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Pragmatic Free Trial Meta Pragmatic Free Trial Meta is a free and 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 allows for diverse metaepidemiological analyses to compare treatment effect estimates across trials of various levels of pragmatism Background Pragmatic studies provide realworld evidence that can be used to make clinical decisions The term pragmatic however is used inconsistently and its definition and evaluation require further clarification Pragmatic trials must be designed to inform clinical practice and policy decisions rather than confirm the validity of a clinical or physiological hypothesis A pragmatic trial should try to be as similar to realworld clinical practice as is possible including its recruitment of participants setting and design of the intervention its delivery and implementation of the intervention as well as the determination and analysis of the outcomes and primary analyses This is a major difference between explanationbased trials as described by Schwartz Lellouch1 that are designed to confirm a hypothesis in a more thorough way The most pragmatic trials should not blind participants or clinicians This can lead to an overestimation of the effect 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 Furthermore trials that are pragmatic must be focused on outcomes that matter to patients like quality of life and functional recovery This is especially important when trials involve invasive procedures or have potentially serious adverse effects The CRASH trial29 for example was focused on functional outcomes to evaluate a twopage case report with an electronic system to monitor the health of patients admitted to hospitals with chronic heart failure Similarly the catheter trial28 utilized urinary tract infections caused by catheters as the 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 pragmatic trials should aim to make their findings as relevant to actual clinical practices as they can This can be accomplished by ensuring that their analysis is based on the intentionto treat approach as defined in CONSORT extensions Many RCTs that dont meet the criteria for pragmatism but contain features contrary to pragmatism have been published in journals of different types and incorrectly labeled pragmatic This could lead to false claims of pragmatism and the terms use should be standardised The creation of a PRECIS2 tool that can provide a standardized objective evaluation of the pragmatic characteristics is a first step Methods In a pragmatic research study it is the intention to inform clinical or policy decisions by showing how an intervention can be integrated into routine care in realworld contexts Explanatory trials test hypotheses regarding the causeeffect relationship within idealised settings Therefore pragmatic trials might have lower internal validity than explanatory trials and may be more susceptible to bias in their design conduct and analysis Despite their limitations pragmatic studies can be a valuable source of information for decisionmaking within the context of healthcare The PRECIS2 tool evaluates an RCT on 9 domains with scores ranging between 1 and 5 very pragmatist In this study the domains of recruitment organisation and flexibility in delivery flexible adherence and followup were awarded high scores However the main outcome and the method of missing data was scored below the pragmatic limit This suggests that a trial can be designed with good practical features yet not compromising its quality However its difficult to determine 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 can be affected by changes to the protocol or logistics during the trial Koppenaal and colleagues discovered that 36 of 89 pragmatic studies were placebocontrolled or conducted prior to the licensing Most were also singlecenter They are not close to the norm and are only considered pragmatic if the sponsors agree that the trials are not blinded A common aspect of pragmatic research is that researchers attempt to make their findings more relevant by studying subgroups within the trial This can result in unbalanced analyses with less statistical power This increases the possibility of omitting or misinterpreting differences in the primary outcomes This was the case in the metaanalysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for covariates that differed at the time of baseline In addition pragmatic studies may pose challenges to gathering and interpretation of safety data This is due to the fact that adverse events tend to be selfreported and are prone to delays errors or coding errors It is essential to increase the accuracy and quality of the outcomes in these trials Results While the definition of pragmatism may not mean that trials must be 100 pragmatic there are advantages to including pragmatic components in clinical trials These include Increasing sensitivity to realworld issues reducing study size and cost and allowing the study results to be faster translated into actual clinical practice by including patients from routine care However pragmatic studies can also have disadvantages For example the right type of heterogeneity can help a study to generalize its findings to a variety of settings and patients However the wrong kind of heterogeneity can reduce assay sensitivity and therefore 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 for distinguishing between explanationbased trials that support a physiological or clinical hypothesis and pragmatic trials that help in the selection of appropriate treatments in clinical practice The framework was comprised of nine domains each scored on a scale ranging from 1 to 5 with 1 indicating more explanatory and 5 suggesting more pragmatic The domains were recruitment and setting delivery of intervention and followup as well as flexible adherence and primary analysis The initial PRECIS tool3 included similar domains and an assessment scale ranging from 1 to 5 Koppenaal et al10 devised an adaptation of this assessment known as the Pragmascope that was easier to use for systematic reviews They discovered that pragmatic reviews scored higher on average in most domains but scored lower in the primary analysis domain This difference in the main analysis domain could be due to the fact that most pragmatic trials analyze their data in the intention to treat method while some explanation trials do not The overall score for pragmatic systematic reviews was lower when the areas of organization flexible delivery and followingup were combined It is important to remember that a study that is pragmatic does not mean a lowquality trial In fact there is an increasing number of clinical trials that employ the term pragmatic either in their abstracts or titles as defined by MEDLINE but which 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 is unclear whether this is evident in the content of the articles Conclusions As the importance of evidence from the real world becomes more widespread the pragmatic trial has gained traction in research They are randomized studies that compare realworld treatment options with experimental treatments in development They involve patient populations more closely resembling those treated in regular medical care This method could help overcome limitations of observational studies which include the biases that arise from relying on volunteers and the lack of availability and coding variability in national registries Other advantages of pragmatic trials are the ability to use existing data sources and a higher chance of detecting meaningful changes than traditional trials However these tests could have some limitations that limit their validity and generalizability For instance participation rates in some trials may be lower than anticipated due to the healthyvolunteer effect and incentives to pay or compete for participants from other research studies eg industry trials Many pragmatic trials are also restricted by the need to recruit participants quickly Certain pragmatic trials lack controls to ensure that the observed differences arent due to biases in the trial 프라그마틱 슬롯버프 of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that selfdescribed as pragmatism They assessed pragmatism using the PRECIS2 tool which includes the eligibility criteria for domains recruitment flexibility in adherence to intervention and followup 프라그마틱 슬롯 환수율 discovered that 14 of these trials scored pragmatic or highly sensible ie scores of 5 or higher in one or more of these domains and that the majority of these were singlecenter Trials with a high pragmatism rating tend to have more expansive eligibility criteria than traditional RCTs that have specific criteria that arent likely to be found in the clinical environment and they include populations from a wide range of hospitals These characteristics according to the authors could make pragmatic trials more relevant and applicable in the daily clinical However they cannot ensure that a study is free of bias In addition the pragmatism that is present in a trial is not a fixed attribute A pragmatic trial that doesnt possess all the characteristics of an explanatory trial can produce valuable and reliable results