Rapid Evidence Review of Bariatric Surgery in Super Obesity (BMI ≥ 50 kg/m2)
Rapid Evidence Review of Bariatric Surgery in Super Obesity (BMI ≥ 50 kg/m2)
Kim Peterson 0
Johanna Anderson 0
Erin Boundy 0
Lauren Ferguson 0
Katherine Erickson 0
0 Evidence-based Synthesis Program (ESP) Coordinating Center, VA Portland Health Care System , Portland, OR , USA
BACKGROUND: Despite accumulating evidence of the important health benefits of bariatric surgery in morbidly obese patients in general, bariatric surgery outcomes are less clear in higher-risk, high-priority populations of patients with BMI ≥ 50 kg/m2. To help the Department of Veterans Affairs (VA) Health Services Research & Development Service (HSR&D) develop a research agenda, we conducted a rapid evidence review to better understand bariatric surgery outcomes in adults with BMI ≥ 50 kg/m2. METHODS: We searched MEDLINE®, the Cochrane Database of Systematic Reviews, the Cochrane Central Registry of Controlled Trials, and ClinicalTrials.gov through June 2016. We included trials and observational studies. We used pre-specified criteria to select studies, abstract data, and rate internal validity and strength of the evidence (PROSPERO registration number CRD42015025348). All decisions were completed by one reviewer and checked by another. RESULTS: Among 1892 citations, we included 23 studies in this rapid review. Compared with usual care, one large retrospective VA study provided limited evidence that bariatric surgery can lead to increased mortality in the first year, but decreased mortality long-term among super obese veterans. Studies that compared different bariatric surgical approaches suggested some differences in weight loss and complications. Laparoscopic gastric bypass generally resulted in greater short-term proportion of excess weight loss than did other procedures. Duodenal switch led to greater long-term weight loss than did gastric bypass, but with more complications. CONCLUSIONS: The published literature that separates the super obese is insufficient for determining the precise balance of benefits and harms of bariatric surgery in this high-risk subgroup. Future studies should evaluate a more complete set of key outcomes with longer follow-up in larger samples of more broadly representative adults.
bariatric surgery; super obese; systematic review
The growth rate of BMI ≥ 50 kg/m2, referred to as super
obesity, rose more rapidly in the USA between 1986 and
2010 compared to prevalence of BMI categories < 50 kg/m2.
Upon initiation of this review, we developed a protocol, with
input from experts, and registered it in the public PROSPERO
database (CRD42015025348). Additionally, our full-evidence
report provides complete details of our methods and data for
this review, including search strategy, full key questions and
inclusion criteria, data abstraction, and risk of bias and
strength of evidence ratings.20 We reported this review
following the Preferred Reporting Items for Systematic Reviews and
Meta-Analyses (PRISMA) guidelines.21
The ESP Coordinating Center investigators and
representatives of the SOTA committee worked together to identify the
population, intervention, comparator, outcome, timing,
setting, and study design characteristics of interest. These
eligibility criteria are presented in Table 1.
To identify articles relevant to the key questions, our
research librarian searched MEDLINE®, the Cochrane
Central Registry of Controlled Trials, PsycINFO, and
ClinicalTrials.gov through June 2016 using various terms
for bariatric surgery and obesity. Due to the large volume
of well-conducted systematic reviews, we relied on
reference lists for studies published through 2012 and
conducted new searches for studies published from 2013 onward.
Additional citations were identified from hand-searching
reference lists and consultation with content experts. We
limited the search to articles involving human subjects
available in the English language.
Two reviewers selected studies based on the eligibility
criteria described above. Titles and abstracts and full-text
Population: Our primary focus is adult patients with BMI ≥50 kg/m2. To
maximize applicability, we included only studies that focused
exclusively on the super obese or that included a subgroup analysis of
super obese. We did not include studies that had patients with mean or
median BMI ≥ 50 kg/m2 but that encompassed a broader range of
Intervention: Bariatric surgery interventions.
