프라그마틱 공식홈페이지 is a non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It collects and distributes cleaned trial data, ratings and evaluations using PRECIS-2. This permits a variety of meta-epidemiological analyses that compare treatment effect estimates across trials of different levels of pragmatism.
Background
Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world for clinical decision making. The term "pragmatic" however, is not used in a consistent manner and its definition and measurement need further clarification. The purpose of pragmatic trials is to guide the practice of clinical medicine and policy decisions rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as close as is possible to actual clinical practices which include the recruiting participants, setting up, delivery and implementation of interventions, determination and analysis outcomes, and primary analyses. This is a major difference between explanatory trials as defined by Schwartz & Lellouch1, which are designed to confirm the hypothesis in a more thorough manner.
The most pragmatic trials should not blind participants or the clinicians. This could lead to bias in the estimations of the effect of treatment. Practical trials should also aim to attract patients from a variety of health care settings so that their results are generalizable to the real world.
Furthermore the focus of pragmatic trials should be on outcomes that are vital for patients, such as quality of life or functional recovery. This is particularly relevant in trials that involve invasive procedures or those with potentially 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, on the other hand was based on symptomatic catheter-related urinary tract infection as its primary outcome.
In addition to these characteristics the pragmatic trial should also reduce the trial's procedures and data collection requirements in order to reduce costs. Additionally the aim of pragmatic trials is to make their results as relevant to actual clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on the intention to treat approach (as defined in CONSORT extensions).
Despite these guidelines, a number of RCTs with features that challenge pragmatism have been incorrectly self-labeled pragmatic and published in journals of all kinds. This could lead to false claims of pragmatism and the use of the term should be standardized. The development of the PRECIS-2 tool, which offers an objective and standard assessment of pragmatic features is a good initial step.
Methods
In a practical trial the goal is to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised settings. Therefore, pragmatic trials might be less reliable than explanatory trials, and could be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials can be a valuable source of information for decisions in the context of healthcare.
The PRECIS-2 tool assesses the degree of pragmatism within an RCT by assessing it across 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study the areas of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up scored high. However, the main outcome and the method for missing data were scored below the practical limit. This suggests that it is possible to design a trial that has good pragmatic features without harming the quality of the outcomes.
It is, however, difficult to assess how pragmatic a particular trial is, since pragmatism is not a binary characteristic; certain aspects of a trial can be more pragmatic than others. A trial's pragmatism can be affected by changes to the protocol or logistics during the trial. Koppenaal and colleagues discovered that 36% of 89 pragmatic studies were placebo-controlled or conducted prior to licensing. Most were also single-center. They aren't in line with the usual practice and are only called pragmatic if their sponsors agree that these trials aren't blinded.
A common aspect of pragmatic studies is that researchers attempt to make their findings more meaningful by studying subgroups within the trial. However, this often leads to unbalanced comparisons with a lower statistical power, which increases the chance of not or incorrectly detecting differences in the primary outcome. In the case of the pragmatic trials that were included in this meta-analysis this was a serious issue since the secondary outcomes weren't adjusted for differences in baseline covariates.
Furthermore practical trials can present challenges in the collection and interpretation of safety data. This is due to the fact that adverse events are usually self-reported and are susceptible to delays in reporting, inaccuracies or coding errors. It is essential to improve the accuracy and quality of outcomes in these trials.
Results
While the definition of pragmatism may not require that all trials be 100% pragmatic, there are benefits to incorporating pragmatic components into clinical trials. These include:
By including routine patients, the trial results are more easily translated into clinical practice. But pragmatic trials can have disadvantages. For instance, the right type of heterogeneity could help a study to generalize its results to many different settings and patients. However, the wrong type of heterogeneity can reduce assay sensitivity and therefore lessen the ability of a trial to detect even minor effects of treatment.
A number of studies have attempted to categorize pragmatic trials, with a variety of definitions and scoring systems. Schwartz and Lellouch1 created a framework to distinguish between explanatory studies that prove a physiological or clinical hypothesis, and pragmatic studies that guide the selection of appropriate treatments in real world clinical practice. The framework consisted of nine domains assessed on a scale of 1-5, with 1 being more lucid while 5 was more pragmatic. The domains included recruitment, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis.
The initial PRECIS tool3 had similar domains and scales from 1 to 5. Koppenaal et. al10 devised an adaptation of the assessment, called the Pragmascope which was more user-friendly to use for systematic reviews. They found that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.
This difference in primary analysis domains can be due to the way in which most pragmatic trials analyse data. 프라그마틱 무료 슬롯버프 don't. The overall score for pragmatic systematic reviews was lower when the domains of organization, flexible delivery, and following-up were combined.
It is important to remember that a pragmatic study should not necessarily mean a low-quality study. In fact, there is increasing numbers of clinical trials that use the word 'pragmatic,' either in their abstract or title (as defined by MEDLINE, but that is neither sensitive nor precise). These terms could indicate that there is a greater awareness of pragmatism within abstracts and titles, however it isn't clear whether this is evident in content.
Conclusions
In recent years, pragmatic trials have been becoming more popular in research as the value of real world evidence is increasingly recognized. They are randomized clinical trials that compare real-world care alternatives rather than experimental treatments under development, they have patient populations which are more closely resembling the ones who are treated in routine medical care, they utilize comparators which exist in routine practice (e.g., existing medications), and they depend on participants' self-reports of outcomes. This method can help overcome the limitations of observational studies, such as the biases that arise from relying on volunteers and limited availability and coding variability in national registries.
Other advantages of pragmatic trials are the ability to utilize existing data sources, and a higher likelihood of detecting meaningful changes than traditional trials. However, these tests could be prone to limitations that undermine their validity and generalizability. Participation rates in some trials could be lower than anticipated because of the healthy-volunteering effect, financial incentives, or competition from other research studies. Many pragmatic trials are also restricted by the need to enroll participants on time. In addition, some pragmatic trials don't have controls to ensure that the observed differences are not due to biases in trial conduct.
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 covers areas such as eligibility criteria, recruitment flexibility, adherence to intervention, and follow-up. They found 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.
Trials with a high pragmatism rating tend to have more expansive eligibility criteria than traditional RCTs, which include very specific criteria that are not likely to be present in clinical practice, and they comprise patients from a wide range of hospitals. According to the authors, may make pragmatic trials more useful and useful in the daily clinical. However they do not guarantee that a trial is free of bias. The pragmatism principle is not a fixed attribute and a test that doesn't have all the characteristics of an explanation study could still yield valid and useful outcomes.