newsletter #17 march 2019 - monash university

10
Newsletter #17 March 2019 1 Greetings! As the New Year began, staff at the Registry were busily entering data to ensure that the Semi-Annual Report contained all the information submitted over the holiday period. Highlights of the Semi-Annual Report are posted in this newsletter. Audit of Surgical Devices The Bariatric Surgery Registry is conducting an important audit of the device preferences of all surgeons who have contributed to the Registry to date. This audit will validate the device data which has been captured for the operations in the Registry. All contributing surgeons have been emailed a request to complete the audit either online using the Survey Monkey link provided or by completing the Audit form. Surgeons who have not yet submitted their device preferences are asked to do so as soon as possible so that the audit can be finalized and data verified. If you have any questions about the audit or would like a form to complete, please contact Jenifer Cottrell by email: [email protected] or phone: +61 03 9903 0721. ______________________________________________ New Sites Last year the Registry submitted an ethics application to add a number of new sites to the Registry under the National Mutual Application (NMA) scheme. This Scheme allows for the streamlining of ethics review by having one lead ethics committee with oversight for the project. Until now, the Registry had been hamstrung by the number of different ethics committees whose approval was required each time an amendment to the protocol was needed. As the number of committees grew to nearly 40, action needed to be taken. The short-term pain for making an NMA application called for the project to be reviewed as a ‘new’ study. Hence the protocol would need considered review to ensure that it adhered to the revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018). The Registry successfully received approval from The Alfred Hospital Human Research Ethics Committee on the 5 th of March 2019. Site Assessment applications have begun for all new sites and must be completed before data may be submitted. However, not all Registry sites are eligible for the NMA scheme. These sites are those with review by the following ethics committees: Mater Misericordiae Limited HREC, Mater North Queensland HREC, the Calvary Care HRECs, St John of God HREC and the Tasmanian Health and Medical Ethics Committee. Protocol amendment applications will now be required to be submitted to these committees. These amendment submissions have commenced, ensuring that all Australian sites are following the revised protocol and related documentation. An amendment to New Zealand’s Health and Disability Ethics Committee will also be submitted by the end of April 2019, which covers the relative differences to meet their local requirements. ________________________________________________ Revised Study Protocol All contributing surgeons and gastroenterologists are considered to be investigators in the study. As such it is vitally important that everyone participating adheres to the study protocol and does not deviate from it. If you are participating in the Registry, please ensure that you are familiar with the new study Protocol version 5.0 which can be found on the Registry’s website here: https://www.monash.edu/medicine/sphpm/regis tries/bariatric/policies-procedures _______________________________________________ Registry Snapshot as of the 7 th of March: Over 61,000 participants enrolled with an opt out rate of 3.35%!

Upload: others

Post on 09-Nov-2021

1 views

Category:

Documents


0 download

TRANSCRIPT

Newsletter #17 March 2019

1

Greetings! As the New Year began, staff at the Registry were busily entering data to ensure that the Semi-Annual Report contained all the information submitted over the holiday period. Highlights of the Semi-Annual Report are posted in this newsletter.

Audit of Surgical Devices The Bariatric Surgery Registry is conducting an important audit of the device preferences of all surgeons who have contributed to the Registry to date. This audit will validate the device data which has been captured for the operations in the Registry. All contributing surgeons have been emailed a request to complete the audit either online using the Survey Monkey link provided or by completing the Audit form. Surgeons who have not yet submitted their device preferences are asked to do so as soon as possible so that the audit can be finalized and data verified. If you have any questions about the audit or would like a form to complete, please contact Jenifer Cottrell by email: [email protected] or phone: +61 03 9903 0721. ______________________________________________