Comparator: Non-surgical weight loss interventions (including lifestyle,
dietary changes, medications) and different bariatric surgical procedures,
Outcomes: Primary outcomes of interest include long-term (defined as ≥
5 years, based on recent NIH Funding Opportunity Announcement
#PAR-14-262 for long-term outcomes of bariatric surgery using large
data sets) weight loss (% excess weight lost, BMI change), mortality,
remission/resolution of physical and mental health conditions,
complications, and cost. Secondary outcomes include barriers to obtaining
bariatric surgery (patient attitudes, provider attitudes, access, etc.) and
short-term (<5 years) weight loss (% excess weight lost, BMI change),
mortality, remission/resolution of physical and mental health conditions,
complications, and cost.
Timing: No restrictions
Setting: Within and outside VA. We will prioritize VA studies, but will
look outside of the VA to fill gaps in VA evidence, including
Study design: Using a best evidence approach, we will prioritize
evidence from systematic reviews and multi-site comparative studies
that adequately controlled for potential patient-, provider-, and
systemlevel confounding factors. Inferior study designs (e.g., single-site,
inadequate control for confounding, non-comparative) will be accepted
only to fill gaps in higher-level evidence.
articles were first reviewed by one investigator and then
checked by another. All disagreements were resolved by
Data Abstraction and Quality Assessment
We abstracted data on each of the eligibility criteria items
(Table 1). We assessed the internal validity of all studies
using predefined criteria. For randomized controlled trials,
we used Cochrane’s Risk of Bias Tool.22 For
observational studies we assessed selection, performance, attrition,
detection, and reporting biases and assigned overall
ratings of high, medium, and low risk of bias.23 For
systematic reviews we used the AMSTAR tool.24 We used a
standardized form to abstract data from all included
studies on key study and patient characteristics and results. All
data abstraction and internal validity ratings were
completed by one reviewer and then checked by another. All
disagreements were resolved by consensus.
We graded the overall strength of the evidence for each
outcome as high, moderate, low, or insufficient based on study
limitations, consistency, directness, precision, and reporting
bias, according to the AHRQ Methods Guide for Comparative
Effectiveness Reviews.25 We did not perform meta-analyses,
due the small number of studies and heterogeneity in
outcomes and comparison evaluated. Instead, we synthesized
the evidence qualitatively by grouping studies by similarity
in bariatric surgery comparison.
Among the wide variety of weight loss metrics
reported, we preferred percent baseline weight loss per the 2013
analysis by Hatoum and Kaplan, which showed it was
least influenced by variation in preoperative BMI.26 When
percent baseline weight loss was not reported, we
evaluated proportion excess body weight loss (%EWL). As
Hatoum and Kaplan found that both %EWL and change
in BMI were similarly sensitive to preoperative BMI (r =
−0.52 and r = 0.56, respectively), we selected %EWL as
the secondary weight loss metric, as it was most
commonly reported and allowed for greater comparison across
studies. We used Microsoft Excel 2010 (Microsoft Corp.,
Redmond, WA) to calculate descriptive statistics and
generate a graph for observational study risk of bias
The literature flow diagram (Fig. 1) summarizes the results of
search and study selection processes. Bibliographic database
searches resulted in 1892 potentially relevant articles. Of these,
we included two systematic reviews, two randomized controlled
trials (RCTs; in five publications), and 19 retrospective cohort
studies. The previous Cochrane review focused only on RCTs
and found super obesity data insufficient for analysis.6 Searches
of ClinicalTrials.gov identified one unpublished study in patients
with BMI > 50 kg/m2 that compared long-limb to
very-longlimb gastric bypass (NCT00868543).
Overview of Study Characteristics
Table 2 displays the characteristics of the included primary
studies. For the comparison of bariatric surgery to non-surgical
treatment, we identified one subgroup analysis from a VA
observational study.27 For the comparison of different bariatric
surgery types, data were available from one systematic
review,28 two RCTs,29,30 and 18 retrospective cohorts.31–48
The majority of studies involved mostly women aged 35 to
We rated the systematic review as fair quality,28 one RCT
(in four studies) as low risk of bias,29,49–51 and one RCT as
unclear risk of bias.30 Figure 2 summarizes the main risk of
bias indicators of the 19 retrospective cohorts. Their overall
risk of bias was medium in 47% and high in 53%. Frequent
methodological limitations were unbalanced comparison
groups at baseline and lack of control for confounders or
cointerventions. Risk of reporting bias was generally low based
on comparing the study reports to outcomes pre-specified in
the methods, but protocols typically were not available.
