A Photo-based Menstrual Blood Loss Metric

基于照片的月经失血量指标

• 批准号: 10693342
• 负责人: Daniel Rogers Burnett
• 金额: $ 60.86万
• 依托单位: THERANOVA, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10693342
• 关键词: Address; Agreement; Algorithmic Analysis; Algorithms; American; Area; Blood Stains; Blood Volume; Blood specimen; Cellular Phone; Classification; Clinical; Clinical Research; Computer software; Data; Devices; Diagnosis; Disease; Distress; Economic Burden; Electronics; Evaluation; Financial Hardship; Funding; Future; Goals; Gynecologist; Hematin; Hemorrhage; High Prevalence; Home; Hospitals; Hysterectomy; Image Analysis; Impairment; Laboratories; Leisure Activities; Light; Measurement; Medical; Menorrhagia; Menstruation; Menstruation Disturbances; Methods; Multicenter Studies; Office Visits; Participant; Patients; Perception; Phase; Physical activity; Physicians; Pilot Projects; Positioning Attribute; Premenopause; Procedures; Qualifying; Quality of Care; Quality of life; Random Allocation; Reporting; Research; Self Assessment; Sensitivity and Specificity; Series; Small Business Innovation Research Grant; Specificity; Surface; Symptoms; System; Tampons; Techniques; Testing; United States; Unnecessary Surgery; Uterine hemorrhage; Woman; Work; accurate diagnosis; accurate diagnostics; aged; associated symptom; clinical decision-making; clinical diagnosis; clinical practice; commercialization; cost; cost effective; cost estimate; diagnostic accuracy; diagnostic tool; diaries; effectiveness evaluation; effectiveness validation; experience; experimental study; image processing; innovation; mobile application; portability; prevent; reproductive; seal; social; tool

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.

抽象的 在美国，大约 30% 的育龄妇女患有 AUB 及相关疾病 严重子宫出血（月经过多）的症状，这是一种严重损害生活质量的月经失调， 每年的经济负担为370亿美元。患有 AUB 的女性在社交、身体、 和休闲活动，并因工作缺勤和居家而造成巨大的个人经济负担 管理费用（每年 >2,000 美元）。尽管这种疾病的患病率很高，但临床医生仍依赖 因月经而苦恼的女性对经期失血量进行主观自我评估 （MBL），已被证明对于准确诊断来说是不可靠的，并且可能导致不必要的手术。给定 这些症状占所有妇科医生就诊的三分之一，选择合适的 治疗过程对于为美国人提供高质量的护理至关重要。目前量化 MBL 的方法 具有限制其使用的主要缺点。碱性血红素 (AH) 测试是监管机构要求的标准 MBL 客观量化机构。不幸的是，AH 测试对于常规临床实践来说是不切实际的，因为 它价格昂贵（每个周期约 1000 美元）且可接受性较差，需要患者收集所有用过的卫生用品 产品并将其邮寄到实验室设施进行分析。虽然图形失血量评估图 (PBLAC) 提供 一种成本较低的 MBL 定量半定量方法，它们表现出较高的假阳性率 结果（~59%），导致月经过多的过度诊断。为了满足对具有成本效益、简单的 TheraNova 开发了一种用于量化绝经前女性 MBL 的客观方法 基于诊断工具，电子 MBL 日记 (eMBLD)。此前，在概念验证临床研究中，我们 证明了 eMBLD 和 AH 测试之间存在很强的相关性，AH 测试是客观的黄金标准方法 MBL 的量化。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过多的女性的 MBL（具体目标 1）。其次，我们将进行 一项关键临床研究，旨在验证 eMBLD 诊断月经过多的有效性（具体目标 2）。这 获得的数据将支持 FDA 510(k) 审批，并使我们能够在四年内将该系统商业化 该提案的资金来源。