David Arterburn, MD, MPH; Robert Wellman, MS; Ana Emiliano, MD; Steven R. Smith, MD; Andrew O. Odegaard, PhD, MPH; Sameer Murali, MD; Neely Williams, MDiv; Karen J. Coleman, PhD; Anita Courcoulas, MD, MPH; R. Yates Coley, PhD; Jane Anau, BS; Roy Pardee, JD, MA; Sengwee Toh, ScD; Cheri Janning, RN, BSN, MS; Andrea Cook, PhD; Jessica Sturtevant, MS; Casie Horgan, MPH; Kathleen M. McTigue, MD, MPH, MS; for the PCORnet Bariatric Study Collaborative *
Disclaimer: The views expressed in this article are those of the authors and do not reflect the views of the Patient-Centered Outcomes Research Institute.
Acknowledgment: The study team thanks the leaders, project managers, programmers, and staff who were involved in the creation of PCORnet and the 11 CDRNs that provided data to the PBS: Stephen R. Perry, Kin Lam, David Hawkes, Thomas Dundon, and Kelli Kinsman (Kaiser Permanente Washington Health Research Institute); Shelly Sital (The Chicago Community Trust); Elizabeth Tarlov and Marian Fitzgibbon (University of Illinois at Chicago); Jasmin Phua (Medical Research Analytics and Informatics Alliance); Mia Gallagher, Lindsey Petro, and Beth Syat (Harvard Pilgrim Health Care Institute and Harvard Medical School); Prakash Nadkarni and Elizabeth Chrischilles (University of Iowa); Steffani Roush, Robert Greenlee, and Laurel Verhagen (Marshfield Clinic Research Institute); Umberto Tachinardi (University of Wisconsin); Phillip Reeder, Shiby Antony, and Rania AlShahrouri (University of Texas Southwestern Medical Center); James Campbell, Russell Buzalko, and Jay Pedersen (University of Nebraska Medical Center); Dan Connolly (University of Kansas Medical Center); Russell Rothman, David Crenshaw, and Katie Worley (Vanderbilt University Medical Center); Emily Pfaff, Robert Bradford, Kellie Walters, Tim Carey, Timothy Farrell, and D. Wayne Overby (University of North Carolina); Maija Neville-Williams and Rhonda G. Kost (The Rockefeller University); Elizabeth Shenkman, William Hogan, Kathryn McAuliffe, and Gigi Lipori (University of Florida); Rebecca Zuvich Essner (Florida Hospital); Howard Su, Michael George, Michael J. Becich, Barbara Postol, Giselle G. Hamad, Ramesh C. Ramanathan, Bestoun H. Ahmed, William F. Gourash, Bill Shirey, Chuck Borromeo, and Desheng Li (University of Pittsburgh); Anthony T. Petrick, Ilene Ladd, Preston Biegley, and H. Lester Kirchner (Geisinger); Daniel E. Ford, Michael A. Schweitzer, Karl Burke, Harold Lehmann, Megan E. Gauvey-Kern, and Diana Gumas (Johns Hopkins); Rachel Hess, Meghan Lynch, and Reid Holbrook (University of Utah); Jody McCullough, Matt Bolton, Wenke Hwang, Ann Rogers, and Alison Bower (Pennsylvania State University); Cecilia Dobi, Mark Weiner, Anuradha Paranjape, Sharon J. Herring, and Patricia Bernard (Temple University); Janet Zahner, Parth Divekar, Keith Marsolo, and Lisa Boerger (Cincinnati Children's Hospital); Kimberly J. Holmquist (Kaiser Permanente Southern California); Ray Pablo, Roni Bracha, and Robynn Zender (University of California, Irvine); Lucila Ohno-Machado, Paulina Paul, and Michele Day (University of California, San Diego); Thomas Carton, Elizabeth Crull, and Iben McCormick-Ricket (Louisiana Public Health Institute); Ashley Vernon, Malcolm Robinson, Scott Shikora, David Spector, Eric Sheu, Edward Mun, Matthew Hutter, Shawn Murphy, Jeffrey Klann, and Denise Gee (Partners Healthcare); Daniel Jones, Benjamin Schneider, Griffin Weber, and Robert Andrews (Beth Israel Deaconess Medical Center); Donald Hess, Brian Carmine, Miguel Burch, and Galina Lozinski (Boston Medical Center); Ken Mandl, Jessica Lyons, and Margaret Vella (Harvard Medical School); and Joseph Skelton and Kun Wei (Wake Forest Integrated Health System).
