Establishment of a Bariatric Surgery Clinical Quality Registry
Conditions: Obesity
Sponsor: Monash University

Establishment of a bariatric surgery clinical quality registry 
 
Version 5.2 
19 January 2021 
 
 
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PROTOCOL 
Establishment of a bariatric surgery 
clinical quality registry 
Prof Wendy Brown, Prof Paul O’Brien, Dr Jenifer Cottrell, Ms Dianne Brown, Ms Brooke Backman 
Ms Aileen Heal 
 
 
Version: 5.2 
Date: 19 January 2021 
 
 
Data Custodian: 
Monash University 
 
 
CONFIDENTIAL 
This document is confidential and the property of Monash University. No part of it may be transmitted, 
reproduced, published, or used without prior written authorization from the institution. 
 
 
Statement of Compliance 
This document is a protocol for a research project. This study will be conducted in compliance with all 
stipulation of this protocol, the conditions of the ethics committee approval, the NHMRC National Statement 
on Ethical Conduct in Human Research 2007 (Updated 2018), the Australian Code for the Responsible 
Conduct of Research (2018), New Zealand’s National Ethical Standards for Health and Disability Research and 
Quality Improvement (2019), Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), ASCSQH 
Operating Principles and Technical Standards for Australian Clinical Quality Registries (2008), Monash 
University research policies and procedures, and state and federal laws of Australia and New Zealand governing 
privacy and confidentiality. 
 
 
 

Establishment of a bariatric surgery clinical quality registry 
 
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19 January 2021 
 
 
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Contents 
 
 
1.0 
Glossary of abbreviations & terms ……………………………………………………………………………………….4 
2.0 
Study sites and ethics committees……………………………………………………………………………………....5 
3.0  
Introduction………………………………………………………………………………………………………………………..12 
 
3.1 Lay summary………………………………………………………………………………………………………………….12 
 
3.2 Background………………………………………………………………………………………………………….………..13 
 
3.3 Rationale………………………………………………………………………………………………………………..……..14 
4.0 
Aims…………………………………………………………………………………………………………………………………….15 
5.0 
Outcomes…………………………………………………………………………………………………………………………….16 
6.0 
Clinical quality indicators………………………………………………………………………………………………….…16 
7.0 
Participant terminology………………………………………………………………………………………………………17 
8.0 
Study design………………………………………………………………………………………………………………………..17 
 
8.1 Participant eligibility…………………………………………………………….……………………………………….18 
 
8.2 Consent………………………………………………………………………………………………………………………….19 
 
8.3 Participant recruitment…………………………………………………………………………………………………20 
8.3.1 Recruitment of eligible participants aged 16 or over (NZ) or 18 or over 
(AU) ………………………………………………………………………………………………………………..........20 
 
 
8.3.2 Recruitment of eligible participants under the age of 16 (NZ) or 18 (AU)......22 
 
 
 
 
8.3.2.1 Re-negotiating consent when a minor participant reaches 
 
 
 
 
 
16 years (NZ) or 18 years (AU)........……………….…………………………….23 
 
 
8.3.3 Waiver of consent…………………………………………………………………………………..……..23 
 
 
 
8.3.3.1 Waiver of consent while completing opt out approach…………………23 
 
 
 
8.3.3.2 Waiver of consent for the deceased………………………………………………23 
 
 
 
8.3.3.3 Waiver of consent for people highly dependent on medical care 
 
 
 
8.3.3.4 Waiver of consent for linkage with participants’ electronic  
 
 
 
 
medical records (EMR)……………………………………………………………..……23 
 
 
 
8.3.3.5 Waiver of consent with data linkages……………………………………………23 
 
8.4 Data……………………………………………………………………………………………………………………………….24 
 
 
8.4.1 Data collection stages…………………………………………………………………………..……….24 
 
 
8.4.2 Data collection processes………………………………………………………………………………24 
 
 
 
8.4.2.1 Data collected from surgeons, gastroenterologists, and hospital 
 
 
 
 
data collectors………………….……………………………………………………………24
 
 
 
8.4.2.2 Data collected from ICD-10-AM coding reports (or similar hospital 
 
 
 
 
discharge reports)………………………………………….………………………………25 

Establishment of a bariatric surgery clinical quality registry 
 
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8.4.2.3 Data collected from participants……………………………………………………25 
 
 
 
8.4.2.4 Data collected from linkages with other repositories of health  
 
 
 
information……………..………………………………………………………………………………...25 
 
 
 
8.4.2.5 Data collected by other interested parties…………………………………….26 
 
 
8.4.3 Data elements……………………..…………………………………………………………..……………28 
 
 
8.4.4 Data quality….……………………..…………………………………………………………………………29 
 
 
8.4.5 Data confidentiality………………………………………………………..……………………………..30 
 
 
8.4.6 Data security……………………………………………………………………..…………………………..30 
9  
Ethical considerations…………………………………………………………………………………………………………33 
 
9.1 Ethical considerations for specific participant groups………………….……………………………….34 
 
 
9.1.1 Ethical considerations for children or young persons………….…….....................34 
 
 
9.1.2 Ethical considerations for persons with cognitive impairment…..…………………34 
 
 
9.1.3 Ethical considerations for people highly dependent on medical care……..……35 
 
 
9.1.4 Ethical considerations for persons who cannot speak English………………..…….35 
 
 
9.1.5 Ethical considerations for persons who are Aboriginal, Torres Strait Islander 
 
 
peoples, Māori or Pacific Islands peoples………….…….…………………………………………….35 
10 
Participant risk management and safety…………………………………………………………………………….37 
11 
Data analysis……………………………………………………………………………………………………………………….38 
 
9.1 Process of data analysis…………………………………………………………………….………………………….38 
 
9.2 Case-mix (risk) adjustment……………………………………………………………………………………….…..38 
12 
Monitoring of outcomes………………………………………………………………………………………………….….38 
13 
Reporting…………………………………………………………………………………………………………………………….38 
 
13.1 Publicly available reports…………………………………………………………………………………………….39 
 
13.2 Individual reports………………………………………………………………………………………………………..39 
 
13.3 Data access for research purposes and ad hoc reports…………………..…………………………..39 
14 
Registry organisation…………………………………………………………………………………………………………..40 
 
14.1 Registry governance…………………………………………………………………………………………………….40 
 
14.2 Funding……………………………………………………………………………………………………………….……….41 
 
14.3 Quality assurance…………………………………………………………………………………………………….….41 
15 
Significance………………………………………………………………………………………………………………………….41 
16 
Other documents to be used in conjunction with the protocol………………………………………….42 
17 
References….……………………………………………………………………………………………………………………….43 
 

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1.0  Glossary of abbreviations & terms  
 
Abbreviation/ 
Term 
Description (using lay language) 
ACSQHC 
Australian Commission on Safety and Quality in Health Care 
ANZGOSA 
Australia & New Zealand Gastro Oesophageal Surgery Association 
ANZMOSS 
Australia & New Zealand Metabolic and Obesity Surgery Society  
(formerly Obesity Surgery Society of Australia & New Zealand) 
AUS 
Australia 
BSR 
Bariatric Surgery Registry 
BSR-i 
Bariatric Surgery Registry interface 
DOS 
Day of Surgery 
EMR 
Electronic Medical Record 
HDEC 
Health and Disability Ethics Committee 
HIS 
Health Information Service  
HREC 
Human Research Ethics Committee 
ICD-10-AM 
International Classification of Disease 10-Australia Modified 
IHI 
Individual Healthcare Identifier 
legacy participant  
participants whose first entry in the Bariatric Surgery Registry is  
with a revision (or subsequent) bariatric surgical procedure 
MBS 
Medicare Benefits Schedule 
Minor 
individual who is not considered to be of age to provide independent 
informed consent; individuals under the age of 16 years in New Zealand  
and set at under 18 years in Australia for purposes of this study 
National Mutual Acceptance System under the NHMRC which allows for single ethical review of multi-
centre human research studies  
NHI 
National Health Index 
NIHI 
National Institute for Health Innovation 
NHMRC  
National Health and Medical Research Council  
NZ 
New Zealand 
Op 
operation 

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OSSANZ   
Obesity Surgery Society of Australia and New Zealand (previous name of  
the Australia & New Zealand Metabolic and Obesity Surgery Society) 
participant 
a person who has had a bariatric procedure and has had details about 
themselves and their procedure submitted to the Registry 
patient 
individual under the care of a clinician (surgeon or gastroenterologist)  
and eligible to be included in the research; patients are not considered  
to be participants unless their information had been entered in the  
database 
PFS 
Participant Fact Sheet 
PI 
Principal Investigator 
primary participant 
participants whose first entry into the Bariatric Surgery Registry is with  
their first bariatric surgical procedure 
primary procedure 
first bariatric surgical procedure undergone by a registry participant 
RACS 
Royal Australasian College of Surgeons 
revision procedure 
any subsequent bariatric procedure undergone by a registry participant 
SMS 
Short Message Service 
SFTP 
Secure File Transfer Platform 
UR 
Unit Record  
 
2.0  Study sites and ethics committees 
The Bariatric Surgery Registry collects information from surgeons and gastroenterologists at public and 
private hospitals in Australia and New Zealand. As it is made known that bariatric procedures are being 
undertaken at additional healthcare facilities, those locations will be added as further study sites. 
A list of study sites where data may be entered into the registry (dependent on bariatric procedures 
being performed at the site and/or if data are collected regarding post-operative defined adverse 
events) is outlined in Table 1 for Australia and Table 2 for New Zealand. In addition, the ethics 
committees which have oversight of the study are listed in Table 3, with the Alfred Hospital HREC as the 
lead ethics committee for the study under the National Mutual Acceptance (NMA) scheme. The other 
ethics committees which granted approvals prior to the application under the NMA reviewed those sites 
are listed in Table 4. The Alfred Hospital Human Research Ethics Committee is the lead ethics committee 
reviewing this protocol. 
Please note the potential involvement of additional sites as stated above. 
Table 1.  List of study sites in Australia 
Site Name 
Address Local Investigator 
Albury-Wodonga Private Hospital 
West Albury, NSW 2640 
Mr Adam Skidmore 
Ashford Private Hospital 
Ashford, SA 5035 
Dr Benjamin Teague 
Austin Hospital 
Heidelberg, VIC 3084 
Mr Ahmad Aly 

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Site Name 
Address Local Investigator 
Baringa Private Hospital 
Coffs Harbour, NSW 2540 
Dr Andrew Ramsay 
Beleura Private Hospital  
Mornington, VIC 3931  
Mr Ali Andrabi 
Belmont Hospital 
Belmont, NSW 2280 
Dr Timothy Wright 
Bethesda Hospital 
Claremont, WA 6010 
Dr Susan Taylor 
Blacktown Hospital 
Blacktown, NSW 2148 
Prof Michael Edye 
Box Hill Hospital  
Box Hill, VIC 3128 
Miss Salena Ward 
Brisbane Private Hospital 
Brisbane, QLD 4000 
Dr Jacobus Jordaan 
Brisbane Waters Private Hospital  
Woy Woy, NSW 2256 
Dr Kenneth Wong 
Buderim Private Hospital 
Birtinya, QLD 4575 
Dr Ian Baxter  
Bunbury Regional Hospital 
Bunbury, WA 6230 
Dr Senarath Werapitiya 
Burnside War Memorial Hospital 
Toorak Gardens, SA 5065 
Mr Philip Game 
Cabrini Hospital Brighton  
Brighton, VIC 3186 
Mr Paul Burton 
Cabrini Hospital Malvern 
Malvern, VIC 3144 
Mr Paul Burton 
Cairns Private Hospital  
Cairns, QLD 4870 
Dr Harish Kumar 
Calvary Adelaide Hospital 
Adelaide, SA 5000 
Dr Justin Bessell 
Calvary Bruce Private Hospital 
Bruce, ACT 2617 
Dr Charles Mosse 
Calvary Central Districts  
Elizabeth Vale, SA 5112 
Mr Paul Leong 
Calvary John James Hospital 
Deakin, ACT2600 
Dr Charles Mosse 
Calvary North Adelaide Hospital 
North Adelaide, SA 5006 
Assoc Prof Lilian Kow 
Calvary Public Hospital Bruce 
Bruce, ACT 2617 
Dr Charles Mosse 
Calvary Riverina Hospital  
Wagga Wagga, NSW 2650 
Assoc Prof Richard Harriso
Dr Nicholas Williams 
Calvary St Vincent’s Hospital 
Launceston, TAS 7250 
Mr Stephen Wilkinson 
Camden Hospital 
Camden, NSW 2570 
Assoc Prof Tania Markovic
Campbelltown Private Hospital  
Campbelltown, NSW 2560 
Dr Govind Krishna  
Canberra Hospital 
Garran, ACT 2605 
Dr Charles Mosse 
Concord Repatriation General Hospit Concord, NSW 2139  
Dr David Martin 
Darwin Private Hospital 
Tiwi, NT 0810 
Mr P. John Treacy 
Delmar Private Hospital 
Dee Why, NSW 2009 
Dr Timothy Wright 
Dubbo Private Hospital 
Dubbo, NSW 2830 
Dr James Chau 
Dudley Private Hospital 
Orange, NSW 2800 
Dr Henry Hook 
Epworth Eastern 
Box Hill, VIC 3128  
Mr Patrick Moore 
Epworth Freemasons 
East Melbourne, VIC 3002 
Mr Jason Winnett 
Epworth Geelong  
Waurn Ponds, VIC 3216 
Mr Matthew Leong 

