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Standardized Outcomes Reporting in Metabolic and Bariatric Surgery
Standardized Outcomes Reporting in Metabolic and Bariatric Surgery
Keywords: Bariatric surgery; Metabolic surgery; Standardized outcome reporting; Medical literature
Executive summary of American Society for Metabolic remained in the study until the study endpoint(s) are
and Bariatric Surgery (ASMBS) outcome reporting reached or for the final reported follow-up interval. The
standards reasons for patient attrition from the study should be
reported when possible. For retrospective studies, the total
The purpose of this document is to provide guidance to
number of patients in the database(s) who meet the
authors and editors who write, review, and publish manu- inclusion criteria should be reported in addition to the
scripts focusing on bariatric and metabolic surgery. In percentage available for data analysis for the study
addition to providing consistency within the field of
endpoints.
bariatric and metabolic surgery, standardized outcome
reporting will provide a uniform method of communicating Duration of follow-up. Short-term follow-up is defined
our findings throughout the medical literature. as o3 years after intervention. Medium-term follow is
defined as 43 and o5 years after intervention. Long-term
1. Follow-up follow-up is defined as 45 years after intervention.
% Follow-up. When appropriate for the study design, the
percentage of patients comprising the original study group
who complete each follow-up period reported for the study 2. Diabetes
should be reported (i.e., report the numerator and denom-
inator available for follow-up at each time point reported). Definitions of glycemic outcomes after bariatric surgery
For prospective studies, % follow-up should represent the Outcome Definition
percentage of patients from the original study group(s) who
Remission (complete) Normal measures of glucose
metabolism (HbA1c o6%,
*
Correspondence: Stacy A. Brethauer, MD Bariatric and Metabolic FBG o100 mg/dL) in the
Center, Digestive Disease Institute, Cleveland Clinic, 9500 Euclid Ave., absence antidiabetic medications
M61, Cleveland, OH 44195. Remission (partial) Subdiabetic hyperglycemia (HbA1c
E-mail: brethas@ccf.org 6%–6.4%, FBG 100–125 mg/dL)
http://dx.doi.org/10.1016/j.soard.2015.02.003
1550-7289/r 2015 Springer ScienceþBusiness Media New York and the American Society for Metabolic and Bariatric Surgery. All rights reserved.
490 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
Subjective: Patients with preoperative documentation of OSA who Examples of major complications
have not or will not undergo repeat objective testing
with PSG. Examples of major complications include the following:
Document personal or witnessed improvement in sleep
hygiene and symptoms of sleep apnea.
Venous thrombotic event (VTE) requiring administration
Have self-discontinued the use of sleep apnea treatment of anticoagulant or intervention, such as embolectomy,
CPAP/BiPAP based on improved symptoms. inferior vena caval (IVC) filter
CPAP ¼ continuous positive airway pressure; Bi-PAP ¼ bilevel positive
Anastomotic leak requiring reoperation, percutaneous drain-
airway pressure. age of abscess, stent placement or conservative management
with parenteral nutrition and nothing per os (NPO)
Gastrointestinal hemorrhage requiring transfusion or
6. Gastroesophageal reflux disease (GERD) intervention
Small bowel obstruction requiring reoperation
In the evaluation and reporting of GERD after bariatric Bowel perforation requiring reoperation
surgery, the following recommendations are made: Trocar site hernia requiring reoperation
Death
1. Use of a validated questionnaire pre- and postsurgery Myocardial infarction
2. Recording and reporting medication use and specific Cerebrovascular accident
indication Renal failure requiring dialysis
3. Minimum of 1-year follow-up and, ideally, long-term Respiratory failure requiring intervention such as
follow-up that is procedure-specific intubation
Prolonged hospitalization (47 d)
Like OSA, there may be subjective self-reported criteria Chronic nausea and vomiting not responsive to conser-
to define improvement of GERD after surgery as well as vative management and requiring total parenteral
objective criteria. Objective, procedure-specific criteria are nutrition (TPN)
preferred. Authors should specify whether their outcomes Gastric sleeve stenosis/obstruction requiring revision to a
are based on objective or subjective criteria. gastric bypass
Surgical site infection (superficial, deep, or organ space)
Complete resolution Absence of symptoms (normal symptom score) requiring debridement or washout in the operating room
(objective): and or percutaneous intervention
No medication use and Small bowel stenosis, stricture, or obstruction requiring
Normal physiologic test (24- or 48-hr pH study,
impedance study [preferred], and/or
revision of the jejunojejunostomy
endoscopy])
Complete resolution Absence of symptoms and
Examples of minor complications. Examples of minor
(subjective): No medication use complications include the following:
Improvement Improved symptom score on validated testing or
(objective): Decreased or as needed medication use* or
Improved physiologic test (24- or 48-hour pH Marginal ulcer diagnosed with upper endoscopy
study, impedance study, and/or endoscopy) Anastomotic stricture requiring endoscopic dilation
Improvement (self- Improved symptom severity or frequency or Nausea and vomiting requiring intravenous fluids (IVF)
reported): Decreased or as needed medication use* but not TPN
*
Decreased or as-needed medication associated with improvement of Acute renal failure managed with IVF without the need
symptoms and not ineffectiveness of medication, cost, or other reasons. of dialysis
Gastrointestinal ileus managed conservatively
Incisional hernia (diagnosed during routine follow-up)
7. Complications Trocar site surgical site infection managed with drainage
and local wound care
Complication Major Minor Negative re-exploration (e.g., diagnostic laparoscopy to
Early o30 days Early major Early minor rule out leak or for unexplained tachycardia)
Late 430 days Late major Late minor Urinary tract infection managed with antibiotics
Dehydration requiring IV hydration as an inpatient
Vitamin or mineral deficiency requiring IV supplemen-
Major complications include any complication that result tation (e.g., severe anemia requiring IV iron infusion or
in a prolonged hospital stay (beyond 7 days), administration severe vitamin B12 requiring vitamin B12 injections or
of an anticoagulant, reintervention, or reoperation. symptomatic thiamine deficiency requiring IV thiamine)
Minor complications include everything else that is not Nephrolithiasis
included under major. Symptomatic cholelithiasis
492 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
study should be reported when possible. For retrospective don’t have insurance coverage for them any longer. In
studies, the total number of patients in the database who prospective trials, these laboratory measurements should be
meet the inclusion criteria should be reported in addition to included in the budgeting for long-term follow-up because
the percentage available for data analysis for the study they may no longer be considered “standard of care” for
endpoints. some patients in remission.
Duration of follow-up. Short-term follow-up is defined The other major challenge is to communicate consistently
as o3 years after intervention. Medium-term follow-up is in the literature and present accurate biochemical parame-
defined as 43 and o5 years after intervention. Long-term ters that are agreeable to our medical colleagues. More
follow-up is defined as 45 years after intervention. mechanistic evaluations such as euglycemic hyperinsuline-
mic clamp studies are extremely helpful in communicating
2. Diabetes our findings to endocrinologists, though this type of study is
not always practical or feasible.
The field of metabolic and bariatric surgery has advanced
rapidly over the last decade and this is due in large part to
the effect of these operations on type 2 diabetes mellitus Recommended reporting.
(T2DM). There is a large body of literature demonstrating
Definitions of glycemic outcomes after bariatric surgery*
the early and mid-term effects of bariatric procedures on
diabetes remission and improvement and several that have Outcome Definition
reported the durability of these effects beyond 5 years. Over Remission Normal measures of glucose metabolism (HbA1c o6%,
time, definitions of diabetes remission based on biochemical (complete) FBG o100 mg/dL) in the absence of antidiabetic
parameters have changed and there is a wide variety of medications
definitions for remission used throughout the bariatric Remission Subdiabetic hyperglycemia (HbA1c 6%–6.4%, FBG
(partial) 100–125 mg/dL) in the absence of antidiabetic
literature. As this field continues to progress, clear bio-
medications
chemical endpoints and definitions of diabetes improve- Improvement Statistically significant reduction in HbA1c and FBG not
ment, remission, and recurrence must be established and meeting criteria for remission or decrease in
reported consistently in the bariatric literature. antidiabetic medications requirement (by
discontinuing insulin or 1 oral agent, or ½ reduction in
dose)
Current practices Unchanged The absence of remission or improvement as described
earlier
There is no consistency in how diabetes remission has
Recurrence FBG or HbA1c in the diabetic range (Z126 mg/dL
been reported in the bariatric literature. Definitions have and Z6.5%, respectively) or need for antidiabetic
ranged from patient-reported medication discontinuation to medication after any period of complete or partial
strict biochemical parameters. The American Diabetes remission
Association (ADA) publishes clear criteria to define the HbA1c ¼ glycosylated hemoglobin; FBG ¼ fasting blood glucose.
disease of T2DM and prediabetes [1]. The current ADA
target of therapy is an HbA1c o7%, but this target of
therapy implies only adequate control with or without Adapted from Buse JB, Caprio S, Cefalu WT, et al. How
medication. Normoglycemia based on HbA1c and fasting do we define cure of diabetes? Diabetes Care 2009;32
blood glucose off medication has been used more com- (11):2133–5; and Schauer PR, Burguera B, Ikramuddin S,
monly in recent publications, but even some recent pub- et al. Effect of laparoscopic Roux-en-Y gastric bypass on
lications in high-impact journals have used subdiabetic type 2 diabetes mellitus. Ann Surg 2003;238(4):467–84.
hyperglycemia in their definition of remission.
Challenges. Even though obtaining fasting glucose levels
References
and HbA1c levels are routine and considered standard of
care for diabetic patients, it can be difficult to obtain these [1] Pories WJ, Swanson MS, MacDonald KG, et al. Who would have
parameters from retrospective studies. Prospective trials that thought it? An operation proves to be the most effective therapy for
are evaluating diabetic outcomes as a primary or secondary adult-onset diabetes mellitus. Ann Surg 1995;222(3):339–50; dis-
cussion 350–2.
endpoint, however, should include these biochemical [2] Schauer PR, Burguera B, Ikramuddin S, et al. Effect of laparoscopic
parameters as well as medication usage in their study Roux-en-Y gastric bypass on type 2 diabetes mellitus. Ann Surg
design if appropriate. One major challenge potentially 2003;238(4):467–84; discussion 84–5.
encountered in longer-term studies, particularly retrospec- [3] Dixon JB, O'Brien PE, Playfair J, et al. Adjustable gastric banding and
tive studies, is that patients who achieve complete remission conventional therapy for type 2 diabetes: a randomized controlled trial.
JAMA 2008;299(3):316–23.
of their diabetes are no longer considered diabetic by their [4] Gill RS, Birch DW, Shi X, et al. Sleeve gastrectomy and type 2
primary physician or insurance company and either don’t diabetes mellitus: a systematic review. Surg Obes Relat Dis; 6
have these laboratory measurements drawn annually or (6):707–13.
494 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
[5] DeMaria EJ, Sugerman HJ, Kellum JM, et al. Results of 281 stage because it can reduce the risk of major cardiovascular
consecutive total laparoscopic Roux-en-Y gastric bypasses to treat events by 18%–42%. The Canadian Hypertension Education
morbid obesity. Ann Surg 2002;235(5):640–5; discussion 645–7.
Program Evidence-Based Recommendations Task Force rec-
[6] Cohen RV, Pinheiro JC, Schiavon CA, et al. Effects of gastric bypass ommended pharmacotherapy targets of BP o140/90 mm Hg
surgery in patients with type 2 diabetes and only mild obesity. Diabetes
Care 2012;35(7):1420–8.
in all patients but o130/80 mm Hg in those with diabetes
[7] Dixon JB, Zimmet P, Alberti KG, et al. Bariatric surgery for diabetes: mellitus or chronic kidney disease. In the United States, 33%
the International Diabetes Federation takes a position. J Diabetes of the population has hypertension and is under medical
2011;3(4):261–4. treatment. The trend to treat prehypertension with pharmaco-
[8] American Diabetes Association. Standards of medical care in diabetes therapy is rapidly gaining favor, and the target blood pressure
—2013. Diabetes Care 2013;36(Suppl 1):S11–66. ranges are also trending lower. There is a wealth of literature
[9] Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2 diabetes that indicates that treating obesity with lifestyle management
after bariatric surgery: systematic review and meta-analysis. Am J
alone or in conjunction with bariatric surgery has major effects
Med 2009;122(3):248–256 e5.
[10] Brethauer SA, Aminian A, Romero-Talamas H, et al. Can diabetes be
on improving hypertension and its associated sequelae.
surgically cured? Long-term metabolic effects of bariatric surgery in
obese patients with type 2 diabetes. Ann Surg 2013;258(4):628–37.
Current reporting practices. Various studies have docu-
[11] Sjostrom L, Peltonen M, Jacobson P, et al. Bariatric surgery and long- mented the significant impact bariatric surgery has on the
term cardiovascular events. JAMA 2012;307(1):56–65. improvement and resolution of hypertension. Currently there is
[12] Buse JB, Caprio S, Cefalu WT, et al. How do we define cure of no standard definition of hypertension or stage of hypertension
diabetes? Diabetes Care 2009;32(11):2133–5. to be used in the bariatric literature. Additionally, stating that a
patient decreased medication use does not provide the
3. Hypertension important details needed to understand the effects of the
Reporting of the effects of weight loss and its impact on intervention (surgery) on the disease of hypertension because
hypertension is rather confusing because of the wide range of many of these medications have multiple indications.
definitions used to quantify hypertension, prehypertension, Challenges and controversies. Multiple issues exist when
and hypertensive crisis. Another point of conflict is the use of reporting the impact of surgery on hypertension, including
hypertension medications for their secondary effects such as patient compliance. Because many hypertensive medica-
for treatment of atrial fibrillation, migraines, and so on. tions have multiple indications beyond hypertension, it is
Lastly, the accepted ranges of normal systolic and diastolic important to ensure that the initial indication for the specific
pressure change over the course of life, and changing hypertensive was to treat a specific stage of hypertension.
“normal” values must be considered when reporting the data. There is also a relative lack of data comparing the efficacy
Hypertension affects 1 billion individuals worldwide and of different bariatric procedures on hypertension or dis-
carries an increased risk of mortality and morbidity because cussions regarding mechanisms beyond weight loss. Addi-
of its association with strokes, coronary heart disease, tionally, reporting of hypertension outcomes in the bariatric
congestive heart failure, and end-stage renal disease. Hyper- literature may be confounded by differences in age, sex, and
tension, as defined by the American Heart Association, is usage of nicotine products among a study cohort.
divided into stages. Stage 1 hypertension occurs when the
systolic blood pressure (BP) is between 140 and 159 mm Recommended reporting practices. For consistency in
Hg or the diastolic range falls between 90 and 99 mm Hg. reporting and comparing data, defined parameters should
Stage 2 hypertension occurs when systolic readings are be followed. Patient age; gender; the presence of diabetes,
consistently 4160 mm Hg or diastolic readings are 4100 chronic kidney disease, or collagen disorders; ethnicity; and
mm Hg. Hypertensive crisis requiring immediate interven- smoking history should carefully be outlined, because each
tion occurs when systolic readings are 4180 mm Hg or of these factors may play an important role in hypertension
diastolic readings are 4110 mm Hg. Normotensive values management. When reporting hypertension outcomes after
are reported as a systolic o120 mm Hg and a diasto- metabolic and bariatric procedures, the following staging
lic o80 mm Hg. Prehypertension occurs when a systolic system should be used:
reading falls between 120 and 139 mm Hg or a diastolic
reading falls between 80 and 89 mm Hg.
Stage of hypertension before and Prehypertension (120–140/80–89)
Treatment of hypertension, regardless of the degree or stage, after bariatric surgery at defined Stage 1 hypertension (140–159/90–99)
begins with lifestyle management (dietary restriction, behavior follow-up intervals: Stage 2 hypertension (460/4100)
modification, and increased activity). Currently there are 475 Antihypertensive medication use: Clearly define indication for medication
antihypertensive medications available in the United States in as treatment of hypertension.
Reporting medication type or class
9 classes with continued interest in newer targeted therapies.
and duration of therapy is also
Although traditional thought was to begin pharmacologic recommended, with the
therapy for stage 1 hypertension, the new paradigm suggests understanding that this may not be
that pharmacologic treatment begin during the prehypertensive feasible in retrospective studies.
