{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T12:02:08Z","timestamp":1779796928067,"version":"3.53.1"},"reference-count":74,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T00:00:00Z","timestamp":1774483200000},"content-version":"vor","delay-in-days":36,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"EORTC Quality of Life Group","award":["004\/2022"],"award-info":[{"award-number":["004\/2022"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Health Qual Life Outcomes"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patient-reported outcome measures (PROMs) play a crucial role in evaluating oncological interventions. Although PROMs are developed to assess the patient\u2019s health status, it remains unknown if patients\u2019 perspectives are considered when developing and validating PROMs. This review aims to describe the nature of patient involvement in PROM development and validation in oncology research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A scoping review was conducted to identify relevant articles on patient involvement in PROM development and validation in cancer research published between 1993 and 2023 using PubMed\/Medline, Embase, Scopus, and Cochrane databases, with the aim of exploring the extent and nature of patient involvement in developing and validating PROMs specifically in cancer research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Out of 1354 initially identified articles, 34 met the inclusion criteria, and included various cancer types. The majority of studies (76%) engaged patients in item development through methods such as focus groups and interviews. Patient involvement across all phases of development and validation was documented in 35% of the studies. The value of patient involvement was illustrated by the improved relevance of the PROM content, leading to the inclusion of issues that were meaningful to patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This scoping review demonstrates that even though the nature and extent of involvement varied throughout the stages of PROM development, the value of patients\u2019 voices was not in question. A potential next step could be to introduce standardized terminology and develop guidelines to enhance a consistent and effective integration of patients\u2019 input into the development of PROMs in the oncology setting.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12955-026-02500-4","type":"journal-article","created":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T04:35:46Z","timestamp":1771389346000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Incorporating patients\u2019 input in the development and validation of patient-reported outcome measures in oncology: a comprehensive scoping review"],"prefix":"10.1186","volume":"24","author":[{"given":"Iryna","family":"Shakhnenko","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shushan","family":"Hovsepyan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily I.","family":"Holthuis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Bulbeck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winette T. A.","family":"van der Graaf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Husson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,18]]},"reference":[{"issue":"12","key":"2500_CR1","doi-asserted-by":"publisher","first-page":"3358","DOI":"10.3390\/jcm11123358","volume":"11","author":"A Printza","year":"2022","unstructured":"Printza A. Patient-Reported outcome measures in diseases of the head and neck. J Clin Med. 2022;11(12):3358.","journal-title":"J Clin Med"},{"issue":"1","key":"2500_CR2","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1186\/1477-7525-4-79","volume":"4","author":"Guidance for industry","year":"2006","unstructured":"Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4(1):79.","journal-title":"Health Qual Life Outcomes"},{"issue":"1","key":"2500_CR3","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1111\/hex.12442","volume":"20","author":"B Wiering","year":"2017","unstructured":"Wiering B, de Boer D, Delnoij D. Patient involvement in the development of patient-reported outcome measures: a scoping review. Health Expect. 