Impact of Screen Failures on Enrollment Process and Patient Characteristics in Large-Scale Randomized Sham-Controlled Trial

Impact of Screen Failures on Enrollment Process and Patient Characteristics in Large-Scale Randomized Sham-Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Impact of Screen Failures on Enrollment Process and Patient Characteristics in Large-Scale Randomized Sham-Controlled Trial Jingang Cui, Changdong Guan, Changpeng Song, Haobo Xu, Juan Wang, and 24 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7266227/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Little is known about impact of screen failures on enrollment process and patient characteristics in large-scale clinical trials. Objectives The objective of this paper is to determine the impact of screen failures on enrollment process and patient characteristics in the randomized FAVOR III China trial, a large-scale, multicenter, randomized trial comparing clinical outcomes between QFR-guided versus standard angiography-guided PCI. Methods The FAVOR III China trial identified patients for enrollment using a 2 stage screening process, patients met both general and angiographic inclusion criteria would be enrolled. Reasons for screen failure were prospectively recorded in a dedicated internet-enabled web-based response system. Center volume and experience were valuated according to total screen number of patients, and sequence of initiation time in the present study. Results Between December 25, 2018, and January 19, 2020, 5881 patients were screened for enrolment. Among them, 2034 patients were excluded. The most common reasons for screen failure were absence of at least 1 lesion present with DS% ≥50% and ≤90% in vessel with RVD ≥2.5 mm (860, 42.3%), eligibility for PCI according to the operators (526, 25.9%), and with only coronary artery lesion had diameter stenosis >90% with TIMI flow <3 (254, 12.5%). Patients excluded due to poor imaging quality or poor interrogated vessel condition that deemed unable for QFR measurement accounted for 6.2% (127). The percentage of screened failure patients were significantly higher in high-volume and more experience center (p<0.0001). Conclusions In clinical practice, approximately two-third of patients were eligible for QFR evaluation, based on the experience from the FAVOR III China trial. Additionally, center experience emerged as a key factor influencing the quality of a prospective trial. screen failure randomized controlled trial enrollment Full Text Supplementary Files CONSORTchecklist.doc Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7266227","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":544199909,"identity":"a69030a9-b24d-481d-9f59-3d9289b8cd89","order_by":0,"name":"Jingang Cui","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences \u0026 Peking Union Medical College Fuwai Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jingang","middleName":"","lastName":"Cui","suffix":""},{"id":544199910,"identity":"009ba86d-bdc7-4e20-8828-7ace7e0c02e4","order_by":1,"name":"Changdong Guan","email":"","orcid":"","institution":"Chinese 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enrollment","lastPublishedDoi":"10.21203/rs.3.rs-7266227/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7266227/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLittle is known about impact of screen failures on enrollment process and patient characteristics in large-scale clinical trials.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe objective of this paper is to determine the impact of screen failures on enrollment process and patient characteristics in the randomized FAVOR III China trial, a large-scale, multicenter, randomized trial comparing clinical outcomes between QFR-guided versus standard angiography-guided PCI.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe FAVOR III China trial identified patients for enrollment using a 2 stage screening process, patients met both general and angiographic inclusion criteria would be enrolled. Reasons for screen failure were prospectively recorded in a dedicated internet-enabled web-based response system. Center volume and experience were valuated according to total screen number of patients, and sequence of initiation time in the present study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBetween December 25, 2018, and January 19, 2020, 5881 patients were screened for enrolment. Among them, 2034 patients were excluded. The most common reasons for screen failure were absence of at least 1 lesion present with DS% ≥50% and ≤90% in vessel with RVD ≥2.5 mm (860, 42.3%), eligibility for PCI according to the operators (526, 25.9%), and with only coronary artery lesion had diameter stenosis \u0026gt;90% with TIMI flow \u0026lt;3 (254, 12.5%). Patients excluded due to poor imaging quality or poor interrogated vessel condition that deemed unable for QFR measurement accounted for 6.2% (127). The percentage of screened failure patients were significantly higher in high-volume and more experience center (p\u0026lt;0.0001).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn clinical practice, approximately two-third of patients were eligible for QFR evaluation, based on the experience from the FAVOR III China trial. Additionally, center experience emerged as a key factor influencing the quality of a prospective trial.\u003c/p\u003e","manuscriptTitle":"Impact of Screen Failures on Enrollment Process and Patient Characteristics in Large-Scale Randomized Sham-Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-24 08:35:42","doi":"10.21203/rs.3.rs-7266227/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8fe573dd-fd7f-43b8-bcec-33145741dbba","owner":[],"postedDate":"November 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-02-09T10:41:43+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-24 08:35:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7266227","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7266227","identity":"rs-7266227","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}