{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T15:46:51Z","timestamp":1786981611988,"version":"build-2736575974"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T00:00:00Z","timestamp":1737590400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T00:00:00Z","timestamp":1737590400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Qual Life Res"],"published-print":{"date-parts":[[2025,4]]},"DOI":"10.1007\/s11136-025-03895-1","type":"journal-article","created":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T10:46:05Z","timestamp":1737629165000},"page":"1137-1146","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Meaningful change threshold estimation for the non-small cell lung cancer symptom assessment questionnaire (NSCLC-SAQ): psychometric analysis from a phase 3 trial (LIBRETTO-431)"],"prefix":"10.1007","volume":"34","author":[{"given":"Nathan","family":"Clarke","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gill","family":"Worthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nalin","family":"Payakachat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrienne M.","family":"Gilligan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Cocks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,1,23]]},"reference":[{"issue":"3","key":"3895_CR1","doi-asserted-by":"publisher","first-page":"209","DOI":"10.3322\/caac.21660","volume":"71","author":"H Sung","year":"2021","unstructured":"Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global Cancer statistics 2020: GLOBOCAN estimates of incidence and Mortality Worldwide for 36 cancers in 185 countries. C Ca: A Cancer Journal for Clinicians, 71(3), 209\u2013249. https:\/\/doi.org\/10.3322\/caac.21660","journal-title":"C Ca: A Cancer Journal for Clinicians"},{"key":"3895_CR2","unstructured":"American Cancer Society. Facts &, & Figures\u00a0(2023). from https:\/\/www.cancer.org\/content\/dam\/cancer-org\/research\/cancer-facts-and-statistics\/annual-cancer-facts-and-figures\/2023\/2023-cancer-facts-and-figures.pdf"},{"issue":"4","key":"3895_CR3","doi-asserted-by":"publisher","first-page":"794","DOI":"10.1016\/j.clinthera.2016.03.012","volume":"38","author":"KP McCarrier","year":"2016","unstructured":"McCarrier, K. P., Atkinson, T. M., DeBusk, K. P., Liepa, A. M., Scanlon, M., & Coons, S. J. (2016). Qualitative development and content validity of the non-small cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), a patient-reported Outcome Instrument. Clinical Therapeutics, 38(4), 794\u2013810. https:\/\/doi.org\/10.1016\/j.clinthera.2016.03.012","journal-title":"Clinical Therapeutics"},{"issue":"21","key":"3895_CR4","doi-asserted-by":"publisher","first-page":"2859","DOI":"10.1200\/jco.2010.33.4425","volume":"29","author":"CS Cleeland","year":"2011","unstructured":"Cleeland, C. S., Mendoza, T. R., Wang, X. S., Woodruff, J. F., Palos, G. R., Richman, S. P., Nazario, A., Lynch, G. R., Liao, K. P., Mobley, G. M., & Lu, C. (2011). Levels of symptom burden during chemotherapy for advanced lung cancer: Differences between public hospitals and a tertiary cancer center. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 29(21), 2859\u20132865. https:\/\/doi.org\/10.1200\/jco.2010.33.4425","journal-title":"Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology"},{"issue":"1","key":"3895_CR5","doi-asserted-by":"publisher","first-page":"64","DOI":"10.1097\/JTO.0b013e3182397b3e","volume":"7","author":"P Yang","year":"2012","unstructured":"Yang, P., Cheville, A. L., Wampfler, J. A., Garces, Y. I., Jatoi, A., Clark, M. M., Cassivi, S. D., Midthun, D. E., Marks, R. S., Aubry, M. C., Okuno, S. H., Williams, B. A., Nichols, F. C., Trastek, V. F., Sugimura, H., Sarna, L., Allen, M. S., Deschamps, C., & Sloan, J. A. (2012). Quality of life and symptom burden among long-term lung cancer survivors. Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer, 7(1), 64\u201370. https:\/\/doi.org\/10.1097\/JTO.0b013e3182397b3e","journal-title":"Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer"},{"key":"3895_CR6","unstructured":"Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Retrieved Jun 06 (2023). from https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims"},{"key":"3895_CR7","unstructured":"Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. Retrieved Septemeber 09 (2023). from https:\/\/www.fda.gov\/media\/159500\/download"},{"key":"3895_CR8","unstructured":"Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints For Regulatory Decision-Making. Retrieved September 04 (2023). from