New Sites Last year the Registry submitted an ethics application to add a number of new sites to the Registry under the National Mutual Application (NMA) scheme. This Scheme allows for the streamlining of ethics review by having one lead ethics committee with oversight for the project. Until now, the Registry had been hamstrung

by the number of different ethics committees whose approval was required each time an amendment to the protocol was needed. As the number of committees grew to nearly 40, action needed to be taken. The short-term pain for making an NMA application called for the project to be reviewed as a ‘new’ study. Hence the protocol would need considered review to ensure that it adhered to the revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018). The Registry successfully received approval from The Alfred Hospital Human Research Ethics Committee on the 5th of March 2019. Site Assessment applications have begun for all new sites and must be completed before data may be submitted. However, not all Registry sites are eligible for the NMA scheme. These sites are those with review by the following ethics committees: Mater Misericordiae Limited HREC, Mater North Queensland HREC, the Calvary Care HRECs, St John of God HREC and the Tasmanian Health and Medical Ethics Committee. Protocol amendment applications will now be required to be submitted to these committees. These amendment submissions have commenced, ensuring that all Australian sites are following the revised protocol and related documentation. An amendment to New Zealand’s Health and Disability Ethics Committee will also be submitted by the end of April 2019, which covers the relative differences to meet their local requirements. ________________________________________________ Revised Study Protocol All contributing surgeons and gastroenterologists are considered to be investigators in the study. As such it is vitally important that everyone participating adheres to the study protocol and does not deviate from it. If you are participating in the Registry, please ensure that you are familiar with the new study Protocol version 5.0 which can be found on the Registry’s website here: https://www.monash.edu/medicine/sphpm/registries/bariatric/policies-procedures _______________________________________________

Registry Snapshot as of the 7th of March:

Over 61,000 participants enrolled with an opt out rate of 3.35%!

2

BARIATRIC SURGERY REGISTRY NEWSLETTER #17 MARCH 2019

Certificates of Outstanding Merit are awarded to:

Milly England (Mr Michael Hii) Kelly Sanguinetti (Mr Ahmad Aly) Rebecca Wade (Mr Ahmad Aly) Shelley Lisle (Mr Ahmad Aly)

Under 18’s in the Registry One of the significant changes made to the Protocol is that patients under 18 years old must go through informed consent in order to participate in the Bariatric Surgery Registry. If your practice is planning a bariatric procedure on a patient under 18 years old, please contact the Registry for an Informed Consent form and for Registry staff to explain what is involved to you or your staff. Bariatric surgery is increasing amongst the younger population. The Registry aims to capture information about procedures performed on young persons in order to reliably report the appropriateness, safety and effectiveness of bariatric surgery in this age group. ___________________________________________

Linkage with LapBase Available The Registry can directly link with LapBase to collect annual follow-up data for those surgeons who have subscriptions to the software. [NOTE: Surgeons are still required to provide operation and perioperative follow-up data.] All enquiries about this linkage must go to LapBase directly. For further information contact Wayne at [email protected] ___________________________________________ Welcome to the Registry’s New Team Members Several staff have recently left the Registry at Monash University as they have completed their tertiary or graduate studies. Whilst they will be sorely missed, the Registry is pleased to welcome the following new staff: Angus Campbell, Rebecca Tourogianis, Declan Wain, Jared Cox and Hayley Cottrell. Marlene Jacobs was also given a fond farewell as she and her husband moved to Mackay. Simone Wilkins has replaced Marlene in the Administration Officer role and will be the new main point of contact for the Registry in Melbourne. Please join the Registry’s warm welcome to them all! ___________________________________________

Recognising Star Staff Mr Michael Hii and Mr Ahmad Aly have nominated their staff for their outstanding dedication and hard work in collecting [our] BSR data.” Mr Hii contacted the Registry first thing in the New Year to nominate Milly England for her dedication and to ensure that she is recognized for Outstanding Merit. Mr Aly nominated the following staff of Darebin Weight Loss Surgery with comments about each of them: Kelly Sanguinetti “Kelly works as our Administrate Manager as well as being the primary Receptionist. Her role is demanding in both volume and breadth of tasks and her dedication is something I am extremely grateful for. She monitors and audits our BSR lists, assists with data extraction and patient recall schedules on top of her already overloaded work program. Kelly deserves rich and formal recognition and a certificate of outstanding merit could not be better placed.” Rebecca Wade “Rebecca has volunteered in the practice for 12 months and has been meticulous in gathering follow up data as well as auditing and correcting where required submitted data. She has instituted several novel processes to aid patient recall and monitoring and has been instrumental in ensuring our high quality data submission to the Registry.” Shelley Lisle “Shelley is our Clinical Nurse Consultant who co-ordinates all the care of patients and without whom we could not provide the care we do. She has been innovative in creating a closed patient face book page which now has 600 members and is a terrific instrument in encouraging patients to re attend follow up and participate in the registry data collection process. She is the glue that holds the practice processes in place.”

