Ciabattoni Antonella, Gregucci Fabiana, D'Ermo Giuseppe, Dolfi Alessandro, Cucciarelli Francesca, Palumbo Isabella, Borghesi Simona, Gava Alessandro, Cesaro Giovanna Maria, Baldissera Antonella, Giammarino Daniela, Daidone Antonino, Maurizi Francesca, Mignogna Marcello, Mazzuoli Lidia, Ravo Vincenzo, Falivene Sara, Pedretti Sara, Ippolito Edy, Barbarino Rosaria, di Cristino Daniela, Fiorentino Alba, Aristei Cynthia, Ramella Sara, D'Angelillo Rolando Maria, Meattini Icro, Iotti Cinzia, Donato Vittorio, Formenti Silvia Chiara
Department of Radiation Oncology, Ospedale San Filippo Neri, ASL Roma 1, 00135 Roma, Italy.
Department of Radiation Oncology, Ospedale Generale Regionale "F. Miulli", Acquaviva delle Fonti, 70021 Bari, Italy.
Cancers (Basel). 2022 Aug 15;14(16):3927. doi: 10.3390/cancers14163927.
Breast IRRADIATA (Italian Repository of RADIotherapy dATA) is a collaborative nationwide project supported by the Italian Society of Radiotherapy and Clinical Oncology (AIRO) and the Italian League Against Cancer (LILT). It focuses on breast cancer (BC) patients treated with radiotherapy (RT) and was developed to create a national registry and define the patterns of care in Italy. A dedicated tool for data collection was created and pilot tested. The results of this feasibility study are reported here. To validate the applicability of a user-friendly data collection tool, a feasibility study involving 17 Italian Radiation Oncology Centers was conducted from July to October 2021, generating a data repository of 335 BC patients treated between January and March 2020, with a minimum follow-up time of 6 months. A snapshot of the clinical presentation, treatment modalities and radiotherapy toxicity in these patients was obtained. A Data Entry Survey and a Satisfaction Questionnaire were also sent to all participants. All institutions completed the pilot study. Regarding the Data Entry survey, all questions achieved 100% of responses and no participant reported spending more than 10 min time for either the first data entry or for the updating of follow-up. Results from the Satisfaction Questionnaire revealed that the project was described as excellent by 14 centers (82.3%) and good by 3 (17.7%). Current knowledge for the treatment of high-prevalence diseases, such as BC, has evolved toward patient-centered medicine, evidence-based care and real-world evidence (RWE), which means evidence obtained from real-world data (RWD). To this aim, Breast IRRADIATA was developed as a simple tool to probe the current pattern of RT care in Italy. The pilot feasibility of IRRADIATA encourages a larger application of this tool nationwide and opens the way to the assessment of the pattern of care radiotherapy directed to other cancers.
乳腺癌辐照数据库（意大利放射治疗数据储存库）是一个由意大利放射治疗与临床肿瘤学会（AIRO）和意大利抗癌联盟（LILT）支持的全国性合作项目。它专注于接受放射治疗（RT）的乳腺癌（BC）患者，旨在创建一个全国性登记册并确定意大利的护理模式。为此创建了一个专门的数据收集工具并进行了试点测试。本文报告了这项可行性研究的结果。为验证一个用户友好型数据收集工具的适用性，于2021年7月至10月在17个意大利放射肿瘤中心开展了一项可行性研究，生成了一个包含335例在2020年1月至3月期间接受治疗的BC患者的数据储存库，最短随访时间为6个月。获取了这些患者的临床表现、治疗方式和放疗毒性的概况。还向所有参与者发送了数据录入调查问卷和满意度问卷。所有机构均完成了试点研究。关于数据录入调查，所有问题的回复率均达到100%，且没有参与者报告首次数据录入或随访更新花费超过10分钟。满意度问卷的结果显示，14个中心（82.3%）将该项目描述为优秀，3个中心（17.7%）描述为良好。目前对于诸如BC等高发性疾病的治疗知识已朝着以患者为中心的医学、循证护理和真实世界证据（RWE）发展，真实世界证据是指从真实世界数据（RWD）中获得的证据。为此，乳腺癌辐照数据库被开发为一个简单工具，以探究意大利目前的放射治疗护理模式。辐照数据库的试点可行性鼓励在全国范围内更广泛地应用该工具，并为评估针对其他癌症的放射治疗护理模式开辟了道路。
