{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T08:15:39Z","timestamp":1788509739731,"version":"build-2803163510"},"reference-count":56,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"unspecified","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Shanghai Municipal Key Course Construction Project in Higher Education Institutions"},{"name":"Laboratory Open Fund of Key Technology and Materials in Minimally Invasive Spine Surgery","award":["2024JZWC-YBA07"],"award-info":[{"award-number":["2024JZWC-YBA07"]}]},{"name":"Laboratory Open Fund of Key Technology and Materials in Minimally Invasive Spine Surgery","award":["2024JZWC-ZDA04"],"award-info":[{"award-number":["2024JZWC-ZDA04"]}]},{"DOI":"10.13039\/501100001809","name":"Natural Science Foundation of China","doi-asserted-by":"crossref","award":["82471935"],"award-info":[{"award-number":["82471935"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,7,19]]},"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Knee osteoarthritis (KOA) is a chronic disease that affects physical function, psychological well-being and has an impact on quality of life (QoL). Despite efforts to monitor QoL of patients with KOA, patient-reported outcome measures (PROMs) developed based on the comprehensive framework of the International Classification of Functioning, Disability and Health (ICF) remain limited. This protocol presents the phases of the development of a comprehensive KOA-specific PROM based on the ICF system<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This study follows the Patient-Reported Outcomes Measurement Information System (PROMIS) scientific standards for instrument development and validation. A qualitative phase, involving a systematic literature review and focus group interviews, will be conducted to establish the conceptual framework. A standardised item pool will be generated based on the ICF framework using refined ICF linking rules and thematic analysis. A modified Delphi process will be performed with a multidisciplinary expert panel to refine the items and establish the initial version, with consensus evaluation via a 4-point rating scale. Item reduction and psychometric evaluation will be informed by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study received ethical approval (K2024-082-01) from Tongren Hospital, Shanghai Jiao Tong University School of Medicine. Results from this cohort will be submitted to peer-reviewed scientific journals and reported at the leading national and international meetings in the field.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-116815","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T11:10:26Z","timestamp":1786619426000},"page":"e116815","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Development and validation of an ICF-based patient-reported outcome measure for patients with knee osteoarthritis: study protocol for a Delphi survey"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4360-3253","authenticated-orcid":false,"given":"Xiaoqing","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Imaging, Tongren Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingyu","family":"Zhong","sequence":"additional","affiliation":[{"name":"Department of Imaging, Tongren Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiwu","family":"Yao","sequence":"additional","affiliation":[{"name":"Department of Imaging, Tongren Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,8,13]]},"reference":[{"key":"2026090400403104000_16.8.e116815.1","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1038\/s41572-025-00594-6","article-title":"Osteoarthritis","volume":"11","author":"Tang","year":"2025","journal-title":"Nat Rev Dis Primers"},{"key":"2026090400403104000_16.8.e116815.2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.19675"},{"key":"2026090400403104000_16.8.e116815.3","doi-asserted-by":"crossref","first-page":"1327","DOI":"10.1016\/j.joca.2024.05.015","article-title":"Psychosocial factors in knee osteoarthritis: Scoping review of evidence and future opportunities","volume":"32","author":"Tan Yijia","year":"2024","journal-title":"Osteoarthr Cartil"},{"key":"2026090400403104000_16.8.e116815.4","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2296-13-14","article-title":"The ideal of biopsychosocial chronic care: how to make it real? A qualitative study among Dutch stakeholders","volume":"13","author":"van Dijk-de Vries","year":"2012","journal-title":"BMC Fam Pract"},{"key":"2026090400403104000_16.8.e116815.5","doi-asserted-by":"crossref","unstructured":"Lundgren-Nilsson \u00c5 , Dencker A , Palstam A , et al . Patient-reported outcome measures in osteoarthritis: a systematic search and review of their use and psychometric properties. RMD Open 2018;4. doi:10.1136\/rmdopen-2018-000715","DOI":"10.1136\/rmdopen-2018-000715"},{"key":"2026090400403104000_16.8.e116815.6","first-page":"1","article-title":"Effects of Golden Plaster on Knee Osteoarthritis: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial","volume":"2022","author":"Chen","year":"2022","journal-title":"Evidence-Based Complementary and Alternative Medicine"},{"key":"2026090400403104000_16.8.e116815.7","doi-asserted-by":"crossref","DOI":"10.1186\/s12891-024-07181-y","article-title":"A cross sectional study exploring the relationship of self-reported physical activity with function, kinesiophobia, self-efficacy