Comparison of Bariatric Surgery to Non
No studies evaluated the comparative effectiveness of bariatric
surgery versus any specific, active non-surgical treatment in
super obese adults. One retrospective study used
administrative data to compare long-term survival in veterans who
underwent bariatric surgery between 2000–2011 to veterans
matched for sex, diabetes diagnosis, race, VA region, BMI,
and age.27 The control group was described as representing
usual care, but there was no information about what care was
provided or their eligibility for bariatric surgery. This study
conducted post hoc analyses to determine whether the
relationship between surgery and mortality might differ in the
Overall, 74% of the veterans in this study were men, and
their mean age was 52 years. The surgical procedure types
were primarily open (53%) or laparoscopic (21%) Roux-en-Y
gastric bypass. Rates of diet, exercise, lifestyle interventions,
or weight loss medication use were not reported for either
group. However, the authors reported that participation in the
VA’s national MOVE!® weight management program was
mandatory for bariatric surgery candidates starting in 2006,
and it is likely that many control group patients also
participated, as it is VA policy to refer all severely obese patients to
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Compared to usual care, post hoc analyses of the super
obese subgroup provided low-strength evidence that risk
of mortality associated with bariatric surgery was higher at
1 year (4.93% vs. 2.77%; aHR 1.57; 95% CI, 1.08–2.76;
N = 2860), then lower from 1 year to 5 years (5.48% vs.
11.4%; aHR 0.46, 95% CI, 0.33–0.64; N = 2723) and
from 5 years to 14 years (9.5% vs. 17.5%; aHR 0.45,
95% CI, 0.34–0.60; N = 2054). Compared to the overall
study population (mean BMI = 47 kg/m2), mortality rates
for the super obese subgroup were numerically higher
across all time periods, and the increased risk in the first
year reached statistical significance.
Although matching for some known confounders was done
well, the main methodological limitations of the study overall
were that (1) there was no information about the care provided
to the controls, and (2) information from administrative data
about many key covariates was either unavailable or missing,
including severity of comorbid conditions and smoking. We
cannot rule out the possibility that the greater mortality risk
factors characteristic of surgical ineligibility were
overrepresented in the non-surgery group. Additionally, this study does
not fully address the balance of benefits and harms of surgery,
as it did not evaluate other outcomes of great interest,
including comorbid disease remission, complications, and quality of
Comparison of Different Bariatric Surgery Types
We identified 20 primary studies29–51 and one systematic
review28 which compared various types of bariatric surgery
among super obese patients. Duodenal switch (DS) versus
laparoscopic Roux-en-Y gastric bypass (LRYGB) is the only
comparison that has outcome data with over 5 years of
followup. For follow-up over 5 years, an RCT (reported in four
publications)29,49–51 provided low-strength evidence that,
compared to LRYGB, DS achieves better weight control (%
patients with BMI > 40 kg/m2: DS = 14% vs. LRYGB =
55.3%, P = 0.001) and has comparable diabetes remission
(100% vs. 80%; P = 0.45) and mortality (3% vs. 0%; P =
0.48), but higher risk of hospital admissions (59% vs. 29%; P
= 0.02) and surgeries related to the initial procedure (45% vs.
10%; P = 0.002). Table 3 summarizes best evidence for each
surgical comparison for up to 5 years of follow-up. These
studies provide low-strength evidence that laparoscopic
gastric bypass generally resulted in greater short-term proportion
of excess weight loss (%EWL) than did other procedures,
particularly when banding versus non-banding was used and
when the bypass was proximal versus distal.
