{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T16:43:21Z","timestamp":1783010601434,"version":"3.54.6"},"reference-count":34,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T00:00:00Z","timestamp":1705881600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T00:00:00Z","timestamp":1705881600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>No specific measures exist to assess patient-reported symptoms experienced by individuals with chronic lymphocytic leukemia (CLL)\/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL). This study was conducted to elicit patient-reported CLL\/SLL- and MCL-related symptoms and their impact on patients\u2019 lives. The study qualitatively and quantitatively evaluated sets of conceptually-selected EORTC Item Library items for assessing CLL\/SLL- and MCL-related symptoms.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The qualitative component of the research included a literature review, clinician consultations, and patient interviews. Concepts important to patients were identified and coded; cognitive debriefing of the selected library items was completed with patients. CLL\/SLL and MCL-related symptoms and impacts were organized in a structured conceptual model, which was mapped to item sets from the Item Library. The quantitative component comprised exploratory macro-level Rasch measurement theory (RMT) analysis conducted to provide supportive quantitative insight on the item sets.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>41 patients (21-MCL; 20-CLL\/SLL) and 5 clinicians participated in the qualitative study; 57 unique patients (30-MCL; 27-CLL\/SLL) completed the EORTC items. The conceptual models generated from the qualitative work included symptoms and functional impacts of CLL\/SLL and MCL. Symptom domains included swollen lymph nodes, B symptoms, abdominal issues, pain, fatigue, subjective cognitive impairment, anemia-related symptoms, bleeding, infection, and other issues (appetite loss, temperature fluctuation, rash, weight gain, sleep problems, cough). Impacts included physical function, role function, and other functions (psychological, social). Cognitive debriefing demonstrated that the separate item sets for CLL\/SLL and MCL-related symptoms were well understood and aligned with patients\u2019 experiences. All selected items were included in the conceptual models. The exploratory RMT analysis showed that the item sets provided adequate coverage of the continuum of CLL\/SLL- and MCL-related symptom severity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This study gathered qualitative and early quantitative evidence supporting use of the EORTC Item Library to assess CLL\/SLL- and MCL-related symptoms and impacts. These items are promising candidates for measurement of patient-reported disease symptoms in these populations. A larger sample size will be essential to establish the psychometric properties necessary to support use in clinical trials.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Plain English summary<\/jats:title>\n                <jats:p>Patients who suffer from rare cancers of the blood, bone marrow, and lymph nodes can experience chronic and debilitating symptoms. At present, however, there are no dedicated instruments for assessing the patient\u2019s experience of symptoms of conditions like chronic lymphocytic leukemia (CLL)\/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL), or for assessing their impact on patients\u2019 lives. This research project aimed to address that need. The researchers selected relevant and clinically meaningful symptoms from the EORTC Item Library that assess fatigue, B symptoms, and CLL\/SLL- and MCL-specific symptoms. Using patients and clinician interviews as well as quantitative analyses, the research revealed no major concerns with using these item sets to assess symptoms of CLL\/SLL and MCL. Interviews with patients demonstrated that the separate item sets for CLL\/SLL and MCL-related symptoms were well understood and aligned with patients\u2019 experiences. All selected items were included in the conceptual models. Item sets identified in this study can potentially be used to assess patient-reported symptom endpoints in clinical trial settings in these disease areas.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-024-00683-2","type":"journal-article","created":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T08:03:07Z","timestamp":1705910587000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Mixed-methods research to support the use of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library"],"prefix":"10.1186","volume":"8","author":[{"given":"Jessica T.","family":"Markowitz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flora","family":"Mazerolle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teya","family":"Lovell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa M.","family":"Hess","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo B.","family":"Abada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Regnault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9526-5356","authenticated-orcid":false,"given":"Nalin","family":"Payakachat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,1,22]]},"reference":[{"issue":"16","key":"683_CR1","first-page":"3367","volume":"114","author":"JA Burger","year":"2009","unstructured":"Burger JA, Ghia P, Rosenwald A, Caligaris-Cappio F (2009) The microenvironment in mature B-cell malignancies: a target for new treatment strategies. 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All participants provided informed consent to participate in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Consent via written consent forms was obtained from patients before proceeding with the interviews.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"NP, LH, and PA are employed by Eli Lilly and Company. AR and FM are employees of Modus Outcomes, which received payment from Eli Lilly and Company to conduct this research. JM and TL were employed by Modus Outcomes at the time this research was conducted.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Editorial assistance was provided by Sara Strzok and Trais Pearson, PhD of Modus Outcomes.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Editorial assistance"}}],"article-number":"8"}}