Quality Control and Training Software for DXA-Based Bone Densitometry

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 energ y 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 architec ture 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 p ropose 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 national ly 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 assessment s 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 expe rimental 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 sk ill 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(t m) 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 crucia l 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 Bo ne 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 challe nge 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.