Clinical Breast Examination: Preliminary Results from a Cluster Randomized Controlled Trial in India
Clinical Breast Examination: Preliminary Results from a Cluster Randomized Controlled Trial in India
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DOI：
10.1093/jnci/djr304
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发表时间：
2011-10-01
影响因子：
10.3
通讯作者：
Mathew, Beela Sara
中科院分区：
文献类型：
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作者：
Sankaranarayanan, Rengaswamy;Ramadas, Kunnambath;Mathew, Beela Sara
2006年1月1日，在特里凡得琅地区（印度喀拉拉邦）启动了一项随机对照试验，以评估三轮三年一次的临床乳腺检查（CBE）是否可以降低晚期疾病发病率和乳腺癌死亡率。共有275个群组，包括115652名健康女性，年龄在30-69岁之间，被随机分配到干预组（CBE; 133个群组; 55844名女性）或对照组（无筛查; 142个群组; 59808名女性）。评估CBE的性能特征（敏感性、特异性、假阳性率和阳性预测值）。对干预组和对照组之间的发病率进行了意向治疗分析。发病率的初步结果是基于随访至2009年5月31日，当第一轮筛查完成。在接受CBE的50366名妇女中，2880名CBE筛查可疑结果的妇女中检出30例乳腺癌，需要进一步调查。CBE的敏感性、特异性、假阳性率和阳性预测值均为51.7%（95%置信区间[CI] = 38.2%至65.0%）、94.3%（95% CI = 94.1%至94.5%）、5.7%（95% CI = 5.5%至5.9%）和1.0%（95% CI = 0.7%至1.5%）。在干预组和对照组中，早期（IIA期或更低）乳腺癌的年龄标准化发病率分别为18.8/10万妇女和8.1/10万妇女，晚期（IIB期或更高）乳腺癌的年龄标准化发病率分别为19.6/10万妇女和21.7/10万妇女。
A cluster randomized controlled trial was initiated in the Trivandrum district (Kerala, India) on January 1, 2006, to evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced disease incidence and breast cancer mortality. A total of 275 clusters that included 115 652 healthy women, aged 30-69 years, were randomly allocated to intervention (CBE; 133 clusters; 55 844 women) or control (no screening; 142 clusters; 59 808 women) groups. Performance characteristics (sensitivity, specificity, false-positive rate, and positive predictive value) of CBE were evaluated. An intention-to-treat analysis was performed for comparison of incidence rates between the intervention and control groups. Preliminary results for incidence are based on follow-up until May 31, 2009, when the first round of screening was completed. Of the 50 366 women who underwent CBE, 30 breast cancers were detected among 2880 women with suspicious findings in CBE screening that warranted further investigations. Sensitivity, specificity, false-positive rate, and positive predictive value of CBE were 51.7% (95% confidence interval [CI] = 38.2% to 65.0%), 94.3% (95% CI = 94.1% to 94.5%), 5.7% (95% CI = 5.5% to 5.9%), and 1.0% (95% CI = 0.7% to 1.5%), respectively. The age-standardized incidence rates for early-stage (stage IIA or lower) breast cancer were 18.8 and 8.1 per 100 000 women and for advanced-stage (stage IIB or higher) breast cancer were 19.6 and 21.7 per 100 000 women, in the intervention and control groups, respectively.