• 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 shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological studies that compare treatment effects estimates across trials that employ different levels of pragmatism as well as other design features.

Background

Pragmatic trials are increasingly acknowledged as providing evidence from the real world to support clinical decision-making. The term "pragmatic" however, is a word that is often used in contradiction and its definition and measurement require clarification. Pragmatic trials are intended to inform clinical practices and 프라그마틱 정품확인 policy decisions, not to confirm a physiological hypothesis or clinical hypothesis. A pragmatic study should strive to be as close as it is to real-world clinical practices, including recruitment of participants, setting up, delivery and implementation of interventions, determining and analysis outcomes, and primary analysis. This is a significant difference between explanation-based trials, as described by Schwartz and Lellouch1 that are designed to prove a hypothesis in a more thorough way.

Trials that are truly practical should not attempt to blind participants or clinicians, as this may result in bias in the estimation of treatment effects. Pragmatic trials will also recruit patients from different healthcare settings to ensure that the results can be generalized to the real world.

Furthermore, pragmatic trials should focus on outcomes that are crucial to patients, such as quality of life or functional recovery. This is particularly important for trials that involve surgical procedures that are invasive or 슬롯 may have serious adverse impacts. The CRASH trial29, for example focused on the functional outcome to evaluate a two-page case report with an electronic system to monitor the health of patients admitted to hospitals with chronic heart failure. In addition, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as its primary outcome.

In addition to these aspects, pragmatic trials should minimize the trial procedures and data collection requirements in order to reduce costs. In the end the aim of pragmatic trials is to make their findings as applicable to current clinical practices as possible. This can be accomplished by ensuring that their primary analysis is based on the intention-to treat approach (as described within CONSORT extensions).

Many RCTs which do not meet the criteria for pragmatism but have features that are in opposition to pragmatism, have been published in journals of different types and incorrectly labeled pragmatic. This can lead to false claims of pragmaticity and the usage of the term needs to be standardized. The creation of a PRECIS-2 tool that can provide an objective, standardized evaluation of pragmatic aspects is a good start.

Methods

In a pragmatic research study the aim is to inform clinical or policy decisions by demonstrating how an intervention can be integrated into routine care in real-world settings. This differs from explanation trials, which test hypotheses about the cause-effect connection in idealized situations. 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 the context of healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, ranging between 1 and 5 (very pragmatic). In this study the domains of recruitment, organisation as well as flexibility in delivery flexibility in adherence, and follow-up scored high. However, the principal outcome and method of missing data were scored below the practical limit. This suggests that a trial can be designed with effective pragmatic features, without damaging the quality.

It is, however, difficult to determine how practical a particular trial is since the pragmatism score is not a binary quality; certain aspects of a study can be more pragmatic than others. Furthermore, logistical or protocol changes during a trial can change its pragmatism score. Additionally 36% of 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled, or conducted prior to licensing, and the majority were single-center. Thus, they are not very close to usual practice and can only be called pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.

A common aspect of pragmatic studies is that researchers try to make their findings more meaningful by analyzing subgroups of the trial sample. This can lead to unbalanced analyses with less statistical power. This increases the chance of omitting or ignoring differences in the primary outcomes. In the instance of the pragmatic trials included in this meta-analysis, this was a major issue because the secondary outcomes weren't adjusted for the differences in baseline covariates.

Additionally, studies that are pragmatic can present challenges in the collection and interpretation safety data. This is because adverse events are generally reported by the participants themselves and are susceptible to reporting errors, delays, or coding variations. It is therefore crucial to enhance the quality of outcomes for these trials, in particular by using national registries rather than relying on participants to report adverse events on the trial's own database.

Results

While the definition of pragmatism does not require that all clinical trials are 100% pragmatist There are advantages of including pragmatic elements in trials. These include:

Incorporating routine patients, the results of trials can be more quickly translated into clinical practice. However, pragmatic studies can also have disadvantages. For example, 프라그마틱 무료체험 메타 the right type of heterogeneity could help a trial to generalise its results to different patients and settings; however, the wrong type of heterogeneity can reduce assay sensitiveness and consequently lessen the ability of a trial to detect minor treatment effects.

A number of studies have attempted to classify pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory trials that confirm a physiological or 프라그마틱 플레이 clinical hypothesis as well as pragmatic trials that aid in the selection of appropriate therapies in real-world clinical practice. The framework was composed of nine domains assessed on a scale of 1-5, with 1 being more lucid while 5 being more pragmatic. The domains were recruitment setting, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis.

The original PRECIS tool3 was built on the same scale and domains. Koppenaal et al10 developed an adaptation of the assessment, called the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic reviews scored higher in most domains, but scored lower in the primary analysis domain.

This difference in the primary analysis domain could be explained by the fact that most pragmatic trials analyze their data in an intention to treat way, whereas some explanatory trials do not. The overall score for pragmatic systematic reviews was lower when the areas of organization, flexible delivery, and follow-up were merged.

It is important to note that the term "pragmatic trial" does not necessarily mean a low-quality trial, and indeed there is an increasing number of clinical trials (as defined by MEDLINE search, however this is neither sensitive nor specific) which use the word 'pragmatic' in their title or abstract. These terms may indicate a greater appreciation of pragmatism in abstracts and titles, however it's unclear whether this is reflected in the content.

Conclusions

As the importance of real-world evidence becomes increasingly popular and pragmatic trials have gained momentum in research. They are randomized trials that compare real world alternatives to experimental treatments in development. They include patient populations closer to those treated in regular care. This approach can overcome the limitations of observational research, for example, the biases that come with the use of volunteers and the limited availability and the coding differences in national registry.

Other advantages of pragmatic trials include the ability to utilize existing data sources, as well as a higher likelihood of detecting meaningful changes than traditional trials. However, these tests could still have limitations which undermine their reliability and generalizability. Participation rates in some trials may be lower than expected because of the healthy-volunteering effect, financial incentives, or competition from other research studies. A lot of pragmatic trials are restricted by the need to enroll participants quickly. Some pragmatic trials also lack controls to ensure that the observed variations aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs self-labeled as pragmatic and that were published up to 2022. The PRECIS-2 tool was used to determine the degree of pragmatism. It covers domains such as eligibility criteria, recruitment flexibility, adherence to intervention, and follow-up. They found that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs that have specific criteria that are unlikely to be found in the clinical setting, and include populations from a wide variety of hospitals. The authors claim that these characteristics could make pragmatic trials more effective and applicable to daily practice, but they do not necessarily guarantee that a trial conducted in a pragmatic manner is completely free of bias. The pragmatism is not a definite characteristic the test that does not possess all the characteristics of an explanation study could still yield reliable and beneficial results.