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Site Name 
Address Local Investigator 
Epworth Richmond 
Richmond, VIC 3121 
Mr Patrick Moore 
Fiona Stanley Hospital 
Murdoch, WA 6150 
Mr Krishna Epari 
Flinders Medical Centre 
Bedford Park, SA 5042 
Assoc Prof Lilian Kow 
Flinders Private Hospital 
Bedford Park, SA 5042 
Assoc Prof Lilian Kow 
Footscray Hospital 
Footscray, VIC 3011 
Miss Ingra Bringmann 
Glen Iris Private Hospital 
Glen Iris, VIC 3146  
Mr Andrew Smith 
Glengarry Private Hospital 
Duncraig, WA 6023 
Dr Kevin Dolan 
Gold Coast Private Hospital  
Southport, QLD 4215 
Dr Jacobus Jordaan 
Gosford Hospital 
Gosford, NSW 2250 
Dr Kenneth Wong 
Gosford Private Hospital  
North Gosford, NSW 2250 
Dr Kenneth Wong 
Greenslopes Private Hospital 
Greenslopes, QLD 4120 
Dr Michael Hatzifotis 
Hamilton Hospital  
Hamilton, VIC 3300 
Dr Stephen Clifforth 
Heidelberg Repatriation Hospital 
Heidelberg, VIC 3084 
Mr Ahmad Aly 
Hillcrest Rockhampton Private Hospit The Range QLD 4700 
Dr Nicole Andrews 
Hobart Private Hospital 
Hobart, TAS 7000 
Mr Stephen Wilkinson 
Hollywood Private Hospital  
Nedlands, WA 6009 
Prof Jeffrey Hamdorf 
Holmesglen Private Hospital 
Moorabbin, VIC 3189 
Mr Adam Skidmore 
Holroyd Private Hospital 
Guildford, NSW 2161 
Dr Fadil Khaleal 
Hurstville Private Hospital 
Hurstville, NSW 2220 
Dr Govind Krishna  
Ipswich Hospital 
Ipswich, QLD 4305 
Dr Phillip Lockie 
Jessie McPherson Private Hospital 
Clayton, VIC 3168 
Mr Zdenek Dubrava 
John Fawkner Private Hospital 
Coburg, VIC 3058 
Mr Ian Michell 
John Flynn Private Hospital 
Tugun, QLD 4224 
Miss Candice Silverman 
John Hunter Hospital 
Lambton Heights, NSW 2305 
Dr Timothy Wright 
Joondalup Health Campus 
Joondalup, WA 6027 
Mr David Yong 
Kawana Private Hospital 
Birtinya, QLD 4575 
Dr Ian Baxter 
Kareena Private Hospital 
Caringbah, NSW 2229 
Dr Ken Loi 
Knox Private Hospital 
Wantirna, VIC 3152 
Mr Geoffrey Kohn 
Lake Macquarie Private Hospital 
Gateshead, NSW 2290 
Dr Timothy Wright 
Lakeview Private Hospital  
Baulkham Hills, NSW 2153 
Dr Roy Brancatisano 
Latrobe Regional Hospital 
Traralgon, VIC 3844 
Mr David Chan 
Launceston General Hospital 
Launceston, TAS 7250 
Mr Stephen Wilkinson  
Lingard Private Hospital  
Merewether, NSW 2291 
Dr Timothy Wright 
Macquarie University Hospital 
Macquarie Park, NSW 2109 
Prof Reginald Lord 

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Site Name 
Address Local Investigator 
Maitland Private Hospital 
Ashtonfield, NSW 2323 
Dr Mark Gately 
Maryvale Private Hospital  
Morwell, VIC 3840 
Dr David Chan  
Mater Hospital  
South Brisbane, QLD 4101 
Dr Anthony Cheng 
Mater Hospital Sydney 
North Sydney, NSW 2060 
Dr Craig Taylor 
Mater Private Hospital (Brisbane) 
South Brisbane, QLD 4101 
Dr Anthony Cheng 
Mater Private Hospital (Redland) 
Cleveland, QLD 4163 
Dr Anthony Cheng 
Mater Private Hospital (Springfield) 
Springfield Central,  
QLD 4300 
Dr Anthony Cheng 
Mater Private Hospital Mackay 
North Mackay, QLD 4740  
Dr John Copp 
Mater Private Hospital Bundaberg 
Bundaberg, QLD 4670 
Dr Geoff De Lacy 
Mater Private Hospital Rockhampton Rockhampton, QLD 4700 
Dr Andrew Russell 
Mater Private Hospital Townsville 
Pimlico, QLD 4812 
Dr Samuel Baker 
Melbourne Private Hospital 
Parkville, VIC 3052 
Assoc Prof Gary Crosthwai
Mildura Base Hospital 
Mildura, VIC 3500 
Mr Salim Chaloob 
Mildura Health Private Hospital 
Mildura, VIC 3500 
Mr Salim Chaloob 
Mitcham Private Hospital  
Mitcham, VIC 
Mr Ahmad Aly 
Monash Medical Centre 
Clayton, VIC 3168 
Mr Zdenek Dubrava 
Mount Hospital 
Perth, WA 6000 
Mr Leon Cohen 
Mulgrave Private Hospital  
Mulgrave, VIC 3170 
Mr Chris Hensman 
Nambour Selangor Private Hospital 
Nambour, QLD 4560 
Mr Michael Donovan 
National Capital Private Hospital 
Garran, ACT 2605  
Dr Charles Mosse 
Nepean Hospital 
Kingswood, NSW 2747 
Dr Michael Devadas 
Nepean Private Hospital  
Kingswood, NSW 2747 
Dr Michael Devadas 
Newcastle Private Hospital  
Lambton, NSW 2305 
Dr Timothy Wright 
Nikol Bay Hospital 
Karratha, WA 6714 
Dr Tony Kierath 
Noosa Private Hospital 
Noosaville, QLD 4566 
Dr Garth McLeod 
North Shore Private Hospital  
St Leonards, NSW 2065 
Assoc Prof Garett Smith 
North West Private Hospital (Brisban Everton Park, QLD 4053 
Dr Philip Lockie 
North West Private Hospital (Burnie) Burnie, TAS 7320 
Mr Stephen Wilkinson 
Northern Beaches Hospital 
Frenchs Forest, NSW 2086 
Dr Philip Le Page 
Northpark Private Hospital 
Bundoora, VIC 3083 
Miss Salena Ward 
Norwest Private Hospital 
Bella Vista, NSW 2153 
Dr Michael Devadas 
Nowra Private Hospital  
Nowra, NSW 2541 
Dr Mark Hehir 
Orange Health Service 
Orange, NSW 2800 
Dr Henry Hook 

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Site Name 
Address Local Investigator 
Peel Health Campus 
Mandurah, WA 6210 
Dr Chris Couch 
Peninsula Private Hospital  
Frankston, VIC 3199 
Mr Geoffrey Draper 
Pindara Private Hospital 
Benowa, QLD 4217 
Dr Jason Free 
Port Macquarie Base Hospital  
Port Macquarie, NSW 2444 
Dr Nigel Peck 
Port Macquarie Private Hospital 
Port Macquarie, NSW 2444 
Dr Nigel Peck 
Prince of Wales Private Hospital 
Randwick, NSW 2031 
Dr David Links 
Princess Alexandra Hospital 
Woolloongabba, QLD 4102 
Assoc Prof Anthony Russe
Queen Elizabeth II Jubilee Hospital 
Coopers Plains, QLD 4108 
Dr Chung Won 
Royal Adelaide Hospital 
 
 
Adelaide, SA 5000 
Dr Shalvin Prasad 
Royal Brisbane and Women’s Hospita Herston, QLD 4006 
Dr George Hopkins 
Royal Hobart Hospital 
Hobart, TAS 7000 
Mr Stephen Wilkinson 
Royal Melbourne Hospital 
Parkville, VIC 3050  
TBA 
Royal North Shore Hospital 
St Leonards, NSW 2065 
Assoc Prof Garett Smith 
Royal Prince Alfred Hospital 
Camperdown, NSW 2025 
Assoc Prof Tania Markovic
St Andrew’s Ipswich Private Hospital Ipswich, QLD 4305 
Dr John Copp 
St Andrew’s Toowoomba Hospital 
Rockville, QLD 4350 
Dr Neil Wylie 
St Andrew’s War Memorial Hospital Brisbane, QLD 4001 
Dr Phillip Lockie 
St George Hospital 
Kogarah, NSW 2217 
Assoc Prof Michael Talbot 
St George Private Hospital 
Kogarah, NSW 2217 
Assoc Prof Michael Talbot 
St John of God Ballarat 
Ballarat, VIC 3353 
Mr Stuart Eaton 
St John of God Bendigo 
Bendigo, VIC3550 
Dr Janine Arnold 
St John of God Berwick 
Berwick, VIC 3806 
Mr Raymond McHenry  
St John of God Bunbury 
Bunbury, WA 6230 
Dr Senarath Werapitiya 
St John of God Geelong  
Geelong, VIC 3220 
Mr Matthew Leong 
St John of God Geraldton 
Geraldton, VIC 6530 
Dr Jacques Perry 
St John of God Mt Lawley 
Mount Lawley, WA 6050 
Mr Leon Cohen 
St John of God Midland 
Midland, WA 6056 
Mr Siva Gounder 
St John of God Murdoch 
Murdoch, WA 6150 
Dr Harsha Chandraratna 
St John of God Subiaco 
Subiaco, WA 6008 
Mr Leon Cohen 
St John of God Warrnambool 
Warrnambool, VIC 3280 
Mr Phillip Gan  
St Luke’s Private Hospital  
Potts Point, NSW 2011 
Dr Clement Tsang 
St Stephen’s Hospital 
Hervey Bay, QLD 4655 
Dr Mikhail Mastakov 
St Vincent’s Hospital Lismore 
Lismore, NSW 2480 
Miss Candice Silverman 

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Site Name 
Address Local Investigator 
St Vincent's Private Hospital Sydney Darlinghurst, NSW 2010 
Prof Reginald Lord 
St Vincent's Private Hospital Northsid Chermside, QLD 4032 
Dr George Hopkins 
St Vincent's Private Hospital ToowoombToowoomba, QLD 4350 
Dr Evan Willingham 
St Vincent’s Private Hospital 
Fitzroy, VIC 3065 
Mr Michael Hii 
St Vincent’s Hospital Melbourne 
Fitzroy, VIC 3065 
Mr Michael Hii 
Shepparton Private Hospital 
Shepparton, VIC 3630 
Mr David Dalton 
Southern Highlands Private Hospital 
Bowral, NSW 2576 
Dr Shirhan Ho 
Sir Charles Gairdner Hospital 
Nedlands, WA 6009 
Mr Michael Tan 
Strathfield Private Hospital 
Strathfield, NSW 2135 
Dr David Martin 
Sunnybank Private Hospital 
Sunnybank, QLD 4109 
Dr Mark Daoud 
Sunshine Hospital 
St Albans, VIC 3021 
Miss Ingra Bringmann 
Sunshine Coast University Private  
Hospital 
Birtinya, QLD 4556 
Dr James Askew 
Sutherland Hospital 
Caringbah, NSW 2229 
Dr Ken Loi 
Sydney Adventist Hospital 
Wahroonga, NSW 2076 
Dr Philip Le Page 
Sydney Private Hospital  
 
 
Ashfield, NSW 2131 
Assoc Prof Michael Talbot 
Sydney Southwest Private Hospital 
Liverpool, NSW 2170 
Dr Govind Krishna 
Tamara Private Hospital  
Tamworth, NSW 2340 
Dr David Lewis 
The Alfred Hospital 
Melbourne, VIC 3004 
Professor Wendy Brown  
The Avenue Hospital 
Windsor, VIC 3181 
Professor Wendy Brown 
The Bays Hospital 
Mornington, VIC 3931 
Mr Ali Andrabi 
The Queen Elizabeth Hospital 
Woodville, SA 5011 
 
Mr Markus Trochsler 
The Wesley Hospital 
Auchenflower, QLD 4066 
Dr Reza Adib 
Tuggerah Lakes Private Hospital 
Kanwal, NSW 2259 
Dr Peter Hamer 
Wagga Wagga Base Hospital 
Wagga Wagga, NSW 2650 
Assoc Prof Richard Harriso
Waikiki Private Hospital 
Waikiki, WA 6169 
Dr Chris Couch 
Wangaratta Private Hospital 
Wangaratta, VIC 3677 
Mr Adam Cichowitz 
Waratah Private Hospital  
Hurstville, NSW 2220 
Dr Clement Tsang 
Warringal Private Hospital 
Heidelberg, VIC 3084 
Mr Ahmad Aly 
Waverley Private Hospital 
Mount Waverley, VIC 3149 
TBA 
Western Hospital 
Henley Beach, SA 5022 
Mr Salim Chaloob 
Western Private Hospital  
Footscray, VIC 3011 
Mr Jason Winnett 
Westmead Private Hospital 
Westmead, NSW 2145 
Dr Anthony Brancatisano 

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Site Name 
Address Local Investigator 
Williamstown Hospital  
Williamstown, VIC 3016 
Miss Ingra Bringmann 
Wollongong Private Hospital 
Wollongong, NSW 2500 
Dr Ulvi Budak 
 
 
Table 2.  List of study sites in New Zealand 
Site Name 
Address 
Principal Investigator 
Auckland City Hospital  
Grafton, Auckland 1023  
Mr Grant Beban 
Boulcott Hospital Specialist Centre 
Lower Hutt 5011 
Mr Atul Dhabuwala 
Chelsea Hospital Trust 
Gisborne 4010 
Mr Peter Stiven 
Christchurch Hospital  
Christchurch Central,  
Christchurch 4710 
Mr Steven Kelly 
Gisborne Hospital  
Gisborne 4010 
Mr Peter Stiven 
Grace Hospital  
Tauranga 3140 
Mr Robert Cable 
Hutt Hospital 
Hutt 5010 
Mr Atul Dhabuwala 
Manuka Street Hospital 
Nelson 7010 
Mr Mark Stewart 
Mercy Hospital  
Dunedin 
Mr Mark Smith 
Mercy Ascot Greenlane Hospital 
Remuera, Auckland 1050 
Mr Jon Morrow 
Middlemore Hospital  
Otahuhu, Auckland 2104  
A/Prof Andrew 
MacCormick 
North Shore Hospital  
Takapuna, Auckland 0620 
Mr Michael Booth 
Ormiston Hospital  
Flat Bush, Auckland 2019  
A/Prof Andrew 
MacCormick 
Palmerston North Hospital 
Palmerston North 4442 
Dr Alexandra Gordon 
Royston Hospital 
Hastings 4122 
Mr John Fleischl 
St George’s Hospital 
Christchurch 8014 
Mr Steven Kelly 
Southern Cross Hospital, Christchurch 
Christchurch 8013 
Mr Steven Kelly 
Southern Cross Hospital, Hamilton 
Hamilton 3216 
Mr David Schroeder 
Southern Cross Hospital, North 
Harbour  
North Harbour 
Mr Michael Booth 
Southern Cross Hospital, Wellington 
Wellington 6021 
Mr Simon Bann 
Southland Hospital  
Kew, Invercargill 9812 
Mr Mark Smith 
Tauranga Hospital  
South Tauranga 3112 
Mr Barnaby Smith 
Waikato Hospital  
Hamilton 3204 
Mr Rowan French 
Wakefield Hospital  
Newtown, Wellington 6021 
Mr Simon Bann 
Wellington Hospital  
Newtown, Wellington, 6021 
Mr Simon Bann 
 
