{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T18:47:59Z","timestamp":1790362079629,"version":"4.1.0"},"reference-count":43,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T00:00:00Z","timestamp":1733356800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Elterninitiative krebskranker Kinder e.V."},{"name":"Tigerauge: Initiative Kinderhospiz Nordbayern e.V."}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objective<\/jats:title>\n<jats:p>Oral antitumour therapeutics (OAT) are increasingly used due to improvements in outcomes and their convenient application. However, complex intake regimens pose several challenges. The randomised AMBORA trial (Medication Safety With Oral Antitumour Drugs) demonstrated highly positive outcomes of a clinical pharmacological\/pharmaceutical care program for adults treated with numerous OAT, but comparable concepts in paediatrics are lacking so far.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>We used a parallel mixed-methods approach to develop a tailored pharmacological\/pharmaceutical care program for OAT in paediatrics (youngAMBORA). We combined a quantitative analysis of tumour entities and used OAT in a paediatric cancer centre with a qualitative survey for patients, caregivers, and healthcare professionals to identify particular demands and educational needs (e.g., application problems, side effects).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Leukaemia (77\/315) and antimetabolites (95\/151) were the most frequently observed entity and OAT, respectively. Of 22 surveyed patients, 81.8% wanted to be involved in oral medication education. Compared to caregivers, significantly more healthcare professionals graded the three most common application problems to be challenging (\u2018<jats:italic>Smell\/taste\u2019<\/jats:italic>: 32\/36 vs. 23\/42, <jats:italic>p<\/jats:italic> = 0.001; <jats:italic>\u2018Refusal of intake\u2019<\/jats:italic>: 31\/36 vs. 16\/42, <jats:italic>p<\/jats:italic>&lt;0.001; \u2018<jats:italic>Swallowing problems\u2019<\/jats:italic>: 28\/36 vs. 21\/42, <jats:italic>p<\/jats:italic> = 0.011). We identified nine relevant side effects, of which two <jats:italic>(\u2018Skin dryness\u2019<\/jats:italic>, <jats:italic>\u2018Taste changes\u2019<\/jats:italic>) were not included in 15 previously published core side effects of the Common Terminology Criteria of Adverse Events (CTCAE) item library.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Based on the present findings, the tailored youngAMBORA care program will include: 1) counselling sessions for classic and targeted OAT, 2) child-friendly support with drug application, and 3) systematic evaluation of 17 relevant side effects from patients\u2019 and caregivers\u2019 points of view including age-appropriate information material.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0315077","type":"journal-article","created":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T19:15:05Z","timestamp":1733426105000},"page":"e0315077","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":3,"title":["Medication safety with oral antitumour therapeutics in paediatrics (youngAMBORA): A mixed-methods approach towards a tailored care 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Netw"},{"issue":"19","key":"pone.0315077.ref005","doi-asserted-by":"crossref","first-page":"3922","DOI":"10.1200\/JCO.2004.01.077","article-title":"Inpatient versus outpatient management of low-risk pediatric febrile neutropenia: Measuring parents\u2019 and healthcare professionals\u2019 preferences.","volume":"22","author":"L Sung","year":"2004","journal-title":"J Clin Oncol"},{"issue":"6","key":"pone.0315077.ref006","doi-asserted-by":"crossref","first-page":"821","DOI":"10.1081\/CNV-120025084","article-title":"Health-related quality of life in patients with advanced metastatic melanoma: Results of a randomized phase III study comparing temozolomide with dacarbazine","volume":"21","author":"GM Kiebert","year":"2003","journal-title":"Cancer Invest"},{"issue":"9","key":"pone.0315077.ref007","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1007\/s10434-000-0674-9","article-title":"A prospective randomized trial comparing intravenous 5-fluorouracil and oral doxifluridine as postoperative adjuvant treatment for advanced rectal cancer","volume":"7","author":"JS Min","year":"2000","journal-title":"Ann Surg Oncol"},{"issue":"46","key":"pone.0315077.ref008","first-page":"775","article-title":"New oral anti-cancer drugs and medication safety.","volume":"116","author":"K Schlichtig","year":"2019","journal-title":"Dtsch Arztebl Int."