and quality of life in an Asian population seeking care for knee osteoarthritis","volume":"25","author":"Goff","year":"2024","journal-title":"BMC Musculoskelet Disord"},{"key":"2026090400403104000_16.8.e116815.8","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.11238"},{"key":"2026090400403104000_16.8.e116815.9","doi-asserted-by":"crossref","first-page":"23","DOI":"10.2519\/jospt.2022.11317","article-title":"Patient-Reported Outcome Measures for Adults and Adolescents with Patellofemoral Pain: A Systematic Review of Content Validity and Feasibility Using the COSMIN Methodology","volume":"53","author":"Hoglund","year":"2023","journal-title":"J Orthop Sports Phys Ther"},{"key":"2026090400403104000_16.8.e116815.10","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1302\/2046-3758.103.BJR-2020-0268.R1","article-title":"Patient-reported outcome measures used in patients undergoing total knee arthroplasty","volume":"10","author":"Wang","year":"2021","journal-title":"Bone Joint Res"},{"key":"2026090400403104000_16.8.e116815.11","doi-asserted-by":"crossref","DOI":"10.1016\/j.heliyon.2024.e36645","article-title":"Reliability and validity of patient-reported outcome measures in assessing knee osteoarthritis in the Chinese population: A systematic review","volume":"10","author":"Ren","year":"2024","journal-title":"Heliyon"},{"key":"2026090400403104000_16.8.e116815.12","unstructured":"PROMIS\u00ae instrument development validation scientific standards version 2.0. 2013."},{"key":"2026090400403104000_16.8.e116815.13","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-024-03761-6"},{"key":"2026090400403104000_16.8.e116815.14","unstructured":"World Health Organization . International classification of functioning, disability and health: ICF. Available: https:\/\/www.who.int\/standards\/classifications\/ [Accessed 22 Jun 2026]."},{"key":"2026090400403104000_16.8.e116815.15","doi-asserted-by":"publisher","DOI":"10.3109\/09638288.2016.1145258"},{"key":"2026090400403104000_16.8.e116815.16","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1080\/16501960410022300","article-title":"Applying the ICF in medicine","volume":"36","author":"Stucki","year":"2004","journal-title":"J Rehabil Med"},{"key":"2026090400403104000_16.8.e116815.17","doi-asserted-by":"publisher","DOI":"10.1080\/0963828031000137063"},{"key":"2026090400403104000_16.8.e116815.18","doi-asserted-by":"publisher","DOI":"10.1080\/09638280110105222"},{"key":"2026090400403104000_16.8.e116815.19","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2648.2000.01567.x"},{"key":"2026090400403104000_16.8.e116815.20","unstructured":"Hsu C-C , Sandford BA . The Delphi technique: Making sense of consensus. Practical Assessment, Research, and Evaluation 2007."},{"key":"2026090400403104000_16.8.e116815.21","doi-asserted-by":"crossref","first-page":"930","DOI":"10.1001\/jamasurg.2016.1640","article-title":"Defining a Research Agenda for Patient-Reported Outcomes in Surgery: Using a Delphi Survey of Stakeholders","volume":"151","author":"Pezold","year":"2016","journal-title":"JAMA Surg"},{"key":"2026090400403104000_16.8.e116815.22","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(03)00211-7"},{"key":"2026090400403104000_16.8.e116815.23","doi-asserted-by":"publisher","DOI":"10.1177\/0269216317690685"},{"key":"2026090400403104000_16.8.e116815.24","doi-asserted-by":"crossref","unstructured":"Guest G , MacQueen KM , Namey EE . Applied Thematic Analysis.2011. Available: https:\/\/methods.sagepub.com\/book\/applied-thematic-analysis","DOI":"10.4135\/9781483384436"},{"key":"2026090400403104000_16.8.e116815.25","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"2026090400403104000_16.8.e116815.26","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.22171"},{"key":"2026090400403104000_16.8.e116815.27","doi-asserted-by":"publisher","DOI":"10.1136\/ard.16.4.494"},{"key":"2026090400403104000_16.8.e116815.28","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1061\/(ASCE)CO.1943-7862.0000137","article-title":"Qualitative Research: Application of the Delphi Method to CEM Research","volume":"136","author":"Hallowell","year":"2010","journal-title":"J Constr Eng Manage"},{"key":"2026090400403104000_16.8.e116815.29","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.02.006"},{"key":"2026090400403104000_16.8.e116815.30","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbp118"},{"key":"2026090400403104000_16.8.e116815.31","first-page":"47","article-title":"The Delphi technique: methodological considerations need reporting guidelines medical journals","volume":"4","author":"Toma","year":"2016","journal-title":"Int J Public Health Res"},{"key":"2026090400403104000_16.8.e116815.32","doi-asserted-by":"crossref","DOI":"10.1186\/s13643-021-01683-9","article-title":"Prognostic models for knee osteoarthritis: a protocol for systematic review, critical appraisal, and meta-analysis","volume":"10","author":"Zhong","year":"2021","journal-title":"Syst Rev"},{"key":"2026090400403104000_16.8.e116815.33","doi-asserted-by":"publisher","DOI":"10.1136\/bjsports-2018-099683"},{"key":"2026090400403104000_16.8.e116815.34","unstructured":"OpenGrey. Available: http:\/\/www.opengrey.eu [Accessed 22 Jun 2026]."},{"key":"2026090400403104000_16.8.e116815.35","unstructured":"British library inside. Available: http:\/\/explore.bl.uk\/primo_library\/ [Accessed 22 Jun 2026]."