Table 3.  Ethics committees with oversight of project 
Name of HREC 
 Status of Review 
The Alfred Hospital HREC (EC00315)  
Approved 
Calvary Health Care Adelaide HREC (EC00302) 
Approved 
Calvary Health ACT HREC (EC00105) 
Approved 

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Name of HREC 
 Status of Review 
HREC of Northern Territory Department of Health and Menzies 
School of Health Research  (EC00153)  
Yet to submit 
Mater Misercordiae Ltd HREC (EC00332)  
Approved 
Monash University Research Ethics Committee (EC00234) 
 
Approved 
St John of God Health Care Ethics Committee (EC00286) 
Approved 
St Vincent’s Health and Aged Care HREC (EC00324) 
 
Approved 
South Metropolitan Health Service HREC (EC00265) 
Approved 
Southern Health and Disability Ethics Committee (NZ)  
Approved 
Tasmania Health and Medical HREC (EC00337)   
Approved 
 
Table 4. Ethics committees which also reviewed project  
Name of HREC 
   Status of Review 
Austin Health HREC (EC00204) 
Approved 
Bellberry HREC (EC003721) 
Approved 
Cabrini Health HREC (EC00239) 
Approved 
Eastern Health HREC (EC00211) 
Approved 
Epworth HealthCare HREC (EC00217)  
Approved 
Gold Coast Hospital and Health Service HREC (EC00160) 
Approved 
Greenslopes Hospital HREC (EC00161) 
Approved 
Hollywood Private Hospital HREC (EC00266)  
Approved 
HREC of the Queen Elizabeth Hospital/Lyell McEwin 
Hospital/Modbury Hospital (EC00190) 
Approved 
Joondalup Health Campus HREC (EC00267) 
Approved 
Mildura Base Hospital HREC (EC00424)  
Approved 
Monash Health HREC (EC00382)  
Approved 
North Shore Private Ethics Committee (EC00443) 
Approved 
Northern Sydney Local Health District (EC00112) 
Approved 
Royal Brisbane and Women’s Hospital HREC (EC00172) 
Approved 
St Vincent’s Hospital (Melbourne) HREC EC00344 
Approved 
St Vincent’s Hospital HREC (EC00140) 
Approved 
South West Healthcare Multidisciplinary Ethics 
Committee (EC00257) 
Approved 
Southern Adelaide Clinical Research Ethics 
Committee (EC00188)  
Approved 
Sydney Local Health District Ethics Review Committee (EC
00113) 
Approved 
The Avenue Hospital HREC (EC00242)  
Approved 
The Adventist HealthCare LTD Ethics Committee 
(EC00141)  
Approved 
UnitingCare Health HREC (EC00374) 
Approved 
Western Health Low Risk Ethics Panel 
Approved 

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Monash University Research Ethics Committee and the Royal Australasian College of Surgeons Ethics 
Committee have also given approval for the study. Bariatric Surgery Registry has been granted an 
Acceptance Status from the New Zealand Ministry of Health for New Zealand personal health 
information to be stored at Monash University in Melbourne Australia.   
 
3.0  Introduction 
3.1 Lay summary 
Obesity is a prevalent disease in Australia and New Zealand. This is a major concern for both countries 
as obesity is an important risk factor for ill health. Obese persons are more likely to suffer from many 
other serious health conditions including diabetes, heart disease, liver disease, infertility, stroke and 
cancer. As a consequence, people who are obese are more likely to have a reduced life expectancy.  
Lifestyle interventions have not been found to be effective in providing a long-term solution for the 
treatment of obesity. When conservative weight loss measures tried by those with obesity are not 
successful, weight loss or ‘bariatric,’ surgery may be considered. 
Bariatric surgical procedures are operations performed with the intention of helping people with 
obesity achieve and sustain weight loss. Weight loss following bariatric surgery leads to significant 
improvement in health and well-being. Individuals who have the surgery are known to live longer. 
However, it is an invasive surgery with known surgical risks and potential side effects, which can be as 
severe as death. Given people are having this surgery to improve their health, it is critical that the 
surgery is performed with a minimum of side effects; otherwise, it cannot be justified. 
The purpose of the Bariatric Surgery Registry (hereafter, Registry) is to monitor the safety of the 
surgery and to assess the long-term changes in the health of people who undergo bariatric surgery in 
Australia and New Zealand.  
The Bariatric Surgery Registry collects data, or information, on the operation performed, who 
performed the operation, where the operation occurred, complications from the surgery, weight at 
various time points and diabetes status and management. It is necessary for the Registry to keep 
identifiable participant details, such as their name, date of birth, address and Medicare number 
(Australia) or National Health Index (NHI) number (New Zealand), in order to track their progress 
through data linkage to other datasets.  
By systematically collecting information on every procedure performed in Australia and New Zealand, 
the Bariatric Surgery Registry will help to identify when surgeons, gastroenterologists, hospitals and/or 
procedures are not performing to the expected standard. In time, this Registry should also be able to 
demonstrate how effectively bariatric surgery results in weight loss and improved health (using 
diabetes as a marker of health) across the two countries. The Registry aims to collect 95% of the 27,000 
(2017) bariatric surgeries performed each year in public and private health care facilities in Australia 
and New Zealand.  
Participants in this study have information related to their bariatric surgery and surgical outcomes 
provided to the Registry by their surgeon, gastroenterologist or hospital. They may be contacted 
directly by the Registry staff to see if they suffered any complications and what impact the surgery had 
on their health (concerning their diabetes status), weight and well-being. The Registry proposes to 
follow participants up to 10 years after their first bariatric surgery. 
The Bariatric Surgery Registry is located at Monash University’s School of Preventive Health and Public 
Medicine (Melbourne Australia). In New Zealand, the Registry is supported by Auckland UniServices 
Limited (UniServices), through its business unit, the National Institute for Health Innovation (NIHI). 
 

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3.2 Background 
Obesity poses a major public health challenge for Australia and New Zealand. According to the 
Australian Health Survey (2014-15), nearly 28% of the adult population are considered obese (defined 
as a BMI >30 kg/m2) compared to 18% in 2004/05.1,2 Amongst those Indigenous Australians who 
regularly attend of Indigenous primary health care organisations, 42.9% are obese.3 In New Zealand, 
the rate of obesity has been increasing by 1% every year since 1989 and as of the 2016/2017 Health 
Survey, 32.2% of the adult population (1,234,000 people aged over 15 years) are obese.. 4,5 Māori and 
Pacific Islands peoples have the highest incidence of obesity with rates of 50% and 69%, respectively 
for adults (aged 15 years and over), and 18% and 29% for children (aged 2-14 years).5  
Obesity is a major risk factor for many preventable diseases including type 2 diabetes, heart disease, 
hypertension, stroke, cancer and musculoskeletal disorders. It can also significantly affect quality of 
life and shorten lifespan.6-10 As those with obesity may suffer from other chronic medical conditions, 
the cost of their healthcare is much greater than for those with a healthy weight.11 In 2010-11, the 
direct cost of obesity on the Australian economy was estimated to be AUS$8.6 billion.12 A New Zealand 
study approximated the healthcare cost of obesity to be NZ$722 million; and the cost of lost 
productivity was estimated to be NZ$849 million.13 These figures demonstrate that the management 
of obesity demands to be a national priority for both countries. 
Although lifestyle interventions can be effective in the short term, they are rarely durable in the long-
term.14,15 Maintenance of weight loss for the long term is a challenge for those on lifestyle intervention 
programmes. For those with class II obesity (BMI>35kg/m2), several Randomized Controlled Trials 
(RCT) and multiple case series suggest that bariatric surgery provides more predictable and durable 
weight loss than conservative regimes and is generally very safe.16-21  
Since 2009, New Zealand has annually published ‘Clinical Guidelines for Weight Management in New 
Zealand Adults’, which continually review the current evidence and priorities for the prevention and 
treatment of obesity.23, 24 These guidelines support the framework set out in the New Zealand Health 
Strategy and the He Korowai Oranga: Māori Health Strategy which guides health related services to 
achieve the best health outcomes for Māori.25, 26 The 2009 Guidelines noted that there was no evidence 
of bariatric outcome data by ethnicity, demonstrating the public’s need for this information.23 
The New Zealand Ministry of Health guidelines ‘Weight Management for Adults” suggests considering 
bariatric surgery for people with Class II obesity with another significant disease.27 Public funding for 
bariatric surgery is available from the Ministry of Health for individuals who meet set criteria. A review 
of publicly funded bariatric surgery by Rahiri et al (2017)28 suggested that there may ethnic disparities 
in the rate of access to public funded procedures. 
Bariatric surgery is burgeoning in Australia. The number of separations for bariatric surgery reported 
by the Australian Institute of Health and Welfare (AIHW) for 2014-15 was 22,713.29 The Medicare 
Benefits Schedule (MBS) data for 2017 indicates the number of procedures has grown to over 26,000 
procedures per year however, this only reflected approximately 1.4% of the Australian morbidly obese 
having bariatric surgery as an intervention.30, 1 The AIHW reported an additional 124,600 bariatric 
surgery–related procedures were billed to Medicare during the 2014-2015 period, with a total cost 
estimated at $62.8 million for all Medicare billed procedures.30  
In New Zealand, figures show that 889 bariatric procedures were performed for the year ending 2014, 
representing 0.04% of those with a BMI >40.31 The Ministry of Health has committed over $30 million 
since 2014 for bariatric surgery for individuals who meet set criteria and additional funding has also 
been made available by local district health boards to support publicly funded procedures.32 In 2017, 
approximately 480 people were able to access publicly funded bariatric surgery of amongst at least 
210,000 individuals who could be eligible. 5 
As the rate of obesity increases across both Australia and New Zealand, so does the demand for 
treatments including bariatric surgical procedures. As the rate of procedures increases, there needs to 

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be a systematic method of ensuring that bariatric surgical procedures continue to be safe and effective 
for those seeking them. In 2012, the Bariatric Surgery Registry was established with this intention.  
 
3.3 Rationale 
The Australian Commission on Safety and Quality in Health Care (ACSQHC) promotes clinical quality 
registries, as they are known to drive change and lead to improved patient care and outcomes.33, 34 A 
clinical quality registry is a specific type of registry with data that can be used to: 
• 
benchmark performance;  
• 
determine variations in clinical outcomes; and 
• 
develop guidelines and standards for clinical practice.  
 
A clinical quality registry focusing on bariatric surgery is in the public interest. Such a registry can 
demonstrate at a population level whether bariatric surgical procedures are safe and if they can 
effectively treat obesity. Data from a clinical quality registry focused solely on bariatric surgery and its 
outcomes has the potential to give confidence to persons considering having bariatric surgery, 
surgeons, gastroenterologists, governments, health funds, hospitals and the wider community that 
bariatric surgery is safe and improves health outcomes for all persons who undergo a bariatric 
procedure. A clinical quality registry can also be used to demonstrate disparities amongst the rate of 
access to publicly bariatric services in New Zealand with the collection of ethnicity data. 
 
With the support of the Australian & New Zealand Metabolic and Obesity Surgery Society (formally 
Obesity Surgery Society of Australia and New Zealand), the Bariatric Surgery Registry was established 
in 2012, following specific recommendations from:  
 
the Georganas Senate Inquiry into Obesity (published as “Weighing it up” May 2009 
Recommendation 6)35; 
 
the Australian Commission on Safety and Quality in Healthcare (2008)33; and  
 
the Health Technology Review Report (Review of Health Technology Assessment in Australia, 
2009).36 
Following a successful two-year pilot study from 2012-2014, the shift to a registry properly commenced 
in Australia in 2014. The Registry launched in New Zealand in mid-2017. The Bariatric Surgery Registry 
is underpinned by a comprehensive governance structure and funding which ensures an ongoing 
independent assessment of data quality.  
As the Registry collects, uses, and stores identifiable participant information, the project adheres to: 
 
the Privacy Act 1988 Cth (2014) 37;  
 
the Australian Privacy Principles as set out in the Act 37;  
 
the NHMRC Guidelines Approved under Section 95A of the Privacy Act 1988 (2014)38;  
 
NHMRC National Statement on Ethical Conduct in Human Research 2007 (2018)38; 
 
NHMRC Ethical Conduct in research with Aboriginal and Torres Strait Islander Peoples and 
Communities: Guidelines for researchers and stakeholders (2018)40;   
 
Privacy Act 1993 (New Zealand)41; 
 
Health Information Privacy Code 1994 (New Zealand)42;  
 
New Zealand’s National Ethical Standards for Health and Disability Research and Quality 
Improvement (2019)43;  
 
Jurisdictional legislation including: 
o Health Records Act 2001 (Vic)44; 
o Privacy and Data Protection Act 2014 (Vic)45; 
o Public Health Act 2005 (Qld)46; 
o Information Privacy Act 2009 (Qld)47; 
o Medical Treatment and Planning and Decisions Act 2016 (Vic)48; 
o Privacy and Personal Information Protection Act 1998 (NSW)49; 

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o Territory Records Act 2002 (ACT)50;  
o Information Act 2017 (NT)51; and 
o Personal Information Protection Act 2004 (Tas)52. 
 
The rights of European data subjects will be considered according to the General Data Protection 
Regulation (EU) 2016/679 in the event that a resident or citizen of the European Union (including the 
United Kingdom) is enrolled.53 
 
4.0  Aims  
As a clinical quality registry, the purpose of the Bariatric Surgery Registry is to gather and analyse data 
in order to monitor and enhance the quality of care received by obese persons undergoing bariatric 
surgery. 
The aims of the Bariatric Surgery Registry are: 
 
to record the immediate safety of bariatric surgery in Australia and New Zealand; 
 
to longitudinally study the safety and efficacy of bariatric surgery in Australia and New Zealand 
assessing procedures, devices, complications and adverse events; 
 
to track key health changes including weight loss/BMI and diabetes management following 
bariatric surgery in Australia and New Zealand; 
 
to report accurate population level data to shape health practices and policy; 
 
to be a basis for further research into bariatric surgery as a safe and effective treatment for 
obesity; and 
 
to allow better analysis of the economic benefits of bariatric surgery as a treatment for obesity 
related illness. 
 
