Expert Panel on Weight Loss Surgery: Executive Report Update

Abstract

Rapid shifts in the demographics and techniques of weight loss surgery (WLS) have led to new issues, new data, new concerns, and new challenges. In 2004, this journal published comprehensive evidence-based guidelines on WLS. In this issue, we've updated those guidelines to assure patient safety in this fast-changing field. WLS involves a uniquely vulnerable population in need of specialized resources and ongoing multidisciplinary care. Timely best-practice updates are required to identify new risks, develop strategies to address them, and optimize treatment. Findings in these reports are based on a comprehensive review of the most current literature on WLS; they directly link patient safety to methods for setting evidence-based guidelines developed from peer-reviewed scientific publications. Among other outcomes, these reports show that WLS reduces chronic disease risk factors, improves health, and confers a survival benefit on those who undergo it. The literature also shows that laparoscopy has displaced open surgery as the predominant approach; that government agencies and insurers only reimburse procedures performed at accredited WLS centers; that best practice care requires close collaboration between members of a multidisciplinary team; and that new and existing facilities require wide-ranging changes to accommodate growing numbers of severely obese patients. More than 100 specialists from across the state of Massachusetts and across the many disciplines involved in WLS came together to develop these new standards. We expect them to have far-reaching effects of the development of health care policy and the practice of WLS.

Full text

842 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
articles nature publishing group
intervention and Prevention
Expert Panel on Weight Loss Surgery:
Executive Report Update
George L. Blackburn1, Matthew M. Hutter2, Alan M. Harvey3, Caroline M. Apovian4,
Hannah R.W. Boulton5, Susan Cummings6, John A. Fallon7, Isaac Greenberg8, Michael E. Jiser9,
Daniel B. Jones1, Stephanie B. Jones10, Lee M. Kaplan11, John J. Kelly12, Rayford S. Kruger Jr13,
David B. Lautz14, Carine M. Lenders4, Robert LoNigro15, Helen Luce16, Anne McNamara17,
Ann T. Mulligan18, Michael K. Paasche-Orlow19, Frank M. Perna20, Janey S.A. Pratt2, Stancel M. Riley Jr21,
Malcolm K. Robinson14, John R. Romanelli22, Edward Saltzman23, Roman Schumann24, Scott A. Shikora25,
Roger L. Snow26,27, Stephanie Sogg28, Mary A. Sullivan29, Michael Tarnoff25, Christopher C. Thompson30,
Christina C. Wee31, Nancy Ridley32, John Auerbach32, Frank B. Hu32, Leslie Kirle32, Rita B. Buckley32
and Catherine L. Annas32
Rapid shifts in the demographics and techniques of weight loss surgery (WLS) have led to new issues, new data, new
concerns, and new challenges. In 2004, this journal published comprehensive evidence-based guidelines on WLS. In
this issue, we’ve updated those guidelines to assure patient safety in this fast-changing field. WLS involves a uniquely
vulnerable population in need of specialized resources and ongoing multidisciplinary care. Timely best-practice
updates are required to identify new risks, develop strategies to address them, and optimize treatment. Findings in
these reports are based on a comprehensive review of the most current literature on WLS; they directly link patient
safety to methods for setting evidence-based guidelines developed from peer-reviewed scientific publications. Among
other outcomes, these reports show that WLS reduces chronic disease risk factors, improves health, and confers
a survival benefit on those who undergo it. The literature also shows that laparoscopy has displaced open surgery
as the predominant approach; that government agencies and insurers only reimburse procedures performed at
accredited WLS centers; that best practice care requires close collaboration between members of a multidisciplinary
team; and that new and existing facilities require wide-ranging changes to accommodate growing numbers of severely
obese patients. More than 100 specialists from across the state of Massachusetts and across the many disciplines
involved in WLS came together to develop these new standards. We expect them to have far-reaching effects of the
development of health care policy and the practice of WLS.
Obesity (2009) 17, 842–862. doi:10.1038/oby.2008.578
1Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; 2Department of Surgery, Massachusetts General Hospital, Boston,
Massachusetts, USA; 3Department of Anesthesiology, Mercy Medical Center/Catholic Health East, Springfield, Massachusetts, USA; 4Department of Medicine, Boston
Medical Center, Boston, Massachusetts, USA; 5Department of Nursing, South Shore Hospital, Weymouth, Massachusetts, USA; 6Massachusetts General Hospital
Weight Center, Massachusetts General Hospital, Boston, Massachusetts, USA; 7Blue Cross Blue Shield of Massachusetts, Boston, Massachusetts, USA; 8Obesity
Consult Center, Tufts-New England Medical Center, Boston, Massachusetts, USA; 9Department of Surgery, Saints Medical Center, Lowell, Massachusetts, USA;
10Department of Anesthesiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; 11Department of Medicine, Massachusetts General Hospital,
Boston, Massachusetts, USA; 12Department of Surgery, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, USA; 13Department of
Surgery, Tobey Hospital, Wareham, Massachusetts, USA; 14Department of Surgery, Brigham and Women’s Hospital, Boston, Massachusetts, USA;
15Care Management, Tufts Health Plan, Boston, Massachusetts, USA; 16Consumer Representative, Boston, Massachusetts, USA; 17Department of Nursing and
Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; 18Department of Nursing, Newton-Wellesley Hospital, Newton, Massachusetts, USA;
19Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA; 20Health Promotion Research Branch Divison of Cancer Control and
Population Sciences, National Cancer Institute, Bethesda, Maryland, USA; 21Patient Care Assessment Division, Massachusetts Board of Registration in Medicine,
Boston, Massachusetts, USA; 22Department of Surgery, Baystate Medical Center, Springfield, Massachusetts, USA; 23Department of Medicine, Tufts-New England
Medical Center, Boston, Massachusetts, USA; 24Department of Anesthesiology, Tufts-New England Medical Center, Boston, Massachusetts, USA; 25Department
of Surgery, Tufts-New England Medical Center, Boston, Massachusetts, USA; 26University of Massachusetts Medical School, Worcester, Massachusetts, USA;
27MassHealth, Boston, Massachusetts, USA; 28Behavioral Medicine Services and MGH Weight Center, Massachusetts General Hospital, Boston, Massachusetts,
USA; 29Division of Medical Specialties, Lahey Clinic and Massachusetts Coalition for the Prevention of Medical Errors, Burlington, Massachusetts, USA; 30Department
of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, USA; 31Department of Medicine, Beth Israel Deaconess Medical Center, Boston,
Massachusetts, USA; 32Betsy Lehman Center for Patient Safety and Medical Error Reduction, Commonwealth of Massachusetts, Boston, Massachusetts, USA.
Correspondence: George L. Blackburn (gblackbu@bidmc.harvard.edu)
Received 26 June 2007; accepted 6 September 2007; published online 19 February 2009. doi:10.1038/oby.2008.578

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INTRODUCTION
Foreword
Sharp increases in the prevalence of severe obesity (BMI >40
and BMI >50) have continued to fuel demand for weight loss
surgery (WLS) (Figure 1). In 2004, the Betsy Lehman Center
for Patient Safety and Medical Error Reduction (Lehman
Center) formed an Expert Panel to assess WLS procedures,
identify issues related to patient safety, and develop evi-
dence-based best practice recommendations to address those
issues.
e resulting document, published as a supplement in
Obesity in 2005, set the standard for WLS across the state
and well beyond it. e Agency for Healthcare Research and
Quality abstracted the report for broad use, and the American
College of Surgeons adopted it as the blueprint for its Bariatric
Surgery Network Center Accreditation Program. Its recom-
mendations inuenced health care policy and medical practice
at home and abroad.
Since 2004, the literature on WLS has expanded rapidly. New
data have been published; new procedures have been devel-
oped; and new issues have been brought to our attention. In
Massachusetts, weight loss operations increased from over
2,700 in Fiscal Year 2003 to nearly 3,500 in Fiscal Year 2006
(Figure 2). We saw a shi from open to laparoscopic operations,
and changes in reimbursement policies.
e safety of WLS continues to be of concern. In response,
the Lehman Center reconvened the Expert Panel to update the
literature review and evidence-based recommendations devel-
oped in 2004. Several new members joined the 2007 Expert
Panel as well its task groups. All told, there were two additional
task groups, bringing the total from 9 to 11. We separated the
Psychology Task Group from Multidisciplinary Evaluation and
Treatment, and formed a new group, Endoscopic Interventions,
to develop best practice guidelines for that emerging technol-
ogy. In addition, we changed the name of the Coding and
Reimbursement Task Group to Policy and Access to better
reect its focus.
e charge to the 2007 Expert Panel was to update the
evi dence-based best practice recommendations for WLS devel-
oped 3 years ago. Toward that end, its members reviewed weight
loss surgical procedures, analyzed the medical literature published
since 2004, recommended specic steps to reduce medical errors
and improve patient safety, developed credentialing and train-
ing standards, identied best practices, and established clinical
guidelines and directions for future research.
What follows is a comprehensive evidence-based update to
the original best practice recommendations. As with the rst
report, we hope that these guidelines will have far-reaching
eects on clinical practice and health care policy, not only in
the Commonwealth, but also nationwide. We hope that they
will equalize access and reduce variability in performance and
outcomes. Ultimately, our objective is to improve the safety of
WLS in the state of Massachusetts and protect the well-being
of patients who undergo it.
More than 100 individuals created this report. I express
my deepest appreciation to the Expert Panel and task group
members for the monumental work that went into this project.
I especially thank George Blackburn, Chair, Matt Hutter, Vice
Chair, Frank Hu, our clinical epidemiologist, and Rita Buckley,
our librarian and medical editor, for their continued leadership
and commitment to this project. Last but not least, I thank the
Department of Public Health and Betsy Lehman Center sta,
especially our project manager, Leslie Kirle, and Katie Annas
for their diligent eorts in coordinating and facilitating the
work of this project.
Preface
Overwhelming data demonstrate a reduction in known dis-
ease risk factors and improvements in health aer WLS (1–3).
Recent studies also indicate that WLS confers a survival
advantage on patients who undergo it compared with com-
munity controls (1,2). Landmark ndings from the Swedish
Obese Subjects study show an estimated 28% reduction in the
adjusted overall mortality rate in the surgical groups compared
with conventionally treated controls (4).
Similar outcomes have been cited in other reports. A col-
laborative research project in Utah compared 7,925 gastric
bypass patients with the same number of age-, gender-, and
BMI-matched controls. Data showed that the rate of death
from all diseases was 52% lower in the surgery group than in
the control group (P < 0.001) (ref. 5). In a case study that com-
pared 821 obese patients who received laparoscopic adjustable
gastric banding (LAGB) with 821 controls treated with medical
0
50,000
100,000
150,000
200,000
250,000
1992 1994 1996 1998 2000 2004 2006
Figure 1 Estimated number of weight loss procedures performed in the
United States, 1992–2006 (Adapted from refs. 20,25,36).
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
Number of operations
1996
150
1998
200
2000
450
2004
3,036
2002
1,950
Year
2006
3,347
Figure 2 The number of weight loss operations performed in
Massachusetts, 1996–2006 (Department of Public Health).

