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1
Effects of Bariatric
surgery on
psychological
outcomes: A
systematic review of
randomized controlled
trials
16th March
2015
Name: Tumi Sotire
Project supervisors: Dr Mark Tarrant,
Dr Sammyh Khan and Stacey Windeat
2
Table of Contents
Declaration Page ................................................................................................. 3
List of Tables ........................................................................................................ 4
List of Abbreviations ........................................................................................... 24
Lay Abstract ....................................................................................................... 25
Abstract .............................................................................................................. 26
Background ........................................................................................................ 27
Methods ............................................................................................................. 32
Discussion .......................................................................................................... 42
References ......................................................................................................... 49
Appendix 1 ......................................................................................................... 55
Appendix 2 ......................................................................................................... 72
Appendix 3 ......................................................................................................... 75
Appendix 4 ......................................................................................................... 79
Appendix 5 ......................................................................................................... 81
Appendix 6 ......................................................................................................... 82
Appendix 7 ......................................................................................................... 84
Appendix 8 ......................................................................................................... 87
Appendix 9 ......................................................................................................... 88
Appendix 10 ....................................................................................................... 90
Appendix 11 ....................................................................................................... 92
3
Declaration Page
I hereby certify that this report, which is 5805 words in length, has been
written by me, that it is the record of work for my Expanding Horizons 4
project Dissertation
Tumi Sotire 16/3/15
Signature Date
4
List of Tables
Table 1
Types of bariatric surgery
Restrictive Surgery Malabsorptive Bariatric
Surgery
Combination of Restrictive
surgery and Malabsorptive
surgery
Adjustable Gastric
Banding
Biliopancreatic Diversion
with Duodenal Switch
Gastric Bypass Roux – en-Y
Sleeve Gastrectomy
Vertically Banded
Gastroplasty
Table 2
PICO of systematic review
Population Intervention Comparator Outcome
Obese adults
aged over 18
Bariatric
surgery
Any
comparator
Psychological
outcomes
5
Table 3
Inclusion and Exclusion criteria
Inclusion Criteria: Exclusion criteria:
Study Design
If the study must is an RCT If the study is not a RCT
Population
If participants in the study were obese BMI
≥30
If participants in the study were not obese
BMI ˂ 30
If participants must be human If non-human animal study
If adults participants aged over 18 years If participants aged under the age of 18
Intervention
If received bariatric surgery of any type If participants did not receive bariatric
surgery of any type
Comparator
If the study had any type of comparator, for
example, no surgery, other type of surgery or
other intervention
If study had no comparator
Outcomes
If Psychological outcomes were reported
such as depression anxiety and Quality of life
If psychological outcomes were not reported
Language
If the study was written in English If studies were not written in English
Study Presentation
If the study was presented as primary
research with full text articles
If the study was presented as secondary
research or primary research without a full
text articles
6
Table 4
Data extraction
Study Characteristics Psychological Outcome Data
Author Author
Year Year
BMI Range Psychological Outcome measure
Number of Participants Range
Age Pre-treatment Mean (Intervention)
Percentage of males Pre–treatment standard deviation
(intervention)
Intervention (Number of participants) Pre-treatment Mean (Control)
Comparator (Number of participants) Pre–treatment standard deviation (control)
Psychological intervention carried out Post - treatment Mean (intervention)
Length of follow up Post-treatment standard deviation
(Intervention)
Post-treatment Mean (Control)
Post–treatment standard deviation
(control)
Difference in mean score (intervention)
Difference in mean score (control)
Difference mean scores (intervention) as a
percentage
Difference in mean score (control) as a
percentage
Statistical significant difference between
the groups (p- values)
Statistical significant difference between
pre-treatment and post treatment for both
the intervention and control (p - values)
7
Table 5
Characteristics of included studies
Author
Year
BMI
Range
Kg/m2
Number of
participants
Age
Years
% of
Males
Intervention (N=)
Comparator
(N=)
Length
of
follow
up
Halperin 2014 36.25 43 52 Roux-en-Y
Gastric Bypass
(22)
Why WAIT
Medication,
Dietary (21)
1 year
Lee 2005 44.3 80 40 31 % Roux-en-Y
Gastric Bypass
(40)
Laparoscopic
Mini-Gastric
Bypass (60)
2 years
van
Mastrigt
2006 46.6 100 38 20% Vertical Banded
Gastroplasty (50)
LAP Band (50) 1 year
Nguyen 2001 48 155 45 27% Laparoscopic
Gastric Bypass
(79)
Open
Gastric Bypass
(76)
10
months
Nguyen 2009 46.5 197 44 24 % Laparoscopic
Gastric Bypass
(111)
Laparoscopic
Adjustable
Gastric Banding
(86)
4 years
O’Brien 2013 33.6 80 53 23.5 % Laparoscopic
Adjustable
Gastric Banding
(40)
Intensive
Medical Weight
Loss
Non-surgical
(40)
10
years
O’Brien 2005 37.8 202 40 11% Laparoscopic
Adjustable
Gastric Banding
Perigastric
pathway (101)
Laparoscopic
Adjustable
Gastric
Banding Pars
Flaccida (101)
2 years
O’Brien 2006 33.6 80 41 24% Laparoscopic
Adjustable
Gastric Banding
(40)
Non-surgical
intensive
medical
programme (40)
2 years
Peterli 2013 43.9 217 43 28 % Laparoscopic
Sleeve
Gastrectomy
(107)
Roux-en-Y
gastric bypass
(110)
1 year
Ponce 2013 35.2 30 42 10 % Intra Gastric Dual
Balloon (21)
Non-Surgical
Intervention (9)
9
months
Puzziferri 2006 48.5 116 49 8% Laparoscopic
Gastric Bypass
Open Gastric
Bypass (57)
3 years
8
(59)
Reis 2010 54.9 39 20 100% Gastric Bypass
(10)
No surgery
(10)
2 years
Sovik 2011 55 36 61 30 % Duodenal Switch
(30)
Gastric Bypass
(31)
2 years
Suter 2005 43 38 180 N/A Laparoscopic
Gastric Banding
(90)
Swedish
Adjustable
Gastric Banding
(90)
1.5
years
Weiner 2001 49 35 101 15% (Esophagogastric
Placement:
Laparoscopic
Adjustable
Silicone Gastric
Banding (50)
Retro Gastric
Placement of
Silicone
Laparoscopic
Adjustable
Silicone Gastric
Banding (51)
1.5
Years
9
Table 6
Risk of bias
Halperin
2005
2 1 2 2 1 1 1
Lee 2005 2 2 2 2 1 1 1
Van
Mastirgt
2006
2 1 2 1 3 1 1
Nguyen
2001
2 2 2 2 2 2 1
Nguyen
2009
2 2 2 2 2 3 1
O’Brien
2005
2 2 2 2 1 1 1
O’Brien
2006
1 1 2 2 2 2 1
O’Brien
2013
2 2 2 2 3 1 3
Perteli
2013
1 2 2 2 2 2 1
Ponce
2013
2 2 2 2 1 2 2
Puzzifferi
2006
2 2 2 2 1 1 1
Reis
2010
2 2 2 2 2 1 1
Sovik
2011
1 2 2 2 1 2 1
Suter
2011
2 2 2 2 2 2 1
Weiner
2001
2 2 1 1 2 1 1
10
Figure 1
Studies included in
systematic review
(n = 15 )
Studies excluded (n= 39)
Reasons for exclusion:
Studies that were not RCT n
(=22)
Conference abstract (n=8)
Intervention was not bariatric
surgery (n=7)
No psychological outcomes
(n=2)
Adolescent population (n=1)
Records identified through
database searching
(n = 370 )
Sc
ree
nin
g
Inc
lud
ed
E
lig
ibilit
y
Ide
nti
fic
ati
on
through other sources
(n = 0)
Records after duplicates removed
(n = 258 )
Records screened
(n =258 )
Records excluded
(n = 204 )
Full-text articles
assessed for eligibility
(n =54 )
Studies included and
additional records
identified for systematic
review
(n = 15)
Studies Included from
forward backward
citation
(n= 0 )
11
Appendix 6
Surgical (intervention) vs Non-Surgical (control) interventions: Psychological outcome data
Author Data Psychological
Outcome
Measure
Range Pre-
treatmen
t mean
and (SD)
interventi
on
Post
treatment
meant and
(SD)
interventio
n
Pre-
treatment
mean and
(SD)
control
Post
treatmen
t mean
and (SD)
control
Difference
between
post
treatment
mean and
pre-
treatment
mean
(interventio
n)
Difference
between
post
treatment
mean and
pre-
treatment
mean
(control)
Percentage
change from
pre-surgery
to post-
surgery
(interventio
n)
Percentag
e change
from pre-
surgery to
post-
surgery
(control)
Statistical
significance
between the
change in
intervention
mean and
change in
control
Statistical
significanc
e between
the post-
treatment
mean and
pre-
treatment
mean
Halperin 2014 SF- 36 (total) 0-100 66.24
(17.75)
68.24 71.56
(12.38)
73.6 2 2 3.02% 2.72% NR NR ( I )
NR( c )
SF- 36
(Physical
Health)
0-100 61.32
(19.66)
66.32 68.61
(13.22)
72.6 5 4 8.15% 5.51% NR NR ( I )
NR( c )
SF- 36 (Mental
Health)
0-100 63.49
(16.24)
68.49 63.67
(1188)
63.5 5 -0.16 7.88% -0.25% NR NR ( I
)S( c )
PAID 0-100 $ 52.63
(16.38)
32.5 56.18
(12.59)
36.8 -20.13 -19.38 -38.25% -52.66% NR S ( I )
S ( C )
EQ-5D 0-1 0.8
(0.15)
0.87
(0.09)
-0.8 -0.87 NR NR ( I )
NR ( C )
EQ-5D VAS 0-100 65.11
(17.67)
81.11 64.19
(14.16)
72.2 16 8 24.57% 11.08% NR S ( I )
S ( C )
I QWOL 0-100 81.5
(26.4))
49.5 68.63
(17.5)
51.63 -32 -17 -39.26% -24.77 S S ( I )
S ( C )
O’Brien 2006 SF -36
Physical
Functioning
0-100 64 90 70 83 26 13 40.63% 15.66% S NR ( I )
NR ( C )
12
SF -36 Role-
Physical
0-100 62 92 66 67 30 1 48.39% 1.49% S NR ( I )
NR ( C )
SF-36 Bodily
Pain
0-100 65 81 70 76 16 6 24.62% 7.89% NR NR ( I )
NR ( C )
SF- 36
General Health
0-100 45 77 58 64 32 6 71.11% 9.38% S NR ( I )
NR ( C )
SF -36 Vitality 0-100 38 77 39 58 39 19 102.63% 32.76% S NR ( I )
NR ( C )
Sf -36 Social
Functioning
0-100 61 82 70 78 21 8 34.43% 10.26% NR NR ( I )
NR ( C )
SF -36 Role-
Emotional
0-100 58 90 71 70 32 -1 55.17% -1.43% S NR ( I )
NR ( C )
SF -36 Mental
Health
0-100 60 73 60 69 13 9 21.67% 13.04% NR NR ( I )
NR ( C )
O’Brien 2013 SF -36
physical
Health
Composite
score
0-100 45.78
(10.6)
48 (10.53) 49.02 (8.1) 52.8
(3.9)
2.22 3.74 4.85% 7.09% S NR ( I )
NR ( C )
SF -36 Mental
Health
composite
score
0-100 46.03
(9.23)
50.77
(6.27)
47.65
(8.46)
49.6
(5.72)
4.74 1.94 10.30% 3.91% NS NR ( I )
NR ( C )
Ponce 2013 SF -36
Physical
component
0-100 49.8 53.2 49.8 52.1 3.4 NR NR ( I )
NR ( C )
SF -36
Physical
Functioning
0-100 83.6 92 82.8 87.1 8.4 4.3 10.05% 4.94% NR NR ( I )
NR ( C )
SF -36 Role- 0-100 91.7 93.8 87 89.3 2.1 2.3 2.29% 2.58% NR NR ( I )
13
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
Physical NR ( C )
SF-36 Bodily
Pain
0-100 83.7 88.7 79.2 85.4 5 6.2 5.97% 7.26% NR NR ( I )
NR ( C )
SF- 36
General
Health
0-100 73.9 81.4 86.8 86.1 7.5 -0.7 10.15% -0.81% NR NR ( I )
NR ( C )
SF -36 Vitality 0-100 70.2 72.5 72.8 68.6 2.3 -4.2 0.033 -6.12% NR NR ( I )
NR ( C )
SF- 36 Mental
Component
0-100 57.6 56.4 58.9 56.3 -1.2 -2.6 -0.02 -4.62% NR NR ( I )
NR ( C )
Sf -36 Social
Functioning
0-100 96.4 95 95.8 94.6 -1.4 -1.2 -0.01 -1.27% NR NR ( I )
NR ( C )
SF -36 Role-
Emotional
0-100 98.4 98.5 100 95.2 0.1 -4.8 0.00 -5.04% NR NR ( I )
NR ( C )
SF -36 Mental
Health
0-100 87.3 87.2 89.6 87.4 -0.1 -2.2 -0.00 -2.52% NR NR ( I )
NR ( C )
Reis 2009 IIEF-5 Jan-25 19.7
(6.6)
23 (2.3) 17.2 (7.9) 17.3
(6.7)
3.3 0.1 0.17 0.58% S NR ( I )
NR ( C )
14
Appendix 7
Laprascopic surgery (intervention) vs Open surgery (Control): Psychological outcome data
Author Year Psychological
Outcome
Measure
Rang
e
Pre-
treatment
mean and
(SD)
interventio
n
Post
treatment
meant and
(SD)
interventio
n
Pre-
treatmen
t mean
and (SD)
control
Post
treatmen
t mean
and (SD)
control
Difference
between
post
treatment
mean and
pre-
treatment
mean
(interventio
n)
Difference
between
post
treatment
mean and
pre-
treatment
mean
(control)
Percentage
change from
pre-surgery
to post-
surgery
(interventio
n)
Percentag
e change
from pre-
surgery to
post-
surgery
(control)
Statistical
significance
between the
change in
intervention
mean and
change in
control
Statistical
significanc
e between
