• 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 shares cleaned trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological research studies to examine the effects of treatment across trials that have different levels of pragmatism and 프라그마틱 무료체험 메타 이미지 (0ffcc2a1.tracker.adotmob.com explains) 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 not uniform and 프라그마틱 its definition and assessment requires 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 study should aim to be as similar to the real-world clinical environment as possible, including in the recruitment of participants, setting and design as well as the execution of the intervention, as well as the determination and analysis of the outcomes, and primary analyses. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1) that are designed to provide more complete confirmation of the hypothesis.

Truly pragmatic trials should not be blind participants or clinicians. This can lead to bias in the estimations of the effects of treatment. Pragmatic trials will also recruit patients from various health care settings to ensure that their outcomes can be compared to the real world.

Finally, pragmatic trials must be focused on outcomes that matter to patients, like the quality of life and functional recovery. This is especially important in trials that involve the use of invasive procedures or potentially dangerous adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic heart failure. The catheter trial28 however, used symptomatic catheter associated urinary tract infection as the primary outcome.

In addition to these characteristics pragmatic trials should reduce trial procedures and data-collection requirements to reduce costs and time commitments. Additionally the aim of pragmatic trials is 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 an intention-to treat method (as described within CONSORT extensions).

Despite these requirements, many RCTs with features that challenge the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all kinds. This can lead to false claims of pragmaticity, and the use of the term needs to be standardized. The creation of a PRECIS-2 tool that offers a standardized objective assessment of pragmatic features is the first step.

Methods

In a practical study, the goal is to inform policy or clinical decisions by demonstrating how an intervention could be integrated into routine care in real-world contexts. This is different from explanatory trials that test hypotheses regarding the cause-effect relationship in idealised settings. Therefore, pragmatic trials could have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials may be a valuable source of information for decision-making in healthcare.

The PRECIS-2 tool evaluates the level of pragmatism that is present in an RCT by scoring it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study, the recruitment, organisation, flexibility: delivery and follow-up domains received high scores, but the primary outcome and the method for missing data were not at the practical limit. This suggests that it is possible to design a trial with excellent pragmatic features without compromising the quality of its outcomes.

However, it is difficult to judge how practical a particular trial is, since pragmaticity is not a definite quality; certain aspects of a trial can be more pragmatic than others. The pragmatism of a trial can 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. The majority of them were single-center. They are not in line with the usual practice, and can only be called pragmatic if their sponsors agree that such trials are not blinded.

A common aspect of pragmatic research is that researchers try to make their findings more meaningful by studying subgroups of the trial sample. This can result in imbalanced analyses and less statistical power. This increases the risk of missing or misdetecting differences in the primary outcomes. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates that differed at baseline.

Additionally, studies that are pragmatic can pose difficulties in the collection and interpretation safety data. This is due to the fact that adverse events tend to be self-reported, and therefore are prone to errors, delays or coding differences. It is crucial to improve the quality and accuracy of the results in these trials.

Results

While the definition of pragmatism may not require that all trials are 100 100% pragmatic, there are advantages to incorporating pragmatic components into clinical trials. These include:

By incorporating routine patients, the trial results can be more quickly translated into clinical practice. However, pragmatic trials may also have drawbacks. The right type of heterogeneity, for example could allow a study to extend its findings to different settings or patients. However the wrong type of heterogeneity could reduce the sensitivity of an assay, and therefore lessen the power of a trial to detect small treatment effects.

Many studies have attempted classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 created a framework to differentiate between explanation studies that support the physiological hypothesis or clinical hypothesis and pragmatic studies that help inform the selection of appropriate treatments in the real-world clinical practice. Their framework included nine domains, each scored on a scale ranging from 1 to 5 with 1 indicating more explanatory and 5 indicating more practical. The domains included recruitment, setting, intervention delivery with flexibility, follow-up and primary analysis.

The initial PRECIS tool3 featured similar domains and an assessment scale ranging from 1 to 5. Koppenaal and colleagues10 developed an adaptation to this assessment called the Pragmascope that was simpler to use in systematic reviews. They found that pragmatic systematic reviews had a higher average score in most domains, with lower scores in the primary analysis domain.

The difference in the primary analysis domain could be explained by the fact that most pragmatic trials analyse their data in the intention to treat manner however some explanation trials do not. The overall score for pragmatic systematic reviews was lower when the domains of management, flexible delivery and follow-up were merged.

It is important to understand that a pragmatic trial does not necessarily mean a low quality trial, and indeed there is an increasing rate of clinical trials (as defined by MEDLINE search, but this is neither specific or sensitive) that use the term 'pragmatic' in their title or abstract. These terms may indicate that there is a greater appreciation of pragmatism in titles and abstracts, but it's unclear if this is reflected in the content.

Conclusions

As the importance of real-world evidence grows widespread the pragmatic trial has gained momentum in research. They are randomized studies that compare real-world alternatives to new treatments that are being developed. They are conducted with populations of patients more closely resembling those treated in regular care. This method has the potential to overcome the limitations of observational studies which include the biases that arise from relying on volunteers, and the limited accessibility and coding flexibility in national registries.

Pragmatic trials have other advantages, such as the ability to draw on existing data sources, and a greater likelihood of detecting meaningful differences from traditional trials. However, these trials could have some limitations that limit their validity and generalizability. For example, participation rates in some trials might be lower than expected 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. Practical trials aren't always equipped with controls to ensure that observed differences aren't caused by biases during the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published from 2022. They assessed pragmatism by using the PRECIS-2 tool, which consists of the eligibility criteria for domains, recruitment, flexibility in adherence to interventions and 프라그마틱 정품확인방법 follow-up. They found that 14 of these trials scored as highly or pragmatic sensible (i.e., scoring 5 or more) in any one or more of these domains and that the majority of them were single-center.

Trials with a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs, which include very specific criteria that are not likely to be found in the clinical setting, and contain patients from a broad range of hospitals. According to the authors, can make pragmatic trials more relevant and applicable in the daily practice. However, they cannot guarantee that a trial will be free of bias. The pragmatism principle is not a fixed attribute and a test that does not have all the characteristics of an explanatory study may still yield valid and useful outcomes.