Current Landscape for Global Regulatory Acceptance of Real-World Evidence for Medical Devices | Endovascular Today | Kenneth Cavanaugh, PhD; Aaron Lottes, PhD; Melanie Raska; Alexia Bwensa; Megan Estes, PhD; Misti Malone, PhD; Rajesh Shah, MD; and Marti Velezis | August 2023 |
Consensus Minimum Core Data Elements Adapted to Peripheral Vascular Intervention in the Drug-Eluting Era: Consensus Report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways “Lean” Working Group | Journal of Vascular Surgery | James H. Black 3rd MD a, Donna Buckley MD b, Martha Velezis b, Jens Eldrup-Jorgensen MD c, Nina D. Serratore PhD d, Jorge A. Gutierrez MD e, Eleni Whatley PhD b, Rebecca Marmor MD a, Daniel J. Bertges MD f, James E. Tcheng MD e, Sara Royce PhD b, Misti Malone PhD b, Andrew Farb MD b, Eric A. Secemsky MD g, Sahil A. Parikh MD h, Joshua Smale i, Michael R. Jaff DO j, Roseann White k, Rebecca W. Wilgus e, Mitchell W. Krucoff MD e | 2023 |
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks | | Sedrakyan A, Marinac-Dabic, D., Campbell, B., Aryal, S., et al. | |
Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia. | | Raizenne BL, Zheng X, Mao J, et al. | |
Validation of an indirect linkage algorithm to combine registry data with Medicare claims. | | Mao J, Moore KO, Columbo JA, Mehta KS, Goodney PP, Sedrakyan A | |
Development and Usability Testing of a Mobile Application to Monitor Patient-Reported Outcomes after Stress Urinary Incontinence Surgery | | Chughtai B, Cho A, Simonyan V, et al. | |
Safety and efficacy of TURP vs. laser prostatectomy for the treatment of benign prostatic hyperplasia in multi-morbid and elderly individuals aged ≥ 75 | | Bouhadana D, Nguyen DD, Zhang X, et al | |
Safety and Efficacy of Outpatient Surgical Procedures for the Treatment of Benign Prostatic Enlargement in New York State and California (2005-2016) | | Stoddard MD, Zheng X, Mao J, Te A, Sedrakyan A, Chughtai B | |
Society for Vascular Surgery Vascular Quality Initiative. Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices | | Bertges DJ, Eldrup-Jorgensen J, Robbins S, Ssemaganda H, Malone M, Marinac-Dabic D, Smale J, Lottes AE, Majithia A, Resnic FS | |
Food and Drug Administration Safety Communication on the Use of Transvaginal Mesh in Pelvic Organ Prolapse Repair Surgery: The Impact of Social Determinants of Health | Female Pelvic Med Reconstr Surg | Mao J, Chughtai B, Ibrahim S, Sedrakyan A | |
Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial | | Krpata DM, Petro CC, Prabhu AS, Tastaldi L, Zolin S, Fafaj A, Rosenblatt S, Poulose BK, Pierce RA, Warren JA, Carbonell AM, Goldblatt MI, Stewart TG, Olson MA, Rosen MJ | |
Association of Sex With Risk of 2-Year Revision Among Patients Undergoing Total Hip Arthroplasty | | Chen A, Paxton L, Zheng X, et al | |
Association between Hospital Volume and Failure to Rescue after Open or Endovascular Repair of Intact Abdominal Aortic Aneurysms in the VASCUNET and International Consortium of Vascular Registries | | D'Oria M, Scali S, Mao J, Szeberin Z, Thomson I, Beiles B, Stone D, Sedrakyan A, Eldrup N, Venermo M, Cassar K, Altreuther M, Boyle JR, Behrendt CA, Beck AW, Mani K | |
Long-Term Safety with Sling Mesh Implants for Stress Incontinence | | Chughtai B, Mao J, Matheny ME, Mauer E, Banerjee S, Sedrakyan A | |
Registry Assessment of Peripheral Interventional Devices Objective Performance Goals for Superficial Femoral and Popliteal Artery Peripheral Vascular Interventions | J Vasc Surg | Bertges DJ, White R, Cheng Y-C, Sun T, Ramkumar N, Goodney PP, Wilgus RW, Lottes AE, Smale JA, Drozda J, Raska M, Heise T, Jones WS, Tcheng JE, Eldrup-Jorgensen J, Sedrakyan A, Malone ML, Marinac-Dabic D, Thatcher R, Morales P, Krucoff MW, Cronenwett JL1. Bertges DJ, White R, Cheng Y-C, Sun T, Ramkumar N, Goodney PP, Wilgus RW, Lottes AE, Smale JA, Drozda J, Raska M, Heise T, Jones WS, Tcheng JE, Eldrup-Jorgensen J, Sedrakyan A, Malone ML, Marinac-Dabic D, Thatcher R, Morales P, Krucoff MW, Cronenwett JL | 2020 |
The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An Effort to Advance Evidence Evaluation for Vascular Devices | J Vasc Surg | Tsougranis G, Eldrup-Jorgensen J, Bertges D, Schermerhorn M, Morales P, Williams S, Bloss R, Simons J, Deery SE, Scali S, Roche-Nagle G, Mureebe L, Mell M, Malas M, Pullin B, Stone DH, Malone M, Beck AW, Wang G, Marinac-Dabic D, Sedrakyan A, Goodney PP | 2020 |
Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis | European Journal of Vascular and Endovascular Surgery | Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kölbel T, Debus ES | 2020 |
Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures | Circ Cardiovasc Qual Outcomes | Resnic FS, Majithia A, Dhruva SS, Ssemaganda H, Robbins S, Marinac-Dabic D, Hewitt K, Ohno-Machado L, Reynolds MR, Matheny ME | 2020 |
Characterizing Reimbursements for Medicare Patients Receiving Endovascular Abdominal Aortic Aneurysm Repair at Vascular Quality Initiative Centers | Annals of Vascular Surgery | Trooboff SW, Wanken ZJ, Gladders B, Lucas BP, Moore KO, Barnes JA, Sedrakyan A, Columbo JA, Suckow BD, Stone DH, Goodney PP | 2020 |
Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data | Journal of the American Heart Association | Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac-Dabic D, Sedrakyan A, Normand ST, Krumholz HM, Ross JS. | 2020 |
Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set | Plast Reconstr Surg | Spronk PER, Begum H, Vishwanath S, Crosbie A, Earnest A, Elder E, Lumenta DB, Marinac-Dabic D, Moore CCM, Mureau MAM, Perks G, Pusic AL, Stark B, von Fritschen U, Klein H, Cooter RD, Rakhorst HA, Hopper I | 2020 |
