VA Cooperative Studies Program Network
19. Califf RM. Simple principles of clinical trials remain powerful. JAMA. 2005;293(4):489-491. 20. Garas G, Ibrahim A, Ashrafian H, et al. Evidence-based surgery: barriers, solutions, and the role of evidence synthesis. World J Surg. 2012;36 (8):1723-1731. 21. Grossi EA, Patel N, Woo YJ, et al; RESTOR-MV Study Group. Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve). J Am Coll Cardiol. 2010;56(24):1984-1993.
Original Investigation Research
22. Taggart DP, Altman DG. Off-pump vs. on-pump CABG: are we any closer to a resolution? Eur Heart J. 2012;33(10):1181-1183.
versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol. 2000;36(4):1152-1158.
23. Detre KM, Takaro T, Hultgren H, Peduzzi P. Long-term mortality and morbidity results of the Veterans Administration randomized trial of coronary artery bypass surgery. Circulation. 1985; 72(6 pt 2):V84-V89.
25. Lederle FA, Freischlag JA, Kyriakides TC, et al; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012;367(21):1988-1997.
24. Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15 years after valve replacement with a mechanical
Invited Commentary
Network of Dedicated Enrollment Sites An Attempt to Improve the Randomized Clinical Trial George W. Machiedo, MD
The multicenter prospective randomized clinical trial (RCT) is the keystone of clinical research. It is the research format that has the greatest possibility of causing a widespread change in clinical practice, with the change based on scientifically valid data. These studies attempt to avoid the biases of an individual site or investigator, generate larger numbers with an increase in the resultant statistical power, and provide more generalizable results. However, despite decades of experience with RCTs, there are still significant challenges in their conception, planning, and execution. Collaboration must be obtained between proponents of the various modalities to be compared. These are frequently practitioners of different and sometimes Related article page 507 competing medical specialties (eg, cardiac surgeons and cardiologists). Selection and staffing of participating sites must be accomplished. Finally, adequate numbers of willing research participants must be identified. The Department of Veterans Affairs (VA), through its Cooperative Studies Program (CSP), has a long history of carrying out high-quality RCTs in surgery as well as in most other medical disciplines. In the past decade alone, studies in such ARTICLE INFORMATION Author Affiliations: Department of Surgery, Rutgers New Jersey Medical School, Mantoloking; Surgical Service, VA New Jersey Healthcare System, East Orange. Corresponding Author: George W. Machiedo, MD, Rutgers New Jersey Medical School, 200 Helm Rd, Mantoloking, NJ 08738 (georgemachiedo @msn.com). Published Online: March 19, 2014. doi:10.1001/jamasurg.2013.4172. Conflict of Interest Disclosures: None reported.
diverse areas as open vs laparoscopic approach to the repair of inguinal hernia,1 on-pump vs off-pump coronary artery bypass graft procedures,2 and open vs endovascular repair of abdominal aortic aneurysms3 have been carried out by VA investigators, with results published in prestigious journals. Even with the ongoing success of the CSP, leaders of VA research have recognized the persistent difficulties in RCT development and execution already noted. To generate objective data on these issues and begin to develop innovative solutions, the VA instituted the Network of Dedicated Enrollment Sites (NODES) program. In this issue, Bakaeen and associates4 do an excellent job of clearly delineating the problems, and their article should be valuable to anyone interested in developing a multicenter study, whether within the VA or not. However, the real value of the program will be seen if and when solutions to the problems are published. Bakaeen et al and their colleagues in the NODES program need to remember a key aspect of the well-designed RCT: the results should be generalizable. They should work to ensure that the solutions generated are not VA-centric but rather are applicable to RCTs carried out in any segment of the medical research community. If they are successful, this work will be a major step forward in our ability to design and implement trials that will continue to shape medical and surgical practice.
Additional Information: Dr Machiedo was the chair of the advisory committee to the VA for the selection of the NODES program sites. REFERENCES 1. Neumayer L, Giobbie-Hurder A, Jonasson O, et al; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004; 350(18):1819-1827. 2. Shroyer AL, Grover FL, Hattler B, et al; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009;361(19):18271837.
jamasurgery.com
3. Lederle FA, Freischlag JA, Kyriakides TC, et al; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009; 302(14):1535-1542. 4. Bakaeen FG, Reda DJ, Gelijns AC, et al. Department of Veterans Affairs Cooperative Studies Program Network of Dedicated Enrollment Sites: implications for surgical trials [published online March 19, 2014]. JAMA Surg. doi:10.1001 /jamasurg.2013.4150.
JAMA Surgery June 2014 Volume 149, Number 6
Copyright 2014 American Medical Association. All rights reserved.