Financial Support: This study was funded by the Patient-Centered Outcomes Research Institute via contract OBS-1505-30683.
Disclosures: Dr. Arterburn reports grants from the National Institutes of Health outside the submitted work. Dr. Courcoulas reports grants from the National Institute of Diabetes and Digestive and Kidney Diseases, Allurion, and Covidien/Ethicon outside the submitted work. Dr. Xanthakos reports grants from TARGET PharmaSolutions and the National Institute of Diabetes and Digestive and Kidney Diseases outside the submitted work. Dr. Inge reports honoraria from and stock options in Standard Bariatrics outside the submitted work. Dr. Tavakkoli reports personal fees from Medtronic and AMAG Pharmaceuticals outside the submitted work. Dr. Nirav Desai reports employment with Shire. Dr. Hynes reports a Research Career Scientist Award from the U.S. Department of Veterans Affairs during the conduct of the study. Dr. Apovian reports personal fees from Nutrisystem, Zafgen, Sanofi-Aventis, Orexigen, Novo Nordisk, GI Dynamics, Takeda, Scientific Intake, Xeno Biosciences, Rhythm Pharmaceuticals, Eisai, EnteroMedics, and Bariatrix Nutrition outside the submitted work; grants from Orexigen, Aspire Bariatrics, GI Dynamics, Myos, Takeda, the Vela Foundation, the Dr. Robert C. and Veronica Atkins Foundation, Coherence Lab, Energesis, and the National Institutes of Health outside the submitted work; and past ownership of stock in Science-Smart LLC. Mr. Nadglowski reports employment with the Obesity Action Coalition, which receives grants and other support from bariatric surgery–related companies, including Ethicon, Medtronic, and many bariatric surgery vitamin supplementation companies. Ms. Saizan reports a grant from the Louisiana Public Health Institute during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-2786.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Proctor & Gamble, Pfizer, and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See the . Additional details are available from Dr. Arterburn (e-mail, email@example.com). Statistical code: Available from Dr. Arterburn. Data set: Our data access committee will review any requests for access to data and make a determination. Please e-mail Dr. Arterburn for details on making a request.
Corresponding Author: David Arterburn, MD, MPH, Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98108; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Arterburn, Coley, and Cook; Mr. Wellman; Ms. Anau; and Mr. Pardee: Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98108.
Dr. Emiliano: Laboratory of Biochemical Genetics and Metabolism, Rockefeller University, Hospital 431, Box 179, 1200 York Avenue, New York, NY 10065.
Dr. Smith: The Translational Research Institute for Metabolism and Diabetes, Florida Hospital, 301 East Princeton Street, Orlando, FL 32804.
Dr. Odegaard: Department of Epidemiology, School of Medicine, University of California, Irvine, 224 Irvine Hall, Irvine, CA 92697.
Dr. Murali: Kaiser Permanente Southern California, 17296 Slover Avenue, Fontana, CA 92337.
Ms. Williams: Community Partners' Network, 850 West Trinity Lane, Nashville, TN 37207.
Dr. Coleman: Kaiser Permanente Southern California, 100 South Los Robles, 4th Floor, Pasadena, CA 91101.
Dr. Courcoulas: Department of Surgery, University of Pittsburgh, 3800 Boulevard of the Allies, Suite 390, Pittsburgh, PA 15213.
Dr. Toh, Ms. Sturtevant, and Ms. Horgan: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401, Boston, MA 02215.
Ms. Janning: Duke Clinical & Translational Science Institute, 701 West Trinity Avenue, #111, Durham, NC 27701.
Dr. McTigue: Center for Research on Health Care, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA 15213.