Association of Sex With Repair Type and Long-term Mortality in Adults With Abdominal Aortic Aneurysm | JAMA Network Open | Ramkumar N, Suckow BD, Arya S, Sedrakyan A, Mackenzie TA, Goodney PP, Brown JR. | 2020 |
Predictors of bleeding or anemia requiring transfusion in complex endovascular aortic repair and its impact on outcomes in health insurance claims | Journal of Vascular Surgery | Behrendt CA, Debus ES, Schwaneberg T, Rieß HC, Dankhoff M, Makaloski V, Sedrakyan A, Kölbel T | 2020 |
Performance of Sacral Neuromodulation and OnabotulinumtoxinA for Overactive Bladder: Focus on Safety and Cost | Journal of Urology | Chughtai B, Clemens JQ, Thomas D, Sun T, Ghomrawi H, Sedrakyan A. | 2020 |
Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data | Journal of the American Heart Association | Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac-Dabic D, Sedrakyan A, Normand ST, Krumholz HM, Ross JS | 2020 |
Mortality After Paclitaxel Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery in the Vascular Quality Initiative | Circulations: Cardiovascular Interventions | Bertges DJ, Sedrakyan A, Sun T, Eslami MH, Schermerhorn M, Goodney PP, Beck AW, Cronenwett JL, Eldrup-Jorgensen J | 2020 |
Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies | BMJ SIT | Gregory Pappas, Jesse Berlin, Erika Avila-Tang, John Carroll, Joseph Drozda, Douglas Dumont, Thomas Gross, Kathleen Hewitt, Ajay Kirtane, David Kong, Mitchell Krucoff, John Lashinger, Nellie Lew, Michael Mack, Fred Masoudi, Danica Marinac-Dabic, Roxanna Mehran, Sharon-Lise Normand, Elizabeth Quin, Fred Resnic, Art Sedrakyan, Ronald Waksman, Larry Wood, Changfu Wu and Tianay Ziegler | 2019 |
Evidence-Based Strategies And Recommendations For Preservation Of Central Venous Access In Children | Journal of Parenteral and Enteral Nutrition | Baskin KM, Mermel LA, Saad TF, Journeycake JM, Schaefer CM, Modi BP, Vrazas JI, Gore B, Drews BB, Doellman D, Kocoshis SA, Abu-Elmagd KM, Towbin RB; Venous Access: National Guideline and Registry Development (VANGUARD) Initiative Affected Persons Advisory Panel | 2019 |
Claims-Based Surveillance For Reintervention After Endovascular Aneurysm Repair Among Non-Medicare Patients | Journal of Vascular Surgery | Columbo JA, Kang R, Hoel AW, Kang J, Leinweber KA, Tauber KS, Hila R, Ramkumar N, Sedrakyan A, Goodney PP. | 2019 |
Gender Disparities In Fenestrated And Branched Endovascular Aortic Repair | European Journal of Cardio-Thoracic Surgery | Henrik Christian Rieß; Eike Sebastian Debus; Thea Schwaneberg; Art Sedrakyan; Tilo Kölbel; Nikolaos Tsilimparis; Axel Larena-Avellaneda; Christian-Alexander Behrendt | 2019 |
Comparative Safety Of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance Of The NCDR CathPCI Registry | Circulation: Cardiovascular Quality and Outcomes | Majithia Arjun; Matheny Michael E; Paulus Jessica K; Marinac-Dabic Danica; Robbins Susan; Ssemaganda Henry; Hewitt Kathleen; Ponirakis Angelo; Loyo-Berrios Nilsa; Moussa Issam; Drozda Joseph; Normand Sharon-Lise; Resnic Frederic S | 2019 |
Seven-Year Outcomes After Hysteroscopic And Laparoscopic Sterilizations | Obstetrics & Gynecology | Mao, Jialin; Guiahi, Maryam; Chudnoff, Scott; Schlegel, Peter; Pfeifer, Samantha; Sedrakyan, Art | 2019 |
Challenging The Myth: Transvaginal Mesh Is Not Associated With Carcinogenesis | Journal of Urology | Chughtai B, Sedrakyan A, Mao J, Thomas D, Eilber KS, Clemens JQ, Anger JT | 2018 |
Sex-Based Assessment Of Patient Presentation, Lesion Characteristics, And Treatment Modalities In Patients Undergoing Peripheral Vascular Intervention | Circulation: Cardiovascular Interventions | Ramkumar N, Suckow BD, Brown JR, Sedrakyan A, Cronenwett JL, Goodney PP | 2018 |
Sex-Based Assessment Of Patient Presentation, Lesion Characteristics, And Treatment Modalities In Patients Undergoing Peripheral Vascular Intervention | Circulation: Cardiovascular Interventions | Ramkumar N, Suckow BD, Brown JR, Sedrakyan A, Cronenwett JL, Goodney PP | 2018 |
Variation In Transfusion Practices And The Association With Perioperative Adverse Events In Patients Undergoing Open Abdominal Aortic Aneurysm Repair And Lower Extremity Arterial Bypass In The Vascular Quality Initiative | Annals of Vascular Surgery | Osborne Z, Hanson K, Brooke BS, Schermerhorn M, Henke P, Faizer R, Schanzer A, Goodney P, Bower T, DeMartino RR | 2018 |
Registry Assessment Of Peripheral Interventional Devices (RAPID): Registry Assessment Of Peripheral Interventional Devices Core Data Elements | Journal of Vascular Surgery | W. SchuylerJones MD, Mitchell W.Krucoff MD, PabloMorales MD, Rebecca W.Wilgus RN MSN, Anne H.Heath BA, Mary F.Williams BS, James E.Tcheng MD, J. Danica Marinac-Dabic MD PhD, Misti L.Malone PhD, Terrie L.Reed MS, Rie Fukaya MMedSc, Robert A. Lookstein MD, Nobuhiro Handa MD, Herbert D. Aronow MD MPH, Daniel J. Bertges MD, Michael R. Jaff DO, Thomas T. Tsai MD MSc, Joshua A. Smale BS, Margo J. Zaugg BSN, Robert J. Thatcher MBA, Jack L. Cronenwett MD | 2018 |
SPEED: A New Initiative In Real-World PAD Evidence Evaluation An Overview Of The FDA’s New Multistakeholder Project To Support Real-World Evidence Evaluation For Devices Aimed At Treating Peripheral Artery Disease | Endovascular Today | Misti Malone | 2018 |
No Increased Risk Of Carcinogenesis With Mesh-Based Hernia Repairs | The American Journal of Surgery | Chughtai B, Sedrakyan A, Thomas D, Mao J, Eilber KS, Clemens JQ, Anger JT | 2018 |