2017;20(1):11\u201323.","journal-title":"Health Expect"},{"issue":"9","key":"2500_CR4","doi-asserted-by":"publisher","first-page":"1129","DOI":"10.1016\/j.acra.2014.05.008","volume":"21","author":"BW Bresnahan","year":"2014","unstructured":"Bresnahan BW, Rundell SD. Including Patient-Reported outcomes and Patient-Reported Resource-Use questionnaires in studies. Acad Radiol. 2014;21(9):1129\u201337.","journal-title":"Acad Radiol"},{"key":"2500_CR5","doi-asserted-by":"crossref","unstructured":"Cella D, Hahn E, Jensen S, Butt Z, Nowinski C, Rothrock N, et al. Patient-Reported outcomes in performance measurement. RTI; 2015.","DOI":"10.3768\/rtipress.2015.bk.0014.1509"},{"issue":"4","key":"2500_CR6","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1007\/BF00434800","volume":"2","author":"MAG Sprangers","year":"1993","unstructured":"Sprangers MAG, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European organization for research and treatment of cancer approach to quality of life assessment: guidelines for developing questionnaire modules. Qual Life Res. 1993;2(4):287\u201395.","journal-title":"Qual Life Res"},{"issue":"5","key":"2500_CR7","doi-asserted-by":"publisher","first-page":"871","DOI":"10.1023\/B:QURE.0000025586.51955.78","volume":"13","author":"C Paterson","year":"2004","unstructured":"Paterson C. Seeking the patient\u2019s perspective: A qualitative assessment of EuroQol, COOP-WONCA charts and MYMOP. Qual Life Res. 2004;13(5):871\u201381.","journal-title":"Qual Life Res"},{"issue":"1","key":"2500_CR8","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1111\/hex.12997","volume":"23","author":"B Addario","year":"2020","unstructured":"Addario B, Geissler J, Horn MK, Krebs LU, Maskens D, Oliver K, et al. Including the patient voice in the development and implementation of patient-reported outcomes in cancer clinical trials. Health Expect. 2020;23(1):41\u201351.","journal-title":"Health Expect"},{"issue":"8","key":"2500_CR9","doi-asserted-by":"publisher","first-page":"1547","DOI":"10.1093\/annonc\/mdv249","volume":"26","author":"NI Cherny","year":"2015","unstructured":"Cherny NI, Sullivan R, Dafni U, Kerst JM, Sobrero A, Zielinski C, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European society for medical oncology magnitude of clinical benefit scale (ESMO-MCBS). Ann Oncol. 2015;26(8):1547\u201373.","journal-title":"Ann Oncol"},{"issue":"1","key":"2500_CR10","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1186\/s41687-022-00466-7","volume":"6","author":"K Maruszczyk","year":"2022","unstructured":"Maruszczyk K, Aiyegbusi OL, Torlinska B, Collis P, Keeley T, Calvert MJ. Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy. J Patient Rep Outcomes. 2022;6(1):57.","journal-title":"J Patient Rep Outcomes"},{"issue":"2","key":"2500_CR11","doi-asserted-by":"publisher","first-page":"e83","DOI":"10.1016\/S1470-2045(19)30790-9","volume":"21","author":"C Coens","year":"2020","unstructured":"Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M, et al. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL consortium. Lancet Oncol. 2020;21(2):e83\u201396.","journal-title":"Lancet Oncol"},{"key":"2500_CR12","volume-title":"Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products","author":"European Medicines Agency(EMA)","year":"2005","unstructured":"European Medicines Agency(EMA). Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. London: European Medicines Agency; 2005."},{"key":"2500_CR13","doi-asserted-by":"publisher","unstructured":"Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Quality of Life Research [Internet]. 2024;33(11):2929\u201339. Available from: https:\/\/doi.org\/10.1007\/s11136-024-03761-6","DOI":"10.1007\/s11136-024-03761-6"},{"key":"2500_CR14","unstructured":"Colin Johnson NAJMB. Guidelines for developing questionnaire modules. EORTC Quality of Life Group; 2011."},{"key":"2500_CR15","unstructured":"Turk A, Boylan A-M. Louise Locock. A Researcher\u2019s Guide to Patient and Public Involvement. 2017."},{"issue":"Suppl 1","key":"2500_CR16","doi-asserted-by":"publisher","first-page":"43","DOI":"10.1111\/j.1743-6109.2012.02995.x","volume":"10","author":"KE Flynn","year":"2013","unstructured":"Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, et al. Development of the NIH PROMIS \u00ae sexual function and satisfaction measures in patients with cancer. J Sex Med. 2013;10(Suppl 1):43\u201352.","journal-title":"J Sex Med"},{"issue":"4","key":"2500_CR17","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1177\/1744987109106811","volume":"14","author":"S Staniszewska","year":"2009","unstructured":"Staniszewska S. Patient and public involvement in health services and health research: A brief overview of evidence, policy and activity. J Res Nurs. 2009;14(4):295\u20138.","journal-title":"J Res Nurs"},{"key":"2500_CR18","doi-asserted-by":"crossref","unstructured":"Dahl LT, Walker JD, Schull M, Paprica PA, McDonald JT, Gavin F, et al. The SPOR-Canadian data platform: a National initiative to facilitate data rich multi-jurisdictional research. Int J Popul Data Sci. 2020;5(1).","DOI":"10.23889\/ijpds.v5i1.1374"},{"issue":"2","key":"2500_CR19","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1370\/afm.2042","volume":"15","author":"S Sheridan","year":"2017","unstructured":"Sheridan S, Schrandt S, Forsythe L, Hilliard TS, Paez KA. The PCORI engagement rubric: promising practices for partnering in research. Annals Family Med. 2017;15(2):165\u201370.","journal-title":"Annals Family Med"},{"key":"2500_CR20","doi-asserted-by":"crossref","unstructured":"Eton D, Elraiyah TA, Yost K, Ridgeway J, Johnson A, Egginton J, et al. A systematic review of patient-reported measures of burden of treatment in three chronic diseases. Patient Relat Outcome Meas. 2013;7.","DOI":"10.2147\/PROM.S44694"},{"issue":"5","key":"2500_CR21","doi-asserted-by":"publisher","first-page":"e002241","DOI":"10.1136\/bmjopen-2012-002241","volume":"3","author":"M de Wit","year":"2013","unstructured":"de Wit M, Abma T, Koelewijn-van Loon M, Collins S, Kirwan J. Involving patient research partners has a significant impact on outcomes research: a responsive evaluation of the international OMERACT conferences. BMJ Open. 2013;3(5):e002241.","journal-title":"BMJ Open"},{"issue":"5","key":"2500_CR22","doi-asserted-by":"publisher","first-page":"413","DOI":"10.1111\/j.1399-0004.2011.01636.x","volume":"79","author":"M McAllister","year":"2011","unstructured":"McAllister M, Wood A, Dunn G, Shiloh S, Todd C. The genetic counseling outcome scale: a new patient-reported outcome measure for clinical genetics services. Clin Genet. 2011;79(5):413\u201324.","journal-title":"Clin Genet"},{"issue":"1","key":"2500_CR23","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1186\/1477-7525-7-83","volume":"7","author":"M Brod","year":"2009","unstructured":"Brod M, Hammer M, Christensen T, Lessard S, Bushnell DM. Understanding and assessing the impact of treatment in diabetes: the Treatment-Related impact measures for diabetes and devices (TRIM-Diabetes and TRIM-Diabetes Device). Health Qual Life Outcomes. 2009;7(1):83.","journal-title":"Health Qual Life Outcomes"},{"issue":"1","key":"2500_CR24","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1002\/j.1550-8528.1995.tb00120.x","volume":"3","author":"RL Kolotkin","year":"1995","unstructured":"Kolotkin RL, Head S, Hamilton M, Tse CJ. Assessing impact of weight on quality of life. Obes Res. 1995;3(1):49\u201356.","journal-title":"Obes Res"},{"issue":"4","key":"2500_CR25","first-page":"313","volume":"19","author":"EJ Neff","year":"1990","unstructured":"Neff EJ, Dale JC. Assessment of quality of life in school-aged children: a method\u2013phase I. Matern Child Nurs J. 1990;19(4):313\u201320.","journal-title":"Matern Child Nurs J"},{"issue":"5","key":"2500_CR26","doi-asserted-by":"publisher","first-page":"1018","DOI":"10.1016\/j.ejca.2012.09.021","volume":"49","author":"HJ Thomson","year":"2013","unstructured":"Thomson HJ, Winters ZE, Brandberg Y, Didier F, Blazeby JM, Mills J. The early development phases of a European organisation for research and treatment of cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction. Eur J Cancer. 