},{"key":"2026090400403104000_16.8.e116815.36","unstructured":"ProQuest dissertations & theses global. Available: https:\/\/search.proquest.com [Accessed 22 Jun 2026]."},{"key":"2026090400403104000_16.8.e116815.37","unstructured":"BIOSIS previews. Available: http:\/\/www.ovid.com [Accessed 22 Jun 2026]."},{"key":"2026090400403104000_16.8.e116815.38","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2024-087798","article-title":"Development of ICF-based patient-reported outcome and experience measures to study social participation among people with chronic diseases: a mixed-methods protocol","volume":"14","author":"Van den Broecke","year":"2024","journal-title":"BMJ Open"},{"key":"2026090400403104000_16.8.e116815.39","unstructured":"Charmaz K . Constructing grounded theory: practical guide through qualitative analysis: sage. 2006."},{"key":"2026090400403104000_16.8.e116815.40","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2474-15-427","article-title":"Acceptability of a \u201cguidebook\u201d for the management of Osteoarthritis: a qualitative study of patient and clinician\u2019s perspectives","volume":"15","author":"Morden","year":"2014","journal-title":"BMC Musculoskelet Disord"},{"key":"2026090400403104000_16.8.e116815.41","doi-asserted-by":"crossref","unstructured":"Rowe G , Wright G . Expert opinions in forecasting: the role of the delphi technique. In: International Series in Operations Research & Management Science. Boston, MA: Springer, 2001: 125\u201344.","DOI":"10.1007\/978-0-306-47630-3_7"},{"key":"2026090400403104000_16.8.e116815.42","doi-asserted-by":"publisher","DOI":"10.1093\/sw\/21.4.338"},{"key":"2026090400403104000_16.8.e116815.43","doi-asserted-by":"publisher","DOI":"10.1016\/j.techfore.2019.07.002"},{"key":"2026090400403104000_16.8.e116815.44","doi-asserted-by":"publisher","DOI":"10.1287\/mnsc.28.10.1187"},{"key":"2026090400403104000_16.8.e116815.45","first-page":"291","article-title":"The performance forecasting groups computer dialogue face-to-face discussion","volume":"68","author":"Brockhoff","year":"1975","journal-title":"Delphi Method: Techniques Applications"},{"key":"2026090400403104000_16.8.e116815.46","unstructured":"Jinglou Q , Yaxin Z , Bo Q . Delphi method its application medical education research. Chinese Journal Medical Education 2019."},{"key":"2026090400403104000_16.8.e116815.47","doi-asserted-by":"crossref","DOI":"10.3389\/fdgth.2023.1137066","article-title":"Patient preferences as human factors for health data recommender systems and shared decision making in orthopaedic practice","volume":"5","author":"Singh","year":"2023","journal-title":"Front Digit Health"},{"key":"2026090400403104000_16.8.e116815.48","unstructured":"Singh A . Digital health design for improving treatment decisions. 2023."},{"key":"2026090400403104000_16.8.e116815.49","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2006.03.012"},{"key":"2026090400403104000_16.8.e116815.50","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-016-1555-2","article-title":"How to select outcome measurement instruments for outcomes included in a \u201cCore Outcome Set\u201d - a practical guideline","volume":"17","author":"Prinsen","year":"2016","journal-title":"Trials"},{"key":"2026090400403104000_16.8.e116815.51","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18637\/jss.v045.i04","article-title":"Multiple Imputation by Chained Equations (MICE): Implementation in Stata","volume":"45","author":"Royston","year":"2011","journal-title":"J Stat Soft"},{"key":"2026090400403104000_16.8.e116815.52","doi-asserted-by":"crossref","DOI":"10.1002\/jgf2.70142","article-title":"Effect of a Clinical Decision Support System on Team-Based Clinical Quiz Performance Among Japanese Medical Students: A Pre-Post Pilot Study","volume":"27","author":"Isoda","year":"2026","journal-title":"J Gen Fam Med"},{"key":"2026090400403104000_16.8.e116815.53","first-page":"600","article-title":"The World Health Organisation International Classification of Functioning, Disability and Health: a conceptual model and interface for the OMERACT process","volume":"34","author":"Stucki","year":"2007","journal-title":"J Rheumatol"},{"key":"2026090400403104000_16.8.e116815.54","doi-asserted-by":"publisher","DOI":"10.1080\/09638280701189960"},{"key":"2026090400403104000_16.8.e116815.55","doi-asserted-by":"crossref","first-page":"1091","DOI":"10.1177\/0733464815602114","article-title":"Painful Choices: A Qualitative Exploration of Facilitators and Barriers to Active Lifestyles Among Adults With Osteoarthritis","volume":"36","author":"Stone","year":"2017","journal-title":"J Appl Gerontol"},{"key":"2026090400403104000_16.8.e116815.56","doi-asserted-by":"crossref","unstructured":"Keeney S , McKenna H , Hasson F . The Delphi Technique in Nursing and Health Research. Chichester, England: Wiley-Blackwell, 2010.","DOI":"10.1002\/9781444392029"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-116815","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T07:40:47Z","timestamp":1788507647000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-116815"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":56,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,13]]},"published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1136\/bmjopen-2026-116815"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-116815","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]}}}