Development Of A Nationally Representative Coordinated Registry Network For Prostate Ablation Technologies | Journal of Urology | Ron Golan; Adrien Bernstein; Art Sedrakyan; Timothy J. Daskivich; Dongyi T. Du; Behfar Ehdaie; Benjamin Fisher; Michael A. Gorin; Ivan Grunberger; Bradley Hunt; Hongying H. Jiang; Hyung L. Kim; Danica Marinac-Dabic; Leonard S. Marks; Timothy D. McClure; Jeffrey S. Montgomery; Dipen J. Parekh; Sanoj Punnen; Stephen Scionti; Charles J. Viviano; John T. Wei; Sven Wenske; James S. Wysock; John Rewcastle; Mark Carol; Marc Oczachowski; Jim C. Hu | 2018 |
Comparing Long-Term Mortality After Carotid Endarterectomy Vs Carotid Stenting Using A Novel Instrumental Variable Method For Risk Adjustment In Observational Time-To-Event Data | JAMA Network Open | Jesse A. Columbo; Pablo Martinez-Camblor; Todd A. MacKenzie; Douglas O. Staiger; Ravinder Kang; Philip P. Goodney; A. James O’Malley | 2018 |
Trends In Use Of Risk-Reducing Mastectomy In A Context Of Celebrity Decisions And Media Coverage: An Observational Study In The United States And Australia | Health Services Research | Mao J, Jorm L, Sedrakyan A | 2018 |
Failures Of Sacral Neuromodulation For Incontinence | JAMA Surgery | Chughtai B, Thomas D, Sun T, Sedrakyan A | 2018 |
Reoperation After Breast-Conserving Surgery For Cancer In Australia: Statewide Cohort Study Of Linked Hospital Data | BMJ Open | van Leeuwen MT, Falster MO, Vajdic CM, Crowe PJ, Lujic S, Klaes E, Jorm L, Sedrakyan A | 2018 |
Registry Assessment Of Peripheral Interventional Devices (RAPID): Registry Assessment Of Peripheral Interventional Devices Core Data Elements | Circulation Journal: official journal of the Japanese Circulation Society | W. Schuyler Jones MD, Mitchell W.Krucoff MD, PabloMorales MD, Rebecca W.Wilgus RN MSN, Anne H.Heath BA, Mary F.Williams BS, James E.Tcheng MD, J. Danica Marinac-Dabic MD PhD, Misti L.Malone PhD, Terrie L.Reed MS, Rie Fukaya MMedSc, Robert A. Lookstein MD, Nobuhiro Handa MD, Herbert D. Aronow MD MPH, Daniel J. Bertges MD, Michael R. Jaff DO, Thomas T. Tsai MD MSc, Joshua A. Smale BS, Margo J. Zaugg BSN, Robert J. Thatcher MBA, Jack L. Cronenwett MD | 2018 |
National Trends In Open Surgical, Endovascular, And Branched-Fenestrated Endovascular Aortic Aneurysm Repair In Medicare Patients | Journal of Vascular Surgery | Suckow BD, Goodney PP, Columbo JA, Kang R, Stone DH, Sedrakyan A, Cronenwett JL, Fillinger MF | 2017 |
Factors Affecting Operative Time And Outcome Of Carotid Endarterectomy In The Vascular Quality Initiative | Journal of Vascular Surgery | DeMartino RR, Huang Y, Mandrekar J, Goodney PP, Oderich GS, Kalra M, Bower TC, Cronenwett JL, Gloviczki P | 2017 |
Adjusting For Bias Introduced By Instrumental Variable Estimation In The Cox Proportional Hazards Model | Journal of Vascular Surgery | Martínez-Camblor P, Mackenzie T, Staiger DO, Goodney PP, O’Malley AJ | 2017 |
Perioperative Clopidogrel Is Associated With Increased Bleeding And Blood Transfusion At The Time Of Lower Extremity Bypass | Journal of Vascular Surgery | Jones DW, Schermerhorn ML, Brooke BS, Conrad MF, Goodney PP, Wyers MC, Stone DH | 2017 |
Association Of Very Low-Volume Practice With Vascular Surgery Outcomes In New York | Annals of Vascular Surgery | Mao J, Goodney P, Cronenwett J, Sedrakyan A | 2017 |
Insight Into The Cerebral Hyperperfusion Syndrome Following Carotid Endarterectomy From The National Vascular Quality Initiative | Journal of Vascular Surgery | Wang GJ, Beck AW, DeMartino RR, Goodney PP, Rockman CB, Fairman RM | 2017 |
Regional Variation In Postoperative Myocardial Infarction In Patients Undergoing Vascular Surgery In The United States | Annals of Vascular Surgery | Steely AM, Callas PW, Neal D, Scali ST, Goodney PP, Schanzer A, Cronenwett JL, Bertges DJ | 2017 |
Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation In Older Adults: Results From The National Cardiovascular Data Registry | Journal of the American Geriatrics Society | Kramer DB, Reynolds MR, Normand SL, Parzynski CS, Spertus JA, Mor V, Mitchell SL | 2017 |
Significant Regional Variation Exists In Morbidity And Mortality After Repair Of Abdominal Aortic Aneurysm | Journal of Vascular Surgery | Zettervall SL, Soden PA, Buck DB, Cronenwett JL, Goodney PP, Eslami MH, Lee JT, Schermerhorn ML | 2017 |
Can Machine Learning Complement Traditional Medical Device Surveillance? A Case-Study Of Dual-Chamber Implantable Cardioverter–Defibrillators | Medical Devices: Evidence and Research | Ross JS, Bates J, Parzynski CS, Akar JG, Curtis JP, Desai NR, Freeman JV, Gamble GM, Kuntz R, Li SX, Marinac-Dabic D, Masoudi FA, Normand SLT, Ranasinghe I, Shaw RE, Krumholz HM | 2017 |
Long-Term Postprocedural Outcomes Of Palliative Emergency Stenting Vs Stoma In Malignant Large-Bowel Obstruction | JAMA Surgery | Abelson JS, Yeo HL, Mao J, Milsom JW, Sedrakyan A. | 2017 |
Constructing The Informatics And Information Technology Foundations Of A Medical Device Evaluation System: A Report From The FDA Unique Device Identifier Demonstration | Journal of the American Medical Informatics Association | Drozda, Joseph P.; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E. | 2017 |
A Pilot Study For Long-Term Outcome Assessment After Aortic Aneurysm Repair Using Vascular Quality Initiative Data Matched To Medicare Claims | Journal of Vascular Surgery | Hoel AW, Faerber AE, Moore KO, Ramkumar N, Brooke BS, Scali ST, Sedrakyan A, Goodney PP | 2017 |
Early Extubation Is Associated With Reduced Length Of Stay And Improved Outcomes After Elective Aortic Surgery In The Vascular Quality Initiative | Journal of Vascular Surgery | David RA, Brooke BS, Hanson KT, Goodney PP, Genovese EA, Baril DT, Gloviczki P, DeMartino RR | 2017 |