Standardized Outcomes Reporting / Surgery for Obesity and Related Diseases 11 (2015) 489–506 495
Improvement: Decrease in dosage or number of Once a diagnosis has been made, the treatment of
antihypertensive medication or dyslipidemia generally starts with lifestyle changes, such
decrease in systolic or diastolic
blood pressure on same as a decrease in the dietary intake of cholesterol-raising
medication (better control). nutrients, overall reduction in saturated fats, use of soluble
Partial remission: Prehypertension values (120–140/ fiber, weight reduction, and increase in exercise. When such
80–89) off medication. measures are insufficient, or in the presence of other risk
Complete remission: Normotensive (BP o120/80) off factors, medications may be started, and include such
antihypertensive medication. If
medication such as beta-blockade
substances as statins, bile acid sequestrants, nicotinic acid,
is used for another indication omega-3 fatty acids, and the fibric acids.
(e.g., atrial fibrillation), this needs Weight loss surgery is not generally discussed as a
to be clearly described but cannot specific treatment for dyslipidemia in the same way it is
be included as complete remission
used as a treatment for diabetes mellitus, and as such there
because of the dual therapeutic
effect of some medications.
are no controlled trials looking specifically at improvement
of blood lipids after weight loss surgery. Nonetheless, there
is a large body of literature, mostly reviews and retro-
spective studies, demonstrating in a variety of ways how
References
dyslipidemia can improve after weight loss surgery.
[1] Victor RG. Systemic hypertension: mechanisms and diagnosis. In: The Swedish Obesity Study looked at outcomes with 10
Bonow RO, Mann DL, Zipes DP, Libby P, editors. Braunwald's heart years of follow-up, which was in part successfully com-
disease: a textbook of cardiovascular medicine. 9th ed. Philadelphia:
pleted because of a national healthcare system. The reporting
Saunders Elsevier; 2011.
[2] Fuchs FD. Prehypertension: the rationale for early drug therapy. of large collective groups of patients who underwent
Cariovasc Ther 2010; 28(6):339–43. “bariatric surgery” is confusing and unhelpful; improvement
[3] Israili ZH, Hernandez-Hernandez R, Valasco M. The future of of dyslipidemia should be reported in the context of which
antihypertensive treatment. Department of Medicine, Emory Univer- surgical procedure was performed, including but not limited
sity School of Medicine
to the various limb lengths in gastric bypass. Patient age and
[4] Khan NA. The 2006 Canadian Hypertension Education Program
recommendations for the management of hypertension: Part II— gender have both been reported to have differential effects
Therapy. Can J Cardiology 2006;22(7):583–93. on various blood lipids before and after surgery, so these
populations should be described separately. In addition,
4. Dyslipidemia improvement of dyslipidemia should be reported in the
context of amount of weight lost. How weight loss or BMI
The words hyperlipidemia and dyslipidemia are used loss is reported is another topic of discussion. Finally,
interchangeably and refer to an abnormal amount of one or whether or not patients are using lipid-lowering medication
more lipids in the blood. Dyslipidemia may be seen in at the time of drawn lipid levels is essential information.
50%–80% of obese persons. Although it is commonly seen Because this can confound the data, controlled studies of
in conjunction with other weight-related co-morbidities lipid levels before and after surgery in patients not taking
such as diabetes mellitus and hypertension, dyslipidemia lipid-lowering medications will be most helpful in clarifying
is a primary major risk factor for both cardiovascular exactly how weight loss operations affect blood lipid levels.
disease and cerebrovascular disease, and therefore its
improvement or resolution has been deemed important to Current reporting practices. Dyslipidemia is common in
study after weight loss surgery. the severely obese population and studies in the surgical
The general recommendation for screening of blood lipids literature generally document improvement of dyslipidemia
is a complete fasting lipoprotein profile, including total after weight loss surgery. Unfortunately, current reporting
cholesterol, LDL cholesterol, HDL cholesterol, and triglycer- practices are not standardized and may include a simple
ides. A secondary option would be to collect nonfasting total reported history of the presence or absence of dyslipidemia,
cholesterol and HDL cholesterol; if total cholesterol is Z200 surveys of medication usage, or comparisons of lipid
mg/dL or if the HDL is o40 mg/dL, then the recommenda- profiles at different time points before and after surgery.
tion would be to proceed to the full fasting panel. Not all studies state whether blood lipid levels were taken
There are many possible causes for dyslipidemia, includ- in a fasting or nonfasting state. Not all studies differentiate
ing overweight and obesity, physical inactivity, alcohol improvement from complete resolution. Many papers,
abuse, smoking, a diet high in carbohydrates, type II diabetes including some meta-analyses, do not define dyslipi-
mellitus, chronic renal insufficiency, various drugs such as demia or state how the diagnosis was arrived at in any
steroids and beta-blockers, and a variety of genetic disorders, particular study. Some studies use various models of risk,
including monogenic familial hypercholesterolemia, type III such as the Regicor model, or the Framingham model to
hyperlipidemia, familial defective apolipoprotein B-100, and assess cardiovascular risk, which is closely tied to
polygenic hypercholesterolemia. dyslipidemia.
496 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
Challenges. One challenge with simple reporting of Improvement: Decrease in number or dose of lipid-lowering agents with
medication use is that patients may have refused medication equivalent control of dyslipidemia or improved control
treatment before surgery despite the presence of dyslipide- of lipids on equivalent medication.
mia, either because of side effects or a general dislike Authors must specify which components of the lipid profile
are being studied and report them as individual outcomes
of taking medications. This phenomenon would tend to when possible.
underreport improvement in dyslipidemia. In addition, there Cardiovascular risk based on TC/HDL or other risk scoring
are other indications for various lipid-lowering medications; systems can be used to provide a more global assessment
for example, not all patients taking statins are using them of lipid changes after surgery.
for dyslipidemia but for other established diagnoses, includ- Remission: Normal lipid panel off medication.
ing osteoporosis, some cancers, cerebrovascular events,
cardiac arrhythmias, renal disease, rheumatoid arthritis,
and others. Statins are sometimes used for the prevention References
of certain diseases such as Alzheimer’s and Parkinson’s [1] Eldor R, Raz I. American Diabetes Association indications for statins in
disease. In this sense, a study of medication use could tend diabetes: is there evidence? Diab Care 2009;32(Sup2):S384–91.
to overreport the presence of dyslipidemia. Statin use is [2] Paraskevas KI, Tzovaras AA, Briana DD, et al. Emerging indications
also widely recommended in the setting of diabetes to achieve for statins: a pluripotent family of agents with several potential
an even lower LDL level than commonly recommended applications. Curr Pharmaceutical Design 2013;13(35).
because of increased risk for coronary events; in this sense a
Review Articles
patient may be taking a statin but may not have dyslipi-
demia by strict definitions. Comparison of the efficacy [3] Noria SF, Grantcharov T. Biological effects of bariatric surgery on
of various operations in improving dyslipidemia will also obesity-related comorbidities. Can J Surg 2013;56(1):47–57.
[4] Ikramuddin S, Buchwald H. How bariatric and metabolic operations
be clouded by the presence of genetic causes of abnor- control metabolic syndrome. Br J Surg 2011;98(10):1339–41.
mal blood lipids, which may not improve simply with [5] Higa K, Ho T, Tercero F, Yunus T, Boone KB. Laparoscopic Roux-en-
weight loss. Y gastric bypass: 10-year follow-up. Surg Obes Relat Dis 2011;7
(4):516–25.
Recommended reporting practices. It is recommended that [6] Sjöström L, Lindroos AK, Peltonen M, et al.; Swedish Obese Subjects
reporting practice for dyslipidemia after bariatric surgery Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors
follow the Adult Treatment Panel III Guidelines, 2001, of 10 years after bariatric surgery. N Engl J Med 2004;351(26):2683–93.
the National Heart, Lung and Blood Institute. These values [7] Garcia-Marirrodriga I, Amaya-Romero C, Ruiz-Diaz GP, et al. Evo-
lution of lipid profiles after bariatric surgery. Obes Surg 2012;22
reflect fasting blood samples: (4):609–16.
[8] Laurino Neto RM, Herbella FA, Tauil RM, Silva FS, de Lima SE Jr.
Comorbidities remission after Roux-en-Y gastric bypass for morbid
LDL cholesterol o100 mg/dL ¼ optimal (or o40 obesity is sustained in a long-term follow-up and correlates with weight
mg/dL if another risk factor is regain. Obes Surg 2012;22(10):1580–5.
present) [9] Jamal M, Wegner R, Heitshusen D, Liao J, Samuel I. Resolution of
100–129 mg/dL ¼ near optimal hyperlipidemia follows surgical weight loss in patients undergoing
130–159 mg/dL ¼ borderline high Roux-en-Y gastric bypass surgery: a 6-year analysis of data. Surg Obes
160–189 mg/dL ¼ high Relat Dis 2011;7(4):473–9.
