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[目的]系统评价国内超声造影诊断乳腺癌的文献质量,并分析偏倚的来源。[方法]计算机检索中国生物医学文献数据库(1995～2011.1)、重庆维普中文科技期刊数据库(1995～2011.1)、万方数据库(1995～2011.1)和中国期刊全文数据库(1995～2011.1),手工检索相关期刊,全面收集超声造影诊断乳腺癌的文献,两名评阅者独立提取特征资料并应用QUADAS评价标准评价纳入文献的方法学质量。[结果]纳入13篇文献的疾病进展偏倚、部分参照偏倚、多重参照偏倚、难以解释的试验结果、退出病例发生偏倚的可能性小,而疾病谱偏倚、选择偏倚、试验解读偏倚、临床解读偏倚发生的可能性大。对诊断阈值描述不清,临床可靠性较低。[结论]纳入文献的偏倚主要来源于疾病谱偏倚和选择偏倚,试验解读偏倚和临床解读偏倚,诊断试验实施的不全面介绍。未来关于乳腺肿瘤的诊断性研究应按照诊断性试验报告标准(STARD)来报告,以提高方法学质量。
[Objective] To systematically evaluate the quality of literature on the diagnosis of breast cancer by contrast-enhanced ultrasound and to analyze the sources of bias. [Methods] The databases of Chinese biomedical literature (1995 ~ 2011.1), Chongqing Weipu Chinese Science and Technology Periodical Database (1995 ~ 2011.1), Wanfang Database (1995 ~ 2011.1) and Chinese Journal Full-text Database (1995 ~ 2011.1) Periodicals, a comprehensive collection of ultrasound contrast diagnosis of breast cancer literature, two reviewers independently extracted characteristic data and QUADAS evaluation criteria to evaluate the quality of the methodology included in the literature. [Results] The disease progression bias, partial reference bias, multiple reference bias, difficult to interpret the test results included in 13 articles were less likely to be exacerbated by the cases, while the disease spectrum bias, selection bias, trial interpretation bias, clinical interpretation bias The likelihood of occurrence is high. The threshold of diagnosis is not clear, the clinical reliability is low. [Conclusion] The bias of the included documents mainly comes from the spectrum bias and selection bias, the bias of trial interpretation and the bias of clinical interpretation, and the incomplete introduction of diagnostic test. Future diagnostic studies on breast tumors should be reported on the basis of diagnostic test report criteria (STARD) to improve the quality of methodologies.