OBJECTIVE: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques. DESIGN: The Web-based Data Extraction and Longitudinal Time Analysis (DELTA) system imports clinical data in real-time from an electronic database and generates alerts for potentially unsafe devices or procedures. The statistical techniques used are statistical process control (SPC), logistic regression (LR), and Bayesian updating statistics (BUS). MEASUREMENTS: We selected in-patient mortality following implantation of the Cypher drug-eluting coronary stent to evaluate our system. Data from the University of Michigan Consortium Bare-Metal Stent Study was used to calculate the event rate alerting boundaries. Data analysis was performed on local catheterization data from Brigham and Women's Hospital from July 1, 2003, shortly after the Cypher release, to December 31, 2004, including 2,270 cases with 27 observed deaths. RESULTS: The single-stratum SPC had alerts in months 4 and 10. The multistrata SPC had alerts in months 5, 10, and 18 in the moderate-risk stratum, and months 1, 4, 7, and 10 in the high-risk stratum. The only cumulative alerts were in the first month for the high-risk stratum of the multistrata SPC. The LR method showed no monthly or cumulative alerts. The BUS method showed an alert in the first month for the high-risk stratum. CONCLUSION: The system performed adequately within the Brigham and Women's Hospital Intranet environment based on the design goals. All three cumulative methods agreed that the overall observed event rates were not significantly higher for the new medical device than for a closely related medical device and were consistent with the observation that the initial concerns about this device dissipated as more data accumulated.
OBJECTIVE: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques. DESIGN: The Web-based Data Extraction and Longitudinal Time Analysis (DELTA) system imports clinical data in real-time from an electronic database and generates alerts for potentially unsafe devices or procedures. The statistical techniques used are statistical process control (SPC), logistic regression (LR), and Bayesian updating statistics (BUS). MEASUREMENTS: We selected in-patient mortality following implantation of the Cypher drug-eluting coronary stent to evaluate our system. Data from the University of Michigan Consortium Bare-Metal Stent Study was used to calculate the event rate alerting boundaries. Data analysis was performed on local catheterization data from Brigham and Women's Hospital from July 1, 2003, shortly after the Cypher release, to December 31, 2004, including 2,270 cases with 27 observed deaths. RESULTS: The single-stratum SPC had alerts in months 4 and 10. The multistrata SPC had alerts in months 5, 10, and 18 in the moderate-risk stratum, and months 1, 4, 7, and 10 in the high-risk stratum. The only cumulative alerts were in the first month for the high-risk stratum of the multistrata SPC. The LR method showed no monthly or cumulative alerts. The BUS method showed an alert in the first month for the high-risk stratum. CONCLUSION: The system performed adequately within the Brigham and Women's Hospital Intranet environment based on the design goals. All three cumulative methods agreed that the overall observed event rates were not significantly higher for the new medical device than for a closely related medical device and were consistent with the observation that the initial concerns about this device dissipated as more data accumulated.
Authors: C P Cannon; A Battler; R G Brindis; J L Cox; S G Ellis; N R Every; J T Flaherty; R A Harrington; H M Krumholz; M L Simoons; F J Van De Werf; W S Weintraub; K R Mitchell; S L Morrisson; R G Brindis; H V Anderson; D S Cannom; W R Chitwood; J E Cigarroa; R L Collins-Nakai; S G Ellis; R J Gibbons; F L Grover; P A Heidenreich; B K Khandheria; S B Knoebel; H L Krumholz; D J Malenka; D B Mark; C R Mckay; E R Passamani; M J Radford; R N Riner; J B Schwartz; R E Shaw; R J Shemin; D B Van Fossen; E D Verrier; M W Watkins; D R Phoubandith; T Furnelli Journal: J Am Coll Cardiol Date: 2001-12 Impact factor: 24.094
Authors: M Moscucci; E Kline-Rogers; D Share; M O'Donnell; A Maxwell-Eward; W L Meengs; P Kraft; A C DeFranco; J L Chambers; K Patel; J G McGinnity; K A Eagle Journal: Circulation Date: 2001-07-17 Impact factor: 29.690
Authors: Michael E Matheny; Randolph A Miller; T Alp Ikizler; Lemuel R Waitman; Joshua C Denny; Jonathan S Schildcrout; Robert S Dittus; Josh F Peterson Journal: Med Decis Making Date: 2010-03-30 Impact factor: 2.583
Authors: Frederic S Resnic; Arjun Majithia; Danica Marinac-Dabic; Susan Robbins; Henry Ssemaganda; Kathleen Hewitt; Angelo Ponirakis; Nilsa Loyo-Berrios; Issam Moussa; Joseph Drozda; Sharon-Lise Normand; Michael E Matheny Journal: N Engl J Med Date: 2017-01-25 Impact factor: 91.245
Authors: Frederic S Resnic; Thomas P Gross; Danica Marinac-Dabic; Nilsa Loyo-Berrios; Sharon Donnelly; Sharon-Lise T Normand; Michael E Matheny Journal: JAMA Date: 2010-11-10 Impact factor: 56.272
Authors: Frederic S Resnic; Arjun Majithia; Sanket S Dhruva; Henry Ssemaganda; Susan Robbins; Danica Marinac-Dabic; Kathleen Hewitt; Lucila Ohno-Machado; Matthew R Reynolds; Michael E Matheny Journal: Circ Cardiovasc Qual Outcomes Date: 2020-04-14
Authors: Amit Kumar; Michael E Matheny; Kalon K L Ho; Robert W Yeh; Thomas C Piemonte; Howard Waldman; Pinak B Shah; Richard Cope; Sharon-Lise T Normand; Sharon Donnelly; Susan Robbins; Frederic S Resnic Journal: Circ Cardiovasc Qual Outcomes Date: 2014-12-09
Authors: Michael E Matheny; David A Morrow; Lucila Ohno-Machado; Christopher P Cannon; Marc S Sabatine; Frederic S Resnic Journal: Med Decis Making Date: 2008-11-17 Impact factor: 2.583
Authors: Michael E Matheny; Sharon-Lise T Normand; Thomas P Gross; Danica Marinac-Dabic; Nilsa Loyo-Berrios; Venkatesan D Vidi; Sharon Donnelly; Frederic S Resnic Journal: BMC Med Inform Decis Mak Date: 2011-12-14 Impact factor: 2.796