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1 Effects of Bariatric surgery on psychological outcomes: A systematic review of randomized controlled trials 16 th March 2015 Name: Tumi Sotire Project supervisors: Dr Mark Tarrant, Dr Sammyh Khan and Stacey Windeat

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Page 1: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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

Page 2: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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

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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

Page 4: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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

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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

Page 6: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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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)

Page 7: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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

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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

Page 9: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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

Page 10: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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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 )

Page 11: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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 )

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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 )

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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 )

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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)

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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

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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

Page 18: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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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)

Page 19: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

19

Key

Notation Meaning

S Statistical significant

NS No Statistical Significance

NR Not Reported

(I) Intervention

(C) Comparator

Page 20: Systematic Reveiw   the effect of bariatric surgery on  psychological outcomes

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

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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

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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)

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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)

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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

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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.

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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.

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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

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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

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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).

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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.

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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.

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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

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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

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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)

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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).

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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 )

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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

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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 )

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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

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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

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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

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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

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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

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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

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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

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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.

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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.

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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.

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http://download.springer.com/static/pdf/700/art%253A10.1007%252Fs11695-013-0990-3.pdf?auth66=1423588864_243df3403a982ca2d432cd022249b98a&ext=.pdf. 60. O'Brien PE, Dixon JB, Laurie C, Anderson M. A prospective randomized trial of placement of the laparoscopic adjustable gastric band: Comparison of the perigastric and pars flaccida pathways. Obesity Surgery. 2005;15(6):820-6. 61. O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, et al. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: A randomized trial. Annals of Internal Medicine. 2006;144(9):625-33. 62. Ponce J, Quebbemann BB, Patterson EJ. Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity. Surgery for Obesity and Related Diseases. 2013;9(2):290-5. 63. Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, et al. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. British Journal of Surgery. 2010;97(2):160-6. 64. Van Mastrigt GAPG, Van Dielen FMH, Severens JL, Voss GBWE, Greve JW. One-year cost-effectiveness of surgical treatment of morbid obesity: Vertical banded gastroplasty versus Lap-Band. Obesity Surgery. 2006;16(1):75-84. 65. Puzziferri N, Austrheim-Smith IT, Wolfe BM, Wilson SE, Nguyen NT. Three-year follow-up of a prospective randomized trial comparing laparoscopic versus open gastric bypass. Annals of surgery [Internet]. 2006 1]; 243(2):[181-8 pp.]. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/596/CN-00554596/frame.html

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1448901/pdf/20060200s00006p181.pdf. 66. Suter M, Giusti V, Worreth M, Héraief E, Calmes JM. Laparoscopic gastric banding: a prospective, randomized study comparing the Lapband and the SAGB: early results. Annals of surgery [Internet]. 2005 1]; 241(1):[55-62 pp.]. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/181/CN-00502181/frame.html

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1356846/pdf/20050100s00008p55.pdf. 67. Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: A prospective randomized controlled clinical trial. Annals of Surgery. 2005;242(1):20-8. 68. Peterli R, Borbély Y, Kern B, Gass M, Peters T, Thurnheer M, et al. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Annals of surgery [Internet]. 2013 1]; 258(5):[690-4; discussion 5 pp.]. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/699/CN-00909699/frame.html

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888472/pdf/ansu-258-690.pdf. 69. Weiner R, Bockhorn H, Rosenthal R, Wagner D. A prospective randomized trial of different laparoscopic gastric banding techniques for morbid obesity. Surgical Endoscopy. 2001;15(1):63-8. 70. Mastrigt GA, Dielen FM, Severens JL, Voss GB, Greve JW. One-year cost-effectiveness of surgical treatment of morbid obesity: vertical banded gastroplasty versus

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Lap-Band. Obesity surgery [Internet]. 2006 1]; 16(1):[75-84 pp.]. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/327/CN-00554327/frame.html

http://download.springer.com/static/pdf/781/art%253A10.1381%252F096089206775222113.pdf?auth66=1422709844_7d3ab004e0e9dfec5c65e71f45dd8211&ext=.pdf

http://download.springer.com/static/pdf/781/art%253A10.1381%252F096089206775222113.pdf?auth66=1423138566_d6977873f4d5489a49520e886585b716&ext=.pdf

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.

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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.

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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/

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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.

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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.

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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

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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.

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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/

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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.

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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

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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.

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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/

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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.

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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

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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)

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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")

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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.

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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 -

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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

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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

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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)

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(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.

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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

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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

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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

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(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.

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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?

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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.

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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.

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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 )

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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

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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 )

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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

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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

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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

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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

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Key

Notation Meaning

S Statistical significant

NS No Statistical Significance

NR Not Reported

(I) Intervention

(C) Comparator

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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

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NR Not Reported

(I) Intervention

(C) Comparator

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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

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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