{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T16:07:51Z","timestamp":1781626071281,"version":"3.54.5"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T00:00:00Z","timestamp":1766534400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:00:00Z","timestamp":1769472000000},"content-version":"vor","delay-in-days":34,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002702","name":"Aalborg Universitet","doi-asserted-by":"publisher","award":["Aalborg Universitet"],"award-info":[{"award-number":["Aalborg Universitet"]}],"id":[{"id":"10.13039\/501100002702","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100006304","name":"Aalborg Universitetshospital","doi-asserted-by":"publisher","award":["Aalborg Universitetshospital"],"award-info":[{"award-number":["Aalborg Universitetshospital"]}],"id":[{"id":"10.13039\/501100006304","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Acute radiation-induced diarrhoea (RID) typically develops from gut mucosa inflammation within 2 weeks of external beam radiation therapy (EBRT) to the pelvis. The Common Terminology Criteria for Adverse Events (CTCAE) commonly assesses RID. In patients with prostate cancer undergoing curative EBRT, acute RID was evaluated using both a clinician-reported outcome (ClinRO)-CTCAE, and a patient-reported (PRO) stool diary.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>During 2022\u20132024, 40 newly diagnosed patients with prostate cancer receiving curative EBRT were enrolled at the Oncology Departments in two centres. CTCAE was assessed at baseline (week 1), at end of EBRT (week 8 or 9), 2 weeks after end of EBRT (week 10 or 11), and 8 weeks after end of EBRT (week 16 or 17). Simultaneously, patients maintained a daily PRO diary from baseline to week 10, and at week 16. Patients\u2019 registration of stool frequency was converted to grades according to the CTCAE criteria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The clinicians assessed all 40 patients with RID Grade 0\/1 using CTCAE, whereas the PRO stool diary showed 29\/40 with Grade 0\/1, 6\/40 with Grade 2, and 5\/40 with Grade 3. Grade 2 appeared in week 2 and Grade 3 in week 4. There was a significant difference (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) between CTCAE and PRO grades from baseline to week 16 or 17. No correlation was observed between irradiation data and RID Grades 2\/3. Significant weight loss differences were noted from baseline to week 8 or 9 between patients with RID Grades 0\/1 and those with Grades 2\/3.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>According to the PRO stool diary, one in four patients with prostate cancer undergoing curative EBRT experienced acute RID Grade 2\/3, but none with ClinRO CTCAE. A PRO stool diary effectively monitored the onset, course of acute RID, and body weight changes. The CTCAE does not adequately assess acute RID and needs PRO stool diary supplementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>Clinicaltrials.gov, NCT05684432. Registered 5 January 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s41687-025-00957-3","type":"journal-article","created":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T09:14:55Z","timestamp":1766567695000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Patient- and clinician-reported acute radiation-induced diarrhoea in patients with prostate cancer during curative external radiation therapy: A prospective observational cohort study"],"prefix":"10.1186","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5278-2759","authenticated-orcid":false,"given":"Mette Overgaard","family":"Holm","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9245-7678","authenticated-orcid":false,"given":"Ursula","family":"Falkmer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9425-2318","authenticated-orcid":false,"given":"Randi","family":"Tobberup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3955-7266","authenticated-orcid":false,"given":"Martin Skovmos","family":"Nielsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8889-2797","authenticated-orcid":false,"given":"Bjarke","family":"Mortensen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5537-6767","authenticated-orcid":false,"given":"Rasmus