MEASUREMENT STRATEGY FOR KYPHOSIS- NEW EVIDENCE FROM PATIENTS AND PHYSICIANS

Author(s)

Bayliss MS1, Miltenburger C2, Van de Maele C3, Alvares L2, Bujanover S41QualityMetric Incorporated, Lincoln, RI, USA, 2Medtronic International, Tolochenaz, VD, Switzerland, 3Medtronic - Spinal and Biologics Europe, Zaventem , Belgium, 4Medtronic, Inc., He

OBJECTIVES:   Kyphosis due at least one vertebral compression fracture (VCF) is prevalent among osteoporotic patients, resulting in well documented symptoms and impact on functioning and well-being.   Assessing health outcomes of interventions concentrates on consequences of back pain, omitting relevant aspects of increased morbidity. A three-part study led to development of a conceptual measurement framework for comprehensive assessment of symptoms, impact and treatment benefits in kyphosis. METHODS: We developed a literature-based (PubMed, Medline) Disease Model (DM) for kyphosis for selecting and developing outcome measures, as recommended by regulatory agencies.  In-depth interviews were conducted among patients (n=10) and physicians (n=10) to test the DM.  Physician respondents were PCPs or specialists currently treating patients with osteoporotic kyphosis.  Patient respondents were >50 years old with an osteoporotic VCF >= 90 days prior.  Relevant Patient-Reported Outcome instruments (PROs) were evaluated for appropriateness in this population.    RESULTS: The DM included signs, symptoms, causes/triggers, exacerbations, and functional/well-being impact of kyphosis.  The DM content was largely confirmed by all respondents, however patients offered new concepts of emotional and functional impact and clinicians discounted psychosocial concepts (well-being and sleep impairment) and added clinical evaluations of the spinal deformity.  Related to these findings, PRO instruments lacked adequate content validity or measurement properties for evaluating kyphosis outcomes. Close matches were the IOF Quality of Life questionnaire (Qualeffo-41) and the Osteoporosis Assessment Questionnaire (OPAQ), though neither includes gastrointestinal or respiratory symptoms. CONCLUSIONS: This study confirms the need for more comprehensive assessment of health outcomes in kyphosis, because  current approaches omit key concepts (gastrointestinal and respiratory symptoms) and functional impact being a major cost-driver.  A comprehensive evaluation of the severity and impact of kyphosis requires clinician evaluation of spinal deformity and patient-report of symptoms (spinal, respiratory, GI) and functional impact and a more complete understanding of the unique information provided by different measurements. 

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PMS78

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Musculoskeletal Disorders

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