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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 collects and distributes clean trial data ratings and evaluations using PRECIS2 This allows for a variety of metaepidemiological analyses to compare treatment effect estimates across trials of various levels of pragmatism Background Pragmatic trials provide realworld evidence that can be used to make clinical decisions The term pragmatic however is used inconsistently and its definition and measurement need further clarification The purpose of pragmatic trials is to inform clinical practices and policy decisions not to confirm a physiological hypothesis or clinical hypothesis A pragmatic trial should aim to be as similar to realworld clinical practice as possible such as its participation of participants setting and design as well as the implementation of the intervention as well as the determination and analysis of outcomes and primary analyses This is a key distinction from explanatory trials as described by Schwartz and Lellouch1 which are intended to provide a more thorough confirmation of a hypothesis The most pragmatic trials should not blind participants or the clinicians This could lead to bias in the estimations of the effects of treatment Pragmatic trials should also seek to attract patients from a wide range of health care settings to ensure that the results can be compared to the real world Finally the focus of pragmatic trials should be on outcomes that are crucial to patients such as quality of life or functional recovery This is particularly relevant in trials that involve invasive procedures or those with potential for serious adverse events The CRASH trial29 for instance was focused on functional outcomes to evaluate a twopage case report with an electronic system to monitor the health of patients in hospitals suffering from chronic heart failure Similarly the catheter trial28 utilized symptomatic catheterassociated urinary tract infections as the primary outcome In addition to these characteristics pragmatic trials should minimize the requirements for data collection and trial procedures to cut costs and time commitments Additionally pragmatic trials should aim to make their results as relevant to realworld clinical practice as is possible This can be accomplished by ensuring that their analysis is based on the intention to treat method as described within 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 could lead to false claims of pragmatism and the terms use should be made more uniform The creation of the PRECIS2 tool which offers an objective and standard assessment of pragmatic characteristics is a good initial step Methods In a practical trial the goal is to inform policy or clinical decisions by demonstrating how an intervention would be incorporated into realworld routine care Explanatory trials test hypotheses concerning the causaleffect relationship in idealized environments In this way pragmatic trials may have lower internal validity than studies that explain and be more susceptible to biases in their design analysis and conduct Despite their limitations pragmatic studies can provide valuable information for decisionmaking within the healthcare context The PRECIS2 tool measures the level of pragmatism that is present in an RCT by assessing it on 9 domains ranging from 1 very explicative to 5 very pragmatic In this study the domains of recruitment organisation as well as flexibility in delivery flexible adherence and followup were awarded high scores However the primary outcome and the method of missing data were scored below the practical limit This suggests that a trial can be designed with effective practical features yet not damaging the quality However its difficult to judge the degree of pragmatism a trial is since the pragmatism score is not a binary characteristic certain aspects of a trial may be more pragmatic than others A trials pragmatism could be affected by modifications to the protocol or logistics during the trial Additionally 36 of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebocontrolled or conducted before approval and a majority of them were singlecenter This means that they are not as common and can only be described as pragmatic when their sponsors are accepting of the absence of blinding in these trials Another common aspect of pragmatic trials is that the researchers attempt to make their findings more valuable by studying subgroups of the trial sample This can lead to unbalanced analyses with lower statistical power This increases the chance of missing or misdetecting differences in the primary outcomes In the case of the pragmatic studies that were included in this metaanalysis this was a serious issue since the secondary outcomes were not adjusted for the differences in baseline covariates Furthermore pragmatic studies can pose difficulties in the collection and interpretation safety data 프라그마틱 플레이 is due to the fact that adverse events are usually selfreported and prone to reporting errors delays or coding deviations It is therefore important to improve the quality of outcomes ascertainment in these trials ideally by using national registries instead of relying on participants to report adverse events on the trials database Results Although the definition of pragmatism does not require that all clinical trials be 100 pragmatic There are advantages to including pragmatic components in trials These include By incorporating routine patients the trial results can be more quickly translated into clinical practice However pragmatic trials can also have disadvantages The right kind of heterogeneity for instance can help a study extend its findings to different settings or patients However the wrong type can reduce the assay sensitivity and thus lessen the power of a trial to detect even minor effects of treatment Many studies have attempted classify pragmatic trials using different definitions and scoring methods Schwartz and Lellouch1 created an approach to distinguish between explanatory trials that confirm the clinical or physiological hypothesis as well as pragmatic trials that aid in the selection of appropriate therapies in realworld clinical practice The framework was composed of nine domains that were scored on a 15 scale with 1 being more informative and 5 was more pragmatic The domains included recruitment setting intervention delivery and followup as well as flexible adherence and primary analysis The original PRECIS tool3 was an adapted version of the PRECIS tool3 that was based on the same scale and domains Koppenaal et al10 devised an adaptation of the assessment known as the Pragmascope that was easier 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 domain can be due to the way in which most pragmatic trials analyze data Some explanatory trials however do not The overall score for pragmatic systematic reviews was lower when the areas of organisation flexible delivery and followingup were combined It is important to remember that a pragmatic trial doesnt necessarily mean a lowquality trial and in fact there is an increasing number 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 The use of these terms in titles and abstracts could suggest a greater awareness of the importance of pragmatism but it isnt clear if this is evident in the content of the articles Conclusions In recent times pragmatic trials are gaining popularity in research as the value of realworld evidence is increasingly recognized They are randomized trials that evaluate realworld treatment options with experimental treatments in development They are conducted with populations of patients more closely resembling those treated in regular care helpful resources can overcome the limitations of observational research for example the biases that come with the use of volunteers and the limited availability and coding variations in national registries Pragmatic trials have other advantages including the ability to leverage existing data sources and a higher chance of detecting significant differences from traditional trials However pragmatic trials may have some limitations that limit their reliability and generalizability For instance the rates of participation in some trials might be lower than expected due to the healthyvolunteer influence and incentives to pay or compete for participants from other research studies eg industry trials The necessity to recruit people in a timely manner also restricts the sample size and the 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 RCTs that were published between 2022 and 2022 that selfdescribed as pragmatic They assessed pragmatism using the PRECIS2 tool that includes the domains eligibility criteria and recruitment criteria as well as flexibility in intervention adherence and followup They discovered 14 trials scored highly pragmatic or pragmatic ie scoring 5 or higher in at least one of these domains Trials that have a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs which have very specific criteria that are unlikely to be found in the clinical setting and contain patients from a broad range of hospitals The authors suggest that these characteristics can help make the pragmatic trials more relevant and useful for everyday clinical practice however they do not guarantee that a trial conducted in a pragmatic manner is free from bias Moreover the pragmatism of a trial is not a fixed attribute A pragmatic trial that does not contain all the characteristics of an explanatory trial can yield reliable and relevant results