Caterina Caminiti , Giuseppe Maglietta , Laura Arenare , Raimondo Di Liello , Gessica Migliaccio , Daniela Barberio , Michelino De Laurentiis , Francesca Di Rella , Francesco Nuzzo , Carmen Pacilio , Giovanni Iodice , Michele Orditura , Fortunato Ciardiello , Sara Di Bella , Luigi Cavanna , Camillo Porta , Filippo Giovanardi , Carla Ida Ripamonti , Domenico Bilancia , Giuseppe Aprile , Francesco Perrone
{"title":"乳腺癌患者患者报告结果通用术语不良事件标准（PRO-CTCAE®）的心理计量特性：前瞻性多中心 VIP 观察研究。","authors":"Caterina Caminiti , Giuseppe Maglietta , Laura Arenare , Raimondo Di Liello , Gessica Migliaccio , Daniela Barberio , Michelino De Laurentiis , Francesca Di Rella , Francesco Nuzzo , Carmen Pacilio , Giovanni Iodice , Michele Orditura , Fortunato Ciardiello , Sara Di Bella , Luigi Cavanna , Camillo Porta , Filippo Giovanardi , Carla Ida Ripamonti , Domenico Bilancia , Giuseppe Aprile , Francesco Perrone","doi":"10.1016/j.breast.2024.103781","DOIUrl":null,"url":null,"abstract":"<div><p>Patients’ self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients.</p><p>Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients’ reporting of side-effects.</p><p>We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors.</p><p>The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions.</p><p>Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires.</p><p>In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer.</p><p>The study is registered on <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (NCT04416672).</p></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"77 ","pages":"Article 103781"},"PeriodicalIF":5.7000,"publicationDate":"2024-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0960977624001127/pdfft?md5=52c5e20e7eec89e76b7bbf7bc9e19727&pid=1-s2.0-S0960977624001127-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study\",\"authors\":\"Caterina Caminiti , Giuseppe Maglietta , Laura Arenare , Raimondo Di Liello , Gessica Migliaccio , Daniela Barberio , Michelino De Laurentiis , Francesca Di Rella , Francesco Nuzzo , Carmen Pacilio , Giovanni Iodice , Michele Orditura , Fortunato Ciardiello , Sara Di Bella , Luigi Cavanna , Camillo Porta , Filippo Giovanardi , Carla Ida Ripamonti , Domenico Bilancia , Giuseppe Aprile , Francesco Perrone\",\"doi\":\"10.1016/j.breast.2024.103781\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Patients’ self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients.</p><p>Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients’ reporting of side-effects.</p><p>We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors.</p><p>The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions.</p><p>Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires.</p><p>In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer.</p><p>The study is registered on <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (NCT04416672).</p></div>\",\"PeriodicalId\":9093,\"journal\":{\"name\":\"Breast\",\"volume\":\"77 \",\"pages\":\"Article 103781\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2024-07-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0960977624001127/pdfft?md5=52c5e20e7eec89e76b7bbf7bc9e19727&pid=1-s2.0-S0960977624001127-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0960977624001127\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0960977624001127","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study
Patients’ self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients.
Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients’ reporting of side-effects.
We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors.
The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions.
Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires.
In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer.
The study is registered on clinicaltrials.gov (NCT04416672).
期刊介绍：
The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.
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