3

BARIATRIC SURGERY REGISTRY NEWSLETTER #17 MARCH 2019

Contact the Registry to nominate your staff who are the “glue” for your practice! Nominees can also include your hospital data collectors. Upon receiving staff nominations, the Registry reviews the recent efforts made on behalf of the practice and confers a Certificate for Outstanding Merit to deserving nominees. Nominations made prior to the next newsletter will be mentioned and all nominees for that period will go into a draw for a $100 VISA gift card. The winner of the $100 Card for this period is: Kelly Sanguinetti!! Congratulations to each staff member who has received a Certificate of Outstanding Merit to date. _________________________________________

Stakeholder Engagement Seminar The first Bariatric Surgery Registry Stakeholder seminar was held in Melbourne on March 15th. Guests came from across Australia and New Zealand to attend this inaugural event.

Featured speakers included: Professor Jeff Hamdorf, The University of Western Australia; Ms. Mary Warner, Medicare Benefits Scheme, Commonwealth Government Department of Health; Mrs. Kaye McMillian, LaTrobe Health Services; Ms. Sandra Marjanovic, Medical Technology Association of Australia; Ms. Nicola Ware, Ramsay Hospital Research Foundation; and Ms. Lyn Keppler, Bariatric Patient.

Dr Nick Williams and Dr Nic Kormas chaired the afternoon session which captivated the audience. All speakers spoke about the relevance of having a bariatric surgery from their unique perspective as well as the importance of a registry. Perhaps most importantly, Ms. Keppler told how those considering bariatric surgery seek out “real-world information.” Her presentation made a profound impact on everyone, and encouraged surgeons to think about the way in which they talked to patients in regards to their procedures.

The Registry would like to extend its sincere appreciation to all who travelled from near and far to take part in the seminar.

Photo

Above photo from the Seminar: Prof Paul O’Brien leading the panel discussion after the first session.

____________________________________

The Bariatric Surgery Registry is funded in Australia by the Department of Health.

These sponsors are acknowledged for their generous support providing additional funding of this important health initiative (including the New Zealand arm of the Registry.)

4

BARIATRIC SURGERY REGISTRY NEWSLETTER #17 MARCH 2019

Leading and Valued Contributors of 2018 Bariatric Surgery Registry has the enormous pleasure of naming the significant contributors of data for 2018. To be considered as a Leading or Valued Contributor, a follow-up completion rate of 75% must have been achieved. Leading Contributors must have at least 100 operations in the Registry and an ongoing contribution of at least 30 operations per calendar year. Valued Contributors need to submit at least 30 operations in a calendar year.

The Registry would like to particularly mention Dr David Schroeder as the first New Zealand surgeon to be included as a Valued Contributor. Dr Schroeder and his team are congratulated and commended for the commitment they have shown to the Registry.

2018 Valued Contributors

Douraid Abbas Janine Arnold James Askew Ingrid Bringmann Paul Caska Anthony Cheng John Copp Mark Hehir Matthew Henderson Andrew Packiyanathan Aravinthan Saravanamuttu David Schroeder

2018 Leading Contributors Reza Adib Ahmad Aly Jon Armstrong Samuel Baker Andrew Barbour Johannes Basson Ian Baxter Justin Bessell Peter Bovey Blair Bowden Roy Brancatisano William Braun Wendy Brown Paul Burton Salim Chaloob Harsha Chandraratna James Chau Richard Chen Yuan Cheng Jacob Chisholm Adam Cichowitz Stephen Clifforth Anthony Clough Leon Cohen Gary Crosthwaite Mark Daoud Michael Devadas Arun Dhir Giuseppe D'Onofrio Continued on next page...

