{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T01:18:00Z","timestamp":1794014280927,"version":"4.8.0"},"reference-count":34,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T00:00:00Z","timestamp":1585267200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T00:00:00Z","timestamp":1585267200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Janssen-Cilag Ltd"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The FACT-8D is a new cancer-specific, preference-based measure (PBM) of health, derived from the Functional Assessment of Cancer Therapy \u2013 General (FACT-G) questionnaire. The FACT-8D\u2019s measurement properties have not been tested to date. We assessed it\u2019s validity and responsiveness in relapsed\/refractory mantle cell lymphoma (RR MCL) and compared the results to the EQ-5D-5L.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Blinded analysis of pooled data from a phase 3 clinical trial. FACT-8D baseline and follow-up data (weeks 4, 7, 16, 31) were scored using Australian preference weights, the first available value-set. Convergent validity was assessed by estimating baseline correlations with the FACT-Lym total score, Trial Outcome Index (TOI), FACT-Lym lymphoma-specific sub-scale (LymS), EQ-5D Visual Analog Scale (VAS), and haemoglobin (HgB). Relevant clinical variables were used to categorise patients to test known groups\u2019 validity and responsiveness was investigated using data from baseline (<jats:italic>n<\/jats:italic>\u2009=\u2009250) and week 31 (<jats:italic>n<\/jats:italic>\u2009=\u2009130). Results were compared with EQ-5D-5L, scored using the UK 3L crosswalk and the 5L England value-sets.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The FACT-8D showed good convergent validity and responsiveness; baseline Pearson correlation coefficients between FACT-8D Index scores and other PRO measures were moderate to very strong (range: 0.49 for the EQ-VAS to 0.79 for FACT TOI) and the size of the change in FACT-8D Index scores at week 31 differed significantly (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.005) between patients categorised as improved, worsened or stable using the FACT-Lym total score, LymS, and HgB. However, when assessing known groups\u2019 validity, FACT-8D failed to discriminate between patients categorised by health status on four of the seven variables analysed. Overall, FACT-8D and EQ-5D-5L performed similarly, although EQ-5D-5L showed better known groups\u2019 validity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This is the first investigation into the psychometric properties of the FACT-8D. In this RR MCL trial dataset, it showed good convergent validity and responsiveness, but poorer known groups\u2019 validity, and EQ-5D performed as well or better on the tests conducted. The FACT-8D may offer an alternative method to generate utilities for the cost-effectiveness analysis of cancer treatments but needs further testing in other types of cancer patients. Evaluation of utility gains may have been limited by high baseline performance status in this RR MCL trial sample.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-020-0185-3","type":"journal-article","created":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T03:04:36Z","timestamp":1585278276000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Testing the validity and responsiveness of a new cancer-specific health utility measure (FACT-8D) in relapsed\/refractory mantle cell lymphoma, and comparison to EQ-5D-5L"],"prefix":"10.1186","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0423-6005","authenticated-orcid":false,"given":"Michael","family":"Herdman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cicely","family":"Kerr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Pavesi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamie","family":"Garside","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Lloyd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Cubi-Molla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Devlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,3,27]]},"reference":[{"key":"185_CR1","volume-title":"Position statement on use of the EQ-5D-5L valuation set","author":"NICE","year":"2017","unstructured":"NICE. 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The RAY MCL3001 clinical trial (NCT01646021) was conducted according to the principles of the Declaration of Helsinki and the Guidelines for Good Clinical Practice and informed consent was obtained from all individual participants. Prior to use in this study, personally identifiable and treatment data were removed so that analysis was conducted on an anonymised and pooled data-set.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"OHE Consulting Ltd. was paid a fixed price by Janssen-Cilag Ltd. to design and conduct this study. Mike Herdman, Patricia Cubi Molla, and Nancy Devlin are or were employees of The Office of Health Economics at the time the study was conducted. Marco Pavesi and Andrew Lloyd were contracted by OHE Consulting Ltd. to conduct analysis and provide consulting input to the study. Cicely Kerr and Jamie Garside are current employees of Janssen-Cilag Ltd.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"22"}}