5.0  Outcomes 
The establishment of the Bariatric Surgery Registry allows the opportunity to achieve the following 
important outcomes: 
 
measure and confirm the outcomes from clinical trials of bariatric surgical procedures at a 
population level; 
 
support measurement and understanding of determinants of obesity and disparities in health 
outcomes for Aboriginals, Torres Strait Islanders, Māori and Pacific Islanders; 
 
identify variations in care and the reasons for those differences; 
 
provide an ability to track the long-term effects of bariatric surgery as an intervention for 
obesity; 
 
promote evidence-based practice by assessing compliance with best practice; 
 
inform public health policy and practice; 
 
provide confidence to clinicians and institutions that they are delivering a high quality service; 
 
assure the public that bariatric surgical procedures are performed under the oversight of a 
robust quality assurance program; 
 
provide bariatric patients with important information about treatment risks and benefits;  
 
enable further studies and research, including studies evaluating patient reported outcomes 
(PROMs) recognizing that: 
o the patients’ sense of well-being is one of the most important outcomes from this type 
of surgery  
o it is important to measure, monitor and understand the impact on bariatric patients 
when losing excess weight; and 
 
empower patients to make informed decisions about care and treatment options. Benefits will 
be realised in the short term by producing risk adjusted comparative outcome data based on 

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currently available treatment and in the longer term by assessing the impact of new 
technologies and discoveries on outcomes. 
 
6.0  Clinical quality indicators 
In order to benchmark the standard of care provided to those who undergo bariatric surgery, 
defined outcomes are measured at established intervals. The Registry will use the following quality 
indicators to evaluate the safety and quality of care and the subsequent clinical effectiveness of 
bariatric surgery. The data collected to assess the indicator, the interval during which it is measured, 
and what the indicator demonstrates are: 
1. Vital status following bariatric surgery 
Data collected:  
o mortality following bariatric surgery; and 
o likeliness that the death was related to the participant having bariatric surgery 
Interval: time of surgery up to 10 years after surgery 
Demonstrates: the safety and quality of bariatric surgery 
 
2. Incidence of defined adverse events following bariatric surgery 
Data collected:  
o date participant seen for post-operative review; 
o occurrence of defined adverse events (unplanned readmission to hospital, unplanned 
admission to the intensive care unit, unplanned return to the operating theatre, 
prolonged length of stay in hospital and/or death); 
o reason(s) for any adverse event; and  
o cause of death  
Interval: time of surgery to 90 days following surgery 
Demonstrates: the safety and quality of bariatric surgery  
 
3. Re-operation rate 
Data collected:  
o subsequent bariatric procedures (following a primary bariatric procedure) 
Interval: 12 months to 10 years after a primary bariatric procedure 
Demonstrates: quality and appropriateness of treatment  
 
4. The effect of bariatric surgery on long term weight loss  
Data collected:  
o participant weight at baseline  
o participant height  
o participant weight on annual basis (following a primary bariatric procedure) 
Interval: 12 months to 10 years after a primary bariatric procedure 
Demonstrates: the sustainability of weight loss in the long term 
 
5. The effect of bariatric surgery on a participant's diabetes status  
Data collected:   
o diabetes status at baseline  
o diabetes status on an annual basis (following a primary bariatric procedure) 
Interval: 12 months to 10 years after a primary bariatric procedure 
Demonstrates: clinical effectiveness of bariatric surgery on diabetes status  
 
6. The effectiveness of bariatric surgery as treatment for diabetes  
Data collected:  
o if the participant still requires further treatment for diabetes; and  

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o if treatment has changed from what was recorded at baseline.  
Interval: 12 months to 10 years following a primary bariatric procedure  
Demonstrates: clinical effectiveness of bariatric surgery on diabetes treatment 
 
7.0  Participant terminology 
Individuals recruited to participate with their first bariatric procedure are termed as “primary 
participants”. If they are recruited with a revision bariatric procedure then the term “legacy 
participants” applies.  
 
8.0  Study design 
The Bariatric Surgery Registry is a population based, observational and epidemiological quality 
improvement study of persons with obesity who undergo bariatric surgery. Non-probability sampling 
is necessary as the Registry aims to capture the entire population.  
Surgeons and/or gastroenterologists who are known to perform bariatric procedures are invited to 
participate in the Registry. Whilst their participation is voluntary, they are asked to sign a participation 
agreement stating that they have read the protocol and will maintain the responsibility for their 
patients’ data. All surgeons and gastroenterologists are provided with flyers and a poster for the 
recruitment of Registry participants using the opt out approach. They are also given The BSR-i User 
Manual for Surgeons and Staff and when requested, paper data forms for submitting their patient and 
operation information.  
Those submitting data directly on the Registry’s web-based interface, the BSR-i, will be given a user ID 
and temporary password. The BSR-i User Manual for Surgeons and Staff contains an authorisation 
form to record anyone who enters information regarding patients on the behalf of surgeons or 
gastroenterologists. Data collectors in public hospitals who enter data on the BSR-i are provided with 
their own account and are able to submit data for each of those hospitals’ surgeons and 
gastroenterologists that participate in the Registry.  
Private and public hospitals in Australia and New Zealand that care for persons who have or had 
bariatric surgery will be contacted to participate in the Registry. Ethics approval and site or locality 
approvals are to be sought for each hospital. A Memorandum of Understanding between Monash 
University and each hospital/hospital group representative should be executed prior to the 
commencement data collection at the hospital(s). Once these steps have been taken and all approvals 
has been granted for the hospital’s or hospital group’s participation, Registry staff will contact the 
person at the hospital responsible for discharge coding. A template will be provided to the coder along 
with access to a secure file transfer platform to send the coding reports to the Registry. 
Principal investigators with credentials for the hospital site will ensure the project is conducted in 
accordance with the National Statement on Ethical Conduct in Research 2007 (2018) and assist with 
the ethical and research requirements for the site.39 
Demographic and operation information for each patient undergoing a bariatric surgical procedure is 
submitted to the Registry following surgery. Data related to patient outcomes during the 90-day period 
after the surgery is collected for all participants and annually for primary participants.  
The Bariatric Surgery Registry conforms to the Operating Principles and Technical Standards for 
Australian Clinical Quality Registries (2008) as set out by the ACSQHC.34 The Registry is expected to be 
ongoing and data will be retained indefinitely.  
 

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8.1 Participant eligibility 
Anyone who undergoes bariatric surgery as treatment for obesity in Australia or New Zealand is eligible 
for inclusion for the study (non-probability sampling). The minimum age for eligibility is set at 2 years 
and a maximum age of 95 years.  
The study population may include:  
 
children or young persons; 
 
persons with a cognitive impairment;  
 
people highly dependent on medical care; 
 
persons who cannot speak English; and/or 
 
persons who identify as Aboriginal, Torres Strait Islander peoples, Māori or Pacific Islands 
peoples. 
Pregnant females are not considered for bariatric surgery and are therefore excluded from the study. 
Figure 1 illustrates the overall recruitment process for the participation of hospitals, surgeons, 
gastroenterologists and bariatric patients in the research.  
 
 
Figure 1. Recruitment for the Bariatric Surgery Registry  
 
 

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8.2 Consent 
The opt out approach to participation is used in for those individuals who are considered able to 
provide independent informed consent, due to the scale and significance of the Registry. In New 
Zealand, the age at which an individual can provide independent informed consent is 16 years. 
However, the Registry will use the age of 18 years in Australia, as the age when an individual can 
provide independent consent varies amongst its states and territories. This will ensure consistency 
amongst Australian participants. Written informed consent will be used for those considered to be 
‘minors’ (those under the age of 16 in New Zealand and under the age of 18 in Australia).  
The Bariatric Surgery Registry adheres to the Guidelines Approved under Sec 95A of the Privacy Act 
1988 (2014) and the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), 
in its rationale for the use of the opt out approach.38, 39 
Although opt out will be most commonly used, a participant’s capacity for consent will need to be 
considered according to the National Statement.39 The responsibility for determining capacity of 
consent will be with the clinician. The concerns and needs of specific groups of participants are 
discussed in sections 9.1-1.5.  
In accordance with the State and Federal privacy legislation of Australia and New Zealand, the National 
Statement for Ethical Conduct in Research (AU), and New Zealand’s Ethical Guidelines, approval for 
using the opt out approach will be sought from an ethics committee nominated by the hospital and 
the Southern Health and Disability Ethics Committee in New Zealand.39, 43 
8.3 Participant recruitment 
Eligible participants are recruited (see Figure 2) when: 
 
a surgeon, gastroenterologist or public hospital data collector submits patient details into the  
BSR-i or with an operation form; or 
 
the Registry receives International Classification of Disease 10-Australia Modified (ICD-10-
AM) coding reports (or similar hospital discharge reports) from contributing hospitals or 
hospital groups (discussed further in section 8.4.2.2). 
 
8.3.1 Recruitment of eligible participants aged 16 or over (NZ) or 18 or over (AU)  
Participants aged 16 or over (NZ) or 18 or over (AU) are recruited using the opt out approach according 
to the requirements set out in Sections 2.3.6-2.3.12 of the National Statement on Ethical Conduct in 
Research 2007 (2018).39 Prospective participants must be told that their identifiable health information 
will be provided to the Bariatric Surgery Registry for medical research that is in the public interest. This 
is done by surgeons, gastroenterologists and/or public hospital clinic staff who are to provide their 
bariatric patients with a Registry information flyer and display a poster which states that their practice 
or clinic participates in the Bariatric Surgery Registry. 
In plain English language, both the poster and flyer advise prospective participants that the Registry 
will contact them after their surgery. The flyer explains:  
 
that the Bariatric Surgery Registry follows the progress of everyone who has a bariatric 
procedure in Australia and New Zealand;  
 
what information is collected by the Registry;  
 
the voluntary nature of their participation; and  
 
that they can inform their surgeon or gastroenterologist of their intention for non-
participation. 
 
After the surgery is performed, surgeons, gastroenterologists, public hospital data collectors, nurses 
and hospital information services provide data to the Registry related to the prospective participant’s 
details and their bariatric procedure/s. Data is provided via paper forms or by direct entry on the web 

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interface, the BSR-i. Upon receipt of this data, the Registry posts potential participants a Participant 
Fact Sheet (PFS), Bariatric Surgery Registry Fact Sheet and a flyer (as a reminder of the one they 
received prior to surgery). The PFS explains the purpose of the Bariatric Surgery Registry and what their 
involvement entails. It also advises that their participation is voluntary and how to opt out if they do 
not want to be involved. General contact information is listed along with details about making a 
complaint to the relevant ethics committee and a free call number (1 800 in Australia or 0 800 in New 
Zealand) is also provided.  
 
These steps ensure that prospective participants are fully informed that their sensitive health data will 
be transmitted to a third party, the Bariatric Surgery Registry at Monash University or Auckland 
UniServices.   
Bariatric patients have three options for participation:  
1. Full participation – Their data is included on the Registry, and Registry staff may contact the 
participant for follow-up information. If the bariatric patient wishes to participate, no further 
action is required by them upon receiving the Participant Fact Sheet. Patient information is 
systematically included on the Registry after 14 days from when the PFS was posted. 
 
2. Partial opt out – Their data is included on the Registry but Registry staff will not contact the 
participant for follow-up information. The bariatric patient is required to phone the free call  
 
1 800 number (AU) or 0 800 number (NZ) to state their decision to partially opt out. 
 
3. Opt out - No clinical data is retained on the Registry. Bariatric patients who choose to opt out 
are required to phone the free call 1 800 number (AU) or 0 800 number (NZ) listed on the PFS 
and state their decision not to participate. Participants can choose to opt out at any time.  
 
The Registry will keep the patients’ name, date of birth, treating hospital & UR Number/NHI and 
treating surgeon in a secure “Do Not Contact” file to ensure the patients will not be contacted in the 
future about that procedure. All information related to their bariatric procedure will be removed from 
the database and destroyed if in paper form.  
Participants who opt out or withdraw will be, upon request, sent a letter confirming their withdrawal 
or, if they have left a voice message. The decision to opt out is recorded per bariatric procedure. Should 
the Registry be notified in the future that the patient has undergone a further revision procedure, they 
will go through the opt out approach again allowing them to re-consider whether they wish to be 
involved with that subsequent operation.  
Amongst the participants who choose to opt out are those who request that their details not be kept 
in any file. These individuals are advised that removing all of their details may result in their being sent 
another PFS if information related to their procedure is added again. The individual will be advised to 
contact their surgeon’s/gastroenterologist’s rooms to have this decision recorded so that any request 
by the Registry for information related to that procedure will not be submitted. 
A secure file is kept of individuals who opt out and this file is strictly accessible to Registry staff only. 
All health information for those who opt out is deleted and/or destroyed, if in paper form, in 
accordance with the National Statement for Ethical Conduct in Human Research 2007 (2018).39 The 
information kept in the secure file is only that which is needed to ensure the individual will not be 
contacted again about their procedure, including their name, date of birth, name of the treating 
surgeon or gastroenterologist and hospital. When individuals contact the Registry to opt out, they will 
be asked for their verbal consent for this information being kept for this purpose. This retained 
information validates that the procedure was submitted, ensuring and verifying that surgeons are not 
selectively enrolling participants. Furthermore, the file allows for accurate reporting of participant opt-
out and withdrawal rates, preventing the Registry from reporting a false opt out rate. 

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If a PFS is returned in the mail, Registry staff will attempt to validate the address used. If a corrected 
and current address cannot be obtained, all information related to the patient will be deleted and 
securely destroyed, if in paper form, as the opt out approach is not able to be completed. 
Figure 2 illustrates the typical participant recruitment process as well as recruitment and data 
verification using the information collected from the hospital discharge reports. 
 
