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患者报告结局与临床医生评估相比如何?乳腺癌放射性皮炎的前瞻性研究。

How do patient-reported outcomes compare with clinician assessments? A prospective study of radiation dermatitis in breast cancer.

机构信息

Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Canada.

MacroStat Inc., Toronto, Canada.

出版信息

Radiother Oncol. 2021 Jun;159:98-105. doi: 10.1016/j.radonc.2021.03.020. Epub 2021 Mar 23.

DOI:10.1016/j.radonc.2021.03.020
PMID:33771577
Abstract

BACKGROUND AND PURPOSE

Breast cancer patients frequently develop radiation dermatitis (RD) when undergoing post-operative radiation therapy (RT). Traditional RD assessment methods measure clinician-reported outcomes (CROs), but patient-reported outcomes (PROs) have gained recent popularity. The purpose of this prospective analysis was to compare PROs with CROs of breast RD.

MATERIALS AND METHODS

Demographic and treatment characteristics were prospectively collected for patients receiving post-operative RT between February 2018 to September 2020. Patients and clinicians completed a skin symptom assessment at baseline, weekly during RT, and at a one- to three-month follow-up visit. Skin treatments used by patients were collected. Concordance between each PRO and CRO was determined using percent concordance and concordance index (C-statistic) by logistic regression analysis.

RESULTS

A total of 777 patients were included in the present study. All skin symptom assessment items were significantly underreported by clinicians in comparison to patients (p < 0.0001), with a low to moderate level of concordance (C-statistic range: 0.58-0.70; percent concordance range: 29-50%). The majority of patients used moisturizing creams as a prophylactic measure (65.1%), as per institutional guidelines.

CONCLUSION

There were significant discrepancies between PROs and CROs when assessing breast RD. CROs alone are insufficient in measuring RD as they fail to capture the impact on patient quality of life. The study findings highlight the need for improved RD symptom assessment and support the development of a new tool with both patient and clinician components.

摘要

背景与目的

乳腺癌患者在接受术后放射治疗(RT)时常会出现放射性皮炎(RD)。传统的 RD 评估方法测量临床医生报告的结果(CRO),但近年来患者报告的结果(PRO)越来越受欢迎。本前瞻性分析的目的是比较 PRO 和 CRO 在乳房 RD 中的应用。

材料与方法

从 2018 年 2 月至 2020 年 9 月期间,前瞻性收集接受术后 RT 的患者的人口统计学和治疗特征。患者和临床医生在基线、RT 期间每周以及 1 至 3 个月的随访时完成皮肤症状评估。收集患者使用的皮肤治疗方法。通过逻辑回归分析确定每个 PRO 和 CRO 的一致性,使用百分比一致性和一致性指数(C 统计量)进行评估。

结果

本研究共纳入 777 例患者。与患者相比,所有皮肤症状评估项目均被临床医生明显低估(p<0.0001),一致性程度较低到中度(C 统计量范围:0.58-0.70;百分比一致性范围:29-50%)。根据机构指南,大多数患者使用保湿霜作为预防措施(65.1%)。

结论

在评估乳房 RD 时,PRO 和 CRO 之间存在显著差异。单独使用 CRO 不足以衡量 RD,因为它们无法捕捉到对患者生活质量的影响。研究结果强调了需要改进 RD 症状评估,并支持开发一种具有患者和临床医生两部分的新工具。

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