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therapy, Favretti et al. (6) found a statistically signicant sur-
vival dierence in favor of the surgically treated group.
Perr y et al. (7) compared a cohort of extremely obese
Medicare beneciaries who underwent WLS to a similar cohort
of extremely obese Medicare beneciaries who did not. At the
2-year follow-up, younger (<65 years old) and older patients
(≥65) in the surgical group had signicantly reduced mortal-
ity compared with those in the nonsurgical group. Similarly,
Sowemimo et al. (8) reported 50–85% mortality reductions
with surgical intervention.
Decreased total mortality in the Swedish Obese Subjects
study (4) surgical groups was primarily due to fewer deaths
from cardiovascular disease (especially myocardial infarc-
tion) and cancer. In the Utah study (5), signicant reductions
in mortality were linked to fewer deaths from coronary artery
disease (CAD), diabetes, and cancer. ese results, which
show substantial and consistent evidence of a survival advan-
tage for severely obese patients who undergo WLS, are in line
with those of earlier reports by Christou et al. (9) and Flum
and Dellinger (10). ey also conrm previous case series
and epidemiologic observations on mortality aer weight loss
operations in more diverse populations (1,11).
But despite reductions in disease-related mortality aer
WLS, death rates from other causes, such as accidents and sui-
cides, exceed those of nonsurgery patients. In Adams et al. (5),
rates of death not caused by disease were 58% higher in the
surgery group than in the control group. Reports reveal that
a substantial number of severely obese persons have unrecog-
nized presurgical mood disorders or post-traumatic stress dis-
order, or have been victims of childhood sexual abuse (12).
Data on the association between presurgical psychological
status and postsurgical outcomes are limited (13). Although
research shows an improved quality of life (QOL) aer gas-
tric bypass surgery (14–17), certain unrecognized presurgical
conditions may reappear aer surgery (18). Some WLS centers
recommend that all patients undergo psychological evaluation,
and, if necessary, treatment before surgery and psychologically
related surveillance postoperatively (12,13,19). Adams et al. (5)
note the need for further research on the optimal approach to
evaluating candidates for WLS, including possible presurgical
assessment, psychiatric treatment, and diligent postoperative
follow-up.
We know from a substantial body of literature that WLS
achieves signicant and durable weight loss with minimal
mortality or complications. We know that laparoscopy short-
ens length of stay and makes for a faster, easier recovery (20).
Now reliable evidence is starting to accumulate on the survival
advantage conferred by WLS on those who undergo it. e eld
is dynamic (21), with surgical approaches being developed and
rened at a rapid pace. Yet technical performance of the opera-
tions, critical though it may be, is only one of many challenges.
WLS deals with a uniquely vulnerable population in need
of specialized resources and ongoing multidisciplinary care.
Timely best practice updates are critical to identify new risks,
develop strategies to address them, and optimize treatment
of WLS patients. As before (22), members of this panel have
come together to protect patient safety and prevent medical
errors with evidence-based standards of care. is update
of best practice guidelines is part of our continued eorts to
improve the ecacy and safety of WLS procedures.
Background
More than 33% of US adults are classied as obese based on
objectively measured weight (23), and one-third of American
children are either obese or at risk of becoming so (24). Between
2000 and 2005, the proportion of Americans with a BMI ≥40
increased by 50%, although those with a BMI ≥50 increased by
75% (25). Severe obesity has been growing at the fastest rate for
the past 20 years (23,25).
Obesity, particularly abdominal obesity, is associated with
increased risk of hypertension, diabetes, hyperlipidemia, sleep
apnea, coronary heart disease, and strokes (26,27). In 1998,
medical costs attributable to overweight and obesity accounted
for 9.1% of total US medical expenditures, and may have
reached as high as $78.5 billion ($92.6 billion in 2002 dollars)
(28,29). In 2000, there were ~360,000 deaths associated with
obesity (30). It has been suggested that in the 21st century,
increasing rates of obesity may lead to a decline in overall life
expectancy in the United States (31).
METHODS AND PROCEDURES
Update on common WLS procedures
Overview. WLS reduces caloric intake by modifying the anatomy of the
gastrointestinal tract via restriction, malabsorption, or a combination of
the two techniques. Ensuing changes in the gut–brain axis alter peptides
that may regulate appetite and satiety (32) (e.g., ghrelin, glucagon-like
peptide, and pancreatic polypeptide). Among the several competing
approaches for the management of severe obesity, the general trend
is toward combined restrictive–malabsorptive procedures (33). Over
the past few decades, the number of weight loss surgeries performed in
the United States has increased signicantly (34,35). Between 1998 and
2004, weight loss operations rose by 900% to 121,055 (ref. 36). In 2006,
the estimated total climbed to 200,000 (refs. 20,25).
Laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered
the gold standard operation for long-term weight control in United
States (35,37). Rates of RYGB per 100,000 adults rose signicantly
from 1998 to 2002, from 7.0 to 38.6. is increase may be attributed,
in part, to improved surgical techniques, better patient outcomes,
and growing popularity of the procedure (38). LAGB is the second
most commonly performed operation in the United States. Despite
rapid growth in LRYGB and other weight loss procedures, only an
estimated 1% of patients who are eligible for WLS receive it in any
given year (39).
Common WLS procedures
LRYGB. Gastric bypass involves the creation of a small (20–30 ml)
gastric pouch and a Roux limb (typically 75–105 cm) (34) that
reroutes a portion of the alimentary tract to bypass the distal stomach
and proximal small bowel (Figure 3). Following LRYGB, a pleio-
tropic endocrine response may contribute to improved glycemic
control, appetite reduction, and long-term changes in body weight
(40). LYRGB also has a profoundly positive impact on obesity- related
comorbidities and QOL (41). Other advantages include established
long-term eectiveness for sustained weight loss, reduction of comor-
bidities, minimal risk for long-term nutritional sequelae, and eective
relief of gastroesophageal reux disease (21). LRYGB is not without
risks. Common causes of death include pulmonary embolism and
anastomotic leaks. Nonfatal perioperative complications include

OBESITY | VOLUME 17 NUMBER 5 | MAY 2009 845
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venous thromboembolism, wound infections, small bowel obstruc-
tion, and bleeding. Postoperative gastrointestinal complications
include nausea and vomiting, micronutrient deciencies, (35) and
possible weight regain (22).
LAGB. LAGB involves the placement of a band or collar around
the upper stomach 1–2 cm below the gastroesophageal junction,
thereby creating an ~30 ml upper gastric pouch. Degree of stomach
constriction can be adjusted by modifying the amount of saline
injected into a subcutaneous port, which is linked to a balloon within
the band (34) (Figure 4). Parikh et al. (42) found that LAGB had fewer
and less severe complications compared with LRYGB or laparoscopic
malabsorptive procedures. But other data link LAGB with intermedi-
ate and long-term complications (e.g., band erosion or slippage, fail-
ure to achieve or maintain weight loss) that require reoperation in up
to 20% of patients (43,44).
Biliopancreatic
limb
Alimentary
limb
Common channel
Figure 5 Biliopancreatic diversion (BPD) with duodenal switch. BPD
creates malabsorption by maintaining a flow of bile and pancreatic
juice through the biliopancreatic limb. The procedure is commonly
performed with a duodenal switch in which a distal, common-channel
length of small intestine severely limits caloric absorption. The extent of
malabsorption is thought to be a function of the length of the common
channel. (Reprinted with permission of Atlas of Metabolic and Weight
Loss Surgery, Jones et al. Cine-Med, 2008.) Copyright of the book and
illustrations are retained by Cine-Med.
Gastric “sleeve”
Pylorus
Figure 6 Sleeve gastrectomy (SG). SG consists of the restrictive
component of the duodenal switch, a vertical resection of the greater
curvature of the stomach creating a long tubular stomach along the
lesser curvature. The pylorus and part of the antrum are preser ved.
(Reprinted with permission of Atlas of Metabolic and Weight Loss
Surgery, Jones et al. Cine-Med, 2008.) Copyright of the book and
illustrations are retained by Cine-Med.
Tube to
carry fluid
Subcutaneous injection port
Gastric band
Figure 4 Adjustable gastric band (LAGB). LAGB involves the
placement of a band or collar around the upper stomach 1–2 cm
below the gastroesophageal junction, thereby creating an ~30 ml
upper gastric pouch. The band is imbricated to prevent slippage of the
stomach in a retrograde manner through the band. Degree of stomach
constriction can be adjusted by modifying the amount of saline injected
into a subcutaneous port, which is linked to a balloon within the band.
(Reprinted with permission of Atlas of Metabolic and Weight Loss
Surgery, Jones et al. Cine-Med, 2008.) Copyright of the book and
illustrations are retained by Cine-Med.
Alimentary
limb
Transverse
mesocolon
Biliopancreatic
limb
Common
channel
Figure 3 Roux-en-Y gastric bypass (RYGB). RYGB involves the
creation of a small (<30 ml) gastric pouch and a Roux limb (typically
75–105 cm) that reroutes a portion of the alimentary tract to bypass the
distal stomach and proximal small bowel. (Reprinted with permission
of Atlas of Metabolic and Weight Loss Surgery, Jones et al. Cine-Med,
2008.) Copyright of the book and illustrations are retained by Cine-Med.