 
Figure 2. Participant recruitment aged 16 or over (NZ) or 18 or over (AU)  
Is Surgeon using 
BSR-i?
Opt-Out?
Is it a new 
participant?
Is this at a site 
with ethics 
approval?
Is procedure 
collected
Is it a new 
participant?
Surgeon Sends Data 
via hard copy forms 
to BSR
Patient & Operation 
Data entered onto 
BSR-i 
Participant Fact 
Sheet (PFS) sent to 
patient
Clinical Data and 
Form Destroyed
Yes
Yes
14 days since PFS 
sent
No
Hospital sends ICD-
10 Data
Has procedure 
been entered in 
BSR?
To Surgeon: Form 
request remainder 
Op and Periop Data 
BSR Database
No
Yes
No
Yes
Revision Operation 
Data entered onto 
BSR-i 
Are there any 
corrections?
No
Surgeon returns 
completed form
Remainder of 
Operation & Perop 
Data entered onto 
BSR-i 
Surgeon searches 
patient details on 
BSR-i
Yes
No
No
Yes
Yes
Corrected Data 
entered onto BSR-i 
Yes
End
No
BSR informs 
Hospital which 
surgeons are 
enrolled at site
Is it a new 
participant?
Opt-Out?
Participant Fact 
Sheet (PFS) sent to 
patient
14 days since PFS 
sent
No
Yes
Patient & Subset of 
Op Data bulk loaded 
onto BSR-i 
Subset of Op Data 
bulk loaded onto 
BSR-i 
No
Yes
Prompted to input 
remainder of op 
data and periop on 
to BSR-i
Does Surgeon 
Respond Within 
Timeframe?
Yes
Does Surgeon 
Respond Within 
Timeframe?
Patient contacted 
by Call Centre
No
No
Yes
Is patient 
contacted within 
5 calls?
No
Yes
Scanned Patient 
Data Forms
No
Patient is Lost to Follow Up 
& no longer pursued for 
information unless they 
have another procedure
 
8.3.2 Recruitment of eligible participants under the age of 16 (NZ) or 18 (AU) 
When the rooms or clinic is made aware that a minor will be presenting for consultation to discuss 
surgical bariatric treatment options, the rooms or clinic should contact the Registry to request a 
consent form in order to potentially recruit the minor patient. The Registry will immediately email the 
consent forms with instructions. This will ensure that the consent forms are on hand for the patient’s 
appointment.  
Consenting a minor to participate in the Registry will follow the Australian Paediatric Research Ethics 
& Governance Network Guide (2017).54 Surgeons, gastroenterologists or hospital clinic staff are to 
discuss the Registry with the minor patients and their parent(s)/legal guardian(s) and give both the 
patient and parent(s)/guardian(s) a Registry flyer. The rooms or clinic should also have a Registry poster 
displayed. Further, the Parent(s)/Legal Guardian(s) Informed Consent Form (ICF) will be provided to 
the parent(s)/legal guardian(s) and the clinician, as an investigator in the study, is to determine the 

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capacity of the minor participant to understand the research. If the clinician investigator determines 
that the minor does not have capacity to consent, he/she is to provide information about what their 
participation will involve in language they understand, using the Information Sheet for Minors. The 
determination of capacity is to be documented by the clinician in the medical record and a study note 
should be provided to the Registry. 
To protect from the perception of coercion to participate, the consent process should be carried out 
by a member of staff/the clinic who is not directly involved in the minor’s care. The member of staff 
will verbally go over the consent form in its entirety with the minor and their parent(s)/guardian(s). 
The staff must clearly state that participation in the Registry is voluntary; that consent can be 
withdrawn at any time; and that their decision whether or not to participate will not affect the quality 
of the treatment they will receive. Further, prior to the individual giving consent, the opportunity must 
be given to consult with another health professional, family member or member of their community.  
The form should only be signed when the staff member has been given surety that it is understood by 
the individual. Three copies of the form are required to be signed by the person giving consent, the 
person who carried out the consent process and a witness. One copy will be given to the person who 
gave consent, one is to be kept in the patient’s medical record (an electronic copy can be made), and 
a copy is required to be sent to the Registry. If the consent process is taking place in a hospital clinic, 
the entire copy of the ICF should be sent to the hospital’s Health Information Services (HIS) to be 
entered in the patient’s medical record. 
If the minor is mature enough to understand and capable of consenting to participation, they should 
also be given their own ICF to sign or they can countersign Parent(s)/Legal Guardian(s) ICF.54 This needs 
to be witnessed by clinic or room staff who are present at the time of the consent or the patient’s 
parent/guardian. One copy will be given to the patient, one is to be kept in the patient’s medical record 
(an electronic copy can be made), and a copy is required to be sent to the Registry. If the consent 
process is taking place in a hospital clinic, the entire copy of the ICF should be sent to the hospital’s 
Health Information Services (HIS) to be entered in the patient’s medical record. 
The Registry will keep a log which will verify that consent was carried out for each minor participant. 
The log will state: the date(s) when the consent form was requested and sent; the date of consent; 
and the date the Registry received the signed copy of the consent form. All Registry copies of the 
consent forms will be securely filed and stored within the Registry.  
No minors’ data will be held within the Registry prior to receiving a signed consent form.  
Consent for participation of the minor can be withdrawn at any time. The ‘Form for Withdrawal of 
Participation-Parent/Guardian’ must be completed. Three copies of the form must be signed with one 
copy given to the parent/guardian, one for the participant’s medical record and one provided to the 
Registry. The Registry will complete the withdrawal in the Consent Log. Once consent has been 
withdrawn, all health information relating to the participant will be deleted from the database. 
8.3.2.1 Re-negotiating consent when a minor participant reaches 16 years (NZ) or 18 years (AU) 
As part of the Registry’s validation processes, it will routinely check the age of Registry participants. 
The process of doing this routinely will alert the Registry to any 16 year old New Zealand or 18 year old 
Australian participants. When a 16 year old (NZ) or 18-year-old (AU) participant is identified by the 
Registry, Registry staff will review the Consent Log to determine who gave consent for treatment. If 
consent was given by a parent or guardian at the time of the patient being a minor, the participant will 
be posted a specific Participant Fact Sheet ‘Participant Fact Sheet for 16+ (NZ)’ or ‘…18+ (AU)’, allowing 
the opportunity to consider whether or not to continue their participation. 
 

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This PFS explains the purpose of the Bariatric Surgery Registry and that they had previously been 
enrolled at the time of their operation when they were younger. It explains how the reason why they 
were enrolled and what their continued participation would involve. It also advises that their 
participation is voluntary and how to opt out if they wish to cease their involvement. General contact 
information is listed along with details about making a complaint to the relevant ethics committee and 
a free call number (0 800 in New Zealand or 1 800 in Australia) is also provided. If no contact with the 
Registry is made within 14 days of posting the PFS, it will be presumed that the participant agrees to 
their continued participation. All participants are able to opt out at any time.  
8.3.3 Waiver of consent  
A waiver of consent is required to allow for the opt out approach; for the deceased: for people highly 
dependent on medical care (in particular instances, only); and for data linkages (including with 
electronic medical records). 
8.3.3.1 Waiver of consent while completing opt out approach  
Patients’ data is held prior to the completion of the opt out approach (which includes the mailing of 
the PFS) twice during the data acquisition process:  
 
from the time bariatric patient information is submitted to the Registry until the two weeks 
since posting the PFS has passed; and 
 
from the time when the Registry receives the discharge coding (ICD-10-AM reports) for 
bariatric patients whose data was not previously submitted until two weeks since posting the 
PFS has passed.   
The Monash University Office of General Counsel considered this process to be acceptable under the 
Privacy Act of 1988 (2014)37. The Registry’s data acquisition process has had prior review and approval 
from the ethics committees in Australia and New Zealand listed in section 2. The lead ethics committee 
for the Bariatric Surgery Registry, the Alfred Hospital Human Research Ethics Committee, considered 
that this process is preferable to the surgeon obtaining direct informed consent at the time of 
consultation, which holds a risk of power imbalance, coercion and difficult to document that the 
process had occurred. Ethical considerations are discussed more completely in section 9.   
8.3.3.2 Waiver of consent for the deceased 
A waiver of consent for the deceased is required in the event that the patient dies following bariatric 
surgery so as not to burden next of kin. Information related to mortality is essential to determine if the 
cause of death was related to the bariatric surgery. The Alfred Hospital HREC (Australia), the New 
Zealand HDEC and all other approving HRECs in Tables 3 and 4 considered this waiver and approved 
its use. Having a waiver of consent for this instance implies that the deceased did not need to give 
previous consent to request or hold their information, nor is consent required from their next of kin to 
hold the data of the deceased. 
8.3.3.3 Waiver of consent for people highly dependent on medical care 
Bariatric patients may become unconscious, receive intensive care, emergency care or end-of-life care 
as a consequence of having their surgical procedure(s). Information about adverse events leading to 
patients receiving this type of care or to be in this condition are critically vital to demonstrate the safety 
and quality of bariatric surgery.  
The surgeon, gastroenterologist or hospital should advise the patient’s parent, guardian, or other 
authorised representative of the patient’s inclusion in the study and allow them to consider whether 
their inclusion would be contrary to the patient’s interests. However, if no other authority is acting on 
behalf of the patient, a waiver of consent is required. If such a patient regains capacity for consent, 
they should be advised as soon as reasonable possible of their inclusion in the Registry and be provided 
with opportunity to opt out. 
8.3.3.4 Waiver of consent for linkage with participants’ electronic medical record (EMR) 
Data can be collected directly from a participant’s medical record held on the medical practice 

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software (an electronic medical record or “EMR”) of their surgeon/gastroenterologist/hospital. (Refer 
to section 8.4.2.1). In order to link with the software, the Registry needs to disclose participant 
information to the software provider for the purpose of locating the participant in the medical record. 
All information disclosed to the software contractor for this purpose is to be deleted after the linkage 
is completed. 
A waiver of consent is needed for the Registry’s disclosure to the software provider to carry out the 
data linkage. 
8.3.3.5 Waiver of consent with data linkages 
The Registry intends to link with other repositories of health information as a means of validating its 
data as described in section 8.4.2.4. Health information about individual participants may be collected 
who have not completed the opt out approach, just as it may be with the hospital ICD-10-AM reports. 
This protocol adheres to the National Statement for Ethical Conduct in Human Research 2007 (2018) 
and with New Zealand’s Ethical Guidelines for Observational Studies: Observational Research, Audits 
and Related Activities (2012).39, 43 Section 6.47 of the NZ guidelines states, “In the case of audits and 
related activities it may be ethical to use health information without additional or specific consent, as 
these activities are sometimes an essential part of high-quality health care delivery, so the activity may 
be one of the reasons why the data were collected”. 43 
 
8.4 Data 
8.4.1 Data collection stages 
i. 
Operation data collection  
Data is collected about bariatric patients and their procedures after the surgery has taken 
place. 
ii. 
Perioperative follow-up data  
Follow-up data is collected peri-operatively, with regard to the first 90 days after the surgery 
for all participants. The Registry will not accept routine follow-up data captured prior to 20 
days after the surgery. See Figure 3. 
 
iii. 
Annual follow-up data collection 
Follow-up data is collected on an annual basis for primary bariatric procedures only. 
Acceptable data collecting periods are from 3 months prior to the anniversary of the surgery 
to 3 months following the anniversary. See Figure 3.  
 

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Figure 3. Follow up data collection  
 
 
8.4.2 Data collection processes 
8.4.2.1 Data collected from surgeons, gastroenterologists, and hospital data collectors 
The health professionals who performed the procedures (surgeons or gastroenterologists) have the 
overarching responsibility for submitting data. However, they can delegate submission to their practice 
staff or hospital data collectors. Data is provided to the Registry: 
 in Australia, using:  
o the web browser with secure authorised entry using the Bariatric Surgery Registry 
Interface (BSR-i); 
o  paper based data forms securely faxed or posted; or 
o  secure electronic record transfer from surgeons’ or hospitals’ electronic medical 
record (EMR) 
 in New Zealand, using:  
o the web browser with secure authorised entry using the Bariatric Surgery Registry 
Interface (BSR-i); or 
o secure electronic record transfer from surgeons’ or hospitals’ electronic medical 
record. 
Practitioners who choose to have data collected from their EMR will sign an agreement with their 
contracted provider to have their patients’ records accessed for the purpose of data collection. The 
Registry would provide an encrypted CSV file on the secure file transfer platform (SFTP) to the software 
provider. Once the software provider carries out the linkage, the data would be encrypted, converted 
to an agreed file format, and uploaded to the Monash University SFTP for Registry staff to access.  
8.4.2.2 Data collected from ICD-10-AM coding reports (or similar hospital discharge reports) 
Hospital Information Services (HIS) at each hospital site, or of a private hospital group, are to provide 
regular ICD-10-AM coding reports (or similar discharge reports) for bariatric procedures performed by 
surgeons or gastroenterologists who participate in the Registry. The coding reports include patient 
demographic and procedure information. In Australia, these reports are sent to the Registry using a 
secure file transfer platform (SFTP). In New Zealand, these reports are sent to UniServices in 
accordance with the agreed Memorandum of Understanding for each site.  

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The ICD-10-AM coding (or similar) reports provided by HIS are used to verify data submitted to the 
Registry. The reports confirm the procedures already submitted and allow Registry staff to identify 
those which have not. Surgeons, gastroenterologists and hospital data collectors will be asked to 
provide the remaining clinical information for the patients whose procedures were identified in the 
coding report: 
o device/stapling information;  
o whether the operation was a primary or revision;  
o height/weight information;  
o diabetes status and treatment; and 
o perioperative follow-up data is also requested for efficiency.  
Patients whose details are obtained from these reports are sent a PFS and the opt-out approach is 
followed according to the process described in section 8.3. Once the opt out period has passed, if the 
request for the missing data elements from the surgeon or gastroenterologist was not met, Registry 
staff will contact the participant to collect the required information. 
8.4.2.3 Data collected from participants 
A. Self-reported clinical and follow up data 
When surgeons, gastroenterologists or public data collectors indicate they have not seen the 
participant and cannot report follow-up, the Registry staff will contact the participant for a brief phone 
call (using the Call Protocols) to collect the follow-up information related to the perioperative period 
and/or 12 month interval after surgery. (See Figure 4.).  
If the participant is a minor, the Registry staff member must check the Consent Log to determine if the 
minor had consented, or a parent/guardian did on their behalf. Registry staff will then speak directly 
with the individual who provided consent as per the consent form. 
Participants (or parent/guardian) may also be asked for any missing data elements about their 
procedure not previously collected. 
As explained in the PFS, participants do not have to agree to this contact but still keep their information 
on the Registry (partial opt out).  
If a participant is to be followed up by the Registry, five attempts will be made to contact the 
participant before they are allocated to “Lost to Follow-Up”. All information about the participants lost 
to follow-up status is held by the Registry, as they have been through the opt out approach. These 
individuals may be captured again if they undergo further bariatric surgery. 
An SMS/Secure Portal platform will be developed as another method to obtain follow-up data from 
Registry participants, through SMS, email and web based links. This platform will invite participants to 
link to a secure portal at various stages of their post-operative experience. If they do not respond to 
the request for follow-up, the Registry will call the participants. The SMS/Secure Portal platform will 
be designed to engage with participants by providing useful information during their post-surgery 
experience and allow them to give their own data back to the Registry. 
 
