A Photo-based Menstrual Blood Loss Metric

摘要 在美国，大约30%的育龄妇女患有AUB和相关的 严重子宫出血(月经过多)的症状，这是一种月经紊乱，严重损害生活质量和 每年的经济负担为370亿美元。患有AUB的女性在社会、身体、 和休闲活动，并因工作缺勤和在家而招致巨大的个人经济负担 管理成本(每年2,000美元)。尽管这种疾病的发病率很高，但临床医生依赖于 月经痛苦的女性对自己的月经失血量进行主观自我评估 (MBL)，已被证明不能准确诊断，并可能导致不必要的手术。vt.给出 这些症状占所有就诊妇科医生的三分之一，选择适当的 治疗疗程对于为美国人提供高质量的护理至关重要。当前量化MBL的方法 有限制其使用的主要缺陷。碱性血色素(AH)检测是法规要求的标准 用于客观量化MBL的机构。不幸的是，AH检测对于常规的临床实践是不切实际的，因为 它很昂贵(每个周期约1000美元)，而且接受性很差，需要患者收集所有用过的卫生用品 并将其邮寄到实验室进行分析。而图片失血评估表(PBLACs)则提供 这是一种成本较低的半定量MBL定量方法，具有较高的假阳性率 结果(~59%)，易误诊为月经过多。为了满足对经济高效、简单易用的 为了使用客观的方法来量化绝经前妇女的MBL，TheraNova开发了一种手机-- 基于诊断工具的电子MBL日记(EMBLD)。此前，在一项概念验证临床研究中，我们 证明eMBLD和AH测试之间有很强的相关性，这是客观的金标准方法 MBL的量化。此第二阶段提案的目标是确定我们的设备对 准确诊断月经过多。首先，我们将验证图像处理算法对 准确量化月经正常和月经过多的女性的MBL(具体目标1)。第二，我们将进行 一项关键的临床研究，以验证eMBLD诊断月经过多的有效性(特定目标2)。这个 获得的数据将支持FDA 510(K)的批准，并将使我们能够在四年内将该系统商业化 这项提案的资金来源。

Abstract In the United States, approximately 30% of reproductive aged women suffer from AUB and the associated symptom of heavy uterine bleeding (menorrhagia), a menstrual disorder that drastically impairs quality of life and has an annual economic burden of $37 billion. Women afflicted by AUB experience limitations in social, physical, and leisure activities, and incur a substantial personal financial burden due to work absence and home management costs (>$2,000 per year). Despite the high prevalence of this medical condition, clinicians rely on women who are distressed by their menses to give a subjective self-assessment of their menstrual blood loss (MBL), which has proven to be unreliable for accurate diagnosis and can lead to unnecessary surgery. Given that these symptoms account for one-third of all office visits to the gynecologist, choosing an appropriate treatment course is critical for providing high-quality care to Americans. Current methods for quantifying MBL have key drawbacks that limit their use. Alkaline hematin (AH) testing is the standard required by regulatory bodies for objective quantification of MBL. Unfortunately, AH testing is impractical for routine clinical practice as it is expensive (~$1000 per cycle) and has poor acceptability, requiring patients to collect all used sanitary products and mail them to a lab facility for analysis. While pictorial blood loss assessment charts (PBLACs) offer a less costly, semi-quantitative method for MBL quantification, they demonstrate a high rate of false positive results (~59%), which leads to the over-diagnosis of menorrhagia. To address the need for a cost-effective, easy- to-use, and objective method to quantify MBL in premenopausal women, TheraNova has developed a cell phone- based diagnostic tool, the electronic MBL Diary (eMBLD). Previously, in a proof of concept clinical study, we demonstrated a strong correlation between eMBLD and AH testing, the gold-standard method for objective quantification of MBL. The goals of this Phase II proposal are to determine the effectiveness of our device for accurately diagnosing menorrhagia. First, we will verify the sensitivity of the image processing algorithm to accurately quantify MBL in women with both normal and heavy menses (Specific Aim 1). Second, we will conduct a pivotal clinical study to validate the effectiveness of eMBLD for diagnosing menorrhagia (Specific Aim 2). The data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within four years of the funding of this proposal.