Froberg","family":"Br\u00f8ndum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8314-3888","authenticated-orcid":false,"given":"Christine Vesterg\u00e5rd","family":"Madsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8951-5494","authenticated-orcid":false,"given":"Henrik H\u00f8jgaard","family":"Rasmussen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4557-0748","authenticated-orcid":false,"given":"Mette Karen","family":"Yilmaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2808-8993","authenticated-orcid":false,"given":"Jimmi","family":"S\u00f8ndergaard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1022-7260","authenticated-orcid":false,"given":"Mette","family":"Moe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0466-976X","authenticated-orcid":false,"given":"Laurids \u00d8stergaard","family":"Poulsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,12,24]]},"reference":[{"key":"957_CR1","doi-asserted-by":"publisher","first-page":"297","DOI":"10.3109\/0284186X.2013.873140","volume":"53","author":"AC Muls","year":"2014","unstructured":"Muls AC (2014) Gastrointestinal consequences of cancer treatment and the wider context: A bad gut feeling. Acta Oncol 53:297\u2013306. https:\/\/doi.org\/10.3109\/0284186X.2013.873140","journal-title":"Acta Oncol"},{"key":"957_CR2","unstructured":"World Health Organization (2024) Diarrhoeal disease. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/diarrhoeal-disease. Accessed 10 Jun 2025"},{"key":"957_CR3","doi-asserted-by":"publisher","first-page":"iv126","DOI":"10.1093\/annonc\/mdy145","volume":"29","author":"P Bossi","year":"2018","unstructured":"Bossi P, Antonuzzo A, Cherny NI et al (2018) Diarrhoea in adult cancer patients: ESMO clinical practice guidelines. Ann Oncol 29:iv126\u2013iv142. https:\/\/doi.org\/10.1093\/annonc\/mdy145","journal-title":"Ann Oncol"},{"key":"957_CR4","unstructured":"Continence Foundation of Australia (2023) Bristol stool chart. https:\/\/www.continence.org.au\/bristol-stool-chart. Accessed 10 Jun 2025"},{"key":"957_CR5","doi-asserted-by":"publisher","first-page":"920","DOI":"10.3109\/00365529709011203","volume":"32","author":"SJ Lewis","year":"1997","unstructured":"Lewis SJ, Heaton KW (1997) Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 32:920\u2013924. https:\/\/doi.org\/10.3109\/00365529709011203","journal-title":"Scand J Gastroenterol"},{"key":"957_CR6","unstructured":"National Cancer Institute (2021) Common Terminology Criteria for Adverse Events (CTCAE). In: Definitions. https:\/\/ctep.cancer.gov\/protocoldevelopment\/electronic_applications\/ctc.htm#ctc_50. Accessed 1 Jul 2025"},{"key":"957_CR7","doi-asserted-by":"publisher","unstructured":"Holm MO, Bye A, Falkmer U et al (2023) The effect of nutritional interventions in acute radiation-induced diarrhoea in patients with primary pelvic cancer: a systematic review. Crit Rev Oncol Hematol 188. https:\/\/doi.org\/10.1016\/j.critrevonc.2023.104038","DOI":"10.1016\/j.critrevonc.2023.104038"},{"key":"957_CR8","doi-asserted-by":"publisher","first-page":"1480","DOI":"10.1200\/JCO.2013.53.5948","volume":"32","author":"G Kotronoulas","year":"2014","unstructured":"Kotronoulas G, Kearney N, Maguire R et al (2014) What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol 32:1480\u20131501","journal-title":"J Clin Oncol"},{"key":"957_CR9","doi-asserted-by":"publisher","DOI":"10.1111\/ans.18510","author":"C Georges","year":"2023","unstructured":"Georges C, Yap R, Bell S et al (2023) Comparison of quality of life, symptom and functional outcomes following surgical treatment for colorectal neoplasia. ANZ J Surg. https:\/\/doi.org\/10.1111\/ans.18510","journal-title":"ANZ J Surg"},{"key":"957_CR10","doi-asserted-by":"publisher","first-page":"1668","DOI":"10.14309\/ajg.0000000000001942","volume":"117","author":"E Nordin","year":"2022","unstructured":"Nordin E, Hellstr\u00f6m PM, Brunius C, Landberg R (2022) Modest conformity between Self-Reporting of Bristol stool form and fecal consistency measured by stool water content in irritable bowel syndrome and a FODMAP and gluten trial. Am J