},{"issue":"4","key":"pone.0315077.ref009","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1016\/j.ejon.2010.10.007","article-title":"Parents\u2019 views on information in childhood cancer care","volume":"15","author":"A K\u00e4stel","year":"2011","journal-title":"Eur J Oncol Nurs"},{"issue":"2","key":"pone.0315077.ref010","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1177\/1043454218820906","article-title":"Education milestones for newly diagnosed pediatric, adolescent, and young adult cancer patients: A quality improvement initiative","volume":"36","author":"S Dobrozsi","year":"2019","journal-title":"J Pediatr 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cancer: Reliability and validity of the Pediatric Quality of Life Inventory generic core scales, multidimensional fatigue scale, and cancer module","volume":"94","author":"JW Varni","year":"2002","journal-title":"Cancer"},{"issue":"1","key":"pone.0315077.ref017","doi-asserted-by":"crossref","first-page":"1271","DOI":"10.1186\/s12889-023-15937-9","article-title":"A review of reviews exploring patient and public involvement in population health research and development of tools containing best practice guidance","volume":"23","author":"S Vinnicombe","year":"2023","journal-title":"BMC Public Health"},{"key":"pone.0315077.ref018","article-title":"Pediatric module of Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE\u00ae) measurement system, item library","author":"National Cancer 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A pilot study.","volume":"23","author":"J Zimmer","year":"2016","journal-title":"Eur J Hosp Pharm."},{"issue":"10","key":"pone.0315077.ref022","first-page":"1656","article-title":"Improving pharmacist-led pediatric patient education on oral chemotherapy at home.","volume":"10","author":"A Patel","year":"2023","journal-title":"Children (Basel)."},{"key":"pone.0315077.ref023","author":"Pharmaceutical Care Network Europe Association","journal-title":"Classification for drug related problems, V9.1."},{"issue":"9","key":"pone.0315077.ref024","doi-asserted-by":"crossref","first-page":"1006","DOI":"10.1002\/pds.1423","article-title":"Reliability evaluation of the adapted national coordinating council medication error reporting and prevention (NCC MERP) index.","volume":"16","author":"RA Snyder","year":"2007","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"8","key":"pone.0315077.ref025","doi-asserted-by":"crossref","first-page":"1176","DOI":"10.1111\/j.1524-4733.2009.00575.x","article-title":"Psychometric properties of a german version of the \"Satisfaction with Information about Medicines Scale\" (SIMS-D).","volume":"12","author":"C Mahler","year":"2009","journal-title":"Value Health"},{"issue":"3","key":"pone.0315077.ref026","doi-asserted-by":"crossref","first-page":"574","DOI":"10.1111\/j.1365-2753.2009.01169.x","article-title":"Assessing reported adherence to pharmacological treatment recommendations. Translation and evaluation of the Medication Adherence Report Scale (MARS) in Germany.","volume":"16","author":"C Mahler","year":"2010","journal-title":"J Eval Clin Pract"},{"issue":"1","key":"pone.0315077.ref027","doi-asserted-by":"crossref","first-page":"81","DOI":"10.6004\/jnccn.2020.0001","article-title":"Pediatric acute lymphoblastic leukemia, version 2.2020, NCCN clinical practice guidelines in oncology.","volume":"18","author":"P Brown","year":"2020","journal-title":"J Natl Compr Canc Netw."},{"issue":"14","key":"pone.0315077.ref028","doi-asserted-by":"crossref","first-page":"3531","DOI":"10.3390\/cancers13143531","article-title":"Pursuing precision: Receptor tyrosine kinase inhibitors for treatment of pediatric solid tumors","volume":"13","author":"AJ Bellantoni","year":"2021","journal-title":"Cancers (Basel)."