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It explains ten standard boxes, each linked to a four-point COSMIN Risk of Bias-based rating scale and includes justifications referencing specific risk-of-bias standards or sample size considerations.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/cosmin-study-design-checklist-for-patient-reported-outcome-measurement-instruments-version-july-2019/241818/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/cosmin-study-design-checklist-for-patient-reported-outcome-measurement-instruments-version-july-2019/241818.png","ImageObject",442,249,{"name":88,"@type":89},"Aditya","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-14","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Who is the COSMIN Study Design checklist intended for?","Question",{"text":109,"@type":110},"It is recommended for researchers and clinicians designing studies on measurement properties of existing PROMs, and for scientific committees, medical ethics committees appraising study protocols, as well as reviewers publishing protocol studies.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What study aspects are covered by the ten-box checklist?",{"text":114,"@type":110},"The checklist covers general recommendations and standards for content validity, structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, responsiveness, plus an additional box for translation of an existing PROM.",{"name":116,"@type":107,"acceptedAnswer":117},"How should the four-point rating scale be used in this checklist?",{"text":118,"@type":110},"The four-point rating scale is provided for illustrative purposes to understand consequences for methodological quality choices, and it is not intended to produce an overall rating using the worst-score counts principle for the study design.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},241818,1791704706,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":8},962085564549,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","COSMIN Study Design checklist for Patient-reported outcome measurement instruments  \nVersion July 2019  \nLidwine B Mokkink  \nCecilia AC Prinsen  \nDonald L Patrick  \nJordi Alonso  \nLex M Bouter  \nHenrica CW de Vet  \nCaroline B Terwee  \nContact  \nL. B. Mokkink, PhD  \nDepartment of Epidemiology and Biostatistics Amsterdam Public Health research institute Amsterdam University Medical Centers, location VUmc  \n[P.O. box 7057](P.O. box 7057)  \n1007 MB Amsterdam The Netherlands [Website:](Website: www.cosmin.nl)[ ](Website: www.cosmin.nl)[www.cosmin.nl](Website: www.cosmin.nl)  \n[E-mail:](E-mail: w.mokkink@amsterdamumc.nl)[ ](E-mail: w.mokkink@amsterdamumc.nl)[w.mokkink@amsterdamumc.nl](E-mail: w.mokkink@amsterdamumc.nl)  \nTable of Content  \nList of abbreviations 2  \nInstructions 3  \nGeneral recommendation for the design of a study on measurement properties 4  \nContent Validity 6  \nStructural validity 9  \nInternal consistency 11  \nCross-cultural validity\\measurement invariance 13  \nMeasurement error and Reliability 15  \nCriterion validity 17  \nHypotheses testing for construct validity 19  \nResponsiveness 22  \nTranslation process 29  \nReferences 32  \nList of abbreviations  \nCTT: classical test theory  \nIRT/Rasch: Item Response Theory and Rasch analyses NA: not applicable  \nOriginal CC: original COSMIN checklist 1  \nPROM: patient-reported outcome measure  \nRoB: Risk of Bias; it refers to the COSMIN Risk of Bias checklist 2  \nInstructions  \nThe COSMIN Study Design checklist is recommended for designing studies to evaluate measurement properties of existing patient-reported outcome measures (PROMs) . It can be used by researchers and clinicians or other professionals who are designing a study to evaluate measurement properties of an existing PROM, or by e.g. scientific committees and medical ethics committees who are appraising protocols of studies on measurement properties, or by reviewers for scientific journals that will publish study protocols of studies on measurement properties of PROMs.  \nThe COSMIN Study Design checklist is based on the original version of the COSMIN checklist 1 3, as well as on the recently developed COSMIN Risk of Bias checklist for PROMs 2. Decisionson adaptations were made based on iterative discussions by the COSMIN steering committee, both at face-to-face meetings (LM, CP, HdV and CT) and by email discussions (entire COSMIN steering committee, i.e. all authors) .  \nThe COSMIN Study Design checklist consists of ten boxes. The first box, i.e. General recommendations for designing a study on a measurement properties, is relevant for all studies. It contains general standards which should be considered in the design of a study on any measurement property. The remaining boxes contain standards for specific studies on each of the nine measurement properties, i.e. content validity, structural validity, internal consistency, cross-cultural validity\\measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness 2 4. In addition, we provide standards for translating an existing PROM in the box Translation process.  \nIn this checklist, each standard is also accompanied with a 4-point rating scale. This rating scale is based on the COSMIN Risk of Bias checklist 2. The 4-point rating scale is added for illustrative purposes to better understand the consequences of choices made in the design of a study for the methodological quality of the study; it is not intended to be used to actually provide an overall rating (i.e. based on the worst-score counts principle) for your study design. The purpose of this checklist is only to check whether all important issues are considered when designing a study on measurement properties. Details on how to design and analyse these studies are described in the book Measurement in Medicine 5. A clarification and explanation of most of the individual standards can be found in the user manuals ([www.cosmin.nl](www.cosm","cbCaimLgz80xhQ0j","https://ap.wps.com/l/cbCaimLgz80xhQ0j","pdf",740968,32,"English","# Table of Contents\n## List of abbreviations\n## Instructions\n## General recommendation for the design of a study on measurement properties\n## Content Validity\n## Structural validity\n## Internal consistency\n## Cross-cultural validity / measurement invariance\n## Measurement error and Reliability\n## Criterion validity\n## Hypotheses testing for construct validity\n## Responsiveness\n## Translation process\n## References","[{\"question\":\"Who is the COSMIN Study Design checklist intended for?\",\"answer\":\"It is recommended for researchers and clinicians designing studies on measurement properties of existing PROMs, and for scientific committees, medical ethics committees appraising study protocols, as well as reviewers publishing protocol studies.\"},{\"question\":\"What study aspects are covered by the ten-box checklist?\",\"answer\":\"The checklist covers general recommendations and standards for content validity, structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, responsiveness, plus an additional box for translation of an existing PROM.\"},{\"question\":\"How should the four-point rating scale be used in this checklist?\",\"answer\":\"The four-point rating scale is provided for illustrative purposes to understand consequences for methodological quality choices, and it is not intended to produce an overall rating using the worst-score counts principle for the study design.\"}]","COSMIN Study Design checklist for Patient-reported outcome measurement instruments - Version July 2019 | PDF",1789181375]