5

BARIATRIC SURGERY REGISTRY NEWSLETTER #17 MARCH 2019

Geoffrey Draper Zdenek Dubrava Stuart Eaton Robert Finch Harry Frydenberg Siva Gounder Jeffrey Hamdorf Richard Harrison Michael Hatzifotis Chris Hensman Michael Hii George Hopkins Carolyn Jameson Jacobus (Jorrie) Jordaan John Jorgensen David Joseph Costa Karihaloo Fadil Khaleal David Koong Lilian Kow Govind Krishna Vytauras Kuzinkovas Steven Leibman Paul Leong Victor Liew Kiat Lim Philip Lockie Damien Loh Ken Loi Raymond McHenry Garth McLeod David Martin Ian Martin Patrick Moore Paul Moroz William Munro Peter Nottle Paul O'Brien Girish Kumar Pande Nigel Peck George Petrou Andrew Ramsay

Andrew Russell Brendan Ryan

David Scott Jon Shenfine Candice Silverman Adam Skidmore Stewart Skinner Andrew Smith Garett Smith Michael Talbot

Susan Taylor Alan Thomas Chek Heng Tog John Treacy Salena Ward Senarath Werapitiya Stephen Wilkinson Nicholas Williams Jason Winnett

Kenneth Wong Timothy Wright

Gary Yee David Yong

Ali Zarrouk

If your practice has more than one surgeon and all sugeons are Leading Contributors, the practice can get a “Bariatric Surgery Registry 2018 Leading Contributors” certificate with the practice name on the certificate. Please contact the Registry if you would like this for your practice.

Important Notice for 2019 Contribution Levels! For 2019, the follow-up rate needed in order to meet the requirements of the Valued or Leader Status will be at 80%, based on the funding agreement with the Commonwealth Government, ensuring that the Registry maintains an 80% follow-up completion rate.

6

BARIATRIC SURGERY REGISTRY NEWSLETTER #17 MARCH 2019

Current Hospital Participation Report for Australian and New Zealand Hospitals where Bariatric Surgery is Provided

As at 11 March 2019

State

Approved Sites Sites in Progress

Ethics/Locality Total

Not Contributing

Contributing

Approvals Yet to Commence

NSW/ACT 4 29 21 2 56 QLD 7 20 3 - 30

SA/NT - 9 4 - 13 TAS - 5 - - 5 VIC 9 31 5 - 45 WA 2 9 4 - 15

AUS Total 22 103 37 2 164 NZ Total 5 6 10 1 22

Approved Sites Sites in Progress

Sites To Do

Not Contributing

Contributing AUS Private 15 80 21 2

AUS Public 7 23 14 -

NZ Private 3 5 3 1

NZ Public 2 1 7 -

Total 27 109 45 3

Hospital Participation in Australia

Previous Report March 2019

Hospitals known to do bariatric surgery

162 162

Hospitals with ethics approval 124 125

Contributing 103 105

Hospital Participation in New Zealand March 2019

2018 Hospitals known to do bariatric surgery

22 Hospitals with ethics approval 11

Contributing 6

7

BARIATRIC SURGERY REGISTRY NEWSLETTER #17 MARCH 2019

Current Report of Surgeon Participation As at 11 March 2019

At Sites with Ethics Approval Enlisted Not Enlisted Not Contributing Contributing but not at

site with ethics

approval

At site with ethics

approval

At site yet to get ethics

approval

Total

NSW/ACT 4 40 6 5 2 58 QLD 4 28 2 6 1 41 SA/NT - 19 1 - - 20 TAS 1 4 - - - 5 VIC 7 59 1 1 - 68 WA 1 26 1 2 - 30 AUS Total 17 176 11 14 3 221 NZ 8 10 0 - 6 24 Total

30 182 14 14 18 245

Surgeon Participation in Australia March 2019

Percent of Total # of Bariatric Surgeons at a Site with Ethics

Approval

Surgeons known to do bariatric surgery 221 (100%) All surgeons at sites with ethics approval 207 93.6% Enlisted 204 92.3% Enlisted and at sites with ethics approval 193 87.3% Contributing 176 79.6%