Registry-Based Prospective, Active Surveillance Of Medical-Device Safety | New England Journal of Medicine (NEJM) | Frederic S. Resnic, M.D., Arjun Majithia, M.D., Danica Marinac-Dabic, M.D., Ph.D., Susan Robbins, B.S., Henry Ssemaganda, M.D., Kathleen Hewitt, M.S.N., Angelo Ponirakis, Ph.D., Nilsa Loyo-Berrios, Ph.D., Issam Moussa, M.D., Joseph Drozda, M.D., Sharon-Lise Normand, Ph.D., and Michael E. Matheny, M.D., M.P.H. | 2017 |
Concurrent Renal Artery Stent During Endovascular Infrarenal Aortic Aneurysm Repair Confers Higher Risk For 30-Day Acute Renal Failure | Journal of Vascular Surgery | Nejim B, Arhuidese I, Rizwan M, Khalil L, Locham S, Zarkowsky D, Goodney P, Malas MB. | 2017 |
External Validation Of A 5-Year Survival Prediction Model After Elective Abdominal Aortic Aneurysm Repair | Journal of Vascular Surgery | DeMartino RR, Huang Y, Mandrekar J, Goodney PP, Oderich GS, Kalra M, Bower TC, Cronenwett JL, Gloviczki P | 2017 |
Use Of Endpoint Adjudication To Improve The Quality And Validity Of Endpoint Assessment For Medical Device Development And Post Marketing Evaluation: Rationale And Best Practices. A Report From The Cardiac Safety Research Consortium | American Heart Journal | Jonathan H Seltzer, MD, MA, MBA; Ted Heise, Phd, RAC; Peter Carson, MD; Daniel Canos, PhD, MPH; Jo Carol Hiatt, MD, MBA; Pascal Vranckx, MD, PhD; Thomas Christen, MD, PhD; Donald E Cutlip, MD | 2017 |
Regulator Loss Functions And Hierarchical Modeling For Safety Decision Making | Medical Decision Making | Hatfield LA, Baugh CM, Azzone V, Normand S-LT | 2017 |
Variations In Abdominal Aortic Aneurysm Care: A Report From The International Consortium Of Vascular Registries | Circulation | Adam W. Beck, Art Sedrakyan, Jialin Mao, Maarit Venermo, Rumi Faizer, Sebastian Debus, Christian-Alexander Behrendt, Salvatore Scali, Martin Altreuther, Marc Schermerhorn, Barry Beiles, Zoltán Szeberin, Nikolaj Eldrup, Gudmundur Danielsson, Ian Thomson, Pius Wigger, Martin Björck, Jack L. Cronenwett, Kevin Mani, on behalf of the International Consortium of Vascular Registries | 2016 |
IDEAL-D: A Rational Framework For Evaluating And Regulating The Use Of Medical Devices | BMJ | Sedrakyan, Art; Campbell, Bruce; Merino, Jose G; Kuntz, Richard; Hirst, Allison; McCulloch, Peter | 2016 |
Perioperative Outcomes, Health Care Costs, And Survival After Robotic-Assisted Versus Open Radical Cystectomy: A National Comparative Effectiveness Study | European Urology | Hu, Jim C; Chughtai, Bilal; O’Malley, Padraic; Halpern, Joshua A; Mao, Jialin; Scherr, Douglas S; Hershman, Dawn L; Wright, Jason D; Sedrakyan, Art | 2016 |
Comparison Of Open, Laparoscopic, And Robotic Colectomies Using A Large National Database: Outcomes And Trends Related To Surgery Center Volume | Diseases of the Colon & Rectum | Yeo HL, Isaacs AJ, Abelson JS, Milsom JW, Sedrakyan A | 2016 |
Adverse Event Triggered Event Reporting For Devices: Report Of A Food And Drug Administration–Supported Feasibility Pilot Of Automated Adverse Event Reporting | Journal of Clinical Engineering | Reed, Terrie L. MS; Levy, Daniel MS; Steen, Leslie Tompkins PhD; Roach, James BCS; Taylor, Thomas BA; Call, Karen PT, MBA; Marion, Jill MS, MBA; Drozda, Joseph P. Jr MD | 2016 |
Handling Incomplete Correlated Continuous And Binary Outcomes In Meta-Analysis Of Individual Participant Data | Statistics in Medicine | Manuel Gomes, Laura Hatfield, Sharon-Lise Normand | 2016 |
Renal Dysfunction and the Associated Decrease in Survival after Elective Endovascular Aneurysm Repair | Journal of Vascular Surgery | Zarkowsky DS, Hicks CW, Bostock IC, Stone DH, Eslami M, Goodney PP | 2016 |
High-Intensity Focused Ultrasound For Prostate Cancer: Novelty Or Innovation? | JAMA | Hu, Jim C; Laviana, Aaron; Sedrakyan, Art | 2016 |
Transvenous ICD Lead Performance: A Meta-Analysis Of Observational Studies | Journal of the American Heart Association | R. Providência, D. Kramer, D. Pimenta, G. G. Babu, L.A. Hatfield, A. Ioannou, J. Novak, R. Hauser, and P. Lambiase | 2016 |
Dual Antiplatelet Therapy Reduces Stroke But Increases Bleeding At The Time Of Carotid Endarterectomy | Journal of Vascular Surgery | Jones DW, Goodney PP, Conrad MF, Nolan BW, Rzucidlo EM, Powell RJ, Cronenwett JL, Stone DH | 2016 |
Advancing Medical Device Innovation Through Collaboration And Coordination Of Structured Data Capture Pilots: Report From The Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank | Healthcare | Terrie L. Reed, Joseph P. Drozda Jr., Kevin M. Baskinc, James Tcheng, Karen Conway, Natalia Wilson, Danica Marinac-Dabic, Theodore Heise, Mitchell W. Krucoff | 2016 |
Minimally Invasive Surgery And Sphincter Preservation In Rectal Cancer | Journal of Surgical Research | Yeo HL, Abelson JS, Mao J, Cheerharan M, Milsom J, Sedrakyan A | 2016 |
The Mercy Unique Device Identifier Demonstration Project: Implementing Point Of Use Product Identification In The Cardiac Catheterization Laboratories Of A Regional Health System | Healthcare | Joseph P. Drozda Jr., Curtis Dudley, Paul Helmering, James Roach, Lisa Hutchison | 2016 |
An In Silico Framework For Integrating Epidemiologic And Genetic Evidence With Healthcare Applications: Ventilation-Related Pneumothorax As A Case Illustration | JAMIA | Torosyan, Yelizaveta, Hu, Yuzhi, Hoffman, Sarah, Luo, Qianlai, Carleton, Bruce, Marinac-Dabic, Danica | 2016 |
Geographic And Temporal Variation In Implanted Electric Devices To Treat Heart Failure | Journal of the American Heart Association | L.A. Hatfield, D. B. Kramer, M. Volya, M. Reynolds, and S-L. T. Normand | 2016 |
Registry Assessment Of Peripheral Interventional Devices (RAPID) | Endovascular Today (EVOTODAY) | Jose Pablo Morales, MD; Jack Cronenwett, MD; And Robert Thatcher, MBA | 2016 |