2013;49(5):1018\u201326.","journal-title":"Eur J Cancer"},{"issue":"7","key":"2500_CR27","doi-asserted-by":"publisher","first-page":"e1000097","DOI":"10.1371\/journal.pmed.1000097","volume":"6","author":"D Moher","year":"2009","unstructured":"Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and Meta-Analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.","journal-title":"PLoS Med"},{"key":"2500_CR28","doi-asserted-by":"publisher","unstructured":"PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med [Internet]. 2018;169(7):467\u201373. Available from: https:\/\/doi.org\/10.7326\/M18-0850","DOI":"10.7326\/M18-0850"},{"issue":"Suppl 5","key":"2500_CR29","doi-asserted-by":"publisher","first-page":"S59","DOI":"10.1097\/MLR.0000000000001085","volume":"57","author":"K Absolom","year":"2019","unstructured":"Absolom K, Gibson A, Velikova G. Engaging patients and clinicians in online reporting of adverse effects during chemotherapy for cancer: the eRAPID system (Electronic patient Self-Reporting of adverse events: patient information and aDvice). Med Care. 2019;57(Suppl 5):S59\u201365.","journal-title":"Med Care"},{"issue":"8","key":"2500_CR30","doi-asserted-by":"publisher","first-page":"2253","DOI":"10.1007\/s11136-020-02483-9","volume":"29","author":"NB Eskildsen","year":"2020","unstructured":"Eskildsen NB, Ross L, Bulsara C, Dietz SM, Thomsen TG, Groenvold M, et al. Development and content validation of a questionnaire measuring patient empowerment in cancer follow-up. Qual Life Res. 2020;29(8):2253\u201374.","journal-title":"Qual Life Res"},{"issue":"6","key":"2500_CR31","doi-asserted-by":"publisher","first-page":"1024","DOI":"10.1016\/j.euf.2023.05.006","volume":"9","author":"LDF Venderbos","year":"2023","unstructured":"Venderbos LDF, Remmers S, Deschamps A, Dowling J, Carl EG, Pereira-Azevedo N, et al. The Europa Uomo patient reported outcome study 2.0-Prostate cancer patient-reported outcomes to support treatment Decision-making. Eur Urol Focus. 2023;9(6):1024\u201336.","journal-title":"Eur Urol Focus"},{"key":"2500_CR32","doi-asserted-by":"publisher","first-page":"e41354","DOI":"10.2196\/41354","volume":"7","author":"SJ Sohl","year":"2023","unstructured":"Sohl SJ, Duncan PW, Thakur E, Puccinelli-Ortega N, Salsman JM, Russell G, et al. Adaptation of a personalized electronic care planning tool for cancer Follow-up care: formative study. JMIR Form Res. 2023;7:e41354.","journal-title":"JMIR Form Res"},{"issue":"4","key":"2500_CR33","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1007\/BF00434800","volume":"2","author":"MA Sprangers","year":"1993","unstructured":"Sprangers MA, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European organization for research and treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC study group on quality of life. Qual Life Res. 1993;2(4):287\u201395.","journal-title":"Qual Life Res"},{"issue":"4","key":"2500_CR34","doi-asserted-by":"publisher","first-page":"219","DOI":"10.1136\/qshc.8.4.219","volume":"8","author":"J Hearn","year":"1999","unstructured":"Hearn J, Higginson IJ. Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Palliative care core audit project advisory group. Qual Health Care. 1999;8(4):219\u201327.","journal-title":"Qual Health Care"},{"issue":"2","key":"2500_CR35","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1001\/jamadermatol.2013.5870","volume":"150","author":"SD Mathias","year":"2014","unstructured":"Mathias SD, Chren MM, Colwell HH, Yim YM, Reyes C, Chen DM, et al. Assessing health-related quality of life for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome: development of the first disease-specific patient-reported outcome questionnaires. JAMA Dermatol. 2014;150(2):169\u201376.","journal-title":"JAMA Dermatol"},{"issue":"5","key":"2500_CR36","doi-asserted-by":"publisher","first-page":"1018","DOI":"10.1016\/j.ejca.2012.09.021","volume":"49","author":"HJ Thomson","year":"2013","unstructured":"Thomson HJ, Winters ZE, Brandberg Y, Didier F, Blazeby JM, Mills J. The early development phases of a European organisation for research and treatment of cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction. Eur J Cancer. 