Selection bias risk in randomised control trials rated as of “low bias” risk according to Cochrane’s Risk of Bias 2 tool (Protocol)

Selection bias risk in randomised control trials rated as of “low bias” risk according to Cochrane’s Risk of Bias 2 tool (Protocol) | 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 Method Article Selection bias risk in randomised control trials rated as of “low bias” risk according to Cochrane’s Risk of Bias 2 tool (Protocol) Steffen Mickenautsch, Veerasamy Yengopal This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3899395/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Jun, 2024 Read the published version in Cureus → Version 1 posted You are reading this latest preprint version Abstract Aim: To investigate the risk of selection bias in “low bias” risk rated randomised control trials (RCT). Methods: A systematic literature search of current systematic reviews of RCTs will be conducted. From the identified reviews, RCTs with overall “high bias” and “low bias” RoB 2 risk ratings will be extracted. All RCTs will be statistically tested for selection bias risk. From the test results true positive, true negative, false positive or false negative ratings will be established and the negative and positive likelihood ratios with 95% Confidence interval computed. From the likelihood ratios the likelihood that RCTs with “low bias” RoB 2 risk ratings are at actual risk of selection bias will be inferred. Ethics and dissemination: Ethical approval is not required for methodological studies. The results will be disseminated as a prior preprint version and subsequent peer-reviewed publication. Internal Medicine clinical trial systematic review trial appraisal selection bias I2 test Full Text Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Published Journal Publication published 30 Jun, 2024 Read the published version in Cureus → 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-3899395","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Method Article","associatedPublications":[],"authors":[{"id":269382957,"identity":"9aebd872-537b-4667-b9b5-98a4fae7f3bb","order_by":0,"name":"Steffen Mickenautsch","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAy0lEQVRIiWNgGAWjYLCCDwwWDAYMzA3E62CcwSAB1MJIghZmHpK0mLM3H91s80tCzpz9YAPDjwoGe35COi17jqXdzu2TMLbsSWxg7DnDwCxxgIAWgxs5ZrdzeyQSNxxIbGBmbGNgYyCo5f77b7ctQVrOPwRr4ZEnbAsP222GH0AtNyC2SBgQ1HImzexmbwPQLzMeNhzsOSNhYEhQy/HDz278+GMjZ86ffPDBjwobezlCWsAA6B4wACqWIEY9CPwhVuEoGAWjYBSMSAAAHuZCQA+ZtRUAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-4994-2328","institution":"University of the Western Cape","correspondingAuthor":true,"prefix":"","firstName":"Steffen","middleName":"","lastName":"Mickenautsch","suffix":""},{"id":269382958,"identity":"f4b821d0-058e-48a8-ab1d-535a7d4ffc7d","order_by":1,"name":"Veerasamy Yengopal","email":"","orcid":"","institution":"University of the Western Cape","correspondingAuthor":false,"prefix":"","firstName":"Veerasamy","middleName":"","lastName":"Yengopal","suffix":""}],"badges":[],"createdAt":"2024-01-26 08:18:44","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-3899395/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3899395/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.7759/cureus.63581","type":"published","date":"2024-07-01T00:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":59502216,"identity":"0e06441d-685b-4920-9674-3dd72cff4600","added_by":"auto","created_at":"2024-07-02 14:23:09","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":285131,"visible":true,"origin":"","legend":"","description":"","filename":"RTESTProtocol.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3899395/v1_covered_453658a6-a431-488b-b2a8-1aabfc609c0a.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eSelection bias risk in randomised control trials rated as of “low bias” risk according to Cochrane’s Risk of Bias 2 tool (Protocol)\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"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},"keywords":"clinical trial, systematic review, trial appraisal, selection bias, I2 test","lastPublishedDoi":"10.21203/rs.3.rs-3899395/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3899395/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cu\u003eAim:\u003c/u\u003e To investigate the risk of selection bias in “low bias” risk rated randomised control trials (RCT).\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eMethods: \u003c/u\u003eA systematic literature search of current systematic reviews of RCTs will be conducted. 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