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患者报告的乳腺磁共振成像检测负担在导管原位癌女性中的研究:ECOG-ACRIN 癌症研究组(E4112)的辅助研究。

Patient-Reported Testing Burden of Breast Magnetic Resonance Imaging Among Women With Ductal Carcinoma In Situ: An Ancillary Study of the ECOG-ACRIN Cancer Research Group (E4112).

机构信息

Department of Radiology, University of California, San Diego.

Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.

出版信息

JAMA Netw Open. 2021 Nov 1;4(11):e2129697. doi: 10.1001/jamanetworkopen.2021.29697.

Abstract

IMPORTANCE

The use of magnetic resonance imaging (MRI) in pretreatment planning of ductal carcinoma in situ (DCIS) remains controversial. Understanding changes in short-term health-related quality of life associated with breast MRI would allow for a more complete comparative effectiveness assessment.

OBJECTIVE

To assess whether there are changes in patient-reported quality of life associated with breast MRI among women diagnosed with DCIS.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study was a substudy of a nonrandomized clinical trial conducted at 75 participating US institutions from March 2015 to April 2016. Women recently diagnosed with unilateral DCIS who were eligible for wide local excision and had a diagnostic mammogram within 3 months of study registration were included. A total of 355 women met the eligibility criteria and underwent the study MRI. Data analysis was performed from June 3, 2020, to July 1, 2021.

EXPOSURES

Participants underwent bilateral breast MRI within 30 days of study registration and before surgery. Information on patient-reported testing burden for breast MRI was collected after MRI and before surgery.

MAIN OUTCOMES AND MEASURES

The primary outcome of this substudy was the patient-reported testing burden of breast MRI, measured by the Testing Morbidities Index (TMI) summated scale score. The TMI is a 7-item instrument that evaluates the temporary changes in quality of life associated with imaging before, during, and after the test (0 represents the worst possible, 100 the hypothetical ideal test experience).

RESULTS

Of the 355 women who met the eligibility criteria, 244 (69%) completed both questionnaires and were included in this analysis. The median age was 59 years (range, 34-85 years). The mean MRI TMI summated scale score was 85.9 (95% CI, 84.6-87.3). Of the 244 women, 142 (58%) experienced at least some fear and anxiety before the examination, and 120 women (49%) experienced fear and anxiety during the examination. A total of 156 women (64%) experienced pain or discomfort during the examination. In multivariable analyses, greater test-related burden was associated with higher levels of cancer worry (regression coefficient, -2.75; SE, 0.94; P = .004).

CONCLUSIONS AND RELEVANCE

In this cohort study, a clinically meaningful breast MRI testing burden among women with DCIS was revealed that was significantly associated with cancer worry. Understanding the potential quality-of-life reduction associated with MRI, especially when used in combination with mammography, may allow development of targeted interventions to improve the patient experience.

摘要

重要性

磁共振成像(MRI)在导管癌原位(DCIS)的预处理计划中的使用仍然存在争议。了解与乳房 MRI 相关的短期健康相关生活质量的变化,可以进行更完整的比较效果评估。

目的

评估在诊断为 DCIS 的女性中,与乳房 MRI 相关的患者报告的生活质量是否存在变化。

设计、地点和参与者:这是一项队列研究,是 2015 年 3 月至 2016 年 4 月在美国 75 家参与机构进行的非随机临床试验的子研究。符合条件的女性为单侧 DCIS 最近诊断出,适合广泛局部切除,且在研究登记后 3 个月内进行了诊断性乳房 X 线摄影。共有 355 名女性符合入选标准,并接受了研究 MRI。数据分析于 2020 年 6 月 3 日至 2021 年 7 月 1 日进行。

暴露

参与者在研究登记后 30 天内并在手术前进行双侧乳房 MRI。在 MRI 后和手术前收集了与乳房 MRI 检测负担相关的患者报告的检测信息。

主要结果和测量指标

该子研究的主要结果是患者报告的乳房 MRI 检测负担,用检测发病率指数(TMI)总和量表评分来衡量。TMI 是一种 7 项仪器,评估成像前、成像期间和成像后与测试相关的生活质量的暂时变化(0 代表最差,100 代表理想测试体验)。

结果

在符合入选标准的 355 名女性中,有 244 名(69%)完成了两份问卷,并纳入了本分析。中位年龄为 59 岁(范围,34-85 岁)。MRI TMI 总和量表的平均评分为 85.9(95%CI,84.6-87.3)。在 244 名女性中,142 名(58%)在检查前至少有一些恐惧和焦虑,120 名女性(49%)在检查期间感到恐惧和焦虑。共有 156 名女性(64%)在检查过程中感到疼痛或不适。在多变量分析中,更高的测试相关负担与更高的癌症担忧程度相关(回归系数,-2.75;SE,0.94;P=0.004)。

结论和相关性

在这项队列研究中,揭示了 DCIS 女性中具有临床意义的乳房 MRI 检测负担,这与癌症担忧显著相关。了解与 MRI 相关的潜在生活质量下降,特别是当与乳房 X 线摄影结合使用时,可能有助于制定有针对性的干预措施,以改善患者体验。

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