846 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
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intervention and Prevention
Biliopancreatic diversion. Biliopancreatic diversion (BPD) cre-
ates malabsorption by maintaining a ow of bile and pancreatic juice
through the biliopancreatic limb (45). e procedure is commonly
performed with a duodenal switch (DS) in which a distal, common-
channel length of small intestine severely limits caloric absorption (35).
e extent of malabsorption is thought to be a function of the length of
the common channel (34). e procedure is combined with a sleeve gas-
trectomy (SG) in which the greater curvature of the stomach is resected,
creating a tubular section along the lesser curvature of the stomach (34)
(Figure 5). e BPD described by Scopinaro (45) is capable of pro-
ducing substantial and sustained weight loss, perhaps associated with
markedly suppressed ghrelin levels (46). However, increased incidence
of stomal ulceration, severe protein-energy malnutrition, diarrhea, and
dumping has limited its broad acceptance (21).
Laparoscopic SG. Laparoscopic SG (LSG) is a new purely restrictive
treatment for severe obesity. e technique consists of the restric-
tive component of the DS, a resection of the greater curvature of the
stomach over a 45–50 F bougie positioned along the lesser curvature.
e pylorus and part of the antrum are preserved, resulting in a lesser
curvature-based “restrictive” gastric sleeve (21) (Figure 6). Early reports
of SG have shown it to be safe and eective (47,48), with marked weight
loss and signicant reduction of major obesity-related comorbidi-
ties (49,50). LSG can be performed as a stand-alone operation or as a
bridge to more complex WLS. Following the operation, the stomach
empties its contents rapidly into the small intestine, but with little or no
vomiting (characteristic of restrictive procedures) (51). ere is also a
signicant reduction in ghrelin associated with resection of the gastric
fundus, the predominant area of human ghrelin production (46,52).
Framework for evidence-based recommendations
We divided the 35-member Expert Panel into 11 task groups:
• SurgicalCare(53).
• MultidisciplinaryEvaluationandTreatment(54).
• BehaviorandPsychologicalCare(55).
• Pediatric/Adolescent(56).
• AnestheticPerioperativeCareandPainManagement(57).
• NursingPerioperativeCare(58).
• InformedConsentandPatientEducation(59).
• PolicyandAccess(CodingandReimbursement)(60).
• SpecializedFacilitiesandResources(61).
• DataCollection(Registries)/FutureConsiderations(62).
• EndoscopicInterventions(63).
Panel members joined one or two task groups, each with an assigned
coordinator. Participants were asked to update recommendations from
the rst Lehman Center report (22) based on the best available evi-
dence, including randomized controlled trials, observational studies,
and expert opinion. A medical librarian performed systematic litera-
ture reviews for each group. Searches were limited to English-language
studies published between April 2004 and May 2007 in MEDLINE,
EMBASE, and the Cochrane Library. Some groups also searched other
databases (e.g., CINHAL). e process used to extract data, assess the
literature, and grade evidence has been previously described (22).
Each task group prepared a critical summary of its literature review
and developed updated best practice recommendations (individual
studies are published in this issue of Obesity) based on the most current
evidence. eir reports were reviewed and approved by the Expert Panel.
is Executive Report, a summary of key recommendations from all the
task groups, was approved by the Expert Panel at its nal meeting on 19
July 2007.
RESULTS AND DISCUSSION
Summary of evidence-based recommendations
I. Surgical Care
e Surgical Care Task Group identied >135 papers; the 65
most relevant were reviewed in detail (53). ese included
randomized control trials, prospective and retrospective
cohort studies, meta-analyses, case reports, prior systematic
reviews, and expert opinion.
A. Overview
RYGB remains the predominant gold standard WLS in the
United States, accounting for 93% of all such operations in
2000 (ref. 64). LAGB is the second most commonly performed
procedure (65,66). RYGB is known to safely improve or reverse
obesity-related comorbidities and produce signicant long-
term weight loss (21). Long-term data on weight loss aer
LAGB vary (42,67,68).
B. Types of WLS
Combination procedures. Combination procedures join a res-
trictive component (e.g., gastric stapling) with some form of
duodenal bypass. ey include RYGB, BPD, and DS.
RYGB (open and laparoscopic): Most gastric bypass opera-
tions are now done laparoscopically. LRYGB reduces pulmo-
nary, wound, hernia-related complications, and postoperative
pain (category B), but may have higher internal hernia rates
than RYGB (category C). Weight loss is similar with both
approaches (category B).
RYGB modications: Long-limb RYGB and very very long-
limb extend the length of the Roux limb to enhance weight loss.
e procedures may increase risk of protein and micronutrient
deciencies (category C); it has yet to be determined whether
they produce superior weight loss (category C).
Banded RYGB may be subject to long-term complications
related to reintervention, reoperation, and QOL (categories C
and D). ere is insucient evidence to make a recommenda-
tion (category D). Long-term drawbacks of mini-gastric bypass
might include bile reux and the need for revisional surgery
(category C). As with banded RYGB, more data are needed to
develop recommendations.
BPD and DS: BPD and DS produce eective weight loss
(category B). In patients with a BMI >50, it may be superior
to that achieved with RYGB (category C). However, the pro-
cedures may increase severe complications (e.g., protein and
micronutrient deciencies) (category B). ey also require
diligent lifelong patient follow-up (category D).
Restrictive procedures. Restrictive WLS (e.g., LAGB) has no
malabsorptive or maldigestive components.
LAGB: Short-term data show promising outcomes with
LAGB, but long-term studies raise questions on durability and
reoperative rates (category B). We recommend monitoring of
long-term data and continuation of current practice patterns,
with yearly follow-up of patients (category D).
LAGB should be performed in accredited, multidiscipli-
nary settings by experienced surgeons. They should have
advanced laparoscopic skills, including those needed to
revise LAGB to an alternate procedure. Barring that, WLS
programs should be able to provide appropriate referrals to
facilities that can provide that level of care (category D). It
is safe for obesity medicine specialists, nurse practitioners,

OBESITY | VOLUME 17 NUMBER 5 | MAY 2009 847
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intervention and Prevention
physician assistants, residents, and bariatric nurse special-
ists to adjust bands under the supervision of a weight loss
surgeon (category D).
LSG: Several short-term studies suggest safe and eective
weight loss with LSG (categories B and C), but long-term data
on safety and ecacy are needed to recommend the approach
as anything other than investigational (category D). If other
WLS options are ruled out for reasons of preference or safety,
LSG may be considered (category D).
Vertical banded gastroplasty: Vertical Banded Gastroplasty
is associated with increased peri- and postoperative com-
plications compared with LAGB. Evidence suggests that
it should not be used as a primary surgical treatment for
obesity (categories A and B). However, it can be considered
when alternative weight loss surgeries are not safe or possible
(category D).
C. Revision of WLS
Revisional WLS can address unsatisfactory weight loss
or complications aer primary WLS. It may also enhance
weight loss and further improve comorbidities (category
B). Complications, length of stay, and mortality are higher
for revisional WLS (category B), but it can be safe and eec-
tive when performed by experienced weight loss surgeons
(category D).
D. Intraoperative techniques
We recommend the following as standard practice:
• testingofgastrojejunalanastomosisforleaksintraopera-
tively or within 48 h (category C);
• strongconsiderationofwhethertoclosemesenteric
defects to avoid internal hernia (category C).
E. Patient selection
Emerging issues in patient selection include treatment of those
with a BMI >50 and individuals >age 60. Although procedure-
specic recommendations for extremely obese patients have
yet to be determined (category C), the literature suggests that
combination procedures (e.g., RYGB, BPD, DS) lead to greater
excess weight loss and resolution of comorbidities than restric-
tive procedures (e.g., LAGB) (category D).
Age may remain an independent risk factor following WLS
(category C), but evidence suggests that WLS can be safe and
eective in patients >60 (categories B and C). We recommend
that older patients not be denied improvements in health and
QOL associated with WLS (category D).
F. Facility and surgeon credentialing standards
e following are best practice updates to guidelines in our
prior report (69). ese recommendations are all based on
category D evidence, unless otherwise noted.
Facilities
• AllWLScentersshouldhave,orbeintheprocessof
obtaining, accreditation by external review;
• theyshouldmeetWLSvolumestandardsspeciedbycre-
dentialing bodies;
• centerswithlowervolumeshouldbeendorsedifrisk-
adjusted outcomes fall within benchmarks determined
by credentialing body data.
Surgeon—credentialing
General requirements: All surgeons seeking WLS credentials
for the rst time should
• completeanaccreditedgeneralsurgeryprogramandbe
board-certied, board-eligible, or the equivalent;
• havedocumentedtraininginthefundamentalsofWLS,
including pre-, peri-, and postoperative care of the WLS
patient.
Open privileges: Most weight loss surgeries are performed
laparoscopically. ose who want only open privileges should
complete the general credentialing requirements above, and
• beproctoredbyanexperiencedweightlosssurgeonuntil
procient;
• havetheirrst10casesreviewedbythechiefofservice
and an experienced weight loss surgeon;
• countfellowshipcasestowardindividualsurgeonvolume
requirements.
Full privileges (open and laparoscopic): It is no longer prac-
tical to require specic and mandatory experience in open
WLS prior to applying for laparoscopic privileges. ose
seeking full laparoscopic privileges should complete the gen-
eral requirements and a laparoscopic fellowship of 50 WLS
procedures. As an alternative, they can be proctored for a
minimum of 25 cases by an experienced (70) (>200 laparo-
scopic cases) weight loss surgeon with full privileges. In addi-
tion, surgeons should
• havetheirrst10casesreviewedbythechiefofstaand
an experienced weight loss surgeon;
• countfellowshipcasestowardindividualsurgeonvolume
requirements.
Fundamentals of Laparoscopic Surgery certication is also
highly recommended for newly trained laparoscopic surgeons.
Surgeon—recredentialing
• Institutionsshoulddevelopin-housestandardsfor
recredentialing based on procedure-specific and
risk-adjusted outcomes (benchmarks) rather than
volume alone.
• Anannualvolumeof25casesmaybesufficientif
outcomes are within accepted standards, reported
to a central database, and performed at an accredited
institution.
• Weightlosssurgeonsshouldcompleteatleast12CME
credits related to WLS or obesity every 2 years.

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Procedure-specific credentialing. Rapid changes in technologies
and techniques warrant disclosure of procedure-specic infor-
mation to patients, and selection of those with lower risk proles
for the rst 25 cases. As part of the educational process, surgeons
should disclose
• thetypeandapproximatenumberofprocedurestheyper-
form (category D);
• alternativeWLSoptionsavailable(categoryD);
• risks,potentialbenefits, and programoutcomes
(category D).
II. Multidisciplinary Evaluation and Treatment
e Multidisciplinary Care Task Group identied over 150
abstracts related to WLS in general, and to medical, nutri-
tional, and multidisciplinary care in particular; 112 of these
studies were reviewed in detail (54).
A. Multidisciplinary care
e American Society for Bariatric Surgery recently changed
its name to the American Society for Metabolic and Bariatric
Surgery, reecting growing knowledge that WLS has benets
beyond the treatment of severe obesity. is change expands
the scope of multidisciplinary expertise required to provide
optimal care for WLS patients. As the nature of multidiscipli-
nary care changes, we recommend
• developmentofuniformminimumstandardsofmultidis-
ciplinary care for WLS patients (category D);
• furtherresearchontheeectivenessofgeneralmedical,
surgical, anesthetic, nutritional, and psychological aspects
of multidisciplinary treatment (category D).
B. Preoperative education and patient selection
Preoperative education allows for more appropriate match-
ing of patients and procedures. It can dispel misperceptions
and unrealistic expectations, and help clarify issues related to
resolution of comorbid conditions, dierences between sur-
gical procedures, and required lifestyle changes aer WLS
(category D).
C. Operative risk
Higher BMI and medical comorbidities (e.g., obstructive
sleep apnea (OSA) and coronary heart disease risk factors)
increase operative risk and postoperative complications. We
recommend assessment of risk factors (71) in each patient
(category C).
Preoperative weight loss. Preoperative weight loss of 5–10% of
initial body weight can decrease operation time and may reduce
surgical risk. Patients, especially those with a BMI ≥50, should
be encouraged to achieve weight loss of 5–10% of initial body
weight prior to surgery (category C). Prospective randomized
controlled trials are needed to determine optimal preoperative
weight loss and improve supervision of preoperative weight
reduction (category C).
Medical evaluation. Specic consideration should be given to
WLSpatientswithahistoryofCADorDVT/PE,thosewhoare
current smokers, and those with known or suspected abnormal
liver function. Helicobacter pylori testing and treatment may also
be useful, but more evidence is needed to determine its impor-
tance. Other risk factors include postprandial hypoglycemia,
chronic renal disease, and HIV.
CAD: Patients with a history of CAD should receive preoper-
ative assessment of cardiovascular conditions as indicated (cat-
egory C). ose with stable or suspected CAD should receive
perioperative β blockade unless contraindicated (category C).
Abnormal liver function: Patients with known or suspected
liver disease should be evaluated to assess severity of cirrhosis
and/orportalhypertension(category B). Intraoperativeliver
biopsy at the time of surgery may be useful for diagnosis and
assessment of liver disease (category C). WLS is not recom-
mended in patients with Child’s Class C cirrhosis (category B).
DVT/PE: We recommend perioperative use of anticoagu-
lants and sequential compression devices to reduce the risk
ofDVT/PEunlessclinicallycontraindicated(categoryB).In
patientswithincreasedriskofDVT/PEextendedprophylaxis
should also be considered (category D).
Smokers: Smokers should be strongly encouraged to stop
smoking prior to WLS (category B). Smoking cessation advice
and treatment should be available at the institution or through
the WLS program (category D).
Hypoglycemia: Patients with known or suspected hypoglyc-
emia should be assessed by an endocrinologist prior to WLS.
In that gastric bypass surgery is already being used to treat dia-
betes (72), purely restrictive procedures should be considered
for WLS patients with a documented history of hypoglycemia
(category D).
Chronic renal disease: Pre- and postoperative monitoring of
renal function is recommended in patients with diabetes and
hypertension (categories A and B). Patients with signicant
renal disease should be evaluated by a nephrologist prior to
WLS (category D). Special consideration should be given to
pre- and postoperative monitoring of uid and intravascular
volume status (category A).
HIV infection: Patients with HIV should be evaluated by an
infectious disease specialist prior to WLS (category D). Special
consideration should be given to preoperative assessment of
viral loads, CD4 counts (category D), and weight gain from
antiretroviral medications (category D).
D. Nutrition
Preoperative and postoperative micronutrients. WLS, especially
malabsorptive procedures, can cause multiple micronutrient
deciencies. Patients should be monitored pre- and postopera-
tively for deciencies in vitamin D, thiamine, calcium (includ-
ing PTH), iron, vitamin B12, and folic acid, with repletion as
indicated (categories A, B, and C).
E. Exercise and physical activity
WLS patients should be encouraged to increase pre- and post-
operative physical activity (category D) and low-to-moderate