the post-
treatment
mean and
pre-
treatment
mean
Nguyen 2001 SF -36
Physical
Functioning
0-100 46.5 (21.9) 80.2 (19.1) 40 (24.4) 67.8
(26.6)
33.7 27.8 72.47% 41.00% S NR ( I )
NR ( C)
SF -36 Role-
Physical
0-100 47.2 (40.2) 80.7 (32.5) 37.5
(37.9)
76.8
(33.3)
33.5 39.3 70.97% 51.17% NS NR ( I )
NR ( C)
SF-36 Bodily
Pain
0-100 51 (22.7) 75.1 (24.7) 48.7
(24.1)
68.1
(25.6)
24.1 19.4 47.25% 28.49% NS NR ( I )
NR ( C)
SF- 36 General
Health
0-100 54.5 (21.6) 77.2 (15.7) 52.9
(22.3)
72.4
(16.5)
22.7 19.5 41.65% 26.93% NS NR ( I )
NR ( C)
SF -36 Vitality 0-100 38.5 (20) 65.8 (17.7) 36.6
(19,9)
73.1
8(95.2)
27.3 36.5 70.91% 49.93% NR NR ( I )
NR ( C)
Sf -36 Social
Functioning
0-100 64.4 (26,3) 87.3 (17.9) 61.6
(29.5)
74.1 (30) 22.9 12.5 35.56% 16.87% S NR ( I )
NR ( C)
SF -36 Role-
Emotional
0-100 49.1 (24.4) 83 (29.0) 45.5
(27.2)
74.6
(40.7)
33.9 29.1 69.04% 39.01% NS NR ( I )
NR ( C)
SF_38 Mental
Health
0-100 73 (15.1) 82.9 (14.2) 71.9
(17.3)
75 9.9 3.1 13.56% 4.13% NS NR ( I )
NR ( C)
15
Moorhead-
Ardelt QOL
(Self-esteem)
-3 -
+3
0.84 (0.27) 0.8 (0.27) 0.84 NS NR ( I )
NR ( C)
Moorhead-
Ardelt QOL
(Physical)
-3 -
+3
0.48 (0.4) 0.34
(0.18)
0.48 NS NR ( I )
NR ( C)
Moorhead-
Ardelt QOL
(Social)
-3 -
+3
0.31 (0.19) 0.29 (0) 0.31 NS NR ( I )
NR ( C)
Moorhead-
Ardelt QOL
(Labour)
-3 -
+3
0.24 (0.19) 0.21
(0.27)
0.24 NS NR ( I )
NR ( C)
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
Laparoscopic (intervention) vs Open (control) RCTs
16
17
Appendix 8
Laparoscopic Roux-en-Y Gastric Bypass (Intervention) vs Mini Roux-en-Y Gastric Bypass (control)
Author Data Psychological
Outcome
Measure
Range Pre-
treatment
mean and
(SD)
intervention
Post
treatment
meant and
(SD)
intervention
Pre-
treatment
mean and
(SD)
control
Post
treatment
mean and
(SD)
control
Difference
between post
treatment
mean and
pre-treatment
mean
(intervention)
Difference
between
post
treatment
mean and
pre-
treatment
mean
(control)
Percentage
change from
pre-surgery
to post-
surgery
(intervention)
Percentage
change
from pre-
surgery to
post-
surgery
(control)
Statistical
significance
between the
change in
intervention
mean and
change in
control
Statistical
significance
between the
post-
treatment
mean and
pre-treatment
mean
Lee 2005 GIQLI Overall 0-128 99.6 (19.1) 113.3 (16.1) 104.6
(18.5)
113.9 (17) 13.7 9.3 13.76% 8.17% NR S ( I )
S (IC)
GIQLI
symptoms
0-128 59.8 (7) 60.1 (9) 63.2 (6.2) 58.9 (10.3) 0.3 -4.3 0.50% -7.30% NR NR (I )
NR (C )
GIQLI physical 0-128 14.6 (6.3) 20.9 (4.8) 16.2 (5.8) 21.3 (4.2) 6.3 5.1 43.15% 23.94% NR S ( I )
S (C )
GIQLI
emotional
0-128 12 (4.4) 15 (3.7) 11.8 (3.3) 15.8 (4.8) 3 4 25.00% 25.32% NR S ( I )
S (C )
GIQLI Social 0-128 13.2 (2) 17.3 (2.8) 13.4 (6.7) 17.9 (6.1) 4.1 4.5 31.06% 25.14% NR S ( I )
S (IC)
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
18
Appendix 9
Roux –en- Y Gastric by pass (intervention) vs Duodenal Switch (control)
Author Data Psychologic
al
Outcome
Measure
Rang
e
Pre-
treatment
mean and
(SD)
interventio
n
Post
treatment
meant and
(SD)
interventio
n
Pre-
treatmen
t mean
and (SD)
control
Post
treatmen
t mean
and (SD)
control
Difference
between
post
treatment
mean and
pre-
treatment
mean
(interventio
n)
Difference
between
post
treatment
mean and
pre-
treatment
mean
(control)
Percentage
change
from pre-
surgery to
post-
surgery
(interventio
n)
Percentag
e change
from pre-
surgery to
post-
surgery
(control)
Statistical
significance
between the
change in
intervention
mean and
change in
control
Statistical
significance
between the
post-
treatment
mean and
pre-
treatment
mean
Sovik 2011 SF -36
Physical
Functioning
0-100 57.3 (21.1) 90.3 50.9 (26) 87.3 33 36.4 58% 41.70% NS NR (I)
NR (C)
SF -36 Role-
Physical
0-100 54 (33.7) 86.9 54.5
(35.3)
76.6 32.9 22.1 61% 28.85% NS NR (I)
NR (C)
SF-36 Bodily
Pain
0-100 43.7 (26.2) 79.6 52 (32.4) 59.4 35.9 7.4 82% 12.46% S NR (I)
NR (C)
SF- 36
General
Health
0-100 49.5 (21.7) 77.2 46 (21.1) 74.9 27.7 28.9 56% 38.58% NS NR (I)
NR (C)
SF -36 Vitality 0-100 37.7 ( 21.7) 58.6 38.8
(24.8)
58.2 20.9 19.4 55% 33.33% NS NR (I)
NR (C)
Sf -36 Social
Functioning
0-100 65.7 (33.3) 78.9 62.5
(32.6)
82.8 13.2 20.3 20% 24.52% NS NR (I)
NR (C)
SF -36 Role-
Emotional
0-100 70.4 (32.8) 82.7 69.3
(36.6)
81 12.3 11.7 17% 14.44% NS NR (I)
NR (C)
SF -36 Mental
Health
0-100 67.9 (20.9) 69.3 62.1
(22.3)
73.1 1.4 11 2% 15.05% NS NR (I)
NR (C)
19
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
20
Appendix 10
Roux -en –Y gastric bypass (intervention) vs Restrictive surgery (control): Psychological outcome data
Author Data Psychological Outcome Measure
Range
Pre-treatment mean and (SD) intervention
Post treatment meant and (SD) intervention
Pre-treatment mean and (SD) control
Post treatment mean and (SD) control
Difference between post treatment mean and pre-treatment mean (intervention)
Difference between post treatment mean and pre-treatment mean (control)
Percentage change from pre-surgery to post-surgery (intervention)
Percentage change from pre-surgery to post-surgery (control)
Statistical significance between the change in intervention mean and change in control
Statistical significance between the post-treatment mean and pre-treatment mean
Nguyen
2009 SF -36 Physical Functioning
0-100 44 50 89 83 6 -3 13.64% 3.75% NS NR (I) NR (C)
SF -36 Role- Physical
0-100 38 42 82 85 4 3 10.53% 3.66% NS NR (I) NR (C)
SF-36 Bodily Pain
0-100 50 52 80 81 2 1 4.00% 1.23% NS NR (I) NR (C)
SF- 36 General Health
0-100 49 80 51 80 31 29 63.27% 36.25% NS NR (I) NR (C)
SF -36 Vitality 0-100 36 45 70 80 9 10 25.00% 14.29% NS NR (I) NR (C)
Sf -36 Social Functioning
0-100 45 90 51 92 45 41 100.00% 44.57% NS NR (I) NR (C)
SF -36 Role-Emotional
0-100 65 96 65 90 31 25 47.69% 27.78% NS NR (I) NR (C)
SF -36 Mental Health
0-100 65 80 70 84 15 14 23.08% 16.67% NS NR (I) NR (C)
Pertelli 2013 GIQLI 0-144 98.8 (17.4) 128 99 (20.5) 128 29.2 28 22.81% 22.81% NR S (I) S (C)
Depression 5% cured 82% improved
11% 15% cured 70% improved
NS
Key
Notation Meaning
21
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
Roux-en–Y gastric bypass (intervention) vs Restrictive surgery (control): Psychological outcome data
Author
Year Outcome Percentage of intervention that had signs of improvement
Percentage of control that had signs of improvement
Pertelli 2013 Depression 82 70
22
Appendix 11
Restrictive surgery vs a different type of restrictive surgery: Psychological outcome data
Author Data Psychological Outcome
Measure
Rang
e
Pre-
treatment
mean and
(SD)
interventio
n
Post
treatme
nt
meant
and
(SD)
interve
ntion
Pre-
treatment
mean and
(SD)
control
Post
treatme
nt
mean
and
(SD)
control
Difference
between
post
treatment
mean and
pre-
treatment
mean
(interventio
n)
Differen
ce
betwee
n post
treatme
nt
mean
and
pre-
treatme
nt
mean
(control
)
Percentage
change
from pre-
surgery to
post-
surgery
(interventio
n)
Percent
age
change
from
pre-
surgery
to post-
surgery
(control
)
Statistical
significance
between the
change in
intervention
mean and
change in
control
Statistical
significance
between the post-
treatment mean
and pre-treatment
mean
Mastrigt 2006 EQ-5D 0-1 0.58 0.84 0.67 0.84 0.26. 0.16 44.8 % 29.28 NS S (I)
S( C)
Obrien 2005 SF -36
Physical
Functioning
0-100 46 81 48 80 35 32 76.09% 40.00% NR S (I)
S (C)
SF -36 Role-
Physical
0-100 44 81 48 78 37 30 84.09% 38.46% NR S (I)
S (C)
SF-36 Bodily
Pain
0-100 61 83 61 76 22 15 36.07% 19.74% NR S (I)
S (C)
SF- 36 General
Health
0-100 41 68 42 70 27 28 65.85% 40.00% NR S (I)
S (C)
SF -36 Vitality 0-100 32 59 35 59 27 24 84.38% 40.68% NR S (I)
S (C)
Sf -36 Social
Functioning
0-100 58 76 58 79 18 21 31.03% 26.58% NR S (I)
S (C)
23
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
Author Year Psychological outcome Percentage of participants
from intervention group
Percentage of participant from
the control group
Weiner 2001 QoL questionnaire made by group
(Excellent )
94 96
QoL questionnaire made by group
(Fair)
4% 2%
QoL questionnaire made by group
No improvement
1
SF -36 Role-
Emotional
0-100 53 79 53 71 26 18 49.06% 25.35% NR S (I)
S (C)
SF -36 Mental
Health
0-100 59 69 59 69 10 10 16.95% 14.49% NR S (I)
S (C)
Suter Moorehead
Ardelt Quality
of life
-3- +3 1.76 1.71 NS NR (I)
NR (C)
24
List of Abbreviations
BARIACT study: Bariatric clinical trial study
BMI: Body Mass Index
COS: Core Outcome Set
EQ-5D: European Quality of Life 5 Dimensional
GIQLI: Gastrointestinal Quality of Life Index
IIEF5: International Index of Erectile Function short version
IWQOL: Impact of Weight on Quality of Life
NHS: National Health Service
PAID: Problem Area In Diabetes
PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-analysis
QoL: Quality of Life
RCT: Randomised Controlled Trials
SF-36 Short Form 36 Health Survey
25
Lay Abstract
Obesity is becoming a global issue. Weight-loss surgery (bariatric surgery) is
described as the best way to treat obesity. However, little is known about how
bariatric surgery impacts an individual’s psychological health. A literature review was
conducted to be easily replicated (systematic review) to examine the impact of
bariatric surgery on an individual’s psychological health.
Randomised controlled trials (RCTs), which are the gold standard for clinical trials,
are used to assess the effect an intervention has on an intended outcome of interest
without the risk of bias. This review analysed data from RCTs of bariatric surgery that
reported the effects of surgery on participants’ psychological health. Whether an
improvement in psychological health was dependent on the type of surgery was
explored. Studies were assessed for risk of bias.
Fifteen studies were used, fourteen of which reported quality of life, a
multidimensional measure of health, social and psychological wellbeing. Two
reported depression, and one study reported sexual function. The different types of
surgery had similar effects on psychological health. All studies considered had a risk
of bias.
There is a shortage of quality RCTs investigating the psychological impact of bariatric
surgery; enhanced RCTs need to be conducted in this area.
26
Abstract
Background: Obesity is rapidly becoming a global pandemic. Bariatric surgery is the
most effective treatment for obesity. However, little is known about the effect bariatric
surgery has on the psychological health of obese individuals. A systematic review
was conducted to explore the effect of bariatric surgery on psychological health
outcomes.
Method: A systematic review of randomised clinical trials (RCTs) of bariatric surgery
with psychological outcomes was carried out in accordance with the PRISMA
guidelines. Studies were analysed to see if an improvement in psychological
outcomes was dependent on the type of surgery. Studies were then assessed for risk
of bias.
Results: Fifteen studies were included in this systematic review. Fourteen studies
reported quality of life as a psychological outcome with two reporting depression.
One reported sexual function. No significant difference was found in psychological
outcomes when different types of surgeries were compared. All studies reported a
moderate to high risk of bias.
Conclusion: There is a lack of well-designed studies investigating the impact of
bariatric surgery on psychological health. Well-designed RCTs are needed to explore
the effect of bariatric surgery on psychological outcomes. Such outcomes should be
considered as part of the core outcome set for bariatric surgery.
27
Background
Obesity a global health problem
Obesity is defined as having a body mass index (BMI) of ≥ 30 (kg/m2)(1). Obesity is a
global pandemic with 62% of the 671 million obese population living in the developed
world(2). The incidence of obesity worldwide is predicted to reach 1.12 billion by 2030,
assuming the trends continues(3). Ng et al reported in 2010 that the global mortality
rate from obesity was 3.4 million people(4). In Germany alone, the number of people
that died from obesity increased by approximately 31% from 2002 to 2008(5). A
systematic review conducted in 2008 linked obesity with 19 different physiological
comorbidities including Type 2 diabetes, cancer and cardiovascular disease(6). This
range of comorbidities helps to explain why obesity produces a significant economic
burden to a nation’s health system(7). In 2005, 21% of the US expenditure on health
was spent on obesity and obesity related disease(7). The cost of obesity in Germany
grew from €8,647 million to €16,797 million from 2002 to 2008(5). In the UK obesity
cost the NHS £5.2 billion in 2007(8).The predicted rise in the prevalence of obesity
implies a higher proportion of related healthcare expenditure in the future(9).
