{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T03:20:46Z","timestamp":1778728846107,"version":"3.51.4"},"reference-count":50,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T00:00:00Z","timestamp":1604102400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T00:00:00Z","timestamp":1604102400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"UCB Pharma, the manufacturer of certolizumab pegol"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Qual Life Res"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA) to assess its appropriateness as an outcome measure in future clinical studies.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients with active axSpA from a Phase III, randomized, double-blind, placebo-controlled trial (RAPID-axSpA, NCT01087762) were included (<jats:italic>N<\/jats:italic>\u2009=\u2009325). Modified New York (mNY) classification criteria were used to classify patients as having ankylosing spondylitis or nr-axSpA; those with nr-axSpA were further categorized based on objective signs of inflammation. Psychometric properties of the ASQoL were assessed\/documented using a mixture of modern psychometric methods and classical test theory methods. These included exploratory factor analysis and item response theory models to assess the domain structure, test the utility of a single domain relative to subdomains, assess bias, and generate statistics to guide an empirical scoring algorithm. The reliability and validity of scores were evaluated via internal consistency, test\u2013retest reliability, concurrent validity, and known-groups validity. Score responsiveness was assessed via anchor-based clinically meaningful change, supplemented with empirical cumulative distribution function visualizations.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The ASQoL data were defined by four domains. However, a four-domain solution was found to be inferior to a bifactor solution in which the four domains were included within a total domain. Scoring statistics supported a unit-weighted total score. Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Our findings suggest that the ASQoL is an appropriate outcome measure in interventional clinical trials in patients with nr-axSpA.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11136-020-02686-0","type":"journal-article","created":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T10:02:53Z","timestamp":1604138573000},"page":"945-954","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Validation of the Ankylosing Spondylitis Quality of Life assessment tool in patients with non-radiographic axial spondyloarthritis"],"prefix":"10.1007","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7487-8559","authenticated-orcid":false,"given":"Bengt","family":"Hoepken","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Serrano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristina","family":"Harris","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2160-1481","authenticated-orcid":false,"given":"Mark C.","family":"Hwang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Reveille","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,10,31]]},"reference":[{"issue":"10","key":"2686_CR1","doi-asserted-by":"crossref","first-page":"1218","DOI":"10.1002\/art.1780341003","volume":"34","author":"M Dougados","year":"1991","unstructured":"Dougados, M., van der Linden, S., Juhlin, R., Huitfeldt, B., Amor, B., Calin, A., et al. 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Retrieved 19 April 2019, from https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm193282.pdf"}],"container-title":["Quality of Life Research"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-020-02686-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s11136-020-02686-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-020-02686-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T19:52:02Z","timestamp":1615492322000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s11136-020-02686-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,31]]},"references-count":50,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["2686"],"URL":"https:\/\/doi.org\/10.1007\/s11136-020-02686-0","relation":{},"ISSN":["0962-9343","1573-2649"],"issn-type":[{"value":"0962-9343","type":"print"},{"value":"1573-2649","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,31]]},"assertion":[{"value":"19 October 2020","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 October 2020","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"BH is an employee of UCB Pharma. DS is an employee of Pharmerit International, which received funds to conduct the study. KH was an employee of UCB Pharma at the time the study was conducted. MCH is supported by the UTHealth Center for Clinical and Translational Sciences Kl2 Program (1KL2-TR-003168\u201301). JDR has consulted in the past year for UCB Pharma, Eli Lilly and Novartis, has received a research grant from the Janssen Pharmaceutical Division of Johnson & Johnson and is engaged in a clinical trial with Pfizer, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This was a non-interventional validation study to evaluate the psychometric performance of the ASQoL within a patient population with nr-axSpA.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Not directly applicable for this validation study, which used patient data from a completed clinical trial; informed consent was obtained from all patients who participated in the original clinical trial (RAPID-axSpA) at the time the study was conducted.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}