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19. Califf RM. Simple principles of clinical trials remain powerful. JAMA. 2005;293(4):489-491. 20. Garas G, Ibrahim A, Ashrafian H, et al. Evidence-based surgery: barriers, solutions, and the role of evidence synthesis. World J Surg. 2012;36 (8):1723-1731. 21. Grossi EA, Patel N, Woo YJ, et al; RESTOR-MV Study Group. Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve). J Am Coll Cardiol. 2010;56(24):1984-1993.
Original Investigation Research
22. Taggart DP, Altman DG. Off-pump vs. on-pump CABG: are we any closer to a resolution? Eur Heart J. 2012;33(10):1181-1183.
versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol. 2000;36(4):1152-1158.
23. Detre KM, Takaro T, Hultgren H, Peduzzi P. Long-term mortality and morbidity results of the Veterans Administration randomized trial of coronary artery bypass surgery. Circulation. 1985; 72(6 pt 2):V84-V89.
25. Lederle FA, Freischlag JA, Kyriakides TC, et al; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012;367(21):1988-1997.
24. Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15 years after valve replacement with a mechanical
Invited Commentary
Network of Dedicated Enrollment Sites An Attempt to Improve the Randomized Clinical Trial George W. Machiedo, MD
The multicenter prospective randomized clinical trial (RCT) is the keystone of clinical research. It is the research format that has the greatest possibility of causing a widespread change in clinical practice, with the change based on scientifically valid data. These studies attempt to avoid the biases of an individual site or investigator, generate larger numbers with an increase in the resultant statistical power, and provide more generalizable results. However, despite decades of experience with RCTs, there are still significant challenges in their conception, planning, and execution. Collaboration must be obtained between proponents of the various modalities to be compared. These are frequently practitioners of different and sometimes Related article page 507 competing medical specialties (eg, cardiac surgeons and cardiologists). Selection and staffing of participating sites must be accomplished. Finally, adequate numbers of willing research participants must be identified. The Department of Veterans Affairs (VA), through its Cooperative Studies Program (CSP), has a long history of carrying out high-quality RCTs in surgery as well as in most other medical disciplines. In the past decade alone, studies in such ARTICLE INFORMATION Author Affiliations: Department of Surgery, Rutgers New Jersey Medical School, Mantoloking; Surgical Service, VA New Jersey Healthcare System, East Orange. Corresponding Author: George W. Machiedo, MD, Rutgers New Jersey Medical School, 200 Helm Rd, Mantoloking, NJ 08738 (georgemachiedo @msn.com). Published Online: March 19, 2014. doi:10.1001/jamasurg.2013.4172. Conflict of Interest Disclosures: None reported.
diverse areas as open vs laparoscopic approach to the repair of inguinal hernia,1 on-pump vs off-pump coronary artery bypass graft procedures,2 and open vs endovascular repair of abdominal aortic aneurysms3 have been carried out by VA investigators, with results published in prestigious journals. Even with the ongoing success of the CSP, leaders of VA research have recognized the persistent difficulties in RCT development and execution already noted. To generate objective data on these issues and begin to develop innovative solutions, the VA instituted the Network of Dedicated Enrollment Sites (NODES) program. In this issue, Bakaeen and associates4 do an excellent job of clearly delineating the problems, and their article should be valuable to anyone interested in developing a multicenter study, whether within the VA or not. However, the real value of the program will be seen if and when solutions to the problems are published. Bakaeen et al and their colleagues in the NODES program need to remember a key aspect of the well-designed RCT: the results should be generalizable. They should work to ensure that the solutions generated are not VA-centric but rather are applicable to RCTs carried out in any segment of the medical research community. If they are successful, this work will be a major step forward in our ability to design and implement trials that will continue to shape medical and surgical practice.
Additional Information: Dr Machiedo was the chair of the advisory committee to the VA for the selection of the NODES program sites. REFERENCES 1. Neumayer L, Giobbie-Hurder A, Jonasson O, et al; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004; 350(18):1819-1827. 2. Shroyer AL, Grover FL, Hattler B, et al; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009;361(19):18271837.
jamasurgery.com
3. Lederle FA, Freischlag JA, Kyriakides TC, et al; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009; 302(14):1535-1542. 4. Bakaeen FG, Reda DJ, Gelijns AC, et al. Department of Veterans Affairs Cooperative Studies Program Network of Dedicated Enrollment Sites: implications for surgical trials [published online March 19, 2014]. JAMA Surg. doi:10.1001 /jamasurg.2013.4150.
JAMA Surgery June 2014 Volume 149, Number 6
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a J H Quillen College User on 06/05/2015
513
