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Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a non-commercial, open data platform and infrastructure that facilitates research on pragmatic trials. It collects and distributes clean trial data, ratings and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological studies to evaluate the effects of treatment across trials of different levels of pragmatism.

Background

Pragmatic trials provide real-world evidence that can be used to make clinical decisions. However, the use of the term "pragmatic" is not uniform and its definition and evaluation requires clarification. Pragmatic trials are intended to guide the practice of clinical medicine and policy choices, rather than prove a physiological or clinical hypothesis. A pragmatic trial should also try to be as similar to actual clinical practice as is possible, including the recruitment of participants, setting and design as well as the implementation of the intervention, and the determination and analysis of outcomes as well as primary analysis. This is a key distinction from explanatory trials (as described by Schwartz and Lellouch1) which are intended to provide a more thorough proof of an idea.

Truely pragmatic trials should not blind participants or clinicians. This could lead to a bias in the estimates of the effect 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.

Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, like the quality of life and functional recovery. This is particularly relevant when trials involve invasive procedures or have potentially harmful adverse impacts. The CRASH trial29, for instance was focused on functional outcomes to evaluate a two-page case report with an electronic system for the monitoring of patients admitted to hospitals with chronic heart failure, and the catheter trial28 utilized urinary tract infections that are symptomatic of catheters as the primary outcome.

In addition to these characteristics the pragmatic trial should also reduce the trial's procedures and data collection requirements to reduce costs. Additionally these trials should strive to make their results as applicable to current clinical practice as is 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 that do not meet the criteria for pragmatism but have features that are contrary to pragmatism, have been published in journals of varying kinds and incorrectly labeled pragmatic. This can lead to misleading claims of pragmatism and the usage of the term should be made more uniform. The development of a PRECIS-2 tool that can provide an objective and standardized evaluation of the pragmatic characteristics is a good start.

Methods

In a pragmatic study it is the intention to inform clinical or policy decisions by demonstrating how an intervention would be incorporated into real-world routine care. This is different from explanatory trials that test hypotheses about the cause-effect relationship in idealised settings. Consequently, 프라그마틱 플레이 pragmatic trials may 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 can be a valuable source of information for 무료 프라그마틱 decision-making in healthcare.

The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatist). In this study, the recruit-ment, organization, flexibility in delivery, flexible adherence and follow-up domains scored high scores, however the primary outcome and the procedure for missing data were below the practical limit. This suggests that a trial could be designed with effective pragmatic features, 무료슬롯 프라그마틱 without compromising its quality.

However, it's difficult to assess the degree of pragmatism a trial really is because the pragmatism score is not a binary characteristic; certain aspects of a trial can be more pragmatic than others. Furthermore, logistical or protocol modifications during the course of the trial may alter its score in pragmatism. In addition 36% of the 89 pragmatic trials identified by Koppenaal and co. were placebo-controlled, 프라그마틱 무료 (great post to read) or conducted prior to licensing, and the majority were single-center. They aren't in line with the usual practice and can only be referred to as pragmatic if their sponsors accept that such trials aren't blinded.

A typical feature of pragmatic research is that researchers try to make their findings more relevant by studying subgroups within the trial. This can lead to unbalanced comparisons with a lower statistical power, increasing the risk of either not detecting 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 the differences in the baseline covariates.

In addition the pragmatic trials may be a challenge in the gathering and interpretation of safety data. This is because adverse events are generally reported by the participants themselves and are susceptible to delays in reporting, inaccuracies or coding deviations. It is important to increase the accuracy and quality of the outcomes in these trials.

Results

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

By incorporating routine patients, the results of the trial can be translated more quickly into clinical practice. But pragmatic trials can have their disadvantages. For instance, the appropriate kind of heterogeneity can allow the trial to apply its findings to a variety of settings and patients. However the wrong type of heterogeneity can reduce assay sensitiveness and consequently lessen the ability of a study to detect small treatment effects.

A variety of studies have attempted to classify pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that support the physiological hypothesis or clinical hypothesis, and pragmatic studies that help inform the selection of appropriate treatments in clinical practice. The framework was comprised of nine domains that were evaluated on a scale of 1-5 with 1 being more explanatory while 5 being more pragmatic. The domains were recruitment setting, 프라그마틱 슬롯 사이트 setting, intervention delivery, flexible adherence, follow-up and primary analysis.

The original PRECIS tool3 had similar domains and an assessment scale ranging from 1 to 5. Koppenaal et al10 created an adaptation to this assessment called the Pragmascope which was more user-friendly to use in systematic reviews. They found that pragmatic reviews scored higher on average in most domains, but scored lower in the primary analysis domain.

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

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

Conclusions

As the value of evidence from the real world becomes more widespread the pragmatic trial has gained traction in research. They are clinical trials randomized that evaluate real-world alternatives to care rather than experimental treatments under development, they involve patients that are more similar to the ones who are treated in routine care, they use comparators which exist in routine practice (e.g. existing drugs) and depend on participants' self-reports of outcomes. This method is able to overcome the limitations of observational research, like the biases associated with the use of volunteers and the limited availability and the coding differences in national registry.

Other advantages of pragmatic trials are the ability to use existing data sources, and a higher chance of detecting meaningful changes than traditional trials. However, these tests could be prone to limitations that undermine their validity and generalizability. The participation rates in certain trials could be lower than expected due to the healthy-volunteering effect, financial incentives or competition from other research studies. The necessity to recruit people in a timely fashion also limits the sample size and impact of many pragmatic trials. Certain pragmatic trials lack controls to ensure that any observed differences 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 as pragmatism. The PRECIS-2 tool was used to determine pragmatism. It includes areas such as eligibility criteria and flexibility in recruitment and adherence to intervention and follow-up. They discovered that 14 of the trials scored pragmatic or highly sensible (i.e. scoring 5 or more) in one or more of these domains, and that the majority were single-center.

Studies that have high pragmatism scores tend to have more criteria for eligibility than conventional RCTs. They also contain patients from a variety of hospitals. The authors argue that these characteristics could make pragmatic trials more meaningful and useful for daily practice, but they do not guarantee that a trial conducted in a pragmatic manner is free from bias. Furthermore, the pragmatism of a trial is not a predetermined characteristic A pragmatic trial that doesn't possess all the characteristics of a explanatory trial may yield reliable and relevant results.