BACKGROUND Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care. METHODS A literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB. RESULTS Nine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58-97%, the specificity was 7.5-95.5%, the positive and negative likelihood ratios were 1.1-13.8 and 0.14-0.56, respectively, and the diagnostic odds ratio was 2.6-52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures. CONCLUSIONS PBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care. REVIEW REGISTRATION NUMBER PROSPERO international prospective register of systematic reviews: CRD42016030083.

中文翻译：

---

在研究和临床实践中评估严重月经出血的图片方法：系统的文献综述。

背景技术图形失血量评估图（PBAC）代表临床试验中评估月经失血（MBL）的最广泛使用的方法。这篇综述的目的是：（1）确定已针对参考碱性血红素技术进行验证的PBAC的诊断准确性；（2）对使用过时的和未经验证的图表进行分类的陷阱；（3）为开发新的PBAC或使用现有图表在临床试验中测量MBL提供指导；（4）考虑在初级保健中使用图示图表的可行性。方法使用Embase和MEDLINE数据库进行文献综述。该评价确定了以下报告：患有自觉或实际月经严重出血（HMB），出血性疾病，子宫异常出血，平滑肌瘤（子宫肌瘤）或子宫内膜异位的妇女，以及接受HMB治疗的妇女以及月经正常的妇女。从专注于PBAC的开发和验证的研究以及使用衍生的非认证图表评估HMB的研究中回顾了数据。结果九项研究报告了针对碱性血红素技术的PBAC评分系统的有效性。在这些研究中，敏感性为58-97％，特异性为7.5-95.5％，阳性和阴性似然比分别为1.1-13.8和0.14-0.56，诊断比值比为2.6-52.4。进行HMB诊断的临界值在50到185之间。这些PBAC的几种修饰用于其他研究中。但是，没有客观证实其有效性。总体而言，图表设计，评分系统，诊断临界限值和治疗后结果指标。结论PBAC最适合定义了临床结果参数的临床研究的受控和特定环境。当前缺乏标准化阻碍了PBAC在初级保健中的广泛使用。复审注册号PROSPERO系统评价的国际前瞻性注册：CRD42016030083。