2013;49(5):1018\u201326.","journal-title":"Eur J Cancer"},{"key":"2500_CR37","doi-asserted-by":"crossref","unstructured":"Glaser AW, Fraser LK, Corner J, Feltbower R, Morris EJA, Hartwell G, et al. Patient-reported outcomes of cancer survivors in England 1\u20135 years after diagnosis: a cross-sectional survey. BMJ Open. 2013;3(4).","DOI":"10.1136\/bmjopen-2012-002317"},{"issue":"8","key":"2500_CR38","doi-asserted-by":"publisher","first-page":"966","DOI":"10.1016\/S0959-8049(00)00417-2","volume":"37","author":"CW Vickery","year":"2001","unstructured":"Vickery CW, Blazeby JM, Conroy T, Arraras J, Sezer O, Koller M, et al. Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer. Eur J Cancer. 2001;37(8):966\u201371.","journal-title":"Eur J Cancer"},{"key":"2500_CR39","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1186\/1477-7525-2-8","volume":"2","author":"K Mystakidou","year":"2004","unstructured":"Mystakidou K, Tsilika E, Kouloulias V, Parpa E, Katsouda E, Kouvaris J, et al. The palliative care quality of life instrument (PQLI) in terminal cancer patients. Health Qual Life Outcomes. 2004;2:8.","journal-title":"Health Qual Life Outcomes"},{"issue":"1","key":"2500_CR40","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1016\/j.bjps.2005.04.060","volume":"59","author":"SJ Cano","year":"2006","unstructured":"Cano SJ, Browne JP, Lamping DL, Roberts AHN, McGrouther DA, Black NA. The patient outcomes of Surgery-Head\/Neck (POS-head\/neck): a new patient-based outcome measure. J Plast Reconstr Aesthet Surg. 2006;59(1):65\u201373.","journal-title":"J Plast Reconstr Aesthet Surg"},{"issue":"10","key":"2500_CR41","doi-asserted-by":"publisher","first-page":"1092","DOI":"10.3736\/jcim20121005","volume":"10","author":"Xu-dongT Ping Wang","year":"2012","unstructured":"Ping Wang Xu-dongT. Bao-yan Liu M Jie Z. Development of a patient-reported outcome instrument for chronic Gastrointestinal diseases: item selection. J Chin Integr Med. 2012;10(10):1092\u20138.","journal-title":"J Chin Integr Med"},{"key":"2500_CR42","unstructured":"Guidelines EORTC. Module Development, 5th Edition. Quality of Life Group [Internet]. 2021; Available from: Module-Guidelines-Version-5-FINAL.pdf."},{"issue":"6","key":"2500_CR43","doi-asserted-by":"publisher","first-page":"452","DOI":"10.1111\/coa.12036","volume":"37","author":"R Govender","year":"2012","unstructured":"Govender R, Lee MT, Davies TC, Twinn CE, Katsoulis KL, Payten CL, et al. Development and preliminary validation of a patient-reported outcome measure for swallowing after total laryngectomy (SOAL questionnaire). Clin Otolaryngol. 2012;37(6):452\u20139.","journal-title":"Clin Otolaryngol"},{"issue":"7","key":"2500_CR44","doi-asserted-by":"publisher","first-page":"430","DOI":"10.1055\/a-0740-8480","volume":"144","author":"S Wagner","year":"2019","unstructured":"Wagner S, Serve H. [Digital medicine in oncology: clinical decision Support, real world data and patient Involvement]. Dtsch Med Wochenschr. 2019;144(7):430\u20134.","journal-title":"Dtsch Med Wochenschr"},{"issue":"6","key":"2500_CR45","doi-asserted-by":"publisher","first-page":"E489","DOI":"10.1188\/12.ONF.E489-E498","volume":"39","author":"B Senn","year":"2012","unstructured":"Senn B, Mueller MD, Hasenburg A, Blankenstein T, Kammermann B, Hartmann A, et al. Development of a postsurgical patient-reported outcome instrument for women with vulvar neoplasia. Oncol Nurs Forum. 2012;39(6):E489\u201398.","journal-title":"Oncol Nurs Forum"},{"issue":"4","key":"2500_CR46","doi-asserted-by":"publisher","first-page":"371","DOI":"10.1002\/bjs.9397","volume":"101","author":"ZE Winters","year":"2014","unstructured":"Winters ZE, Balta V, Thomson HJ, Brandberg Y, Oberguggenberger A, Sinove Y, et al. Phase III development of the European organization for research and treatment of cancer quality of life questionnaire module for women undergoing breast reconstruction. Br J Surg. 2014;101(4):371\u201382.","journal-title":"Br J Surg"},{"issue":"6","key":"2500_CR47","doi-asserted-by":"publisher","first-page":"837","DOI":"10.1016\/j.jpainsymman.2013.02.007","volume":"46","author":"LA Williams","year":"2013","unstructured":"Williams LA, Agarwal S, Bodurka DC, Saleeba AK, Sun CC, Cleeland CS. Capturing the patient\u2019s experience: using qualitative methods to develop a measure of patient-reported symptom burden: an example from ovarian cancer. J Pain Symptom Manage. 