Research

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Introduction: IONmed Systems’ core tool, the Bone Safety Evaluation (BSE) was developed to measure physical performance of patients with osteoporosis during ordinary movements and the risk of these movements on skeletal health. The reliability and validity of the BSE has been evaluated across multiple independent studies including mathematical modeling for spine loading.  Below is a combined description of these studies and findings.


  1. 1.Interrater Reliability

  2. 2.Test-retest Reliability

  3. 3.Construct Validity

  4. Balance Construct of  Safe Functional Motion Test

  5. Functional Performance Construct of the Safe Functional Motion Test

  6. Strength and Flexibility Construct of the Safe Functional Motion Test

  7. Quality of Life Construct of the Valued Activities Checklist

  8. Medication Adherence Construct of the Medication Adherence Assessment

  9. 4.BSE Measures Change Pre-Post Assessment

Settings/Evaluation Description:  For all the studies conducted, the BSE was administered at the United Osteoporosis Centers (UOC) in Gainesville, GA or Hiawassee, GA.  The Bone Safety Evaluation is a battery of three novel assessments and standard measurement components.  The battery consists of the Safe Functional Motion Test (9 activities of daily living and 1 simulated emergency task are performed and scored for strength, flexibility, balance and spinal compression); the Valued Activities Checklist (survey of activities performed and physical symptoms present during those activities), and the Osteoporosis Medication Adherence Questionnaire (OMAQ) with actual adherence assessment (OMAQ-MAS) and risk-based assessment (OMAQ-MAA).  The risk-based assessment is comprised of 21 questions addressing lifestyle, medication issues, osteoporosis awareness and cognitive risk factors affecting medication adherence).  Additionally the BSE collects physical symptoms data (measurements of height, weight, spine curve, pain and dizziness). The BSE yields performance and risk reports.

Outcomes Measures:  The Bone Safety Evaluation is believed to measure multiple dimensions of function.  The outcome measures selected across the studies included:  Berg Balance Test, Timed Up and Go, Community Balance and Mobility Scale, Computerized Dynamic Posturography, Modified Test of Sensory Interaction on Balance, manual muscle testing, range of motion testing, Physical Performance Test, Morisky Green (medication adherence assessment) and the ECOS-16 (Assessment of health related quality of life in osteoporosis).

Overview of Results of Studies:  Interrater Reliability for the Safe Functional Motion Test  ranged from  .86 to .98.  Test-retest reliability of the SFM is excellent (ICC range 0.89-0.90, SEM = 1.85 to 2.0).  Results from the SFM test has been demonstrated to be a surrogate marker for vertebral fracture (p<.0001; OR-.826).  Construct convergent validity of the balance domain was established with Berg Balance Test, Timed Up and Go, Community Balance and Mobility Scale, computerized dynamic posturography and Modified Test of Sensory Interaction and Balance: Spearman rho= .69, .76, .82, .62, and.45, (with one outlier removed) respectively.  Construct validity with the ECOS-16, a quality of life questionnaire, was significant at r =-0.86; p<.0001.  The SFM measured a significant improvement in the performance of patients with osteoporosis given instruction in safe motion (t=3.33, p<. 02).  Investigation of the OMAQ-MAA Risk Factor Section demonstrated excellent reliability ICC= .955 and interrater reliability investigation of the OMAQ-MAS also revealed excellent reliability (ICC=1.00).  Convergent construct validity of the OMAQ-MAA revealed that as patients reported more risk factors on the OMAQ, adherence on the Morisky-Green Test (a test of medication adherence) declined (Spearman rho correlation coefficient of -.56).

Conclusions:  The BSE is a valid and reliable physical performance assessment of vertebral fracture risk, physical functioning, medication adherence and quality of life in patients with osteoporosis.  The assessment is useful for evaluating balance, spinal compression and activity level associated with quality of life.  Components of the BSE could be used for both clinical and research purposes to measure and track physical performance and quality of life in patients with osteoporosis

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