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％的生殖老年妇女患有AUB和相关的妇女 子宫出血（月经）的症状是一种月经疾病，会严重损害生活质量和 年度经济负担为370亿美元。妇女受到社会，身体，身体经验限制的妇女 和休闲活动，并因工作缺席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）。尽管这种医疗疾病的患病率很高，但临床医生依靠 因月经而感到沮丧的妇女，以对月经失血进行主观自我评估 （MBL），事实证明，这对于准确的诊断是不可靠的，可能导致不必要的手术。给出 这些症状占所有办公室访问妇科医生的三分之一，选择了适当的 治疗课程对于为美国人提供高质量护理至关重要。量化MBL的当前方法 具有限制其使用的关键缺点。碱性系统（AH）测试是调节的标准 物体用于MBL的客观定量。不幸的是，AH测试对于常规临床实践是不切实际的 它很昂贵（每个周期约1000美元），可接受性差，要求患者收集所有二手卫生 产品并将其邮寄到实验室设施进行分析。而绘画失血评估图（PBLAC）提供 MBL定量的成本较低，半定量的方法，它们表现出很高的假阳性率 结果（约59％），导致月经过度诊断。满足对经济高效，容易的需求 Theranova开发了一部手机，用于量化绝经前女性MBL的客观方法和客观方法 - 基于电子MBL日记（EMBLD）的诊断工具。以前，在概念临床研究的证明中，我们 表现出EMBLD和AH测试之间的密切相关性，AH测试是物镜的金标准方法 MBL的定量。该第二阶段提案的目标是确定我们设备的有效性 准确诊断月经。首先，我们将验证图像处理算法对 准确地量化具有正常月经和重度的女性的MBL（特定目标1）。其次，我们将进行 一项关键临床研究，以验证EMBLD诊断月经的有效性（特定目标2）。这 获得的数据将支持FDA 510（k）批准，并使我们能够在四年内商业化系统。 该提议的资金。