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Pragmatic Free Trial Meta Pragmatic Free Trail Meta is an open data platform that facilitates research into pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2 permitting multiple and varied meta-epidemiological studies to evaluate the effect of treatment on trials that have different levels of pragmatism, as well as other design features. Background Pragmatic studies are increasingly acknowledged as providing evidence from the real world to support clinical decision-making. However, the use of the term “pragmatic” is inconsistent and its definition and evaluation requires clarification. The purpose of pragmatic trials is to guide clinical practice and policy decisions, rather than to prove an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should try to be as similar to real-world clinical practice as possible, including in the selection of participants, setting up and design as well as the implementation of the intervention, as well as the determination and analysis of outcomes as well as primary analyses. This is a major distinction between explanatory trials, as described by Schwartz & Lellouch1, which are designed to confirm a hypothesis in a more thorough manner. Truly pragmatic trials should not conceal participants or clinicians. This could lead to a bias in the estimates of treatment effects. The trials that are pragmatic should also try to enroll patients from a wide range of health care settings, to ensure that their findings are generalizable to the real world. Additionally, clinical trials should concentrate on outcomes that are important to patients, such as the quality of life and functional recovery. This is particularly relevant when trials involve surgical procedures that are invasive or may have dangerous adverse impacts. The CRASH trial29 compared a 2 page report with an electronic monitoring system for patients in hospitals with chronic heart failure. The trial with a catheter, on the other hand was based on symptomatic catheter-related 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 cut down on costs and time commitments. Finaly the aim of pragmatic trials is to make their findings as relevant to actual clinical practices as possible. This can be achieved by ensuring that their analysis is based on the intention-to treat method (as described within CONSORT extensions). Many RCTs which do not meet the requirements for pragmatism but contain features contrary to pragmatism, have been published in journals of various types and incorrectly labeled as pragmatic. This can lead to false claims of pragmatism and the use of the term should be standardised. The development of the PRECIS-2 tool, which provides an objective and standard assessment of practical features is a great first step. Methods In a pragmatic study the aim is to inform clinical or policy decisions by showing how an intervention can be integrated into routine treatment in real-world settings. Explanatory trials test hypotheses regarding the cause-effect relationship within idealised environments. Therefore, pragmatic trials might have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic research can provide valuable information for decision-making within the healthcare context. The PRECIS-2 tool evaluates an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study, the areas of recruitment, organization as well as flexibility in delivery flexible adherence, and follow-up received high scores. However, the principal outcome and the method of missing data scored below the pragmatic limit. This suggests that it is possible to design a trial using excellent pragmatic features without compromising the quality of its results. However, it is difficult to determine how pragmatic a particular trial really is because pragmaticity is not a definite attribute; some aspects of a trial can be more pragmatic than others. Moreover, protocol or logistic modifications made during the trial may alter its pragmatism score. Additionally 36% of 89 pragmatic trials identified by Koppenaal et al were placebo-controlled or conducted before approval and a majority of them were single-center. This means that they are not very close to usual practice and are only pragmatic in the event that their sponsors are supportive of the lack of blinding in these trials. Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the trial sample. However, this can lead to unbalanced comparisons and lower statistical power, thereby increasing the chance of not or misinterpreting differences in the primary outcome. In the case of the pragmatic studies that were included in this meta-analysis this was a serious issue since the secondary outcomes were not adjusted for differences in baseline covariates. In addition, pragmatic studies 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 therefore are prone to delays, inaccuracies or coding differences. It is essential to increase the accuracy and quality of outcomes in these trials. Results Although the definition of pragmatism may not mean that trials must be 100% pragmatic, there are some advantages to incorporating pragmatic components into clinical trials. These include: Increasing sensitivity to real-world issues, reducing study size and cost, and enabling the trial results to be more quickly translated into actual clinical practice (by including routine patients). However, pragmatic trials can also have disadvantages. The right type of heterogeneity for instance, can help a study expand its findings to different patients or settings. However, the wrong type can decrease the sensitivity of the test and thus reduce a trial's power to detect small treatment effects. Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 created a framework for distinguishing between explanation-based trials that support a physiological or clinical hypothesis, and pragmatic trials that inform the choice of appropriate therapies in clinical practice. The framework was comprised of nine domains that were scored on a 1-5 scale, with 1 being more lucid while 5 being more pragmatic. The domains included recruitment of intervention, setting up, delivery of intervention, flexible compliance and primary analysis. The initial PRECIS tool3 had similar domains and scales from 1 to 5. Koppenaal and colleagues10 created an adaptation of this assessment, called the Pragmascope which was more user-friendly to use for systematic reviews. They found that pragmatic reviews scored higher on average across all domains, however they scored lower in the primary analysis domain. This difference in the primary analysis domain could be due to the fact that most pragmatic trials process their data in the intention to treat way, whereas some explanatory trials do not. The overall score for systematic reviews that were pragmatic was lower when the domains of organization, flexible delivery, and following-up were combined. It is important to remember that a study that is pragmatic does not mean that a trial is of poor quality. In fact, there is an increasing number of clinical trials that use the term “pragmatic” either in their abstracts or titles (as defined by MEDLINE however it is not precise nor sensitive). 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 content of the articles. Conclusions In recent years, pragmatic trials have been becoming more popular 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 include patient populations which are more closely resembling the ones who are treated in routine medical care, they utilize comparators that are used in routine practice (e.g., existing drugs) and rely on participant self-report of outcomes. This approach can help overcome the limitations of observational research that are prone to biases associated with reliance on volunteers and the lack of availability and the variability of coding in national registry systems. Other advantages of pragmatic trials include the ability to utilize existing data sources, and a greater chance of detecting meaningful changes than traditional trials. However, they may have some limitations that limit their effectiveness and generalizability. For instance the rates of participation in some trials might be lower than anticipated due to the healthy-volunteer effect and incentives to pay or compete for participants from other research studies (e.g., industry trials). The necessity to recruit people in a timely fashion also reduces the size of the sample and the impact of many practical 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-described themselves as pragmatic and were published from 2022. They assessed pragmatism by using the PRECIS-2 tool, which includes the domains eligibility criteria as well as recruitment, flexibility in intervention adherence, and follow-up. They discovered that 14 of the trials scored highly or pragmatic pragmatic (i.e. scores of 5 or more) in any one or more of these domains and that the majority were single-center. Trials that have a high pragmatism score tend to have higher eligibility criteria than traditional RCTs, which include very specific criteria that are unlikely to be used in clinical practice, and they comprise patients from a wide range of hospitals. According to 프라그마틱 공식홈페이지 , may make pragmatic trials more useful and useful in the daily practice. However, they don't guarantee that a trial will be free of bias. Moreover, the pragmatism of a trial is not a predetermined characteristic A pragmatic trial that does not have all the characteristics of a explanatory trial can produce valuable and reliable results.