Home based digital urinalysis in antenatal pathway

Healhy.io将在皇家联合医院巴斯NHS基金会信托基金的100名女性中测试基于智能手机的家庭尿液测试，用于产前护理。我们的目标是评估支持智能手机的家庭尿液分析与家庭血压测量相结合，如何通过更早地检测到蛋白尿来提高患者的安全性，通过避免面对面的访问来减少对医疗服务的需求，并以经济高效和可扩展的方式改善患者体验。Healhy.io‘s使用计算机视觉和以用户为中心的设计，是第一家将智能手机摄像头转变为临床级医疗设备的公司。我们的尿液分析产品(Dip.io)是首个获得CE认证和FDA批准的智能手机自动尿液分析设备。该设备围绕10个参数的试纸、自我检测套件和智能手机应用程序构建，使非专业用户能够在舒适的家中自检尿液中的蛋白质和其他分析物质，而不会影响质量。我们的专有算法和基于云的服务允许与任何临床系统进行互操作和集成。结果立即提供给临床医生进行后续检查。血压监测和尿检是常规产前护理的一部分。我们的“产妇看护箱”结合了尿检试剂盒和血压监测仪，使女性能够在就诊前和就诊之间进行自我检测，并可靠地与助产士分享结果。这项研究将从2019年7月开始，持续12个月。将为70名妊娠无并发症的妇女和30名妊娠高血压的妇女提供一个产妇保健箱。他们将被指示在参加产前预约之前进行尿检和血压测量。怀孕高血压的妇女将接受额外的Dip.io检测试剂盒，以增加两次预约之间的检测频率。将常规检测转移到家有可能：改善妇女的体验和对其健康的参与减少常规检测所花费的预约时间，使助产士能够专注于临床和面向患者的活动。通过更频繁的家庭检测以早期发现并发症(例如先兆子痫)来降低高危怀孕的风险。在妊娠晚期(如果结果正常)，高危妊娠所需的日间评估单元就诊次数减少高达60%。将电子结果直接嵌入临床记录。该模型已在非NHS医疗保健环境中实施，并从患者和临床医生那里获得了积极的反馈。这项研究将评估该模型在国民健康保险制度下的可行性和可接受性，以产生证据来帮助衡量创新，进行产品改进，并测试由Kent Surrey和Sussex AHSN设计的预算影响模型。

Healthy.io will be testing smartphone-based home urine testing for antenatal care in 100 women in the Royal United Hospitals Bath NHS Foundation Trust. We aim to assess how smartphone-enabled home urinalysis, combined with home blood pressure measurement, improves patient safety through proteinuria earlier detection, reducing demand on health services by avoiding face-to-face visits and improving patient experience in a cost-effective and scalable way.Using computer vision and user-centric design, Healthy.io's is the first company to turn the smartphone camera into a clinical-grade medical device. Our urinalysis product (Dip.io) is the first CE accredited and FDA cleared smartphone-enabled automated urinalysis device. Built around the 10 parameter dipstick, a self-testing kit and a smartphone application, the device enables lay users to self-test for protein and other analytes in their urine, in the comfort of their home, with no quality compromise. Our proprietary algorithm and cloud-based service allow for interoperability and integration with any clinical system. Results are immediately available to clinicians for follow-up.Blood pressure monitoring and urinalysis are part of routine antenatal care. Our 'maternity care box' combines our urinalysis test kit and a blood pressure monitor enabling women to self-test before and if needed, between visits and reliably share results with their midwife.The study will last 12 months starting July 2019. A maternity care box will be offered to 70 women with uncomplicated pregnancies and 30 women with hypertensive pregnancies. They'll be instructed to conduct the urine test and BP measure before attending their antenatal appointment. Women with hypertensive pregnancies will receive additional Dip.io test kits to increase testing frequency between appointments. Shifting routine testing to the home has the potential to:Improve women's experience and involvement in their healthReduce appointment time spent on routine testing to enable midwives to focus on clinical and patient-facing activity.Mitigate against risks in at-risk pregnancies through more frequent home testing to early detect complications (e.g. preeclampsia).reduce up to 60% of Day Assessment Unit visits needed for at-risk pregnancies during the third trimester (if normal results).Embed electronic results directly into clinical record.This model has been implemented in non-NHS healthcare settings and has received positive feedback from both patients and clinicians. This study will evaluate the feasibility and acceptability of the model in an NHS setting, to generate evidence to help scale the innovation, make product improvements and test the Budget Impact Model designed by Kent Surrey & Sussex AHSN.