OBESITY | VOLUME 17 NUMBER 5 | MAY 2009 849
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intervention and Prevention
intensity exercise (category A). Guidance and periodic moni-
toring should be used to help WLS patients remain physically
active (category D).
F. Pregnancy
WLS should not be performed in patients who are known to
be pregnant; we strongly recommend preoperative testing for
women of childbearing age (category C). Patients should be
strongly counseled to not get pregnant for at least 18 months
aer surgery (category C).
G. Post-WLS body contouring
Post-WLS body contouring is an emerging eld. e task
group identied and reviewed in detail 80 relevant articles,
ranging from case reports and expert opinion to prospective
randomized trials.
Insurance coverage. Body contouring should generally be
reserved until a patient has achieved a stable weight. is usually
happens at 18 months (or more) aer WLS. ere are no widely
accepted guidelines for insurance coverage of body contouring
aer substantial weight loss. We recommend third party cover-
age of excess skin excision, if medically indicated (category D).
Surgeon criteria. Body contouring should only be performed
by board-eligible or board-certied surgeons with training and
experience in the relevant procedures (category D).
III. Behavioral and Psychological Care
e Behavioral and Psychological Care Task Group identied
17 papers; the 13 most relevant were reviewed in detail (55).
ese included randomized controlled trials, prospective and
retrospective cohort studies, meta-analyses, case reports, and
prior systematic reviews.
A. Patient selection and preoperative evaluation
WLS patients are an emotionally vulnerable population. All
candidates for WLS should undergo psychosocial evaluation
by a credentialed expert in psychology and behavior change
(category C). Evaluations should be carried out by a social
worker, psychologist, or psychiatrist with a strong background
in the current literature on obesity and WLS, and some experi-
ence in the pre- and postoperative assessment and care of WLS
patients (category D). ough not essential, it is preferable that
the evaluator be on sta or aliated with the WLS center to
facilitate communication, maintain the support network, and
provide continuity of care (category D).
To address long-term complications, mental health resources
should be made available to patients beyond the standard post-
operative period of 6 months (category D). is recommenda-
tion can be met in a variety of ways (e.g., sta mental health
professional, referral network).
Mental illness, including eating pathology, should not nec-
essarily be a contraindication to WLS. Evaluations should
determine the degree to which mental illness, including eat-
ing pathology, may jeopardize the safety or ecacy of WLS
(category C). ey should be used to identify patients in need
of preoperative psychosocial intervention, and develop recom-
mendations on if, how, and when to best address signicant
psychosocial risk factors (category C).
Psychological assessment and support have become essential
components of multidisciplinary care in WLS. We recommend
that organizations that provide education on obesity and WLS
(e.g., North American Association for the Study of Obesity)
oer continuing education units to mental health providers.
is will facilitate the development of continuing education
standards for mental health specialists in the elds of obesity
and WLS (category D).
B. Binge eating disorder
Binge eating disorder in patients seeking WLS is clinically impor-
tant, especially in the long-term. It should be taken into account
in the development of treatment plans. Assessment should be
done in a standardized, empirically validated way (e.g., screening
with EDE-Q and follow-up with a brief, standardized inter-
view based on DSM-IV-TR criteria) (category C). e disorder
should not be considered a contraindication for WLS, but rather,
a potential complication that may need to be addressed before or
aer surgery to ensure optimal outcome (category C).
Patients should know that eating pathology can recur aer
WLS, and that they may need professional help to deal with
recurring patterns of binge eating. is disorder should be
included in the informed consent process and as part of the
WLS program’s standard educational component (category C).
C. Night eating syndrome
In that there is no clear evidence that night eating syndrome
has any impact on surgical outcome, the condition should not
be considered a contraindication for WLS. Rather, it should be
seen as a potentially complicating factor that may need to be
addressed before or aer surgery to ensure optimal outcome
(category D).
D. Emotional eating
Data are insucient to make recommendations on the assess-
ment and treatment of emotional eating. As with night eating
syndrome, the issue should be considered a potentially com-
plicating factor that may need to be addressed before or aer
WLS to assure optimal outcome (category D).
E. Substance abuse
Findings on the prevalence of substance abuse among those
seeking WLS are conicting, and there are few studies on the
subject. Evidence is insucient to conclude that the problem is
a frequent one aer WLS. Further research is needed to estab-
lish the prevalence of substance abuse aer WLS as well as its
predictors, its relation to surgical outcome, and eective treat-
ment approaches (category D).
F. Psychotropic medications
Data indicate signicantly higher use of psychotropic medica-
tions in WLS patients compared with the general population.

850 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
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intervention and Prevention
Further research is needed to determine the relation between
various psychotropic medications and their impact on postop-
erative weight loss and psychosocial adjustment (category D).
e eects of WLS on the dissolution, absorption, and clini-
cal response to psychotropic drugs are not well understood. For
this reason, we recommend close postoperative monitoring of
WLS patients, especially aer gastric bypass (category D).
G. Future research needs
e needs of future research are
• adequatelypoweredandcontrolledprospectivetrialsthat
examine the relation between psychosocial factors and
surgical outcomes;
• randomizedcontrolledtrialsontheeectivenessoftreat-
ments to reduce the impact of psychosocial risk factors on
outcomes.
IV. Pediatric/Adolescent
ePediatric/AdolescentWLSTaskGroupidentied>1,085
papers; 186 of the most relevant were reviewed in detail (56).
A. Types of surgery
RYGB is considered a safe and eective option for extremely
obese adolescents as long as appropriate long-term follow-up
is provided (category B). e adjustable gastric band has
not been approved by the FDA for use in adolescents, and
therefore, should be considered investigational. O-label
use can be considered, if done in an IRB-approved study
(category C).
BPD and DS procedures cannot be recommended in adoles-
cents. Current data suggest substantial risks of protein malnutri-
tion, bone loss, and micronutrient deciencies. ese nutritional
risks are of particular concern during pregnancy. In addition,
several late maternal deaths have been reported (category C).
SG should be considered investigational; existing data are
not sucient to recommend widespread and general use in
adolescents (category D).
B. Comorbidities
Strong indications for WLS in adolescents include estab-
lished type 2 diabetes (category B), moderate to severe OSA
with AHI ≥15 (categoryC),severeand/orprogressiveNASH
(category C), and pseudotumor cerebri (category C). Other
indications for WLS in adolescents include mild OSA, mild
NASH, hypertension, dyslipidemia, and signicantly impaired
QOL (categories C and D).
All adolescents with obesity should be formally assessed for
depression. If found to be depressed, they should be treated
prior to WLS (category B). e presence of eating disturbances
is not an exclusion criterion for WLS, but adolescents with
such disorders should be treated prior to surgery (category B).
C. Patient selection
When combination procedures are used in adolescents, physi-
cal maturity (completion of 95% of adult stature based on
radiographic study) should be documented. In most cases, this
criterion will limit surgery to children over age 12 (category D).
Psychological maturity—demonstrated by understanding of
the surgery, mature motivations for the operation, and compli-
ance with preoperative therapy—should be assessed prior to
WLS (category D).
BMI cutpoints in children and adolescents who meet other cri-
teria should be ≥35 with major comorbidities (i.e., type 2 diabetes
mellitus, moderate to severe sleep apnea (AHI >15), pseudotu-
mor cerebri, or severe NASH) and ≥40 with other comorbidities
(e.g., hypertension, insulin resistance, glucose intolerance, sub-
stantially impaired QOL or activities of daily living, dyslipidemia,
sleep apnea with AHI ≥5) (categories B and C).
ere are no data available to suggest that prolonged preop-
erative weight management programs are of benet to adoles-
cents who undergo WLS. However, children and adolescents
should demonstrate the ability to comply with treatment regi-
mens and medical monitoring before WLS. In many cases,
consistent attendance in a prolonged weight management pro-
gram will provide important assurance of postoperative com-
pliance (category D).
Individuals with mental retardation vary in their capacity
to demonstrate knowledge, motivation, and compliance; they
should, therefore, be evaluated for WLS on a case-by-case
basis. For these children, we suggest including an ethicist on
the multidisciplinary evaluation team (category D).
Others who should be screened on a case-by-case basis include
patients with syndromic obesity, endocrine disorders, obesity
that appears to be related to the use of weight-promoting medi-
cations, and those in whom obesity cannot be controlled through
medicalinterventionsand/orcarefully designedenvironmental
and behavioral management. Very limited information is avail-
able about the outcomes of WLS for such patients (category D).
Patients with uncontrolled psychosis (presence of hallucinations
and delusions), bipolar disorder (extreme mood lability), or sub-
stance use disorders can be considered for WLS on a case-by-case
basis aer they have been in remission for 1 year (category C).
D. Team member qualifications
Although few hospitals have sucient volume for a stand-alone
pediatric surgical center, the ideal WLS team should include a
minimum of four or ve professionals who are colocated and
have at least one preoperative face-to-face meeting to prepare a
treatment plan for each patient (category D). Sta should include
• surgeon—experiencedadultbariatricsurgeonorpedi-
atric surgeon with bariatric fellowship or the equivalent
experience;
• pediatricspecialist—internistorpediatricianwithadoles-
cent and obesity training and experience;
• registereddietician—withweightmanagementcerti-
cate and experience in treating obesity and working with
children and families;
• mentalhealthprofessional—withspecialtytrainingin
child, adolescent, and family treatment, and experience
treating eating disorders and obesity;

