BMD Predicts Fracture Risk Ten Year Fracture Probability (%) 50 40 30 20 10 Age 80 70 60 50 E. Michael Lewiecki, MD Director, New Mexico Clinical Research & Osteoporosis Center Director, Bone TeleHealth ECHO University of New Mexico Health Sciences Center Albuquerque, New Mexico, USA 0 1.0 0.5 0.0-0.5-1.0-1.5-2.0-2.5-3.0-3.5-4.0 Femoral Neck T-score Probability of first fracture of hip, distal forearm, proximal humerus, and symptomatic vertebral fracture in women of Malmö, Sweden. Adapted from Kanis JA et al. Osteoporosis Int. 2001;12:989-995. Dual-energy X-ray Absorptiometry: DXA Bone Mineral Density (BMD) Diagnosis Fracture Risk (including FRAX/TBS) Monitor Vertebral Fracture Assessment (VFA) Trabecular Bone Score (TBS) Hip Structural Analysis (HSA) Body Composition (Body Comp) What is the problem? Too many bad DXAs Bad DXAs can harm patients 1
DXA Quality Gap Leads to Adverse Clinical Outcomes Watts NB. 2004. Fundamentals and pitfalls of bone densitometry using dual-energy X-ray absorptiometry (DXA). Osteoporos Int. 15:847 854. Lewiecki EM, Binkley N, Petak SM. 2006. DXA quality matters. J Clin Densitom. 9:388 392. Lewiecki EM, Lane NE. 2008. Common mistakes in the clinical use of bone mineral density testing. Nat Clin Pract Rheumatol. 4:667 674. Messina C, Bandirali M, Sconfienza LM et al. 2015. Prevalence and type of errors in dual-energy X-ray absorptiometry. Eur Radiol. 25:1504 1511. Binkley N et al. 2016. Error prevalence in DXA performance and reporting: Improving DXA quality is essential. ISCD Annual Meeting. Galway, Ireland. Poster presentation. Borges JLC, Haddad LP, Lewiecki EM. 2016. Bone Loss or a Case of Mistaken Gender? J Clin Exp Orthop. 2:20. Percent of Women Age 65+ 26% 24% 22% 20% 18% 16% 14% 12% 10% US Hip Fracture Trends 2002-2015 884 $139 Hip Fracture Rates DXA Medicare Payments Osteoporosis Diagnosis DXA Testing $82 14,391 additional hip fractures $576 million additional expenses 2,878 additional deaths 13.2% 17.9% $42 11.3% 738 693 14.8% 900 850 800 750 700 650 600 550 500 Fractures per 100,000 Women Age 65+ Age-adjusted to the 2014 Age Distribution Lewiecki EM et al. ASBMR Oral Presentation #1077. 2016. Low DXA Reimbursement Leads to Poor DXA Quality Losing money with DXA No investment in education and training Suboptimal DXA studies Inappropriate clinical decisions Potential harm to patients: higher medical expenses, unnecessary lab tests, wrong treatment, fractures that might have been prevented Open access: download FREE at www.iscd.org 2
DXA Quality the degree to which DXA measurements and interpretation are consistent with current professional standards to facilitate desired health outcomes is NOT... A comprehensive list of all features that characterize a high quality DXA facility A substitute for appropriate education, certification, and accreditation The only means of addressing the many unmet needs in the care of patients with osteoporosis is... A guide and expectation for DXA supervisors, technologists, interpreters, and clinicians A set of essential markers that are consistent with high quality DXA Intended to aid patients, referring providers, and payers in recognizing high quality DXA services Applicable worldwide for adult and pediatric DXA (according to local circumstances and countryspecific standards) Expected to evolve over time as new data emerge and new standards are developed Methodology ISCD Position Development Conferences held regularly since 2001, with rigorous reviews of best medical evidence evaluated by international panels of experts ISCD Official Positions, developed with modified RAND Corporation and UCLA method (RAM) for recent PDCs Written, reviewed, and vetted by numerous experts in adult and pediatric DXA worldwide, including the ISCD Scientific Advisory Committee, and approved by the ISCD 3
How to use if you are NOT a bone densitometrist Ask about the following Certification for DXA tech and interpreter Facility accreditation Precision assessment has been done and least significant change is known Look at the report Make and model of DXA instrument are identified One diagnosis per patient, not different diagnosis for each skeletal site One fracture risk assessment per patient, not different one for each skeletal site Look at the images Spine positioning and vertebral body labeling Hip positioning Comparing apples with apples How to use if you are a bone densitometrist Download Be familiar with it Follow the recommendations Be trained and stay updated Get certified (if not already) Facility accreditation is the best way to demonstrate that high quality DXA is being performed 1.1. At least one practicing DXA technologist, and preferably all, has a valid certification in bone densitometry. 4
1.2. Each DXA technologist has access to the manufacturer s manual of technical standards and applies these standards for BMD measurement. 1.4. The DXA facility must comply with all applicable radiation safety requirements. 1.3. Each DXA facility has detailed standard operating procedures for DXA performance that are updated when appropriate and available for review by all key personnel. 1.5. Spine phantom BMD measurement is performed at least once weekly to document stability of DXA performance over time. BMD values must be maintained within a tolerance of ±1.5%, with a defined ongoing monitoring plan that defines a correction approach when the tolerance has been exceeded. 5
1.6. Each DXA technologist has performed in vivo precision assessment according to standard methods and the facility LSC has been calculated. 2.1. At least 1 practicing DXA interpreter, and preferably all, has a valid certification in bone densitometry. 1.7. The LSC for each DXA technologist should not exceed 5.3% for the lumbar spine, 5.0% for the total proximal femur, and 6.9% for the femoral neck. 2.2. The DXA manufacturer and model are noted on the report. 6
2.3. The DXA report includes a statement regarding scan factors that may adversely affect acquisition/analysis quality and artifacts/confounders, if present. 2.5. There is a single diagnosis reported for each patient, not a different diagnosis for each skeletal site measured. 2.4. The DXA report identifies the skeletal site, region of interest, and body side for each technically valid BMD measurement. 2.6. A fracture risk assessment tool is used appropriately. 7
2.7. When reporting differences in BMD with serial measurements, only those changes that meet or exceed the LSC are reported as a change. Summary High quality DXA is essential for correct diagnostic classification, optimal fracture risk assessment, and BMD monitoring provide a framework for DXA supervisors, technologists, interpreters, and clinicians to achieve and assess DXA quality are expected to evolve with advances in medical evidence and changes in standards 8