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Both studies administered selected PRO-CTCAE items and EORTC QLQ-C30 scales. Conceptually, relevant QLQ-C30 domains were used as anchors to estimate meaningful change thresholds for deterioration in corresponding PRO-CTCAE items and their composite scores. Items or composites with \u01c0\n                      <jats:italic>\u03c1<\/jats:italic>\n                      \u01c0\u2009\u2265\u20090.30 correlation with QLQ-C30 scales were included. Changes in PRO-CTCAE scores and composites were estimated for patients who met or exceeded a 10-point deterioration on the corresponding QLQ-C30 scale. Change scores were computed between baseline and the 3-month timepoint in PRO-TECT, and in the PRO-CTCAE validation study between baseline and a single follow-up visit that occurred between 1 and 7\u00a0weeks later. For each PRO-CTCAE item, change scores could range from \u2212\u20094 to 4; for a composite, change scores could range from \u2212\u20093 to 3.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Change scores in QLQ-C30 and PRO-CTCAE were available in 406 and 792 patients in PRO-TECT and the validation study, respectively. Across QLQ-C30 scales, the proportion of patients with a 10-point or greater worsening on QLQ-C30 ranged from 15 to 30% in the PRO-TECT data and 13% to 34% in the validation data. Across PRO-CTCAE items, anchor-based meaningful change estimates for deterioration ranged from 0.05 to 0.30 (mean 0.19) in the PRO-TECT data and from 0.19 to 0.53 (mean 0.36) in the validation data. For composites, they ranged from 0.06 to 0.27 (mean 0.17) in the PRO-TECT data and 0.22 to 0.51 (mean 0.37) in the validation data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In both datasets, the minimal meaningful individual-level change threshold for worsening was one point for all items and composite scores.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>ClinicalTrials.gov:<\/jats:bold>\n                      NCT03249090 (AFT-39), NCT02158637 (MC1091)\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11136-024-03819-5","type":"journal-article","created":{"date-parts":[[2024,11,6]],"date-time":"2024-11-06T03:08:20Z","timestamp":1730862500000},"page":"495-507","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE\u00ae)"],"prefix":"10.1007","volume":"34","clinical-trial-number":[{"clinical-trial-number":"nct03249090","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02158637","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1301-4319","authenticated-orcid":false,"given":"Minji K.","family":"Lee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra A.","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ethan","family":"Basch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gina L.","family":"Mazza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blake T.","family":"Langlais","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita","family":"Thanarajasingam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenda F.","family":"Ginos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Rogak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric A.","family":"Meek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Jansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison M.","family":"Deal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Carr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria S.","family":"Blinder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mattias","family":"Jonsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita N.","family":"Mody","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tito R.","family":"Mendoza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia V.","family":"Bennett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Schrag","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amylou C.","family":"Dueck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,11,6]]},"reference":[{"key":"3819_CR1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dju244","author":"E Basch","year":"2014","unstructured":"Basch, E., Reeve, B. 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Journal of Patient-Reported Outcomes, 3(1), 16. https:\/\/doi.org\/10.1186\/s41687-019-0100-y","journal-title":"Journal of Patient-Reported Outcomes"}],"container-title":["Quality of Life Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-024-03819-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11136-024-03819-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-024-03819-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T20:39:50Z","timestamp":1740602390000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11136-024-03819-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,6]]},"references-count":28,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["3819"],"URL":"https:\/\/doi.org\/10.1007\/s11136-024-03819-5","relation":{},"ISSN":["0962-9343","1573-2649"],"issn-type":[{"value":"0962-9343","type":"print"},{"value":"1573-2649","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,6]]},"assertion":[{"value":"21 October 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 November 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"EB reports research funding to the University of North Carolina from the National Cancer Institute and Patient-Centered Outcomes Research Institute, and direct funding as a scientific advisor to Sivan, Carevive, Resilience, N-Power, Navigating Cancer, and AstraZeneca. DS reports research funding to the Dana Farber Cancer Institute from the National Cancer Institute, Patient-Centered Outcomes Research Institute, and American Association of Cancer Research, and Grail. She reports serving as an uncompensated advisor to Grail and as a compensated advisor to the Centers for Medicare and Medicaid Services, and to several states and International Governments. She reports compensation from JAMA for editorial services. Other authors declare they have no competing interests. The views expressed here are those of the authors only and do not represent any official position of the National Cancer Institute or National Institutes of Health.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This was a secondary analysis of data from prospective trials. For the original validation study, institutional review board (IRB) approval was obtained at all sites and at the National Cancer Institute, and all participants provided written informed consent. For the PRO-TECT data, the trial protocol and consent were approved by central and local IRBs.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}