Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study

被引：0

作者：

Caminiti, Caterina ^{[1
]}

Maglietta, Giuseppe ^{[1
]}

Arenare, Laura ^{[2
]}

Di Liello, Raimondo ^{[3
]}

Migliaccio, Gessica ^{[4
]}

Barberio, Daniela ^{[4
]}

De Laurentiis, Michelino ^{[5
]}

Di Rella, Francesca ^{[5
]}

Nuzzo, Francesco ^{[5
]}

Pacilio, Carmen ^{[5
]}

Iodice, Giovanni ^{[5
]}

Orditura, Michele ^{[6
,19
]}

Ciardiello, Fortunato ^{[6
]}

Di Bella, Sara ^{[7
]}

Cavanna, Luigi ^{[8
,20
]}

Porta, Camillo ^{[9
,10
]}

Giovanardi, Filippo ^{[11
]}

Ripamonti, Carla Ida ^{[12
,21
]}

Bilancia, Domenico ^{[13
]}

Aprile, Giuseppe ^{[14
]}

Ruelle, Tommaso ^{[15
,16
]}

Diodati, Francesca ^{[1
]}

Piccirillo, Maria Carmela ^{[2
]}

Iannelli, Elisabetta ^{[17
]}

Pinto, Carmine ^{[18
]}

Perrone, Francesco ^{[2
]}

机构：

[1] Univ Hosp, Clin & Epidemiol Res Unit, Parma, Italy

[2] IRCCS Fdn G Pascale, Clin Trial Unit, Ist Nazl Tumori, Naples, Italy

[3] Osped Mare, Div Med Oncol, Naples, Italy

[4] IRCCS, Fdn G Pascale, Ist Nazl Tumori, Dept Struct Clin Psychooncol, Naples, Italy

[5] IRCCS Fdn G Pascale, Ist Nazl Tumori, Expt & Clin Senol Oncol Unit, Naples, Italy

[6] Univ Campania Luigi Vanvitelli, Dept Precis Med, Naples, Italy

[7] ASST Rhodense, Med Oncol, Rho, MI, Italy

[8] Osped Guglielmo Saliceto, Med Oncol, Piacenza, Italy

[9] Univ A Moro, Interdisciplinary Dept Med, Bari, Italy

[10] Polyclin Consortium Univ Hosp, Bari, Italy

[11] Osped Civile, Med Oncol, Guastalla, RE, Italy

[12] IRCCS, Ist Nazl Tumori, Support Care Unit, Milan, Italy

[13] Osped S Carlo, Med Oncol, Potenza, Italy

[14] Osped S Bortolo, Med Oncol, Azienda ULSS 8 Nerica, Vicenza, Italy

[15] IRCCS Osped Policlin San Martino, Med Oncol, Genoa, Italy

[16] Univ Genoa, Dept Internal Med & Med Specialties, DIMi, Genoa, Italy

[17] FAVO Federaz Italiana Assoc Volontariato Oncol, Rome, Italy

[18] AUSL IRCCS, Med Oncol, Reggio Emilia, Italy

[19] Osped Civile, Div Med Oncol, Caserta, Italy

[20] Casa Cura Piacenza, Internal Med & Oncol Unit, Piacenza, Italy

[21] Univ Brescia, Brescia, Italy

来源：

BREAST | 2024年 / 77卷

关键词：

Patient-reported outcome measures (PROMs); Electronic PROMs (ePROMs); PRO-CTCAE; HADS; EORTC BR-23; Convergent validity; Responsiveness; Breast cancer; VALIDITY; VERSION;

D O I：

10.1016/j.breast.2024.103781

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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).

引用

页数：8

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