Author Contributions: Drs Lederle and Kyriakides had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Lederle, Freischlag, Kyriakides, Padberg, Kohler, Lin, Peduzzi.
Acquisition of data: Freischlag, Kyriakides, Padberg, Matsumura, Kohler, Lin, Jean-Claude, Cikrit, Swanson.
Analysis and interpretation of data: Lederle, Freischlag, Kyriakides, Padberg, Matsumura, Kohler, Jean-Claude, Swanson.
Drafting of the manuscript: Lederle, Kyriakides, Padberg, Matsumura, Kohler, Jean-Claude, Swanson, Peduzzi.
Critical revision of the manuscript for important intellectual content: Lederle, Freischlag, Kyriakides, Padberg, Matsumura, Kohler, Lin, Jean-Claude, Cikrit, Peduzzi.
Statistical analysis: Kyriakides.
Obtained funding: Lederle, Freischlag, Peduzzi.
Administrative, technical, or material support: Lederle, Freischlag, Padberg, Matsumura, Kohler, Lin, Swanson, Peduzzi.
Study supervision: Lederle, Freischlag, Padberg, Lin, Cikrit.
Financial Disclosures: Dr Matsumura reported receiving research support, consultant fees, or training director fees from Abbott/Guidant, Abraxis, Bard, Cook, Cordis, ev3, Lumen, Medtronic, Sanofi, and WL Gore. Dr Kohler reported receiving research support as an investigator for the Medtronic AneuRx Phase III clinical trial. All other authors reported no financial disclosures.
Investigators and Site Coordinators of the Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group:Participating Veterans Affairs Medical Centers: Albuquerque, New Mexico: E. R. Ketteler, MD, D. D. Kingsley, MD, J. M. Marek, MD, R. J. Massen, MD, B. D. Matteson, MD, J. D. Pitcher, MD, M. Langsfeld, MD, J. D. Corson, MD, J. M. Goff Jr, MD, K. Kasirajan, MD, C. Paap, RN, D. C. Robertson, RN; Atlanta, Georgia: R. Veeraswamy, MD, R. Milner, MD, A. Salam, MD, K. Kasirajan, MD, J. Guidot, RN; Baltimore, Maryland: S. Busuttil, MD, M. P. Lilly, MD, M. Braganza, K. Ellis, RN; Birmingham, Alabama: M. A. Patterson, MD, W. D. Jordon, MD, D. Whitley, MD, S. Taylor, MD, M. Passman, MD, D. Kerns, RN, C. Inman, RN, J. Poirier, RN; Boston, Massachusetts: J. Ebaugh, MD, J. Raffetto, MD, D. Chew, MD, S. Lathi, MD, C. Owens, MD, K. Hickson, RN; Buffalo, New York: H. H. Dosluoglu, MD, K. Eschberger, RN; Chicago, Illinois: M. R. Kibbe, MD, H. M. Baraniewski, MD, J. Matsumura, MD, A. Busman, RN, W. Meadows, RN, M. Evans, RN; Cincinnati, Ohio: H. El Sayed, MD, A. B. Reed, MD, J. S. Giglia, MD, S. Ross, RN, M. Ruf, RN; Cleveland, Ohio: J. M. Jean-Claude, MD, G. Pinault, MD, P. Kang, MD, N. White, RN, M. Eiseman, RN, R. Jones, RN†; Dallas, Texas: J. G. Modrall, MD, C. H. Timaran, MD, M. B. Welborn III, MD, J. Lopez, MD, T. Nguyen; Detroit, Michigan: J. K.Y. Chacko, MD, K. Granke, MD, A. G. Vouyouka, MD, E. Olgren, P. Chand, MD, B. Allende; M. Ranella, C. Yales, RN; Denver, Colorado: T. A. Whitehill, MD, W. C. Krupski, MD†, M. R. Nehler, MD, S. P. Johnson, MD, D. N. Jones, PhD, P. Strecker, RN, M. A. Bhola, RN; Durham, North Carolina: C. K. Shortell, MD, J. L. Gray, MD, J. H. Lawson, MD, M. W. Sebastian, MD, J. Kistler Tetterton, NP, C. Blackwell, RN, P. A. Prinzo, BS, N. Lee, RN; East Orange, New Jersey: F. T. Padberg Jr, MD, J. J. Cerveira, MD, B. K. Lal, MD, R. W. Zickler, MD, K. A. Hauck, RN; Gainesville, Florida: