A Photo-based Menstrual Blood Loss Metric

摘要 在美国，大约30%的育龄妇女患有AUB及其相关疾病。 大量子宫出血（月经过多）的症状，这是一种严重损害生活质量的月经失调， 每年的经济负担高达370亿美元。患有AUB的妇女在社会，身体， 和休闲活动，并因工作缺勤和家庭而产生巨大的个人经济负担 管理费用（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 对月经感到痛苦的妇女对月经失血量进行主观自我评估 (MBL)，这已被证明是不可靠的准确诊断，并可能导致不必要的手术。给定 这些症状占所有妇科医生办公室访问的三分之一，选择适当的 治疗过程对于为美国人提供高质量的护理至关重要。目前用于定量MBL的方法 有限制其使用的主要缺点。碱性血红素（AH）检测是监管机构要求的标准 对MBL进行客观定量的机构。不幸的是，AH测试对于常规临床实践是不切实际的， 它是昂贵的（每周期约1000美元），并具有较差的可接受性，需要病人收集所有使用过的卫生 产品并将其邮寄到实验室进行分析。虽然图形失血评估图表（PBLACs）提供了 一种成本较低的半定量MBL定量方法，它们显示出较高的假阳性率 结果：月经过多的诊断率为59%，这导致了对月经过多的过度诊断。为了满足成本效益高、简单易行的需求- 使用和客观的方法来量化绝经前妇女的MBL，TheraNova开发了一种手机- 电子MBL日记（eMBLD）。此前，在一项概念验证临床研究中， 证明了eMBLD和AH测试之间的强相关性，这是客观评估的金标准方法。 MBL的定量。本第二阶段提案的目标是确定我们的设备的有效性， 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量大的妇女的MBL（具体目标1）。第二，我们将开展 一项验证eMBLD诊断月经过多有效性的关键临床研究（具体目标2）。的 获得的数据将支持FDA 510（k）许可，并允许我们在四年内将该系统商业化 这一提案的资金来源。

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.