• 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 facilitates research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological research studies to examine the effects of treatment across trials that employ different levels of pragmatism and other design features.

Background

Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world for clinical decision making. The term "pragmatic", however, is a word that is often used in contradiction and its definition and assessment require further clarification. Pragmatic trials must be designed to guide clinical practice and 프라그마틱 슬롯버프 policy decisions, rather than to prove the validity of a clinical or physiological hypothesis. A pragmatic trial should strive to be as close to the real-world clinical environment as is possible, including its participation of participants, setting and design as well as the execution of the intervention, as well as the determination and analysis of outcomes as well as primary analyses. This is a major distinction between explanatory trials, as described by Schwartz and Lellouch1, which are designed to confirm a hypothesis in a more thorough way.

Truly pragmatic trials should not blind participants or clinicians. This can lead to an overestimation of the effects of treatment. Pragmatic trials should also seek to recruit patients from a wide range of health care settings to ensure that the results can be applied to the real world.

Furthermore, trials that are pragmatic must concentrate on outcomes that are important to patients, like quality of life and functional recovery. This is especially important for trials that involve invasive procedures or have potentially dangerous adverse effects. The CRASH trial29, for example focused on the functional outcome to compare a two-page report with an electronic system for 프라그마틱 무료체험 monitoring of hospitalized patients with chronic heart failure. In addition, the catheter trial28 utilized urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these aspects, pragmatic trials should minimize trial procedures and data-collection requirements to reduce costs and time commitments. Finally pragmatic trials should try to make their findings as applicable to real-world clinical practice as they can 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 requirements, a number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all types. This can lead to false claims about pragmatism, and the use of the term should be standardised. The creation of a PRECIS-2 tool that provides an objective, standardized evaluation of the pragmatic characteristics is a good start.

Methods

In a pragmatic study the aim is to inform policy or clinical decisions by showing how an intervention could be integrated into routine treatment in real-world contexts. This differs from explanation trials that test hypotheses about the cause-effect connection in idealized conditions. Therefore, pragmatic trials could be less reliable 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 data for making decisions within the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatic). In this study, the areas of recruitment, organisation and flexibility in delivery, flexible adherence and follow-up scored high. However, the main outcome and the method of missing data was scored below the pragmatic limit. This suggests that it is possible to design a trial that has excellent pragmatic features without damaging the quality of its results.

It is hard to determine the level of pragmatism that is present in a trial because pragmatism does not have a single attribute. Certain aspects of a research study can be more pragmatic than other. Additionally, logistical or protocol modifications during the course of the trial may alter its score in pragmatism. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. Most were also single-center. Thus, 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.

Furthermore, a common feature of pragmatic trials is that the researchers attempt to make their findings more valuable by studying subgroups of the sample. However, this often leads to unbalanced comparisons with a lower statistical power, thereby increasing the likelihood of missing or misinterpreting differences in the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates that differed at the baseline.

Additionally, studies that are pragmatic can present challenges in the gathering and interpretation of safety data. It is because adverse events are usually self-reported and are susceptible to errors, delays or coding variations. Therefore, it is crucial to improve the quality of outcomes ascertainment in these trials, in particular by using national registries instead of relying on participants to report adverse events on the trial's own database.

Results

Although the definition of pragmatism does not require that all clinical trials are 100% pragmatic there are benefits when incorporating pragmatic components into trials. These include:

By including routine patients, the results of trials are more easily translated into clinical practice. However, pragmatic trials may have their disadvantages. The right amount of heterogeneity, like could help a study extend its findings to different settings or patients. However, the wrong type can reduce the sensitivity of an assay and, consequently, reduce a trial's power to detect minor treatment effects.

A number of studies have attempted to categorize pragmatic trials, with various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between research studies that prove a clinical or physiological hypothesis as well as pragmatic trials that aid in the choice of appropriate therapies in clinical practice. The framework was comprised of nine domains, each scoring on a scale of 1-5, with 1 being more informative and 5 indicating more pragmatic. The domains included recruitment, setting, intervention delivery, flexible adherence, 프라그마틱 슬롯버프 follow-up and primary analysis.

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

This distinction in the primary analysis domain could be due to the fact that most pragmatic trials analyze their data in the intention to treat method however some explanation trials do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery and follow-up were merged.

It is important to note that a pragmatic trial doesn't necessarily mean a low quality trial, and in fact there is a growing number of clinical trials (as defined by MEDLINE search, but this is not specific nor sensitive) which use the word "pragmatic" in their title or abstract. The use of these terms in abstracts and titles could suggest a greater awareness of the importance of pragmatism but it isn't clear if this is manifested in the contents of the articles.

Conclusions

In recent years, pragmatic trials are gaining popularity in research as the value of real-world evidence is becoming increasingly acknowledged. They are clinical trials that are randomized that evaluate real-world alternatives to care instead of experimental treatments under development. They involve patient populations which are more closely resembling those treated in routine care, they use comparators which exist in routine practice (e.g., existing drugs) and rely on participant self-report of outcomes. This method can help overcome the limitations of observational research, such as the biases associated with the reliance on volunteers as well as the insufficient availability and codes that vary in national registers.

Pragmatic trials also have advantages, like the ability to leverage existing data sources and a higher likelihood of detecting meaningful distinctions from traditional trials. However, pragmatic trials may be prone to limitations that compromise their reliability and generalizability. Participation rates in some trials may be lower than anticipated due to the healthy-volunteering effect, financial incentives, or competition from other research studies. The need to recruit individuals in a timely manner also reduces the size of the sample and the impact of many practical trials. Certain pragmatic trials lack controls to ensure that observed variations aren't due to biases that occur during the trial.

The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described themselves as pragmatic. They assessed pragmatism by 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 of these trials scored highly or pragmatic pragmatic (i.e., scoring 5 or more) in any one or more of these domains and that the majority of them were single-center.

Studies with high pragmatism scores tend to have broader criteria for eligibility than traditional RCTs. They also include patients from a variety of hospitals. 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. Moreover, the pragmatism of a trial is not a predetermined characteristic; a pragmatic trial that doesn't have all the characteristics of an explanatory trial may yield valuable and 프라그마틱 정품 reliable results.