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intervention and Prevention
• coordinator—RN,socialworker,oroneoftheotherteam
members who has the responsibility of coordinating each
child or adolescent’s care and assuring compliance and
follow-up.
eideal setting would be in an adult/pediatric hospital,
with a pediatric program partnered with an adult program that
has full access to pediatric specialists (category D). A compre-
hensive family-based evaluation should be provided to parents
seeking surgery for their adolescent children (category D).
E. Risks and outcomes
Early WLS may reduce obesity-related mortality and mor-
bidity. However, early timing must be weighed against the
patient’s possible psychological immaturity and the risk of
decreased compliance and long-term follow-up (category C).
All adolescents undergoing WLS should be included in pro-
spective longitudinal data collection to improve the evidence
base for evaluating the risks and benets of WLS in this age
group (category D).
Emphasis on compliance strategies, careful monitoring of
vitamin and mineral intake, and periodic laboratory surveil-
lance to detect deciencies is crucial (category D). Adolescent
girls are particularly vulnerable to nutritional deciencies; this
group is at substantial risk of developing iron deciency ane-
mia and vitamin B deciencies during menstruation and preg-
nancy (category C), and should receive special attention.
Risk of pregnancy increases aer WLS. All female adolescents
should be informed about increased fertility following weight
loss, and possible risks associated with pregnancy during the
rst 18 months aer surgery. ey should be counseled to avoid
pregnancy during this period, and oered contraception (cat-
egory D). In addition to risks for deciencies of iron, calcium,
and vitamin B12 aer WLS, adolescents may also be at particu-
lar risk for osteopenia and thiamine deciency (category C).
F. Informed consent
Informed assent by the adolescent should be obtained sepa-
rately from the parents to avoid coercion (as in other pedi-
atric chronic illnesses that require surgical intervention)
(category D). e patient’s knowledge of the risks and benets
of the procedure and the importance of postoperative fol-
low-up should be formally evaluated to ensure true informed
assent (category C). e parental permission process should
include discussion of the risks of adult obesity (category C),
available medical treatments (category B), surgical alterna-
tives, and the specic risks and outcomes of the proposed WLS
in the proposed institution.
V. Anesthetic Perioperative Care and Pain Management
e Anesthetic Perioperative Care and Pain Management
Task Group’s literature search yielded 1,788 abstracts, with 162
potentially relevant titles. Following full-text evaluation of the
latter, 45 articles were reviewed in detail. Best practice recom-
mendations integrate the latest research on obesity and col-
laborative multidisciplinary care (57).
A. Preoperative evaluation and preparation
Mandatory polysomnography for WLS patients has been
proposed (category C). However, we recommend that it be
used in selected patients as indicated. When uncertain of
the indication for such testing, clinical assessment should be
supplemented to include gender, waist-to-hip ratio, and neck
circumference (category B). Preoperative CPAP treatment
should be strongly considered for patients with a polysom-
nography diagnosis of moderate to severe OSA (categories B
and C). We recommend smoking cessation at least 6 weeks
prior to surgery (category C); the WLS program should pro-
vide active support to help patients achieve and sustain com-
pliance (category D).
B. Intraoperative management
Induction and emergence. e ≥30° reverse Trendelenburg
position prolongs the ability of severely obese patients to
tolerate apnea during induction of (category A), and emer-
gence from (category D), anesthesia. CPAP of ~10 cm H
2
O
may be considered during preoxygenation to prolong non-
hypoxic apnea (category A). Intubating laryngeal mask air-
way devices provide an alternative mechanical approach
to securing the airway (categories A and B), and may also
improve success when attempting ventilation prior to secur-
ing the airway. Intubating laryngeal mask airway devices
should be included among the alternative airway manage-
ment devices immediately available in the operating room
(categories A and B).
Maintenance of anesthesia. Preoperative oral administration of
clonidine (an α-2 agonist) to obese patients with OSA is asso-
ciated with reduced anesthetic requirements as well as reduced
intra- and postoperative opioid requirements. Its use may
be considered unless medically or surgically contraindicated
(categories A and C).
Intraoperative oxygenation. Several methods to improve intra-
operative oxygenation during WLS have been evaluated. We
recommend initial treatment of intraoperative hypoxemia with
recruitment maneuvers and positive end-expiratory pressure
while monitoring their potential hemodynamic eects (catego-
ries A and B).
Other interventions. Postoperative nausea and vomiting in lap-
aroscopic WLS patients is related to the volume and rate of
intraoperative uid replacement. To reduce postoperative nau-
sea and vomiting, we recommend maintenance of euvolemia
(category C).
Intraoperative drug dosing. Pharmacodynamic studies in severely
obese patients have suggested optimal dosing requirements for
dierent neuromuscular blocking agents. Cisatracurium and
rocuronium should be dosed according to ideal body weight
during standard induction of general anesthesia (category A).
emusclerelaxantsuccinylcholineshouldbe dosedat 1mg/
kg total body weight (category A). For target controlled

852 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
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intervention and Prevention
infusion (not yet approved in the United States), propofol dose
should be calculated to more closely reect total body weight
(category C).
C. Postanesthesia care
Positive outcomes have been reported with early treatment of
postoperative hypoxemia employing noninvasive positive pres-
sure ventilatory support (NIV) in nonobese, non-OSA patients
at high risk of respiratory failure. A joint decision between
the surgeon, anesthesiologist, respiratory therapist, and nurse
should determine NIV use on selected WLS patients (categories
A, B, and C). LRYGB and LAGB have been performed safely as
23-h stay and outpatient procedures. However, patients with
OSA should not be considered candidates for outpatient WLS
(category C); we recommend adherence to the American Society
of Anesthesiologists Practice Guidelines for the Perioperative
Management of Patients with OSA (category C).
Postoperative pain management. Based on new evidence of e-
cacy and safety specic to WLS patients, we recommend use of
opioid sparing multimodal analgesic strategies, including local
anesthetic wound inltration and nonsteroidal anti-inam-
matory medications, unless contraindicated (categories A and
C). Solutions for thoracic epidural pain management in OSA
patients should be opioid-free to reduce the risk of respiratory
depression (category C).
D. Credentialing
No evidence indicates that specic credentialing of anesthesia
personnel for WLS will improve patient safety or outcomes.
We recommend the selection of a board-certied anesthesiolo-
gist to coordinate intradepartmental sta education and proc-
toring to establish prociency. is individual will also serve as
an interdepartmental liaison to WLS programs and the multi-
disciplinary WLS care team (category D).
E. Medical error reduction and systems improvement
Optimal outcomes require unimpaired intra- and periopera-
tive multidisciplinary communication among WLS caregivers
(category D). Development of perioperative care pathways for
patients with OSA is at an early stage (category C) and needs
further renement for WLS patients.
F. Future research needs
Research is needed in the following areas:
• theroleandparametersofpreoperativeOSAtreatment
for perioperative safety outcomes in WLS;
• intra-andperioperativedrugdosing,includingprophy-
lactic antibiotic tissue pharmacokinetic assessment;
• appropriateuseofα-2 agonists in the perioperative care
of WLS patients;
• strategies forintra- and postoperativeglycemic
management;
• impactofadvancedmonitoringofanestheticeectson
outcomes;
• evidence-basedpostoperativecareguidelinesforWLS
patients with OSA;
• optimalanestheticcareforWLSpatientswithincreased
BMI, age, and quantity and severity of comorbidities;
• impactofanorganizedmultidisciplinarycareteamon
WLS safety outcomes;
• effectofsurgicalandoverallcareteampathwaysto
decreaseand/ortreatperioperativeanestheticandsurgi-
cal complications.
VI. Nursing Perioperative Care
A systematic review of MEDLINE, nursing journals, and the
CINHAL database for nursing and allied health literature iden-
tied >54 papers; the most relevant were reviewed in detail.
Recommendations are based on published evidence and the
consensus of the Task Group members (58).
A. Planning and communication
Eective communication between all members of the health
care team is paramount in the delivery of quality care. It
requires sucient time for the collection of information from
patients, site verication in the operating room, timely and
concise reporting of symptoms, and the “repeating back” of
information exchanged between team members. To optimize
communication, we recommend
• continueddevelopmentofclinicalpathways(categoryD);
• anAdvancedPracticeNurseorClinicalBariatricNurse
Specialist on sta in WLS programs (category D);
• developmentandfosteringofgoodcommunicationskills
between patients and practitioners and between members
of the health care team (category D);
• promotionofcollaborationbetweennurses,physicalther-
apists, discharge planners, social workers, nutritionists,
and facilitators of support groups (category D).
B. Perioperative management
Unit-specic triage based on individual comorbidities can pro-
mote patient safety (category D). We also recommend use of
the Association of Perioperative Registered Nurses Bariatric
Surgery Guideline (category D) and the American Society of
Anesthesiologists Practice Guidelines for the Perioperative
Management of Patients with OSA (category C). Preferably,
a dedicated operative team of nurses and surgical technicians
should regularly assist in WLS procedures (category D).
Preventing complications. Risk of venous thromboembolic
events aer gastric bypass is signicant. Other postoperative
complications include those associated with monitoring of uid
balance, hypoxemia, anastomotic leak, tachycardia, peripheral
nerve injury, and risk of skin irritation, infection, ulceration in
skinfolds, and decubitus ulcers. We recommend ambulation
onthedayofsurgery,anddeepbreathing/coughing(category
D); careful positioning to decrease risk of peripheral nerve
injury (categories C and D); and education of emergency

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intervention and Prevention
department sta on early and late complications in WLS
patients (category D).
Perianesthesia. Obese patients present with distinct respiratory
care considerations. ey should be closely monitored for
rapid oxyhemoglobin desaturation and respiratory depression
aer extubation. Facilities should reference the Association of
Perioperative Registered Nurses Bariatric Surgery Guideline
(category D) and educate sta on pulmonary pathophysiology
in obese patients (category D).
Postoperative analgesia. e goal of postoperative pain man-
agement is to promote participation in activity, ambulation,
incentive spirometry, deep breathing, and coughing. Nursing
sta should consult with a pharmacist on equianalgesic agents
and dosing (category D), and use multimodal, opioid-sparing
strategies to keep patients comfortable (category D).
C. Patient and staff safety
WLS patients move through many areas of hospitals for tests
and procedures. Facilities should review each area and its equip-
ment to make certain that they can accommodate extremely
obese patients. e weight capacity of tables, beds, stretch-
ers, and wheelchairs should be clearly marked (categories C
and D). A comprehensive ergonomics program, including
liing and transferring equipment, should be used to prevent
patient handling injuries (category B). A designated nurse or
back injury resource nurse should coordinate equipment selec-
tion, maintenance, sta training, and reporting (category D).
D. Outpatient postoperative nursing follow-up
Dehydration, pulmonary embolisms, and anastomotic leaks
are the serious conditions most likely to occur in the early dis-
charge phase. Later complications can include hyperinsuline-
mic hypoglycemia, metabolic bone disease, problems with
redundant skin, nutritional deciencies, suboptimal weight
loss, issues with psychosocial adjustment, and pregnancy.
Medications and vitamin supplements should be reviewed
at each postoperative outpatient visit (categories C and D).
Nurses should be knowledgeable about possible late complica-
tions, know how to support patients, and be prepared to make
referrals to appropriate caregivers (category D). WLS patients
should be encouraged to continue treatment through ongoing
WLS support groups and networks (categories A and D).
E. Credentialing
e American Society for Metabolic and Bariatric Surgery has
developed national certication criteria for Clinical Bariatric
Nurse Specialists. We recommend certication (category D).
F. Future research needs
Studies are needed in the following areas:
• clinicalpathwaysforWLS, including emergency
departments;
• comprehensiveergonomicsprograms;
• teach-to-goaleducationalmethodsforpre-andpostop-
erative education;
• programretentiontoolsandoutcomemeasures;
• nursingresearchandinvolvementinpediatricWLS
programs.
VII. Informed Consent and Patient Education
is Task Group’s literature search identied 120 papers, 38
of which were reviewed in detail. No articles were specic to
informed consent and WLS. Recommendations are extrapo-
lated from, and supported by, existing data (59).
A. Content
Risks/complications. Informed consent should include realistic
risk estimates that take into account patient factors (category C)
and relevant institutional and health provider characteristics
that might aect risk (e.g., experience and outcomes for spe-
cic WLS procedures) (category B). Short- and long-term risks
and complications, and the potential for unknown or unfore-
seeable long-term risks, should be discussed (category D).
Benefits/effectiveness. Patients should receive realistic estimates
of short- and long-term weight loss, including the potential for
weight regain and modest benets (category B). ey should
also be informed if long-term data (>5 years) are unavailable
(category D).
ey should be advised of the long-term health benets of
weight loss produced by WLS (category B), but also be made
aware that not all pre-existing medical and psychosocial con-
sequences of obesity (including eating disorders) will improve
with WLS (category C). Candidates for WLS should be given
realistic estimates for health outcomes if they decline surgical
treatment (categories B and C), and be advised of known factors
and interventions that might optimize benets (category D).
Informed consent and education should consider patient
expectations, the value placed on dierent outcomes, and the
risks each candidate is willing to accept. It should also address
unrealistic expectations or other misconceptions patients
might have (category C).
Consequences. Patients should be advised of required behav-
ioral and dietary changes and other reasonable and foresee-
able consequences of WLS that could aect health or QOL in
a substantive way, e.g., gastrointestinal symptoms, cosmetic
eects, nutritional restrictions (category D).
B. Alternative treatments
Patients should be advised about alternative WLS procedures
and nonsurgical treatment options (e.g., medical and behavio-
ral) (category C). ey should be informed about them even if
they are not available through the consenting health provider
or institution (category C).
C. Patient comprehension
Each patient should have their comprehension of the risks,
benets, consequences, and alternatives to WLS evaluated