Impact of obesity on psychological health
In addition to all of the physical comorbidities associated with obesity, obese
individuals also experience psychological issues(10-12). To understand these
psychological issues it is pertinent to discuss the impact of obesity on: sexual
satisfaction, stigma, mental illness, quality of life and wellbeing(11,12).
Obesity and sexual satisfaction
Weight-related comorbidities such as diabetes are frequently accompanied by
impaired sexual function. 50% of diabetic men developed erectile dysfunction over
the course of the disease in a study(13). Another study found that obese males are
more likely to demonstrate an increased rate of erectile dysfunction, lower levels of
sex hormones and lower sexual desire when compared with non-obese
participants(14). It has also been suggested that women with higher BMI may either
lack sexual desire, or are more likely to worry about feeling unattractive during sex(15).
Obese individuals have been shown to have lower self-esteem and body image
dissatisfaction when compared to non-obese individuals. This can have a significant
28
impact on their psychological health(16). Physical limitations in combination with poor
sexual function, body image dissatisfaction and mood disorders result in some obese
individuals having sexual dissatisfaction(17).
Obesity and stigma
People who are obese are more likely to experience stigmatisation, which can lead to
stigma-related depression, psychosocial stress, anxiety, low self-esteem, and a
decrease in both emotional and physical wellbeing(18, 19). Obese individuals often
experience bias from different sections of society including employers, health
professionals, the media and family members(19-21). This is because, obese
individuals are assumed to have negative characteristics such as laziness,
unintelligence and are thought to lack will power(20, 21). Furthermore, Ashore et al
reported a positive correlation between stigmatisation and psychological distress(22).
Individuals who are obese may have internalised weight bias (self-stigma), which can
result in lower self-esteem and lower self-efficacy(23). Therefore obese individuals
have poor psychological functioning due to stigmatisation.
Obesity and mental illness
People who experience weight discrimination are found to be 2.41 times likely to
have more than three psychiatric diagnoses than those who have not suffered weight
discrimination(24). Studies show the link between obesity and depression. 25 to 35%
of obese individuals are found to have clinical symptoms of depression(25).
Furthermore, a meta-analysis of eight longitudinal studies has shown that obesity
increases the risk of depression(26). There is also been evidence to suggest that there
is an association between obesity and anxiety disorders, which are the most common
mental health disorder in the developed world(27). Moreover, the link between mental
health disorders and obesity is shown to be bi-directional; factors such as body
image dissatisfaction and stigmatisation are associated with a decline in mental
health, whilst a decline in mental health is linked with changes in eating behaviours(26,
28, 29).
Obesity in relation to quality of life and wellbeing
With all the aspects mentioned above, it is not surprising that obesity has shown to
be inversely related to Quality of Life (QoL)(30). Obesity has a detrimental effect on
29
functional mobility, thereby reducing the ability to take part in physical activity leading
to a reduction in QoL(30). A study conducted by Renzaho using the Short Form 36
Health Survey (SF-36) in obese population, showed that a decline in emotional
wellbeing, in addition to physical wellbeing, was also responsible for a reduction in
the QoL(31). People with a BMI ≥ 30 have been shown to have a reduction in
psychological wellbeing compared to people of normal BMI, which reduces the
quality of life of obese individuals(32, 33). This negative correlation between BMI and
quality of life was confirmed by using the European Quality of Life 5 Dimensional
(EQ-5D) to assess the QoL of people diagnosed with obesity(34). Several other
studies also show that obesity has a negative effect on QoL(17, 35-37).
With the significant impacts of obesity on an individual’s health and a nation’s health
system, it follows therefore that interventions are necessary to curtail this resulting
epidemic(38, 39).
Bariatric surgery: intervention for obesity
Many systematic reviews have been carried out to suggest that bariatric surgery is
the most effective treatment for people with obesity. This not only results in dramatic
weight loss, but a reduction in physiological comorbidities such as type 2 diabetes
and stroke(40-44). Understandably, the number of people undergoing bariatric surgery
is increasing in line with the increase in the prevalence of obesity; the global number
of bariatric surgeries performed increased from 146,301 to 340,768 between the
years 2003 to 2011(44, 45).
Individuals are eligible for bariatric surgery if they have a BMI ≥ 40 (kg/m2), or have a
BMI ≥ 35 (kg/m2), along with severe comorbidities and if non-surgical interventions
have failed(38). There are many different types of bariatric surgery; these aim to
reduce and maintain weight loss either by limiting food intake (restrictive surgery), the
malabsorption of food (malabsorptive surgery) or by a combination of the two types
of surgery(46, 47). Table 1 describes what types of bariatric surgery are classified as
restrictive, malabsorptive or a combination of both. Bariatric surgery can be
performed laparoscopically, and is known as laparoscopic bariatric surgery, allowing
surgeons to perform surgery without making large incisions through the skin, making
it less invasive than the open surgery(48).
30
Restrictive Bariatric
Surgery
Malabsorptive Bariatric
Surgery
Combination of
Restrictive surgery and
Malabsorptive surgery
Adjustable Gastric
Banding
Biliopancreatic Diversion
with duodenal switch
Gastric Bypass Roux –en-Y
Sleeve Gastrectomy
Vertically Banded
Gastroplasty
Table 1: Brief outline of procedures used by different types of surgery used to
achieve and maintain weight loss
Despite the strong evidence supporting the success of bariatric surgery in achieving
weight loss and reducing the physiological comorbidities of obesity, the psychological
effect of bariatric surgery on an individual appears to be overlooked(17, 49). Many
studies fail to report psychological outcome measures or when reported they are
included as secondary outcome measures(40, 41). Given that the World Health
Organisation's definition of health is, “Complete physical, mental and social well-
being and not merely the absence of disease or infirmity”, questions still need to be
asked as to whether bariatric surgery helps obese individuals to achieve good,
complete health(50).
Research question
This systematic review aims to answer the following questions: What is the impact of
bariatric surgery on the psychological health outcomes on obese individuals? Is the
effect of surgery on psychological outcomes dependent on the type of surgery
performed?
Objectives
The objectives of this systematic review are:
To identify randomised controlled trials of the effect of bariatric surgery on
psychological health outcomes of obese individuals.
31
To review and synthesise the psychological health outcomes reported in randomised
control trials of bariatric surgery in obese individuals.
To critically appraise the quality of existing randomised controlled trials of the
psychological health outcomes of obese individuals.
To assess whether there is a difference in psychological health outcomes in
randomised controlled trials that compare bariatric surgery with a non-surgical
intervention.
To assess whether there is a difference in psychological outcomes in obese
individuals between different types of bariatric surgery.
32
Methods
The methods and reporting framework used for this systematic review followed the
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis)
guidance, which has been adapted for this systematic review(51).
Information about sources
The following databases were searched on 03/02/15: Medline in process (Ovid);
Embase (Ovid); PsycINFO (Ovid); Cochrane Library (all databases) and CINAHL
(Ebsco).
Search strategy and search terms
The search strategy was developed to identify randomised controlled trials (RCTs)
using an evidence-based decision-making process by considering the population,
intervention, comparator, outcome (PICO) of studies that matched the inclusion and
exclusion criteria. The PICO, the inclusion and exclusion criteria can be seen in
Table 2 and Table 3 retrospectively(52).
Population Intervention Comparator Outcome
Obese adults
aged over 18
Bariatric
surgery
Any
comparator
Psychological
outcomes
Table 2: Shows the PICO used to identify RCTs in this systematic review
The search strategy comprised of three elements used in combination:
i) Terms to identify papers relating to the population: Obesity, examples included
“obesity” and “BMI”
ii) Terms to identify papers relating to the intervention: Bariatric surgery, examples
included “bariatric surgery” and “gastric banding”
iii) Terms to identify papers relating to the outcome: psychological outcomes,
examples included wellbeing and “body image”.
The search terms were devised through the use of the Ovid databases, guidance
from discussions with psychologists at the University of Exeter Medical School, and
by reading Helpertz et al’s a systematic review on the impact of bariatric surgery on
psychological outcomes(53). The search strategy contained subject headings such as
33
MESH terms and text words to identify relevant studies. The search terms were
altered according to the requirements of the databases. Limits, in accordance to
inclusion and exclusion criteria were added to the search terms where possible. The
list search terms used in this study together with the limits added can be seen in
Appendix 1. The inclusion and exclusion criteria can be seen in Table 3.
Table 3: Inclusion and exclusion criteria
Inclusion Criteria: Exclusion criteria:
Study Design
If the study must is an RCT If the study is not a RCT
Population
Participants in the study were
obese BMI ≥30
Participants in the study were not
obese BMI ˂ 30
Participants must be human Non-human animal study
Adults participants aged over 18
years
Participants aged under the age of
18
Intervention
Participants should have received
bariatric surgery of any type
Participants did not receive
bariatric surgery of any type
Comparator
Any type of comparator, for
example, no surgery, other type
of surgery or other intervention
Study had no comparator
Outcomes
Psychological outcomes reported
such as depression anxiety and
Quality of life
Psychological outcomes were
not reported
Language
Studies written in English If studies not written in English
Type of research
Primary research with full text
articles
Secondary research or primary
research without a full text articles
34
Screening
The screening was undertaken in two stages. In the first stage, two independent
reviewers identified papers that matched the inclusion and exclusion criteria of this
review by reading all the titles and abstracts identified by the systematic search.
Articles that seemed dubious as to whether or not they should be included were
included, and disagreements were debated and resolved. Instructions for the first
stage can be found in Appendix 2.
The full texts of the of the potentially eligible studies were gathered for the
second stage to verify inclusion or exclusion. A different reviewer replaced the
second reviewer. Whilst reading, the PICO form was filled out to justify reasons for
inclusion or exclusion. Instructions for the eligibility stage and the PICO form can be
found in Appendix 3 and Appendix 4 respectively.
Forward and backward citation searching were carried out on the included studies
using the ISI web of science database.
Data extraction
Data was extracted from the included studies. Table 4 provides an overview of the
items that were extracted.
Study Characteristics Psychological Outcome Data
Author Author
Year Year
BMI Range Psychological Outcome measure
Number of Participants Range
Age Pre-treatment Mean (Intervention)
Percentage of males Pre –treatment standard deviation
(intervention)
Intervention (Number of participants) Pre-treatment Mean (Control)
Comparator (Number of participants) Pre –treatment standard deviation
(control)
Psychological intervention carried out Post -treatment Mean (intervention)
35
Length of follow up Post - treatment standard deviation
(Intervention)
Post-treatment Mean (Control)
Post –treatment standard deviation
(control)
Change in mean scores ( intervention)
Change in mean score (control)
Change in mean scores ( intervention)
as a percentage
Change in mean score (control) as a
percentage
Statistical significant difference
between the groups (p- values)
Statistical significant difference
between pre-treatment and post
treatment for both the intervention and
control
(p - values)
Table 4: List of data extracted from the included studies
Data Analysis
The difference in mean scores for the intervention and control were calculated by
subtracting the pre-treatment mean from the post-treatment mean. The percentage
change for both the control and treatment were calculated by dividing change in
mean score by post-surgery and multiplying the answer by 100. Data from studies
were reported as statistically significant if the p-value was less than 0.05.
Quality Assessment
All the included studies were assessed for the risk of bias by filling out the Cochrane
risk of bias form (see Appendix 5)(54).
36
Results
Study selection
Figure 1 shows a flow diagram of the number of studies identified, screened, found
eligible and included. 370 papers were identified from the electronic databases as
potentially eligible. 112 studies were duplicates, 258 studies remained after
deduplication and were screened based on title and abstract. After the first stage of
screening, 204 studies were excluded. The full texts articles of the remaining fifty five
studies were gathered and assessed for eligibility. Fifteen studies were included in
this review.
Figure 1: Flow chart summarising the systematic search
Studies included in systematic
review (n = 15)
Studies excluded (n= 39)
Reasons for exclusion:
Studies that were not RCT n (=22)
Conference abstract (n=8)
Intervention was not bariatric
surgery (n=7)
No psychological outcomes
(n=2)
Adolescent population (n=1)
Records identified through
database searching (n = 370)
Sc
ree
nin
g
Inclu
de
d
Eli
gib
ilit
y
Iden
tifi
cati
on
Through other sources
(n = 0)
Records after duplicates removed
(n = 258 )
Records screened
(n =258)
Records excluded
(n = 204)
Full-text articles assessed for
eligibility (n = 54)
Studies included and
additional records identified for
systematic review
(n = 15)
Studies Included from
forward backward
citation(n= 0 )
37
Characteristics of included studies
The studies were published from 2001 to 2013, the mean BMI ranged from 33.6 to 55
and number of participants ranged from 20 to 217. The mean participant age ranged
from 35 to 53. The average percentage of males included in these studies was
27.7%. Six studies had a follow up length of one year or less; seven studies had a
follow up length between one to two years and four studies had a follow up length of
three years or more. A summary of the included studies can be found below in Table
5.
