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<h1>Medical Device Research </h1>
<p>The ABS team has extensive experience conducting various strategic and tactical, prospective and retrospective research and consulting services to assess and demonstrate the value of medical devices. Examples of this work are presented here.</p>
<h2>Indications</h2>
<ul>
<li>Abdominal and colorectal surgery</li>
<li>Blood transfusion</li>
<li>Cardiac pacing and revascularization</li>
<li>Cartilage repair</li>
<li>Diabetes</li>
<li>Intraocular lenses and other devices in ophthalmology</li>
<li>In vitro fertilization</li>
<li>Minimally-invasive surgery</li>
<li>Needlestick injury </li>
<li>Overactive bladder/urinary stress incontinence </li>
<li>Pain </li>
<li>Peri-operative hypothermia </li>
<li>Spinal fusion and implants </li>
<li>Surgical complications </li>
<li>Wound healing</li>
</ul>
<h2>Strategic Consulting and Research Examples</h2>
<ul>
<li>Strategic analysis of office-based surgery for a spinal implant </li>
<li>Strategic outcomes and economic research plan in minimally-invasive heart procedures </li>
<li>Strategic outcomes research and reimbursement plan in vitro fertilization </li>
<li>Systematic review of the economic and quality of life burden of needlestick injuries</li>
</ul>
<h2>Selected Prospective Studies</h2>
<ul>
<li>Global registries in cartilage repair, coronary revascularization and urinary stress incontinence </li>
<li>Patient registry in percutaneous coronary intervention </li>
<li>Phase IV clinical trial of longitudinal outcomes in colorectal surgical procedures </li>
<li>Global longitudinal outcomes survey of a cardiovascular device </li>
<li>Insulin pen patient satisfaction study</li>
<li>Clinical and economic assessment of a medical device to prevent peri-operative hypothermia</li>
<li>Pre-market approval (PMA) trial of an intraocular lens</li>
</ul>
<h2>Selected Retrospective Studies</h2>
<ul>
<li>Analysis of use of analgesic paste and pain outcomes using medical chart data </li>
<li>Analysis of use of cardiac procedures and outcomes in acute myocardial infarction in the U.S. and Canada </li>
<li>Employer data analysis of use and outcomes of implantable direct current stimulation for lumbar spinal fusion </li>
<li>Longitudinal Medicare analysis of outcomes following open colorectal and general surgical procedures </li>
<li>Multiple Medicare analyses of use and outcomes of surgical procedures for urinary stress incontinence</li>
</ul>
<h2>Selected Modeling Studies</h2>
<ul>
<li>Economic analysis of transmyocardial revascularization</li>
<li> Markov model of support surfaces for wound healing in multiple health care settings</li>
</ul>
<h2>Selected Policy Engagements</h2>
<ul>
<li>Analysis of factors affecting the diffusion of MRI technologies</li>
<li>Assessment of the impact of an electronic medical record-based clinical reminder system</li>
<li>Evaluation of rural applications of telemedicine</li>
</ul>
<h2>Selected Publications & Presentations of ABS Team Members</h2>
<p> Hu JC, Wang Q, Pashos CL, et al. Utilization and outcomes of minimally invasive radical prostatectomy. J Clin Oncol 2008; 26(14): 2278-84. </p>
<p> Anger JT, Litwin MS, Wang Q, Pashos CL, et al. Variations in stress incontinence and prolapse management by surgeon specialty. J Urol 2007; 178(4): 1411-7.</p>
<p> Anger JT, Rodriguez LV, Wang Q, Pashos CL, Litwin MS. The role of pre-operative testing on outcomes after sling surgery for stress urinary incontinence. J Urol 2007; 178 (4): 1364-9.</p>
<p> Anger JT, Litwin MS, Wang Q, Pashos CL, et al. The effect of age on outcomes after sling surgery for urinary incontinence. J Am Geriatr Soc 2007; 55(12): 1927-31.</p>
<p> Anger JT, Rodriguez LV, Wang Q, Chen E, Pashos CL, et al. Racial disparities in the surgical management of stress incontinence among female Medicare beneficiaries. J Urol 2007; 177(5): 1846-50.</p>
<p> Anger JT, Rodríguez LV, Wang Q, Pashos CL, et al. The role of provider volume on outcomes after sling surgery for stress urinary incontinence. J Urol 2007; 177(4): 1457-62.</p>
<p> Anger JT, Litwin MS, Wang Q, Pashos CL, et al. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol 2007; 109(3): 707-14.</p>
<p> Reddy P, et al. The economic impact of blue-light filtering intraocular lenses on age-related macular degeneration associated with cataract surgery: a third-party payer’s perspective. Curr Med Res Opin 2006; 22(7): 1311-18.</p>
<p> Lee WC, Nicklasson L, Cobden D, Chen E, Conway D, Pashos CL. Short term economic impact associated with occupational needlestick injuries among acute care nurses. Curr Med Res Opin 2005; 21(12): 1915-22.</p>
<p> Lee JM, Botteman MF, Nicklasson L, Cobden D, Pashos CL. Needlestick injury in acute care nurses caring for patients with diabetes mellitus: a retrospective study. Curr Med Res Opin 2005; 21(5): 741-47.</p>
<p> Cobden D, Pashos CL, et al. Needlestick injuries in the care of patients with diabetes. Life Sciences Bus & Tech Rev 2005; 5:74-76.</p>
<p> Bell CE, et al. Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States. Clin Ther 2003; 25: 2464-86.</p>
<p> Pashos CL. Designing health-related quality of life studies to meet regulatory requirements for medical devices. RAPS, Annual Meeting, Washington, DC, October 4, 2000.</p>
<p> Pashos CL. The importance of spine outcomes research. Fusions 1997; 6(2): 1-4.</p>
<p> Kahanovitz N, Pashos CL. The role of implantable direct current stimulation in the critical pathway for lumbar spinal fusion. North American Spine Society, 11th Annual Conference, Vancouver, B.C., Canada, October 25, 1996.</p>
<p> Kahanovitz N, Pashos CL. The role of implantable direct current stimulation in the critical pathway for lumbar spinal fusion. J Care Management 1996; 2(6): 46-58.</p>
<p> Ahmed WH, Pashos CL, et al. 30-day and one-year mortality in hemodialysis patients undergoing coronary revascularization: Results from a national cohort. AHA, 68th Scientific Sessions, Anaheim, CA, November 13-16, 1995.</p>
<p> Lamas GA, Pashos CL, et al. Effect of pacing mode on first hospitalization for atrial fibrillation, stroke, or heart failure in Medicare pacemaker patients. North American Society of Pacing and Electrophysiology, 16th Annual Scientific Sessions, Boston, MA, May 4, 1995.</p>
<p> Lamas GA, Pashos CL, et al. Permanent pacemaker selection and subsequent survival in elderly Medicare pacemaker recipients. Circulation 1995; 51(4): 1063-69.</p>
<p> </p>
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