Development of Multi-Platform Mobile App Technology for Real-Time Measurement of Menstrual Cycle Characteristics in Adolescents

项目摘要/摘要 超过25%的青少年会出现异常子宫出血。建立规范的月经数据 出血将有助于早期诊断异常出血和早期干预，以改善健康和 生活质量。月经初潮至月经正常的持续时间和时间的最新数据 周期性是稀少的，尽管种族和肥胖对月经初潮的时间有已知的影响，但标准数据 按种族和体重指数划分的限制更大。智能手机等进步使人们能够更好地访问 并减少月经研究的障碍。在这一领域成功的技术需要 多平台应用程序(APP)，允许将符合HIPAA标准的患者级别信息直接传输到 研究人员并展示了持续的患者参与度。此R21应用程序的目标是扩展 基于我们之前的工作，开发多平台应用程序，并测试与 APP适用于种族和体重不同的青少年。这项研究的基本原理是 患者导向的即时无缝电子月经跟踪技术的发展 数据向研究人员的过渡将使月经出血的多项纵向研究得以设计 模式。拟议的工作响应了NICHD的呼吁，即“开发创新工具和 测量月经周期特征的技术，如出血、疼痛和月经不规律。这个 这个应用的具体目标是：1)开发一个多平台的月经跟踪应用程序来测量月经程度 出血持续时间、不规则性、疼痛部位和严重程度(痛经)，以及心理社会影响 2)在六个月内测试患者对该应用程序的满意度、遵从性和持续参与度 10-14岁女性的前瞻性队列研究，评估患者年龄、种族和体重的影响 关于这些结果的索引。拟议的工作是创新的，因为我们的技术允许将 向多个领域的研究人员提供患者级别的月经数据，我们的患者群体包括年轻人 不同种族和体重的青少年。完成此R21奖励将产生以下预期结果 结果：1)多平台月经跟踪应用程序，具有高患者可用性和满意度，以及2) 论证了移动电子月经跟踪在青少年中的可行性和初步可持续性。 这些结果将导致提交R01申请，以利用此处创建的技术来执行 青春期月经出血模式的种族和体重标准的纵向评估 进步。这项拟议的工作意义重大，因为它将产生一种新的技术应用，可以 在我们的研究团队和其他人未来的多项研究中使用，以建立正常的范围 跨年龄段和跨人群的月经周期特征，并测量患者报告 异常子宫出血干预措施的临床试验结果。

PROJECT SUMMARY / ABSTRACT Abnormal uterine bleeding occurs in over 25% of adolescents. Establishing normative data for menstrual bleeding would facilitate earlier diagnosis of abnormal bleeding and earlier interventions to improve health and quality of life. Current data on duration and timing from menarche to the establishment of normal menstrual cyclicity are sparse, and despite the known impact of race and obesity on timing of menarche, normative data by race and body mass index are even more limited. Advancements such as smart phones enable greater access to adolescents and decrease barriers to research on menstruation. Successful technology in this arena requires a multi-platform application (app) that allows for transfer of HIPAA-compliant patient-level information directly to researchers and demonstrates sustained patient engagement. The objective of this R21 application is to expand upon our prior work by developing a multi-platform application, and testing compliance and engagement with the app in younger adolescents with diversity in race and body weight. The rationale for this research is that development of patient-directed electronic menstrual tracking technology with immediate and seamless transition of data to researchers will enable the design of multiple longitudinal studies of menstrual bleeding patterns. The proposed work is responsive to the NICHD's call for the “development of innovative tools and technologies to measure menstrual cycle characteristics such as bleeding, pain, and menstrual irregularity.” The specific aims of this application are: 1) develop a multi-platform menstrual tracking app to measure the degree and duration of bleeding, irregularity, location and severity of pain (dysmenorrhea), and the psychosocial impact of menses; and 2) test patient satisfaction, compliance, and sustained engagement with the app in a six-month prospective cohort study of 10-14 year-old females, and evaluate the impact of patient age, race and body mass index on these outcomes. The proposed work is innovative because our technology allows for the transfer of patient-level menstrual data to investigators on a variety of domains and our patient population includes young adolescents of diverse race and body weight. Completion of this R21 award will yield the following expected outcomes: 1) a multi-platform menstrual tracking app with high patient usability and satisfaction ratings, and 2) demonstration of the feasibility and initial sustainability of mobile electronic menstrual tracking in adolescents. These outcomes will lead to submission of an R01 application to utilize the technology herein created to perform a longitudinal assessment of race and weight-based norms of menstrual bleeding patterns during pubertal progression. The proposed work is significant because it will yield a new application of technology that can be used in multiple future research studies by our research team and others to both establish normal ranges of menstrual cycle characteristics across the age spectrum and across populations, and measure patient-reported outcomes in clinical trials of interventions for abnormal uterine bleeding.