{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T15:18:47Z","timestamp":1783523927251,"version":"3.55.0"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T00:00:00Z","timestamp":1681948800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T00:00:00Z","timestamp":1681948800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100015661","name":"UCB Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015661","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Previous research on concepts that are important to people living with early-stage Parkinson\u2019s indicated that \u2018<jats:italic>functional<\/jats:italic>\u2019 slowness, fine motor skills, and subtle gait abnormalities are cardinal concepts that are not comprehensively captured by existing patient-reported outcome (PRO) instruments that are used in clinical practice and research to assess symptoms and daily functioning within this patient population. We sought to develop novel PRO instruments to address this unmet need.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>PRO instrument development was led by a multidisciplinary research group, including people living with Parkinson\u2019s (termed \u2018patient experts\u2019), as well as patient engagement and involvement, regulatory science, clinical, and outcome measurement experts. A first set of PRO instruments, termed Early Parkinson\u2019s Function Slowness (42 items) and Early Parkinson\u2019s Mobility (26 items), were drafted to capture \u2018<jats:italic>functional<\/jats:italic>\u2019 slowness, fine motor skills, and subtle gait abnormalities. These PRO instruments were used in cognitive debriefing interviews with people living with early-stage Parkinson\u2019s (who were not involved with the multidisciplinary research group) to identify issues with relevance, clarity, ease of completion, conceptual overlap, or missing concepts.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Sixty people living with early-stage Parkinson\u2019s were interviewed, which led to refining the items to 45 for the Early Parkinson\u2019s Functional Slowness and 23 for the Early Parkinson\u2019s Mobility PRO instruments. Refinement included rewording items to address clarity issues, merging or splitting items to address overlap issues, and adding new items to address missing concepts. The Early Parkinson\u2019s Function Slowness PRO instrument resulted in a multidimensional instrument covering upper limb, complex\/whole body, general activity, and cognitive functional slowness. The Early Parkinson\u2019s Mobility PRO instrument resulted in comprehensive coverage of everyday mobility tasks, with a focus on gait concepts, plus complex\/whole body, balance, and lower limb mobility.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The Early Parkinson\u2019s Function Slowness and Early Parkinson\u2019s Mobility PRO instruments aim to address gaps in existing PRO instruments to measure meaningful symptoms and daily functioning in people living with early-stage Parkinson\u2019s. Utilizing a meticulous study design led by a multidisciplinary research group that included patient experts helped to ensure that the PRO instruments were patient-centric, content valid, and meaningful from a clinical and measurement perspective.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-023-00577-9","type":"journal-article","created":{"date-parts":[[2023,4,20]],"date-time":"2023-04-20T18:26:24Z","timestamp":1682015184000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Development and early qualitative evidence of two novel patient-reported outcome instruments to assess daily functioning in people with early-stage Parkinson\u2019s"],"prefix":"10.1186","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0690-5359","authenticated-orcid":false,"given":"Thomas","family":"Morel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Cleanthous","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Andrejack","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger A.","family":"Barker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milton","family":"Biagioni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geraldine","family":"Blavat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bastiaan R.","family":"Bloem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Babak","family":"Boroojerdi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Brooks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Burns","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Cano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Casey","family":"Gallagher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley","family":"Gosden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carroll","family":"Siu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley F.","family":"Slagle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Ratcliffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karlin","family":"Schroeder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,20]]},"reference":[{"issue":"11","key":"577_CR1","doi-asserted-by":"publisher","first-page":"877","DOI":"10.1016\/s1474-4422(17)30299-5","volume":"16","author":"GBD","year":"2015","unstructured":"GBD (2015) Neurological Disorders Collaborator Group (2017) Global, regional, and national burden of neurological disorders during 1990\u20132015: a systematic analysis for the Global Burden of Disease Study 2015. 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In the UK, the Health Research Authority ethics tool was completed, which indicated that no National Health Service Research Ethics Committee approval was necessary.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All participants were required to complete consent forms before proceeding to the interview.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All participants were required to complete consent forms before proceeding to the interview. TM, MB and BB are employees and shareholders of UCB. JA reports patient advocate in training, Parkinson\u2019s Foundation (volunteer work, unpaid). RAB reports receiving grants or contracts from The European Union, Rosetrees Trust, The Medical Research Council, Wellcome, UK Research and Innovation: Digital Research Infrastructure, Aligning Science Against Parkinson\u2019s, and Cure Parkinson\u2019s; receiving royalties for books and editorial work from Wiley and Nature Springer; receiving consulting fees from Novo Nordisk, BlueRock Therapeutics, Aspen Neuroscience, and Transine Therapeutics; participation on a Data Safety Monitoring Board or Advisory Board from the ongoing NIHR-funded exenatide study entitled \u2018A randomised, double blind, parallel group, placebo controlled Phase 3 trial of Exenatide once weekly over 2\u00a0years as a potential disease modifying treatment for Parkinson's disease\u2019. RAB is a Director of the International Society for Stem Cell Research and is part of the research advisory panel for The Swedish Research Council and Cure Parkinson\u2019s. BRB reports receiving grants or contracts from: The Netherlands Organization for Scientific Research, The Michael J Fox Foundation, Not Impossible Labs, Parkinson Vereniging, Parkinson Foundation, Hersenstichting, The Davis Phinney Foundation, Parkinson NL, Stichting Woelse Waard, Stichting Alkemade-Keuls, Maag Lever Darm Stichting, Verily Life Sciences, Horizon 2020, Topsector Life Sciences and Health, UCB, and Zambon; consulting fees from Critical Path Institute, Kyowa Kirin, UCB, and Zambon; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Bial, Biogen, GE Healthcare, Oruen, Roche, UCB, and Zambon. CG, NR and KS report receiving support from UCB for travel, lodging, and meals to attend one in-person, research team scientific meeting for the purpose of PRO development for the present study. Since the completion of the study, NR has changed her affiliation from Parkinson\u2019s UK, London, UK to COUCH Health, Manchester, UK. LG has participated in a Glial Cell Line-Derived Neurotrophic Factor Advisory Board (working voluntarily with Parkinson\u2019s UK as a patient expert). AFS reports receiving consulting fees from UCB for advisory services related to outcome assessment development and patient engagement in early-stage Parkinson\u2019s; receiving payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from UCB for a clinical outcomes assessment regulatory workshop presentation that was provided to the patient experts who were involved across this research; receiving travel reimbursement from UCB for attending face-to-face meetings that were relevant to this manuscript. All authors report receiving support from UCB for funding the study and third-party medical writing assistance.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"40"}}