Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM)
Objective Patient-reported outcomes (PROs) are considered the gold standard for the assessment of subjective symptoms, quality of life (QoL) and patient well-being in both clinical trials and clinical practice. Here, we report key discussions and findings from the 21st National Conference of the Ita...
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BMJ Publishing Group
2025-06-01
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| author | Oriana Ciani Carla Ida Ripamonti Fabio Efficace Giuseppe Viscardi Francesco De Lorenzo Massimo Di Maio Lara Gitto Elisabetta Iannelli Francesco Perrone Ethan Basch Alessandra Raimondi Antonella Brunello Carmine Pinto Alberto Puccini Silvana Quaglini Evaristo Maiello Martina Pagliuca Saverio Cinieri Gianmauro Numico Paolo Bossi Patrizia Popoli Tiziana Latiano Laura Marandino Francesco Longo Alberto Servetto Angela Piattelli Giordano Domenico Beretta Davide Petruzzelli Marco Zibellini Laura Locati Gualberto Gussoni Gianluca Mignone Pricivel M Carrera |
| author_facet | Oriana Ciani Carla Ida Ripamonti Fabio Efficace Giuseppe Viscardi Francesco De Lorenzo Massimo Di Maio Lara Gitto Elisabetta Iannelli Francesco Perrone Ethan Basch Alessandra Raimondi Antonella Brunello Carmine Pinto Alberto Puccini Silvana Quaglini Evaristo Maiello Martina Pagliuca Saverio Cinieri Gianmauro Numico Paolo Bossi Patrizia Popoli Tiziana Latiano Laura Marandino Francesco Longo Alberto Servetto Angela Piattelli Giordano Domenico Beretta Davide Petruzzelli Marco Zibellini Laura Locati Gualberto Gussoni Gianluca Mignone Pricivel M Carrera |
| author_sort | Oriana Ciani |
| collection | DOAJ |
| description | Objective Patient-reported outcomes (PROs) are considered the gold standard for the assessment of subjective symptoms, quality of life (QoL) and patient well-being in both clinical trials and clinical practice. Here, we report key discussions and findings from the 21st National Conference of the Italian Association of Medical Oncology, held in Bologna on 21–22 June 2024, with a focus on the integration and impact of PROs in oncology research and clinical practice.Methods and analysis Leading national and international experts presented and analysed data regarding the use of PROs in clinical trials and routine oncology care. Topics included the role of electronic PROs (ePROs), digital therapeutics, financial toxicity as a PRO and methodologies for standardising QoL assessment. Insights were drawn from expert presentations, consensus discussions and practical experiences shared during the conference sessions.Results Experts emphasised that PROs should be included as key endpoints in clinical trials, with timely publication of results and standardised methodologies for analysis and interpretation. The conference highlighted the critical importance of incorporating PROs and QoL measures throughout the cancer care continuum—from screening to survivorship. In clinical practice, PROs improve patient-centred care and communication, particularly when oncologists are trained to interpret QoL data. The use of ePROs was noted as a valuable tool to support digital health interventions. Financial toxicity emerged as a significant PRO, with screening tools recommended to identify and support at-risk patients. Key organisational challenges were identified, including technological barriers, resource constraints and the need for responsive infrastructure to support real-time PRO integration.Conclusion The implementation of PROs, including ePROs and financial toxicity assessments, is essential for advancing quality cancer care. Standardisation, digital innovation and targeted clinician education are critical to integrating PROs effectively in both research and clinical settings. Addressing infrastructural and technological challenges will be vital for optimising patient outcomes and ensuring optimal care across the cancer journey. |
| format | Article |
| id | doaj-art-e2e11c6c40f946c0aa24e45ed3ab2e8c |
| institution | Kabale University |
| issn | 2752-7948 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Oncology |
| spelling | doaj-art-e2e11c6c40f946c0aa24e45ed3ab2e8c2025-08-20T03:45:40ZengBMJ Publishing GroupBMJ Oncology2752-79482025-06-014110.1136/bmjonc-2025-000783Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM)Oriana Ciani0Carla Ida Ripamonti1Fabio Efficace2Giuseppe Viscardi3Francesco De Lorenzo4Massimo Di Maio5Lara Gitto6Elisabetta Iannelli7Francesco Perrone8Ethan Basch9Alessandra Raimondi10Antonella Brunello11Carmine Pinto12Alberto Puccini13Silvana Quaglini14Evaristo Maiello15Martina Pagliuca16Saverio Cinieri17Gianmauro Numico18Paolo Bossi19Patrizia Popoli20Tiziana Latiano21Laura Marandino22Francesco Longo23Alberto Servetto24Angela Piattelli25Giordano Domenico Beretta26Davide Petruzzelli27Marco Zibellini28Laura Locati29Gualberto Gussoni30Gianluca Mignone31Pricivel M Carrera32Centre for Research on Health and Social Care Management, Bocconi University, Milan 20136, Italy12 Oncology-Supportive Care Unit, Department of Oncology-Haematology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, ItalyHealth Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, ItalyMedical Oncology, Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Caserta, Campania, ItalyAssociazione Italiana Malati di Cancro (AIMAC), Roma, ItalyDepartment of Oncology, University of Turin, AOU Città della Salute e della Scienza di Torino, Turin, ItalyDipartimento di Economia, Università degli Studi di Messina, Messina, ItalyFederazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Roma, ItalyNational