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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 allowing for multiple and diverse meta-epidemiological research studies to compare treatment effects estimates across trials that employ different levels of pragmatism and 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 inconsistent and its definition and assessment requires further clarification. Pragmatic trials are intended to guide the practice of clinical medicine and 프라그마틱 무료 policy decisions, not to confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should also aim to be as similar to the real-world clinical environment as is possible, including the participation of participants, setting and design of the intervention, its delivery and 프라그마틱 슬롯체험 execution of the intervention, as well as the determination and analysis of outcomes and primary analysis. This is a major difference between explanation-based trials, as defined by Schwartz & Lellouch1 that are designed to test a hypothesis in a more thorough manner.

Truely pragmatic trials should not blind participants or clinicians. This can result in an overestimation of the effects of treatment. Pragmatic trials should also seek to attract patients from a variety of health care settings, to ensure that the results can be applied to the real world.

Additionally, pragmatic trials should focus on outcomes that are crucial to patients, like quality of life or functional recovery. This is particularly relevant for trials that involve invasive procedures or have potentially serious adverse impacts. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients suffering from chronic cardiac failure. The catheter trial28 on the other hand, used symptomatic catheter associated urinary tract infections as its primary outcome.

In addition to these characteristics, pragmatic trials should minimize the procedures for conducting trials and requirements for data collection to reduce costs. Additionally, pragmatic trials should seek to make their findings as applicable to real-world clinical practice as possible 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 kinds. This can lead to false claims of pragmatism, and the term's use should be standardized. The development of a PRECIS-2 tool that provides an objective, standardized assessment of pragmatic features is a first step.

Methods

In a practical 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 is different from explanatory trials that test hypotheses about the causal-effect relationship in idealized settings. In this way, pragmatic trials could have less internal validity than explanatory studies and be more prone to biases in their design as well as analysis and conduct. Despite these limitations, pragmatic trials can contribute valuable information to decisions in the context of healthcare.

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

However, it's difficult to determine the degree of pragmatism a trial really is because pragmaticity is not a definite quality; certain aspects of a study can be more pragmatic than others. A trial's pragmatism could be affected by changes to the protocol or logistics during the trial. In addition, 36% of the 89 pragmatic trials discovered by Koppenaal and co. were placebo-controlled or conducted prior to licensing, 프라그마틱 무료 and the majority were single-center. They aren't in line with the usual practice, and can only be called pragmatic if their sponsors accept that these trials are not blinded.

Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more meaningful by analysing subgroups of the trial sample. However, this often leads to unbalanced results and lower statistical power, thereby increasing the likelihood of missing or incorrectly detecting differences in the primary outcome. This was the case in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for covariates' differences at baseline.

Furthermore, pragmatic trials can also be a challenge in the gathering and interpretation of safety data. This is because adverse events are typically reported by participants themselves and prone to reporting delays, inaccuracies or coding errors. It is therefore important to improve the quality of outcomes assessment in these trials, ideally by using national registries rather than relying on participants to report adverse events on the trial's database.

Results

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

Enhancing sensitivity to issues in the real world, reducing study size and cost, and enabling the trial results to be more quickly implemented into clinical practice (by including patients from routine care). However, pragmatic trials have disadvantages. For instance, the appropriate type of heterogeneity could help a trial to generalise its results to different settings and patients. However the wrong type of heterogeneity may reduce the assay's sensitivity, and thus reduce the power of a study to detect minor treatment effects.

Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can discern between explanation-based studies that support a physiological or clinical hypothesis, and pragmatic studies that help inform the selection of appropriate therapies in clinical practice. The framework was comprised of nine domains that were scored on a 1-5 scale which indicated that 1 was more informative and 5 was more pragmatic. The domains included recruitment setting, setting, intervention delivery with flexibility, follow-up and primary analysis.

The original PRECIS tool3 had similar domains and scales from 1 to 5. Koppenaal and colleagues10 created an adaptation of the assessment, dubbed the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic systematic reviews had higher average score in most domains, but lower scores in the primary analysis domain.

The difference in the primary analysis domains can be explained by the way most pragmatic trials approach 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 important to understand that a pragmatic trial does not necessarily mean a low quality trial, and there is a growing number of clinical trials (as defined by MEDLINE search, but this is neither sensitive nor specific) that employ the term "pragmatic" in their abstract or title. These terms may signal an increased awareness of pragmatism within abstracts and titles, 프라그마틱 정품확인방법 however it isn't clear whether this is reflected in content.

Conclusions

In recent years, pragmatic trials have been 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 have populations of patients that more closely mirror the ones who are treated in routine care, they use comparators which exist in routine practice (e.g. existing medications) and depend on the self-reporting of participants about outcomes. This method can help overcome the limitations of observational research, for example, the biases associated with the reliance on volunteers, and the limited availability and coding variations in national registries.

Pragmatic trials offer other advantages, such as the ability to draw on existing data sources and a higher probability of detecting meaningful distinctions from traditional trials. However, pragmatic trials may still have limitations that undermine their validity and generalizability. The participation rates in certain trials may be lower than anticipated due to the healthy-volunteering effect, financial incentives, or competition from other research studies. The requirement to recruit participants in a timely manner also restricts the sample size and the impact of many practical trials. Additionally some pragmatic trials lack controls to ensure that the observed differences aren't due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described as pragmatism. They assessed pragmatism by using the PRECIS-2 tool, which includes the domains eligibility criteria, recruitment, flexibility in intervention adherence and follow-up. They found that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials with high pragmatism scores are likely to have broader criteria for eligibility than traditional RCTs. They also have populations from various hospitals. These characteristics, according to the authors, could make pragmatic trials more useful and applicable in the daily practice. However, they don't guarantee that a trial is free of bias. Moreover, the pragmatism of the trial is not a definite characteristic; a pragmatic trial that doesn't possess all the characteristics of a explanatory trial may yield valuable and reliable results.