• 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 gathers and distributes clean trial data, ratings and evaluations using PRECIS-2. This permits a variety of meta-epidemiological studies to examine the effect of treatment across trials of various levels of pragmatism.

Background

Pragmatic studies are increasingly recognized as providing real-world evidence to support clinical decision-making. However, the use of the term "pragmatic" is not consistent and its definition and assessment requires clarification. Pragmatic trials are intended to guide clinical practices and policy choices, rather than verify a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as close as possible to real-world clinical practices which include the recruitment of participants, 프라그마틱 슬롯무료 setting, design, delivery and implementation of interventions, determination and analysis outcomes, and primary analysis. This is a significant difference between explanatory trials as described by Schwartz and Lellouch1, which are designed to confirm the hypothesis in a more thorough way.

The trials that are truly pragmatic must not attempt to blind participants or the clinicians, as this may lead to distortions in estimates of the effects of treatment. Practical trials should also aim to enroll patients from a variety of health care settings to ensure that their findings can be applied to the real world.

Furthermore, trials that are pragmatic must focus on outcomes that matter to patients, like the quality of life and functional recovery. This is particularly important when it comes to trials that involve surgical procedures that are invasive or have potential serious adverse events. The CRASH trial29 compared a 2-page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The trial with a catheter, however was based on symptomatic catheter-related urinary tract infection as the primary outcome.

In addition to these characteristics the pragmatic trial should also reduce the procedures for conducting trials and requirements for data collection to reduce costs. Furthermore pragmatic trials should try to make their results 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 criteria, 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 of pragmatism, and the use of the term should be standardized. The development of a PRECIS-2 tool that provides an objective and standardized evaluation of pragmatic aspects is the first step.

Methods

In a pragmatic 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 settings. This is different from explanatory trials that test hypotheses regarding the cause-effect connection in idealized situations. Therefore, pragmatic trials could have less internal validity than explanatory trials and may be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials can contribute valuable information to 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 as well as flexibility in delivery flexibility in adherence, and follow-up received high scores. However, the principal outcome and method of missing data was scored below the pragmatic limit. This suggests that a trial can be designed with well-thought-out practical features, yet not compromising its quality.

It is hard to determine the amount of pragmatism in a particular trial because pragmatism does not possess a specific characteristic. Some aspects of a study may be more pragmatic than others. The pragmatism of a trial can be affected by changes 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 the licensing. They also found that the majority were single-center. They are not close to the standard practice and can only be referred to as pragmatic if their sponsors agree that these trials aren't blinded.

A common aspect of pragmatic research is that researchers attempt to make their findings more meaningful by studying subgroups of the trial sample. However, this often leads to unbalanced results and lower statistical power, which increases the likelihood of missing or misinterpreting differences in the primary outcome. In the instance of the pragmatic trials included in this meta-analysis this was a significant problem since the secondary outcomes were not adjusted for differences in the baseline covariates.

Furthermore, pragmatic studies can present challenges in the collection and interpretation of safety data. This is because adverse events are usually self-reported and are susceptible to delays in reporting, inaccuracies or coding deviations. Therefore, it is crucial to improve the quality of outcomes ascertainment in these trials, in particular by using national registry databases instead of relying on participants to report adverse events on the trial's database.

Results

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

Enhancing sensitivity to issues in the real world which reduces cost and size of the study and allowing the study results to be more quickly implemented into clinical practice (by including patients from routine care). However, pragmatic trials can also have disadvantages. The right type of heterogeneity, like could help a study extend its findings to different patients or settings. However, the wrong type can reduce the assay sensitivity, and therefore lessen the power of a trial to detect minor treatment effects.

A variety of studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 developed an approach to distinguish between explanation-based trials that support a clinical or physiological hypothesis, and pragmatic trials that aid in the choice of appropriate therapies in clinical practice. The framework was comprised of nine domains, each scored on a scale ranging from 1-5, with 1 indicating more explanatory and 5 suggesting more pragmatic. The domains included recruitment of intervention, setting up, delivery of intervention, flex compliance and primary analysis.

The original PRECIS tool3 was based on a similar scale and domains. Koppenaal et. al10 devised an adaptation of this assessment, dubbed the Pragmascope, that was easier to use for 프라그마틱 이미지 systematic reviews. They found that pragmatic reviews scored higher on average in all domains, but scored lower in the primary analysis domain.

This difference in primary analysis domain can be due to the way in which most pragmatic trials analyze data. Some explanatory trials, however do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organisation, flexible delivery and following-up were combined.

It is crucial to keep in mind that a study that is pragmatic does not necessarily mean a low-quality study. In fact, there is a growing number of clinical trials that use the term 'pragmatic' either in their title or abstract (as defined by MEDLINE however it is not precise nor sensitive). These terms may indicate that there is a greater understanding of pragmatism in abstracts and titles, however it's not clear if this is reflected in the content.

Conclusions

As appreciation for the value of real-world evidence becomes increasingly popular, pragmatic trials have gained traction in research. They are clinical trials randomized which compare real-world treatment options rather than experimental treatments under development, they include patient populations that more closely mirror the patients who receive routine care, they use comparators that are used in routine practice (e.g. existing drugs), and they depend on the self-reporting of participants about outcomes. This approach has the potential to overcome the limitations of observational research that are prone to limitations of relying on volunteers and the lack of accessibility and coding flexibility in national registries.

Pragmatic trials also have advantages, including the ability to use 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 프라그마틱 게임 프라그마틱 무료 슬롯 하는법 (you can try Xylvip) instance the participation rates in certain trials may be lower than expected due to the healthy-volunteer influence and incentives to pay or compete for participants from other research studies (e.g. industry trials). The necessity to recruit people in a timely manner also reduces the size of the sample and impact of many pragmatic trials. Some pragmatic trials also lack controls to ensure that observed differences aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published up to 2022. They evaluated pragmatism using the PRECIS-2 tool that includes the eligibility criteria for domains, recruitment, flexibility in adherence to interventions and follow-up. They discovered that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Studies that have high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also have populations from many different hospitals. The authors argue that these characteristics could make pragmatic trials more meaningful and applicable to daily practice, but they do not necessarily guarantee that a pragmatic trial is free of bias. The pragmatism principle is not a fixed characteristic and a test that does not have all the characteristics of an explicative study can still produce reliable and beneficial results.