Long Term Survival With Stereotactic Ablative Radiotherapy (SABR) Versus Thoracoscopic Sublobar Lung Resection In Elderly People: National Population Based Study With Propensity Matched Comparative Analysis | BMJ | Paul, Subroto; Lee, Paul C; Mao, Jialin; Isaacs, Abby J; Sedrakyan, Art | 2016 |
Need For A National Evaluation System For Health Technology | JAMA | Jeffrey Shuren, MD, JD; Robert M. Califf, MD | 2016 |
Report On Device Safety Recommends Unique Device Identifiers (UDI) | US News and World Report (Associated Press), The New York Times, The Wall Street Journal | null | 2016 |
Vascular Quality Initiative. Relationships Between 2-Year Survival, Costs, And Outcomes Following Carotid Endarterectomy In Asymptomatic Patients In The Vascular Quality Initiative | Annals of Vascular Surgery | Wallaert JB, Newhall KA, Suckow BD, Brooke BS, Zhang M, Farber AE, Likosky D, Goodney PP | 2016 |
Need For A National Evaluation System For Health Technology | New England Journal of Medicine (NEJM) | Jeffrey Shuren, MD, JD; Robert M. Califf, MD | 2016 |
Hospice Use Following Implantable Cardioverter-Defibrillator Implantation In Older Patients: Results From The National Cardiovascular Data Registry | Circulation | Kramer D, Reynolds M, Normand S-L, Parzynski C, Spertus J, Mor V, Mitchell S. | 2016 |
Dual Antiplatelet Therapy Reduces Stroke But Increases Bleeding At The Time Of Carotid Endarterectomy | Journal of Vascular Surgery | Jones DW, Goodney PP, Conrad MF, Nolan BW, Rzucidlo EM, Powell RJ, Cronenwett JL, Stone DH | 2016 |
An Overview Of Statistical Approaches For Comparative Effectiveness Research | Methods in Comparative Effectiveness Research | Lauren Kunz, Sherri Rose, Sharon-Lise Normand | 2015 |
Post-Market Clinical Research Conducted By Medical Device Manufacturers: A Cross-Sectional Survey | Medical Devices: Evidence and Research | Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM | 2015 |
Use And Risks Of Surgical Mesh For Pelvic Organ Prolapse Surgery In Women In New York State: Population Based Cohort Study | BMJ | Chughtai, Bilal; Mao, Jialin; Buck, Jessica; Kaplan, Steven; Sedrakyan, Art | 2015 |
Strengthening Patient Care: Building an Effective national Medical Device Surveillance System | Report | | 2015 |
Transvenous Implantable Cardioverter-Defibrillator Lead Reliability: Implications For Postmarket Surveillance | Journal of the American Heart Association | D.B. Kramer, L. Hatfield, D. McGriff, C.R. Ellis, M.T. Gura, M. Samuel, L.K. Retel, R.G. Hauser | 2015 |
Meta-Analysis Of Survival Curve Data Using Distributed Health Data Networks: Application To Hip Arthroplasty Studies Of The International Consortium Of Orthopaedic Registries | Research Synthesis Methods | Cafri, Guy; Banerjee, Samprit; Sedrakyan, Art; Paxton, Elizabeth; Furnes, Ove; Graves, Stephen; Marinac-Dabic, Danica | 2015 |
Characteristics Of Clinical Studies Conducted Over The Total Product Life Cycle Of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval In 2010 And 2011 | JAMA | Rathi VK, Krumholz HM, Masoudi FA, Ross JS | 2015 |
Mesh Use In Surgery For Pelvic Organ Prolapse | BMJ | Barber, Matthew D | 2015 |
Comparative Effectiveness Of Cardiac Implantable Electrical Devices | Heart | Daniel Kramer, Laura Hatfield, Sharon-Lise Normand | 2015 |
Editorial: Arthroplasty Devices: Registries And Beyond | Clinical Orthopaedics and Related Research | Torosyan, Y., Kurtz, S.M., Mihalko, W.M., Marinac-Dabic, D., Rimnac, C.M.; Editorial: arthroplasty devices: registries and beyond | 2015 |
Implementing Unique Device Identification In Electronic Health Record Systems: Organizational, Workflow, And Technological Challenges | Medical Care | Campion, Thomas R JR; Johnson, Stephen; Paxton, Elizabeth; Mushlin, Alvin; Sedrakyan, Art | 2015 |
Clipping And Coiling Of Unruptured Intracranial Aneurysms Among Medicare Beneficiaries, 2000 To 2010 | Stroke | Jalbert JJ, Isaacs AJ, Kamel H, & Sedrakyan A. | 2015 |
Population-Based Estimates Of The Prevalence Of Uterine Sarcoma Among Patients With Leiomyomata Undergoing Surgical Treatment | JAMA Surgery | Mao, Jialin ; Pfeifer,Samantha; Zheng, Xi Emily; Schlegel, Peter; Sedrakyan, Art | 2015 |
Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks | Journal of the American Medical Association | Mitchell W. Krucoff, MD; Art Sedrakyan, MD, PhD; Sharon-Lise T. Normand, PhD | 2015 |
A Population-Based Analysis Of Robotic-Assisted Mitral Valve Repair | The Annals of Thoracic Surgery | Paul, Subroto; Isaacs, Abby; Jalbert, Jessica; Osakwe, Nonso; Salemi, Arash; Girardi, Leonard; Sedrakyan, Art | 2015 |
Combining Randomized Trial Data To Estimate Heterogeneous Treatment Effects | | Hatfield, Laura; Kramer, Daniel; Normand, Sharon-Lise | 2015 |
Long-Term Clinical Outcomes Of Silzone Era St. Jude Medical Mechanical Heart Valves | Journal of Heart Valve Disease | Brennan JM, Zhao Y, Williams J, O’Brien S, Dokholyan R, Gammie J, Edwards F, Loyo-Berrios N, Canos D, Gross T, Marinac-Dabic D, Peterson E. | 2015 |
Why Interoperability Matters | Report | American Hospital Association | 2015 |
Recommendations For A National Medical Device Evaluation System. Stratigically Coordinated Registry Networks To Bridge Clinical Care And Research | Report | Medical Device Registry Task Force & the Medical Devices Epidemiology Network | 2015 |
Regulatory Warnings And Use Of Surgical Mesh In Pelvic Organ Prolapse | JAMA Internal Medicine | | 2015 |