Gastroenterol 117:1668\u20131674. https:\/\/doi.org\/10.14309\/ajg.0000000000001942","journal-title":"Am J Gastroenterol"},{"key":"957_CR11","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1136\/gut.44.1.77","volume":"44","author":"CJ Vaizey","year":"1999","unstructured":"Vaizey CJ, Carapeti E, Cahill JA, Kamm MA (1999) Prospective comparison of faecal incontinence grading systems. Gut 44:77\u201380. https:\/\/doi.org\/10.1136\/gut.44.1.77","journal-title":"Gut"},{"key":"957_CR12","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1007\/BF02050307","volume":"36","author":"JMN Jorge","year":"1993","unstructured":"Jorge JMN, Wexner SD (1993) Etiology and management of fecal incontinence. Dis Colon Rectum 36:77\u201397. https:\/\/doi.org\/10.1007\/BF02050307","journal-title":"Dis Colon Rectum"},{"key":"957_CR13","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1080\/0284186X.2021.1979246","volume":"61","author":"SE Petersen","year":"2022","unstructured":"Petersen SE, Thorsen LB, Hansen S et al (2022) A phase I\/II study of acute and late physician assessed and patient-reported morbidity following whole pelvic radiation in high-risk prostate cancer patients. Acta Oncol (Madr) 61:179\u2013184. https:\/\/doi.org\/10.1080\/0284186X.2021.1979246","journal-title":"Acta Oncol (Madr)"},{"key":"957_CR14","unstructured":"DaProCa (2023) Kurativ str\u00e5lebehandling for prostatacancer. https:\/\/www.dmcg.dk\/siteassets\/kliniske-retningslinjer---skabeloner-og-vejledninger\/kliniske-retningslinjer-opdelt-pa-dmcg\/daproca\/daproca_stralebehandling_v3.0_admgodk_061123.pdf. Accessed 10 Jun 2025"},{"key":"957_CR15","doi-asserted-by":"publisher","unstructured":"Lawton CAF, Michalski J, El-naqa I et al (2009) RTOG GU radiation oncology specialists reach consensus. 74:383\u2013387. https:\/\/doi.org\/10.1016\/j.ijrobp.2008.08.002.RTOG","DOI":"10.1016\/j.ijrobp.2008.08.002.RTOG"},{"key":"957_CR16","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jbi.2019.103208","volume":"95","author":"PA Harris","year":"2019","unstructured":"Harris PA, Taylor R, Minor BL et al (2019) The REDCap consortium: building an international community of software platform partners. J Biomed Inf 95:1\u201310. https:\/\/doi.org\/10.1016\/j.jbi.2019.103208","journal-title":"J Biomed Inf"},{"key":"957_CR17","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","volume":"42","author":"PA Harris","year":"2009","unstructured":"Harris PA, T R, R. T, et al (2009) Research electronic data capture (REDCap)\u2014A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inf 42:377\u2013381. https:\/\/doi.org\/10.1016\/j.jbi.2008.08.010","journal-title":"J Biomed Inf"},{"key":"957_CR18","doi-asserted-by":"publisher","first-page":"693","DOI":"10.1111\/apt.13746","volume":"44","author":"MR Blake","year":"2016","unstructured":"Blake MR, Raker JM, Whelan K (2016) Validity and reliability of the Bristol stool form scale in healthy adults and patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther 44:693\u2013703. https:\/\/doi.org\/10.1111\/apt.13746","journal-title":"Aliment Pharmacol Ther"},{"key":"957_CR19","doi-asserted-by":"publisher","first-page":"294","DOI":"10.1016\/j.radonc.2010.04.001","volume":"97","author":"G Halkett","year":"2010","unstructured":"Halkett G, Aoun S, Hayne D et al (2010) EORTC radiation proctitis-specific quality of life module - Pretesting in four European countries. Radiother Oncol 97:294\u2013300. https:\/\/doi.org\/10.1016\/j.radonc.2010.04.001","journal-title":"Radiother Oncol"},{"key":"957_CR20","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1177\/0148607112440285","volume":"36","author":"JV White","year":"2012","unstructured":"White JV, Guenter P, Jensen G et al (2012) Consensus statement: academy of nutrition and dietetics and American society for parenteral and enteral nutrition: characteristics recommended for the identification and Documentation of adult malnutrition (undernutrition). J Parenter Enter Nutr 36:275\u2013283. https:\/\/doi.org\/10.1177\/0148607112440285","journal-title":"J Parenter Enter Nutr"},{"key":"957_CR21","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1200\/JCO.2014.56.1894","volume":"33","author":"L