B. Participant feedback and quality assurance 
For quality assurance purposes and as a basis for the development of the SMS/Secure Portal platform 
as described above, participants will be given the opportunity to provide feedback on their experience 
with the Registry and offer how the Registry could better support their journey as bariatric patients. 
This feedback may take place during follow-up phone calls made by the Registry’s call centre staff or 
via an online form on the Bariatric Surgery Registry website that is currently under construction. 
 
8.4.2.4 Data collected from linkages with other repositories of health information  
Data may be collected with linkages to other repositories, or datasets, of health information for the 
purpose of verifying critical quality data as explained in the section 8.4.4. Any request to link with a 
data linkage unit will require the necessary ethic approvals.  

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8.4.2.5 Data Collected by other interested parties 
More comprehensive data can potentially be collected by interested sub-groups but approval from the 
Bariatric Surgery Registry Steering Committee and the lead ethics committee, the Alfred Hospital 
Human Research Ethics Committee, is required.   

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Figure 4. Follow-up data collection scheme. 
BSR Database 

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8.4.3 Data elements 
Data elements are defined in the Registry’s data dictionary and governed by the Steering Committee, with 
any changes managed through a data element variation process.  
The data elements collected include: 
 
Patient data elements:   
 
Patient Identifiers:  
o full name; 
o address;  
o date of birth; 
o UR number/hospital (and IHI numbers when available); and 
o email address (if supplied by patient) 
 
Patient demographic information:  
o Medicare number (Australia only) 
o Department of Veterans Affairs (DVA) number; 
o NHI number (New Zealand only);  
o phone numbers;  
o gender; and   
o indigenous status (Australia)/ethnicity (New Zealand) 
 
Operation data elements: 
 
Clinical details:  
o start weight (for primary participants only); 
o day-of-surgery (DOS) weight;  
o height; 
o diabetes status and treatment; and 
o concurrent renal and liver transplant 
 
Procedural information:  
o surgeon name; 
o procedure date; 
 
 
o procedure type; 
o surgical approach used (open, laparoscopic, robotic) 
o primary/ revision;  
o planned or unplanned revision status; 
o reason for revision; 
o bariatric procedure prior to revision; 
o if the procedure was abandoned; 
o reason for abandoning procedure; 
o length of hospital stay; and 
o mortality status including date of death and whether the death was likely to be related to 
the bariatric procedure 
Device or Staple details:  
o type; 
o brand;  
o model; 
o port fixation method; and  
o buttress 
 
Follow-up data elements  
 
Elements for Perioperative (up to 90 days post-surgery) Data:  
o date participant had a post-operative review  
o occurrence of unplanned return to theatre and reason/ complication occurrence of 
unplanned admission to intensive care and reason/ complication; 
o occurrence of unplanned re-admission to hospital and reason/ complication; 
o prolonged hospital stay and reason/ complication; and,  

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o mortality status including date of death and whether the death was likely to be related to the 
bariatric procedure 
Elements for Subsequent Clinical Data of Primary Participants (collected annually for ten years):  
o weight;  
o diabetes status and treatment; 
o re-operation and reason; and 
o mortality status including date of death and whether the death was likely to be related to the 
bariatric procedure 
 
8.4.4 Data quality 
Data completeness and accuracy are optimised through routine in-built validation and completion checks 
in the Registry database to minimize data entry error. These include: 
 
data entry controlled by form logic and limited to feasible data; 
 
use of built in edit checks to ensure data meets the required formats and range; 
 
accuracy enhanced by the use of exhaustive drop down lists providing all possible answers to 
minimize free text entry where applicable; 
 
use of hide and show mechanisms to guide data entry to required fields; 
 
use of explanatory texts to assist data entry; 
 
validation rules applied at the time of submission with alerts to assist with errors and missing 
data; and, 
 
the use of a participant management system to list incomplete data and other actions required. 
Additional quality checks post data entry includes checking for: 
 
duplicate data; 
 
missing data; 
 
data consistency; and 
 
data validity. 
Data quality and completeness are checked at a number of stages of the data management process. 
Errors in data quality, when identified, may be referred back to contributing surgeons, 
gastroenterologists or hospitals for review. 
Case ascertainment, as well as both brief and comprehensive audit processes, are performed on site by 
Monash University Registry staff (Australia only). Registry staff perform regular remote audit checks to verify 
the accuracy of data received from surgeons and gastroenterologists. This is done during the course of a follow-
up phone call from the call centre or by Registry staff directly contacting surgeons’ or gastroenterologists’ rooms. 
Completeness and accuracy of the eligible population captured by the Registry is assessed using hospital 
ICD-10-AM coding reports (or similar hospital discharge reports) provided by participating hospitals or 
hospital groups. Cross-checking with these reports allows for complete data capture at each hospital site 
and provides data validation for each procedure submitted by the surgeon or gastroenterologist. These 
reports are provided at regular intervals by the organisation’s administrator and only contain data of 
participating surgeons and gastroenterologists.   
In Australia, periodic linkages are intended with other repositories, or datasets, of health information that 
can validate Registry data. The ICD-10-AM discharge report validations and other data linkages will ensure 
that all eligible patients are included in the Registry and minimise the risk of bias in data entry by contributing 
surgeons and gastroenterologists. The linkages will also verify critical quality data such as patient mortality, 
defined adverse events and other outcome measures are completely captured. Requests to link New Zealand 
Registry data to national data sets will be considered by the Steering Committee on a case-by-case basis. For 
data linkages in Australia and New Zealand, the necessary approvals from an HREC/HDEC will be sought when 
required. Examples of repositories, their role in data validation, and what information will be collected and 
disclosed by the Registry are described in Table 5. 

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8.4.5 Data confidentiality 
Only those employed by Monash University and UniServices for the purpose of the project, such as the 
Registry epidemiologists, data custodian, clinicians involved with the research, research assistants and/or 
data managers have access to the data which is limited to the extent required to perform their employment 
duties.  
Registry staff involved with data monitoring, analysis or reporting undertake training to ensure that they 
understand their obligations about data confidentiality and privacy relating to research activities. The 
Registry researchers and staff are required to complete and submit a Confidentiality Agreement to ensure 
that they understand the confidentiality and privacy parameters. Registry database users have their own 
unique username and password to access the interface.  
For the purpose of monitoring and/or auditing to determine case ascertainment, accuracy and completion 
of data, authorised Registry staff may liaise with surgeons and sites to organise access to patient records. 
The Privacy Policy of the Bariatric Surgery Registry sets out how and why information is to be collected about 
individuals in the course of the study and how that information will be used and stored in accordance with 
Australian and New Zealand Privacy Principles. 
8.4.6 Data security 
Registry data is secured according Australian Privacy Act of 1988 (2014), the Australian Privacy Principles 
(especially APP11), the Privacy Act 1993 (New Zealand), the Health Information Privacy Code 1994 and the 
relevant jurisdictional legislation.37, 41-2 Registry management and staff will ensure that “reasonable steps” 
are taken to protect private information as outlined by the Office of the Australian Information Commissioner 
(2015). 55 
Prior to conversion to electronic files by Registry staff, forms completed in hard copy are stored securely in a 
locked filing cabinet behind swipe card-only accessible doors. Other electronic files are stored on the Monash 
University secure shared drive where access to the computers is username and password specific to each 
user. 
The BSR-i database is held electronically and stored securely within the Clinical Data Management Unit, 
Monash University (Melbourne Australia) where other confidential registries are stored and maintained. The 
Registry database is routinely backed up and encrypted on a secure server (according to ISO27001 standards) 
in the event of unauthorised data access. 
All communication between the users’ browsers and the server (BSR-i) occurs on a secure channel, commonly 
referred to as Secure Sockets Layer (SSL). SSL ensures that a private key on the server encrypts all data before 
it is sent to the user where it is decrypted by a public key. This ensures the data is not compromised in transit.  
All users of the BSR-i access the system through a login screen with a pre-figured username and password 
controlled by administrators of the system. 
Disposal of any information will be in accordance with the National Statement on Ethical Conduct in Research 
Involving Humans 2007 (2018) and New Zealand’s Ethical Guidelines for Observational Studies: Observational 
Research, Audits and Related Activities (2012).39, 43 Archived information will be securely stored for an 
indefinite period. 

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Table 5. Examples of repositories of health information and the Information to be collected and disclosed 
Repository 
Data held by 
Data validation description 
Data collected by BSR 
Data disclosed by BSR 
ICD-10-AM Extract 
Each Hospital 
Ascertain cases that are coded to the set of bariatric 
codes to determine if reported to BSR or omitted 
• 
participant name  
• 
address 
• 
date of birth 
• 
Medicare number  
• 
treating surgeon/gastroenterologist  
• 
length of hospital stay 
• 
procedure codes 
Participant name and date of 
birth 
Practice or Hospital 
Electronic Medical 
record (EMR) 
Medical 
Practitioner/Hospital 
software provider  
Validate participant and operation information. 
Linkage is primarily for the purpose of collecting 
data. 
• 
participant weight 
• 
diabetes status and treatment 
• 
further operation(s) as a consequence 
of having bariatric surgery 
• 
participant name,  
• 
date of birth,  
• 
date of operation 
• 
surgeon/gastroenterologist 
who performed operation 
• 
hospital for operation 
Births Deaths & 
Marriages (Australia) 
Each State Jurisdiction  
Ascertain death of bariatric patient/registry participant 
to ensure it is recorded and that no further attempts to 
collect follow up are made subject to application 
• 
participant name 
• 
address  
• 
date of birth 
• 
date of death  
• 
cause of death 
• 
participant name,  
• 
date of birth 
Private Health Insurers’ 
Datasets 
Current: Latrobe Health 
Service 
Future: TBA via 
amendment 
Private Insurers 
Ascertain if registry participants have returned to 
hospital (defined adverse event), been admitted to ICU 
and/ or had a procedure (includes procedures not in 
the bariatric code set but revision procedures for 
stapling procedures e.g. stents, lavage, etc.)  
• 
participant name  
• 
address  
• 
date of birth 
• 
Medicare number  
• 
treating surgeon/gastroenterologist  
• 
length of hospital stay  
• 
procedure codes 
• 
 hospital re-admissions 
None 
Coronial Court Findings 
(Australia) 
Each State Jurisdiction  
Ascertain the likelihood that death was related to 
bariatric procedure subject to application and ethics 
committee approval 
• 
participant name  
• 
address  
• 
date of birth 
• 
date of death  
• 
cause of death 
• 
participant name,  
• 
date of birth 
National Coronial 
Information System (NCIS) 
Commonwealth of 
Australia 
Ascertain the likelihood that death was related to 
bariatric procedure subject to application and ethics 
committee approval 
• 
participant name 
• 
address  
• 
date of birth  
• 
date of death  
• 
cause of death 
• 
participant name,  
• 
date of birth 
• 
date of death 
National Death Index 
Commonwealth of 
Australia 
Ascertain the likelihood that death was related to 
bariatric procedure subject to application and ethics 
committee approval 
• 
participant name 
• 
address 
• 
date of birth  
• 
date of death  
• 
participant name,  
• 
date of birth 
• 
date of death 

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• 
cause of death 
New Zealand Collections 
New Zealand Ministry 
of Health 
National collections including Mortality Collection that 
can be linked using NHI number, subject to application 
• 
participant name  
• 
address 
• 
date of birth  
• 
NHI number  
• 
treating surgeon/gastroenterologist  
• 
length of hospital stay 
• 
procedure codes  
• 
hospital re-admissions  
• 
cause of death 
• 
participant name,  
• 
date of birth 
• 
date of death 
Admission and episodic 
datasets for each State or 
Territory: 
ACT: Admitted Participant 
Care Collection, 
NT: In-Participant Activity, 
NSW: Admitted Participant 
Data Collection, 
QLD: Hospital Admitted 
Participant Data 
Collection,  
SA: Integrated South 
Australia Activity Data 
Collection, 
TAS: Public Hospital 
Admitted Participant 
Collection, 
VIC: Victoria Admitted 
Episodes Dataset 
WA: Hospital Morbidity 
Data Collection 
Each Jurisdiction 
Ascertain if registry participants have returned to 
hospital (defined adverse event) and/ or if they have 
had a procedure (includes procedures not in the 
bariatric code set but revision procedures for stapling 
procedures e.g. stents, lavage, etc.)  
subject to application and ethics committee approval 
• 
participant name 
• 
address 
• 
date of birth  
• 
Medicare number  
• 
treating surgeon/gastroenterologist  
• 
length of hospital stay 
• 
procedure codes 
• 
hospital re-admissions 
None 

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9 Ethical considerations 
The Bariatric Surgery Registry was established for the purposes of health research and is considered to be in 
the public’s interest and follows the specific recommendations by the Georganas Inquiry into Obesity in 2009, 
the Australian Commission on Safety and Quality in Healthcare, and the Health Technology Review Report. 
35, 36 
To function as a clinical quality registry, the Bariatric Surgery Registry collects, stores, and uses identifiable, 
personal and sensitive health information about bariatric patients for research into the quality, safety and 
effectiveness of bariatric surgery as treatment for obesity. In order to collect longitudinal outcomes of those 
who underwent bariatric surgery, identifiable information is necessary so that hospitals, surgeons, 
gastroenterologists and their staff can link back to participants’ medical records and provide information on 
participants’ health status following their procedures.  
Ordinarily, consent is sought from individuals whose health information is being collected. All quality and 
safety registries require near total capture of potentially eligible participants to ensure reliable reporting of 
outcomes. If participation in a quality and safety registry is less than 90%, there is significant risk of bias and 
underreporting of adverse outcomes. International experience suggests that obtaining prior consent can 
cause participation rates to drop to around 60%, potentially rendering data unreliable.56 Obtaining consent, 
therefore, for a clinical quality registry would ‘prejudice [its] scientific value’, justifying the use the opt out 
approach when considering New Zealand’s Ethical Guidelines for Observational Studies.43 
Further, based on the anticipated numbers of participants expected to be recruited for the study, obtaining 
direct consent would be difficult. Based on the current data, it is estimated that least 27,000 bariatric patients 
per year will be eligible for recruitment across Australia and New Zealand.30,31  As such, the scale and 
significance of the Bariatric Surgery Registry indicates that an opt out approach to participation, rather than 
informed consent, is necessary. 
It is acknowledged, however, that using the opt out approach carries a risk as the Registry stores data without 
participant consent for the period of time whilst the opt out approach is being undertaken and when 
discharge coding reveals a patient that a surgeon did not enter into the Registry. This risk is mitigated by 
participating surgeons, gastroenterologists or hospital clinics providing flyers; displaying the Bariatric Surgery 
Registry poster; and, advising patients that their information will be provided to the Registry. The Monash 
Office of General Council, forty ethics committees across Australia and New Zealand’s Southern Health and 
Disability Ethics Committee have considered this to be an adequate process and a waiver of consent was 
granted allowing for the opt out approach to be used 
In Australia, the Registry must comply with the Privacy Act 1988 Cth (2014) and the Privacy Principles in s14 
regarding the collection, use and storage of private and sensitive health information.37 Jurisdictional 
legislation and the privacy legislation of New Zealand have similar principles. 41-2, 44-7,49-52 Australian Privacy 
Principles 3 and 6, respectively, allow for the collection of health information and for stored personal 
information to be used or disclosed for a secondary purpose without consent of the individual, if there is a 
permitted health situation as defined in s16B of the Privacy Act 1988. 37 
Section 16B(2)(d)(iii) allows health information to be collected and s16B(3) allows for the use or disclosure 
of health information following the Guidelines Approved under Section 95A of the Privacy Act 1988 (2014).38 
The Bariatric Surgery Registry must comply with the S95A Guidelines, the National Statement, and seek ethics 
approval from an NHMRC constituted human research ethics committee, as it has been determined that: 
 the health information it collects is necessary for the purposes of research; 
 the research is relevant to public health and safety; 
 it is impractical to obtain consent; 
 identifiable data is necessary; and 

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 the opt out approach will be used instead of consent.38-39 
In New Zealand, the Registry must comply with the Privacy Act 1993 and the Health Information Privacy Code 
1994. 41-2 
Any future addition of hospital sites will be submitted for ethical review.   
Data from New Zealand is held at Monash University in Melbourne Australia. The Bariatric Surgery Registry 
has been granted an Acceptance Status from the New Zealand Ministry of Health for personal health 
information to be stored at Monash University.   
 