Comparative Effectiveness Of Cardiac Resynchronization Therapy Defibrillators Versus Standard Implantable Defibrillators In Medicare Patients | The American Journal of Cardiology | Zusterzeel R, Caños DA, Sanders WE, Silverman H, MaCurdy TE, Worrall CM, Kelman J, Marinac-Dabic D, Strauss DG | 2015 |
National Trends In Utilization And In-Hospital Outcomes Of Mechanical Versus Bioprosthetic Aortic Valve Replacements | The Journal of Thoracic and Cardiovascular Surgery | Isaacs, Abby; Shuhaiber, Jeffrey; Salemi, Arash; Isom, O. Wayne; Sedrakyan, Art | 2015 |
Characterizing The Evolution Of Perioperative Outcomes And Costs Of Endovascular Abdominal Aortic Aneurysm Repair | Journal of Vascular Surgery | Salzler GG, Meltzer AJ, Mao J, Isaacs A, Connolly PH, Schneider DB, Sedrakyan A | 2015 |
FDA Draft Guidance: Adaptive Designs For Medical Device Clinical Studies | | | 2015 |
National Projections Of Time, Cost And Failure In Implantable Device Identification: Consideration Of Unique Device Identification Use | Healthcare | Wilson N, Broatch J, Jehn M, Davis C. | 2015 |
Safety And Efficacy Of Hysteroscopic Sterilization Compared With Laparoscopic Sterilization: An Observational Cohort Study | BMJ | Mao J, Pfeifer S, Schlegel P, & Sedrakyan A. | 2015 |
Meta-Analysis Of Rate Ratios With Differential Follow-Up By Treatment Arm: Inferring Comparative Effectiveness Of Medical Devices | Statistics in Medicine | Kunz, Laura; Normand, Sharon-Lise; Sedrakyan, Art | 2015 |
Robotic Surgery: Revisiting “No Innovation Without Evaluation” | BMJ | Paul, Subroto; McCulloch, Peter; Sedrakyan, Art | 2014 |
International Comparative Evaluation Of Knee Replacement With Fixed Or Mobile-Bearing Posterior-Stabilized Prostheses | Journal of Bone and Joint Surgery, American Volume | Graves, Stephen; Sedrakyan, Art; Baste, Valborg; Gioe, Terence; Namba, Robert; Martínez Cruz, Olga; Stea, Susanna; Paxton, Elizabeth; Banerjee, Samprit; Isaacs, Abby; Robertsson, Otto | 2014 |
Prevalence And Outcomes Of Anatomic Lung Resection For Hemoptysis: An Analysis Of The Nationwide Inpatient Sample Database. | The Annals of Thoracic Surgery | Paul, Subroto; Andrews, Weston; Nasar, Abu; Port, Jeffrey L.; Lee, Paul C.; Stiles, Brendon M.; Sedrakyan, Art; Altorki, Nasser K. | 2014 |
A Different Point Of View On Sex And Risk Of Hip Implant Failure And Failure Rate In Women—Reply | JAMA Internal Medicine | Inacio, Maria CS; Paxton, Elizabeth W.; Sedrakyan, Art | 2014 |
Safety Of Robotic Prostatectomy Over Time: A National Study Of In-Hospital Injury | Journal of Endourology | Chughtai Bilal, Isaacs Abby J., Mao Jialin, Lee Richard, Te Alexis, Kaplan Steven, and Sedrakyan Art. | 2014 |
Revision Total Hip And Knee Arthroplasty Implant Identification: Implications For Use Of Unique Device Identification 2012 AAHKS Member Survey Results | The Journal of Arthroplasty | Wilson NA, Jehn M, York S, Davis CM | 2014 |
Medical Device Research At A Regional Health System | Asian Hospital and Healthcare Management | Joseph P Drozda and Timothy R Smith | 2014 |
Long Term Survival With Thoracoscopic Versus Open Lobectomy: Propensity Matched Comparative Analysis Using SEER-Medicare Database | BMJ | Subroto Paul, Abby J Isaacs, Tom Treasure, Nasser K Altorki, Art Sedrakyan | 2014 |
A Distributed Health Data Network Analysis Of Survival Outcomes: The International Consortium Of Orthopaedic Registries Perspective | Journal of Bone and Joint Surgery, American Volume | Banerjee, Samprit; Cafri, Guy; Isaacs, Abby; Graves, Stephen; Paxton, Elizabeth; Marinac-Dabic, Danica; Sedrakyan, Art | 2014 |
Which Implant Should We Use For Primary Total Hip Replacement? A Systematic Review And Meta-Analysis | Journal of Bone and Joint Surgery, American Volume | Keurentjes, J Christiaan; Pijls, Bart; Van Tol, Floris; Mentink, Jill; Mes, Stephanie; Schoones, Jan; Fiocco, Marta; Sedrakyan, Art; Nelissen, Rob | 2014 |
Comparative Effectiveness Of Drug-Eluting Stents On Long-Term Outcomes In Elderly Patients Treated For In-Stent Restenosis: A Report From The National Cardiovascular Data Registry | Catheterization and Cardiovascular interventions | Kutcher, Michael A.; Brennan, J. Matthew; Rao, Sunil V.; Dai, David; Anstrom, Kevin J.; Mustafa, Nowwar; Sedrakayan, Art | 2014 |
Distributed Analysis Of Hip Implants Using Six National And Regional Registries: Comparing Metal-On-Metal With Metal-On-Highly Cross-Linked Polyethylene Bearings In Cementless Total Hip Arthroplasty In Young Patients | Journal of Bone and Joint Surgery, American Volume | Furnes, Ove; Paxton, Elizabeth; Cafri, Guy; Graves, Stephen; Bordini, Barbara; Comfort, Thomas; Rivas, Moises Coll; Banerjee, Samprit; Sedrakyan, Art | 2014 |
The Food And Drug Administration’s Unique Device Identification System Better Postmarket Data On The Safety And Effectiveness Of Medical Devices | JAMA | Rising J, Moscovitch B. | 2014 |
Long Term Safety Of Sacral Nerve Modulation In Medicare Beneficiaries | Neurology and Urodynamics | Chughtai Bilal I., Simma-Chiang Vannita, Lee Richard, Isaacs Abby, Te Alexis E., Kaplan Steven A., and Sedrakyan Art. | 2014 |
National And International Postmarket Research And Surveillance Implementation: Achievements Of The International Consortium Of Orthopaedic Registries Initiative | Journal of Bone and Joint Surgery, American Volume | Sedrakyan, Art; Paxton, Elizabeth; Graves, Stephen; Love, Rebecca; Marinac-Dabic, Danica | 2014 |
Comparative Effectiveness Of Ceramic-On-Ceramic Implants In Stemmed Hip Replacement: A Multinational Study Of Six National And Regional Registries | Journal of Bone and Joint Surgery, American Volume | Sedrakyan, Art; Graves, Stephen; Bordini, Barbara; Pons, Miguel; Havelin, Leif; Mehle, Susan; Paxton, Elizabeth; Barber, Thomas; Cafri, Guy | 2014 |