4190 mg/dL ¼ very high [10] Benaiges D, Flores-Le-Roux JA, Pedro-Botet J, et al. Impact of
HDL cholesterol o40 mg/dL ¼ low restrictive (sleeve gastrectomy) vs hybrid bariatric surgery (Roux-en-
460 mg/dL ¼ high Y gastric bypass) on lipid profile. Obes Surg 2012;22(8):1268–75.
Total cholesterol o200 mg/dL ¼ desirable
200–239 mg/dL ¼ borderline high
4240 mg/dL ¼ high 5. Obstructive sleep apnea
Triglycerides o150 mg/dL ¼ normal
150–199 mg/dL ¼ borderline high Obstructive sleep apnea is a common chronic respiratory
200–499 mg/dL ¼ high condition that is estimated to affect up to 17%–24% of
4500 mg/dL ¼ very high North American Adults and severely affect 2%–6%. The
Cardiovascular risk may then be ½ average risk ¼ 3.27
incidence of OSA is thought to be significantly higher in the
calculated as the cholesterol/HDL
ratio: morbidly obese population although variably reported
average risk ¼ 4.44 between 41%–98% in published literature.
2 average risk ¼ 7.05 OSA results in the periodic reduction (hypopnea) or
3 average risk ¼ 11.04 cessation (apnea) of breathing as a result of narrowing or
occlusion of the upper airway during sleep. The repetitive
collapse of the upper airway leads to sleep fragmentation,
Indication for cholesterol and lipid-lowering medication hypoxemia, hypercapnia, and changes in intrathoracic
should be clearly stated. pressure. OSA has been documented to be an independent
Standardized Outcomes Reporting / Surgery for Obesity and Related Diseases 11 (2015) 489–506 497
risk factor for the development of diabetes, acute and the neck and airway), as well as varying degree of overall
chronic cardiovascular events, cardiac arrhythmias, hyper- weight loss after bariatric procedures and the presence of
tension as well as sudden death. Although some patients other associated risk factors for OSA, the complete reso-
may be asymptomatic, classic symptoms of sleep apnea lution of OSA after bariatric surgery is likely to be less than
include daytime sleepiness, loud snoring, witnessed apneic previously thought. It is also likely that postbariatric
events or awakenings caused by gasping or choking. The patients may prematurely abandon primary treatment
diagnosis of OSA may be suggested but cannot be made on (CPAP/BI-PAP) before it would otherwise be recom-
symptoms or physical examination alone. mended based on objective testing.
Screening tools such as the Epworth Sleepiness Score
and Berlin Questionnaire (BQ) are commonly used; how- Challenges and controversies
ever, no screening tool to date has been validated in the Preoperative testing for sleep apnea before bariatric
morbidly obese or bariatric population. These screening surgery is not a mandated practice and likely underutilized.
tools in conjunction with a comprehensive sleep history are Because of this, it is difficult to determine true prevalence of
generally used to help assess and stratify a patient’s risk for the disease in the bariatric population.
OSA. A BMI 435 or preoperative status for bariatric Initial treatment of OSA in the overweight, severely obese,
surgery alone is sufficient to be considered high risk for and bariatric surgery population should include CPAP/BI-PAP
OSA by the American Academy of Sleep Medicine treatment as a primary treatment regardless of planned weight
(AASM) and would prompt further evaluation to determine loss. Stratifying disease severity of OSA with PSG, however,
severity. There is no clinical method available to predict the does not imply that all preoperative patients will be compliant
severity of OSA, which is necessary to determine treatment with CPAP/BI-PAP treatment. Although it is recommended
strategies, including continuous positive airway pressure that bariatric surgeons consider the use of preoperative PSG to
(CPAP) or bi-level positive airway pressure (BI-PAP). The determine the severity of OSA, it is also understood that the
2 objective methods of testing severity of sleep apnea resolution of OSA can only be determined by repeat objective
include in-laboratory polysomnography (PSG) (gold stand- testing. Many patients discontinue using their CPAP/BI-PAP
ard) and home testing with portable monitors (PM) to assess after losing significant weight after surgery but do not undergo
for the presence of apneic and hypopneic events. A repeat testing to assess the presence, severity, or absence of
preoperative clinical sleep evaluation that includes PSG is disease. This is partially because of the fact that it is unclear
recommended by the AASM for patients before they what the optimal time is to retest postbariatric patients with
undergo bariatric surgery. The apnea hypoxia index (AHI) repeat PSG, particularly with procedures such as the laparo-
or respiratory disturbance index (RDI) is used to classify the scopic adjustable gastric band (LAGB), where long plateaus
severity of OSA, with o5 events as normal, 5 to o15 as can be encountered and greatest weight loss may aver-
mild, 15–30 events as moderate, and 430 as severe. age 4 18 months. It is likely safe to consider retesting after
procedures that provide rapid, predictable weight loss and in
Current reporting practices patients who have achieved a stable weight regardless of
whether this occurs at 12 or 18þ months.
As mentioned earlier, the only method of determining the Complete resolution or improvement of OSA as docu-
severity and presence of sleep apnea in bariatric patients is mented on repeat PSG would be defined as a normal AHI or
through objective testing with PSG. Although it is thought RDI of o5/hr or a lower AHI from baseline, respectively,
that the prevalence of sleep apnea is several-fold higher in but the definition currently reported in the literature is often
the bariatric population, the true prevalence is unknown. subjective based on patient discontinuance of CPAP or
Underdiagnosis is likely, in part because of the added sleeping better on lower CPAP settings.
potential cost, time, and discomfort associated with under- OSA is a chronic disease. Therefore, despite documenta-
going a PSG. In a study by Chung et al., o9% of patients tion of complete resolution of symptoms, the disease should
invited to undergo a preoperative PSG participated. Testing be considered to be in remission and still requires ongoing
with PSG has also been recommended to be considered surveillance regarding return of symptoms after weight
after successful weight loss (although there is not a direct regain, which should prompt consideration for additional
correlation between the degree of weight loss and remission objective testing.
of OSA) in patients with preoperative OSA as well as those
patients with significant weight regain or those considering
Recommended reporting practices
revisional/repeat bariatric surgery.
Current and historical reporting practices often label Recognizing that not all patients will undergo repeat
subjective or self-reported improvement (self- and wit- testing, a subjective category is included here in addition to
nessed reports of reduced symptoms of OSA) as an the objective findings. Reporting complete remission or
endpoint. Because of varying degrees in the loss of soft objective improvement is preferred over subjective
tissue adiposity (truncal losses are generally greater than in improvement.
498 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
Complete In those patients with preoperative PSG with diagnosis of (24- or 48-hr pH studies, impedance study). A 24-hour pH
remission: OSA, complete remission is defined as AHI/RDI study is considered by many as “the gold standard” for
of o5 off CPAP/BI-PAP on repeat objective testing diagnosis of GERD. There are 420 symptom scales that
with PSG. have been designed as screening, evaluative, and diagnostic
Improvement
Objective: Requires some form of measurable improvement.
tools, including health-related quality-of-life instruments.
Reduced pressure settings on CPAP/BI-PAP as These instruments have undergone various degrees of
recommended by a sleep medicine provider. psychomotor testing and only a few have been designed
Decreased severity of disease on repeat objective testing or used to evaluate GERD before and after surgical
with PSG (e.g., going from severe to mild). intervention.
Improved repeat score on screening tool compared with
preoperative score.
Published studies evaluating the effect of bariatric
Subjective: Patients with preoperative documentation of OSA who surgery on GERD have used all of the aforementioned
have not or will not undergo repeat objective testing diagnostic methods. There is no widely accepted definition
with PSG. of remission of GERD; one of the best attempts includes
Document personal or witnessed improvement in sleep both parameters from physiology and quality of life:
hygiene and symptoms of sleep apnea.