2013;46(6):837\u201345.","journal-title":"J Pain Symptom Manage"},{"issue":"1","key":"2500_CR48","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1016\/j.ijrobp.2018.04.048","volume":"102","author":"KA Sandler","year":"2018","unstructured":"Sandler KA, Mitchell SA, Basch E, Raldow AC, Steinberg ML, Sharif J, et al. Content validity of anatomic Site-Specific Patient-Reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) item sets for assessment of acute symptomatic toxicities in radiation oncology. Int J Radiat Oncol Biol Phys. 2018;102(1):44\u201352.","journal-title":"Int J Radiat Oncol Biol Phys"},{"issue":"11","key":"2500_CR49","doi-asserted-by":"publisher","first-page":"2929","DOI":"10.1007\/s11136-019-02233-6","volume":"28","author":"JM Herman","year":"2019","unstructured":"Herman JM, Kitchen H, Degboe A, Aldhouse NVJ, Trigg A, Hodgin M, et al. Exploring the patient experience of locally advanced or metastatic pancreatic cancer to inform patient-reported outcomes assessment. Qual Life Res. 2019;28(11):2929\u201339.","journal-title":"Qual Life Res"},{"issue":"10","key":"2500_CR50","doi-asserted-by":"publisher","first-page":"e049128","DOI":"10.1136\/bmjopen-2021-049128","volume":"11","author":"S Riva","year":"2021","unstructured":"Riva S, Arenare L, Di Maio M, Efficace F, Montesarchio V, Frontini L, et al. Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system. BMJ Open. 2021;11(10):e049128.","journal-title":"BMJ Open"},{"key":"2500_CR51","doi-asserted-by":"publisher","unstructured":"Brunelli C, Borreani C, Caraceni A, et al. PATIENT VOICES, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study. Health Qual Life Outcomes [Internet]. 2020;18:252. Available from: https:\/\/doi.org\/10.1186\/s12955-020-01501-1","DOI":"10.1186\/s12955-020-01501-1"},{"key":"2500_CR52","doi-asserted-by":"publisher","unstructured":"van Janse HJ, Liu Z, Watson GA, Veitch ZW, Shepshelovich D, Spreafico A, et al. A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events. Br J Cancer [Internet]. 2023;129(4):612\u20139. Available from: https:\/\/doi.org\/10.1038\/s41416-023-02307-w","DOI":"10.1038\/s41416-023-02307-w"},{"issue":"7","key":"2500_CR53","doi-asserted-by":"publisher","first-page":"1178","DOI":"10.1097\/01.MLG.0000166177.98414.5E","volume":"115","author":"JS Rhee","year":"2005","unstructured":"Rhee JS, Matthews BA, Neuburg M, Burzynski M, Nattinger AB. Creation of a quality of life instrument for nonmelanoma skin cancer patients. Laryngoscope. 2005;115(7):1178\u201385.","journal-title":"Laryngoscope"},{"key":"2500_CR54","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1186\/1477-7525-5-29","volume":"5","author":"G Rodrigues","year":"2007","unstructured":"Rodrigues G, Bauman G, Lock M, D\u2019Souza D, Mahon J. Psychometric properties of a prostate cancer radiation late toxicity questionnaire. Health Qual Life Outcomes. 2007;5:29.","journal-title":"Health Qual Life Outcomes"},{"key":"2500_CR55","doi-asserted-by":"publisher","first-page":"105701","DOI":"10.1016\/j.oraloncology.2021.105701","volume":"125","author":"AI Mendez","year":"2022","unstructured":"Mendez AI, Wihlidal JGJ, Eurich DT, Nichols AC, MacNeil SD, Seikaly HR. Validity of functional patient-reported outcomes in head and neck oncology: a systematic review. Oral Oncol. 2022;125:105701.","journal-title":"Oral Oncol"},{"issue":"3","key":"2500_CR56","doi-asserted-by":"publisher","first-page":"570","DOI":"10.1200\/JCO.1993.11.3.570","volume":"11","author":"DF Cella","year":"1993","unstructured":"Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11(3):570\u20139.","journal-title":"J Clin Oncol"},{"issue":"2","key":"2500_CR57","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1016\/j.jpainsymman.2008.01.011","volume":"37","author":"JL Helbostad","year":"2009","unstructured":"Helbostad JL, H\u00f8len JC, Jordh\u00f8y MS, Ringdal GI, Oldervoll L, Kaasa S. A first step in the development of an international self-report instrument for physical functioning in palliative cancer care: a systematic literature review and an expert opinion evaluation study. J Pain Symptom Manage. 