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intervention and Prevention
(category C). Conrmation of comprehension should be
included as a protection for patients engaged in the informed
consent process (category C).
D. Future research needs
Future research is needed to better identify factors that aect
short- and long-term outcomes so that patients can be cited
appropriate and individualized outcome information. Research
should focus on important gaps in knowledge on outcomes and
consequences of WLS, and the dierent approaches that facilitate
patient understanding of, and decision making about, WLS.
VIII. Policy and Access (Coding and Reimbursement)
e Policy and Access group identied 51 publications in
its literature search; the 20 most relevant were examined in
detail (60). ese included reviews, cost–benet analyses, and
trend and cost studies from administrative databases.
A. Policy and access
Access disparities (all category D). Public health policy should be
aligned with long-term goals for the treatment of severe obesity.
Barriers to WLS in populations with high prevalence of severe
obesity should be identied and eliminated, and there should be
uniform standards of coverage for all WLS candidates. We rec-
ommend advocacy for increased access to WLS for underserved
regions and population groups; support for community-based
eorts to ght health disparities; and public education about the
obesityepidemicandtherisks/benetsofWLS.
Childhood obesity (categories C and D). Sharp increases in child-
hood obesity lend urgency to the need to address the problem
(category C). Policy initiatives to identify pediatric and adoles-
cent populations most likely to benet from surgical treatment
of obesity are needed. Surgical treatment should be considered a
potentially eective option for appropriately selected individuals,
and there should be uniform standards of coverage for adolescent
patients. We need to educate legislators, community leaders, and
other stakeholders on the costs and benets of WLS for extremely
obese adolescents, and leverage opportunities for collaboration
between teachers, parents, and community leaders (category D).
Insurance policies (category A, B, C, and D). Controversial issues
include required documentation of prior weight loss attempts
through more conservative means; access to WLS for those with
a BMI of 35–40 and obesity-related comorbidities; and proof of
extreme obesity for at least 5 years. We recommend
• routineexaminationofweightlosshistoriesduringbehav-
ioral evaluation to determine whether additional attempts
at nonsurgical weight loss are advisable;
• coverageofWLSforthosewithaBMIof35–40and
comorbid conditions that require ongoing treatment
(e.g., CPAP, medication);
• researchtocharacterizeweightlosshistoriesofsurgical
candidates, and explore the relation between dieting his-
tory and postoperative outcomes;
• ongoingcollectionanddisseminationofdataonWLS
costs, risks, and benets;
• collaborativeeortsbetweengovernment,industry,and
other stakeholders to promote safe and eective delivery
of WLS.
Cost-effectiveness issues. Obesity is linked to higher health
care costs than smoking or drinking, and plays a major role
in disability (category B). Accurate short- and long-term cost
savings(andrisk/benets)foremployersandinsurancecom-
panies need to be collected and disseminated. Clinical path-
ways that reduce unnecessary costs to providers should also be
developed (category D).
Innovation, evidence-based medicine, and cost containment. e
application of standard cost-containment policies to surgical
innovations may stie new developments. We recommend the
use of evidence-based medicine to both guide clinical decisions
and show reasonable trends for health care cost containment
(category C).
Legislation. We need to keep legislators apprised of the personal
and economic costs of obesity in the communities they serve.
Dissemination of evidence-based information on the risks, ben-
ets, and cost-eectiveness of WLS can bring these issues to
their attention (categories C and D).
Stigma (all category D). e highest BMI groups are the fastest
growing and the most stigmatized. To address this problem, we
recommend targeted education campaigns; community-level
publicinformation/education;andsensitivitytrainingfor hos-
pital personnel. Hospitals should also acquire obese-appropriate
products (e.g., gowns, chairs, commodes).
B. Coding and reimbursement
Centers for Medicare and Medicaid Services. Centers for
Medicare and Medicaid Services allows national coverage
for RYGB (open and laparoscopic), LAGB, and BPD with DS
(open and laparoscopic). Nationally covered procedures and
new 2006 CPT codes are available.
C. Potential pathways to new codes
Category III and S codes. CPT category III Codes are a tempo-
rary set of tracking codes used to identify new and emerging
technologies. CPT category III codes (T codes) support data
collection on new services and procedures. CPT category III
codes may be converted to CPT category I codes if the FDA
and CPT Editorial Panel approve the clinical ecacy of the
particularservice orprocedure.BlueCross/BlueShieldand
other commercial payers have developed the category of S
codes, which were added to HCPCS Level II to report drugs,
services, and supplies. S codes are typically used in conjunc-
tion with a nonspecic CPT code.
Medicare does not recognize or reimburse for services
reported under S codes, and may or may not reimburse for
CPT category III codes, depending on the service or procedure.

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intervention and Prevention
Individual commercial insurers may or may not reimburse
for S codes or CPT category III codes as medical policies and
reimbursement polices are specic to each insurer.
D. Issues and recommendations
Alignment of reimbursement policies with clinical objectives.
Reimbursement policies should reect the importance of
comprehensive, multidisciplinary care. ere should be full
coverage for medical, nutritional, and psychological preop-
erative evaluation as well as pre-, peri-, and postoperative care
required by insurers (category D).
CPT codes for WLS and related clinical services (all category D).
CPT codes for WLS should be updated to reect current
practice. New CPT category I codes should be requested and
approved as evidence accumulates in favor of new procedures
(e.g., vertical SG, endoscopic interventions). T codes should
be considered for evolving technologies, and procedures.
e use of T codes may create a pathway for reimbursement
by supporting consistent data collection and development of
evidence. Evidence indicating that a promising technology
or new procedure leads to improved health outcomes could
support conversion of category III codes to category I codes.
ere should be support for the development of appropriate
CPT codes for each component of multidisciplinary care (e.g.,
exercise therapy, pre- and postoperative support groups).
Data collection, tracking, and reporting systems. ere are se veral
national data collection, tracking, and reporting databases (see
Data Collection) (62) as well as proprietary systems. We recom-
mend standardized collection, tracking, and reporting of tiered
and risk-adjusted data (category D).
IX. Specialized Facilities and Resources
e Specialized Facilities and Resources Task Group identi-
ed 1,647 papers in its literature search; the 46 most relevant
were reviewed in detail (61). ese included randomized
control trials, prospective and retrospective cohort studies,
meta-analyses, case reports, prior systematic reviews, and
expert opinion.
A. Personnel
All medical and support sta must be adequately trained and
credentialed as specied in the following task group reports:
Surgical Care (53), Anesthesia Perioperative Care and Pain
Management (57), Behavioral and Psychological Care (55),
and Nursing Care (58). A team of dedicated medical special-
ists—fully aware of the problems and sensitivities of patients
with severe obesity—should be readily available, and all per-
sonnel (including ancillary and nonclinical sta) should have
obesity-specic education focused on sensitivity training.
B. Equipment
All facilities performing WLS, including pediatric WLS cent-
ers, require the same equipment. We strongly recommend that
WLS centers have well-dened plans for the evaluation and
treatment of post-WLS surgery patients with potential com-
plications who cannot t into available diagnostic equipment.
Recommended equipment includes the following.
Ancillary
• Widewheelchairs,stretchers,andwalkers.
• WideBPcus.
• Biphasicdebrillators.
• Size-appropriatesequentialcompressiondevices.
• Emergencyairwayequipment.
• Wideexaminationtablesboltedtotheoor.
• Scalesofappropriatesizeandcapacity.
Operating room. Specially equipped operating room and ancil-
lary equipment should be available to support patients with
severe obesity, including
• anautomatedextra-wideoperatingtablewithappropriate
weight capacity;
• extra-longabdominalinstrumentsets;
• appropriatelysizedretractors;
• 43–46cmlaparoscopes.
Radiology equipment. Special diagnostic and interventional
equipment is required to support and accommodate WLS
patients. Such equipment should include
• CTscannerswith400lbweightcapacity;
• MRImagnetwith400lbweightcapacity;
• uoroscopicequipmentwith300lbcapacitythatcanstudy
patients in a standing position with high beam voltages;
• interventionalfacilitiesavailable24haday,7daysa
week.
C. Physical plant
Size-appropriate facilities should be available in both
postan esthesia and intensive care units; postoperative, dedi-
cated in-patient oors with specially trained personnel should
be available. Patient rooms and elevators must have suciently
wide entrances. Floor-mounted commodes are recommended,
but support systems can be used as an alternative. Design of
new facilities that will accommodate the WLS patient must
comply with the American Institute of Architects Planning
and Design Guidelines for Bariatric Healthcare Facilities (73).
D. Extent of facility changes
WLS patients travel throughout hospitals for tests and pro-
cedures; there should be size-appropriate accommodations
in all in-patient and outpatient points of service. These
should include chairs and bathroom facilities, transferring
equipment (stretchers and wheelchairs), and monitoring
devices.
E. Investment
Specialized resources for WLS patients require a signicant
investment, the size of which depends on everything from