},{"issue":"1","key":"pone.0315077.ref029","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1007\/s12672-023-00658-7","article-title":"Modern treatment strategies in pediatric oncology and hematology","volume":"14","author":"K Adamczewska-Wawrzynowicz","year":"2023","journal-title":"Discov Oncol"},{"issue":"5","key":"pone.0315077.ref030","doi-asserted-by":"crossref","first-page":"2161","DOI":"10.1007\/s00431-022-04419-6","article-title":"Drug-handling problems and expectations of the ideal pediatric drug-reported by children and their parents","volume":"181","author":"B Herziger","year":"2022","journal-title":"Eur J Pediatr"},{"issue":"4","key":"pone.0315077.ref031","doi-asserted-by":"crossref","first-page":"818","DOI":"10.1177\/10781552221080445","article-title":"Improved home management of oral pediatric anticancer drugs as a result of an intervention comprising practical training, written instructions and movie clips: A pilot study.","volume":"29","author":"R Akkawi El Edelbi","year":"2023","journal-title":"J Oncol Pharm 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AALL03N1","volume":"127","author":"AL Hoppmann","year":"2021","journal-title":"Cancer"},{"issue":"6","key":"pone.0315077.ref035","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1136\/ejhpharm-2013-000396","article-title":"Optimising medicines for children: Considerations for clinical pharmacists.","volume":"21","author":"CE Benn","year":"2014","journal-title":"Eur J Hosp Pharm"},{"key":"pone.0315077.ref036","first-page":"100272","article-title":"Pharmacist and child communication: A phenomenological multidisciplinary study from the perspectives of undergraduate students in pharmacy and child development","volume":"10","author":"I Fedai Kayin","year":"2023","journal-title":"Explor Res Clin Soc Pharm"},{"issue":"9","key":"pone.0315077.ref037","doi-asserted-by":"crossref","first-page":"900","DOI":"10.1136\/archdischild-2018-316511","article-title":"Children\u2019s views on taking medicines and participating in clinical trials","volume":"104","author":"S Nordenmalm","year":"2019","journal-title":"Arch Dis Child"},{"issue":"1","key":"pone.0315077.ref038","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.pedneo.2012.10.002","article-title":"Effectiveness of education programs about oral antibiotic suspensions in pediatric outpatient services.","volume":"54","author":"H Hu","year":"2013","journal-title":"Pediatr Neonatol."},{"issue":"12","key":"pone.0315077.ref039","doi-asserted-by":"crossref","first-page":"2218","DOI":"10.1002\/pbc.25203","article-title":"Medication errors on oral chemotherapy in children with acute lymphoblastic leukemia in a developing country","volume":"61","author":"S Oberoi","year":"2014","journal-title":"Pediatr Blood Cancer"},{"issue":"15","key":"pone.0315077.ref040","doi-asserted-by":"crossref","first-page":"1623","DOI":"10.1200\/JCO.21.02669","article-title":"Lack of concordance in symptomatic adverse event reporting by children, clinicians, and caregivers: Implications for cancer clinical trials","volume":"40","author":"DR Freyer","year":"2022","journal-title":"J Clin Oncol"},{"issue":"7","key":"pone.0315077.ref041","doi-asserted-by":"crossref","first-page":"1075","DOI":"10.1007\/s00431-019-03393-w","article-title":"Parental experiences and coping strategies when caring for a child receiving paediatric palliative care: A qualitative study","volume":"178","author":"LM Verberne","year":"2019","journal-title":"Eur J Pediatr"},{"issue":"6","key":"pone.0315077.ref042","article-title":"Leveraging grief: Involving bereaved parents in pediatric palliative oncology program planning and development.","volume":"8","author":"HL Spraker-Perlman","year":"2021","journal-title":"Children (Basel)."},{"issue":"6","key":"pone.0315077.ref043","doi-asserted-by":"crossref","first-page":"1359","DOI":"10.1007\/s11096-023-01626-5","article-title":"Prevalence, contributing factors, and interventions to reduce medication errors in outpatient and ambulatory settings: A systematic 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