Have self-discontinued the use of sleep apnea treatment
“GERD patients are in remission when they are no longer
CPAP/BI-PAP based on improved symptoms. exposed to the risk of physical complications from gastro-
esophageal reflux and have no clinically significant impair-
ment of health-related well-being (quality of life) due to
reflux-related symptoms.” Currently, MBSAQIP instructs
References
reporting postoperative GERD in patients who carry the
[1] ASMBS Clinical Issues Committee. Peri-operative management of diagnosis of GERD and are being treated with either a
obstructive sleep apnea. Surg Obes Relat Dis 2012;8(3):e27–32. protein pump inhibitor (PPI) or histamine-2 (H2) blocker on
[2] Khan A, King WC, Patterson EJ, et al. Assessment of obstructive sleep a regular basis (PPIs or H2 blockers may be prescription or
apnea in adults undergoing bariatric surgery in the longitudinal
over the counter). This definition includes in the remission
assessment of bariatric surgery-2 (LABS-2) study. J Clin Sleep Med
2013;9(1):21–9. group patients who have occasional symptoms or use
[3] Epstein LJ, Kristo D, Strollo PJ Jr, et al.; Adult Obstructive Sleep Apnea medications on an as-needed (PRN) basis.
Task Force of the American Academy of Sleep Medicine. Clinical
guideline for the evaluation, management and long-term care of
obstructive sleep apnea in adults. J Clin Sleep Med 2009;5(3):263–76.
Challenges/controversies. GERD symptoms often overlap
with symptoms of other disorders, and antacid use and PPI
6. Gastroesophageal reflux disease (GERD)
prescriptions are often given for vague symptoms or symp-
GERD is a condition that develops when the reflux of toms that are atypical for GERD. Additionally, the diagnostic
stomach contents causes symptoms and/or complications. methods for GERD have limitations because there are patients
Symptoms related to gastroesophageal reflux become trou- with typical GERD symptoms but a normal esophagus on
blesome when they adversely affect an individual’s well- endoscopy and normal pH studies (these patients are often
being (mild symptoms occurring Z2 d/wk; moderate/severe labeled as having functional heartburn).
symptoms occurring 41 d/wk). Prevalence of at least Approximately 50%–60% of patients suffering from
weekly GERD in North America ranges from 18% to heartburn and regurgitation have no esophagitis, and o20%
28%. GERD is related to 22% of primary care visits. of patients with endoscopically confirmed esophagitis
Heartburn (burning sensation in the retrosternal area) and experience heartburn; there is no consensus regarding the
regurgitation (perception of flow of refluxed gastric content routine use of endoscopy or GERD evaluation before
into the mouth or hypopharynx) are the characteristic bariatric surgery.
symptoms of GERD. Other symptoms of GERD include A 24-hour pH study, which is considered the “gold
epigastric pain, chest pain, and dysphagia. Extraesophageal standard” for diagnosis of GERD, is an invasive test and not
symptoms of GERD include chronic cough, laryngitis, and easily accepted by patients. It also adds to the cost of
asthma. Obesity increases the risk for GERD and its healthcare for these patients and may not be necessary in the
complications, such as erosive esophagitis and esophageal setting of classic GERD symptoms or a mechanical defect
adenocarcinoma. such as hiatal hernia.
There are a many scoring systems and scales designed to
Current reporting practices. Diagnosis of GERD can be assess GERD symptoms but not a single “gold standard” to
achieved with a variety of methods, including typical provide a subjective evaluation of GERD. There are also no
symptoms and response to medications, symptom scales, established definitions of GERD remission in the bariatric
endoscopy, radiographic studies, and physiologic studies surgery population.
Standardized Outcomes Reporting / Surgery for Obesity and Related Diseases 11 (2015) 489–506 499
GERD can develop de novo after bariatric surgery, 3. Improved physiologic test (24- or 48-
particularly after sleeve gastrectomy or after complications hr pH study, impedance study) and/or
endoscopy
of an LAGB. There is little guidance on the evaluation or
management of these patients. Patients can also develop Improvement (self-reported): 1. Improved symptom severity or
GERD after a Roux-en-Y gastric bypass (RYGB), and this frequency or
can present a clinical challenge if related to a large gastric 2. Decreased or as needed medication
pouch or a refractory marginal ulcer. use*
Medications that are typically prescribed to treat *Decreased or as needed medication associated with improvement of
GERD, such as PPI or H2 blockers, are also used to treat symptoms and not ineffectiveness of medication, cost or other reasons.
or prevent complications (anastomotic ulcer) and gastro-
intestinal symptoms that may develop after bariatric References
surgery. There is no consensus regarding the use of these [1] El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the
agents after bariatric surgery or the appropriate duration epidemiology of gastro-oesophageal reflux disease: a systematic
of ulcer prophylaxis after surgery. Also, many postbari- review. Gut 2014;63(6):871–80.
atric surgery patients will develop intermittent epigastric [2] Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus
symptoms at some point in their life after surgery and the Group. The Montreal definition and classification of gastro-esophageal
reflux disease (GERD)—a global evidence-based consensus. Am J
empiric use of acid-reducing medication is a confounding Gastroenterol 2006;101(8):1900–20.
factor when assessing the incidence of GERD in this [3] Ayazi S, Hagen JA, Chan LS, et al. Obesity and gastroesophageal
population. reflux: quantifying the association between body mass index, esoph-
Finally, there are few long-term evaluations of GERD ageal acid exposure, and lower esophageal sphincter status in a large
after bariatric surgery in the literature, so the true incidence series of patients with reflux symptoms. J Gastrointest Surg 2009;13
(8):1440–7.
of GERD after commonly performed procedures is [4] Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the
unknown and confounded by different surgical techniques risk for gastroesophageal reflux disease and its complications. Ann
and variable weight loss patterns. The evaluation and Intern Med 2005;143(3):199–211.
reporting of GERD after bariatric surgery, then, needs to [5] Stanghellini V, Armstrong D, Mönnikes H, Bardhan KD. Systematic
be procedure specific to draw meaningful conclusions. review: do we need a new gastro-oesophageal reflux disease ques-
tionnaire? Aliment Pharmacol Ther 2004;19(5):463–79.
Recommended reporting practices. In the evaluation of [6] Vakil NB, Halling K, Becher A, Rydén A. Systematic review of
patient-reported outcome instruments for gastroesophageal reflux
GERD after bariatric surgery, the following recommenda-
disease symptoms. Eur J Gastroenterol Hepatol. 2013;25(1):2–14.
tions are made: [7] Chiu S, Birch DW, Shi X, Sharma AM, Karmali S. Effect of sleeve
gastrectomy on gastroesophageal reflux disease: a systematic review.
Surg Obes Relat Dis 2011;7(4):510–5.
1. Use of a validated questionnaire pre- and postsurgery [8] Mejía-Rivas MA, Herrera-López A, Hernández-Calleros J, Herrera MF,
2. Recording and reporting medication use and specific Valdovinos MA. Gastroesophageal reflux disease in morbid obesity: the
indication effect of Roux-en-Y gastric bypass. Obes Surg 2008;18(10):1217–24.
3. Minimum of 1-year follow-up and, ideally, long-term [9] Tolonen P, Victorzon M, Niemi R, Mäkelä J. Does gastric banding for
morbid obesity reduce or increase gastroesophageal reflux? Obes Surg
follow-up that is procedure specific
2006;16(11):1469–74.
[10] Heading R. Complete remission in GERD. Dream or reality? J Clin
As in OSA, there may be subjective self-reported criteria Gastroenterol 2007;41:S198–S203.
to define improvement of GERD after surgery as well as
objective criteria. Objective, procedure-specific criteria are
preferred. Authors should specify whether their outcomes 7. Complications
are based on objective or subjective criteria. 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
Complete resolution (objective): 1. Absence of symptoms (normal
symptom score) and actual surgical complication in addition to the issue of time
2. No medication use and frame of the occurrence add to the confusion. This section is
3. Normal physiologic test (24- or 48-hr intended to review the current practices of reporting
pH study, impedance study) bariatric complications and to recommend a standard
(preferred) and/or endoscopy
framework for reporting complications that can be easily
Complete resolution (subjective): 1. Absence of symptoms and adopted and used in the bariatric literature.
2. No medication use
Improvement (objective): 1. Improved symptom score on Current reporting practices
validated testing or
2. Decreased or as needed medication When evaluating the general surgical literature, one
use* or classification system developed to define complications
500 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
was described by Clavien in 1992. This classification was symptomatic cholelithiasis, anastomotic strictures, and so
subsequently modified to make it more inclusive and on, often occur after 30 days.
comprehensive. However, those changes made the system In terms of the actual complication, we recommend
more difficult to use. Briefly, the grading system includes 5 dividing those into major and minor.
grades (I–V) that are based on the therapy used to correct a Major complications include any complication that
specific complication after surgery. Some grades have results in a prolonged hospital stay (47 d), administra-
subgrades; for example grade III includes IIIa and IIIb. tion of an anticoagulant, reoperation, or reintervention.