Surgeon Participation in New Zealand March 2019

Percent of Total # of Bariatric Surgeons at a Site with Ethics

Approval Surgeons known to do bariatric surgery 24 (100%) All surgeons at sites with ethics approval 18 75% Enlisted 18 75% Enlisted and at sites with ethics approval 18 75 % Contributing 10 41.6 %

8

BARIATRIC SURGERY REGISTRY Newsletter #17 March 2019

Australian Hospitals with

Ethics Approval

Albury-Wodonga Private Hospital

Ashford Private Hospital

Austin Hospital

Baringa Private Hospital

Belmont District Hospital

Bethesda Hospital

Box Hill Hospital

Brisbane Waters Private Hospital

Cabrini Hospital Brighton

Cabrini Hospital Malvern

Cairns Private Hospital

Calvary Central District Hospital

Calvary North Adelaide Hospital

Calvary Riverina Hospital

Calvary St Vincent's Hospital

Calvary Wakefield Hospital

Campbelltown Private Hospital

Concord Repatriation General Hospital

Darwin Private Hospital

Epworth Eastern Hospital

Epworth Freemasons Hospital

Epworth Geelong Hospital

Epworth Richmond Hospital

Essendon Private Hospital

Fiona Stanley Hospital

Flinders Medical Centre

Flinders Private Hospital

Footscray Hospital

Geelong Private Hospital

Glen Iris Private

Glengarry Private Hospital

Gold Coast Private Hospital

Gosford Private Hospital

Gosford Public Hospital

Greenslopes Private Hospital

Hamilton Hospital

Heidelberg Repatriation Hospital

Hobart Private Hospital

Hollywood Private Hospital

Holy Spirit Northside Hospital

Hospital for Specialist Surgery

Hurstville Private Hospital

Ipswich General Hospital

Jessie McPherson Private Hospital

John Fawkner Private Hospital

John Flynn Private Hospital

John Hunter Hospital

Joondalup Health Campus

Kareena Private Hospital

Kawana Private Hospital

Knox Private Hospital

Lake Macquarie Private Hospital

Latrobe Regional Hospital

Launceston General Hospital

Linacre Private Hospital

Lingard Private Hospital

Maryvale Private Hospital

Mater Hospital (Brisbane)

Mater Private Hospital (Brisbane)

Mater Private Hospital (Bundaberg)

Mater Private Hospital Mackay

Mater Private Hospital (North Sydney)

Mater Private Hospital Pimlico

Mater Private Hospital (Redland)

Mater Private Hospital Rockhampton

Mater Private Hospital (Springfield)

Mildura Base Hospital

Mildura Private Hospital

Mitcham Private Hospital

Monash Medical Centre

Mount Hospital

Mulgrave Private Hospital

Nambour Selangor Private Hospital

National Capital Private Hospital

Nepean Private Hospital

Newcastle Private Hospital

Noosa Private Hospital

North Shore Private Hospital

North West Private Hospital (Brisbane)

North West Private Hospital (Burnie)

Northpark Private Hospital

Norwest Private Hospital

Nowra Private Hospital

Peninsula Private Hospital

Pindara Private Hospital

Port Macquarie Private Hospital

Prince of Wales Private Hospital

Princess Alexandra Hospital

Queen Elizabeth Hospital

Queen Elizabeth II Jubilee Hospital

Repatriation General Hospital

Royal Adelaide Hospital

Royal Brisbane and Women's Hospital

Royal Hobart Hospital

Royal North Shore Hospital

Royal Prince Alfred Hospital

Shepparton Private Hospital

Southern Highlands Private Hospital

St Andrew's War Memorial Hospital

St Andrew's-Ipswich Private Hospital

St George Private Hospital

St John of God Hospital Ballarat

St John of God Hospital Bendigo

St John of God Hospital Berwick

St John of God Hospital Bunbury

St John of God Hospital Geelong

St John of God Hospital Geraldton

St John of God Hospital Mt Lawley

St John of God Hospital Murdoch

St John of God Hospital Subiaco

St John of God Hospital Warrnambool

St Vincent's Hospital Melbourne

St Vincent's Private Hospital (Fitzroy)