2009;37(2):196\u2013205.","journal-title":"J Pain Symptom Manage"},{"issue":"1","key":"2500_CR58","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1007\/s11136-013-0470-1","volume":"23","author":"JL Hay","year":"2014","unstructured":"Hay JL, Atkinson TM, Reeve BB, Mitchell SA, Mendoza TR, Willis G, et al. Cognitive interviewing of the US National cancer institute\u2019s Patient-Reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Qual Life Res. 2014;23(1):257\u201369.","journal-title":"Qual Life Res"},{"key":"2500_CR59","doi-asserted-by":"publisher","first-page":"e43210","DOI":"10.2196\/43210","volume":"7","author":"DMJ Delnoij","year":"2023","unstructured":"Delnoij DMJ, Derks M, Koolen L, Shekary S, Suitela J. Using patient blogs on social media to assess the content validity of patient-Reported outcome measures: qualitative analysis of patient-Written blogs. JMIR Form Res. 2023;7:e43210.","journal-title":"JMIR Form Res"},{"issue":"3","key":"2500_CR60","doi-asserted-by":"publisher","first-page":"695","DOI":"10.1016\/S0360-3016(01)01512-7","volume":"50","author":"A Eisbruch","year":"2001","unstructured":"Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50(3):695\u2013704.","journal-title":"Int J Radiat Oncol Biol Phys"},{"issue":"5","key":"2500_CR61","doi-asserted-by":"publisher","first-page":"314","DOI":"10.1001\/archfaci.8.5.314","volume":"8","author":"JS Rhee","year":"2006","unstructured":"Rhee JS, Matthews BA, Neuburg M, Logan BR, Burzynski M, Nattinger AB. Validation of a quality-of-life instrument for patients with nonmelanoma skin cancer. Arch Facial Plast Surg. 2006;8(5):314\u20138.","journal-title":"Arch Facial Plast Surg"},{"issue":"2","key":"2500_CR62","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1001\/jamadermatol.2013.5870","volume":"150","author":"SD Mathias","year":"2014","unstructured":"Mathias SD, Chren MM, Colwell HH, Yim YM, Reyes C, Chen DM, et al. Assessing Health-Related quality of life for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. JAMA Dermatol. 2014;150(2):169.","journal-title":"JAMA Dermatol"},{"issue":"4","key":"2500_CR63","doi-asserted-by":"publisher","first-page":"371","DOI":"10.1002\/bjs.9397","volume":"101","author":"ZE Winters","year":"2014","unstructured":"Winters ZE, Balta V, Thomson HJ, Brandberg Y, Oberguggenberger A, Sinove Y, et al. Phase III development of the European organization for research and treatment of cancer quality of life questionnaire module for women undergoing breast reconstruction. Br J Surg. 2014;101(4):371\u201382.","journal-title":"Br J Surg"},{"issue":"4","key":"2500_CR64","doi-asserted-by":"publisher","first-page":"e002317","DOI":"10.1136\/bmjopen-2012-002317","volume":"3","author":"AW Glaser","year":"2013","unstructured":"Glaser AW, Fraser LK, Corner J, Feltbower R, Morris EJA, Hartwell G, et al. Patient-reported outcomes of cancer survivors in England 1\u20135\u2005years after diagnosis: a cross-sectional survey. BMJ Open. 2013;3(4):e002317.","journal-title":"BMJ Open"},{"issue":"8","key":"2500_CR65","doi-asserted-by":"publisher","first-page":"966","DOI":"10.1016\/S0959-8049(00)00417-2","volume":"37","author":"CW Vickery","year":"2001","unstructured":"Vickery CW, Blazeby JM, Conroy T, Arraras J, Sezer O, Koller M, et al. Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer. Eur J Cancer. 2001;37(8):966\u201371.","journal-title":"Eur J Cancer"},{"key":"2500_CR66","doi-asserted-by":"crossref","unstructured":"Wu CC, Wang JH, Chang MC, Chen YH, Wang YC, Lee MH et al. Shared decision-making and patient decision aids in choosing first-line targeted therapy for metastatic colorectal cancer in Taiwan. J Oncol Pharm Pract [Internet]. 2022;28(6):1293\u2013302. Available from: http:\/\/ovidsp.ovid.com\/ovidweb.cgi?T=JS%26PAGE=reference%26D=med21%26NEWS=N%26AN=34060351","DOI":"10.1177\/10781552211020806"},{"issue":"2","key":"2500_CR67","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1016\/j.jpainsymman.2008.01.011","volume":"37","author":"JL Helbostad","year":"2009","unstructured":"Helbostad JL, H\u00f8len JC, Jordh\u00f8y MS, Ringdal GI, Oldervoll L, Kaasa S. A first step in the development of an international Self-Report instrument for physical functioning in palliative cancer care: A systematic literature review and an expert opinion evaluation study. J Pain Symptom Manage. 