Quality Control and Training Software for DXA-Based Bone Densitometry

描述(申请人提供)：骨骼健康是一个日益重要的公共卫生问题。迫切需要准确和具有成本效益的工具，以应对快速增长的老年人口带来的前所未有的医疗挑战。双能X射线骨密度仪(DXA)扫描仍然是诊断和治疗骨质疏松症的骨密度成像的黄金标准-其非侵入性、定量成像过程结合了成本效益和诊断能力。然而，随着越来越多的医生提供DXA筛查测试，缺乏经验和培训可能会产生不准确或有偏见的测试。2003年，Cardea技术公司开始销售BoneStation(Tm)，这是一种基于浏览器的数据存储、报告和工作流程系统，其独特的分布式架构与DXA的量化模式完全集成在一起。这一赠款项目旨在探索一个质量控制模块，为所有骨健康医生提供一种工具，以最大限度地提高骨密度测量的准确性。Cardea技术公司的软件架构师建议测试开发附加模块DXA-Pro(Tm)(正在申请专利)的可行性，方法是与波士顿马萨诸塞州总医院骨密度中心的医生和临床统计师以及另外两名全国知名专家进行磋商。主要资源是一个从当地人口中提取的大型未识别数据库。该模块将提供计算机辅助警报式的模式和异常检测系列DXA测试，基于定量评估和算法，捕捉经验丰富的骨密度从业者的思维过程。实验设计包括定义最多六种算法，旨在检测常见的测量误差和生理异常。盲实验对照将用于验证：(1)算法(S)将应用于对照数据库和来自经验较少的骨密度中心的邻近人群的较小的未识别数据库；以及(2)被确定为正常或异常的DXA扫描的随机盲抽样将由咨询医生审查。基于统计学的方法提供了不断改进的机会：随着来自临床应用的证据的增加，软件的算法(S)可以进行调整，以提高灵敏度和使用率。该模块将用于：(1)交互式培训医生以识别DXA扫描中的问题；(2)确保准确的测试解释；(3)在任何技能水平或培训的医生中促进统一的专业知识标准；(4)提高DXA的成本效益诊断能力；以及(5)通过对患者当前骨骼健康的准确诊断为患者提供长期益处。DXA-Pro(Tm)(正在申请专利)和BoneStation(Tm)的多重优势表明，这种独特的产品可以使小型骨保健诊所迅速达到骨密度测试所需的专业水平，从而在全国范围内立即产生影响。这项SBIR第一阶段赠款申请旨在通过一种创新的基于统计的技术来满足骨质疏松症和骨骼健康准确诊断的关键市场需求，该技术有望在骨密度测试和其他保健技术中获得更广泛的商业应用。公共卫生相关性骨骼健康应该是健康衰老过程中正常的一部分，然而许多本来健康的人却容易患上骨质疏松症和骨折导致的致残后果。需要准确和具有成本效益的工具来应对前所未有的医学挑战，即了解和治疗与快速增长的老年人口相关的疾病状况。Cardea Technology Inc.建议开发一个关键的软件程序，该程序将帮助最大限度地提高每个骨骼健康医生在评估单个患者的整体骨骼健康时准确使用DXA成像的能力。

DESCRIPTION (provided by applicant): Bone health is an increasingly important public health issue. Accurate and cost-effective tools are urgently needed to face the unprecedented medical challenges of a rapidly increasing elderly population. The dual energy X-ray absorptiometry (DXA) scan remains the gold standard for bone density imaging in the diagnosis and treatment of osteoporosis-its noninvasive, quantitative imaging process combines cost effectiveness and diagnostic capability. Yet as more physicians offer DXA screening tests, a lack of experience and training can produce inaccurate or biased testing. In 2003, Cardea Technology began marketing BoneStation(tm) a browser- based data storage, reporting and workflow system whose unique distributed architecture is fully integrated with DXA's quantitative modality. This grant project aims to explore a quality control module to provide all bone health physicians a tool to maximize accuracy of bone density measurements. Cardea technology's software architects propose to test feasibility of developing the add-on module, DXA-Pro(tm) (patent pending), by working in consultation with physicians and a clinical statistician from the Bone Density Center at Massachusetts General Hospital in Boston and two other nationally prominent specialists. The principal resource is a large de-identified database drawn from a local population. The module would offer computer-assisted alert-style detection of patterns and anomalies in serial DXA tests, based on quantitative assessments and algorithms that capture the thought processes of experienced bone density practitioners. The experimental design consists of defining up to a half-dozen algorithms aimed at detecting common measurement errors and physiological anomalies. Blinded experimental controls will serve to validate: (1) the algorithm(s) will be applied to the control database and a smaller de-identified database from a closely proximate population in a less-experienced bone density center; and (2) a randomized blinded sampling of DXA scans identified as normative or anomalous will be reviewed by the consulting physicians. The statistics-based approach offers the opportunity for continuous refinement: as evidence from clinical applications grows, the software's algorithm(s) can adjust to increase sensitivity and usage. The module will be designed to: (1) interactively train physicians to recognize problems in DXA scans; (2) ensure accurate test interpretation; (3) promote a uniform standard of expertise among physicians of any skill level or training; (4) enhance DXA's cost-effective diagnostic capability; and (5) provide a long-term benefit to patients via an accurate diagnosis of their current bone health. The multiple advantages of DXA-Pro(tm) (patent pending) and BoneStation(tm) suggest this unique product could have immediate impact at a national scale by enabling small bone health clinics to rapidly achieve the required level of expertise in bone density testing. This SBIR Phase I grant application proposes to meet the crucial market need for accurate diagnosis of osteoporosis and bone health with an innovative statistics-based technique that holds the promise of wider commercial applications in bone density testing and other healthcare technologies. PUBLIC HEALTH RELEVANCE Bone health should be a normal part of the healthy aging process, yet many otherwise healthy people are subject to osteoporosis and the disabling consequences of fractures. Accurate and cost-effective tools are needed to meet the unprecedented medical challenge of understanding and treating disease conditions associated with a rapidly increasing elderly population. Cardea Technology Inc proposes to develop a key software program that will help maximize every bone health physician's ability to use DXA imaging accurately when assessing the individual patient's total bone health.