Su Rila, Snyder Claire, Wu Albert W, Gross Alden L, Ji Jiafu, Zhang Jiaming, Morlock Laura
Department of Oncology, Inner Mongolia People's Hospital, Hohhot, Inner Mongolia, China.
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Qual Life Res. 2025 Jun 18. doi: 10.1007/s11136-025-04004-y.
Breast cancer (BC) is the most prevalent cancer among women, with hormone receptor-positive BC making up approximately 70% of cases. Adjuvant Endocrine Therapy (AET) is critical in reducing recurrence in this patient population. Still, it often leads to side effects that negatively impact patients' health-related quality of life (HRQoL). Patient-reported outcome measures (PROMs) are widely used to assess HRQoL, but there is inconsistency in the instruments used to evaluate the impact of AET on BC patients. This systematic review aimed to identify and evaluate PROMs that assess HRQoL in BC patients undergoing AET, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
A systematic search was conducted across MEDLINE, EMBASE, Cochrane Library, and Google Scholar for studies published between 2007 and 2023. Studies that developed and validated PROMs for BC patients on AET were included. The measurement properties of each PROM were appraised following COSMIN guidelines, and their relevance, comprehensiveness, and comprehensibility were assessed.
The review included 24 studies assessing six PROMs. The European Organization for Research and Treatment of Cancer-Breast Cancer45 (EORTC BR45) and Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) demonstrated sufficient content validity and covered the majority of AET-related symptoms. Both instruments were rated highly for structural validity, internal consistency, cross-cultural validity, and reliability. FACT-ES also demonstrated strong responsiveness to treatment-related changes.
EORTC BR45 and FACT-ES are the most suitable PROMs for assessing HRQoL in BC patients undergoing AET due to their robust psychometric properties and comprehensive coverage of AET-related symptoms.
乳腺癌（BC）是女性中最常见的癌症，激素受体阳性乳腺癌约占病例的70%。辅助内分泌治疗（AET）对于降低该患者群体的复发率至关重要。然而，它常常会导致副作用，对患者的健康相关生活质量（HRQoL）产生负面影响。患者报告结局测量（PROMs）被广泛用于评估HRQoL，但用于评估AET对BC患者影响的工具并不一致。本系统评价旨在使用基于共识的健康测量工具选择标准（COSMIN）指南，识别和评估用于评估接受AET的BC患者HRQoL的PROMs。
在MEDLINE、EMBASE、Cochrane图书馆和谷歌学术上进行系统检索，查找2007年至2023年发表的研究。纳入为接受AET的BC患者开发和验证PROMs的研究。按照COSMIN指南评估每个PROM的测量属性，并评估其相关性、全面性和可理解性。
该评价纳入了24项评估6种PROMs的研究。欧洲癌症研究与治疗组织-乳腺癌45（EORTC BR45）和癌症治疗功能评估-内分泌症状（FACT-ES）显示出足够的内容效度，涵盖了大多数与AET相关的症状。这两种工具在结构效度、内部一致性、跨文化效度和信度方面均获得了高度评价。FACT-ES还显示出对治疗相关变化的强烈反应性。
EORTC BR45和FACT-ES因其强大的心理测量特性和对与AET相关症状的全面覆盖，是评估接受AET的BC患者HRQoL的最合适的PROMs。