To our knowledge, this is the first evidence review that has
focused exclusively on adults with BMI ≥ 50 kg/m2 across a
wide variety of bariatric surgery types. This rapid evidence
review found the published literature that separately evaluates
adults with BMI ≥ 50 kg/m2 to be insufficient for determining
the precise balance of benefits and harms of bariatric surgery
compared to non-surgical treatment (i.e., lifestyle, dietary
changes, pharmacotherapy) in this subpopulation. This
paucity of research in individuals with BMI ≥ 50 kg/m2 is
important, because it may be contributing to under- or overuse of
bariatric surgery in this unique population.
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One large retrospective VA study provided limited evidence
that, compared with usual care, bariatric surgery could lead to
increased mortality in the first year but reduced mortality over
the long term among super obese veterans. However, the care
provided to the control group, whether non-surgical or no
treatment, was not well-defined. Also, information about
many key issues was missing (e.g., smoking, severity of
comorbidities), and the study did not evaluate a complete set
of key outcomes including weight loss, obesity-related disease
remission, complications, and cost.
Studies comparing different bariatric surgical approaches in
people with BMI ≥ 50 kg/m2 provide low-strength evidence of
some differences in weight loss and complications.
Laparoscopic gastric bypass generally resulted in a greater short-term
proportion of excess weight loss (%EWL) than did other
procedures, particularly when banding versus non-banding
was used and when the bypass was proximal versus distal.
The exception was that duodenal switch led to greater
longterm weight loss than did gastric bypass, but this was at the
expense of more complications for duodenal switch. However,
the applicability of these findings may be limited primarily to
women in their mid-30s to 40s, and information was missing
on diabetes, mental illness, and other important comorbidities.
The potential limitations of this rapid evidence review are
related to the modifications we made to standard systematic
review methodology in order to meet a constrained timeline of
3 months. With 100 rapid reviews published between 1997
and 2013, they have become an increasingly common form of
evidence synthesis used to inform more urgent needs of health
care decision-makers.52 Surveys of rapid evidence review
endusers found that they were willing to accept certain
methodological shortcuts in order to increase reviewer efficiency,53 and
that availability of rapid reviews increased their uptake of
evidence to inform time-sensitive system-level
decisionmaking.54 However, there is no consensus yet on what
represents best practice for rapid reviews. A scoping review of rapid
reviews found that shortcut approaches varied widely across
all steps of the review process and were applied
inconsistently.52 Concerns have been expressed about methodological
shortcuts potentially increasing the risk of bias in rapid
reviews, leading to suggestions for future research comparing
findings of standard and rapid reviews.52,53,55,56 The two main
methodological limitations of this evidence brief are its scope
and our abbreviated search methods. Regarding scope,
because of our abbreviated time frame, we limited our focus to
the SOTA committee’s highest-priority outcomes of weight
loss, mortality, obesity-related disease remission,
complications, and cost. Therefore, this review does not address
additional outcomes that can also have important clinical
implications (e.g., surgical time, conversion to open procedure,
quality of life, functional capacity, minor adverse effects). Also,
given our time constraint, to obtain the most precise estimates
of outcomes in the super obese, we focused on studies that
included only super obese patients or that separated out the
super obese subgroup. However, given more time, further
assessment of the very large body of existing evidence of
broader patient populations with BMI > 35 kg/m2 could
provide additional information about patients with BMI ≥ 50. As
many studies that enrolled patients with BMI > 35 kg/m2
included a subgroup of patients with BMI ≥ 50 kg/m2,
individual patient data meta-analysis could be used to evaluate
patients with BMI ≥ 50 kg/m2. Regarding our search methods,
although we attempted to use an exhaustive list of search
terms, the lack of a standard taxonomy for describing super
obesity in the literature made searching for this topic
somewhat difficult. Also, for studies published through 2012, we
relied on the reference lists of previous well-conducted
systematic reviews, and only conducted new searches for studies
published from 2013 onward. For these two reasons, our
search may have missed relevant studies. However, extensive
peer review by multiple bariatric surgery experts did not
uncover any additional studies.