National Study Of Utilization Of Male Incontinence Procedures | Urology and Nerodynamics | Chughtai, Bilal, Art Sedrakyan, Abby J. Isaacs, Jialin Mao, Richard Lee, Alexis Te, and Steven Kaplan | 2014 |
Comparative Effectiveness Of Robotic-Assisted Vs Thoracoscopic Lobectomy. | Journal of Endourology | Subroto Paul, MD, FCCP; Jessica Jalbert, PhD, MD; Abby J. Isaacs, MS; Nasser K. Altorki, MD, FCCP; O. Wayne Isom, MD; Art Sedrakyan, MD, PhD | 2014 |
Most Frequent Operating Room Procedures Performed In U.S. Hospitals, 2003-2012 | Healthcare Cost and Utilization Project | Kathryn R. Fingar, Carol Stocks, Audrey J. Weiss, and Claudia A. Steiner | 2014 |
International Comparative Evaluation Of Fixed-Bearing Non-Posterior-Stabilized And Posterior-Stabilized Total Knee Replacements | Journal of Bone and Joint Surgery, American Volume | Comfort, Thomas; Baste, Valborg; Froufe, Miguel Angel; Namba, Robert; Bordini, Barbara; Robertsson, Otto; Cafri, Guy; Paxton, Elizabeth; Sedrakyan, Art; Graves, Stephen | 2014 |
Risk Of Revision Following Total Hip Arthroplasty: Metal-On-Conventional Polyethylene Compared With Metal-On-Highly Cross-Linked Polyethylene Bearing Surfaces: International Results From Six Registries | Journal of Bone and Joint Surgery, American Volume | Paxton, Elizabeth; Cafri, Guy; Havelin, Leif; Stea, Susanna; Pallisó, Francesc; Graves, Stephen; Hoeffel, Daniel; Sedrakyan, Art | 2014 |
Journal Of Bone And Joint Surgery, Vol 96, Issue Supplement 1 | Journal of Bone & Joint Surgery, Vol 96. Supplement 1 – International Consortium of Orthopedic Registries | | 2014 |
Extracorporeal Membrane Oxygenation In Adults: A Brief Review And Ethical Considerations For Nonspecialist Health Providers And Hospitalists | Journal of Hospital Medicine | Meltzer, Ellen C., Natalia S. Ivascu, Cathleen A. Acres, Meredith Stark, James N. Kirkpatrick, Subroto Paul, Art Sedrakyan, and Joseph J. Fins. | 2014 |
Survivorship Of Hip And Knee Implants In Pediatric And Young Adult Populations: Analysis Of Registry And Published Data | Journal of Bone and Joint Surgery, American Volume | Sedrakyan, Art; Romero, Lucas; Graves, Stephen; Davidson, David; de Steiger, Richard; Lewis, Peter; Solomon, Michael; Vial, Robyn; Lorimer, Michelle | 2014 |
Review Of Clinical Outcomes-Based Anchors Of Minimum Clinically Important Differences In Hip And Knee Registry-Based Reports And Publications | The Journal of Bone and Joint Surgery | Romero, Lucas, Nieuwenhuijse, Marc, Carr, Andrew, & Sedrakyan, Art | 2014 |
Implementing Unique Device Identification In Electronic Health Record Systems: Organizational, Workflow, And Technological Challenges | Medical Care | Campion Jr, Thomas R., Stephen B. Johnson, Elizabeth W. Paxton, Alvin I. Mushlin, and Art Sedrakyan | 2014 |
Appraisal Of Evidence Base For Introduction Of New Implants In Hip And Knee Replacement: A Systematic Review Of Five Widely Used Device Technologies | BMJ | Nieuwenhuijse, Marc; Nelissen, Robert; Schoones, Jan; Sedrakyan, Art | 2014 |
Trends And Utilization Of Laser Prostatectomy In Ambulatory Surgical Procedures For The Treatment Of Benign Prostatic Hyperplasia In New York State (2000-2011). | Journal of Endourology | Chughtai Bilal I., Simma-Chiang Vannita, Lee Richard, Isaacs Abby, Te Alexis E., Kaplan Steven A., and Sedrakyan Art. | 2014 |
Effect Of Femoral Head Size On Metal-On-HXLPE Hip Arthroplasty Outcome In A Combined Analysis Of Six National And Regional Registries | Journal of Bone and Joint Surgery, American Volume | Allepuz, Alex; Havelin, Leif; Barber, Thomas; Sedrakyan, Art; Graves, Stephen; Bordini, Barbara; Hoeffel, Daniel; Cafri, Guy; Paxton, Elizabeth | 2014 |
Sex And Risk Of Hip Implant Failure: Assessing Total Hip Arthroplasty Outcomes In The United States | JAMA Internal Medicine | Inacio, Maria CS; Ake, Christopher F.; Paxton, Elizabeth W.; Khatod, Monti; Wang, Cunlin; Gross, Thomas P.; Kaczmarek, Ronald G.; Marinac-Dabic, Danica; Sedrakyan, Art | 2014 |
Safety And Effectiveness Of Endovascular Therapy For Claudication In Octogenarians | Annals of Vascular Surgery | Jones, Douglas W., Jeffrey J. Siracuse, Ashley Graham, Peter H. Connolly, Art Sedrakyan, Darren B. Schneider, and Andrew J. Meltzer | 2014 |
Comparative Safety Of Endovascular And Open Surgical Repair Of Abdominal Aortic Aneurysms In Low-Risk Male Patients | Journal of Vascular Surgery | Siracuse, Jeffrey J., Heather L. Gill, Ashley R. Graham, Darren B. Schneider, Peter H. Connolly, Art Sedrakyan, and Andrew J. Meltzer | 2014 |
Application Of The IDEAL Framework To Robotic Urologic Surgery | European Urology | Dahm, Philipp; Sedrakyan, Art; McCulloch, Peter | 2014 |
Precarious Innovation Of Anti-Infective Coated Devices | The Lancet | Sedrakyan, Art | 2014 |
International Comparative Evaluation Of Knee Replacement With Fixed Or Mobile Non-Posterior-Stabilized Implants | Manage "Publications (Publications)" Collection Edit Live Data Sync Journal of Bone and Joint Surgery, American Volume | Namba, Robert; Graves, Stephen; Robertsson, Otto; Furnes, Ove; Stea, Susanna; Puid-Verdié, Lluis; Hoeffel, Daniel; Cafri, Guy; Paxton, Elizabeth; Sedrakyan, Art | 2014 |
Unique Device Identifiers For Coronary Stent Postmarket Surveillance And Research: A Report From The Food And Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration | The American Heart Journal | Tcheng, James; Crowley, Jay; Tomes, Madris; Reed, Terrie; Dudas, Joseph; Thompson, Kweli; Garratt, Kirk; Drozda, Joseph Jr.; on behalf of the MDEpiNet UDI Demonstration Expert Workgroup | 2014 |