Author Contributions: Conception and design: D. Arterburn, R. Wellman, S.R. Smith, S. Murali, K.J. Coleman, R.Y. Coley, S. Toh, C. Janning, K.M. McTigue, J. Vitello, E. Malanga, C.L. McBride, T. St. Clair, J. Nadglowski, R. Saizan, W. Richardson, L. Rasmussen-Torvik, J. Brown, J.N. Tobin, J. Clark, T.H. Inge, J. Tice.
Analysis and interpretation of the data: D. Arterburn, R. Wellman, A. Emiliano, A.O. Odegaard, K.J. Coleman, A. Courcoulas, R.Y. Coley, J. Anau, R. Pardee, S. Toh, A. Cook, K.M. McTigue, J. Nadglowski, M. Michalsky, R. Saizan, W. Richardson, C. Apovian, E. Cirelli, A. Tavakkoli, J.N. Tobin, L.P. Hanrahan, M. Duke, S. Malhotra, M.R. Lent, J.L. Kraschnewski, M. Conroy, M.F. Daley, M. Horberg, D. Bell.
Drafting of the article: D. Arterburn, R. Wellman, A. Emiliano, K.J. Coleman, R.Y. Coley, E. Malanga, C.L. McBride, E.E. Harmata, A. Odor, W. Richardson, W.G. Adams, J. Brown, L.R. Waitman, M.R. Lent, J.R. Desai, D. Bell.
Critical revision of the article for important intellectual content: D. Arterburn, R. Wellman, A. Emiliano, A.O. Odegaard, S. Murali, N. Williams, K.J. Coleman, R.Y. Coley, J. Anau, S. Toh, A. Cook, K.M. McTigue, C.L. McBride, D. Schlundt, J. Nadglowski, M. Michalsky, N. Desai, W. Richardson, E. Cirelli, R. Zeiger, L. Rasmussen-Torvik, A. Tavakkoli, J. Holmes, R. Nemr, J.N. Tobin, J. Clark, W. Bennett, T.H. Inge, S.A. Xanthakos, L. Bazzano, E. Nauman, D.M. Hynes, D. Meltzer, B. Chand, J.J. VanWormer, L.P. Hanrahan, J. Bian, M.R. Lent, J.L. Kraschnewski, J. Tice, M.A. Edwards, M. Conroy, M.F. Daley, M. Horberg, J.R. Desai, S.L. Fitzpatrick, D. Bell, C.C. Wee.
Final approval of the article: D. Arterburn, R. Wellman, A. Emiliano, S.R. Smith, A.O. Odegaard, S. Murali, N. Williams, K.J. Coleman, A. Courcoulas, R.Y. Coley, J. Anau, R. Pardee, S. Toh, C. Janning, A. Cook, J. Sturtevant, C. Horgan, K.M. McTigue, J. Vitello, E. Malanga, C.L. McBride, J. McClay, E.E. Harmata, D. Schlundt, T. St. Clair, J. Nadglowski, M. Michalsky, N. Desai, A. Odor, R. Saizan, W. Richardson, C. Apovian, W.G. Adams, E. Cirelli, R. Zeiger, L. Rasmussen-Torvik, G. Purcell, J. Brown, A. Tavakkoli, J. Holmes, R. Nemr, J.N. Tobin, J. Clark, W. Bennett, T.H. Inge, S.A. Xanthakos, L. Bazzano, E. Nauman, D.M. Hynes, D. Meltzer, B. Chand, J.J. VanWormer, L.R. Waitman, L.G. Cowell, L.P. Hanrahan, M. Duke, D.M. Herron, S. Malhotra, J. Choi, J. Bian, M.R. Lent, J.L. Kraschnewski, J. Tice, M.A. Edwards, M. Conroy, M.F. Daley, M. Horberg, J.R. Desai, S.L. Fitzpatrick, D. Bell, E. Roe, X. Zhou, C.C. Wee.