Martin","year":"2015","unstructured":"Martin L, Senesse P, Gioulbasanis I et al (2015) Diagnostic criteria for the classification of cancer-associated weight loss. J Clin Oncol 33:90\u201399. https:\/\/doi.org\/10.1200\/JCO.2014.56.1894","journal-title":"J Clin Oncol"},{"key":"957_CR22","unstructured":"R Core Team (2024) _R: A Language and environment for statistical Computing_. R Foundation for Statistical Computing"},{"key":"957_CR23","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-24277-4","volume-title":"ggplot2: elegant graphics for data analysis","author":"H Wickham","year":"2016","unstructured":"Wickham H (2016) ggplot2: elegant graphics for data analysis. Springer-, New York"},{"key":"957_CR24","unstructured":"WHO GCPs (2002) Handbook for good clinical research practice (GCP): guidance for implementation"},{"key":"957_CR25","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3389\/fmed.2021.800823","volume":"8","author":"X Xiong","year":"2022","unstructured":"Xiong X, Xu H, Wang S et al (2022) Association of novel androgen receptor Axis-Targeted therapies with diarrhea in patients with prostate cancer: A bayesian network analysis. Front Med 8:1\u201310. https:\/\/doi.org\/10.3389\/fmed.2021.800823","journal-title":"Front Med"},{"key":"957_CR26","doi-asserted-by":"publisher","first-page":"639","DOI":"10.1080\/02841860601099241","volume":"46","author":"A Larsen","year":"2007","unstructured":"Larsen A, Bj\u00f8rge B, Klementsen B et al (2007) Time patterns of changes in biomarkers, symptoms and histopathology during pelvic radiotherapy. Acta Oncol (Madr) 46:639\u2013650. https:\/\/doi.org\/10.1080\/02841860601099241","journal-title":"Acta Oncol (Madr)"},{"key":"957_CR27","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1016\/j.ctro.2021.09.003","volume":"31","author":"RO Kowalchuk","year":"2021","unstructured":"Kowalchuk RO, Hillman D, Daniels TB et al (2021) Assessing concordance between patient-reported and investigator-reported CTCAE after proton beam therapy for prostate cancer. Clin Transl Radiat Oncol 31:34\u201341. https:\/\/doi.org\/10.1016\/j.ctro.2021.09.003","journal-title":"Clin Transl Radiat Oncol"},{"key":"957_CR28","first-page":"11","volume":"27","author":"DE Magee","year":"2020","unstructured":"Magee DE, Singal RK (2020) Androgen deprivation therapy: indications, methods of utilization, side effects and their management. Can J Urol 27:11\u201316","journal-title":"Can J Urol"},{"key":"957_CR29","doi-asserted-by":"publisher","unstructured":"Lawrie TA, Green JT, Beresford M et al (2018) Interventions to reduce acute and late adverse Gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers. https:\/\/doi.org\/10.1002\/14651858.CD012529.pub2. Cochrane Database Syst Rev 2018:","DOI":"10.1002\/14651858.CD012529.pub2"}],"container-title":["Journal of Patient-Reported Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s41687-025-00957-3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41687-025-00957-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41687-025-00957-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T15:42:56Z","timestamp":1781624576000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s41687-025-00957-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,24]]},"references-count":29,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["957"],"URL":"https:\/\/doi.org\/10.1186\/s41687-025-00957-3","relation":{},"ISSN":["2509-8020"],"issn-type":[{"value":"2509-8020","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,24]]},"assertion":[{"value":"16 June 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 September 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 December 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The current study was conducted in accordance with the Declaration of Helsinki, approved by the Northern Denmark Regional Ethics Committee (N-20210040), and registered in ClinicalTrials.gov (NCT05684432). All patients participating in the study provided written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors have no competing interests to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"15"}}