2009;37(2):196\u2013205.","journal-title":"J Pain Symptom Manage"},{"issue":"1","key":"2500_CR68","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1186\/1477-7525-2-8","volume":"2","author":"K Mystakidou","year":"2004","unstructured":"Mystakidou K, Tsilika E, Kouloulias V, Parpa E, Katsouda E, Kouvaris J, et al. The palliative care quality of life instrument (PQLI) in terminal cancer patients. Health Qual Life Outcomes. 2004;2(1):8.","journal-title":"Health Qual Life Outcomes"},{"issue":"3","key":"2500_CR69","doi-asserted-by":"publisher","first-page":"570","DOI":"10.1200\/JCO.1993.11.3.570","volume":"11","author":"DF Cella","year":"1993","unstructured":"Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11(3):570\u20139.","journal-title":"J Clin Oncol"},{"key":"2500_CR70","doi-asserted-by":"crossref","unstructured":"Williams LA, Agarwal S, Bodurka DC, Saleeba AK, Sun CC, Cleeland CS. Capturing the patient\u2019s experience: using qualitative methods to develop a measure of patient-reported symptom burden: an example from ovarian cancer. J Pain Symptom Manage [Internet]. 2013;46(6):837\u201345. Available from: http:\/\/ovidsp.ovid.com\/ovidweb.cgi?T=JS%26PAGE=reference%26D=med10%26NEWS=N%26AN=23615044","DOI":"10.1016\/j.jpainsymman.2013.02.007"},{"issue":"5","key":"2500_CR71","doi-asserted-by":"publisher","first-page":"698","DOI":"10.1177\/1049732304273903","volume":"15","author":"K Nunkoosing","year":"2005","unstructured":"Nunkoosing K. The problems with interviews. Qual Health Res. 2005;15(5):698\u2013706.","journal-title":"Qual Health Res"},{"issue":"6","key":"2500_CR72","doi-asserted-by":"publisher","first-page":"452","DOI":"10.1111\/coa.12036","volume":"37","author":"R Govender","year":"2012","unstructured":"Govender R, Lee MT, Davies TC, Twinn CE, Katsoulis KL, Payten CL, et al. Development and preliminary validation of a patient-reported outcome measure for swallowing after total laryngectomy (SOAL questionnaire). Clin Otolaryngol. 2012;37(6):452\u20139.","journal-title":"Clin Otolaryngol"},{"key":"2500_CR73","doi-asserted-by":"publisher","first-page":"e43210","DOI":"10.2196\/43210","volume":"7","author":"DMJ Delnoij","year":"2023","unstructured":"Delnoij DMJ, Derks M, Koolen L, Shekary S, Suitela J. Using patient blogs on social media to assess the content validity of patient-Reported outcome measures: qualitative analysis of patient-Written blogs. JMIR Form Res. 2023;7:e43210.","journal-title":"JMIR Form Res"},{"key":"2500_CR74","unstructured":"European Joint Programme on Rare Diseases. Short guide on patient partnerships in rare disease research projects [Internet]. 2020. Available from: https:\/\/www.ejprarediseases.org\/our-actions-and-services\/patients-in-research\/"}],"container-title":["Health and Quality of Life Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12955-026-02500-4","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12955-026-02500-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12955-026-02500-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T11:02:40Z","timestamp":1779793360000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s12955-026-02500-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,18]]},"references-count":74,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["2500"],"URL":"https:\/\/doi.org\/10.1186\/s12955-026-02500-4","relation":{},"ISSN":["1477-7525"],"issn-type":[{"value":"1477-7525","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,18]]},"assertion":[{"value":"16 July 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 February 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 February 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Human ethics and consent to participate"}},{"value":"This project was approved by the Project and Module Development Committee and the Executive Committee of the EORTC Quality of Life Group.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Approval committee"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"40"}}