{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T21:29:54Z","timestamp":1790112594240,"version":"4.0.1"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,12,20]],"date-time":"2020-12-20T00:00:00Z","timestamp":1608422400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Hepatitis B virus (HBV) carries a large global burden. Efforts abound to decrease the burden, which necessitates reporting of patient\u2010reported outcomes (PROs). We aimed to develop and validate an HBV\u2010specific PRO instrument using the Chronic Liver Disease Questionnaire (CLDQ). Data were obtained from patients enrolled in our HBV registries who completed the CLDQ, Short Form\u201036 (SF\u201036) and FACIT\u2010F. The sample was split randomly 1:1 into training and testing groups. A standard PRO instrument validation pipeline was used to develop and validate the new CLDQ\u2010HBV instrument. HBV patients (n\u00a0=\u00a01,339) were 48\u00a0\u00b1\u00a013\u00a0years old, 60% male, 8% cirrhosis, with 53% receiving oral antivirals (OAV). After reduction of 10 redundant items, exploratory factor analysis for the remaining 19 items found 95% of variance was explained by five factors\u2014emotional function, fatigue, systemic symptoms, worry and sleep. Good\u2010to\u2010excellent internal consistency was found: Cronbach's alphas 0.70\u20100.90 and item\u2010to\u2010own\u2010domain correlations &gt;0.50 for 18\/19 items. Known\u2010group validity tests discriminated between HBV patients with and without cirrhosis, with FIB\u20104\u00a0\u2265\u00a03.25 vs &lt;3.25, with and without history of depression or clinically overt fatigue (all <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.0001), and treatment (all <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05, all but one &lt;0.0001). After 48\u2010week follow\u2010up, HBV patients receiving OAV (N\u00a0=\u00a0144) with \u22652.7 log 10\/mL decline in HBV viral load experienced significant improvements in fatigue, worry and total CLDQ\u2010HBV scores (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05). The newly developed CLDQ\u2010HBV is a short, disease\u2010specific PRO instrument for HBV patients which was developed and validated using large data set and an established methodology showing excellent psychometric characteristics.<\/jats:p>","DOI":"10.1111\/jvh.13451","type":"journal-article","created":{"date-parts":[[2020,12,11]],"date-time":"2020-12-11T16:30:15Z","timestamp":1607704215000},"page":"484-492","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Development and validation of a hepatitis B\u2010specific health\u2010related quality\u2010of\u2010life instrument: CLDQ\u2010HBV"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9313-577X","authenticated-orcid":false,"given":"Zobair M.","family":"Younossi","sequence":"first","affiliation":[{"name":"Betty and Guy Beatty Center for Integrated Research Inova Health System Falls Church VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Stepanova","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research in Liver Disease Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Issah","family":"Younossi","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research in Liver Disease Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrei","family":"Racila","sequence":"additional","affiliation":[{"name":"Betty and Guy Beatty Center for Integrated Research Inova Health System Falls Church VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00046-19"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10903-013-9871-z"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2015.12.044"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31173"},{"key":"e_1_2_7_6_1","unstructured":"Centers for Disease Control and Prevention (CDC).Health Related Quality of Life. Obtained from the world wide web at:https:\/\/www.cdc.gov\/hrqol\/concept.htm. Last accessed on 9\/21\/2020."},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21692"},{"key":"e_1_2_7_8_1","volume-title":"How to Score the Revised MOS Short\u2010Form Health Scale (SF\u201036)","author":"Ware JE","year":"1988"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.45.2.295"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.11.039"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12072-019-09943-6"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000013983"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.12997"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2016.02.005"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2019.01.001"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.14171"},{"key":"e_1_2_7_17_1","unstructured":"IrwingP HughesDJ.Test Development in The Wiley Handbook of Psychometric Testing: A Multidisciplinary Reference on Survey Scale and Test Development. Editors\u2010 Irwing P Booth T Hughes DJ Available at:https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/9781118489772.ch1#:~:text=The%20test%20development%20should%20use terms%20of%20its%20psychometric%20properties. Last accessed on 9\/21\/2020."},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2009.05.033"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.10245"},{"key":"e_1_2_7_20_1","unstructured":"FDA.Patient Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims. Guidance for Industry;2009."},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp0911494"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-11-184"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/MCG.0000000000001179"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.5604\/01.3001.0010.0290"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.psym.2010.12.019"}],"container-title":["Journal of Viral Hepatitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvh.13451","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jvh.13451","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvh.13451","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T15:55:46Z","timestamp":1693583746000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jvh.13451"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,20]]},"references-count":24,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1111\/jvh.13451"],"URL":"https:\/\/doi.org\/10.1111\/jvh.13451","archive":["Portico"],"relation":{},"ISSN":["1352-0504","1365-2893"],"issn-type":[{"value":"1352-0504","type":"print"},{"value":"1365-2893","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,20]]},"assertion":[{"value":"2020-10-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-26","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}