Although this system is very inclusive and was reported to For example, a leak that requires reoperation will be
be reliable, it is confusing, inflexible, and does not take into obviously included as a major complication and a leak
consideration the time frame of the occurrence. For that is managed nonoperatively by placing the patient
example, the administration of an antiemetic for nausea NPO and starting TPN would also be considered major
after a sleeve is considered a grade I complication. Bariatric because it required reintervention (peripherally inserted
literature reporting on surgical complications does not central catheter [PICC] placement), possible percutane-
include a consistent or a well-defined grading system. ous drainage, or prolonged hospital stay (TPN admin-
In its 2009 report on perioperative safety profile of bariatric istration). A DVT or a pulmonary embolism (PE) would
surgery, the Longitudinal Assessment of Bariatric Surgery also be included because it requires anticoagulation or
(LABS) Consortium reported a 30-day composite endpoint reintervention (IVC filter placement). Gastrointestinal
including death, VTE, reintubation, reintervention using endo- bleeding that requires transfusion or endoscopy or reop-
scopic, percutaneous or operative technique, and failure of eration to control the bleeding would also be included as
discharge after 30 days. However, when the Surgical Review a major complication. A slight drop in hemoglobin (Hb),
Committee (SRC) presented its summary of key statistics of which may be secondary to bleeding that is only observed
patient data collected and entered in a national database of and managed without further intervention, would not be
centers participating in the Bariatric Surgery Center of included in this category.
Excellence (BSCOE) program, it used 2 separate definitions Minor complications include everything that is not
of complications: serious and others. Serious complications included under major. Vitamin deficiency, urinary tract
include death, deep venous thrombosis (DVT), stroke/cere- infection, dehydration requiring intravenous fluid, and so
brovascular accident, heart attack, pulmonary embolus, heart on, are all examples of minor complications. Some further
failure or pulmonary edema, renal failure, liver failure, multi- examples of major and minor complications are listed next,
system organ failure, sepsis from leak or other abdominal but these lists are not intended to address every possible
source, and systematic inflammatory response. The remaining complication that can occur after bariatric procedures.
complications were bundled under others. This system leaves
a wide variety of postoperative complications open to
Examples of major complications
interpretation. For example, a patient with low-grade fever
and tachycardia after a gastric bypass can be considered as
having a systematic inflammatory response and therefore VTE requiring administration of anticoagulant or inter-
included under serious complications. vention such as embolectomy
Anastomotic leak requiring reoperation, percutaneous
Recommended practice drainage of abscess, stent placement, or conservative
management with parenteral nutrition and NPO
We recommend using 2 separate methods of reporting Gastrointestinal hemorrhage requiring transfusion or
complications: one based on the time frame—that is, early intervention
(o30 d) versus late (430 d)—and another based on the Small bowel obstruction requiring reoperation
complication itself: major versus minor (or serious versus Bowel perforation requiring reoperation
nonserious). Trocar site hernia requiring reoperation
Death
Complication Major Minor
Myocardial infarction
Early o30 d Early major Early minor Cerebrovascular accident
Late 430 d Late major Late minor Renal failure requiring dialysis
An early complication will be any complication that Respiratory failure requiring intubation
occurs within 30 days and a late complication will be any Prolonged hospitalization (47 d)
complication that occurs after 30 days. This is based on the Chronic nausea and vomiting not responsive to conser-
knowledge that most of the bariatric complications, such as vative management and requiring TPN administration or
leak, infection, and obstruction, will occur within a few enteral access
days or weeks of the operation. However, other complica- Gastric sleeve stenosis/obstruction requiring revision to a
tions, such as stricture, delayed leak with a sleeve, ulcers, gastric bypass
Standardized Outcomes Reporting / Surgery for Obesity and Related Diseases 11 (2015) 489–506 501
Surgical site infection (superficial, deep, or organ space) number of bariatric operations performed annually world-
requiring debridement or washout in the operating room wide has increased to 4340,000 with a corresponding
or percutaneous intervention increase in the number of publications reporting bariatric
Small bowel stenosis, stricture, or obstruction, requiring surgery outcomes in the medical and surgical literature. A
revision of the jejunojejunostomy well-established and widely accepted reporting standard for
weight loss is needed to communicate effectively between
Examples of minor complications different clinical specialties and to provide consistency in
the medical and surgical literature.
Marginal ulcer diagnosed with upper endoscopy but not Current reporting practices. Although percent excess
requiring endoscopic intervention weight loss (%EWL) is currently the most often measured
Anastomotic stricture requiring endoscopic dilation and reported weight loss outcome measure in the bariatric
Nausea and vomiting requiring IVF but not TPN surgical literature, other commonly used metrics include
Acute renal failure managed with IVF without the need total weight loss and percent total weight loss (%TWL),
of dialysis body mass index (BMI) reduction, and percent excess BMI
Gastrointestinal ileus managed conservatively but requir- loss (%EBMIL). There is currently no consensus regarding
ing prolonged hospital stay the ideal reporting method for medical or surgical weight
Incisional hernia (diagnosed during routine follow-up) loss. Here are some of the most commonly reported
Trocar site surgical site infection managed with drainage methods.
and local wound care. Total absolute weight loss (TWL in kg) and percent total
Negative reexploration (e.g., diagnostic laparoscopy to weight loss (%TWL):
rule out leak or for unexplained tachycardia) %TWL ¼ [(Initial Weight) – (Postop Weight)]/[(Initial
Urinary tract infection managed with antibiotics Weight)] 100
Dehydration requiring IV hydration as an inpatient Absolute weight loss provides a metric that is easy to
Vitamin or mineral deficiency requiring IV supplemen- measure and easy to comprehend by physicians as well as
tation (e.g., severe anemia requiring IV iron infusion or patients and is commonly reported in the medical literature
severe vitamin B12 requiring vitamin B12 injections or as a percentage of total initial weight.
symptomatic thiamine deficiency requiring IV thiamine) Percent excess weight loss (%EWL):
Nephrolithiasis %EWL ¼ [(Initial Weight) – (Postoperative Weight)] /
Symptomatic cholelithiasis [(Initial Weight) – (Ideal Weight)] 100
Percent excess weight loss is a quotient that is calculated
References
from initial weight, postoperative weight, and ideal weight
[1] Hutter MM, Schirmer BD, Jones DB, et al. First report from the and represents the amount of excess weight (EW) lost as %
American College of Surgeons Bariatric Surgery Center Network. Ann of total EW. This outcome measure allows for comparison
Surg 2011;254(3):410–22.
of individuals with varying initial weights and varying
[2] Flum DR, Belle SH, King WC, et al. Perioperative safety in the
longitudinal assessment of bariatric surgery. N Engl J Med 2009;361 excess weights, making it useful as a standard measure
(5):445–54. across populations, and some have argued it should be the
[3] Deitel M, Gagner M, Erickson AL, Crosby RD. Third International standard metric for reporting in general. It is the most
Summit: current status of sleeve gastrectomy. Surg Obes Relat Dis common method of reporting weight loss in the bariatric
2011;7(6):749–59.
surgical literature. The disadvantage of using %EWL is that
[4] Dindo D, Demartines N, Clavien PA. Classification of surgical
complications: a new proposal with evaluation in a cohort of 6336 it may not reflect successful weight loss in very high BMI
patients and results of a survey. Ann Surg 2004;240(2):205–13. patients. In fact, patients with super-obesity often have
[5] Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos lower %EWL than lower BMI groups despite achieving
GM. Perioperative safety and volume: outcomes relationships in greater absolute weight loss. Therefore, %EWL has limi-
bariatric surgery: a study of 32,000 patients. J Am Coll Surg
tations when used as the sole measure of success after
2011;213(6):771–7.
bariatric surgery.