Author
Year
BMI
Range
Kg/m2
Number of
participants
Age
Years
% of
Males
Intervention (N=)
Comparator
(N=)
Length
of
follow
up
Halperin 2014 36.25 43 52 Roux-en-Y
Gastric Bypass
(22)
Why WAIT
Medication,
Dietary (21)
1 year
Lee 2005 44.3 80 40 31 % Roux-en-Y
Gastric Bypass
(40)
Laparoscopic
Mini-Gastric
Bypass (60)
2 years
van
Mastrigt
2006 46.6 100 38 20% Vertical Banded
Gastroplasty (50)
LAP Band (50) 1 year
Nguyen 2001 48 155 45 27% Laparoscopic
Gastric Bypass
(79)
Open
Gastric Bypass
(76)
10
months
Nguyen 2009 46.5 197 44 24 % Laparoscopic
Gastric Bypass
(111)
Laparoscopic
Adjustable
Gastric Banding
(86)
4 years
O’Brien 2013 33.6 80 53 23.5 % Laparoscopic
Adjustable
Gastric Banding
(40)
Intensive
Medical Weight
Loss
Non-surgical
(40)
10
years
O’Brien 2005 37.8 202 40 11% Laparoscopic
Adjustable
Gastric Banding
Perigastric
pathway (101)
Laparoscopic
Adjustable
Gastric
Banding Pars
Flaccida (101)
2 years
O’Brien 2006 33.6 80 41 24% Laparoscopic
Adjustable
Non-surgical
intensive
2 years
38
Gastric Banding
(40)
medical
programme (40)
Peterli 2013 43.9 217 43 28 % Laparoscopic
Sleeve
Gastrectomy
(107)
Roux-en-Y
gastric bypass
(110)
1 year
Ponce 2013 35.2 30 42 10 % Intra Gastric Dual
Balloon (21)
Non-Surgical
Intervention (9)
9
months
Puzziferri 2006 48.5 116 49 8% Laparoscopic
Gastric Bypass
(59)
Open Gastric
Bypass (57)
3 years
Reis 2010 54.9 39 20 100% Gastric Bypass
(10)
No surgery
(10)
2 years
Sovik 2011 55 36 61 30 % Duodenal Switch
(30)
Gastric Bypass
(31)
2 years
Suter 2005 43 38 180 N/A Laparoscopic
Gastric Banding
(90)
Swedish
Adjustable
Gastric Banding
(90)
1.5
years
Weiner 2001 49 35 101 15% (Esophagogastric
Placement:
Laparoscopic
Adjustable
Silicone Gastric
Banding (50)
Retro Gastric
Placement of
Silicone
Laparoscopic
Adjustable
Silicone Gastric
Banding (51)
1.5
Years
Table 5: An overview of the characteristics of the included studies
Psychological outcome measures in the included studies
All the included studies with the exception of one, that measured sexual function(55),
assessed QoL. Studies used either one or more QoL measures. Eight studies used
SF-36 (56-63); two studies used the EQ-5D(56, 64). The remaining studies used disease
specific QoL measures. Two studies used the Moorehead-Ardelt quality of life
questionnaire(65, 66). Two studies used Gastro Intestinal Quality of Life Questionnaire
(GIQOL)(67, 68). One study used the International Weight Related Quality of Life Index
(IQWOL)(56). One study used a questionnaire developed by their group containing
twenty-four questions related to QoL(69). Problem Areas in Diabetes (PAID) was also
used to assess QoL in one of the studies(56). Two studies reported depression as an
outcome measure. One study reported sexual function using the International Index
of Erectile Function short version (IIEF5)(55) (Appendix 6-10).
Records identified through
database searching
Scre
enin
g
Incl
ud
ed
Elig
ibili
ty
Iden
tifi
cati
on
through other sources
(n = 0)
Records after duplicates removed
(n = 258 )
Records screened
(n =258 )
Records excluded
(n = 204 )
Full-text articles
assessed for eligibility
Studies included in
systematic review
Studies included and
additional records
identified for systematic
review
(n = 15)
Studies Included from
forward backward
citation
(n= 0 )
39
Surgery versus
Five studies compared a surgical intervention with a non-surgical intervention as
shown in Table 5(55, 56, 59, 61, 62). Four of these studies reported an improvement in QoL
compared with a non-surgical intervention. One of the five studies used the IIEF-5 to
measure sexual function(55). This study reported a statistical significant difference in
the improvement in sexual function, with the intervention group having a higher result
compared to the control.
The combined percentage change in QoL was notably higher for the surgical group
compared to the non-surgical group. The scores were 11.02% and 2.54%
respectively.
The study conducted by Halperin et al used the SF-36, PAID, EQ-5D, EQ-5D VAS
and IWQOL to measure QoL(56). IWQOL reported a statistically significant difference
between both groups. Both groups reported a statistically significant decline in QoL
over the course of treatment when IWQOL was used as a measure. There was also
an improvement in the EQ-5D VAS after surgery, with a statistically significant
difference between the pre-treatment and post-treatment results. Both groups had an
improvement in QoL the difference between the pre-surgery scores and post-scores
were statistically significant and were increased when PAID was used to measure
QoL. The other measures saw an improvement in QoL, the statistical significance
difference between pre-treatment score and post-treatment scores, the significant
difference between the groups was not reported. The O’Brien et al study reported a
significant difference between pre-treatment and the post-treatment group with five
out of the eight SF-36 domains showing an improvement in QoL(59): physical
functioning, physical role, general health, vitality and emotional role. These results
suggest that surgery may improve the QoL and sexual function to a greater extent
than non-surgical; however, the differences in both types of interventions do not
appear to be significant on the whole (see Appendix 6).
Laparoscopic vs open surgery
Two studies compared laparoscopic surgery with open surgery20. Nuygen et al
reported an improvement in QoL, post-surgery, with participants who had both the
control and the intervention(57). In both the vitality and physical functioning domains of
40
the SF-36, there was a statistically significant difference between the pre-treatment
and post-treatment scores(57). Both of these studies reported the post-treatment for
Moorehead-Ardelt QoL and Baros scores as their psychological outcomes. The
combined average Moorehead-Ardelt QoL score for the Laparoscopic surgery group
and open surgery group were 0.32 and 0.24, respectively. No significant difference
was reported between the groups.
In the Puzziferri et al trial, there was a 9% difference in the percentage of people who
reported “excellent”, “very good" and "good” results after Laparoscopic and open
surgery in both of the studies - 79% and 88% respectively(65). 79% of the people
who had Laparoscopic surgery had improvements in depression compared to the 71%
who had open surgery (see Appendix 7).
Laparoscopic Roux-en-Y Gastric Bypass vs Mini Roux-en-Y Gastric Bypass
One study compared different techniques of Roux-en-Y gastric banding(67). Lee et al
reported a significant difference between the overall, physical, emotional and social
GIQOL post-treatment scores when Laparoscopic Roux-en-Y gastric bypass
compared to Mini Roux-en-Y Gastric bypass(67). The percentage change in overall
GIQOL was 13.76 and 8.76% respectively (see Appendix 8).
Laparoscopic Roux–en-Y Gastric bypass vs Duodenal Switch
One study compared Laparoscopic Roux-en-Y gastric bypass surgery with duodenal
switch surgery and reported an improvement in QoL in all 8 domains of the SF- 36(57).
The mean increase in percentage change for the intervention and control was 43.88%
and 26.12% respectively. The improvement in bodily pain was the only domain that
was statistically significant different between the two groups, with a greater
improvement reported in the intervention (Appendix 9).
Roux-en-Y gastric bypass vs restrictive surgery
Two studies compared two different types of restrictive surgery with Roux-en-Y
gastric bypass(58, 68). Nguyen et al used adjustable gastric banding(58) and Perterli et
al used sleeve gastrectomy as a comparator group(68). Both groups showed an
improvement in QoL after surgery, the combined percentage change for both Roux-
en-Y gastric band and restrictive surgery was 34.45% and 19% respectively. Perterli
41
et a reported a statistically significant difference between the baseline GIQoL scores
and the post-treatment scores for both the intervention group and control group. Both
groups were found to have an improvement in QoL. There was no statistical
significant difference between the two groups(68). 82% of people who had Roux-en-Y
gastric by-pass showed a reduction in depressive symptoms and 70% of patients
who had gastrectomy also showed this improvement(68) (see Appendix 10).
Restrictive surgery vs restrictive surgeries
The remaining four RCTs compared a restrictive surgery with another type of
surgery(70) (60, 66, 69). Mastrigt et al compared vertical banded gastroplasty with Lap-
Band and found a significant difference between the pre-treatment and post-
treatment EQ-5D scores(70). There was no significant difference between the
intervention and the comparator. O’Brien et al compared the placement of an
adjustable gastric band at the Perigastric and Pars Flaccida Pathways(60). A
significant difference was reported between the SF-36 scores before and after
surgery in both groups(60). Suter et al compared the lap band with Swedish adjustable
gastric binding the Moorehead Ardelt QoL scores was 1.76 and 1.71 respectively(66).
Researchers in the Weiner et al study developed their own QoL questionnaire, to
assess the QoL of patients who had different techniques of gastric banding they
compared esophagastric placement against retrograstic placement. The percentage
of participants increased by 2%(69)(Appendix 11).
Risk of bias of the included studies
Halperin
2005
2 1 2 2 1 1 1
Lee 2005 2 2 2 2 1 1 1
Van
Mastirgt
2006
2 1 2 1 3 1 1
Nguyen
2001
2 2 2 2 2 2 1
Nguyen
2009
2 2 2 2 2 3 1
O’Brien
2005
2 2 2 2 1 1 1
O’Brien
2006
1 1 2 2 2 2 1
42
O’Brien
2013
2 2 2 2 3 1 3
Perteli
2013
1 2 2 2 2 2 1
Ponce
2013
2 2 2 2 1 2 2
Puzzifferi
2006
2 2 2 2 1 1 1
Reis
2010
2 2 2 2 2 1 1
Sovik
2011
1 2 2 2 1 2 1
Suter
2011
2 2 2 2 2 2 1
Weiner
2001
2 2 1 1 2 1 1
Table 6: Presents the risk of bias for all of the included studies 1 indicates low
risk of bias 2 indicates uncertain risk of bias 3 indicates high risk of bias
Table 6 shows all the included studies in this review had an uncertain or high risk of
bias. The random sequence generator was adequate for only three studies(61, 63, 68).
Concealment of allocation of group was clear in two studies(61, 70). Only one study
blinded participants and data collectors and outcome adjudicators(69) another study
also blinded data collectors. Seven studies had a complete set of data(56, 61, 62, 65, 67, 69,
70). Only one study showed clear signs of selective reporting(58). The signs of
selective reporting were unclear for six of the included studies(57, 61-63, 66, 68).
Discussion
Summary of findings
To our knowledge, this systematic review is the most comprehensive systematic
review of the psychological health outcomes of obese patients after bariatric surgery,
with 60 different search terms relating to psychological outcomes included and five
different databases searched (see Appendix 1). Another strength of this study was
that forward and backward citation searches were carried out on the included studies.
Only RCTs were included in this review; RCTs are considered the gold standard
method of measuring the effectiveness of a treatment(71). This is because, in theory it
43
can be assumed that the outcome in a study is solely based on the intervention as all
the other confounding factors are removed due to randomisation(71, 72).
Fourteen out of the fifteen included trials had QoL as an outcome measure; two of
these reporting levels of depression. Both studies failed to mention how depression
was measured. This ambiguity weakens the evidence suggesting that bariatric
surgery improves depression(62, 65). The other study investigated the effect of bariatric
surgery on sexual function using the IIEF-5. Eight studies used generic measures of
QoL; six studies used condition specific measures of QoL. All studies showed
improvements in these outcome measures in both the intervention and control group.
Surgical weight loss interventions were shown to have a greater improvement on the
psychological outcomes of obese patients when compared to non-surgical
interventions for weight loss. Evidence from the included studies indicate that the
effect of bariatric surgery on psychological outcomes was independent of the type of
surgery, as on the whole, few studies showed a statistical difference in improvement
in QoL a when comparing different types of surgery. All of the included trials were
poorly designed as they had either an unclear or high risk of bias.
Limitations of this systematic review
This systematic review had limitations. Firstly, only English written studies were
included. In Brazil and Mexico alone, 84000 bariatric surgical procedures were
carried out in 2011(45). Given the global prevalence of obesity, it is highly probable
that eligible studies were excluded because they were not written in English.
Secondly, the inclusion criteria of only RCTs may have caused this review to miss
studies that assessed the effect of bariatric surgery on psychological outcomes due
to a different study design. A systematic review, conducted by Coulman et a, into the
patient reported outcomes, which include psychological outcomes, of bariatric
surgery included 78 non randomised prospective studies compared to eight RCTs(73).
Thus, it is highly likely that potentially relevant studies to this review were missed.
Thirdly, the studies that were combined to calculate the average percentage change
in QoL after surgery were heterogeneous as some studies reported different
psychological outcomes measures, had slightly different surgical procedures for both
44
the intervention and controls, and different lengths of follow up. The studies also had
weak study design therefore caution should be taken when interpreting results.
Likewise, heterogeneity and poor study design were the reasons why Coulman et al
was unable to conduct a meta-analysis of the included RCTs in her systematic
review, some of which are included in this systematic review(57, 58, 60, 61, 64, 67, 73). For
the same reason, it may be inappropriate to conduct a meta-analysis from the RCTs
in this systematic review.
It would have been inappropriate to calculate the combined average restrictive
surgery vs surgery group as all the RCTs had different controls and interventions
could.
Nevertheless, this systematic review highlights that there is a lack of well-designed
RCTs that explore the effect of bariatric surgery on psychological health outcomes of
obese patients.
Extant literature on the effect of bariatric surgery on psychological outcomes
The literature on the effect of bariatric surgery appears to be divided. Herpetz et al
concluded from their systematic review that there was considerable evidence to
suggest that bariatric surgery was associated with an improvement in psychological
outcomes(53). However, all of the studies included in this systematic review were non-
controlled trials which means that they lacked a comparator(53). A comparator is
needed in trials that asses the efficacy of treatment. This is because efficacy is a
relative measure that is acquired by making the comparison between new treatment
and that of a control(73). Due to the absence of a comparator, non-controlled clinical
trials are ranked lower than randomised clinical trials in the hierarchy of evidence.
Hence, caution must be taken when inferring from the results of these studies(72).
Furthermore, there have been studies that contradict Herpetz et al’s conclusion.
There is evidence to suggest that the risk of suicide increases in bariatric surgery
patients compared to the normal population(74, 75). This would imply that bariatric
surgery has a negative effect on psychological outcomes; however, direction of
causality should be considered as obese individuals, due to poor psychological
45
functioning, have been shown to be suicidal. Therefore suicide may be independent
of bariatric surgery in this population(76) (77).
Excessive weight loss after bariatric surgery can lead to a surplus of skin thus
increasing body image dissatisfaction; a third of patients receive body contouring
surgery after bariatric surgery in order to deal with the surplus of skin(78). A study
showed that 75% of women 68% of men desired body contouring after gastric
bypass(79). The high demand for body contouring surgery after bariatric surgery
implies that having bariatric surgery can increase the likelihood of body image
dissatisfaction therefore, worsening psychological outcomes.
Kubil on the other hand, concluded that bariatric surgery improved QoL, depression
and body image satisfaction(80). This review failed to report the inclusion and
exclusion criteria, the number of articles that were identified from searching, and the
number of papers that were excluded. The large degree of ambiguity left the
researchers with an inability to justify how the authors ended up with 27 studies(80).
This review appears non-systematic which weakens the evidence as it is not possible
to comment whether the authors examined the evidence in a thorough and bias-free
way.
There have been other systematic reviews of RCTs investigating the efficacy of
surgery these reviews reported QoL but no other psychological outcome(46, 81).
Quality of Life and its limitations as a psychological measure
QoL is an important useful outcome measure in medical research as it captures an
individual’s self-reported perception of physical social and psychological functioning
in one measure(81). Generic measures of QoL like the SF-36 and EQ-5D are used by
national health institutions in decision-making as they can be used to compare
effectiveness of different interventions across different diseases(82). However, due to
its multidimensional nature, QoL can be seen as an ambiguous umbrella term(17, 83).