This rapid evidence brief identified several key gaps in the
evidence base in adults with BMI ≥ 50 kg/m2 that helped the
VA HSR&D realign its obesity treatment future research
priorities57 and which may be actionable for other research
efforts. First, for studies comparing different bariatric surgery
treatments in adults with BMI ≥ 50 kg/m2, half were from
nonUS settings. Differences in health care systems and standards
of care in these studies may have low applicability to US
health care systems (e.g., accreditation, level and type of
multidisciplinary care, pre-procedure
preparation/postprocedure support). Next, the majority of studies in adults with
BMI ≥ 50 kg/m2 comprised primarily females in their mid-30s
to 40s, and lacked information about other key patient
characteristics (e.g., smoking, presence and severity of medical
and mental health comorbidities), preoperative care and
requirements, care in quaternary systems of care, and adherence
to post-procedure recommendations, which could have
influenced their outcome. These gaps greatly limit the applicability
of their findings. To broaden the applicability of evidence in
adults with BMI ≥ 50 kg/m2 and to help identify predictors of
best outcomes, future research should better report and
evaluate the role of a broader range of key covariates.
Lastly, although the majority of studies consistently
reported short-term weight loss outcomes, reporting on
complications was limited and inconsistent, and studies generally
lacked long-term follow-up and neglected important
obesityrelated disease remission outcomes. To better determine the
precise balance of benefits and harms of bariatric surgery in
people with BMI ≥ 50 kg/m2, future research needs to measure
a more complete set of long-term outcomes. For weight loss
outcome assessment, in 2013 Hatoum and Kaplan
recommended adoption of percentage of baseline weight loss as
the preferred weight loss measure, because it was the least
influenced by preoperative BMI.26 However, studies used a
wide variety of methods, including BMI loss, weight loss,
proportion of excess weight loss, proportion of patients with
a BMI over a certain threshold, and proportion of patients that
failed to lose 50% or more of their excess weight, and many
studies did not report measures of variance. There is also a lack
of standardized definitions for surgical complication
outcomes. This heterogeneity makes it difficult to combine and
compare findings across studies. The bariatric surgery field in
general would benefit from work toward standardization of
outcome definitions.11,58 Further, we found no defined goals
for the magnitude of weight loss that is required for a
meaningful benefit in longevity and resolution of obesity-related
comorbidity. Philosophically, it may be ideal to strive to
reduce BMI to a level that would eliminate eligibility for
bariatric surgery.41 But as this is more difficult to achieve in super
obese patients, it could be clinically useful to document what
level of weight loss is really necessary to achieve the greater
overall goals. As the current evidence is very limited in the
super obese, we recommended that the HSR&D SOTA
committee, in setting their research agenda, prioritize confirmation
of the subgroup findings from Arterburn et al. about the
comparison of bariatric surgery to non-surgical treatment in
the super obese.27 Answering questions about the long-term
comparative effectiveness of surgical and non-surgical weight
loss interventions will help to determine the relevance of
questions about choice of surgical approach.
In conclusion, our rapid evidence review found that, in
adults with BMI ≥ 50 kg/m , there is limited evidence that,
compared to usual care, bariatric surgery can increase
mortality in the first year, but decrease longer-term mortality. Despite
their potentially greater health care challenges, existing
evidence suggests that people with BMI ≥ 50 kg/m2 may benefit
from bariatric surgery. However, to more precisely determine
the balance of benefits and harms of bariatric surgery in this
high-risk subgroup, future research should (1) evaluate and
better characterize larger samples of more broadly
representative adults and (2) better define and assess a more complete set
of key outcomes with longer follow-up.
Acknowledgements: We would like to thank Linda Humphrey, MD,
FACP, for providing clinical expertise; Julia Haskin, MA, for editorial
support; and Robin Paynter, MLIS, for searching support.
Corresponding Author: Kim Peterson, MS; Evidence-based
Synthesis Program (ESP) Coordinating CenterVA Portland Health Care
System, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71,
Portland, OR 97239, USA (e-mail: ).
Compliance with Ethical Standards:
Funders: This material is based upon work supported by the
Department of Veterans Affairs, Veterans Health Administration, Office of
Research and Development, Quality Enhancement Research Initiative
(QUERI), Evidence-Based Synthesis Program (ESP).
Prior Presentations: None.
Conflict of Interest: The authors declare that they do not have a
conflicts of interest.
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