Body mass index (BMI) and change in BMI (ΔBMI)
8. Weight Loss
BMI, expressed as kg/m2, is a common method for
Weight loss is the most commonly reported outcome reporting weight as a function of height; BMI ¼ (weight) /
after bariatric surgery. The efficacy of a specific bariatric (height)2. It is used to define the classes of obesity, as well
operation and a patient's progress is often measured and as candidacy for bariatric surgery. A BMI of 25 kg/m2 is
compared in terms of weight loss. Indeed, a primary goal of regarded as the upper limit of normal weight and the
weight loss surgery and the measure of its success is the threshold of overweight. It has been used as a convenient
attainment of significant and durable weight loss. The proxy for "ideal weight" and is simply determined by height
502 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
and weight alone. It is easy to calculate BMI from available at the time and were restricted to individuals 25–29 years
clinical data and it has been reported to correlate with total old who had no significant co-morbid conditions, thus bring-
body fat content. Thus, BMI is generally a convenient ing into question the validity of these data for a contemporary
measure of weight burden and can be readily used to population. Also, the ideal weights in each body-frame
compare individuals, populations, and specific treatment category are reported as a range rather than a single number,
outcomes. Like %TWL, change in BMI is a useful further adding variability to the value of ideal weight. The
comparison tool for treatment efficacy. importance of the %EWL, despite its limitations, has been
Percent excess BMI loss (%EBMIL): described previously in ASMBS guidelines.
%EBMIL ¼ [change in BMI / (Initial BMI – 25)] 100 Because of these shortcomings, some authors advocate
the use of a BMI of 25 kg/m2, instead of Metropolitan Life
Compared with %EWL, the %EBMIL is not yet used
tables, for determining the clinically desirable weight. BMI
routinely in medical and surgical literature. Similar to %
measurements, however, also exclude variables such as
EWL, %EBMIL depends on initial weight measurements
gender, age, or race, which have been reported to have
that can be variable and inconsistent, as described earlier.
clinically significant effects on the measurement of obesity.
However, it is a measurement of weight loss that avoids the
Percent excess BMI loss (%EBMIL) is determined from
difficulties of determining ideal weight, as defined by
easily available clinical data, is readily reproducible, and is
Metropolitan Life tables. Rather, it sets ideal BMI at 25
consistent with other bariatric metrics that rely on body
kg/m2, greatly simplifying the calculation.
mass index, such as obesity classification and thresholds for
Challenges/controversies. While there are several methods surgery, making it clinically relevant.
of reporting weight loss outcomes after bariatric surgery,
there is no established standard for reporting of a single Recommended reporting practices. Reporting of weight
weight loss metric. Although the goal is to achieve outcome loss outcomes after bariatric surgery should include the
reporting that is reproducible, easy to use, and clinically following parameters (in which initial weight is the patient's
meaningful, each of the commonly used metrics is asso- weight as measured closest to the time of surgery and initial
ciated with a shortcoming or limitation. BMI is the BMI determined closest to the time of surgery in
The data obtained from %TWL may be clinically the preoperative period):
misleading, especially in the setting of variable clinically Complete reporting is recommended as follows:
ideal and initial weights. A heavier individual with greater
excess weight needs to lose more weight than a less-heavy 1. Initial mean BMI of the cohort
individual to attain a similar clinical impact and approach a 2. Change in BMI (ΔBMI):
normal weight range. For example, a 30-kg weight loss in ΔBMI ¼ (Initial BMI) – (Postop BMI)
an individual with super-obesity is likely to be inadequate
and less clinically relevant compared with a similar amount 3. Percent of total weight loss (%TWL):
of total weight loss in a severely obese individual. Thus, %TWL ¼ [(Initial Weight) - (Postop Weight)] / [(Initial
reporting of absolute or percent total weight loss (%TWL) Weight)] 100
may not provide sufficient clinically relevant information to
4. Percent excess BMI loss (%EBMIL):
reflect weight loss success or failure.
%EBMIL ¼ [ΔBMI/(Initial BMI – 25)] 100
Percent excess weight loss (%EWL) relies on a measure-
and/or
ment of initial weight and determination of ideal weight.
However, the values of initial weight and ideal weight, on Percent excess weight loss (%EWL)
which the calculation of %EWL relies, are not uniform and %EWL ¼ [(Initial Weight) - (Postop Weight)] / [(Initial
can lead to wide variability in the meaning of reported Weight) – (Ideal Weight)]
outcomes. "Initial weight" can mean different things in (in which ideal weight is defined by the weight corre-
different studies. It may reflect a measurement taken months sponding to a BMI of 25 kg/m2; see Appendix A)
before surgery or may reflect a measurement taken on the
day of surgery. There is no established standard, and the References
method used to measure the initial weight is rarely
[1] Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011.
specifically specified in literature reports. Obes Surg 2013;23(4):427–36.
"Ideal weight" has historically been determined based on [2] Mason EE, Amaral J, Coman GSM, Deitel M, Gleysteen JJ, Oria HE.
the Metropolitan height and weight tables published in Standard for reporting results. Obes Surg 1994;4(1):56–65.
1983. Determining ideal weight from these tables depends [3] Dixon JB, McPail T, O'Brien PE. Minimal reporting requirements for
on gender, body frame (small, medium, large), and height. weight loss: current methods not ideal. Obes Surg 2005;15:1034–39.
[4] Montero PN, Stefanidis D, Norton HJ, Gersin K, Kuwada T. Reported
When these tables were established, "ideal" was linked to excess weight loss after bariatric surgery could vary significantly
mortality data obtained from 4.2 million individuals over an depending on calculation method: a plea for standardization. Surg
18-year period. These data, however, were 4 40 years old Obes Relat Dis 2011;7(4):531–35.
Standardized Outcomes Reporting / Surgery for Obesity and Related Diseases 11 (2015) 489–506 503
[5] Bray GA, Bouchard C, Church TS, et al. Is it time to change the way general concept produce similar scores. Internal consistency
we report and discuss weight loss? Obesity 2009;17(4):619–21. is typically reported as Cronbach's α, and the instrument is
[6] NIH conference. Gastrointestinal surgery for severe obesity. Con-
sensus development conference panel. Ann Intern Med 1991;115 considered to have acceptable internal consistency if Cron-
(12):956–61. bach’s α is Z .7. In general, the tabulated tools are valid,
[7] Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes have acceptable test-retest reliable, and have acceptable
Surg 2007;17(5):565–68. internally consistency. All instruments were initially vali-
[8] Deitel M, Greenstein RJ. Recommendations for reporting weight loss. dated in specific culturally distinct populations, which may
Obes Surg 2003; 13(2):159–60.
[9] Metropolitan Life Foundation. 1983 Metropolitan Height and Weight
limit general applicability. However, many instruments are in
Tables. Stat Bull 1983;64:2–9. the process of being validated or modified for expanded use.
[10] American Society for Bariatric Surgery Standards Committee, 2004–
2005, Oria HE, Carrasquilla C, Cunningham P, et al.. Guidelines for Challenges. Unfortunately, no single instrument is ideal for
weight calculations and follow-up in bariatric surgery. Surg Obes
all clinical situations. Each instrument attempts to balance
Relat Dis 2005;1(1):67–8.
[11] Gallagher D, Heymsfield SB, Heo M, Jebb SA, Murgatroyd PR,
scope of the survey, ease of administration, and statistical
Sakamoto Y. Healthy percentage body fat ranges: an approach for properties. By necessity every instrument represents a
developing guidelines based on body mass index. Am J Clin Nutr compromise between these factors.
2000;72(3):694–701. The scope of the survey is determined by the type of
instrument. Generic instruments are designed to measure
9. Quality-of-life outcomes how multiple factors influence the HR-QOL but tend to be
less sensitive to the impact of any specific factor, such as
Morbid obesity has significant detrimental effects on both
physical and psychosocial health. The adverse impact of obesity. One advantage of this approach is that it provides a
obesity on psychosocial health is reflected in a reduction in framework for comparing HR-QOL of differing etiologies.