856 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
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intervention and Prevention
geography to patient population. Capital investments are
preferred for renovations to existing facilities, and strongly
recommended for new construction. WLS centers with lower
volume or storage space problems should consider renting
equipment.
F. Staff injury reduction
Health care consistently ranks among the top elds for back
injuries. Well-established, agreed-upon, and well-known plans
for transferring severely obese patients at all points of care can
help reduce injuries. We also recommend that proper equip-
ment, as well as training on how to use it, should be immedi-
ately available for the transfer of WLS patients. Sta should be
well-educated in the use, location, and operation of available
li equipment. Portable equipment is more useful than ceiling
lis, but requires more room clearance. Trained and available
on call “li team” alternatives to equipment (as appropriate)
should be considered.
G. Medical error reduction
We recommend dedicated facilities and sta to reduce risk of
medical errors, including a dedicated hospital administrator
to provide consistent support and oversight. All medical sta
should be adequately trained and credentialed in best practice
care of WLS patients (53,57,58). A team of designated medi-
cal subspecialists, fully aware of the problems and sensitivities
of extremely obese patients, should be readily available, and all
personnel who interact with WLS patients should attend obesi-
ty-specic education programs focused on sensitivity training.
H. Medication error reduction
Medication guidelines released by the Joint Commission
Accreditation of Healthcare Organizations in 2004 (ref. 74)
emphasize safety. We recommend that facilities follow these
recommendations, as well as those specied in our prior
report (61). We also recommend an Institutional Pharmacy
and erapeutics Committee to oversee WLS medical dosing
regimens, and further research on medication use in the WLS
patient.
I. Systems improvements
Clinical pathways are required by WLS accreditation programs,
such as the American College of Surgeons Bariatric Surgery
Center Network Accreditation Program (75). Clinical pathways
specic to WLS patients should be established. ese should
be procedure-specic, updated frequently, and consistent with
order sets. Regular meetings by the WLS team to review patient
outcomes and address possible systems changes are essential,
as is investment in a WLS database. e database should track
patient outcomes and be compatible with the needs of the cre-
dentialing body that certies the center. We recommend risk-
adjusted outcomes to adequately evaluate performance.
X. Data Collection (Registries)/Future Considerations
is Task Group identied 212 papers and reviewed the
63 most relevant in detail. Recommendations are based on
available evidence as well as consensus of opinions from Task
Group and Expert Panel members (62,76).
A. Administrative and nonadministrative databases
Administrative databases have inherent problems, includ-
ing unreliable coding and lack of WLS-specic data points.
Clinical databases that are not WLS-specic have other
shortcomings (e.g., short-term follow-up, sampling of WLS
procedures), and single-institution, WLS-specic databases
lack standardized denitions and appropriate quality bench-
marks. Rather, we recommend collection of WLS-specic
data (categories B and D) on 100% of weight loss surgeries
performed (category D).
B. New developments
Longitudinal assessment of bariatric surgery.
e NIH-funded
Longitudinal Assessment of Bariatric Surgery consortium has
developed a database of standardized information on WLS
patients at six clinical centers. Data are being collected on
patient characteristics, surgical procedures, medical and psy-
chosocial outcomes, and economic factors.
Accreditation programs. e Centers for Medicare and
Medicaid Services made a national decision to cover WLS,
but only if performed by institutions and surgeons that are
accredited by either the American College of Surgeons Bar-
iatric Surgery Center Network or the American Society for
Metabolic and Bariatric Surgery/Surgical Review Corpora-
tion Centers of Excellence program. WLS-specic, longi-
tudinal data collection systems are a major part of each of
these accreditation programs. e optimal data collection
system should gather information on all WLS procedures
using a longitudinal, universal database system. It should
be prospective, risk adjusted, and benchmarked, with WLS-
specic data points that track clinical eectiveness and com-
plications following WLS (categories B and D).
e American College of Surgeons Bariatric Surgery
Network Data Collection System, the Society of American
Gastrointestinal Endoscopic Surgeons Bariatric Data Collection
System, and the American Society for Metabolic and Bariatric
Surgery/SurgicalReviewCorporationsystemshouldmeetthese
criteria. If these systems are not compatible (i.e., cannot agree
on the same denitions), an interface should be developed that
makes them so (category D).
C. Areas that need more data
Risk adjustment. Risk adjustment helps control for dierences
in patient risk factors and case mix. Appropriate risk adjust-
ment models should be developed and rened over time to
account for these variables (categories C and D).
Determining the best data collector. Data entered into the sys-
tem must be of the highest quality to ensure accurate analyses
on quality of care. To avoid bias, data should be collected by
audited, trained data collectors not directly involved in patient
care (categories B and C). at data, in turn, should be analyzed

OBESITY | VOLUME 17 NUMBER 5 | MAY 2009 857
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intervention and Prevention
to see whether information collected by audited, trained non-
nurse reviewers is as valid as that collected by nurse reviewers
(category D).
Defining data points. High inter-rater reliability requires data
points that are clinically relevant, objective, and easy to identify.
Data points, denitions, and systems training programs should
be developed that optimize clinical relevance and minimize
subjectivity, and in so doing, maximize inter-rater reliability
(categories C and D).
Quality indicators and benchmarking capabilities. Denitions
of quality and benchmark indicators of progress can be dicult
to develop. To advance patient safety, quality indicators and
metrics should be appropriate and actionable (category D).
Outliers. Accurate determination of what constitutes an outlier,
or bad performer, can have a direct eect on patient safety and
access to WLS. Responsible analysis of data and careful denition
of outliers is essential to improve quality of care. e means to
regularly report that data to stakeholders should be determined
(categories C and D). Poor performers, or high outliers, should
be identied, and a mechanism for corrective action developed
(category D).
Novel therapies. Safe introduction of novel technologies and
assessment of the appropriateness of those procedures in
new patient populations are critical for patient safety. Novel
and experimental therapies, new patient populations, and
expanded indications for WLS should be carefully stud-
ied through comprehensive data collection and analysis
(category D). Experimental therapies should be performed
with IRB approval, and data collected and audited by a data
monitoring board to assess clinical eectiveness and patient
safety (category D).
Cost-effectiveness and utility analyses. ere is a critical need
for well-designed prospective studies that evaluate the cost-
eectiveness, cost utility, return on investment, and economic
impact of WLS. Cost utility studies should be carried out to
guide decision-making on the appropriate allocation of resources
(category D).
State coalition. We pro pose t he de velo pment of a s tate wide coali -
tion to collectively gather and share data, and determine quality
indicators and processes of care that could lead to best practices
in WLS (categories C and D).
XI. Endoscopic Interventions
is Task Group’s literature search identied 18 related articles,
all of which were reviewed in detail. All of our recommenda-
tions are based on expert opinion (63).
A. Overview
Endoscopic interventions may provide valuable approaches to
the management of WLS complications, and should be a high
priority for development and investigation. Similarly, endo-
scopic interventions, endoscopically placed devices, and other
minimally invasive, image-guided techniques may also pro-
vide valuable approaches to the primary management of obes-
ity; they too should be a high priority for development and
investigation (category D).
B. Experimental status
Until formally approved by appropriate regulatory bodies,
novel endoscopic interventions and endoscopically placed
devices should only be used in the setting of IRB-approved
clinical trials (category D).
C. Credentials
Treatment with endoscopic and other image-guided interven-
tions should be performed only by clinicians with specialized
training and expertise in their eective and appropriate use
(category D).
D. Clinical application
As is the standard for other medical and surgical therapies for
obesity, endoscopic interventions should be studied and used
only in the context of comprehensive patient evaluation and
treatment that reects the complex medical, nutritional, and
behavioral contributors to obesity.
E. Risks and benefits
As new technologies become available, choice among thera-
peutic options for obesity should be determined by the
comparative risk–benet proles of each modality. ese
considerations should be matched to the specic clinical
characteristics, needs, and treatment goals of each patient
(category D).
F. Data collection
To facilitate tracking of utilization, adverse events, and com-
parative outcomes, all patients who undergo endoscopic and
other minimally invasive interventions for obesity and its com-
plications should be entered into a standard registry. Methods
of tracking should be compatible with those used for patients
undergoing WLS (category D).
G. Coding and reimbursement
As new devices and minimally invasive surgical therapies
for obesity and its complications are approved for clini-
cal use, a new category of provisional billing codes should
be established for these interventions. Reimbursement
for novel therapies for obesity should be determined on
the basis of scientic evidence of their safety and ecacy
(category D).
H. Future research
Randomized, blinded, sham-controlled clinical trials should
be the standard for investigation of the safety and ecacy of
endoscopic interventions for the treatment of obesity and its
complications (category D).

858 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
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intervention and Prevention
ACKNOWLEDGMENTS
This Expert Panel on Weight Loss Surgery report was prepared for the
Betsy Lehman Center for Patient Safety and Medical Error reduction. The
report was commissioned by N.R., Director, Betsy Lehman Center for
Patient Safety and Medical Error Reduction. We thank all Expert Panel and
Task Group members for their important contributions to the report. We
also acknowledge Eileen McHale at the Betsy Lehman Center and Jane
Guilfoyle at the Department of Public Health.
DISCLOSURE
The authors declared no conflict of interest.
© 2009 The Obesity Society
APPENDIX I
To view Task Group Appendices, go to http://www.mass.gov.dph and search
“weight loss surgery.”
Framework and methodology for evidence-based systematic
reviews of literature on weight loss surgery
e Expert Panel was charged with reviewing WLS operations,
identifying potential safety issues, and recommending specic
actions to reduce safety risks and improve patient outcomes. It
used the methodology of evidence-based medicine to system-
atically search available literature on the subject, and devel-
oped a classication system from established models to grade
the quality of evidence.
e systematic review involved a MEDLINE search of
studies published from April 2004 to May 2007. ese
included prior systematic reviews on the subject, ran-
domized controlled trials, prospective cohort studies, cross-
sectional surveys, case reports, and existing guidelines on
WLS procedures from national organizations. e panel
based its grading classication system on those used by the
US Preventive Services Task Force, the American Diabetes
Association, and the National Heart, Lung, and Blood
Institute (NHLBI) Obesity Education Initiative Expert
Panel on the Identication, Evaluation, and Treatment of
Overweight and Obesity in Adults.
Randomized controlled trials (RCTs) are considered the
highest-level evidence of clinical ecacy and safety, but there
are few such studies on WLS operations. e Expert Panel’s
recommendations are based on the best available evidence.
e sections below detail the procedures and methodology
used to develop recommendations.
1. Panel selection
At the request of Massachusetts Public Health Commissioner,
Christine Ferguson, the Betsy Lehman Center for Patient Safety
and Medical Error Reduction (Lehman Center) convened an
Expert Panel to study patient-related safety issues in the state’s
WLS programs and procedures.
e 35-member panel included experienced weight loss
surgeons, nurses, psychologists, and a nutritionist who
counsels patients before and aer the procedures; other
physicians who care for patients with obesity (an anesthe-
siologist, internist, and pediatrician); a hospital patient
safety ocer; a health plan medical director; an ethicist; and
a consumer. e panel delivered a report on its progress to
the Lehman Center and the Department of Public Health in
mid-July 2007.
2. Task groups
We divided the panel into 11 task groups:
• SurgicalCare(53).
• MultidisciplinaryEvaluationandTreatment(54).
• BehavioralandPsychologicalCare(55).
• Pediatric/Adolescent(56).
• AnestheticPerioperativeCareandPainManagement(57).
• NursingPerioperativeCare(58).
• InformedConsentandPatientEducation(59).
• PolicyandAccess(CodingandReimbursement)(60).
• SpecializedFacilitiesandResources(61).
• DataCollection(Registries)/FutureConsiderations(62).
• EndoscopicInterventions(63).
Panel members joined one or two task groups, each with an
assigned coordinator. ey were asked to update reports from
the prior Lehman Center supplement (22).
3. Literature search
A medical librarian, aided by a clinical epidemiologist
with experience in systematic reviews, carried out litera-
ture searches for each task group. Studies were included or
excluded based on a priori criteria, i.e., written protocols that
dened research questions and search parameters, including
patient characteristics, study designs, surgical interventions,
and outcomes.
MEDLINE searches were limited to English-language stud-
ies published from April 2004 to May 2007. (Some groups
searched other databases or focused on more recent litera-
ture.) References in retrieved articles, guidelines from national
organizations, and systematic reviews from the Cochrane
Library were also examined. Task group coordinators, with
input from the clinical epidemiologist, screened all titles and
abstracts; they selected only those most relevant to the review
questions.
4. Data extraction and tabulation
e panel developed a data extraction sheet and used it to cull
detailed information from selected full articles aer review.
Key data included study design; size; patient demographics;
follow-up time; dropout rate; description of the intervention;
outcome measures, including adverse eects; and main con-
clusions. Information was tabulated in a format suitable for
publication.
5. Synthesis of evidence
We primarily used narrative (or qualitative) summaries for
the literature review because study designs and outcomes
were too dissimilar to combine results in a formal meta-
analysis. All selected studies were critically assessed for
internal validity or methodological rigor. They were ranked
according to levels of evidence based on study design