Provision of study materials or patients: A. Emiliano, N. Williams, C.L. McBride, W.G. Adams, A. Tavakkoli, J. Clark, W. Bennett, E. Nauman, D.M. Hynes, D. Meltzer, D.M. Herron, J. Choi, J.L. Kraschnewski, M.A. Edwards, M.F. Daley, J.R. Desai, S.L. Fitzpatrick, E. Roe, X. Zhou.
Statistical expertise: R. Wellman, R.Y. Coley, S. Toh, A. Cook, A. Odor, L.P. Hanrahan.
Obtaining of funding: D. Arterburn, K.J. Coleman, J. Anau, K.M. McTigue, L. Rasmussen-Torvik, G. Purcell, J. Brown, D. Meltzer, L.P. Hanrahan, J. Tice, M. Horberg, X. Zhou.
Administrative, technical, or logistic support: A. Courcoulas, J. Anau, J. Sturtevant, C. Horgan, J. Vitello, E. Malanga, J. McClay, D. Schlundt, A. Odor, W.G. Adams, J. Brown, J. Holmes, L. Bazzano, D.M. Hynes, D. Meltzer, L.R. Waitman, L.P. Hanrahan, C.C. Wee.
Collection and assembly of data: D. Arterburn, R. Wellman, A. Emiliano, S.R. Smith, K.J. Coleman, R.Y. Coley, J. Anau, R. Pardee, J. Sturtevant, C. Horgan, K.M. McTigue, E. Malanga, J. McClay, D. Schlundt, A. Odor, C. Apovian, E. Cirelli, L. Rasmussen-Torvik, J. Brown, A. Tavakkoli, E. Nauman, D.M. Hynes, D. Meltzer, L.R. Waitman, L.G. Cowell, L.P. Hanrahan, M. Duke, D.M. Herron, S. Malhotra, M.R. Lent, M. Conroy, M.F. Daley, M. Horberg, D. Bell, X. Zhou.
There has been a dramatic shift in use of bariatric procedures, but little is known about their long-term comparative effectiveness.
To compare weight loss and safety among bariatric procedures.
Retrospective observational cohort study, January 2005 to September 2015. (ClinicalTrials.gov: NCT02741674)
41 health systems in the National Patient-Centered Clinical Research Network.
65 093 patients aged 20 to 79 years with body mass index (BMI) of 35 kg/m2 or greater who had bariatric procedures.
32 208 Roux-en-Y gastric bypass (RYGB), 29 693 sleeve gastrectomy (SG), and 3192 adjustable gastric banding (AGB) procedures.
Estimated percent total weight loss (TWL) at 1, 3, and 5 years; 30-day rates of major adverse events.
Total numbers of eligible patients with weight measures at 1, 3, and 5 years were 44 978 (84%), 20 783 (68%), and 7159 (69%), respectively. Thirty-day rates of major adverse events were 5.0% for RYGB, 2.6% for SG, and 2.9% for AGB. One-year mean TWLs were 31.2% (95% CI, 31.1% to 31.3%) for RYGB, 25.2% (CI, 25.1% to 25.4%) for SG, and 13.7% (CI, 13.3% to 14.0%) for AGB. At 1 year, RYGB patients lost 5.9 (CI, 5.8 to 6.1) percentage points more weight than SG patients and 17.7 (CI, 17.3 to 18.1) percentage points more than AGB patients, and SG patients lost 12.0 (CI, 11.6 to 12.5) percentage points more than AGB patients. Five-year mean TWLs were 25.5% (CI, 25.1% to 25.9%) for RYGB, 18.8% (CI, 18.0% to 19.6%) for SG, and 11.7% (CI, 10.2% to 13.1%) for AGB. Patients with diabetes, those with BMI less than 50 kg/m2, those aged 65 years or older, African American patients, and Hispanic patients lost less weight than patients without those characteristics.
Potential unobserved confounding due to nonrandomized design; electronic health record databases had missing outcome data.
Adults lost more weight with RYGB than with SG or AGB at 1, 3, and 5 years; however, RYGB had the highest 30-day rate of major adverse events. Small subgroup differences in weight loss outcomes were observed.
Patient-Centered Outcomes Research Institute.
Appendix Table 1. Participating PCORnet CDRNs and Sites Contributing Data
Appendix Table 2. Bariatric Surgery Procedure Codes Used as Inclusion Criteria*
Appendix Table 3. Codes Used as Exclusion Criteria*
Flow diagram for identification of the adult PCORnet Bariatric Study cohort in 11 CDRNs.
BMI = body mass index; CDRN = Clinical Data Research Network; PCORnet = National Patient-Centered Clinical Research Network.
* Patients could be excluded for >1 reason.
Table 1. Baseline Characteristics of the Adult PBS Cohort*
Table 2. Comparative Effectiveness of RYGB, SG, and AGB for TWL Among Adults at 1, 3, and 5 Years*
Estimated percentage of TWL through 5 y after bariatric surgery, by procedure type.
This plot shows the estimated percentage of TWL for a patient with the average baseline covariate profile using results from our sensitivity analysis, which included all follow-up weight measurements from 56 156 patients with any postsurgery weight observations. Additional details are provided in the Methods section of the text and the Statistical Appendix section of the Supplement. Shaded areas indicate pointwise 95% CIs. AGB = adjustable gastric banding; RYGB = Roux-en-Y gastric bypass; SG = sleeve gastrectomy; TWL = total weight loss.
Proportions of AGB, RYGB, and SG patients with TWL >5%, >10%, >20%, and >30% at 1, 3, and 5 y.
AGB = adjustable gastric banding; RYGB = Roux-en-Y gastric bypass; SG = sleeve gastrectomy; TWL = total weight loss.
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In this video, David Arterburn, MD, MPH, and Neely Williams, MDiv, offer additional insight into the article, "Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss. A PCORnet Cohort Study."
Francis A. Neelon, MD
November 13, 2018
Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss
The paper by Arterburn, Wellman, Emiliano, and colleagues (Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss; Ann Intern Med. 2018; doi: 10.7326/M17-27860) brings into clear focus the relative merits of three bariatric surgical procedure for weight loss. Roux-en-Y gastric bypass (RYGB) surpasses sleeve gastrectomy (SG), and far outdistances adjustable gastric banding (AGB) in terms of percentage initial weight lost and maintained lost following surgery. The magnitude of weight loss (31% of total body weight for RYGB) seems so dazzling that it may obscure the long road to true wellbeing that still lies ahead.For instance, assume that wisdom underlies the commonly accepted definition of “Healthy Weight” as that which confers a Body Mass Index (BMI) between 18.5 and 24.9. The goal of medical treatment ought to be to help subjects attain such a healthy weight (ie, get their BMI under 25). It is possible to estimate from the data supplied by Arterburn, et al, the percentage of excess BMI * that remains at years 1, 3, and 5 after each surgical procedure. Those calculations show that at one year after surgery, when weight loss is about maximal, patients who have undergone RYGB still retain 37% of their original excess weight (corresponding figures are 48% after SG; 71% after AGB). Excess weight increases afer the first year, so after 5 years, the average BMI ranges between 37 (following RYGB) and 41 (after AGB). Bariatric surgery may be the present “best hope” for sustained weight loss, but it is far from a full solution. Looking at excess weight remaining after surgery illuminates how far we have left to travel rather than how far we have come, and prohibits being satisfied with what we have. Rather than proposing the untold millions of dollars that would be needed to revise the intestinal anatomy of all the world’s obese subjects, medicine needs to devote the kind of energy, money and ingenuity that has been invested in bariatric surgery into helping patients help themselves to become not just a little less ill, but truly healthy.*Fractional excess BMI = (BMI at time point N - 25) / (BMI at time point 0 - 25); multiply by 100 to convert to percentage excess BMI
Arterburn D, Wellman R, Emiliano A, Smith SR, Odegaard AO, Murali S, et al. Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study. Ann Intern Med. ;169:741–750. doi: 10.7326/M17-2786
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Published: Ann Intern Med. 2018;169(11):741-750.
Published at www.annals.org on 30 October 2018
Healthcare Delivery and Policy, Obesity.
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