{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T23:08:36Z","timestamp":1782169716618,"version":"3.54.5"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T00:00:00Z","timestamp":1734393600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100031288","name":"F2G, Ltd.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100031288","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000038","name":"US FDA","doi-asserted-by":"publisher","award":["75F40121C00145"],"award-info":[{"award-number":["75F40121C00145"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,3,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Coccidioidomycosis (Valley Fever) is a dimorphic fungal infection endemic to the southwest United States, Mexico, Central and South America, which can lead to chronic debilitating illness and death.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>This qualitative study was conducted to develop a bespoke patient-reported outcome measure for patients with chronic disseminated coccidioidomycosis to assess health-related quality of life (HRQoL) impacts.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and methods<\/jats:title>\n                  <jats:p>Online, first-person narratives of patient experiences of disseminated coccidioidomycosis were used to create a patient-centred conceptual model of symptoms and impacts of the condition. Interviews were conducted with expert clinicians, followed by concept elicitation interviews with patients, to generate key symptom and impact concepts from which an initial patient-reported outcome measure was developed. The draft measure was reviewed with clinicians for clinical relevance and further assessed in cognitive debriefing interviews with patients to refine the measure and establish content validity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 25 patients were interviewed, which identified impacts relating to physical function, activities of daily living, cognitive function, social\/role function and emotional function of disseminated coccidioidomycosis. Twenty items were developed simultaneously in English and Spanish to capture the main impacts across these 5 areas. In general, items were clear and well understood by patients, and clinicians found the measure clinically relevant and appropriate for assessing the burden of disseminated coccidioidomycosis on HRQoL.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Once fully validated, the Valley Fever\u2014Patient Reported Outcome measure may be used in interventional studies to assess HRQoL outcomes, and in clinical practice to monitor patients\u2019 HRQoL.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkae453","type":"journal-article","created":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T13:54:42Z","timestamp":1734443682000},"page":"657-665","source":"Crossref","is-referenced-by-count":3,"title":["Development of a novel patient-reported outcome measure for disseminated coccidioidomycosis (valley fever)"],"prefix":"10.1093","volume":"80","author":[{"given":"Emma","family":"Harvey","sequence":"first","affiliation":[{"name":"Clinical R&D, F2G, Ltd , Manchester ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8153-5351","authenticated-orcid":false,"given":"Jennifer","family":"Clegg","sequence":"additional","affiliation":[{"name":"Clincial Outcomes Assessments, Clinical Outcomes Solutions , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Bresnik","sequence":"additional","affiliation":[{"name":"Clinical R&D, F2G, Ltd , Manchester ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elliott","family":"Blatt","sequence":"additional","affiliation":[{"name":"Clincial Outcomes Assessments, Clinical Outcomes Solutions , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Hughes","sequence":"additional","affiliation":[{"name":"Clinical Outcomes Assesments, Clinical Outcomes Solutions , Folkestone, Kent ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Umanzor-Figueroa","sequence":"additional","affiliation":[{"name":"Clincial Outcomes Assessments, Clinical Outcomes Solutions , Chicago, IL ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"Purdie","sequence":"additional","affiliation":[{"name":"Patient Coordination, Valley Fever Institute at Kern Medical , Bakersfield, CA ,","place":["USA"]},{"name":"MyCology Advocacy, Research and Education (MyCARE) , Colorado Springs, CO ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8518-5750","authenticated-orcid":false,"suffix":"III","given":"George R","family":"Thompson","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Internal Medicine, UC Davis Health , Sacramento, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tara","family":"Symonds","sequence":"additional","affiliation":[{"name":"Clinical Outcomes Assesments, Clinical Outcomes Solutions , Folkestone, Kent ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,12,17]]},"reference":[{"key":"2025030423055480200_dkae453-B1","doi-asserted-by":"publisher","first-page":"840","DOI":"10.1007\/s10393-018-1375-9","article-title":"Investigating the relationship between climate and Valley Fever (coccidioidomycosis)","volume":"15","author":"Weaver","year":"2018","journal-title":"Ecohealth"},{"key":"2025030423055480200_dkae453-B2","doi-asserted-by":"publisher","first-page":"e793","DOI":"10.1016\/S2542-5196(22)00202-9","article-title":"Effects of precipitation, heat, and drought on incidence and expansion of coccidioidomycosis in western USA: a longitudinal surveillance study","volume":"6","author":"Head","year":"2022","journal-title":"Lancet Planet Health"},{"key":"2025030423055480200_dkae453-B3","doi-asserted-by":"publisher","first-page":"1","DOI":"10.15585\/mmwr.ss7107a1","article-title":"Surveillance for coccidioidomycosis, histoplasmosis, and blastomycosis\u2014United States, 2019","volume":"71","author":"Smith","year":"2022","journal-title":"MMWR Surveill