9.1 Ethical considerations for specific participant groups 
With regard to the inclusion of vulnerable individuals, the Registry takes into account the federal and 
jurisdictional legislation related to consent and decision making.48, 54, 58-61 In accordance with the Australian 
Privacy Principles (APP) guidelines (Chapter B. Key concepts B.52-B.55), as surgeons and gastroenterologists 
are APP entities, they must assess whether patients have the capacity to consent to treatment, and the 
subsequent capacity to consent to participate in research.57 
The Registry considers the needs of all participant groups, respecting their rights as prospective participants 
in this research. 
9.1.1 Ethical considerations for children or young persons 
As bariatric surgery is known to be performed on children and young people, persons under 18 years old are 
expected to be recruited to participate in the Registry. The collection of their data is essential to reliably 
report the appropriateness, safety and effectiveness of bariatric surgery as a treatment for obesity in young 
people.  
Children and young persons will not be directly involved in the research as observational data is collected 
from surgeons, gastroenterologists and hospitals. Their participation in the Registry has a low risk to their 
safety, emotional and psychological security and well-being. 
Written consent will be required for the participation of any minor in the Registry, following the process as 
set out in section 8.3.2. When a minor participant reaches 18 years, consent for participation will be re-
negotiated for those whose participation was consented by a parent or guardian. This allows the individual 
to decide for his/her self whether or not to continue their involvement with the study. Refer to section 8.3.2.1. 
9.1.2 Ethical considerations for persons with cognitive impairment 
Persons who have a cognitive impairment, intellectual disability or mental illness and undergo a bariatric 
procedure in Australia or New Zealand are eligible for participation in the Registry. As participants, they 
would have no direct involvement in the research and their participation has a low risk to their safety, 
emotional and psychological security and their well-being. 
The surgeon or gastroenterologist should assess the degree of cognitive impairment of the patient. For 
patients capable of consent, the surgeon or gastroenterologist should follow the opt out process for 
participant recruitment for which he/she is responsible, advise the patient about their details being given to 
the Registry and give the patient a flyer. The Registry would then send the patient a Participant Fact Sheet 
(PFS) further advising of the opt out process. The patient can opt out at any time or his/her next of kin or 
legal guardian can opt out the patient on his/her behalf. 
If the surgeon or gastroenterologist is aware that another individual has been authorised to give consent to 
medical treatment on behalf of the patient, it is the surgeon's or gastroenterologist’s responsibility to contact 
the Registry and advise who should be sent the Participant Fact Sheet. Nonetheless, the participant should 
always be sent their own PFS and retain the right to decide whether to participate. 

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The research carries low risk as an observational study, however, vulnerable persons may be distressed when 
contacting the Registry. The Registry staff are trained to follow the Registry’s call protocols to minimise 
participant discomfort or distress. 
9.1.3 Ethical Considerations for people highly dependent on medical care 
As a clinical quality registry, the Bariatric Surgery Registry collects outcome measures related to a defined 
time frame for every bariatric surgical procedure performed. There is the possibility that, as a result of having 
bariatric surgery, a patient may become unconscious, receive intensive care, emergency care or end-of-life 
care. 
Information about adverse events that occur to people receiving this type of care or in this condition 
following a bariatric surgical procedure is vital to demonstrate the safety and quality of bariatric surgery. The 
Registry will use this information to benchmark procedures, outcomes and providers of care (surgeons, 
gastroenterologists, and hospitals). It will lead to greater understanding about the safety of bariatric surgery, 
which has the potential to give confidence to patients, surgeons, gastroenterologists, hospitals, governments 
and the wider community. 
As stated in section 8.3.3.3, if such a patient is to have their information submitted to the Registry, the 
surgeon, gastroenterologist or hospital should advise the patient’s parent or guardian or other authorised 
representative of the patient’s inclusion in the study and be allowed to consider whether it would be contrary 
to the patient’s interests. If no other authority is acting on behalf of the patient, a waiver of consent is 
required. If such a patient regains capacity for consent, they should be advised as soon as reasonable possible 
of their inclusion in the Registry and be provided with opportunity to opt out. 
9.1.4 Ethical considerations for persons who cannot speak English 
Individuals who do not speak English may be recruited to the Registry. To ensure the opt out process can be 
completed, these patients require an explanation in their own language stating that their information will be 
submitted to the Registry. The surgeon or gastroenterologist is to give the patient a flyer prior to sending 
their information to the Registry and ensure that the patient has someone who can translate the flyer for 
them, such as a support person or translator who attends the surgeons’ rooms with the patient. The patient 
should be advised and understand that after the operation, he/she will receive a letter from Monash 
University or the University of Auckland with further Registry information. 
If the patient indicates that they have no one who can translate the information for them, the surgeon or 
gastroenterologist will need to contact the Registry to request a translated version of a flyer. The surgeon or 
gastroenterologist would need to be provide the translation to the patient before sending any information 
to the Registry. 
It will be presumed that patients who require a translated flyer will also need a translated Participant Fact 
Sheet. The Registry has Participant Fact Sheets available in Mandarin and Arabic. If another language is 
required, the Registry will organise a translation with the Victorian Translation Service or a similar service in 
New Zealand. Surgeons will need to note that a translated PFS is required and in which language, upon 
submission of the patient’s operation data. 
If Registry staff need to contact a participant who cannot speak English for follow-up information and a 
translator is unavailable, no further attempts to obtain follow-up information from the participant will be 
made. The participant will automatically be considered “Lost to Follow-Up.” 
9.1.5 Ethical considerations for persons who are Aboriginal, Torres Strait Islander peoples, Māori 
or Pacific Islands peoples 
The Bariatric Surgery Registry has the potential to identify ethnic disparities for Aboriginal and Torres Strait 
Islanders in Australia and for New Zealand's Māori and Pacific Islands peoples. The Registry has the capacity 
to support improving quality outcomes for these groups and it is hoped that these data will enable the 
development of guidelines for bariatric surgical procedures leading to improved outcomes for all indigenous 

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participants. The contribution of the first peoples of Australia and New Zealand will be acknowledged in 
reports and presentations. 
 
This research will involve Māori as participants and will adhere to Guidelines for Researchers on Health 
Research Involving Māori v2 2010 and the Te Mana Rararunga - Māori Data Sovereignty Network Charter. 
Māori consultation is sought in New Zealand as part of locality approvals with the district health boards. 62-3  
The Waitematā and Auckland District Health Boards Māori Research Committee have reviewed the study and 
given their approval. In giving its approval the Waitematā Māori Research Committee stated “While the study 
does not include the analysis of outcomes by ethnicity, the collection of ethnicity data may provide baseline 
data for other researchers or Māori communities. Existing research being undertaken with a focus on 
disparities in Māori bariatric surgery outcomes supports the view that this data may provide valuable 
information for other studies” and also advised that the Participant Fact Sheet (PFS) be available in Te Reo 
Māori (upon request).  
The New Zealand version of the Participant Fact Sheet, provided by UniServices, informs prospective 
participants that they are encouraged to talk to their Whānau in the first instance for Māori cultural support. 
This PFS also provides the contact numbers for He Kamaka Waiora (Māori Health Team), Māori Research 
Committee and the Māori Research Advisor. 
With a high incidence of obesity amongst Pacific Island peoples, they are also likely to be involved in this 
research and will be identified by their specific ethnic origin in order to have ethnicity data of high quality. 
This study will adhere to the Pacific Health Research Guidelines (2014).64 The researchers will uphold the four 
Pacific cultural values of communal relationships, reciprocity, holism and respect and will ensure that Pacific 
peoples’ way of life should not be threatened by this study. Community consultation will be undertaken as 
required. 
In Australia, it is anticipated that members of Aboriginal and Torres Strait Islander community will be 
recruited to the Registry. An ethics application will be made to the HREC of Northern Territory Department 
of Health and Menzies School of Health Research, which will further address the ethical considerations of 
including this community in the study. 
Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines 
for researchers and stakeholders (NHMRC 2018) and Keeping Research on Track II (NHMRC 2018) have been 
considered and will be regarded in the instances of participation of indigenous persons. 40, 65 
The researchers involved with the Bariatric Surgery Registry aim to uphold the six core values of the 
Aboriginal and Torres Strait Islander peoples as defined in the guidelines.40 
Spirit and Integrity The investigators and researchers respect the cultural inheritance of the past, present 
and future generations of Aboriginal and Torres Strait Islander people and are committed ensuring that the 
Registry is carried out with integrity. 
Cultural continuity The researchers acknowledge that Aboriginal and Torres Strait Islander peoples may have 
a negative perception about research and view it as an exploitative process. The conduct of the Registry is 
not expected to impact upon or erode the social or cultural norms amongst Aboriginal or Torres Strait 
Islander peoples. Community consultation will be sought as required respecting the role of community in the 
Aboriginal and Torres Strait Islander culture.  
Equity The Bariatric Surgery Registry does not target any one single group, culture or ethnicity but rather the 
entire population of those who have undergone bariatric surgery. The Registry aims to record and follow the 
quality and safety of bariatric surgery and ultimately improve health outcomes for all patients. It is the 
researchers' intention that any benefit from the Registry will be shared with stakeholders, investigators and 
the public, including Aboriginal and Torres Strait Islander peoples.   

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Reciprocity The researchers recognise the contribution of all participants and groups in the study and aim to 
ensure that all groups and participants will benefit from its conduct. Obesity is particularly prevalent amongst 
indigenous Australians; hence, the inclusion of Aboriginal and Torres Strait Islanders in the Registry is 
essential to improving their health outcomes. It is considered of vital importance to include the Aboriginal 
and Torres Strait Islander community in this research project, not only for the research but also for the wider 
communities of Australia.  
Respect The Bariatric Surgery Registry's investigators, researchers and staff are cognisant of the different 
values, norms, aspirations, expectations and beliefs that individuals, cultures and groups hold, including 
Aboriginal and Torres Strait Islander peoples. The researchers want to ensure trust amongst the Aboriginal 
and Torres Strait Islander community and will remain open to the input of their community throughout the 
conduct of the Registry. The researchers will negotiate a process for individual and community decision 
making for involvement in the Registry. Participation the research is voluntary. Only those who are fully 
informed about the Registry can determine whether or not to participate. The contribution of Aboriginal and 
Torres Strait Islander peoples will be acknowledged in reports and presentations. 
Responsibility Investigators, researchers, and all staff are bound by their professional standards to conduct 
appropriate and ethical research. The Bariatric Surgery Registry is primarily a quality and safety registry aimed 
at improving the health outcomes of bariatric surgery patients. The study is and will continue to be monitored 
to ensure it upholds the responsibility of complying with the protocol, that all adverse events are recorded 
and reviewed. Gaining ethics approval ensures the appropriate ethical oversight of the conduct of the 
Registry. Publication of annual reports provides feedback and communication to stakeholders, participants, 
and the public. The Registry maintains its responsibility of communication and reporting for all jurisdictions 
and among all people, cultures, and groups.   
 
10 
Participant risk management and safety 
The Bariatric Surgery Registry is an observational and epidemiological study collecting data at the time of 
procedure or from medical records and is unlikely to result in any harm to participants.  
Participants who are contacted by telephone for follow-up information may experience minimal 
discomfort related to anxiety answering personal questions related to their weight, health and medical 
procedures. The Registry’s   staff are trained to minimise their distress. 
It is not unusual that a participant may not want anyone to know that they have undergone a bariatric 
surgical procedure and this will be evident if it is made known that they participate in the Bariatric 
Surgery Registry. This could cause the participant to become upset or aggrieved. The likelihood of harm 
occurring is perceived to be very low as evidenced by the Registry’s low opt out rate which has remained 
at less than 4% since it began in 2012. Of the participants who have contacted the Registry or ethics 
committees to complain and/or express their emotional distress when they receive their Participant 
Fact Sheet, the severity has not been demonstrated to be beyond the level of discomfort. No 
consequences of any discomfort have been made known to the Registry. 
Participants are advised of the low risks associated with participating in the Participant Fact Sheet as 
well as the indirect benefits of participating in such a registry. Indirect benefits of participating in the 
research include the monitoring of the quality of care provided by hospitals, surgeons, and 
gastroenterologists; the delivery of the best possible health service to people undergoing bariatric 
surgery can be ensured; and, participants can be notified if a significant issue is identified with the 
medical device or procedure. 
 