Generic measures of QoL may be unable to capture all the psychological
consequences of obesity. Generic measures, the SF–36 for example, is more likely
to be liable to this criticism, compared to condition specific measures such as the
IWQoL and the Moorehead Adelt QoL questionnaire(84, 85).The differences in the
46
content validity of the IWQoL and SF-36 in measuring the psychological health
outcomes of obese patients, is a possible explanation for the contrasting results of
the two measures in Halperin et al's RCT(56) (see Appendix 6). The use of QoL
outcomes that lack the content validity of the psychological health of obese patients
instead of unidimensional psychological outcomes such as body image and anxiety,
may contribute to the lack of evidence on the psychological outcomes of obese
patients after bariatric surgery.
The lack of evidence on psychological outcomes and its implications
It could be argued, that bariatric surgery is an intervention solely intended to achieve
weight loss, rather than an intervention to improve psychological wellbeing. This
questions the severity of implications on the lack of well-designed
RCTs examining the effect of bariatric surgery on psychological health. However, as
we have already discussed, obesity is as much a physical problem as it is
psychological problem. Since bariatric surgery is regarded as the most effective
treatment for obese patients, it is crucial that the impact of bariatric surgery on the
person’s psychological wellbeing should be considered in conjunction with its effect
on weight loss(73, 86).
A study concluded that bariatric surgery alone is unable to provide sufficient
improvement in a patient's psychological health(49). To date, a majority of research
geared to obesity and psychological interventions, are aimed at achieving weight
loss rather than improving psychological health which is a cause for concern(38, 46,
87). Interventions post bariatric surgery that improve the psychological health of obese
patients are desperately required. Health services should focused on monitoring and
improving psychological health offered to obese patient after bariatric surgery(49, 88).
The lack of evidence in this review still leaves us with a degree of uncertainty on the
effect of bariatric surgery on the psychological health of obese patients.
Psychological services after bariatric surgery are being underutilised within the
UK’s national health service (NHS) as a result of the lack of information about how
bariatric psychological services should run within the NHS (83). This lack of
information, may be a consequence of the insufficient evidence currently available
on the psychological impact of bariatric surgery on obese patients.
47
Future research and recommendations
Well-designed RCTs that investigate the effect of bariatric surgery are required to
investigate efficacy of bariatric surgery on improving psychological health of obese
individuals. These RCTs should use other psychological outcomes measures as
well as QoL, such as the Hospital Anxiety and Depression Scale and the Body
Appreciation Scale(89)(90). One potential hurdle that would need to be crossed will be
selecting which psychological outcome to measure, as obesity effects many multiple
aspects of an individual’s psychological well-being(32-). Qualitative research that
explores what psychological issues are most important to this population may be a
potential solution to overcome this hurdle.
Bariatric psychologists should monitor and evaluate patients who have had bariatric
surgery. Alternative interventions and strategies should be developed to improve an
individual’s psychological wellbeing after bariatric surgery. Guidelines should be put
in place for health practitioners on how to monitor and improve the psychological
health of patients post bariatric surgery.
Finally, psychological outcomes should be considered to part of the COS (Core
Outcomes Set) for bariatric surgery. A COS is a standardised collection outcome
measures established by a consensus of researchers and clinicians that are
reported in all trials across a diseases area. It is currently being developed for
bariatric surgery in the Bariatric clinical trial study (BARIACT study)(91). This initiative
was original created by COMET (Core Outcome Measure In Effectiveness trials) to
improve the quality of clinical research by reducing heterogeneity across studies
thereby increasing the strength of potential meta-analysis, and reducing outcome
report bias in trials, amongst other things(92). Including psychological outcomes as
part of the COS could be a significant step in increasing the standard and scope of
research into the psychological impact of bariatric surgery which would could
potentially enhance bariatric psychological care in the long run.
48
Conclusion
This systematic review investigated the effect of surgery on psychological outcomes.
Results from this study suggest that there is insufficient evidence on the effect of
bariatric surgery on psychological outcomes. Fourteen studies reported QoL. Two, of
these studies reported depression. One study reported sexual function. No other
psychological outcomes were reported. However, it is a possibility that this lack
of evidence is due to the fact that only RCTs were included in this study. All
of the studies had a moderate to high risk of bias so inferences must be made with
caution when interpreting the results from these studies.
Conclusions about the relationship between psychological outcomes and the type of
bariatric surgery cannot be made. This is because of the heterogeneity of studies, the
number of studies, the absences of statistical differences between the intervention
and the control group being reported and the poor study design of these studies.
Hence, a greater number of well-designed RCTs are needed for following reasons.
Firstly, to investigate the impact of bariatric surgery on the diverse range of
psychobiological outcomes that affects obese individuals. Secondly, to develop other
interventions that could be used in conjunction with bariatric surgery, not only to
promote weight loss but to improve the psychological health of obese patients.
Including psychological outcomes, into the COS of bariatric surgery is a potential
strategy of improving the research on the effects of bariatric surgery on psychological
health.
49
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http://download.springer.com/static/pdf/781/art%253A10.1381%252F096089206775222113.pdf?auth66=1423588912_6f0cfdaac001b21aacaa6fe535c526c9&ext=.pdf. 71. Barton S. Which clinical studies provide the best evidence?: The best RCT still trumps the best observational study. BMJ: British Medical Journal. 2000;321(7256):255. 72. Evans D. Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions. Journal of clinical nursing. 2003;12(1):77-84. 73. Coulman KD, Abdelrahman T, Owen-Smith A, Andrews RC, Welbourn R, Blazeby JM. Patient-reported outcomes in bariatric surgery: a systematic review of standards of reporting. Obesity Reviews. 2013;14(9):707-20. 74. Tindle H, Omalu B, Courcoulas A, Marcus M, Hammers J, Kuller L. Risk of suicide after long-term follow-up from bariatric surgery. The American journal of medicine. 2010;123(11):1036-42. 75. Peterhänsel C, Petroff D, Klinitzke G, Kersting A, Wagner B. Risk of completed suicide after bariatric surgery: a systematic review. Obesity Reviews. 2013;14(5):369-82. 76. Carpenter KM, Hasin DS, Allison DB, Faith MS. Relationships between obesity and DSM-IV major depressive disorder, suicide ideation, and suicide attempts: results from a general population study. American Journal of Public Health. 2000;90(2):251. 77. Mukamal KJ, Kawachi I, Miller M, Rimm EB. Body mass index and risk of suicide among men. Archives of internal medicine. 2007;167(5):468-75. 78. Klopper EM, Kroese-Deutman HC, Berends FJ. Massive weight loss after bariatric surgery and the demand (desire) for body contouring surgery. European Journal of Plastic Surgery. 2014;37(2):103-8. 79. Kitzinger HB, Abayev S, Pittermann A, Karle B, Kubiena H, Bohdjalian A, et al. The prevalence of body contouring surgery after gastric bypass surgery. OBES SURG. 2012;22(1):8-12. 80. Kubik JF, Gill RS, Laffin M, Karmali S. The Impact of Bariatric Surgery on Psychological Health. Journal of Obesity. 2013;2013:5. 81. Warkentin LM, Das D, Majumdar SR, Johnson JA, Padwal RS. The effect of weight loss on health-related quality of life: systematic review and meta-analysis of randomized trials. Obesity Reviews. 2014;15(3):169-82. 82. Longworth L, Yang Y, Young T, Hernandez Alva M, Mukuria C, Rowen D, et al. Use of generic and condition-specific measures of health-related quality of life in NICE decision-making: systematic review, statistical modelling and survey. 2014. 83. Barcaccia B, Esposito G, Matarese M, Bertolaso M, Elvira M, De Marinis MG. Defining quality of life: a wild-goose chase? Europe’s Journal of Psychology. 2013;9(1):185-203. 84. Kolotkin RL, Crosby RD. Psychometric evaluation of the impact of weight on quality of life-lite questionnaire (IWQOL-lite) in a community sample. Quality of Life Research. 2002;11(2):157-71. 85. Moorehead M, Ardelt-Gattinger E, Lechner H, Oria H. The Validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obesity Surgery. 2003;13(5):684-92. 86. Bocchieri LE, Meana M, Fisher BL. A review of psychosocial outcomes of surgery for morbid obesity. Journal of Psychosomatic Research. 2002;52(3):155-65. 87. Shaw K, O’Rourke P, Del Mar C, Kenardy J. Psychological interventions for overweight or obesity. Cochrane Database Syst Rev. 2005;2(2). 88. Ratcliffe D, Ali R, Ellison N, Khatun M, Poole J, Coffey C. Bariatric psychology in the UK National Health Service: input across the patient pathway. BMC Obesity. 2014;1(1):20.
54
89. Avalos L, Tylka TL, Wood-Barcalow N. The Body Appreciation Scale: development and psychometric evaluation. Body image. 2005;2(3):285-97. 90. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: an updated literature review. Journal of psychosomatic research. 2002;52(2):69-77. 91. Hopkins JC, Howes N, Chalmers K, Savovic J, Whale K, Coulman KD, et al. Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. Obesity Reviews. 2015;16(1):88-106. 92. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132.
55
Appendix 1 Search strategy Embase
1. exp morbid obesity/
2. exp Prader Willi syndrome/
3. exp body mass index/
4. exp obesity/
5. exp abdominal obesity/
6. exp obesity hypoventilation syndrome/
7. Pickwickian.ti,ab.
8. obes*.ti,ab.
9. (obes* adj1 (morbid* or abdom* or diabet*)).ti,ab.
10. (BMI or "body mass index").ti,ab.
11. (hypoventilation adj1 syndrome adj3 obes*).ti,ab.
12. exp stomach bypass/ or exp bariatric surgery/ or exp gastroplasty/
13. (bariatric adj1 surgery).ti,ab.
14. ((gastric or stomach) adj1 (banding or bypass or balloon or stapl*)).ti,ab.
15. " restrictive surgery".ti,ab.
16. "Biliopancreatic diversion".ti,ab.
17. "weight loss surgery".ti,ab.
18. "Laparoscopic adjustable gastric banding".ti,ab.
19. "Rouxen-Y gastric bypass".ti,ab.
20. "Laparoscopic sleeve gastrectomy".ti,ab.
21. Gastroplasty.ti,ab.
22. 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21
23. exp mental health/
56
24. exp depression/
25. exp anxiety/
26. exp "quality of life"/
27. exp body image/
28. exp satisfaction/
29. exp mental disease/
30. exp self esteem/
31. exp psychological aspect/ or exp social adaptation/ or exp attitude to health/
32. exp social interaction/
33. exp social isolation/
34. exp health status/ or exp life satisfaction/ or exp satisfaction/
35. exp self concept/
36. exp psychiatric diagnosis/
37. exp beauty/
38. exp hope/
39. exp mood/
40. exp life stress/ or stress/ or exp mental stress/
41. exp social stigma/ or exp stigma/
42. exp bipolar disorder/
43. exp panic/
44. exp agoraphobia/
45. (mari*l adj1 (satisf* or adjust*)).ti,ab.
46. (sex* adj3 (function* or satisf*)).ti,ab.
47. Divorce*.ti,ab.
57
48. (social adj (function* or inadequ* or isolat* or support* or network* or connect* or
participat*)).ti,ab.
49. lonel*.ti,ab.
50. "Group member*".ti,ab.
51. (satisf* adj3 life).ti,ab.
52. (self adj1 (esteem or concept)).ti,ab.
53. psychopathology.ti,ab.
54. (psychiatric adj1 (symtptoms or diagnosis)).ti,ab.
55. mental health.ti,ab.
56. psychoneuro*.ti,ab.
57. neuro*.ti,ab.
58. satis*.ti,ab.
59. (self adj1 (consciousness or image)).ti,ab.
60. attractiv*.ti,ab.
61. embarras*.ti,ab.
62. (body adj1 (image or disorder* or satis*)).ti,ab.
63. ((concern* or satis*) adj3 (shape or weight)).ti,ab.
64. Grievance.ti,ab.
65. depress*.ti,ab.
66. Hop*.ti,ab.
67. Mood.ti,ab.
68. (psycholog* adj1 (adjust* or health* or wellbeing or "well being" or "well-being" or
adapt*)).ti,ab.
69. ("well being" or wellbeing or "well-being").ti,ab.
70. (perceive* adj3 health*).ti,ab.
58
71. distress*.ti,ab.
72. anxi*.ti,ab.
73. stress*.ti,ab.
74. cop*.ti,ab.
75. ("self efficacy" or "self-efficacy").ti,ab.
76. "locus of control".ti,ab.
77. ("Quality of life" or QoL).ti,ab.
78. ("health related quality of life" or HRQoL).ti,ab.
79. (health adj1 (report* or asses* rate*)).ti,ab.
80. "single-item general health state".ti,ab.
81. "bipolar disorder*".ti,ab.
82. pani*.ti,ab.
83. agoraphobia.ti,ab.
84. 23 or 24 or 25 or 26 or 27 or 28 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or
38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52
or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64 or 65 or 66 or
67 or 68 or 69 or 70 or 71 or 72 or 73 or 74 or 75 or 76 or 77 or 78 or 79 or 80 or 81
or 82 or 83
85. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11
86. 22 and 84 and 85
87. limit 86 to (human and english language and (evidence based medicine or
consensus development or meta analysis or outcomes research or "systematic
review") and randomized controlled trial and ("reviews (maximizes sensitivity)" or
"reviews (maximizes specificity)" or "reviews (best balance of sensitivity and
specificity)" or "therapy (maximizes sensitivity)" or "therapy (maximizes specificity)" or
"therapy (best balance of sensitivity and specificity)" or "diagnosis (maximizes
sensitivity)" or "diagnosis (maximizes specificity)" or "diagnosis (best balance of
59
sensitivity and specificity)" or "prognosis (maximizes sensitivity)" or "prognosis
(maximizes specificity)" or "prognosis (best balance of sensitivity and specificity)" or
"causation-etiology (maximizes sensitivity)" or "causation-etiology (maximizes
specificity)" or "causation-etiology (best balance of sensitivity and specificity)" or
"economics (maximizes sensitivity)" or "economics (maximizes specificity)" or
"economics (best balance of sensitivity and specificity)") and (article or conference
abstract or conference paper or conference proceeding or "conference review" or
journa
l or "review") and (adult <18 to 64 years> or aged <65+ years>))
Search strategy for Medline
1. exp morbid obesity/
2. exp Prader Willi syndrome/
3. exp body mass index/
4. exp obesity/
5. exp abdominal obesity/
6. exp obesity hypoventilation syndrome/
7. Pickwickian.ti,ab.
8. obes*.ti,ab.