Obesity-specific instruments are designed to measure the
health-related quality of life (HR-QOL). Although bariatric
surgery produces marked weight loss and improvement of impact of obesity on the quality of life while minimizing the
co-morbidities, the impact on HR-QOL is less well estab- influence of other factors. Consequently, these instruments
are able to discern changes in HR-QOL caused by small
lished. One factor hampering this effort is the lack of
guidelines for reporting psychosocial outcomes. changes in obesity-related factors. The main disadvantage
of using obesity-specific instruments is the loss of context;
Current practices. A list of commonly used health-related specifically, the relationship of obesity-related quality of life
quality-of-life instruments for bariatric surgery is found in to the overall HR-QOL is uncertain. This limits the ability
Table 1. These instruments have been categorized as to determine the impact of obesity on HR-QOL relative to
generic, system- and condition-specific, and obesity- the impact of other disorders.
specific instruments. Generic tools measure overall HR- Ease of administration reflects the ability to obtain useful
QOL, system- and condition-specific tools measure the HR- psychosocial data and is influenced by method of administra-
QOL related to a specific body system or health condition, tion (e.g., self-administered, structured interview, etc.), scoring
and obesity-specific tools measure the HR-QOL related to (e.g., hand scoring versus computer scoring, proprietary versus
obesity. Based on a recent study, the most commonly used nonproprietary, etc.), and length of the instrument. In general,
instruments in bariatric surgery publications are the instruments with more items (e.g., SF-36, QOLI) are useful for
Moorehead-Ardelt Quality of Life Questionnaire (MAQOL) examining treatment responses in individual patients but are
in 21%, 36-item Short-Form Health Survey (SF-36) in 20%, less likely to be completed by patients, whereas instruments
Gastrointestinal Quality of Life Index (GIQOL) in 9%, with fewer items (e.g., SF-12) are completed at higher rates but
European Quality of Life-5 D (EQ-5 D) in 5% and Impact of tend to be most useful for examining populations.
Weight on Quality of Life-Lite (IWQOL-Lite) in 4%. Two The cost of administering these instruments is beyond the
newer obesity-specific instruments (Laval questionnaire, scope of this review but is most strongly influenced by the
Bariatric Quality of Life Index [BQL]) were not included method of administration and type of scoring. The use of
in Table 1 because of their currently limited clinical use. structured interviews or proprietary instruments can be
All of the tabulated tools were evaluated for validity—the expensive. Fortunately, some of the proprietary tools are
ability to measure what it claims to measure—and reliability available for limited use for low or no cost.
—the degree to which the instrument is free of measurement
error. Reliability is assessed 2 ways: reproducibility and Recommended reporting. Currently, psychological testing in
internal consistency. Reproducibility is typically reported bariatric surgery has been used primarily as a descriptive
using the test-retest reliability—the ability of the instrument measure or to determine treatment effects in well-defined
to obtain the same result when testing is repeated without populations. Consequently, in the context of evaluating
intervention. A test-retest reliability coefficient Z .7 is program outcomes, no specific recommendations are sup-
considered satisfactory. Internal consistency reliability eval- ported by the current literature. In the context of reporting
uates whether items that are intended to measure the same treatment effects, the need for a generic instrument, a system-
504 S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 11 (2015) 489–506
Table 1
Health-related quality of life instruments
Test Description Origin Reliability / internal Strengths Limitations
consistency
Generic Instruments
Short Form Health Self-administered USA Test-retest Useful for measuring: Lengthy
Survey 36 (SF-36) 36 items in 8 domains: Physical reliability, r ¼ .74-.91 1. Individual patient administration
Functioning, Bodily Pain, Role Internally consistency, improvemen t or
Limitations Due to Physical Cronbach’s a 0.85 decline
Health Problems, Role, 2. Treatment effects
Limitations Due To Personal or 3. Populations
Emotional Problem, Emotional
Well-Being, Social Functioning,
Energy/Fatigue, General Health
Perceptions, Perceived Change in
Health
Short Form Health Self-administered Administration brief
Survey 12 (SF-12) Same 8 health domains (2–3 minutes)
Short Form Health Useful for measuring
Survey 8 (SF-8) populations only
European Quality of Self-administered Finland, the Test-retest reliability, Translated into 460
Life-5D (EQ5D) 5 items in 5 dimensions: Netherlands, r ¼ .73-.78 languages
Mobility, Self-Care, Usual Norway, Sweden, Internally consistency,
Activities, Pain / Discomfort, the United Cronbach’s a .73
Anxiety/Depression Kingdom
System-/condition-specific Instruments
Gastrointestinal Self-administered Germany Internal consistency,
Quality of Life 36 items in 3 domains: Physicial, Cronbach’s a .91
Index (GIQLI) Emotional, Social, Symptoms
Recall: last 2 wks
Obesity-specific instruments
The Obesity-related Self-administered Sweden Test-retest reliability: Brief administration
Psychosocial 8 items assessing the impact of not done
Problems scale obesity on psychosocial function Internal consistency,
(OP-scale) 4 point scale Cronbach's
a ¼ .89–.92
Impact of Weight on Self–administered USA Test–retest reliability
Quality of Life 74 items in 8 domains: Health, Items: r ¼ .75
(IWQOL) Social / Interpersonal, Work, Domains: r ¼ .89
Mobility, Self-esteem, Sexual Internal consistency
life, Activities of daily living, Cronbach’s a ¼ .87
Comfort with food
5 point Likert scale
Impact of Weight on Self-administered USA Test-retest reliable Widely available
Quality of Life- 31 items in 5 domains: Physical r ¼ 0.94 (culturally adapted and
Lite (IWQOLLite) Function, Self-esteem, Sexual Internal consistency, translated)
life, Public distress, Work. Cronbach's a = 0.96
5-point Likert scale
Bariatric Analysis and Self-administered USA Test-retest reliability Brief administration
Reporting 7 items in 3 domains: “satisfactory”
Outcomes System Weight loss, Medical Conditions, Internal consistency:
(BAROS) Quality of Life (Self-esteem, not done
Physical Well-being, Social
Relationships, Work, Sexuality)
Moorehead-Ardelt Self-administered USA (Austria) Test retest reliability Brief administration
Quality of Life 6 items in 6 domains: Selfesteem, “satisfactory”
Questionnaire II Physical Well-being, Social Internal consistency
(M-AQoLQII) Relationships, Work, Sexuality, cronbach’s a = .84
Eating Behavior
10-point Likert scale
Standardized Outcomes Reporting / Surgery for Obesity and Related Diseases 11 (2015) 489–506 505
Table 1
Continued.
Obesity and Weight Designed to be used with WRSM USA & Europe Test-retest reliability, Multicultural
Loss Quality of Self-administered r ¼ .95 Brief administration
Life (OWL-QOL) 17 items "evaluates obesity and Internally consistency,
trying to lose weight in terms of Cronbach’s a = .93
feelings that unobservable.
7-point Likert scale
Recall period: at this time,
presently
Weight-Related Designed to be used with USA & Europe Test-retest reliability, Multicultural
Symptom Measure OWL-QOL r ¼ 0.83
(WRSM) Self-administered Internally
20 items assessing “presence and consistency,
bothersomeness of symptoms” Cronbach’s a .87
Yes/no (Presence) and 7 point
Likert scale (bothersomeness)
Recall period: last 4 weeks
Lewin-Technology Self-administered USA Test-retest reliability,
Assessment Group 55 items with global domains r ¼ 0.70 (0.59-0.90)
(Lewin-TAG) (General health, Comparative Internal Consistency,
health) and obesity-specific Cronbach’s a .85–.94
domains (Overweight distress,
Depression, Self-esteem)
Obesity-Related Well- Self-administered Italy Test-retest reliability, Scores age independent
Being Scale 18 items in 3 domains: r ¼ .92
(ORWELL97) Symptoms, Discomfort, Impact. Internally consistency,
4-point Likert scale Cronbach’s a .83
Obesity Coping (OC) Self-administered Sweden Test-retest Reliablity Derived from a subset
& 16 items in 3 OC scales: social r ¼ 0.71-0.77 of SOS participants
trust, fighting spirit, wishful Internal consistency, Scales were developed
thinking Cronbach’s a .69–.77 using factor analysis.
Validated in an
independent group.
Obesity Distress (OD) 13 items in 2 OD Scales: Test-retest Reliablity,
Helplessness, Intrusion r ¼ .84–.89
Internal consistency,
Cronbach’s
a .51–.78
Obesity Adjustment Self-administered Canada Test-retest reliablity, Items chosen by
Survey-Short Form 20 items in 1 domain: r¼ .87 individual
(OAS-SF) psychological distress over Internally consistency, statistical
obesity Cronbach’s a ¼ .72 properties; not
5 point Likert scale from factor
analysis
Obesity Specific Self-administered France Test–retest reliability: Brief administration
Quality of Life 11 items in 4 domains: Physical Not done
(OSQOL) State; Vitality/Desire to Do Internal consistency,
Thing; Relations with Other Cronbach’s
People; Mood/ a ¼ 0.77
Psychological State
5-point Likert scale