{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T13:41:42Z","timestamp":1790948502088,"version":"4.1.0"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson and Johnson","doi-asserted-by":"publisher","award":["NA"],"award-info":[{"award-number":["NA"]}],"id":[{"id":"10.13039\/100004331","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>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>Warm autoimmune hemolytic anemia (wAIHA) is a rare disorder characterized by premature destruction of red blood cells (hemolysis) and fatigue that affects patients\u2019 health-related quality of life. This study aimed to identify fatigue concepts important to patients and evaluate the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) in the wAIHA patient population.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methodology<\/jats:title>\n            <jats:p>Two observational studies collected data via 60-minute, individual interviews. Eligible participants were English-speaking, US-resident adults diagnosed with wAIHA by a physician. Both studies gathered data regarding fatigue experiences that mattered to patients and comprehension and relevance of the FACIT-Fatigue; one study also gathered data about patient perspectives on meaningful change in item-level response selection.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Each study enrolled 10 individuals with wAIHA (<jats:italic>n<\/jats:italic>\u2009=\u200920). All participants described fatigue as the most prominent or most bothersome symptom, with substantial impacts on daily functioning, family and social life, and emotional well-being. The FACIT-Fatigue was well understood, comprehensive, and relevant to participants\u2019 experiences with wAIHA. Data analysis indicated that at least a 3-point change in total score likely reflects a meaningful change in fatigue.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Fatigue is the primary patient-reported wAIHA symptom and important to measure from the patient perspective. Findings demonstrated that wAIHA patients found the FACIT-Fatigue understandable, comprehensive, and relevant, and the data indicated that the instrument can detect a meaningful change in fatigue symptoms and impacts. Study findings support the content validity of the FACIT-Fatigue and contribute to the evidence that the FACIT-Fatigue is fit-for-purpose to evaluate fatigue in adults with wAIHA.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s41687-025-00930-0","type":"journal-article","created":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T12:12:52Z","timestamp":1753791172000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients"],"prefix":"10.1186","volume":"9","author":[{"given":"Sheryl","family":"Pease","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6231-5890","authenticated-orcid":false,"given":"Rikki","family":"Mangrum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karolina","family":"Schantz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Slota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey","family":"Rubin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathye","family":"Shu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayla","family":"Scippa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,7,29]]},"reference":[{"issue":"5","key":"930_CR1","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1159\/000439002","volume":"42","author":"W Barcellini","year":"2015","unstructured":"Barcellini W (2015) New insights in the pathogenesis of autoimmune hemolytic anemia. Transfus Med Hemother 42(5):287\u2013293. https:\/\/doi.org\/10.1159\/000439002","journal-title":"Transfus Med Hemother"},{"issue":"5","key":"930_CR2","doi-asserted-by":"publisher","first-page":"321","DOI":"10.1159\/000540475","volume":"51","author":"W Barcellini","year":"2024","unstructured":"Barcellini W, Fattizzo B (2024) Autoimmune hemolytic anemias: challenges in diagnosis and therapy. Transfus Med Hemother 51(5):321\u2013331. https:\/\/doi.org\/10.1159\/000540475","journal-title":"Transfus Med Hemother"},{"key":"930_CR3","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1186\/1477-7525-12-15","volume":"12","author":"A Br\u00e9dart","year":"2014","unstructured":"Br\u00e9dart A, Marrel A, Abetz-Webb L, Lasch K, Acquadro C (2014) Interviewing to develop patient-reported outcome (PRO) measures for clinical research: eliciting patients\u2019 experience. Health Qual Life Outcomes 12:15. https:\/\/doi.org\/10.1186\/1477-7525-12-15","journal-title":"Health Qual Life Outcomes"},{"issue":"1","key":"930_CR4","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1186\/s41687-022-00508-0","volume":"6","author":"D Cella","year":"2022","unstructured":"Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L et al (2022) Functional assessment of chronic illness therapy-fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes 6(1):100. https:\/\/doi.org\/10.1186\/s41687-022-00508-0","journal-title":"J Patient Rep Outcomes"},{"issue":"1\u20133","key":"930_CR5","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1007\/s12026-009-8153-2","volume":"47","author":"WW Eaton","year":"2010","unstructured":"Eaton WW, Pedersen MG, Atladottir HO, Gregory PE, Rose NR, Mortensen PB (2010) The prevalence of 30 ICD-10 autoimmune diseases in Denmark. Immunol Res 47(1\u20133):228\u2013231. https:\/\/doi.org\/10.1007\/s12026-009-8153-2","journal-title":"Immunol Res"},{"issue":"1","key":"930_CR6","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1186\/s41687-021-00294-1","volume":"5","author":"D Eek","year":"2021","unstructured":"Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D (2021) Content validity and psychometric evaluation of the functional assessment of chronic illness therapy-fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes 5(1):27. https:\/\/doi.org\/10.1186\/s41687-021-00294-1","journal-title":"J Patient Rep