Summ"},{"key":"2025030423055480200_dkae453-B4","doi-asserted-by":"publisher","first-page":"ofaa623","DOI":"10.1093\/ofid\/ofaa623","article-title":"Clinical and economic burden of valley fever in Arizona: an incidence-based cost-of-illness analysis","volume":"8","author":"Grizzle","year":"2020","journal-title":"Open Forum Infect Dis"},{"key":"2025030423055480200_dkae453-B5","doi-asserted-by":"publisher","first-page":"2337","DOI":"10.1056\/NEJMoa2000024","article-title":"Disseminated coccidioidomycosis treated with interferon-\u03b3 and dupilumab","volume":"382","author":"Tsai","year":"2020","journal-title":"N Engl J Med"},{"key":"2025030423055480200_dkae453-B6","doi-asserted-by":"publisher","first-page":"308","DOI":"10.3201\/eid2302.160505","article-title":"Risk factors for disseminated coccidioidomycosis, United States","volume":"23","author":"Odio","year":"2017","journal-title":"Emerg Infect Dis"},{"key":"2025030423055480200_dkae453-B7","doi-asserted-by":"publisher","first-page":"e112","DOI":"10.1093\/cid\/ciw360","article-title":"2016 Infectious Diseases Society of America (IDSA) clinical practice guideline for the treatment of coccidioidomycosis","volume":"63","author":"Galgiani","year":"2016","journal-title":"Clin Infect Dis"},{"key":"2025030423055480200_dkae453-B8","author":"US Food and Drug Administration"},{"key":"2025030423055480200_dkae453-B9","doi-asserted-by":"publisher","first-page":"873","DOI":"10.1007\/s11136-009-9496-9","article-title":"Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items","volume":"18","author":"Hays","year":"2009","journal-title":"Qual Life Res"},{"key":"2025030423055480200_dkae453-B10","doi-asserted-by":"publisher","first-page":"ofac492.063","DOI":"10.1093\/ofid\/ofac492.063","article-title":"870. Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)","volume":"9","author":"Maertens","year":"2022","journal-title":"Open Forum Infect Dis"},{"key":"2025030423055480200_dkae453-B11","doi-asserted-by":"publisher","first-page":"674","DOI":"10.1086\/590566","article-title":"Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria","volume":"47","author":"Segal","year":"2008","journal-title":"Clin Infect Dis"},{"key":"2025030423055480200_dkae453-B12","author":"US Food and Drug Administration"},{"key":"2025030423055480200_dkae453-B13","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects","volume":"310","author":"World Medical Association","year":"2013","journal-title":"JAMA"},{"key":"2025030423055480200_dkae453-B14","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1186\/s41687-022-00461-y","article-title":"Content validity of a newly developed observer-reported measure for pediatric asthma in children aged 2\u20135\u2005years","volume":"6","author":"Zhang","year":"2022","journal-title":"J Patient Rep Outcomes"},{"key":"2025030423055480200_dkae453-B15","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"Braun","year":"2006","journal-title":"Qual Res Psychol"},{"key":"2025030423055480200_dkae453-B16","doi-asserted-by":"publisher","first-page":"839","DOI":"10.1016\/j.jval.2017.11.014","article-title":"Informing a priori sample size estimation in qualitative concept elicitation interview studies for clinical outcome assessment instrument development","volume":"21","author":"Turner-Bowker","year":"2018","journal-title":"Value Health"},{"key":"2025030423055480200_dkae453-B17","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1177\/1049732316665344","article-title":"Code saturation versus meaning saturation: how many interviews are enough?","volume":"27","author":"Hennink","year":"2017","journal-title":"Qual Health Res"},{"key":"2025030423055480200_dkae453-B18","doi-asserted-by":"publisher","first-page":"1229","DOI":"10.1080\/08870440903194015","article-title":"What is an adequate sample size? Operationalising data saturation for theory-based interview studies","volume":"25","author":"Francis","year":"2010","journal-title":"Psychol Health"},{"key":"2025030423055480200_dkae453-B19","author":"US Food and Drug Administration"},{"key":"2025030423055480200_dkae453-B20","author":"Natsoulis"},{"key":"2025030423055480200_dkae453-B21","doi-asserted-by":"publisher","first-page":"197","DOI":"10.1080\/1059924X.2021.2002223","article-title":"Coccidioidomycosis knowledge and behaviors of California Hispanic farm workers","volume":"27","author":"Sipan","year":"2021","journal-title":"J Agromedicine"},{"key":"2025030423055480200_dkae453-B22","doi-asserted-by":"publisher","first-page":"1979","DOI":"10.1111\/hex.13554","article-title":"Improving diversity in study participation: patient perspectives on barriers, racial differences and the role of communities","volume":"25","author":"Shea","year":"2022","journal-title":"Health Expect"},{"key":"2025030423055480200_dkae453-B23","doi-asserted-by":"publisher","first-page":"106740","DOI":"10.1016\/j.cct.2022.106740","article-title":"Inclusion and diversity in clinical trials: actionable steps to drive lasting change","volume":"116","author":"Kelsey","year":"2022","journal-title":"Contemp Clin Trials"}],"container-title":["Journal of Antimicrobial Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/80\/3\/657\/61214235\/dkae453.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/80\/3\/657\/61214235\/dkae453.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T23:06:11Z","timestamp":1741129571000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jac\/article\/80\/3\/657\/7926512"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,17]]},"references-count":23,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,12,17]]},"published-print":{"date-parts":[[2025,3,3]]}},"URL":"https:\/\/doi.org\/10.1093\/jac\/dkae453","relation":{},"ISSN":["0305-7453","1460-2091"],"issn-type":[{"value":"0305-7453","type":"print"},{"value":"1460-2091","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,3]]},"published":{"date-parts":[[2024,12,17]]}}}