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Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.
Bates, Jonathan; Parzynski, Craig S; Dhruva, Sanket S; Coppi, Andreas; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Shaw, Richard E; Warner, Frederick; Krumholz, Harlan M; Ross, Joseph S.
Afiliação
  • Bates J; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.
  • Parzynski CS; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.
  • Dhruva SS; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.
  • Coppi A; National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA.
  • Kuntz R; Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA.
  • Li SX; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.
  • Marinac-Dabic D; Medtronic, Inc., Minneapolis, MN, USA.
  • Masoudi FA; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.
  • Shaw RE; Division of Epidemiology, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Warner F; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Krumholz HM; Department of Clinical Informatics, California Pacific Medical Center, San Francisco, CA, USA.
  • Ross JS; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.
Pharmacoepidemiol Drug Saf ; 27(8): 848-856, 2018 08.
Article em En | MEDLINE | ID: mdl-29896873
PURPOSE: To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. METHODS: We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. RESULTS: At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. CONCLUSIONS: Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Falha de Prótese / Sistema de Registros / Bases de Dados Factuais / Desfibriladores Implantáveis Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Pharmacoepidemiol Drug Saf Assunto da revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Falha de Prótese / Sistema de Registros / Bases de Dados Factuais / Desfibriladores Implantáveis Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Pharmacoepidemiol Drug Saf Assunto da revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos