Breast Imaging Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Nigeria.
Lancet Glob Health. 2022 Apr;10(4):e555-e563. doi: 10.1016/S2214-109X(22)00030-4.
The iBreastExam electronically palpates the breast to identify possible abnormalities. We assessed the iBreastExam performance compared with clinical breast examination for breast lesion detection in high risk and symptomatic Nigerian women.
This prospective study was done at the Obafemi Awolowo University Teaching Hospital Complex (OAUTHC) in Nigeria. Participants were Nigerian women aged 40 years or older who were symptomatic and presented with breast cancer symptoms or those at high risk with a first-degree relative who had a history of breast cancer. Participants underwent four breast examinations: clinical breast examination (by an experienced surgeon), the iBreastExam (performed by recent nursing school graduates, who finished nursing school within the previous year), ultrasound, and mammography. Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of the iBreastExam and clinical breast examination for detecting any breast lesion and suspicious breast lesions were calculated, using mammography and ultrasound as the reference standard.
Between June 19 and Dec 5, 2019, 424 Nigerian women were enrolled (151 [36%] at high risk of breast cancer and 273 [64%] symptomatic women). The median age of participants was 46 years (IQR 42-52). 419 (99%) women had a breast imaging-reporting and data system (BI-RADS) assessment and were included in the analysis. For any breast finding, the iBreastExam showed significantly better sensitivity than clinical breast examination (63%, 95% CI 57-69 vs 31%, 25-37; p<0·0001), and clinical breast examination showed significantly better specificity (94%, 90-97 vs 59%, 52-66; p<0·0001). For suspicious breast findings, the iBreastExam showed similar sensitivity to clinical breast examination (86%, 95% CI 70-95 vs 83%, 67-94; p=0·65), and clinical breast examination showed significantly better specificity (50%, 45-55 vs 86%, 83-90; p<0·0001). The iBreastExam and clinical breast examination showed similar NPVs for any breast finding (56%, 49-63 vs 52%, 46-57; p=0·080) and suspicious findings (98%, 94-99 vs 98%, 96-99; p=0·42), whereas the PPV was significantly higher for clinical breast examination in any breast finding (87%, 77-93 vs 66%, 59-72; p<0·0001) and suspicious findings (37%, 26-48 vs 14%, 10-19; p=0·0020). Of 15 biopsy-confirmed cancers, clinical breast examination and the iBreastExam detected an ipsilateral breast abnormality in 13 (87%) women and missed the same two cancers (both <2 cm).
The iBreastExam by nurses showed a high sensitivity and NPV, but lower specificity than surgeon's clinical breast examination for identifying suspicious breast lesions. In locations with few experienced practitioners, the iBreastExam might provide a high sensitivity breast evaluation tool. Further research into improved specificity with device updates and cost feasibility in low-resource settings is warranted.
Prevent Cancer Foundation Global Community Grant Award with additional support from the P30 Cancer Center Support Grant (P30 CA008748).
iBreastExam 通过电子触诊来识别可能的异常。我们评估了 iBreastExam 与临床乳房检查在高风险和有症状的尼日利亚女性中检测乳房病变的性能。
这项前瞻性研究在尼日利亚奥巴费米·阿沃洛沃大学教学医院（OAUTHC）进行。参与者为年龄在 40 岁或以上有症状且出现乳腺癌症状或有乳腺癌病史的一级亲属的高风险尼日利亚女性。参与者接受了四项乳房检查：临床乳房检查（由经验丰富的外科医生进行）、iBreastExam（由刚毕业于护理学校的应届毕业生进行，他们在过去一年中毕业于护理学校）、超声和乳房 X 光检查。使用乳房 X 光检查和超声作为参考标准，计算 iBreastExam 和临床乳房检查对检测任何乳房病变和可疑乳房病变的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
2019 年 6 月 19 日至 12 月 5 日期间，共有 424 名尼日利亚女性入组（151 名[36%]为乳腺癌高风险人群，273 名[64%]为有症状女性）。参与者的中位年龄为 46 岁（IQR 42-52）。419 名（99%）女性进行了乳房影像报告和数据系统（BI-RADS）评估，并纳入了分析。对于任何乳房发现，iBreastExam 的敏感性明显高于临床乳房检查（63%，95%CI 57-69 比 31%，25-37；p<0·0001），而临床乳房检查的特异性明显更高（94%，90-97 比 59%，52-66；p<0·0001）。对于可疑的乳房发现，iBreastExam 的敏感性与临床乳房检查相似（86%，95%CI 70-95 比 83%，67-94；p=0·65），而临床乳房检查的特异性明显更高（50%，45-55 比 86%，83-90；p<0·0001）。iBreastExam 和临床乳房检查对任何乳房病变的阴性预测值（56%，49-63 比 52%，46-57；p=0·080）和可疑病变（98%，94-99 比 98%，96-99；p=0·42）相似，而临床乳房检查对任何乳房病变的阳性预测值（87%，77-93 比 66%，59-72；p<0·0001）和可疑病变（37%，26-48 比 14%，10-19；p=0·0020）明显更高。在 15 例经活检证实的癌症中，临床乳房检查和 iBreastExam 在 13 名（87%）女性中检测到同侧乳房异常，并漏诊了同样的 2 例癌症（均<2 厘米）。
护士进行的 iBreastExam 检查对识别可疑的乳房病变具有较高的敏感性和阴性预测值，但特异性低于外科医生的临床乳房检查。在经验丰富的医生较少的地区，iBreastExam 可能是一种敏感性较高的乳房评估工具。需要进一步研究如何通过设备更新来提高特异性，并评估在资源匮乏环境下的成本可行性。
预防癌症基金会全球社区赠款奖，额外得到 P30 癌症中心支持赠款（P30 CA008748）的支持。
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