OBESITY | VOLUME 17 NUMBER 5 | MAY 2009 859
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intervention and Prevention
(Ta bl e 1 ). For example, well-conducted RCTs (category
A) provide the strongest evidence on the effectiveness of
a surgical weight loss procedure. We used expert opinion
(category D) (including clinical experience, the opinions
of respected authorities, reports from expert committees,
and consensus of the Expert Panel) in conjunction with
evidence from RCTs or observational studies to develop
recommendations.
6. Developing evidence-based recommendations
Each task group prepared a critical summary of the literature
(Ta bl e 2 ) and developed evidence-based recommendations
on its assigned topic; these were presented to the full group
for comments. is Executive Report of key recommendations
from all groups was approved by the Expert Panel at its last
meeting on 19 July 2007.
Literature search process
Literature review process
REFERENCES FOR THE FRAMEWORK
1. Oxford Centre for Evidence-based Medicine Levels. <http://www.musckids.
com/~annibald/ebm/oxford_levels_of_evidence.pdf> (2001). Accessed 23
August 2007.
2. Clinical Guidelines on the Identification, Evaluation, and Treatment,
of Overweight and Obesity in Adults. The Evidence Report: National
Institutes of Health. National Heart, Lung, and Blood Institute; 1998.
No. 98-4083.
3. Introduction. Diabetes Care 2004;27:S1–S2.
4. Agency for Healthcare Research and Quality. Current Methods of the
US Preventive Services Task Force: a Review of the Process.
<http://www.ahrq.gov/clinic/ajpmsuppl/harris1.htm>. Accessed 24
August 2007.
5. Harris RP, Helfand M, Woolf SH et al. Current methods of the US
Preventive Services Task Force: a review of the process. Am J Prev Med
2001;20(3 Suppl):21–35.
6. Naylor CD, Guyatt GH. Users’ guides to the medical literature. X.
How to use an article reporting variations in the outcomes of health
services. The Evidence-Based Medicine Working Group. JAMA
1996;275:554–558.
7. Barton MB, Miller T, Wolff T et al. How to read the new recommendations
statement: methods update for the U.S. Preventive Services Task Force.
Ann Intern Med 2007;147:123–127.
8. Guirguis-Blake J, Calonge N, Miller T et al. Current processes of the U.S.
Preventive Services Task Force: refining evidence-based recommendation
development. Ann Intern Med 2007;147:117–122.
Define research questions
Determine literature search strategy
Search MEDLINE database
Print titles and abstracts of identified studies
Screen abstracts for relevant studies
Identify additional studies by examining references from relevant
studies
Define research questions and literature search parameters
Search for studies that meet eligibility criteria
Abstract data from identified studies and assess study quality
Assemble a complete database from the studies
Conduct narrative or quantitative reviews
Prepare a critical summary of the literature review and make
evidence-based recommendations
Table 2 Inclusion/exclusion criteria—example used in
literature search, laparoscopic vs. open gastric bypass
surgery
Inclusion criteria
English language
Published between April 2004 and May 2007
RCTs or controlled trials without randomization, cohort studies
Surgical procedures: gastric bypass, Roux-en-Y gastric bypass,
open vs. laparoscopic
Minimum follow-up: 6 months
Outcomes: change in body weight, excess weight, and BMI;
mortality and major morbidity
Exclusion criteria
Selection criteria not indicated
Small sample size (n < 10 for each intervention)
Dropout rate >50%
Table 1 Grading system for evidence-based recommen-
dations
Category A Evidence obtained from at least one well-conducted
randomized clinical trial or a systematic review of all
relevant RCTs
Category B Evidence from well-conducted prospective
cohort studies, registry or meta-analysis of cohort
studies, or population-based case–control
studies
Category C Evidence obtained from uncontrolled or poorly
controlled clinical trials, or retrospective case–control
analyses, cross-sectional studies, case series, or
case reports
Category D Evidence consisting of opinion from expert panels
or the clinical experience of acknowledged
authorities
Adapted from the criteria used by the US Preventive Services Task Force (USPSTF)
and the American Diabetes Association.

860 VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
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intervention and Prevention
APPENDIX II
Task Groups for Lehman Center Report on Weight Loss
Surgery
Surgical Care
Coordinator
John Kelly, M.D., University of Massachusetts Memorial
Medical Center
Co-chair
Scott Shikora, M.D., Tus-New England Medical Center
George L. Blackburn, M.D., Ph.D., Beth Israel Deaconess
Medical Center
Frederick Buckley, M.D., North Shore Medical Center
Matthew Hutter, M.D., Massachusetts General Hospital
Daniel B. Jones, M.D., M.S., Beth Israel Deaconess Medical
Center
David Lautz, M.D., Brigham and Women’s Hospital
Andrew B. Lederman, M.D., Berkshire Medical Center
Malcolm K. Robinson, M.D., Brigham and Women’s Hospital
John Romanelli, M.D., F.A.C.S., Baystate Medical Center
Multidisciplinary Evaluation and Treatment
Coordinator
Caroline Apovian, M.D., Boston Medical Center
Co-chair
Susan Cummings, M.S., R.D., L.D.N., Massachusetts General
Hospital
Wendy Anderson, R.D., L.D.N., Boston Medical Center
Loren J. Borud, M.D., Beth Israel Deaconess Medical Center
Kelly Moore, R.D., L.D.N., Beth Israel Deaconess Medical
Center
Kristina Day, R.D., L.D.N., Beth Israel Deaconess Medical
Center
Edward Hatchigian, M.D., Beth Israel Deaconess Medical
Center
Barbara Hodges. R.D., M.P.H., L.D.N., Brigham and Women’s
Hospital
Mary Elizabeth Patti, M.D., Joslin Diabetes Center
Frank Perna, Ph.D., National Cancer Institute
Mark Pettus, M.D., Berkshire Medical Center
Daniel Rooks, Ph.D., Beth Israel Deaconess Medical Center
Edward Saltzman, M.D., Tus-New England Medical Center
June Skoropowski, R.D., L.D.N., Beth Israel Deaconess
Medical Center
Michael B. Tantillo, M.D., Private Practice, Brookline, MA
Phyllis omason, M.S., R.D., L.D.N., Faulkner Hospital
Behavioral and Psychological Care
Coordinator
Isaac Greenberg, Ph.D., Tus-New England Medical Center
Co-chair
Stephanie Sogg, Ph.D., Massachusetts General Hospital
Frank Perna, Ph.D., National Cancer Institute
Pediatric/Adolescent
Coordinator
Janey S.A. Pratt, M.D., Massachusetts General Hospital
Co-chair
Carine Lenders, M.D., M.S., Boston Medical Center
Emily Dionne, Massachusetts General Hospital
Alison G. Hoppin, M.D., Massachusetts General Hospital
George Hsu, M.D., Tus-New England Medical Center
omas Inge, M.D., Ph.D., Cincinnati Children’s Hospital
Medical Center
David Lawlor, M.D., Massachusetts General Hospital
Margaret Marino, Ph.D., Boston Medical Center
Alan Meyers, M.D., Boston Medical Center
Jennifer Rosenblum, M.D., Massachusetts General Hospital
Vivian Sanchez, M.D., Beth Israel Deaconess Medical
Center
Anesthetic Perioperative Care and Pain Management
Coordinator
Roman Schumann, M.D., Tus-New England Medical Center
Co-chair
Stephanie Jones, M.D., Beth Israel Deaconess Medical Center
Daniel B. Carr, M.D. (Advisor), Tus-New England Medical
Center
Kathy Connor, M.D., Newton-Wellesley Hospital
Bronwyn Cooper, M.D., University of Massachusetts
Memorial Medical Center
Alan M. Harvey, M.D., M.B.A., Brigham and Women’s
Hospital
Michael Kaufman, M.D., Lahey Clinic
Scott Kelley, M.D., Brigham and Women’s Hospital
Vilma E. Ortiz, M.D., Massachusetts General Hospital
Mark Vanden Bosch, M.D., Berkshire Medical Center
Nursing Perioperative Care
Coordinator
Ann Mulligan, R.N., Newton-Wellesley Hospital
Co-chair
Anne McNamara, R.N., Beth Israel Deaconess Medical
Center
Hannah Boulton, R.N., M.S.N., South Shore Hospital
Ann Mullen, R.N., B.S.N., Newton-Wellesley Hospital
Carol Raiano, R.N., C.C.R.N., Newton-Wellesley Hospital
Linda Trainor, R.N., B.S.N., Beth Israel Deaconess Medical
Center
Informed Consent and Patient Education
Coordinator
Christina C. Wee, M.D., M.P.H. Beth Israel Deaconess
Medical Center
Co-chair
Michael Paasche-Orlow, M.D., M.P.H. Boston University
School of Medicine
Robert Fanelli, M.D., Berkshire Medical Center
Janey Pratt, M.D., Massachusetts General Hospital
Patricia Samour, M.M.Sc., R.D., L.D.N., Beth Israel Deaconess
Medical Center
Linda Trainor, R.N., B.S.N., Beth Israel Deaconess Medical
Center

OBESITY | VOLUME 17 NUMBER 5 | MAY 2009 861
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Policy and Access (Coding and Reimbursement)
Coordinator
Scott Shikora, M.D., Tus-New England Medical Center
Co-chair
Rayford Kruger M.D., F.A.C.S., Tobey Hospital
George L. Blackburn, M.D., Ph.D., Beth Israel Deaconess
Medical Center
John A. Fallon, M.D., M.B.A., F.A.C.P., Blue Cross Blue
Shield of Massachusetts
Alan M. Harvey, M.D., M.B.A., Mercy Medical Center/
Catholic Health East
Elvira Johnson, M.S., R.D., C.D.E., L.D.N., Massachusetts
Dietetics Association
Lee Kaplan, M.D., Ph.D., Massachusetts General Hospital
David Lautz, M.D., Brigham and Women’s Hospital
Robert LoNigro, M.D., M.S., Tus Health Plan
Edward C. Mun, M.D., Brigham and Women’s Hospital
Malcolm K. Robinson, M.D., Brigham and Women’s Hospital
Roger L. Snow, M.D., M.P.H., University of Massachusetts
Medical School and MassHealth
Lee Steingisser, M.D., Blue Cross Blue Shield of
Massachusetts
James Sabin, M.D., Harvard Pilgrim Health Care
Stancel M. Riley Jr., M.D., Massachusetts Board of
Registration in Medicine
Specialized Facilities and Resources
Coordinator
David Lautz, M.D., Brigham and Women’s Hospital
Co-chair
Michael E. Jiser, M.D., Saints Memorial Medical Center
Robert J. Cella, M.D., Berkshire Medical Center
John Kelly, M.D., University of Massachusetts Medical Center
Sheila K. Partridge, M.D., Newton-Wellesley Hospital
John Romanelli, M.D., F.A.C.S., Baystate Medical Center
John P. Ryan, R.N., Beth Israel Deaconess Medical Center
Scott Shikora, M.D., Tus-New England Medical Center
Data Collection (Registries)/Future Considerations
Coordinator
Matthew M. Hutter, M.D., Massachusetts General Hospital
Co-Chair
Daniel B. Jones, M.D., M.S., Beth Israel Deaconess Medical
Center
Robert J. Cella, M.D., Berkshire Medical Center
Stancel M. Riley Jr., M.D., Massachusetts Board of
Registration in Medicine
Benjamin Schneider, M.D., Beth Israel Deaconess Medical
Center
Roger L. Snow, M.D., M.P.H., University of Massachusetts
Medical School and MassHealth
Kerri Clancy, R.N., Brigham and Women’s Hospital
Endoscopic Interventions
Coordinator
Lee Kaplan, M.D., Ph.D., Massachusetts General Hospital
Co-chair
Christopher C. ompson, M.D., M.H.E.S., Brigham and
Women’s Hospital
William R. Brugge, M.D., Massachusetts General Hospital
Ram Chuttani, M.D., Beth Israel Deaconess Medical Center
David Desilets, M.D., Baystate Medical Center
James C. Ellsmere, M.D., Beth Israel Deaconess Medical
Center
David W. Rattner, M.D., Massachusetts General Hospital
Michael Tarno, M.D., Tus-New England Medical Center
SUPPLEMENTARY MATERIAL
To review task group appendices, go to www.mass.gov/dph and search
“Weight Loss Surgery.”
DISCLOSURE
The authors declared no conflict of interest.
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