Outcomes"},{"key":"930_CR7","unstructured":"FACIT Group. FACIT-fatigue. Retrieved 21 (2024) November from https:\/\/www.facit.org\/measures\/facit-fatigue"},{"issue":"1","key":"930_CR8","doi-asserted-by":"publisher","first-page":"690","DOI":"10.1182\/asheducation-2016.1.690","volume":"2016","author":"TA Kalfa","year":"2016","unstructured":"Kalfa TA (2016) Warm antibody autoimmune hemolytic anemia. Hematol Am Soc Hematol Educ Program (1):690\u2013697. https:\/\/doi.org\/10.1182\/asheducation-2016.1.690","journal-title":"Hematol Am Soc Hematol Educ Program"},{"issue":"1","key":"930_CR9","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1002\/ajh.27144","volume":"99","author":"DJ Kuter","year":"2024","unstructured":"Kuter DJ, Piatek C, R\u00f6th A, Siddiqui A, Numerof RP, Dummer W (2024) Fostamatinib for warm antibody autoimmune hemolytic anemia: phase 3, randomized, double-blind, placebo-controlled, global study (FORWARD). Am J Hematol 99(1):79\u201387. https:\/\/doi.org\/10.1002\/ajh.27144","journal-title":"Am J Hematol"},{"issue":"1","key":"930_CR10","doi-asserted-by":"publisher","first-page":"541","DOI":"10.1007\/s40744-021-00292-1","volume":"8","author":"K Raymond","year":"2021","unstructured":"Raymond K, Park J, Joshi AV, White MK (2021) Patient experience with fatigue and qualitative interview-based evidence of content validation of the FACIT-fatigue in systemic lupus erythematosus. Rheumatol Ther 8(1):541\u2013554. https:\/\/doi.org\/10.1007\/s40744-021-00292-1","journal-title":"Rheumatol Ther"},{"key":"930_CR11","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-024-03829-3","author":"M Regueiro","year":"2024","unstructured":"Regueiro M, Su S, Vadhariya A, Zhou X, Durand F, Stassek L et al (2024) Psychometric evaluation of the functional assessment of chronic illness therapy-fatigue (FACIT-fatigue) in adults with moderately to severely active crohn\u2019s disease. Qual Life Res. https:\/\/doi.org\/10.1007\/s11136-024-03829-3","journal-title":"Qual Life Res"},{"issue":"1","key":"930_CR12","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1186\/s41687-021-00298-x","volume":"5","author":"R Rendas-Baum","year":"2021","unstructured":"Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M (2021) Psychometric properties of FACIT-fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes 5(1):33. https:\/\/doi.org\/10.1186\/s41687-021-00298-x","journal-title":"J Patient Rep Outcomes"},{"issue":"1","key":"930_CR13","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1186\/s41687-024-00685-0","volume":"8","author":"R Rendas-Baum","year":"2024","unstructured":"Rendas-Baum R, Lin X, Kosinski M, Bjorner JB, Bracher MG, Chen WH (2024) Meaningful score changes for SF-36v2, FACIT-fatigue, and RASIQ in rheumatoid arthritis. J Patient Rep Outcomes 8(1):9. https:\/\/doi.org\/10.1186\/s41687-024-00685-0","journal-title":"J Patient Rep Outcomes"},{"key":"930_CR14","doi-asserted-by":"publisher","first-page":"3753","DOI":"10.1182\/blood-2023-174965","volume":"142","author":"K Scippa","year":"2023","unstructured":"Scippa K, Mangrum R, Martin S, Cueto D, Bryant A, Schantz K et al (2023) Establishing content validity of the FACIT-fatigue scale in patients living with warm autoimmune hemolytic anemia: results from qualitative interview studies. Blood 142:3753","journal-title":"Blood"},{"issue":"1","key":"930_CR15","doi-asserted-by":"publisher","first-page":"12","DOI":"10.14740\/jh303w","volume":"6","author":"SR Sudulagunta","year":"2017","unstructured":"Sudulagunta SR, Kumbhat M, Sodalagunta MB, Settikere Nataraju A, Bangalore Raja SK, Thejaswi KC et al (2017) Warm autoimmune hemolytic anemia: clinical profile and management. J Hematol 6(1):12\u201320. https:\/\/doi.org\/10.14740\/jh303w","journal-title":"J Hematol"},{"issue":"2","key":"930_CR16","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1016\/s0885-3924(96)00274-6","volume":"13","author":"SB Yellen","year":"1997","unstructured":"Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E (1997) Measuring fatigue and other anemia-related symptoms with the functional assessment of cancer therapy (FACT) measurement system. J Pain Symptom Manage 13(2):63\u201374. https:\/\/doi.org\/10.1016\/s0885-3924(96)00274-6","journal-title":"J Pain Symptom Manage"}],"container-title":["Journal of Patient-Reported Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41687-025-00930-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s41687-025-00930-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41687-025-00930-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T06:28:59Z","timestamp":1757312939000},"score":1,"resource":{"primary":{"URL":"https:\/\/jpro.springeropen.com\/articles\/10.1186\/s41687-025-00930-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,29]]},"references-count":16,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["930"],"URL":"https:\/\/doi.org\/10.1186\/s41687-025-00930-0","relation":{},"ISSN":["2509-8020"],"issn-type":[{"value":"2509-8020","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,29]]},"assertion":[{"value":"16 April 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 July 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 July 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval was provided by RTI IRB for study 1 and Advarra CIRBI for study 2. All participants in both studies provided written consent to participate and consent was affirmed at the beginning of each interview.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Does not apply.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SP, KS, and CS are employees of Johnson & Johnson. RM, KS, and LR are employees of Vector Psychometric Group, LLC, which received funding to conduct study 2 and synthesize the results with study 1. CS and SM are employees of RTI International, which received funding to conduct study 1.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"97"}}