Author Contributions: Dr Jonasson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Fitzgibbons, Gibbs, Dunlop, Reda, McCarthy, Neumayer, Jonasson.
Acquisition of data: Fitzgibbons, Giobbie-Hurder, Barkun, Hoehn, Murphy, Sarosi, Syme, Thompson, Jonasson.
Analysis and interpretation of data: Fitzgibbons, Giobbie-Hurder, Gibbs, Dunlop, Reda, McCarthy, Neumayer, Barkun, Hoehn, Sarosi, Syme, Thompson, Wang, Jonasson.
Drafting of the manuscript: Fitzgibbons, Giobbie-Hurder, Gibbs, Dunlop, McCarthy, Neumayer, Jonasson.
Critical revision of the manuscript for important intellectual content: Fitzgibbons, Giobbie-Hurder, Gibbs, Dunlop, Reda, McCarthy, Neumayer, Barkun, Hoehn, Murphy, Sarosi, Syme, Thompson, Wang, Jonasson.
Statistical analysis: Giobbie-Hurder, Dunlop, Reda, Wang.
Obtained funding: Fitzgibbons, Jonasson.
Administrative, technical, or material support: Fitzgibbons, Gibbs, Reda, McCarthy, Neumayer, Jonasson.
Study supervision: Fitzgibbons, Gibbs, Neumayer, Barkun, Hoehn, Murphy, Sarosi, Syme, Thompson, Jonasson.
Financial Disclosures: Dr Fitzgibbons has been retained as an expert witness by Davol, manufacturer of mesh plug used in plug and patch surgical repair of hernia and is a consultant for TyRx Pharma Inc, developers of an antibiotic- and local anesthetic–impregnated mesh for tension-free repair of hernia. No other authors reported disclosures.
Funding/Support: This study was funded by Agency for Healthcare Research and Quality grant RO1 HS 09860, and the American College of Surgeons provided logistic and budget management support.
Role of the Sponsors: The Agency for Healthcare Research and Quality had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. The American College of Surgeons had no role in the analysis and interpretation of data or in the preparation, review, or approval of the manuscript.
Members of the Watchful Waiting vs Open Tension-free Repair Study (asterisks denote former participants):Chair: R. J. Fitzgibbons (Creighton University); Biostatistician: A. Giobbie-Hurder; Health Scientist: J. O. Gibbs; Lead Health Economist: L. Manheim, D. Dobrez*; Health Economist: K. Stroupe; Patient-Reported Outcomes Consultant: M. McCarthy; Coinvestigator: L. Neumayer; National Study Coordinator: K. Kaczmarek; Data and Safety Monitoring Board: H. Buchwald (University of Minnesota Hospital and Clinics), R. Burney (University of Michigan), B. Craig (Purdue University), L. Kazis (Edith Norse Rogers Memorial Veterans Hospital), K. Kelly (Mayo Clinic–Scottsdale); Executive Committee: C. J. Carrico (deceased) (University of Texas Southwestern Medical Center, Dallas); J. Chmiel, D. Dobrez*, D. Dunlop, J. O. Gibbs, L. Manheim (Northwestern University); R. J. Fitzgibbons, Jr (Creighton University); J. Thompson (University of Nebraska Medical Center); A. Giobbie-Hurder, D. Reda (Cooperative Studies Program Coordinating Center); W. G. Henderson* (University of Colorado Health Outcomes Program); O. Jonasson (University of Illinois); J. Barkun, J. Meakins* (McGill University); J. Hoehn (Marshfield Clinic); J. Murphy, G. Sarosi (UT Southwestern Medical Center); W. Syme (Lovelace Health Systems); Site Personnel: J. Murphy, G. Sarosi, D. Climer, L. Kim* (Dallas, Tex); W. Syme, A. Von Worley, M. Kestner* (Albuquerque, NM); J. Hoehn, J. Kolb, K. Noreen*, N. Goldberg* (Marshfield, Wis); J. Barkun, D. Papamikhael, C. Flemming (Montreal, Quebec); R. J. Fitzgibbons, R. Christian, K. Kaczmarek, C. Marcuzzo*, M. Ricceri*, J. Ortiz, J. Thompson (Omaha, Neb); K. Richards, E. Callaham, S. Ali, S. Thomas*, K. Johnson* (American College of Surgeons); J. Wang, S. Heard, J. Motyka*, C. Sullivan* (Cooperative Studies Program Coordinating Center, Hines, Ill).
Acknowledgment: We thank William Henderson, PhD, University of Colorado Health Outcomes Program, Aurora, for his participation in the design and concept of the study, and we are grateful to C. James Carrico, MD (deceased), Department of Surgery, University of Texas Southwestern, Dallas, for his assistance with obtaining study funding.