generalise its results to many different patients and settings; however the wrong kind of heterogeneity may reduce the assay's sensitiveness and consequently decrease the ability of a study to detect small treatment effects.

Numerous studies have attempted to categorize pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 created a framework to discern between explanation-based studies that support the physiological hypothesis or clinical hypothesis, and pragmatic studies that inform the choice for appropriate therapies in real world clinical practice. The framework was comprised of nine domains that were assessed on a scale of 1-5 with 1 being more explanatory while 5 was more pragmatic. The domains covered recruitment, setting up, delivery of intervention, flexible adherence and primary analysis.

The original PRECIS tool3 had similar domains and an assessment scale ranging from 1 to 5. Koppenaal and colleagues10 developed an adaptation to this assessment, dubbed the Pragmascope that was simpler to use in systematic reviews. They discovered that pragmatic reviews scored higher in most domains, but scored lower in the primary analysis domain.

This difference in primary analysis domain can be explained by the way most pragmatic trials analyse data. Certain explanatory trials however don't. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery, and follow-up were combined.

It is important to understand that a pragmatic trial doesn't necessarily mean a poor quality trial, and indeed there is a growing number of clinical trials (as defined by MEDLINE search, but it is neither specific nor sensitive) that employ the term 'pragmatic' in their abstracts or titles. The use of these words in abstracts and titles may suggest a greater awareness of the importance of pragmatism but it is unclear whether this is evident in the contents of the articles.

Conclusions

In recent years, pragmatic trials are becoming more popular in research as the importance of real-world evidence is becoming increasingly acknowledged. They are clinical trials that are randomized that evaluate real-world alternatives to care rather than experimental treatments under development, they involve populations of patients that more closely mirror the ones who are treated in routine care, they use comparators that are used in routine practice (e.g., existing medications), and they depend on participants' self-reports of outcomes. This method can help overcome limitations of observational studies which include the biases that arise from relying on volunteers and limited availability and the variability of coding in national registry systems.

Other benefits of pragmatic trials include the possibility of using existing data sources, and a greater likelihood of detecting meaningful changes than traditional trials. However, pragmatic tests may still have limitations which undermine their effectiveness and generalizability. For example, participation rates in some trials might be lower than anticipated due to the healthy-volunteer influence and financial incentives or competition for participants from other research studies (e.g., industry trials). Many pragmatic trials are also restricted by the need to enroll participants in a timely manner. In addition some pragmatic trials do not have controls to ensure that the observed differences aren't due to biases in the conduct of trials.

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

Trials with a high pragmatism rating tend to have higher eligibility criteria than traditional RCTs that have specific criteria that are unlikely to be present in clinical practice, and they comprise patients from a wide range of hospitals. According to the authors, may make pragmatic trials more relevant and relevant to everyday clinical. However they do not guarantee that a trial is free of bias. The pragmatism characteristic is not a fixed attribute the test that does not possess all the characteristics of an explicative study could still yield reliable and beneficial results.