Quality Control and Training Software for DXA-Based Bone Densitometry

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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.