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Pragmatic Free Trial Meta Pragmatic Free Trial Meta is a noncommercial open data platform and infrastructure that facilitates research on pragmatic trials It gathers and distributes clean trial data ratings and evaluations using PRECIS2 This permits a variety of metaepidemiological analyses to compare treatment effect estimates across trials with different levels of pragmatism Background Pragmatic studies are increasingly acknowledged as providing evidence from the real world for clinical decision making The term pragmatic however is a word that is often used in contradiction and its definition and evaluation need further clarification The purpose of pragmatic trials is to inform clinical practice and policy decisions rather than to prove an hypothesis that is based on a clinical or physiological basis A pragmatic trial should aim to be as close as it is to realworld clinical practices which include the recruiting participants setting design implementation and delivery of interventions determination and analysis results as well as primary analysis This is a major distinction between explanatory trials as described by Schwartz Lellouch1 that are designed to test the hypothesis in a more thorough way The trials that are truly pragmatic must be careful not to blind patients or healthcare professionals as this could result in distortions in estimates of the effects of treatment Practical trials should also aim to attract patients from a wide range of health care settings so that their results are generalizable to the real world Additionally pragmatic trials should focus on outcomes that are vital to patients such as quality of life or functional recovery This is particularly important in trials that involve the use of invasive procedures or potential dangerous adverse events The CRASH trial29 compared a 2page report with an electronic monitoring system for hospitalized patients with chronic heart failure The catheter trial28 however used symptomatic catheter associated urinary tract infection as the primary outcome In addition to these aspects the pragmatic trial should also reduce the trials procedures and requirements for data collection to reduce costs Finaly the aim of pragmatic trials is to make their findings as relevant to realworld clinical practices as they can This can be achieved by ensuring that their primary analysis is based on an intentionto treat method as defined in CONSORT extensions Despite these guidelines many RCTs with features that challenge pragmatism have been incorrectly selflabeled pragmatic and published in journals of all types This can lead to false claims of pragmatism and the usage of the term should be standardized The development of a PRECIS2 tool that provides an objective standardized evaluation of pragmatic aspects is the first step Methods In a pragmatic research study it is the intention to inform clinical or policy decisions by demonstrating how an intervention could be integrated into routine care in realworld contexts This is distinct from explanation trials which test hypotheses about the causeeffect connection in idealized situations In this way pragmatic trials may have a lower internal validity than studies that explain and are more susceptible to biases in their design as well as analysis and conduct Despite their limitations pragmatic studies can provide valuable information for decisionmaking within the context of healthcare The PRECIS2 tool assesses the degree of pragmatism within an RCT by scoring it across 9 domains ranging from 1 very explicative to 5 very pragmatic In this study the recruitment organization flexibility in delivery flexible adherence and followup domains scored high scores however the primary outcome and the procedure for missing data were not at the limit of practicality This suggests that it is possible to design a trial with highquality pragmatic features without harming the quality of the results It is hard to determine the degree of pragmatism within a specific trial because pragmatism does not have a binary characteristic Some aspects of a research study can be more pragmatic than other A trials pragmatism can be affected by modifications to the protocol or logistics during the trial Additionally 36 of the 89 pragmatic trials discovered by Koppenaal and co were placebocontrolled or conducted prior to licensing and the majority were singlecenter This means that they are not quite as typical and are only pragmatic if their sponsors are tolerant of the absence of blinding in these trials Additionally a typical feature of pragmatic trials is that the researchers attempt to make their findings more valuable by studying subgroups of the trial This can lead to imbalanced analyses and less statistical power This increases the chance of omitting or misinterpreting differences in the primary outcomes This was the case in the metaanalysis of pragmatic trials because secondary outcomes were not adjusted for covariates differences at the baseline In addition pragmatic studies can present challenges in the gathering and interpretation of safety data This is due to the fact that adverse events are generally reported by the participants themselves and are prone to reporting delays inaccuracies or coding variations Therefore it is crucial to enhance the quality of outcomes assessment in these trials ideally by using national registries rather than relying on participants to report adverse events in a trials own database Results While the definition of pragmatism may not require that all trials are 100 100 pragmatic there are some advantages of including pragmatic elements in clinical trials These include By incorporating routine patients the results of trials can be more quickly translated into clinical practice However pragmatic trials can also have disadvantages The right kind of heterogeneity like can help a study extend its findings to different settings or patients However the wrong kind of heterogeneity can reduce the sensitivity of an assay and consequently reduce a trials power to detect small treatment effects A variety of studies have attempted to categorize pragmatic trials using various definitions and scoring methods Schwartz and Lellouch1 created an approach to distinguish between explanationbased trials that support a physiological or clinical hypothesis and pragmatic trials that inform the selection of appropriate therapies in clinical practice Their framework included nine domains each scoring on a scale of 1 to 5 with 1 being more informative and 5 indicating more practical The domains were recruitment and setting delivery of intervention flexible adherence followup and primary analysis The initial PRECIS tool3 included similar domains and an assessment scale ranging from 1 to 5 Koppenaal et al10 developed an adaptation of the assessment dubbed the Pragmascope that was simpler to use for systematic reviews They found that pragmatic systematic reviews had a higher average scores across all domains but lower scores in the primary analysis domain The difference in the main analysis domain could be due to the fact that most pragmatic trials analyse their data in an intention to treat way while some explanation trials do not The overall score was lower for pragmatic systematic reviews when the domains of organisation flexible delivery and followup were merged It is important to understand that the term pragmatic trial does not necessarily mean a poor quality trial and indeed there is an increasing rate of clinical trials as defined by MEDLINE search but it is neither specific nor sensitive which use the word pragmatic in their abstract or title These terms may indicate an increased understanding of pragmatism in abstracts and titles but its unclear if this is reflected in the content Conclusions As appreciation for the value of realworld evidence grows widespread pragmatic trials have gained traction in research They are clinical trials randomized which compare realworld treatment options instead of experimental treatments in development they have patient populations which are more closely resembling the patients who receive routine care they use comparators which exist in routine practice eg existing medications and they depend on the selfreporting of participants about outcomes This method can help overcome the limitations of observational research like the biases that are associated with the reliance on volunteers as well as the insufficient availability and coding variations in national registries Pragmatic trials also have advantages like the ability to use existing data sources and a higher chance of detecting significant differences than traditional trials However pragmatic trials may have some limitations that limit their validity and generalizability For example participation rates in some trials could be lower than expected due to the healthyvolunteer effect and incentives to pay or compete for participants from other research studies eg industry trials The necessity to recruit people quickly restricts the sample size and impact of many pragmatic trials Additionally some pragmatic trials do not 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 48 RCTs selflabeled as pragmatic and were published up to 2022 The PRECIS2 tool was used to evaluate the degree of pragmatism 프라그마틱 무료체험 메타 covers domains such as eligibility criteria and flexibility in recruitment adherence to intervention and followup They discovered that 14 of these trials scored highly or pragmatic sensible ie scoring 5 or more in any one or more of these domains and that the majority were singlecenter Trials with a high pragmatism score tend to have broader eligibility criteria than traditional RCTs which include very specific criteria that are unlikely to be found in the clinical setting and comprise patients from a wide variety of hospitals The authors claim that these characteristics can help make pragmatic trials more meaningful and relevant to everyday practice but they dont necessarily mean that a pragmatic trial is free of bias The pragmatism principle is not a fixed characteristic a pragmatic test that does not have all the characteristics of an explanatory study can still produce valuable and valid results