9. (obes* adj1 (morbid* or abdom* or diabet*)).ti,ab.
10. (BMI or "body mass index").ti,ab.
11. (hypoventilation adj1 syndrome adj3 obes*).ti,ab.
12. exp stomach bypass/ or exp bariatric surgery/ or exp gastroplasty/
13. (bariatric adj1 surgery).ti,ab.
14. ((gastric or stomach) adj1 (banding or bypass or balloon or stapl*)).ti,ab.
15. " restrictive surgery".ti,ab.
16. "Biliopancreatic diversion".ti,ab.
60
17. "weight loss surgery".ti,ab.
18. "Laparoscopic adjustable gastric banding".ti,ab.
19. "Rouxen-Y gastric bypass".ti,ab.
20. "Laparoscopic sleeve gastrectomy".ti,ab.
21. Gastroplasty.ti,ab.
22. 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21
23. exp mental health/
24. exp depression/
25. exp anxiety/
26. exp "quality of life"/
27. exp body image/
28. exp satisfaction/
29. exp mental disease/
30. exp self esteem/
31. exp psychological aspect/ or exp social adaptation/ or exp attitude to health/
32. exp social interaction/
33. exp social isolation/
34. exp health status/ or exp life satisfaction/ or exp satisfaction/
35. exp self concept/
36. exp psychiatric diagnosis/
37. exp beauty/
38. exp hope/
39. exp mood/
40. exp life stress/ or stress/ or exp mental stress/
61
41. exp social stigma/ or exp stigma/
42. exp bipolar disorder/
43. exp panic/
44. exp agoraphobia/
45. (mari*l adj1 (satisf* or adjust*)).ti,ab.
46. (sex* adj3 (function* or satisf*)).ti,ab.
47. Divorce*.ti,ab.
48. (social adj (function* or inadequ* or isolat* or support* or network* or connect* or
participat*)).ti,ab.
49. lonel*.ti,ab.
50. "Group member*".ti,ab.
51. (satisf* adj3 life).ti,ab.
52. (self adj1 (esteem or concept)).ti,ab.
53. psychopathology.ti,ab.
54. (psychiatric adj1 (symtptoms or diagnosis)).ti,ab.
55. mental health.ti,ab.
56. psychoneuro*.ti,ab.
57. neuro*.ti,ab.
58. satis*.ti,ab.
59. (self adj1 (consciousness or image)).ti,ab.
60. attractiv*.ti,ab.
61. embarras*.ti,ab.
62. (body adj1 (image or disorder* or satis*)).ti,ab.
63. ((concern* or satis*) adj3 (shape or weight)).ti,ab.
64. Grievance.ti,ab.
62
65. depress*.ti,ab.
66. Hop*.ti,ab.
67. Mood.ti,ab.
68. (psycholog* adj1 (adjust* or health* or wellbeing or "well being" or "well-being" or
adapt*)).ti,ab.
69. ("well being" or wellbeing or "well-being").ti,ab.
70. (perceive* adj3 health*).ti,ab.
71. distress*.ti,ab.
72. anxi*.ti,ab.
73. stress*.ti,ab.
74. cop*.ti,ab.
75. ("self efficacy" or "self-efficacy").ti,ab.
76. "locus of control".ti,ab.
77. ("Quality of life" or QoL).ti,ab.
78. ("health related quality of life" or HRQoL).ti,ab.
79. (health adj1 (report* or asses* rate*)).ti,ab.
80. "single-item general health state".ti,ab.
81. "bipolar disorder*".ti,ab.
82. pani*.ti,ab.
83. agoraphobia.ti,ab.
84. 23 or 24 or 25 or 26 or 27 or 28 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or
38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52
or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64 or 65 or 66 or
67 or 68 or 69 or 70 or 71 or 72 or 73 or 74 or 75 or 76 or 77 or 78 or 79 or 80 or 81
or 82 or 83
85. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11
63
86. 22 and 84 and 85
87. limit 86 to (english language and humans and "young adult (19 to 24 years)" or
"adult (19 to 44 years)" or "young adult and adult (19-24 and 19-44)" or "middle age
(45 to 64 years)" or "middle aged (45 plus years)" or "all aged (65 and over)" or "aged
(80 and over)") and randomized controlled trial and ("reviews (maximizes sensitivity)"
or "reviews (maximizes specificity)" or "reviews (best balance of sensitivity and
specificity)" or "therapy (maximizes sensitivity)" or "therapy (maximizes specificity)" or
"therapy (best balance of sensitivity and specificity)" or "diagnosis (maximizes
sensitivity)" or "diagnosis (maximizes specificity)" or "diagnosis (best balance of
sensitivity and specificity)" or "prognosis (maximizes sensitivity)" or "prognosis
(maximizes specificity)" or "prognosis (best balance of sensitivity and specificity)" or
"causation-etiology (maximizes sensitivity)" or "causation-etiology (maximizes
specificity)" or "causation-etiology (best balance of sensitivity and specificity)" or
"economics (maximizes sensitivity)" or "economics (maximizes exp Prader Willi
syndrome/
Psyc Info
1. exp Prader Willi syndrome/
2. exp body mass/
3. exp obesity/
4. exp diabetic obesity/
5. Pickwickian.ti,ab.
6. obes*.ti,ab.
7. (obes* adj1 (morbid* or abdom* or diabet*)).ti,ab.
8. (BMI or "body mass index").ti,ab.
9. (hypoventilation adj1 syndrome adj3 obes*).ti,ab.
10. 1 or 2 or 3 or 4 or 6 or 7 or 8 or 9
11. exp stomach bypass/ or exp bariatric surgery/ or exp gastroplasty/
12. (bariatric adj1 surgery).ti,ab.
64
13. ((gastric or stomach) adj1 (banding or bypass or balloon or stapl*)).ti,ab.
14. " restrictive surgery".ti,ab.
15. "Biliopancreatic diversion".ti,ab.
16. "weight loss surgery".ti,ab.
17. "Laparoscopic adjustable gastric banding".ti,ab.
18. "Rouxen-Y gastric bypass".ti,ab.
19. "Laparoscopic sleeve gastrectomy".ti,ab.
20. Gastroplasty.ti,ab.
21. 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20
22. exp mental health/
23. exp depression/
24. exp anxiety/
25. exp "quality of life"/
26. exp well being/
27. exp body image/
28. exp satisfaction/
29. exp self esteem/
30. exp emotional stability/
31. exp psychological aspect/ or exp social adaptation/ or exp attitude to health/
32. exp social interaction/
33. exp social isolation/
34. exp health status/ or exp life satisfaction/ or exp satisfaction/
35. exp self concept/
36. exp physical attractiveness/
65
37. exp hope/
38. exp life stress/ or stress/ or exp mental stress/
39. exp social stigma/ or exp stigma/
40. exp bipolar disorder/
41. exp panic/
42. exp agoraphobia/
43. (mari*l adj1 (satisf* or adjust*)).ti,ab.
44. (sex* adj3 (function* or satisf*)).ti,ab.
45. Divorce*.ti,ab.
46. (social adj1 (function* or inadequ* or isolat* or support* or network* or connect*
or participat*)).ti,ab.
47. lonel*.ti,ab.
48. "Group member*".ti,ab.
49. (satisf* adj3 life).ti,ab.
50. (self adj1 (esteem or concept)).ti,ab.
51. psychopathology.ti,ab.
52. (psychiatric adj1 (symtptoms or diagnosis)).ti,ab.
53. mental health.ti,ab.
54. psychoneuro*.ti,ab.
55. neuro*.ti,ab.
56. satis*.ti,ab.
57. (self adj1 (consciousness or image)).ti,ab.
58. attractiv*.ti,ab.
59. embarras*.ti,ab.
60. (body adj1 (image or disorder* or satis*)).ti,ab.
66
61. ((concern* or satis*) adj3 (shape or weight)).ti,ab.
62. Grievance.ti,ab.
63. depress*.ti,ab.
64. Hop*.ti,ab.
65. Mood.ti,ab.
66. (psycholog* adj1 (adjust* or health* or wellbeing or "well being" or "well-being" or
adapt*)).ti,ab.
67. ("well being" or wellbeing or "well-being").ti,ab.
68. (perceive* adj3 health*).ti,ab.
69. distress*.ti,ab.
70. anxi*.ti,ab.
71. stress*.ti,ab.
72. cop*.ti,ab.
73. ("self efficacy" or "self-efficacy").ti,ab.
74. "locus of control".ti,ab.
75. ("Quality of life" or QoL).ti,ab.
76. ("health related quality of life" or HRQoL).ti,ab.
77. (health adj1 (report* or asses* rate*)).ti,ab.
78. "bipolar disorder*".ti,ab.
79. pani*.ti,ab.
80. agoraphobia.ti,ab.
81. 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or
36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50
or 51 or 52 or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64 or
65 or 66 or 67 or 68 or 69 or 70 or 71 or 72 or 73 or 74 or 75 or 76 or 77 or 78 or 79
or 80
67
82. 10 and 21 and 81
83. limit 82 to (randomized controlled trial and ("reviews (maximizes sensitivity)" or
"reviews (maximizes specificity)" or "reviews (best balance of sensitivity and
specificity)" or "therapy (maximizes sensitivity)" or "therapy (maximizes specificity)" or
"therapy (best balance of sensitivity and specificity)" or "diagnosis (maximizes
sensitivity)" or "diagnosis (maximizes specificity)" or "diagnosis (best balance of
sensitivity and specificity)" or "prognosis (maximizes sensitivity)" or "prognosis
(maximizes specificity)" or "prognosis (best balance of sensitivity and specificity)" or
"causation-etiology (maximizes sensitivity)" or "causation-etiology (maximizes
specificity)" or "causation-etiology (best balance of sensitivity and specificity)" or
"economics (maximizes sensitivity)" or "economics (maximizes specificity)" or
"economics (best balance of sensitivity and specificity)") and english and (conference
abstract or conference paper or journal or "review") and (adult <18 to 64 years> or
aged <65+ years>))
Search terms for CINHAL
1. (MH "Obesity+") OR (MH "Obesity, Morbid")
2. (MH "Pickwickian Syndrome")
3. TI obes*. AND AB obes*.
4. (MH "Body Mass Index")
5. TI((obes* N1 (morbid* or abdom* or diabet*)). AND AB ((obes* N1 (morbid* or abdom* or
diabet*))
6. TI ( (BMI or "body mass index") ) AND AB ( (BMI or "body mass index") )
7. TI (hypoventilation N1 syndrome N3 obes*). AND AB (hypoventilation N1 syndrome N3
obes*)
8. 1 OR 2 OR 3 OR 4 OR 5 OR 6 or 7 or S83 or s86
9. (MH "Bariatric Surgery")
10. (MH "Gastric Bypass")
11. MH "Gastroplasty")
12. TI (bariatric N1 surgery) AND AB (bariatric N1 surgery)
68
13. TI ( ((gastric or stomach) N1 (banding or bypass or balloon)) ) AND AB ( ((gastric or
stomach) N1 (banding or bypass or balloon)) )
14. TI "biliopancreatic diversion" AND AB "Biliopancreatic diversion" TI “restrictive surgery”.
AND AB “restrictive surgery”.
15. TI mood AND AB mood
16. TI “weight loss surgery”. AND AB “weight loss surgery”.
17. TI ( TI Laparoscopic adjustable gastric banding AND AB Laparoscopic ) AND AB
adjustable gastric banding
18. TI Rouxen-Y gastric bypass AND AB Rouxen-Y gastric bypass
19. TI Laparoscopic sleeve gastrectomy AND AB Laparoscopic sleeve gastrectomy
20. TI gastroplasty AND AB gastroplasty
21. 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19
22. (Mental Health")
23. (MH "Depression+") OR (MH "Bipolar Disorder+")
24. (MH "Anxiety+")
25. (MH "Quality of Life+")
26. (MH "Psychological Well-Being")
27. TI ( (health N1 (report* or asses* rate*)) ) AND AB ( (health N1 (report* or asses* rate*)) )
28. (MH "Body Image+")
29. (MH "Personal Satisfaction+")
30. MH "Self Concept")
31. (MH "Psychosocial Aspects of Illness+")
32. (MH "Adaptation, Psychological+")
33. (MH "Attitude to Health+")
34. (MH "Interpersonal Relations+")
35. (MH "Social Isolation+")
36. (MH "Health Status+")
37. (MH "Diagnosis, Dual (Psychiatry)")
38. TI "Pickwickian" OR AB "Pickwickian"
39. (MH "Mental Disorders+")
40. (MH "Personal Appearance+")
41. (MH "Hope")
42. (MH "Affect")
69
43. (MH "Stress+")
44. (MH "Stigma")
45. (MH "Panic Disorder")
46. (MH "Agoraphobia")
47. TI ( (mar* N1 (satisf* or adjust*)). ) AND AB ( (mar* N1 (satisf* or adjust*)). )
48. TI ( (sex* N3 (function* or satisf*)) ) AND AB ( (sex* N3 (function* or satisf*)) )
49. TI Divorce*. AND AB Divorce*.
50. TI ( (social N3 (function* or inadequ* or isolat* or support* or network* or connect* or
participat*)) ) AND AB ( (social N3 (function* or inadequ* or isolat* or support* or network*
or connect* or participat*)) )
51. TI Lonel*. AND AB Lonel*.
52. TI “Group member*”. AND AB “Group member*”.
53. TI (satisf* N3 life). AND AB (satisf* N3 life).
54. TI ( (self N1 (esteem or concept)). ) AND AB ( (self N1 (esteem or concept)). )
55. TI psychopathology. AND AB psychopathology
56. TI ( ((psychiatric N1 (symptoms or diagnosis)). ) AND AB ( ((psychiatric N1 (symptoms or
diagnosis)). )
57. TI “mental health”. AND AB “mental health”.
58. TI psychoneuro*. AND AB psychoneuro*.
59. TI neuro*. AND AB neuro*.
60. TI Satisf*. AND AB Satisf*.
61. Search modes - Boolean/Phrase
62. TI ( (self N1 (consciousness or image)). ) AND AB ( (self N1 (consciousness or image)). )
63. TI Attractive*. AND AB Attractive*.
64. TI Embarras*. AND AB Embarras*.
65. TI Embarras*. AND AB Embarras*.
66. TI ( (body N1 (image or disorder* or satisf*)). ) AND AB ( (body N1 (image or disorder* or
satisf*)). )
67. TI ( ((concern* or satisf*) N3 (shape or weight)) ) AND AB ( ((concern* or satisf*) N3
(shape or weight)) )
68. TI Grievance. AND AB Grievance.
70
69. TI depressio* AND AB depressio*
70. TI Hop*. AND AB Hop*.
71. TI ( (psycholog* N1 (adjust* or health* or wellbeing or “well being” or “well-being” or
adapt*)) ) AND AB ( (psycholog* N1 (adjust* or health* or wellbeing or “well being” or “well-
being” or adapt*)
72. TI ( (Wellbeing or “well being” or “well-being”). ) AND AB (Wellbeing or “well being” or
“well-being”).