S. A. Berceli, MD, W. A. Lee, MD, C. K. Ozaki, MD, P. R. Nelson, MD, A. S. Irwin, RN, R. Baum, RN; Hines, Illinois: B. Aulivola, MD, H. Rodriguez, MD, F. N. Littooy, MD, H. Greislev, MD, M. T. O’Sullivan, RN; Houston, Texas: P. H. Lin, MD, R. L. Bush, MD, P. Kougias, MD, G. Guinn, MD, C. Cagiannos, MD, S. Pillack, RN, B. Guillory, RN; Indianapolis, Indiana: D. Cikrit, MD, S. G. Lalka, MD, R. Nachreiner, MD, M. Rusomaroff, RN, E. O’Brien, RN; Iowa City, Iowa: J. Hoballah, MD, W. J. Sharp, MD, J. L. McCandless, RN, V. Beach; Lexington, Kentucky: D. Minion, MD, T. H. Schwarcz, MD, J. Kimbrough, RN, L. Ashe, A. Rockich, MS, J. Warner-Carpenter, RN; Little Rock, Arkansas: M. Moursi, MD, J. F. Eidt, MD, S. Brock RN; Loma Linda, California: C. Bianchi, MD, V. Bishop, RN; Long Beach, California: I. L. Gordon, MD, R. Fujitani, MD, S. M. Kubaska III, MD, R. Azadegan, C. Ma Agas, MPH, K. Zalecki; Madison, Wisconsin: J. R. Hoch, MD, S. C. Carr, MD, C. Acher, MD, M. Schwarze, MD, G. Tefera, MD, M. Mell, MD, J. Rieder, RN; Memphis, Tennessee: J. M. Stuart, MD, D. S. Weiman, MD, O. Abul-Khoudoud, MD, H. E. Garrett, MD, S. M. Walsh, MA, K. L. Wilson, RN; Milwaukee, Wisconsin: G. R. Seabrook, MD, R. A. Cambria, MD, K. R. Brown, MD, B. Lewis, MD, S. Framberg, RN, C. Kallio, RN; Minneapolis, Minnesota: R. A. Barke, MD, S. M. Santilli, MD, A. C. d’Audiffret, MD, N. Oberle, RN, C. Proebstle, NP, L. L. Johnson, RN; New York, New York: G. R. Jacobowitz, MD, N. Cayne, MD, C. Rockman, MD, M. Adelman, MD, P. Gagne, MD, M. Nalbandian, MD, L. J. Caropolo, BS; Omaha, Nebraska: I. I. Pipinos, MD, J. Johanning, MD, T. Lynch, MD, H. DeSpiegelaere, RN, G. Purviance, RN; Palo Alto, California: W. Zhou, MD, R. Dalman, MD, J. T. Lee, MD, B. Safadi, MD, S. M. Coogan, MD, S. M. Wren, MD, D. Bahmani, D. Maples, NP, S. Thunen, RN; Philadelphia, Pennsylvania: M. A. Golden, MD, M. E. Mitchell, MD, R. Fairman, MD, S. Reinhardt, RN; Pittsburgh, Pennsylvania: M. A. Wilson, MD, E. Tzeng, MD, S. Muluk, MD, N. M. Peterson, RN, M. Foster, RN; Portland, Oregon: J. Edwards, MD, G. L. Moneta, MD, G. Landry, MD, L. Taylor, MD, R. Yeager, MD, E. Cannady, RN; Salt Lake City, Idaho: G. Treiman, MD, S. Hatton-Ward, RN, B. Salabsky, RN†; San Francisco, California: J. H. Rapp, MD, L. M. Reilly, MD, R. Sarkar, MD, S. S. Dwyer, RN; Seattle, Washington: T. R. Kohler, MD, T. S. Hatsukami, MD, D. G. Glickerman, MD, M. Sobel, MD, T. S. Burdick, MD, K. Pedersen, RN, P. Cleary, NP; San Diego, California: N. Kansal, MD, N. H. Kumins, MD, M. Estes, RN, B. A. Forbes, RN, C. Sobotta, RN; Tampa, Florida: M. Back, MD, D. Bandyk, MD, B. Johnson, MD, M. Shames, MD, R. L. Reinhard, RN, S. C. Thomas, RN; Tucson, Arizona: L. R. Leon Jr, MD, A. Westerband, MD, R. J. Guerra, MD, M. Riveros, MD, J. L. Mills, SR, MD, J. D. Hughes, MD, S. .B. Psalms, N. N. Day, RN; Washington, DC: A. Sidawy, MD, J. M. Weiswasser, MD, S. Arora, MD, B. J. Jasper, M Ed; West Haven, Connecticut: A. Dardik, MD, V. Gahtan, MD, B. E. Muhs, MD, B. E. Sumpio, MD, R. J. Gusberg, MD, M. Spector, MD, J. Pollak, MD, J. Aruny, MD, E. L. Kelly, MD, J. Wong, MD, P. Vasilas, RN, C. Joncas, RN; West Los Angeles, California: H. A. Gelabert, MD, C. DeVirgillio, MD, D. A. Rigberg, MD, L. Cole, RN.