Strathfield Private Hospital

Sunnybank Private Hospital

Sunshine Coast Private Hospital

Sunshine Coast University Private Hospital

Sunshine Hospital

Sydney Adventist Hospital

Sydney Southwest Private Hospital

The Alfred Hospital

The Avenue Private Hospital

The Wesley Hospital

Wagga Wagga Rural Referral Hospital

Waikiki Private Hospital

Wangaratta Private Hospital

Warringal Private Hospital

Waverley Private Hospital

Western Private Hospital

Westmead Private Hospital

Williamstown Hospital

New Zealand Hospitals with

Ethics Approval

Auckland City Hospital

Chelsea Hospital Gisborne

Gisborne Hospital

Grace Hospital Tauranga

Middlemore Hospital

Ormiston Hospital

St George’s Hospital

Southern Cross Hospital Christchurch

Southern Cross Hospital Hamilton

Southern Cross Hospital North Harbour

Southern Cross Hospital Wellington

CONTACT INFORMATION

Bariatric Surgery Registry

AUSTRALIA

T: 03 9903 0725

F: 03 9907 0717

Email:[email protected]

Bariatric Surgery Registry

NEW ZEALAND T: 0800 636 276

F: 9 273 1710

Email: [email protected] ________________________________

2019 Steering Committee

Meeting Dates

Friday 22 June

Friday 20 September

Friday 22 November g Co

The Bariatric Surgery Registry aims to monitor the safety and standards of bariatric surgeryperformed at public and private hospitals in Australia and New Zealand. As a clinical qualityregistry, it can lead to improved patient care and outcomes. This initiative has the supportof the Australia & New Zealand Metabolic and Obesity Surgery Society (ANZMOSS) andthe Royal Australasian College of Surgeons (RACS), with funding primarily from theCommonwealth Government of Australia and the medical technology industry.

59,036 Participants

Registry Data as at 31 December 2018

112 Hospitalshavecontributed

19.2% LegacyProcedures

Procedure Mix (n = 19,757)

6.4% Public Hospitals

One Revision Procedures Two Revision Procedures

Three Revision Procedures Four (or more) Rev. Procedures

967

180

40 18

47,523 Primary Participants having a total of:

93.6%PrivateHospitals

78.6% PrimaryProcedures

http://www.med.monash.edu/medicine/sphpm/registries/bariatric/

21% Male

79% Female

Calendar Year: 1 Jan 2018 - 31 Dec 2018

3.47% Opt out

% MBS Procedures Captured (n=24,479)Jan 2018 - Oct 2018 only (Aus only)

2.2% Revision on BSR Primary Patients

Includes Sleeve, Band, SAGB, RYGB & Reversal only

70%Sleeve

4% Band7% Reversal

3% Other

16% RYGB

& OAGB

190 Surgeonshavecontributed

Total Procedures Recorded:

40,270

23,051

63,657

31 Dec2016

31 Dec2018

Australia:      (61) 3 9903 0725 

[email protected]

New Zealand:  (64) 9 373 7599 [email protected]

31 Dec2017

Unplanned Return to Theatre Unplanned Admission to ICU

Unplanned Re-admit to Hospital

258

23

239

Peri-operative Defined Adverse Events(Completed peri-operative follow-up, n = 13,731)

68.3%

AdverseEvent in aPrimaryProcedure

27.1%

AdverseEvent in aRevisionProcedure

2.1%

Excess WeightLoss after 12 months

Thanks to our Supporters:

(n=2,986)

(n=18,789)

Total WeightLoss after 12 months

7.2%

Weight Outcomes

Diabetes Outcomes

Safety Outcomes in 2018

(n=10,745)

14.5%

PrimaryParticipantsidentifed ashavingdiabetesbefore surgery

(n=19,057)

Diabetes Treatment Before and After Surgery (n=3,277)

(n=47,523)

% Weight Loss of Participants Who Have Reached3 Year Follow Up (n = 2,433)

Excess Weight Loss Total Weight Loss

0 1 2 30

10

20

30

40

50

60

Years After Surgery

% W

eigh

t Los

s