Outcome reporting in bariatric surgery: An in-depth analysis to inform the development of a core outcome set, the BARIACT Study

Obesity Reviews

Volumn 16, Issue 1, 2015, Pages 88-106

  Hopkins, J C ^a   Howes, N ^b,c   Chalmers, K ^b   Savovic, J ^b   Whale, K ^b   Coulman, K D ^b   Welbourn, R ^c   Whistance, R N ^b   Andrews, R C ^b,c   Byrne, J P ^a   Mahon, D ^c   Blazeby, J M ^b,d   Jane M Blazeby, ^d   Reeves, Barney ^d   Welbourn, Richard ^d   Donovan, Jenny ^d   Rogers, Chris ^d   Andrews, Robert ^d   Wordsworth, Sarah ^d   Byrne, James ^d   Thompson, Janice ^d   Roderick, Paul ^d   more..

^a UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF BRISTOL   (United Kingdom)

^c MUSGROVE PARK HOSPITAL   (United Kingdom)

^d UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Bariatric surgery; Complications; Core outcome set; Outcome reporting

Indexed keywords

ANALYSIS; ANASTOMOSIS LEAKAGE; ARTICLE; BARIATRIC SURGERY; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CONSENSUS DEVELOPMENT; CORE OUTCOME SET; HUMAN; IN DEPTH ANALYSIS; OBESITY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; WEIGHT REDUCTION; CONTROLLED STUDY; OBESITY, MORBID; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

BARIATRIC SURGERY; HUMANS; OBESITY, MORBID; PATIENT OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; WEIGHT LOSS;

EID: 84923262232     PISSN: 14677881     EISSN: 1467789X     Source Type: Journal    
DOI: 10.1111/obr.12240     Document Type: Article

References (92)

1. O'Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg 2013; 257: 87-94.
2. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg 2013; 23: 427-436.
3. Welbourn R, Fiennes A, on behalf of the NBSR Data Committee. The United Kingdom National Bariatric Surgery Registry First Registry Report to March 2010. Dendrite Clinical Systems: Henley-on-Thames, UK, 2011. ISBN 1-903968-27-5.
4. National Institutes of Health Consensus Development Panel. Gastrointestinal surgery for severe obesity: National Institutes of Health Consensus Development Conference Statement. Ann Intern Med 1991; 115: 956-961.
5. Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews? A survey of the Co-ordinating Editors of Cochrane Review Group. Trials 2013; 14: 21.
6. Dixon JB, McPhail T, O'Brien PE. Minimal reporting requirements for weight loss: current methods not ideal. Obes Surg 2005; 15: 1034-1039.
7. Oria HE, Carrasquilla C, Cunningham P etal. Guidelines for weight calculations and follow-up in bariatric surgery. Surg Obes Relat Dis 2005; 1: 67-68.
8. van de Laar A. Bariatric Outcomes Longitudinal Database (BOLD) suggests excess weight loss and excess BMI loss to be inappropriate outcome measures, demonstrating better alternatives. Obes Surg 2012; 22: 1843-1847.
9. Picot J, Jones J, Colquitt JL etal. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess 2009; 13: 1-190, 215-357, iii-iv.
10. Guyatt GH, Oxman AD, Kunz R etal. Rating quality of evidence and strength of recommendations: what is 'quality of evidence' and why is it important to clinicians? BMJ 2008; 336: 995-998.
11. Williamson PR, Altman DG, Blazeby JM etal. Developing core outcome sets for clinical trials: issues to consider. Trials 2012; 13: 132.
12. Boonen A, Stucki G, Maksymowych W, Rat AC, Escorpizo R, Boers M. OMERACT-ICF Reference Group. Integrating the ICF into the OMERACT process: opportunities and challenges. J Rheumatol 2009; 36: 2057-2060.
13. Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials 2007; 8: 38.
14. Whistance RN, Forsythe RO, McNair AG etal. A systematic review of outcome reporting in colorectal cancer surgery. Colorectal Dis. 2013; 15: e548-e560.
15. Blencowe NS, McNair AG, Davis CR, Brookes ST, Blazeby JM. Standards of outcome reporting in surgical oncology: a case study in esophageal cancer. Ann Surg Oncol 2012; 19: 4012-4018.
16. Coulman KD, Abdelrahman T, Owen-Smith A, Andrews RC, Welbourn R, Blazeby JM. Patient-reported outcomes in bariatric surgery: a systematic review of standards of reporting. Obes Rev 2013; 14: 707-720.
17. The COMET Initiative. [WWW document]. URL http://www.comet-initiative.org (accessed June 2014).
18. Kirkham JJ, Dwan KM, Altman DG etal. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010; 340: c365.
19. Begg CB, Berlin JA. Publication bias and dissemination of clinical research. J Natl Cancer Inst 1989; 81: 107-115.
20. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life: a conceptual model of patient outcomes. JAMA 1995; 273: 59-65.
21. DeMaria EJ, Pate V, Warthen M, Winegar DA. Baseline data from American Society for Metabolic and Bariatric Surgery-designated Bariatric Surgery Centers of Excellence using the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis 2010; 6: 347-355.
22. Kinnersley P, Phillips K, Savage K etal. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev 2013; (7): CD009445.
23. Nguyen NT, Nguyen B, Gebhart A, Hohmann SJ. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. Am Coll Surg 2013; 216: 252-257.
24. Boers M, Kirwan JR, Wells G etal. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014; 67: 745-753.
25. Luce BR, Kramer JM, Goodman SN etal. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med 2009; 151: 206-209.
26. Aasheim ET, Bjorkman S, Sovik TT etal. Vitamin status after bariatric surgery: a randomized study of gastric bypass and duodenal switch. Am J Clin Nutr 2009; 90: 15-22.
27. Angrisani L, Cutolo PP, Ciciriello MB etal. Laparoscopic adjustable gastric banding with truncal vagotomy versus laparoscopic adjustable gastric banding alone: interim results of a prospective randomized trial. Surg Obes Relat Dis 2009; 5: 435-438.
28. Arterburn D, Livingston EH, Schifftner T etal. Predictors of long-term mortality after bariatric surgery performed in Veterans Affairs medical centers. Arch Surg 2009; 144: 914-920.
29. Ballantyne GH, Wasielewski A, Saunders JK. The surgical treatment of type II diabetes mellitus: changes in HOMA Insulin resistance in the first year following laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic adjustable gastric banding (LAGB). Obes Surg 2009; 19: 1297-1303.
30. Basso N, Casella G, Rizzello M etal. Laparoscopic sleeve gastrectomy as first stage or definitive intent in 300 consecutive cases. Surg Endosc 2011; 25: 444-449.
31. Benaiges D, Goday A, Ramon JM etal. Laparoscopic sleeve gastrectomy and laparoscopic gastric bypass are equally effective for reduction of cardiovascular risk in severely obese patients at one year of follow-up. Surg Obes Relat Dis 2011; 7: 575-580.
32. Blackstone RP, Cortes MC. Metabolic acuity score: effect on major complications after bariatric surgery. Surg Obes Relat Dis 2010; 6: 267-273.
33. Bond DS, Phelan S, Leahey TM etal. Weight-loss maintenance in successful weight losers: surgical vs non-surgical methods. Int J Obes (Lond) 2009; 33: 173-180.
34. Boza C, Gamboa C, Awruch D. etal. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic adjustable gastric banding: five years of follow-up. Surg Obes Relat Dis 2010; 6: 470-475.
35. Braghetto I, Csendes A, Korn O etal. Laparoscopic resectional gastric bypass in patients with morbid obesity: experience on 112 consecutive patients. J Gastrointest Surg 2011; 15: 71-80.
36. Burton PR, Yap K, Brown WA etal. Effects of adjustable gastric bands on gastric emptying, supra- and infraband transit and satiety: a randomized double-blind crossover trial using a new technique of band visualization. Obes Surg 2010; 20: 1690-1697.
37. Campos GM, Rabl C, Roll GR etal. Better weight loss, resolution of diabetes, and quality of life for laparoscopic gastric bypass vs banding: results of a 2-cohort pair-matched study. Arch Surg 2011; 146: 149-155.
38. Ceriani V, Lodi T, Porta A. etal. Laparoscopic versus open biliopancreatic diversion: a prospective comparative study. Obes Surg 2010; 20: 1348-1353.
39. Chang CY, Huang CK, Chang YY etal. Prospective study of health-related quality of life after Roux-en-Y bypass surgery for morbid obesity. Br J Surg 2010; 97: 1541-1546.
40. Christou N, Efthimiou E. Five-year outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in a comprehensive bariatric surgery program in Canada. Can J Surg 2009; 52: E249-258.
41. Coskun H, Bostanci O. Assessment of the application of the intragastric balloon together with sibutramine: a prospective clinical study. Obes Surg 2010; 20: 1117-1120.
42. Cottam DR, Fisher B, Sridhar V etal. The effect of stoma size on weight loss after laparoscopic gastric bypass surgery: results of a blinded randomized controlled trial. Obes Surg 2009; 19: 13-17.
43. Csendes A, Maluenda F, Burgos AM. A prospective randomized study comparing patients with morbid obesity submitted to laparotomic gastric bypass with or without omentectomy. Obes Surg 2009; 19: 490-494.
44. Dallal RM, Quebbemann BB, Hunt LH etal. Analysis of weight loss after bariatric surgery using mixed-effects linear modeling. Obes Surg 2009; 19: 732-737.
45. Dapri G, Cadiere GB, Himpens J. Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing three different techniques. Obes Surg 2010; 20: 462-467.
46. Daskalakis M, Berdan Y, Theodoridou S etal. Impact of surgeon experience and buttress material on postoperative complications after laparoscopic sleeve gastrectomy. Surg Endosc 2011; 25: 88-97.
47. DeMaria EJ, Pate V, Warthen M etal. Baseline data from American Society for Metabolic and Bariatric Surgery-designated Bariatric Surgery Centers of Excellence using the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis 2010; 6: 347-355.
48. DeMaria EJ, Winegar DA, Pate VW etal. Early postoperative outcomes of metabolic surgery to treat diabetes from sites participating in the ASMBS bariatric surgery center of excellence program as reported in the Bariatric Outcomes Longitudinal Database. Ann Surg 2010; 252: 559-566; discussion 566-557.
49. Di Lorenzo N, Furbetta F, Favretti F etal. Laparoscopic adjustable gastric banding via pars flaccida versus perigastric positioning: technique, complications, and results in 2, 549 patients. Surg Endosc 2010; 24: 1519-1523.
50. Dumonceau JM, Francois E, Hittelet A etal. Single vs repeated treatment with the intragastric balloon: a 5-year weight loss study. Obes Surg 2010; 20: 692-697.
51. Flum DR, Belle SH, King WC etal. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 2009; 361: 445-454.
52. Fried M, Dolezalova K, Sramkova P. Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial. Surg Obes Relat Dis 2011; 7: 23-31.
53. Garb J, Welch G, Zagarins S etal. Bariatric surgery for the treatment of morbid obesity: a meta-analysis of weight loss outcomes for laparoscopic adjustable gastric banding and laparoscopic gastric bypass. Obes Surg 2009; 19: 1447-1455.
54. Gehrer S, Kern B, Peters T. etal. Fewer nutrient deficiencies after laparoscopic sleeve gastrectomy (LSG) than after laparoscopic Roux-Y-gastric bypass (LRYGB)-a prospective study. Obes Surg 2010; 20: 447-453.
55. Genco A, Cipriano M, Bacci V etal. Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients. Obes Surg 2010; 20: 1496-1500.
56. Herrera MF, Pantoja JP, Velazquez-Fernandez D etal. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care 2010; 33: 1413-1418.
57. Himpens J, Cadiere GB, Bazi M etal. Long-term outcomes of laparoscopic adjustable gastric banding. Arch Surg 2011; 146: 802-807.
58. Hinojosa MW, Varela JE, Parikh D etal. National trends in use and outcome of laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2009; 5: 150-155.
59. Iaconelli A, Panunzi S, De Gaetano A etal. Effects of bilio-pancreatic diversion on diabetic complications: a 10-year follow-up. Diabetes Care 2011; 34: 561-567.
60. Inabnet WB, Belle SH, Bessler M etal. Comparison of 30-day outcomes after non-LapBand primary and revisional bariatric surgical procedures from the Longitudinal Assessment of Bariatric Surgery study. Surg Obes Relat Dis 2010; 6: 22-30.
61. Jantz EJ, Larson CJ, Mathiason MA etal. Number of weight loss attempts and maximum weight loss before Roux-en-Y laparoscopic gastric bypass surgery are not predictive of postoperative weight loss. Surg Obes Relat Dis 2009; 5: 208-211.
62. Jurowich C, Thalheimer A, Seyfried F etal. Gastric leakage after sleeve gastrectomy-clinical presentation and therapeutic options. Langenbecks Arch Surg 2011; 396: 981-987.
63. Kasza J, Brody F, Vaziri K etal. Analysis of poor outcomes after laparoscopic adjustable gastric banding. Surg Endosc 2011; 25: 41-47.
64. Lee WJ, Chong K, Ser KH etal. Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg 2011; 146: 143-148.
65. Leyba JL, Aulestia SN, Llopis SN. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study of 117 patients. Obes Surg 2011; 21: 212-216.
66. Makary MA, Clark JM, Shore AD etal. Medication utilization and annual health care costs in patients with type 2 diabetes mellitus before and after bariatric surgery. Arch Surg 2010; 145: 726-731.
67. Marsk R, Tynelius P, Rasmussen F etal. Short-term morbidity and mortality after open versus laparoscopic gastric bypass surgery. A population-based study from Sweden. Obes Surg 2009; 19: 1485-1490.
68. Nguyen NT, Dakin G, Needleman B etal. Effect of staple height on gastrojejunostomy during laparoscopic gastric bypass: a multicenter prospective randomized trial. Surg Obes Relat Dis 2010; 6: 477-482.
69. Nguyen NT, Slone JA, Nguyen XM etal. A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life, and costs. Ann Surg 2009; 250: 631-641.
70. Padwal RS, Majumdar SR, Klarenbach S etal. The Alberta population-based prospective evaluation of the quality of life outcomes and economic impact of bariatric surgery (APPLES) study: background, design and rationale. BMC Health Serv Res 2010; 10: 284.
71. Peterli R, Wolnerhanssen B, Peters T etal. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg 2009; 250: 234-241.
72. Phillips E, Ponce J, Cunneen SA etal. Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States. Surg Obes Relat Dis 2009; 5: 588-597.
73. Ponce J, Lindsey B, Pritchett S etal. New adjustable gastric bands available in the United States: a comparative study. Surg Obes Relat Dis 2011; 7: 74-79.
74. Prachand VN, Ward M, Alverdy JC. Duodenal switch provides superior resolution of metabolic comorbidities independent of weight loss in the super-obese (BMI>or=50 kg/m2) compared with gastric bypass. J Gastrointest Surg 2010; 14: 211-220.
75. Ruz M, Carrasco F, Rojas P etal. Zinc absorption and zinc status are reduced after Roux-en-Y gastric bypass: a randomized study using 2 supplements. Am J Clin Nutr 2011; 94: 1004-1011.
76. Sabbagh C, Verhaeghe P, Dhahri A etal. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg 2010; 20: 679-684.
77. Scozzari G, Farinella E, Bonnet G etal. Laparoscopic adjustable silicone gastric banding vs laparoscopic vertical banded gastroplasty in morbidly obese patients: long-term results of a prospective randomized controlled clinical trial. Obes Surg 2009; 19: 1108-1115.
78. Singhal R, Kitchen M, Bridgwater S etal. Dietetic-led management of patients undergoing laparoscopic gastric banding: early results. Surg Endosc 2010; 24: 1268-1273.
79. Skroubis G, Karamanakos S, Sakellaropoulos G etal. Comparison of early and late complications after various bariatric procedures: incidence and treatment during 15 years at a single institution. World J Surg 2011; 35: 93-101.
80. Sovik TT, Taha O, Aasheim ET etal. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg 2010; 97: 160-166.
81. Strain GW, Gagner M, Pomp A etal. Comparison of weight loss and body composition changes with four surgical procedures. Surg Obes Relat Dis 2009; 5: 582-587.
82. Stroh C, Birk D, Flade-Kuthe R etal. A nationwide survey on bariatric surgery in Germany - results 2005-2007. Obes Surg 2009; 19: 105-112.
83. Stroh C, Birk D, Flade-Kuthe R etal. Results of sleeve gastrectomy-data from a nationwide survey on bariatric surgery in Germany. Obes Surg 2009; 19: 632-640.
84. Sultan S, Gupta D, Parikh M etal. Five-year outcomes of patients with type 2 diabetes who underwent laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2010; 6: 373-376.
85. Tarnoff M, Rodriguez L, Escalona A etal. Open label, prospective, randomized controlled trial of an endoscopic duodenal-jejunal bypass sleeve versus low calorie diet for pre-operative weight loss in bariatric surgery. Surg Endosc 2009; 23: 650-656.
86. Tian HL, Tian JH, Yang KH etal. The effects of laparoscopic vs. open gastric bypass for morbid obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev 2011; 12: 254-260.
87. Toouli J, Kow L, Ramos AC etal. International multicenter study of safety and effectiveness of Swedish Adjustable Gastric Band in 1-, 3-, and 5-year follow-up cohorts. Surg Obes Relat Dis 2009; 5: 598-609.
88. Turner PL, Oyetunji TA, Gantt G etal. Demographically associated variations in outcomes after bariatric surgery. Am J Surg 2011; 201: 475-480.
89. Valezi AC, Mali J, de Menezes MA etal. Weight loss outcome after silastic ring Roux-en-Y gastric bypass: 8 years of follow-up. Obes Surg 2010; 20: 1491-1495.
90. Woelnerhanssen B, Peterli R, Steinert RE etal. Effects of postbariatric surgery weight loss on adipokines and metabolic parameters: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy-a prospective randomized trial. Surg Obes Relat Dis 2011; 7: 561-568.
91. Woodard GA, Peraza J, Bravo S etal. One year improvements in cardiovascular risk factors: a comparative trial of laparoscopic Roux-en-Y gastric bypass vs. adjustable gastric banding. Obes Surg 2010; 20: 578-582.
92. Zingg U, McQuinn A, DiValentino D etal. Revisional vs. primary Roux-en-Y gastric bypass-a case-matched analysis: less weight loss in revisions. Obes Surg 2010; 20: 1627-1632.