ECMO As An Emergency Medical Countermeasure | The Lancet Respiratory Medicine | Paul, Subroto, Bruce Campbell, Ellen C. Meltzer, and Art Sedrakyan. | 2014 |
The International Registry Infrastructure For Cardiovascular Device Evaluation And Surveillance | JAMA | Sedrakyan, Art; Marinac-Dabic, Danica; Holmes, David R. | 2014 |
Multinational Comprehensive Evaluation Of The Fixation Method Used In Hip Replacement: Interaction With Age In Context | Journal of Bone and Joint Surgery, American Volume | Stea, Susanna; Comfort, Thomas; Sedrakyan, Art; Havelin, Leif; Marinelli, Marcella; Barber, Thomas; Paxton, Elizabeth; Banerjee, Samprit; Isaacs, Abby; Graves, Stephen | 2014 |
Sex And Risk Of Hip Implant Failure: Assessing Total Hip Arthroplasty Outcomes In The United States | JAMA Internal Medicine | Inacio, Maria; Ake, Christopher; Paxton, Elizabeth; Khatod, Monti; Wang, Cunlin; Gross, Thomas; Kaczmarek, Ronald; Marinac-Dabic, Danica; Sedrakyan, Art | 2013 |
Value Of Unique Device Identification In The Digital Health Infrastructure | JAMA | Wilson, Natalia A.; Drozda, Joseph Jr. | 2013 |
Unique Device Identification In The Service Of Public Health | New England Journal of Medicine | Gross TP, Crowley J. | 2012 |
Risk Of Revision For Fixed Versus Mobile-Bearing Primary Total Knee Replacements | Journal of Bone and Joint Surgery, American Volume | Namba, Robert; Inacio, Maria; Paxton, Elizabeth; Ake, Christopher; Wang, Cunlin; Gross, Thomas; Marinac-Dabic, Danica; Sedrakyan, Art | 2012 |
Evaluation Of Total Hip Arthroplasty Devices Using A Total Joint Replacement Registry | Pharmacoepidemiology and Drug Safety | Paxton, Elizabeth; Ake, Christopher; Inacio, Maria; Khatod, Monti; Marinac-Dabic, Danica; Sedrakyan, Art | 2012 |
Comparative Effectiveness Research: Does One Size Fit All? | Statistics in Medicine | Kunz, Lauren M.; Yeh, Robert W.; Normand, Sharon-Lise T. | 2012 |
Beyond Joint Implant Registries: A Patient-Centered Research Consortium For Comparative Effectiveness In Total Joint Replacement | BMJ | Franklin, Patricia; Allison, Jeroan; Ayers, David | 2012 |
Postmarket Surveillance For Medical Devices: America’s New Strategy | BMJ | Normand, Sharon-Lise T.; Hatfield, Laura; Drozda, Joseph; Resnic, Fred | 2012 |
Postmarketing Surveillance Of Medical Devices – Filling In The Gaps | New England Journal of Medicine | Resnic, Frederic S.; Normand, Sharon-Lise T. | 2012 |
Multiple Outcomes And Multiple Sources Of Evidence: Best Statistical Practices | Circulation Cardiovascular Quality and Outcomes Research | Normand, Sharon-Lise | 2011 |
Journal Of Bone & Joint Surgery, Vol 93. Supplement 3-Multiple Articles | Journal of Bone & Joint Surgery, Vol 93. Supplement 3 – International Consortium of Orthopedic Registries | | 2011 |
Evaluation Of An Automated Safety Surveillance System Using Risk Adjusted Sequential Probability Ratio Testing | BMC Medical Informatics and Decision Making | Matheny ME; Normand SL; Gross TP; Marinac-Dabic D; Loyo-Berríos N,; Vidi VD; Donnelly S; Resnic FS. | 2011 |
Use Of Patient-Reported Outcomes In The Context Of Different Levels Of Data | Journal of Bone and Joint Surgery, American Volume | Rolfson, Ola; Rothwell, Alastair; Sedrakyan, Art; Chenok, Kate Eresian; Bohm, Eric; Bozic, Kevin; Garellick, Göran | 2011 |
The International Consortium Of Orthopaedic Registries: Overview And Summary | The Journal of Bone and Joint Surgery | | 2011 |
Stages And Tools For Multinational Collaboration: The Perspective From The Coordinating Center Of The International Consortium Of Orthopaedic Registries (ICOR) | Journal of Bone and Joint Surgery, American Volume | Sedrakyan, Art; Paxton, Elizabeth; Marinac-Dabic, Danica | 2011 |
The International Consortium Of Orthopaedic Registries: Overview And Summary | Journal of Bone and Joint Surgery, American Volume | Sedrakyan, Art; Paxton, Elizabeth; Phillips, Charlotte; Namba, Robert; Funahashi, Tadashi; Barber, Thomas; Sculco, Thomas; Padgett, Douglas; Wright, Timothy; Marinac-Dabic, Danica | 2011 |
A Multinational Assessment Of Metal-On-Metal Bearings In Hip Replacement | Journal of Bone and Joint Surgery, American Volume | Graves, Stephen; Rothwell, Alastair; Tucker, Keith; Jacobs, Joshua; Sedrakyan, Art | 2011 |
Comparative Assessment Of Implantable Hip Devices With Different Bearing Surfaces: Systematic Appraisal Of Evidence | BMJ | Sedrakyan, Art; Normand, Sharon-Lise; Dabic, Stefan; Jacobs, Samantha; Graves, Stephen; Marinac-Dabic, Danica | 2011 |
Comparative Evidence Assessment Of Implantable Hip Devices By Bearing Surface: Systematic Appraisal Of Evidence | BMJ | Sedrakyan A; Normand S-L; Dabic S; Jacobs S; Graves S; Marinac-Dabic D | 2011 |
Multiple Outcomes And Multiple Sources Of Evidence | Circulation: Cardiovascular Quality Outcomes | Normand, Sharon-Lise T. | 2011 |
A Framework For Evidence Evaluation And Methodological Issues In Implantable Device Studies | Medical Care | Sedrakyan A; Marinac-Dabic D; Normand SL; Mushlin A; Gross T. | 2010 |
Rethinking Analytical Strategies For Surveillance Of Medical Devices: The Case Of Hip Arthroplasty | Medical Care | | 2010 |
Rethinking Analytical Strategies For Surveillance Of Medical Devices: The Case Of Hip Arthroplasty | Medical Care | Normand SL; Marinac-Dabic D; Sedrakyan A; Kaczmarek R | 2010 |
Automated Surveillance To Detect Post-Procedure Safety Signals Of Approved Cardiovascular Devices | JAMA | Resnic FS; Gross TP; Marinac-Dabic D; Loyo-Berríos N; Donnelly S; Normand SL; Matheny ME | 2010 |
Unique Device Identifiers For Coronary Stent Postmarket Surveillance And Research: A Report From The Food And Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration | | | |
