ASMBS, SOARD, outcome reporting standards
Standardized outcomes reporting in metabolic and bariatric surgery

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Executive summary of American Society for Metabolic and Bariatric Surgery (ASMBS) outcome reporting standards

The purpose of this document is to provide guidance to authors and editors who write, review, and publish manuscripts focusing on bariatric and metabolic surgery. In addition to providing consistency within the field of bariatric and metabolic surgery, standardized outcome reporting will provide a uniform method of communicating our findings throughout the medical literature.

Standardized outcomes reporting in metabolic and bariatric surgery

To date, there has been no standardized or systematic method of reporting outcomes in the bariatric surgery literature. As a result, weight loss is commonly reported differently throughout the medical and surgical literature. Additionally, the definitions of co-morbidity improvement and remission have been inconsistent and this has made interpretation of these results across studies difficult.

Several systematic reviews of the bariatric and metabolic surgery literature have been conducted. The

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[2] Schauer PR, Burguera B, Ikramuddin S, et al. Effect of laparoscopic Roux-en-Y gastric bypass on type 2 diabetes mellitus. Ann Surg 2003;238(4):467–84; discussion 84–5.

[3] Dixon JB, O׳Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a

3. Hypertension

Reporting of the effects of weight loss and its impact on hypertension is rather confusing because of the wide range of definitions used to quantify hypertension, prehypertension, and hypertensive crisis. Another point of conflict is the use of hypertension medications for their secondary effects such as for treatment of atrial fibrillation, migraines, and so on. Lastly, the accepted ranges of normal systolic and diastolic pressure change over the course of life, and changing “normal” values

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[3] Israili ZH, Hernandez-Hernandez R, Valasco M. The future of antihypertensive treatment. Department of Medicine, Emory University School of Medicine

[4] Khan NA. The

4. Dyslipidemia

The words hyperlipidemia and dyslipidemia are used interchangeably and refer to an abnormal amount of one or more lipids in the blood. Dyslipidemia may be seen in 50%–80% of obese persons. Although it is commonly seen in conjunction with other weight-related co-morbidities such as diabetes mellitus and hypertension, dyslipidemia is a primary major risk factor for both cardiovascular disease and cerebrovascular disease, and therefore its improvement or resolution has been deemed important to

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[2] Paraskevas KI, Tzovaras AA, Briana DD, et al. Emerging indications for statins: a pluripotent family of agents with several potential applications. Curr Pharmaceutical Design 2013;13(35).

Review Articles

[3] Noria SF, Grantcharov T. Biological effects of bariatric surgery on obesity-related comorbidities. Can J Surg 2013;56(1):47–57.

[4] Ikramuddin S, Buchwald H. How bariatric and metabolic operations control metabolic syndrome. Br J Surg 2011;98(10):1339–41.

[5] Higa K, Ho T, Tercero F, Yunus T, Boone KB. Laparoscopic Roux-en-Y gastric bypass: 10-year follow-up. Surg Obes Relat Dis 2011;7(4):516–25.

[6] Sjöström L, Lindroos AK, Peltonen M, et al.; Swedish Obese Subjects Study Scientific Group.

5. Obstructive sleep apnea

Obstructive sleep apnea is a common chronic respiratory condition that is estimated to affect up to 17%–24% of North American Adults and severely affect 2%–6%. The incidence of OSA is thought to be significantly higher in the morbidly obese population although variably reported between 41%–98% in published literature.

OSA results in the periodic reduction (hypopnea) or cessation (apnea) of breathing as a result of narrowing or occlusion of the upper airway during sleep. The repetitive collapse

References

[1] ASMBS Clinical Issues Committee. Peri-operative management of obstructive sleep apnea. Surg Obes Relat Dis 2012;8(3):e27–32.

[2] Khan A, King WC, Patterson EJ, et al. Assessment of obstructive sleep apnea in adults undergoing bariatric surgery in the longitudinal assessment of bariatric surgery-2 (LABS-2) study. J Clin Sleep Med 2013;9(1):21–9.

[3] Epstein LJ, Kristo D, Strollo PJ Jr, et al.; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical

6. Gastroesophageal reflux disease (GERD)

GERD is a condition that develops when the reflux of stomach contents causes symptoms and/or complications. Symptoms related to gastroesophageal reflux become troublesome when they adversely affect an individual’s well-being (mild symptoms occurring≥2 d/wk; moderate/severe symptoms occurring>1 d/wk). Prevalence of at least weekly GERD in North America ranges from 18% to 28%. GERD is related to 22% of primary care visits. Heartburn (burning sensation in the retrosternal area) and regurgitation

References

[1] El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 2014;63(6):871–80.

[2] Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastro-esophageal reflux disease (GERD)—a global evidence-based consensus. Am J Gastroenterol 2006;101(8):1900–20.

[3] Ayazi S, Hagen JA, Chan LS, et al. Obesity and gastroesophageal reflux: quantifying the

7. Complications

The issue of reporting surgical complications can be confusing and controversial. The lack of agreement on the definition of a surgical complication and what constitutes an actual surgical complication in addition to the issue of time frame of the occurrence add to the confusion. This section is intended to review the current practices of reporting bariatric complications and to recommend a standard framework for reporting complications that can be easily adopted and used in the bariatric

References

[1] Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network. Ann Surg 2011;254(3):410–22.

[2] Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 2009;361(5):445–54.

[3] Deitel M, Gagner M, Erickson AL, Crosby RD. Third International Summit: current status of sleeve gastrectomy. Surg Obes Relat Dis 2011;7(6):749–59.

[4] Dindo D, Demartines N, Clavien PA.

8. Weight Loss

Weight loss is the most commonly reported outcome after bariatric surgery. The efficacy of a specific bariatric operation and a patient׳s progress is often measured and compared in terms of weight loss. Indeed, a primary goal of weight loss surgery and the measure of its success is the attainment of significant and durable weight loss. The number of bariatric operations performed annually worldwide has increased to>340,000 with a corresponding increase in the number of publications reporting

References

[1] Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg 2013;23(4):427–36.

[2] Mason EE, Amaral J, Coman GSM, Deitel M, Gleysteen JJ, Oria HE. Standard for reporting results. Obes Surg 1994;4(1):56–65.

[3] Dixon JB, McPail T, O׳Brien PE. Minimal reporting requirements for weight loss: current methods not ideal. Obes Surg 2005;15:1034–39.

[4] Montero PN, Stefanidis D, Norton HJ, Gersin K, Kuwada T. Reported excess weight loss after bariatric surgery could vary significantly

9. Quality-of-life outcomes

Morbid obesity has significant detrimental effects on both physical and psychosocial health. The adverse impact of obesity on psychosocial health is reflected in a reduction in health-related quality of life (HR-QOL). Although bariatric surgery produces marked weight loss and improvement of co-morbidities, the impact on HR-QOL is less well established. One factor hampering this effort is the lack of guidelines for reporting psychosocial outcomes.

Disclosures

None of the authors or committee members has any relevant disclosures. No funding was provided for this work.

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