73. Ti (perceive* N3 health*) AND AB (perceive* N3 health*).
74. TI Distress*. AND AB Distress*.
75. TI Anxi*. AND AB Anxi*.
76. TI Stress*. AND AB Stress*.
77. TI Cop*. AND AB Cop*.
78. TI ( (“self efficacy” or “self-efficacy”). ) AND AB ( (“self efficacy” or “self-efficacy”). )
79. TI “locus of control”. AND AB “locus of control”.
80. TI ( (“Quality of life” or QoL). ) AND AB ( (“Quality of life” or QoL). )
81. TI ( (“health related quality of life” or HRQoL). ) AND AB ( (“health related quality of life” or
HRQoL). )
82. TI “bipolar disorder*”. AND AB “bipolar disorder*”.
83. . TI Pani*. AND AB Pani*.
84. TI Agoraphobia. AND AB Agoraphobia.
85. 20 OR 21 OR 22 OR 23 OR 24 OR 25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32
OR 33 OR 34 OR 35 OR 36 OR 37 OR 38 OR 39 OR 40 OR 41 OR 42 OR 43 OR 44 OR
45 OR 46 OR 47 OR 48 OR 49 OR 50 OR 51 OR 52 OR 53 OR 54 OR 55 OR 56 OR 57
OR 58 OR 59 OR 60 OR 61 OR 62 OR 63 OR 64 OR 65 OR 66 OR 67 OR 68 OR 69 OR
70 OR 71 OR 72 OR 73 OR 74 OR 75 OR 76 OR 77 OR 78 OR 79 OR 80 OR 81 OR 82
OR 84 OR 85
86. 9 AND 19 AND 85
87. Limit 86 to - English Language; Clinical Queries: Therapy - High Sensitivity, Therapy -
High Specificity, Therapy - Best Balance, Prognosis - High Sensitivity, Prognosis -
71
Specificity, Prognosis - Best Balance, Review - High Sensitivity, Review - High Specificity,
Review - Best Balance, Causation (Etiology) - High Sensitivity, Causation (Etiology) - High
Specificity, Causation (Etiology) - Best Balance; Human; Randomized Controlled Trials;
Publication Type: Abstract, Clinical Trial, Journal Article, Meta Analysis, Proceedings,
Protocol, Randomized Controlled Trial, Research, Systematic Review; Age Groups:
Adolescent: 13-18 years, Adult: 19-44 years, Middle Aged: 45-64 years, Aged: 65+ years,
Aged, 80 and over, All Adult
72
Appendix 2
Guidelines for titles and abstracts screening
The Endnote file (prepared by Tumi) contains full citations for all research articles
identified by the database searches. It also contains links to PDFs of the full text
articles. The task now is to review all of the articles against the criteria listed below.
The purpose of this is to determine which articles will be included in the final review.
Work your way through each article and complete the details on the attached “PICO”
form (one for each article). This requires you to look at characteristics of the
Population, the Intervention, the Comparator (control), and the Outcomes and decide
whether the article meets the specified criteria outlined on the next page.
Once you have made this decision, you need to indicate whether the article should
be included in the review, also taking account of the “general characteristics” of the
article overleaf. Note that to be included in the review, the article must meet all of the
criteria (if it doesn’t meet the criteria, it shouldn’t be included). There is a space for
you to comment on your decision (e.g., a study might not be an RCT, the population
might not be adults, or the outcomes might not be psychological and so on).
Finally, use the “second reviewer” column in the Endnote file to indicate whether you
are recommending the article for inclusion or not:
Code 1 = Study should be included
Code 2 = Study should not be included
Criteria to be used in deciding selections are on the next page
73
Selection criteria
(a) General characteristics of the article
i) Articles must report a randomized controlled trial OR present a review of
randomized controlled trials (e.g., a systematic review)
ii) Articles must be written in English
iii) There are no date restrictions
iv) Research participants must be humans (we are not interested in non-human,
animal studies)
(b) Study Population (the participants in the study)
To include:
Obese people with BMI equal to or more than 30
- Adults equal to or older than 18 years
(c) Intervention (what participants in the study are exposed to)
To include:
Participants should have received weight-loss surgery (bariatric surgery) of any type
(d) Comparator (what the intervention is compared to — possibly the “control”)
To include:
Any comparator (e.g., other surgery, no surgery, other intervention/treatment)
74
(e) Outcomes (what effects are tested on: i.e., the outcome variables)
Must report at least one psychological outcome including, but not limited to*:
- Mental disorders (e.g., depression, bipolar disorder, anxiety, agoraphobia etc.)
- Psychological symptoms (e.g., distress, stress, panic, grievance, loneliness, coping,
hopefulness, mood etc.)
- Health (e.g., wellbeing, quality of life, health status, life satisfaction etc.)
- Social (e.g., martial/sexual satisfaction, social function, social inadequacy, social
isolation, social participation etc.)
- Self (e.g., self-esteem, self-efficacy, attractiveness, embarrassment, body image
disorder, body shape satisfaction, self-consciousness etc.)
*See Tumi’s search terms for the definitive list
ANY ARTICLES THAT YOU ARE NOT SURE ABOUT MUST BE INCLUDED, BUT
ADD A NOTE TO THE FORM SAY THAT YOU ARE UNSURE.
75
t at least one psychological outcome including, but not limited to*:
- Mental disorders (e.g., depression, bipolar disorder, anxiety, agoraphobia etc.)
- Psychological symptoms (e.g., distress, stress, panic, grievance, loneliness, coping,
hopefulness, mood etc.)
- Health (e.g., wellbeing, quality of life, health status, life satisfaction etc.)
- Social (e.g., martial/sexual satisfaction, social function, social inadequacy, social
isolation, social participation etc.)
- Self (e.g., self-esteem, self-efficacy, attractiveness, embarrassment, body image
disorder, body shape satisfaction, self-consciousness etc.)
*See Tumi’s search terms for the definitive list
ANY ARTICLES THAT YOU ARE NOT SURE ABOUT MUST BE INCLUDED, BUT
ADD A NOTE TO THE FORM SAY THAT YOU ARE UNSURE.
Appendix 3
Guidelines for eligibility screening of full articles
The Endnote file (prepared by Tumi) contains full citations for all research articles
identified by the database searches. It also contains links to PDFs of the full text
articles. The task now is to review all of the articles against the criteria listed below.
The purpose of this is to determine which articles will be included in the final review.
Work your way through each article and complete the details on the attached “PICO”
form (one for each article). This requires you to look at characteristics of the
Population, the Intervention, the Comparator (control), and the Outcomes and decide
whether the article meets the specified criteria outlined on the next page.
Once you have made this decision, you need to indicate whether the article should
be included in the review, also taking account of the “general characteristics” of the
article overleaf. Note that to be included in the review, the article must meet all of the
76
criteria (if it doesn’t meet the criteria, it shouldn’t be included). There is a space for
you to comment on your decision (e.g., a study might not be an RCT, the population
might not be adults, or the outcomes might not be psychological and so on).
Finally, use the “second reviewer” column in the Endnote file to indicate whether you
are recommending the article for inclusion or not:
Code 1 = Study should be included
Code 2 = Study should not be included
Criteria to be used in deciding selections are on the next page
77
Selection criteria
(a) General characteristics of the article
i) Articles must report a randomized controlled trial OR present a review of
randomized controlled trials (e.g., a systematic review)
ii) Articles must be written in English
iii) There are no date restrictions
iv) Research participants must be humans (we are not interested in non-human,
animal studies)
(b) Study Population (the participants in the study)
To include:
- Obese people with BMI equal to or more than 30
- Adults equal to or older than 18 years
(c) Intervention (what participants in the study are exposed to)
To include:
- Participants should have received weight-loss surgery (bariatric surgery) of any type
78
(d) Comparator (what the intervention is compared to — possibly the “control”)
To include:
- Any comparator (e.g., other surgery, no surgery, other intervention/treatment)
(e) Outcomes (what effects are tested on: i.e., the outcome variables)
Must report at least one psychological outcome including, but not limited to*:
- Mental disorders (e.g., depression, bipolar disorder, anxiety, agoraphobia etc.)
- Psychological symptoms (e.g., distress, stress, panic, grievance, loneliness, coping,
hopefulness, mood etc.)
- Health (e.g., wellbeing, quality of life, health status, life satisfaction etc.)
- Social (e.g., martial/sexual satisfaction, social function, social inadequacy, social
isolation, social participation etc.)
- Self (e.g., self-esteem, self-efficacy, attractiveness, embarrassment, body image
disorder, body shape satisfaction, self-consciousness etc.)
*See Tumi’s search terms for the definitive list
ANY ARTICLES THAT YOU ARE NOT SURE ABOUT MUST BE INCLUDED, BUT
ADD A NOTE TO THE FORM SAY THAT YOU ARE UNSURE.
79
Appendix 4
Full Paper Screening - PICO Form
Please complete all fields in this section:
Author:
Year:
Title:
Citation:
Screener:
Please complete this section using the Guidelines provided. A mark in the ‘no’ field
will be deemed the reason for exclusion and additional fields need not be filled in
such an instance:
Yes No
Population:
Obese (e.g., BMI =>30)?
Intervention:
Bariatric Surgery?
Comparison:
Control? (any)
Outcome:
Psychological Outcome?
Comments?
80
Please indicate whether you recommend to include this paper, or not, at data
extraction stage:
Recommendation:
Include for data extraction?
DON’T FORGET TO COMPLETE THE “SECOND REVIEWER” COLUMN IN
ENDNOTE TO INDICATE YOUR DECISION.
81
Appendix 5 Cochrane Risk of Bias
Domain Support for judgement Review author’s judgement
Selection bias.
Domain Support for judgement Review authors judgement
Selection bias
Random sequence
generation.
Allocation concealment.
Performance bias.
Blinding of participants
and personnel
Assessment should be made
for each main outcome (or
class of outcomes.)
Detection bias.
Blinding of outcomes
assessment Assessments
should be made for each
main outcome (or class of
outcomes).
Attrition bias.
Incomplete outcome data
Assessment should be made
for each main outcome (or
class of outcomes).
Reporting bias.
Selective reporting.
Other bias.
Other sources of bias.