President, AIOM, Milan, ItalyDepartment of Health Policy and Management, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USAMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, ItalyDepartment of Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto IOV—IRCCS, Istituto Oncologico Veneto IRCCS, Padua, ItalyMedical Oncology, Comprehensive Cancer Centre IRCCS-AUSL, Azienda USL—IRCCS di Reggio Emilia, Reggio Emilia, ItalyIRCCS Humanitas Research Hospital, Rozzano, ItalyUniversity of Pavia, Department of Electrical, Computer and Biomedical Engineering, Pavia, Italy1Foundation Casa Sollievo della Sofferenza IRCCS, Oncology, San Giovanni Rotondo, Italy24 Department of Clinical Medicine and Surgery, Oncology Unit, Università degli Studi di Napoli Federico II, Napoli, Campania, ItalyGruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma, ItalyDepartment of Medical Oncology, Santa Croce e Carle Hospital, Cuneo, ItalyIRCCS Humanitas Research Hospital, Rozzano, Italydirector of the national centre for drug research and evaluation3 Division of Gastroenterology and Endoscopy, Fondazione IRCCS “Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, ItalyDepartment of Medical Oncology, IRCCS Ospedale San Raffaele, Milano, ItalyCentre for Health Economics, University of York, York, UKDepartment of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyUOC Oncologia Medica—Dipartimento Oncoematologico Azienda Ospedaliera di Cosenza, Azienda Sanitaria Provinciale di Cosenza, Cosenza, ItalyMedical Oncology, Hospital, Pescara Hospital, Pescara, ItalyLa Lampada di Aladino, Brugherio (MB), ItalyDirezione Tecnico Scientifica, Farmindustria, Roma, ItalyDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, ItalyClinical Research Department, Italian Scientific Society of Internal Medicine, Milan, ItalyStudio Legale Mignone, Benevento, ItalyGerman Cancer Research Center, Heidelberg, GermanyObjective Patient-reported outcomes (PROs) are considered the gold standard for the assessment of subjective symptoms, quality of life (QoL) and patient well-being in both clinical trials and clinical practice. Here, we report key discussions and findings from the 21st National Conference of the Italian Association of Medical Oncology, held in Bologna on 21–22 June 2024, with a focus on the integration and impact of PROs in oncology research and clinical practice.Methods and analysis Leading national and international experts presented and analysed data regarding the use of PROs in clinical trials and routine oncology care. Topics included the role of electronic PROs (ePROs), digital therapeutics, financial toxicity as a PRO and methodologies for standardising QoL assessment. Insights were drawn from expert presentations, consensus discussions and practical experiences shared during the conference sessions.Results Experts emphasised that PROs should be included as key endpoints in clinical trials, with timely publication of results and standardised methodologies for analysis and interpretation. The conference highlighted the critical importance of incorporating PROs and QoL measures throughout the cancer care continuum—from screening to survivorship. In clinical practice, PROs improve patient-centred care and communication, particularly when oncologists are trained to interpret QoL data. The use of ePROs was noted as a valuable tool to support digital health interventions. Financial toxicity emerged as a significant PRO, with screening tools recommended to identify and support at-risk patients. Key organisational challenges were identified, including technological barriers, resource constraints and the need for responsive infrastructure to support real-time PRO integration.Conclusion The implementation of PROs, including ePROs and financial toxicity assessments, is essential for advancing quality cancer care. Standardisation, digital innovation and targeted clinician education are critical to integrating PROs effectively in both research and clinical settings. Addressing infrastructural and technological challenges will be vital for optimising patient outcomes and ensuring optimal care across the cancer journey.https://bmjoncology.bmj.com/content/4/1/e000783.full |
| spellingShingle | Oriana Ciani Carla Ida Ripamonti Fabio Efficace Giuseppe Viscardi Francesco De Lorenzo Massimo Di Maio Lara Gitto Elisabetta Iannelli Francesco Perrone Ethan Basch Alessandra Raimondi Antonella Brunello Carmine Pinto Alberto Puccini Silvana Quaglini Evaristo Maiello Martina Pagliuca Saverio Cinieri Gianmauro Numico Paolo Bossi Patrizia Popoli Tiziana Latiano Laura Marandino Francesco Longo Alberto Servetto Angela Piattelli Giordano Domenico Beretta Davide Petruzzelli Marco Zibellini Laura Locati Gualberto Gussoni Gianluca Mignone Pricivel M Carrera Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM) BMJ Oncology |
| title | Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM) |
| title_full | Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM) |
| title_fullStr | Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM) |
| title_full_unstemmed | Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM) |
| title_short | Patient-reported outcomes (PROs) in clinical trials and in clinical practice: report from the XXI national conference of the Italian Association of Medical Oncology (AIOM) |
| title_sort | patient reported outcomes pros in clinical trials and in clinical practice report from the xxi national conference of the italian association of medical oncology aiom |
| url | https://bmjoncology.bmj.com/content/4/1/e000783.full |
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