자유게시판

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

Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that supports research on pragmatic trials. It collects and distributes cleaned trial data, ratings, and evaluations using PRECIS-2. This allows for 프라그마틱 카지노 diverse meta-epidemiological studies to examine the effect of treatment across trials with different levels of pragmatism.

Background

Pragmatic studies 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 assessment need further clarification. The purpose of pragmatic trials is to guide clinical practices and 프라그마틱 슬롯무료 policy decisions, not to confirm a physiological hypothesis or clinical hypothesis. A pragmatic study should aim to be as similar to actual clinical practice as possible, such as its participation of participants, setting and design, the delivery and execution of the intervention, and the determination and analysis of the outcomes, and primary analyses. This is a major distinction from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more thorough confirmation of the hypothesis.

Trials that are truly pragmatic must avoid attempting to blind participants or the clinicians in order to result in bias in the estimation of treatment effects. Pragmatic trials will also recruit patients from different healthcare settings to ensure that their results can be generalized to the real world.

Finally, pragmatic trials must concentrate on outcomes that are important to patients, like quality of life and functional recovery. This is particularly important for trials involving invasive procedures or those with potentially serious adverse events. The CRASH trial29, for example focused on the functional outcome to evaluate a two-page case report with an electronic system for monitoring of patients admitted to hospitals with chronic heart failure. Similarly, the catheter trial28 utilized urinary tract infections caused by catheters as its primary outcome.

In addition to these aspects, pragmatic trials should minimize the trial's procedures and requirements for data collection to reduce costs. Furthermore, pragmatic trials should seek to make their results as relevant to actual clinical practice as possible by making sure that their primary method of analysis follows the intention-to treat approach (as described in CONSORT extensions for pragmatic trials).

Despite these criteria, a number of RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to misleading claims of pragmatism, and the term's use should be standardised. The creation of the PRECIS-2 tool, which provides a standard objective assessment of pragmatic characteristics, is a good first step.

Methods

In a pragmatic research study it is the intention to inform policy or clinical decisions by showing how an intervention can be integrated into routine care in real-world situations. This is different from explanatory trials, which test hypotheses about the causal-effect relationship in idealized settings. Consequently, pragmatic trials may have less 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 context of healthcare.

The PRECIS-2 tool evaluates the level of pragmatism that is present in an RCT by assessing it across 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the domains of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the main outcome and the method for missing data was scored below the pragmatic 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 that is present in a study because pragmatism is not a have a single characteristic. Some aspects of a research study can be more pragmatic than other. Furthermore, logistical or protocol changes during a trial can change its score on pragmatism. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. The majority of them were single-center. Therefore, they aren't quite as typical and are only pragmatic in the event that their sponsors are supportive of the absence of blinding in these trials.

Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the sample. However, this often leads to unbalanced results and lower statistical power, which increases the risk of either not detecting or misinterpreting the results of the primary outcome. In the instance of the pragmatic trials included in this meta-analysis this was a significant problem since the secondary outcomes weren't adjusted for differences in baseline covariates.

Additionally, studies that are pragmatic can pose difficulties in the collection and interpretation safety data. This is because adverse events are usually self-reported and prone to reporting delays, inaccuracies or coding deviations. It is therefore important to improve the quality of outcome assessment in these trials, ideally by using national registries rather than relying on participants to report adverse events on the trial's own database.

Results

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

Incorporating routine patients, the results of trials can be translated more quickly into clinical practice. However, pragmatic trials have disadvantages. The right type of heterogeneity for instance could allow a study to generalise its findings to many different settings or patients. However, the wrong type can decrease the sensitivity of the test, and therefore lessen the power of a trial to detect even minor effects of treatment.

A number of studies have attempted to classify pragmatic trials with various definitions and 프라그마틱 추천 scoring systems. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that prove the physiological hypothesis or clinical hypothesis, and pragmatic studies that help inform the choice for appropriate therapies in the real-world clinical practice. The framework consisted of nine domains that were evaluated on a scale of 1-5, 프라그마틱 플레이 (yourbookmark.stream) with 1 being more lucid while 5 was more pragmatic. The domains included recruitment and setting up, the delivery of intervention, flex compliance and primary analysis.

The original PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal and colleagues10 created 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 across all domains, however they scored lower in the primary analysis domain.

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

It is important to remember that the term "pragmatic trial" does not necessarily mean a poor quality trial, and indeed there is an increasing number of clinical trials (as defined by MEDLINE search, however this is not specific or sensitive) that use the term 'pragmatic' in their abstracts or titles. The use of these words in abstracts and titles could suggest a greater awareness of the importance of pragmatism however, it is not clear if this is reflected in the content of the articles.

Conclusions

As the value of evidence from the real world becomes more popular and pragmatic trials have gained traction in research. They are clinical trials that are randomized that compare real-world care alternatives instead of experimental treatments under development. They involve 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 they depend on the self-reporting of participants about outcomes. This method is able to overcome the limitations of observational research, such as the biases that come with the use of volunteers as well as the insufficient availability and codes that vary in national registers.

Pragmatic trials have other advantages, like the ability to draw on existing data sources and a higher probability of detecting meaningful differences from traditional trials. However, pragmatic trials may be prone to limitations that compromise their reliability and generalizability. For instance the participation rates in certain trials might 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). A lot of pragmatic trials are restricted by the need to enroll participants on time. Certain pragmatic trials lack controls to ensure that the observed differences aren't caused by biases that occur during the trial.

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

Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs which have very specific criteria that are not likely to be found in the clinical environment, and they contain patients from a broad range of hospitals. The authors claim that these characteristics can help make pragmatic trials more meaningful and relevant to daily practice, but they do not guarantee that a trial conducted in a pragmatic manner is free from bias. Moreover, the pragmatism of a trial is not a predetermined characteristic; a pragmatic trial that doesn't contain all the characteristics of an explanatory trial can produce valuable and reliable results.