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11 
  Data analysis 
11.1 Process of data analysis 
Non-identifiable data is provided to an independent biostatistician by secure file transfer for review on a 6 
monthly basis. 
The results are provided to the Registry’s Programme Manager. Only Monash University Registry staff, who 
are non-clinical, have access to identifiable data. All data used in reports and/or publications is cleaned, de-
identified and verified prior to analysis. Routine re-analysis of data is undertaken by the Programme Manager 
to ensure findings are reproducible.  
 
11.2 Case-mix (risk) adjustment 
Operative outcomes for each individual surgeon or gastroenterologist need to be interpreted with great care 
as the case-mix of surgical practice can vary. For example, some surgeons may only take on patients needing 
more difficult revision surgery while others may operate predominantly on higher risk patients having 
primary surgery. As a result, the comparison of outcomes must carefully consider the patient characteristics 
that are beyond the control of the surgeons or gastroenterologists. This typically will involve taking account 
of a participant’s age, sex, body mass index (BMI) and the existence of any other co-morbidity.  
Other confounders to be considered are the socioeconomic status (SES), demographic location and 
complexity of the surgery. In cases where clear exceptions exist, as identified by validated bio-statistical 
means, individuals may be excluded from sample data to ensure results are not misleading. Documentation 
of decisions to remove cases from samples for data analysis purposes is maintained by the Registry’s Data 
Manager. The number and percent of such observations will be reported to the Steering Committee.  
It is expected that this information will eventually be used for the development of a policy, which will be able 
to identify potential outliers. 
 
12 
Monitoring of outcomes  
The Steering Committee will review the risk adjustment model and its performance characteristics until such 
time that Registry data has matured to allow for a policy to be developed to identify potential outliers. The 
Bariatric Surgery Registry aims to one day provide information which can minimise patient harm should a 
device, procedure, surgeon, gastroenterologist or hospital prove to be deficient. The Registry can also be a 
useful tool in contacting participants should a device recall ever be necessary. 
 
13 
Reporting 
The Bariatric Surgery Registry issues regular reports to deliver data that is valuable to key stakeholders. A 
range of reports is prepared for various stakeholders, as described below.  
All data related to participant information is presented in aggregate and is not identifiable to protect 
participant privacy. No data from patients who have declined to participate will be included in any data 
analysis or reporting, as their clinical information is securely destroyed. The percentage of participant opt 
outs is to be reported to demonstrate the level of participation amongst those recruited. 

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Information related to individual surgeons or gastroenterologists is also reported in aggregate and are non-
identifiable. Contributing hospitals are listed in reports but data related to the procedures and outcomes 
from those sites are not reported publicly or to other parties without prior consent.  
 
13.1 Publicly available reports 
As required by the 2008 ACSQHC Operating Principles34, the Registry produces regular publicly available 
reports. Annual reports comprehensively review the data held on the Registry’s database, analysing the 
safety and quality of bariatric surgical procedures and the effect on participants’ clinical outcomes (diabetes 
management and total and excess weight loss maintained following surgery). These aggregate reports are 
available on the Bariatric Surgery Registry website and are sent directly to contributing surgeons, 
gastroenterologists, hospital executives, hospital group executives, ethics committees, state and federal 
health departments, medical device manufacturers, third party private insurers and other professional 
organisations with a vested interest in the outcomes of bariatric surgery. A semi-annual brief update is also 
made available by the same channels. 
Annual reports are published as at June 30 each year and are released in the September of the same year. 
The semi-annual update is published as at 31 December each year and is released in the following March. 
 
13.2 Individual reports 
Contributing surgeons and gastroenterologists can receive benchmarked reports once they have submitted 
sufficient data to the Registry to allow for comparison. These reports compare the non-identifiable data for 
that surgeon or gastroenterologist against the Registry as a whole and include information on their case mix 
demographics of their participating patients, follow-up rates and the safety and clinical outcomes. These are 
published as at 30 September each year and are confidentially released to each of the surgeons or 
gastroenterologists\in the December of that year.  
Other key stakeholders including hospital groups and device manufacturers receive benchmarked annual 
reports. All information presented in their reports is based on aggregate data and no identifiable participant, 
surgeon or gastroenterologist information is disclosed. 
Progress reports for the Registry are also prepared and delivered annually for each contributing hospital and 
the ethics committee providing oversight for project and to relevant research governance offices. These 
reports generally detail participant recruitment, withdrawal figures, and disclose serious adverse events and 
mortality figures.  
Bi-annual progress reports are also delivered to the Commonwealth’s Department of Health in line with the 
Registry’s funding agreement. These progress reports provide an oversight of the current status of the 
Registry and detail participant recruitment, withdrawal figures, and disclose serious adverse events and 
mortality figures. However, these reports do not contain any identifiable information with regard to 
participants, surgeons or hospitals.  
 
13.3 Data access for research purposes and ad hoc reports 
Governments, institutions, organisations and researchers may seek access to data or request analysis 
of data. Such ad-hoc reports may be prepared following data requests approved in accordance with the 
Bariatric Surgery Registry Data Access Policy. These requests need to be reviewed by the Registry's Steering 
Committee and may also require ethics review. 

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Where a request for data for research purposes utilises only non-identifiable existing Registry data, 
ethics approval for the project may be sought from the Alfred Hospital HREC in Australia or the Southern 
Health and Disability Ethics Committee in New Zealand. 
14 
Registry organisation 
The Bariatric Surgery Registry is a multi-centred, investigator driven endeavour. Each site is to have a local 
principal investigator (PI), responsible for ensuring that research activities undertaken at their site are 
conducted in accordance with the Registry protocol, site Registry agreements and related policy 
documentation. To contribute to the Registry, all surgeons and gastroenterologists are asked to sign a 
participation form outlining their responsibilities. 
Each Australian hospital site is required to have ethics approval from an NHMRC constituted human research 
ethics committee and grant governance for the Registry project. A Memorandum of Understanding (MoU) 
will be executed between the site or private hospital group outlining the roles and responsibilities of the 
respective site or hospital group and Monash University. The MoU will also document the agreement of the 
relevant site to make the necessary resources and reports available for the Registry. Data will only be 
collected from hospital sites once these necessary steps are taken. 
In New Zealand, a Memorandum of Understanding (MoU) will be executed between each approved site and 
UniServices outlining the roles and responsibilities of the respective site, surgeon(s)/ gastroenterologist(s), 
Monash University and UniServices. The MoU will also document the agreement of the relevant site to make 
the necessary resources and reports available for the Registry. Ethics and governance approval, including 
locality, will be obtained prior to the collection of data at any hospital site where bariatric surgical procedures 
are performed.   
The School of Public Health and Preventive Medicine within Monash University is the data custodian. 
Custodianship responsibilities of Monash University entail accountability for the information held within 
the Registry. Day to day project management is undertaken at Monash University. While Registry staff 
at Monash University oversee all project related activities; contributing surgeons, gastroenterologists, 
and hospitals are ultimately responsible for ensuring timely and accurate data collection (where central 
data collection is not used). This is supervised by the Programme Manager and Data Manager at Monash 
who report and provide feedback on data completion and quality to sites and the Bariatric Surgery 
Registry Steering Committee, the governing body of the Registry. 
Support for the free call number in New Zealand will be provided by trained staff located at the National 
Institute for Health Innovation, UniServices, in conjunction with Monash University. UniServices will also 
provide support with implementations of MoU with new sites and the on boarding and training of 
surgeons and gastroenterologists. Monash University retains overall responsibility for project 
management of the Bariatric Surgery Registry in New Zealand and for ensuring that the protocol is 
updated and ethics approvals are maintained for the duration of the study. 
 
14.1 Registry governance 
The governance structure is in keeping with the operating principles established by the ACSQHC and the 
Terms of Reference for the Bariatric Surgery Registry Steering Committee are written to comply with such 
principles.3 4 The Steering Committee oversees the governance of the Registry, provides strategic direction, 
and ensures the agreed outcomes of the registry are achieved. This Committee meets formally at least two 
(2) times a year. 
A diverse range of key stakeholders has been engaged to formally join the Steering Committee. The 
membership currently represents the bariatric surgical profession (through ANZMOSS), the broader surgical 
profession (through RACS and ANZGOSA), Monash University (as data custodian), the Commonwealth (as a 

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major funder and key user of bariatric surgery services), the medical technology industry (as providers of 
devices used in bariatric procedures) and a community advocate. The Chair is an independent obesity expert, 
who is not a surgeon or gastroenterologist, to maintain impartiality across the Registry’s processes. The 
Steering Committee also nominates a Clinical Lead from Australia and a Clinical Lead from New Zealand. 
The Steering Committee is to: 
 provide oversight of the Registry, including the Executive Management Committee; 
 provide ongoing review of the objectives of the Registry and its effectiveness in meeting them; 
 establish policies to address issues of clinical interest or significance that may arise; 
 facilitate policy support for issues identified by the Executive Management Committee; 
 provide advice on the Registry’s management, organisation, scope, development and funding; 
 monitor the Registry’s data quality management processes and timeliness of reporting; 
 develop and monitor policies for access to data and responses to quality of care issues identified; 
 review and advise on outputs from the Registry; 
 review all research and data requests for identifiable data; 
 review publications arising from the Registry; and 
 review and advise communication strategies, including communication with the media and consumers. 
 
14.2 Funding 
Commonwealth funding up to $850,000 per year for the period 1 July 2017 to 30 September 2022 has been 
secured to support Australian implementation, quality control, data collection and reporting of the Registry. 
A proposed business case for continued Commonwealth funding will be prepared in 2021 for beyond this 
current funding period.  
A broad-based funding model engaging those within the profession, insurers, medical technology industry, 
federal, state and territory governments and medical defense organisations, is being developed to secure at 
least 20 stakeholders as funders. It is proposed that these stakeholders will initially contribute $20,000 per 
annum then increase to $50,000 per annum towards the Registry. These funds will be used in conjunction 
with the Commonwealth funding until 2022.  
Funding for the New Zealand launch of the Registry was provided by the medical technology industry and 
future funding will be sought from additional sources to support the on-going operations there. 
 
14.3 Quality assurance 
As part of the funding agreement with the Commonwealth Government, Registry management will 
undertake quality assurance activities with its stakeholders including persons who have bariatric surgery, 
surgeons, gastroenterologists, hospitals, medical technology industry, health services and the Jurisdictions. 
These activities may be undertaken as online surveys, focus groups, forums and/or other related self-audit 
endeavours designed to gain understanding of the service the Registry provides. These activities will also help 
the Registry align its practices with this evolving medical field as well as remain current and relevant as a 
clinical quality registry.  
 
15 
 Significance 
Establishing a bariatric surgery clinical quality registry allows for community wide comparisons of the safety 
of care provided by procedures, devices, surgeons, gastroenterologists and hospitals. This provides surety 
for patients and payers that the delivered services are of the highest quality. Importantly, the Bariatric 
Surgery Registry provides the opportunity for early recognition of a problem device, procedure, surgeon, 

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gastroenterologist, or hospital, allowing for rapid intervention to prevent patient harm. The Registry has the 
potential to identify ethnic disparities for Aboriginal, Torres Strait Islander, Māori and Pacific Islander peoples 
and can support improving quality outcomes for these groups. In the future, it is hoped that Registry data 
will enable the development of guidelines for bariatric surgical procedures leading to improved outcomes for 
all patients. This research will provide longitudinal, long term community data on the outcomes of bariatric 
surgery including weight loss, change in diabetes, and need for reoperation. At an individual level, these data 
will give patients a more accurate view of what to expect from a bariatric procedure and will enable more 
valid informed consent for surgery. At a community level, this data will allow for the assessment of the 
economic and societal benefits that bariatric surgery potentially holds when offered as a treatment for 
obesity.  
 
16 
Other documents to be used in conjunction with the protocol  
 Bariatric Surgery Registry Poster 
 Bariatric Surgery Registry Flyer 
 Bariatric Surgery Registry Fact Sheet 
 Participant Fact Sheets (AUS and NZ versions) 
 Parent(s)/Legal Guardian(s) Informed Consent Form (and Withdrawal of Consent) 
 Information Sheet for Minor Participants 
 Data Forms (Australian sites only) 
 BSR-i User Manual for Surgeons and Staff (AUS and NZ versions) 
 Call Protocols  
 Data Access Policy 
 Privacy Policy 
 Grievance and Complaint Policy 
 Data Dictionary 
 Steering Committee Terms of Reference 
 
17     References 
 
1 ABS 2015. National Health Survey: First Results, 2014-15, 2011-13, ABS Cat. No. 4364.0.55.001 
 
2 ABS 2008. Overweight and Obesity in Adults, 2004-05, ABS Cat. No. 4719. 0 
 
3 Australian Institute of Health and Welfare. [Internet] Canberra. Aboriginal and Torres Strait Islander Health 
Performance Framework (HPF). 2017. {Cited 29 October 2018} Available from: 
https://www.aihw.gov.au/reports/the-health-welfare-of-australia-s-aboriginal-torres-strait-islander-
peoples/health-performance-framework/report-editions 
 
4 Ministry of Health. 2016. Annual Update of Key Results 2015/16: New Zealand Health Survey. [Internet]. 
Wellington: Ministry of Health. [cited 2018 April 23]. Available from: 
https://www.health.govt.nz/system/files/documents/publications/annual-update-key-results-2015-16-
nzhs-dec16-v2.pdf 

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5 Ministry of Health. 2017. Annual Update of Key Results 2016/17: New Zealand Health Survey. [Internet]. 
Wellington: Ministry of Health. [cited 2018 October 2018]. Available from: 
https://minhealthnz.shinyapps.io/nz-health-survey-2016-17-annual-data explorer/_w_ae6f23c7/#!/home 
 
6Parr CL, Batty GD, Lam TH, Barzi F, Fang X, Ho SC, et al. Body-mass index and cancer mortality in the Asia-
Pacific Cohort Studies Collaboration: pooled analyses of 424,519 participants. Lancet Oncol 2010; 11(8): 
741-52.  
 
7 World Cancer Research Fund /American Institute for Cancer Research. Policy and Action for Cancer 
Prevention. Food, Nutrition, and Physical Activity: A Global Perspective. Washington DC: AICR, 2009, 
http://www.dietandcancerreport.org/.  
 
8 Alberti KG, Zimmet P, Shaw J. International Diabetes Federation: A consensus on type 2 diabetes 
prevention. Diabet Med 2007; 24(5): 451-63.  
 
9 Australian Government Department of Health. About Overweight and Obesity. May 2009. 
http:/www.health.gov.au/internet/main/publioshing.nsf/content/health-publth-strateg-hlthwt-obesity.htm 
 
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