Reasons Women at Elevated Risk of Breast Cancer Refuse Breast MR Imaging Screening: ACRIN 6666

Reasons Women at Elevated Risk of Breast Cancer Refuse Breast MR Imaging Screening: ACRIN 6666
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DOI:
10.1148/radiol.2541090953
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发表时间:
2010-01-01
期刊:
影响因子:
19.7
通讯作者:
Mendelson, Ellen B.
Mendelson, Ellen B.
中科院分区:
医学1区
文献类型:
--
作者:
Berg, Wendie A.;Blume, Jeffrey D.;Mendelson, Ellen B.

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目的:为了确定原因不参加试验的补充筛查与磁共振(MR)成像后,乳房X光检查和超声检查(US)。材料和方法:妇女(n = 2809)在乳腺癌的高风险参加了美国放射学院成像网络6666美国筛选协议在21个机构。14家机构符合该机构审查委员会批准的、符合HIPAA的MR成像补充筛查子研究的技术和经验要求。那些已经完成0个月、12个月和24个月乳腺X线摄影联合US筛查的女性,在完成24个月乳腺X线摄影-US筛查后8周内考虑进行单次造影剂增强MR检查。共有1593名女性有完整的MR子研究登记数据:其中378名不符合研究条件,1215名有可分析的数据。确定不参与的原因。研究参与者和nonparticipants.Results之间的人口统计学数据进行了比较:1215名妇女与可分析的数据,703(57.9%),平均年龄为54.8岁,参加了MR子研究和512(42.1%)拒绝参与。乳腺癌终生风险为25%或更高的女性更有可能参与(比值比,1.53; 95%置信区间:1.10,2.12)。在512名非参与者中,(25.4%)因幽闭恐惧症而被拒绝; 93(18.2%),由于时间限制; 62(12.1%),由于财务问题; 47(9.2%),因为他们的医生不提供转诊和/或不相信磁共振成像的指示; 40(7.8%),因为他们不感兴趣; 39(7.6%),因为他们在医学上对MR成像不耐受; 29(5.7%),因为不想接受静脉注射;(5.3%),因为随后可能需要进行额外的活检或其他手术; 21(4.1%),由于磁共振成像时间安排限制; 11(2.2%),因为需要旅行; 7(1.4%),由于钆相关的风险或过敏;(1.2%),原因不明。在1215名乳腺癌风险升高的女性中,根据方案指南,只有57.9%的人同意参加乳腺MR成像。(C)RSNA,2010年
Purpose: To determine reasons for nonparticipation in a trial of supplemental screening with magnetic resonance (MR) imaging after mammography and ultrasonography (US).Materials and Methods: Women (n = 2809) at elevated risk of breast cancer were enrolled in the American College of Radiology Imaging Network 6666 US Screening Protocol at 21 institutions. Fourteen institutions met technical and experience requirements for this institutional review board-approved, HIPAA-compliant substudy of supplemental screening with MR imaging. Those women who had completed 0-, 12-, and 24-month screenings with mammography combined with US were considered for a single contrast material-enhanced MR examination within 8 weeks after completing the 24-month mammography-US screening. A total of 1593 women had complete MR substudy registration data: 378 of them were ineligible for the study, and 1215 had analyzable data. Reasons for nonparticipation were determined. Demographic data were compared between study participants and nonparticipants.Results: Of 1215 women with analyzable data, 703 (57.9%), with a mean age of 54.8 years, were enrolled in the MR substudy and 512 (42.1%) declined participation. Women with a 25% or greater lifetime risk of breast cancer were more likely to participate (odds ratio, 1.53; 95% confidence interval: 1.10, 2.12). Of 512 nonparticipants, 130 (25.4%) refused owing to claustrophobia; 93 (18.2%), owing to time constraints; 62 (12.1%), owing to financial concerns; 47 (9.2%), because their physician would not provide a referral and/or did not believe MR imaging was indicated; 40 (7.8%), because they were not interested; 39 (7.6%), because they were medically intolerant to MR imaging; 29 (5.7%), because they did not want to undergo intravenous injection; 27 (5.3%), owing to additional biopsy or other procedures that might be required subsequently; 21 (4.1%), owing to MR imaging scheduling constraints; 11 (2.2%), because of the travel required; seven (1.4%), owing to gadolinium-related risks or allergies; and six (1.2%), for unknown reasons.Conclusion: Of 1215 women with elevated breast cancer risk who could, according to protocol guidelines, undergo breast MR imaging, only 57.9% agreed to participate. (C) RSNA, 2010