Executive Committee: Frank A. Lederle, MD, and Julie A. Freischlag, MD (co-chairpersons), Ted R. Kohler, MD, Jon Matsumura, MD, Frank T. Padberg Jr, MD, Tassos C. Kyriakides, PhD, Kathleen M. Swanson, MS, RPh, Julie Thornton, Yvonne Jonk, PhD, Kevin T. Stroupe, PhD.
Coordinating Centers and Committees:Cooperative Studies Program Coordinating Center (CSPCC) VA CT Healthcare System,West Haven, Connecticut: Peter Peduzzi, PhD (director), Margaret Antonelli (assistant director, operations), Cindy Cushing (programmer), Lynn Durant (quality assurance officer), Shirley Joyner, MHA (research coordinator), Tassos C. Kyriakides, PhD (biostatistician), Mary LeGwin (project manager), Terry O’Connor, PhD (biostatistician), Scott Zellner, PhD (research coordinator), Vanessa McBride (research coordinator), Susan Stratton† (project manager), Elizabeth Davis, RN, Alice Kossack, June Poulton, RN (research associate); Regulatory Affairs and Clinical Compliance Section, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico: Kathleen M. Swanson, MS, RPH, Julie Thornton, BS; VA Research Site Management and Review Team (SMART)VA Cooperative Studies Program,Albuquerque, New Mexico: Clair M. Haakenson, RPH, MS; Health Economists: Kevin T. Stroupe, PhD (Center for Management of Complex Chronic Care, CSPCC, Veterans Affairs Medical Center, Hines, Illinois), Yvonne Jonk, PhD (Center for Chronic Disease Outcomes Research, Veterans Affairs Medical Center, Minneapolis, Minnesota); Human Rights Committee, West Haven, Connecticut: Richard Marottoli, MD, Stanislav Kasl, PhD, Rajni Mehta, MPH, Richard Feldman, William Farrell, Heather Allore, PhD, Edward Perry, MD, James Niederman, MD, Sister Frances Randall, Reverend Michael Zeman, Donald Beckwith; National Project Coordinators, Minneapolis VAMC: Elizabeth Latts, MSW, Marilyn Bader; Central Administration, Cooperative Studies Program (VA Central Office): Timothy J. O’Leary, MD, PhD, director, Clinical Science R&D Service, Grant D. Huang, PhD, deputy director, CSP. †Deceased.
Data and Safety Monitoring Board: John (Jeb) W. Hallett, MD (Roper-St. Francis Heart and Vascular Center, Charleston, South Carolina), Norman Hertzer, MD (The Cleveland Clinic, Cleveland, Ohio), Jonathan Towne, MD (Medical College of Wisconsin, Milwaukee), David A. Katz, MD, MSc (Center for Research in the Implementation of Innovative Strategies in Practice, US Department of Veterans Affairs, Iowa City Health Care System, Iowa City, Iowa), Theodore Karrison, PhD (biostatistician) (Department of Health Studies, University of Chicago, Chicago, Illinois), John P. Matts, PhD (biostatistician) (Coordinating Centers for Biometric Research, University of Minnesota, Minneapolis).
Funding/Support: This work was supported by the Cooperative Studies Program of the Department of Veterans Affairs (VA) Office of Research and Development, Washington, DC. Study nurses were compensated directly by the VA study grant. Physician time was donated by the respective VA Medical Centers. Statistical and other central VA personnel were employed by the VA to work on various studies, including this trial.
Role of the Sponsor: The sponsor had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.