https:\/\/www.fda.gov\/media\/166830\/download"},{"issue":"5","key":"3895_CR9","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1016\/0959-8049(94)90535-5","volume":"30a","author":"B Bergman","year":"1994","unstructured":"Bergman, B., Aaronson, N. K., Ahmedzai, S., Kaasa, S., & Sullivan, M. (1994). The EORTC QLQ-LC13: A modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. European Journal of Cancer, 30a(5), 635\u2013642. https:\/\/doi.org\/10.1016\/0959-8049(94)90535-5","journal-title":"European Journal of Cancer"},{"issue":"3","key":"3895_CR10","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1016\/0169-5002(95)00450-f","volume":"12","author":"DF Cella","year":"1995","unstructured":"Cella, D. F., Bonomi, A. E., Lloyd, S. R., Tulsky, D. S., Kaplan, E., & Bonomi, P. (1995). Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer, 12(3), 199\u2013220. https:\/\/doi.org\/10.1016\/0169-5002(95)00450-f","journal-title":"Lung Cancer"},{"issue":"Suppl 1","key":"3895_CR11","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1016\/s0959-8049(05)80262-x","volume":"29A","author":"PJ Hollen","year":"1993","unstructured":"Hollen, P. J., Gralla, R. J., Kris, M. G., & Potanovich, L. M. (1993). Quality of life assessment in individuals with lung cancer: Testing the Lung Cancer Symptom Scale (LCSS). European Journal of Cancer, 29A(Suppl 1), 51\u201358. https:\/\/doi.org\/10.1016\/s0959-8049(05)80262-x","journal-title":"European Journal of Cancer"},{"issue":"2","key":"3895_CR12","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1634\/theoncologist.2010-0193","volume":"16","author":"TR Mendoza","year":"2011","unstructured":"Mendoza, T. R., Wang, X. S., Lu, C., Palos, G. R., Liao, Z., Mobley, G. M., Kapoor, S., & Cleeland, C. S. (2011). Measuring the symptom burden of lung cancer: The validity and utility of the lung cancer module of the M. D. Anderson Symptom Inventory Oncologist, 16(2), 217\u2013227. https:\/\/doi.org\/10.1634\/theoncologist.2010-0193","journal-title":"Anderson Symptom Inventory Oncologist"},{"key":"3895_CR13","doi-asserted-by":"publisher","first-page":"100642","DOI":"10.1016\/j.curtheres.2021.100642","volume":"95","author":"DM Bushnell","year":"2021","unstructured":"Bushnell, D. M., Atkinson, T. M., McCarrier, K. P., Liepa, A. M., DeBusk, K. P., & Coons, S. J. (2021). Non-small Cell Lung Cancer Symptom Assessment Questionnaire: Psychometric Performance and Regulatory qualification of a Novel patient-reported Symptom measure. Curr Ther Res Clin Exp, 95, 100642. https:\/\/doi.org\/10.1016\/j.curtheres.2021.100642","journal-title":"Curr Ther Res Clin Exp"},{"issue":"3","key":"3895_CR14","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1001\/jamaoncol.2015.0530","volume":"1","author":"E Basch","year":"2015","unstructured":"Basch, E., Geoghegan, C., Coons, S. J., Gnanasakthy, A., Slagle, A. F., Papadopoulos, E. J., & Kluetz, P. G. (2015). Patient-reported outcomes in Cancer Drug Development and US Regulatory Review: Perspectives from industry, the Food and Drug Administration, and the patient. JAMA Oncol, 1(3), 375\u2013379. https:\/\/doi.org\/10.1001\/jamaoncol.2015.0530","journal-title":"JAMA Oncol"},{"key":"3895_CR15","unstructured":"Plan for Issuance of Patient-Focused Drug Development Guidance. Retrieved Jun 11 (2023). from https:\/\/www.fda.gov\/files\/about%20fda\/published\/Plan-for-Issuance-of-Patient%E2%80%90Focused-Drug-Development-Guidance.pdf"},{"issue":"5","key":"3895_CR16","doi-asserted-by":"publisher","first-page":"743","DOI":"10.1038\/clpt.2011.203","volume":"90","author":"SJ Coons","year":"2011","unstructured":"Coons, S. J., Kothari, S., Monz, B. U., & Burke, L. B. (2011). The patient-reported outcome (PRO) consortium: Filling measurement gaps for PRO end points to support labeling claims. Clinical Pharmacology and Therapeutics, 90(5), 743\u2013748. https:\/\/doi.org\/10.1038\/clpt.2011.203","journal-title":"Clinical Pharmacology and Therapeutics"},{"issue":"4","key":"3895_CR17","doi-asserted-by":"publisher","first-page":"100298","DOI":"10.1016\/j.jtocrr.2022.100298","volume":"3","author":"P Williams","year":"2022","unstructured":"Williams, P., Burke, T., Norquist, J. M., Daskalopoulou, C., Speck, R. M., Samkari, A., Eremenco, S., & Coons, S. J. (2022). Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): Measurement Properties and estimated clinically meaningful thresholds from a phase 3 study. JTO Clin Res Rep, 3(4), 100298. https:\/\/doi.org\/10.1016\/j.jtocrr.2022.100298","journal-title":"JTO Clin Res Rep"},{"key":"3895_CR18","doi-asserted-by":"publisher","unstructured":"(March, G. K. (2021). FP14.05 LIBRETTO-431: Selpercatinib in Treatment-Na\u00efve patients with RET Fusion-positive Non-small Cell Lung Cancer (NSCLC). Journal of Thoracic Oncology, S228\u2013S229. https:\/\/doi.org\/10.1016\/j.jtho.2021.01.148. 16(3 (Supplement).","DOI":"10.1016\/j.jtho.2021.01.148"},{"issue":"7","key":"3895_CR19","doi-asserted-by":"publisher","first-page":"763","DOI":"10.2217\/fon-2020-0935","volume":"17","author":"BJ Solomon","year":"2021","unstructured":"Solomon, B. J., Zhou, C. C., Drilon, A., Park, K., Wolf, J., Elamin, Y., Davis, H. M., Soldatenkova, V., Sashegyi, A., Lin, A. B., Lin, B. K., HH, F. L., Novello, S., Arriola, E., P\u00e9rol, M., Goto, K., & Santini, F. C. (2021). Phase III study of selpercatinib versus chemotherapy\u2009\u00b1\u2009pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncology, 17(7), 763\u2013773. https:\/\/doi.org\/10.2217\/fon-2020-0935","journal-title":"Future Oncology"},{"key":"3895_CR20","unstructured":"PM, F. (2001). The EORTC QLQ-C30 Scoring Manual (3rd edn.). Brussels: European Organisation for Research and Treatment of Cancer."},{"key":"3895_CR21","unstructured":"FACIT Item GP5, Functional Assessment of Chronic Illness Therapy - Item GP5. Retrieved Jul 31 (2023). from https:\/\/www.facit.org\/measures\/FACIT-Item-GP5"},{"key":"3895_CR22","unstructured":"Development and Testing of the PRO-CTCAE Measurement System. Retrieved Jul 31 (2023). from https:\/\/healthcaredelivery.cancer.gov\/pro-ctcae\/testing.html"},{"key":"3895_CR23","doi-asserted-by":"crossref","unstructured":"Devlin, N., Pickard, S., & Busschbach, J. (2022). The development of the EQ-5D-5L and its value sets. In N. Devlin, B. Roudijk, & K. Ludwig (Eds.), Value sets for EQ-5D-5L: A compendium, comparative Review & user guide (pp. 1\u201312). Springer International Publishing.","DOI":"10.1007\/978-3-030-89289-0_1"},{"issue":"5","key":"3895_CR24","doi-asserted-by":"publisher","first-page":"1223","DOI":"10.1007\/s11136-023-03413-1","volume":"32","author":"A Trigg","year":"2023","unstructured":"Trigg, A., Lenderking, W. R., & Boehnke, J. R. (2023). Introduction to the special section: Methodologies and considerations for meaningful change. Quality of Life Research, 32(5), 1223\u20131230. https:\/\/doi.org\/10.1007\/s11136-023-03413-1","journal-title":"Quality of Life Research"},{"issue":"2","key":"3895_CR25","doi-asserted-by":"publisher","first-page":"102","DOI":"10.1016\/j.jclinepi.2007.03.012","volume":"61","author":"D Revicki","year":"2008","unstructured":"Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61(2), 102\u2013109. https:\/\/doi.org\/10.1016\/j.jclinepi.2007.03.012","journal-title":"Journal of Clinical Epidemiology"},{"issue":"1","key":"3895_CR26","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1186\/s12874-021-01307-9","volume":"21","author":"A Vanier","year":"2021","unstructured":"Vanier, A., S\u00e9bille, V., Blanchin, M., & Hardouin, J. B. (2021). The minimal perceived change: A formal model of the responder definition according to the patient\u2019s meaning of change for patient-reported outcome data analysis and interpretation. Bmc Medical Research Methodology, 21(1), 128. https:\/\/doi.org\/10.1186\/s12874-021-01307-9","journal-title":"Bmc Medical Research Methodology"},{"issue":"12","key":"3895_CR27","doi-asserted-by":"publisher","first-page":"e114468","DOI":"10.1371\/journal.pone.0114468","volume":"9","author":"R Froud","year":"2014","unstructured":"Froud, R., & Abel, G. (2014). Using ROC curves to choose minimally important change thresholds when sensitivity and specificity are valued equally: The forgotten lesson of pythagoras. Theoretical considerations and an example application of change in health status. PLoS One, 9(12), e114468. https:\/\/doi.org\/10.1371\/journal.pone.0114468","journal-title":"PLoS One"},{"issue":"5","key":"3895_CR28","doi-asserted-by":"publisher","first-page":"581","DOI":"10.1586\/14737167.4.5.581","volume":"4","author":"GR Norman","year":"2004","unstructured":"Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2004). The truly remarkable universality of half a standard deviation: Confirmation through another look. Expert Rev Pharmacoecon Outcomes Res, 4(5), 581\u2013585. https:\/\/doi.org\/10.1586\/14737167.4.5.581","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"issue":"2","key":"3895_CR29","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1586\/erp.11.9","volume":"11","author":"MT King","year":"2011","unstructured":"King, M. T. (2011). A point of minimal important difference (MID): A critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res, 11(2), 171\u2013184. https:\/\/doi.org\/10.1586\/erp.11.9","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"issue":"10","key":"3895_CR30","doi-asserted-by":"publisher","first-page":"2755","DOI":"10.1007\/s11136-021-02957-4","volume":"30","author":"A Trigg","year":"2021","unstructured":"Trigg, A., & Griffiths, P. (2021). Triangulation of multiple meaningful change thresholds for patient-reported outcome scores. Quality of Life Research, 30(10), 2755\u20132764. https:\/\/doi.org\/10.1007\/s11136-021-02957-4","journal-title":"Quality of Life Research"},{"key":"3895_CR31","doi-asserted-by":"publisher","unstructured":"Ren, J., Bushmakin, A. G., Cislo, P. R., Abraham, L., Cappelleri, J. C., Dworkin, R. H., & Farrar, J. T. (2023). Meaningful within-patient change for clinical outcome assessments: Model-based approach versus cumulative distribution functions. Journal of Biopharmaceutical Statistics, 1\u201313. https:\/\/doi.org\/10.1080\/10543406.2023.2281575","DOI":"10.1080\/10543406.2023.2281575"},{"issue":"1","key":"3895_CR32","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1200\/jco.2010.28.0107","volume":"29","author":"K Cocks","year":"2011","unstructured":"Cocks, K., King, M. T., Velikova, G., St-James, M., Fayers, M., P. M., & Brown, J. M. (2011). Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology, 29(1), 89\u201396. https:\/\/doi.org\/10.1200\/jco.2010.28.0107","journal-title":"Journal of Clinical Oncology"},{"issue":"1","key":"3895_CR33","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1002\/cncr.22799","volume":"110","author":"J Ringash","year":"2007","unstructured":"Ringash, J., O\u2019Sullivan, B., Bezjak, A., & Redelmeier, D. A. (2007). Interpreting clinically significant changes in patient-reported outcomes. Cancer, 110(1), 196\u2013202. https:\/\/doi.org\/10.1002\/cncr.22799","journal-title":"Cancer"},{"issue":"3","key":"3895_CR34","doi-asserted-by":"publisher","first-page":"207","DOI":"10.1023\/a:1015276414526","volume":"11","author":"D Cella","year":"2002","unstructured":"Cella, D., Hahn, E. A., & Dineen, K. (2002). Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening. Quality of Life Research, 11(3), 207\u2013221. https:\/\/doi.org\/10.1023\/a:1015276414526","journal-title":"Quality of Life Research"},{"key":"3895_CR35","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-022-03181-4","author":"K Cocks","year":"2022","unstructured":"Cocks, K., & Buchanan, J. (2022). How scoring limits the usability of minimal important differences (MIDs) as responder definition (RD): An exemplary demonstration using EORTC QLQ-C30 subscales. Quality of Life Research. https:\/\/doi.org\/10.1007\/s11136-022-03181-4","journal-title":"Quality of Life Research"},{"key":"3895_CR36","unstructured":"HCWW, V. (2011). Measurement in Medicine: A practical guide (practical guides to Biostatistics and Epidemiology) (1st edn.). Cambridge University Press."}],"container-title":["Quality of Life Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-025-03895-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11136-025-03895-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11136-025-03895-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T14:40:20Z","timestamp":1744209620000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11136-025-03895-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,23]]},"references-count":36,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["3895"],"URL":"https:\/\/doi.org\/10.1007\/s11136-025-03895-1","relation":{},"ISSN":["0962-9343","1573-2649"],"issn-type":[{"value":"0962-9343","type":"print"},{"value":"1573-2649","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,23]]},"assertion":[{"value":"8 January 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 January 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted in accordance with Good Clinical Practice and all study materials were approved by the appropriate ethics body at each participating site.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"For investigations involving human subjects, Informed consent has been obtained from the participants involved.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The manuscript does not contain any individual person\u2019s data in any form. Therefore, consent for publication was not required.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Nalin Payakachat and Adrienne M. Gilligan are employees and minor shareholders of Eli Lilly and Company. Nathan Clarke, Gill Worthy and Kim Cocks are employees of Adelphi Values, which was contracted by Eli Lilly and Company to conduct this study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}