82
Appendix 6 Surgical (intervention) vs Non-surgical RCTs (Control)
Author Data Psychological Outcome Measure
Range Pre-treatment mean and (SD) intervention
Post treatment meant and (SD) intervention
Pre-treatment mean and (SD) control
Post treatment mean and (SD) control
Difference between post treatment mean and pre-treatment mean (intervention)
Difference between post treatment mean and pre-treatment mean (control)
Percentage change from pre-surgery to post-surgery (intervention)
Percentage change from pre-surgery to post-surgery (control)
Statistical significance between the change in intervention mean and change in control
Statistical significance between the post-treatment mean and pre-treatment mean
Halperin 2014 SF- 36 (total) 0-100 66.24 (17.75)
68.24 71.56 (12.38)
73.6 2 2 3.02% 2.72% NR NR ( I ) NR( c )
SF- 36 (Physical Health)
0-100 61.32 (19.66)
66.32 68.61 (13.22)
72.6 5 4 8.15% 5.51% NR NR ( I ) NR( c )
SF- 36 (Mental Health)
0-100 63.49 (16.24)
68.49 63.67 (1188)
63.5 5 -0.16 7.88% -0.25% NR NR ( I )S( c )
PAID 0-100 $
52.63 (16.38)
32.5 56.18 (12.59)
36.8 -20.13 -19.38 -38.25% -52.66% NR S ( I ) S ( C )
EQ-5D 0-1 0.8 (0.15) 0.87 (0.09)
-0.8 -0.87 NR NR ( I ) NR ( C )
EQ-5D VAS 0-100 65.11 (17.67)
81.11 64.19 (14.16)
72.2 16 8 24.57% 11.08% NR S ( I ) S ( C )
I QWOL 0-100 81.5 (26.4)) 49.5 68.63 (17.5)
51.63 -32 -17 -39.26% -24.77 S S ( I ) S ( C )
O'Brien 2006 SF -36 Physical Functioning
0-100 64 90 70 83 26 13 40.63% 15.66% S NR ( I ) NR ( C )
SF -36 Role- Physical
0-100 62 92 66 67 30 1 48.39% 1.49% S NR ( I ) NR ( C )
SF-36 Bodily Pain
0-100 65 81 70 76 16 6 24.62% 7.89% NR NR ( I ) NR ( C )
SF- 36 General Health
0-100 45 77 58 64 32 6 71.11% 9.38% S NR ( I ) NR ( C )
SF -36 Vitality 0-100 38 77 39 58 39 19 102.63% 32.76% S NR ( I ) NR ( C )
Sf -36 Social Functioning
0-100 61 82 70 78 21 8 34.43% 10.26% NR NR ( I ) NR ( C )
SF -36 Role-Emotional
0-100 58 90 71 70 32 -1 55.17% -1.43% S NR ( I ) NR ( C )
SF -36 Mental Health
0-100 60 73 60 69 13 9 21.67% 13.04% NR NR ( I ) NR ( C )
O'Brien 2013 SF -36 physical Health Composite score
0-100 45.78 (10.6) 48 (10.53) 49.02 (8.1) 52.8 (3.9) 2.22 3.74 4.85% 7.09% S NR ( I ) NR ( C )
SF -36 Mental Health composite score
0-100 46.03 (9.23) 50.77 (6.27) 47.65 (8.46) 49.6 (5.72) 4.74 1.94 10.30% 3.91% NS NR ( I ) NR ( C )
83
Table showing psychological outcomes data of RCTs that compared surgical intervention with non surgical intervention Statiscal significance
p<0.005 . Range: Higher the numbers = belter quality of life. $ : Higher number = worse quality of life
Ponce 2013 SF -36 Physical component
0-100 49.8 53.2 49.8 52.1 3.4 NR NR ( I ) NR ( C )
SF -36 Physical Functioning
0-100 83.6 92 82.8 87.1 8.4 4.3 10.05% 4.94% NR NR ( I ) NR ( C )
SF -36 Role- Physical
0-100 91.7 93.8 87 89.3 2.1 2.3 2.29% 2.58% NR NR ( I ) NR ( C )
SF-36 Bodily Pain
0-100 83.7 88.7 79.2 85.4 5 6.2 5.97% 7.26% NR NR ( I ) NR ( C )
SF- 36 General Health
0-100 73.9 81.4 86.8 86.1 7.5 -0.7 10.15% -0.81% NR NR ( I ) NR ( C )
SF -36 Vitality 0-100 70.2 72.5 72.8 68.6 2.3 -4.2 0.033 -6.12% NR NR ( I ) NR ( C )
SF- 36 Mental Component
0-100 57.6 56.4 58.9 56.3 -1.2 -2.6 -0.02 -4.62% NR NR ( I ) NR ( C )
Sf -36 Social Functioning
0-100 96.4 95 95.8 94.6 -1.4 -1.2 -0.01 -1.27% NR NR ( I ) NR ( C )
SF -36 Role-Emotional
0-100 98.4 98.5 100 95.2 0.1 -4.8 0.00 -5.04% NR NR ( I ) NR ( C )
SF -36 Mental Health
0-100 87.3 87.2 89.6 87.4 -0.1 -2.2 -0.00 -2.52% NR NR ( I ) NR ( C )
Reis 2009 IIEF-5 Jan-25 19.7 (6.6) 23 (2.3) 17.2 (7.9) 17.3 (6.7) 3.3 0.1 0.17 0.58% S NR ( I ) NR ( C )
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
84
Appendix 7
Laparoscopic (intervention) vs Open (control) RCTs
Author Data Range Pre-treatment mean and (SD) intervention
Post treatment meant and (SD) intervention
Pre-treatment mean and (SD) control
Post treatment mean and (SD) control
Difference between post treatment mean and pre-treatment mean (intervention)
Difference between post treatment mean and pre-treatment mean (control)
Percentage change from pre-surgery to post-surgery (intervention)
Percentage change from pre-surgery to post-surgery (control)
Statistical significance between the change in intervention mean and change in control
Statistical significance between the post-treatment mean and pre-treatment mean
Nguyen 2001 0-100 46.5 (21.9) 80.2 (19.1) 40 (24.4) 67.8 (26.6) 33.7 27.8 72.47% 41.00% S NR ( I ) NR ( C)
0-100 47.2 (40.2) 80.7 (32.5) 37.5 (37.9) 76.8 (33.3) 33.5 39.3 70.97% 51.17% NS NR ( I ) NR ( C)
0-100 51 (22.7) 75.1 (24.7) 48.7 (24.1) 68.1 (25.6) 24.1 19.4 47.25% 28.49% NS NR ( I ) NR ( C)
0-100 54.5 (21.6) 77.2 (15.7) 52.9 (22.3) 72.4 (16.5) 22.7 19.5 41.65% 26.93% NS NR ( I ) NR ( C)
0-100 38.5 (20) 65.8 (17.7) 36.6 (19,9) 73.1 8(95.2) 27.3 36.5 70.91% 49.93% NR NR ( I ) NR ( C)
0-100 64.4 (26,3) 87.3 (17.9) 61.6 (29.5) 74.1 (30) 22.9 12.5 35.56% 16.87% S NR ( I ) NR ( C)
0-100 49.1 (24.4) 83 (29.0) 45.5 (27.2) 74.6 (40.7) 33.9 29.1 69.04% 39.01% NS NR ( I ) NR ( C)
0-100 73 (15.1) 82.9 (14.2) 71.9 (17.3) 75 9.9 3.1 13.56% 4.13% NS NR ( I ) NR ( C)
-3 - +3 0.84 (0.27) 0.8 (0.27) 0.84 NS NR ( I ) NR ( C)
-3 - +3 0.48 (0.4) 0.34 (0.18) 0.48 NS NR ( I ) NR ( C)
-3 - +3 0.31 (0.19) 0.29 (0) 0.31 NS NR ( I ) NR ( C)
-3 - +3 0.24 (0.19) 0.21 (0.27) 0.24 NS NR ( I ) NR ( C)
-3 - +3 0.26 (0.2) 0.19 (0.25) 0.26 NS NR ( I ) NR ( C)
25% 11% NR NR ( I ) NR ( C)
47% 39% NR NR ( I ) NR ( C)
25& 32% NR NR ( I ) NR ( C)
3% 14% NR NR ( I ) NR ( C)
0% 4% NR NR ( I ) NR ( C)
Puzziferri 2006 -3 - +3 0.89 0.88 NR NR ( I ) NR ( C)
-3 - +3 0.4 0.36 NR NR ( I )
85
NR ( C)
-3 - +3 0.34 0.33 NR NR ( I ) NR ( C)
-3 - +3 0.33 0.25 NR NR ( I ) NR ( C)
-3 - +3 0.2 0.24 NR NR ( I ) NR ( C)
-3 - +3 0 4.3 % 2% NR NR ( I ) NR ( C)
9% 4.5% NR NR ( I ) NR ( C)
13.4% 18.1% NR NR ( I ) NR ( C)
50% 63.6% NR NR ( I ) NR ( C)
22.7% 13.6% NR NR ( I ) NR ( C)
Table showing psychological outcome data studies that compared Laparoscopic surgery with open surgery statistical significance
P<0.005 . Range: higher number = better quality of life
Open surgery (control) vs Laparoscopic surgery (intervention) continued
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
86
Author
Year Outcome Percentage of intervention participation
Percentage of control participation
Nguyen 2001 BAROS Failure Rate Score 0 4
BAROS Fair Sore 3 14
BAROS Good Score 25 32
BAROS Very Good Sore 47 39
BAROS Excellent Score 25 11
Puzziferri 2006 BAROS Failure Rate Score 4.3 2
BAROS Fair Sore 9 4.5
BAROS Good Score 13.4 18.1
BAROS Very Good Score 50 63.6
BAROS Excellent Score 22.7 13.6
Depression improvement Score 79 71
87
Appendix 8
Laparoscopic Roux -en Y Gastric Bypass (intevention ) vs Mini Roux - en-Y Gastric Bypass (control)
Author Data Psychological Outcome Measure
Range Pre-treatment mean and (SD) intervention
Post treatment meant and (SD) intervention
Pre-treatment mean and (SD) control
Post treatment mean and (SD) control
Difference between post treatment mean and pre-treatment mean (intervention)
Difference between post treatment mean and pre-treatment mean (control)
Percentage change from pre-surgery to post-surgery (intervention)
Percentage change from pre-surgery to post-surgery (control)
Statistical significance between the change in intervention mean and change in control
Statistical significance between the post-treatment mean and pre-treatment mean
Lee 2005 GIQLI Overall 0-128 99.6 (19.1) 113.3 (16.1) 104.6 (18.5)
113.9 (17) 13.7 9.3 13.76% 8.17% NR S ( I ) S (IC)
GIQLI symptoms
0-128 59.8 (7) 60.1 (9) 63.2 (6.2) 58.9 (10.3) 0.3 -4.3 0.50% -7.30% NR NR (I ) NR (C )
GIQLI physical 0-128 14.6 (6.3) 20.9 (4.8) 16.2 (5.8) 21.3 (4.2) 6.3 5.1 43.15% 23.94% NR S ( I ) S (C )
GIQLI emotional
0-128 12 (4.4) 15 (3.7) 11.8 (3.3) 15.8 (4.8) 3 4 25.00% 25.32% NR S ( I ) S (C )
GIQLI Social 0-128 13.2 (2) 17.3 (2.8) 13.4 (6.7) 17.9 (6.1) 4.1 4.5 31.06% 25.14% NR S ( I ) S (IC)
Table showing the psychological outcome data of a RCT that compared laparoscopic Roux en Y Gastric Bypass with Mini Roux en Y
Gastric bypass Statistical significance = p <0.005. Range: higher numbers = better quality of life .
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
88
Appendix 9
Roux –en- Y Gastric by pass vs Duodenal Switch
Author Data Psychological Outcome Measure
Range Pre-treatment mean and (SD) intervention
Post treatment meant and (SD) intervention
Pre-treatment mean and (SD) control
Post treatment mean and (SD) control
Difference between post treatment mean and pre-treatment mean (intervention)
Difference between post treatment mean and pre-treatment mean (control)
Percentage change from pre-surgery to post-surgery (intervention)
Percentage change from pre-surgery to post-surgery (control)
Statistical significance between the change in intervention mean and change in control
Statistical significance between the post-treatment mean and pre-treatment mean
Sovik 2011 SF -36 Physical Functioning
0-100 57.3 (21.1) 90.3 50.9 (26) 87.3 33 36.4 58% 41.70% NS NR (I) NR (C)
SF -36 Role- Physical
0-100 54 (33.7) 86.9 54.5 (35.3) 76.6 32.9 22.1 61% 28.85% NS NR (I) NR (C)
SF-36 Bodily Pain
0-100 43.7 (26.2) 79.6 52 (32.4) 59.4 35.9 7.4 82% 12.46% S NR (I) NR (C)
SF- 36 General Health
0-100 49.5 (21.7) 77.2 46 (21.1) 74.9 27.7 28.9 56% 38.58% NS NR (I) NR (C)
SF -36 Vitality 0-100 37.7 ( 21.7) 58.6 38.8 (24.8) 58.2 20.9 19.4 55% 33.33% NS NR (I) NR (C)
Sf -36 Social Functioning
0-100 65.7 (33.3) 78.9 62.5 (32.6) 82.8 13.2 20.3 20% 24.52% NS NR (I) NR (C)
SF -36 Role-Emotional
0-100 70.4 (32.8) 82.7 69.3 (36.6) 81 12.3 11.7 17% 14.44% NS NR (I) NR (C)
SF -36 Mental Health
0-100 67.9 (20.9) 69.3 62.1 (22.3) 73.1 1.4 11 2% 15.05% NS NR (I) NR (C)
Table showing the psychological outcomes of data from an RCT that compare Roux en Y Gastric By Pass with Duodenal Switch Significance
between the intervention and control. Significance within comparing post treatment with post treatment. Statistical significance: p<0.005 higher
numbers = better quality of life
89
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator
90
Appendix 10 Roux -en –Y gastric bypass (intervention) vs Restrictive surgery (control)
Author Data Psychological Outcome Measure
Range Pre-treatment mean and (SD) intervention
Post treatment meant and (SD) intervention
Pre-treatment mean and (SD) control
Post treatment mean and (SD) control
Difference between post treatment mean and pre-treatment mean (intervention)
Difference between post treatment mean and pre-treatment mean (control)
Percentage change from pre-surgery to post-surgery (intervention)
Percentage change from pre-surgery to post-surgery (control)
Statistical significance between the change in intervention mean and change in control
Statistical significance between the post-treatment mean and pre-treatment mean
Nguyen 2009 SF -36 Physical Functioning
0-100 44 50 89 83 6 -3 13.64% 3.75% NS NR (I) NR (C)
SF -36 Role- Physical
0-100 38 42 82 85 4 3 10.53% 3.66% NS NR (I) NR (C)
SF-36 Bodily Pain
0-100 50 52 80 81 2 1 4.00% 1.23% NS NR (I) NR (C)
SF- 36 General Health
0-100 49 80 51 80 31 29 63.27% 36.25% NS NR (I) NR (C)
SF -36 Vitality 0-100 36 45 70 80 9 10 25.00% 14.29% NS NR (I) NR (C)
Sf -36 Social Functioning
0-100 45 90 51 92 45 41 100.00% 44.57% NS NR (I) NR (C)
SF -36 Role-Emotional
0-100 65 96 65 90 31 25 47.69% 27.78% NS NR (I) NR (C)
SF -36 Mental Health
0-100 65 80 70 84 15 14 23.08% 16.67% NS NR (I) NR (C)
Pertelli 2013 GIQLI 0-144 98.8 (17.4) 128 99 (20.5) 128 29.2 28 22.81% 22.81% NR S (I) S (C)
Depression 5% cured 82% improved
11% 15% cured 70% impuuxroved
NS
Table showing the psychologicial outcome data of Roux -en –Y gastric bypass vs Restrictive surgery. Range: higher number = better quality of
life. Statistical significance, p < 0.005.
Key
Notation Meaning
S Statistical significant
NS No Statistical Significance
91
NR Not Reported
(I) Intervention
(C) Comparator
92
Appendix 11
Restrictive surgery (intervention) vs Restrictive surgery ( control)
Author Year Psychological outcome measure
Range Pre-surgery mean SD intervention
Post-surgery mean SD Control
Pre-surgery mean SD intervention
Post-surgery SD control
Change in intervention
Change in control
% Change in intervention
% change in control
Significance B
Significance W
Mastrigt 2006 EQ-5D 0-1 0.58 0.84 0.67 0.84 0.26. 0.16 44.8 % 29.28 NS S (I) S( C)
Obrien 2005 SF -36 Physical Functioning
0-100 46 81 48 80 35 32 76.09% 40.00% NR S (I) S (C)
SF -36 Role- Physical
0-100 44 81 48 78 37 30 84.09% 38.46% NR S (I) S (C)
SF-36 Bodily Pain 0-100 61 83 61 76 22 15 36.07% 19.74% NR S (I) S (C)
SF- 36 General Health
0-100 41iv 68 42 70 27 28 65.85% 40.00% NR S (I) S (C)
SF -36 Vitality 0-100 32 59 35 59 27 24 84.38% 40.68% NR S (I) S (C)
Sf -36 Social Functioning
0-100 58 76 58 79 18 21 31.03% 26.58% NR S (I) S (C)
SF -36 Role-Emotional
0-100 53 79 53 71 26 18 49.06% 25.35% NR S (I) S (C)
SF -36 Mental Health
0-100 59 69 59 69 10 10 16.95% 14.49% NR S (I) S (C)
Suter Moorehead Ardelt Quality of life
-3- +3 1.76 1.71 NS NR (I) NR (C)
Weiner 2001 anonymous 0 0 NR NR (I) NR (C)
Excellent 94% 96% -0.94 0.96 NR NR (I) NR (C)
Fair 4% 2% -0.04 0.02 NR NR (I) NR (C)
No improvement 1% -0.01 0 NR NR (I ) NR (C)
Table showing the psychological outcomes of data from a an RCT that compare a form of restrictive surgery against another type of restrictive
significance P<0.005. Range : higher numbers = better quality of life
Key
Notation Meaning
S Statistical significant
93
Restrictive (intervention) vs restrictive surgery(control) continued
Author Year Psychological outcome Percentage of participants
from intervention group
Percentage of participant from
the control group
Weiner 2001 QoL questionnaire made by group
(Excellent )
94 96
QoL questionnaire made by group
(Fair)
4% 2%
QoL questionnaire made by group
No improvement
1
NS No Statistical Significance
NR Not Reported
(I) Intervention
(C) Comparator