Newsletter #15 July 2018 End of 2017/2018 Reporting Year The registry was delighted with the response to the call for data as its reporting year drew to a close. We greatly appreciate and thank all surgeons and their teams for the time and effort that was made over the past several weeks. The data for this period has been extracted and currently under- going analysis for the Sixth Annual Report of the Bariatric Surgery Registry. The Report is due to be published in early September. Anticipating the Next Phase The establishment of the Bariatric Surgery Registry is nearing completion in Australia and, is well underway in New Zealand. The capture of NZ participant data has successfully begun, realising the long awaited inclusion of data from across the Tasman. In its next phase, the Bariatric Surgery Registry will aim for both further exponential growth and improved stakeholder engagement. Plans are also underway to embolden the Registry’s profile locally and inter- nationally. Eliminating Bias in Reporting Concerns have been raised, on occasion, to the Registry in regard to the potential for reporting bias. Indeed, the perception of trans- parency in reporting is not achiev- able with surgeons self-reporting to the Registry. 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. (Tu JV, Willison DJ, Silver FL, et al. Impracticability of Informed Consent in the Registry of the Canadian Stroke Network. New England Journal of Medicine 2004; 350: 1414-21.) The OPT OUT process can ensure that patients are not “cherry picked” by their surgeons. It is equally important that the OPT OUT decision is reported to the Registry by the patients themselves, NOT the surgeons or their staff. Over 90% of Australian surgeons known to perform bariatric surgery have committed to participating in the Bariatric Surgery Registry. To date, 89% of these surgeons have contributed data. Governance for the project is provided by the Steering Committee with a broadly based membership and is chaired by an independent nonsurgical obesity expert to ensure transparency and maintain impartiality. The Registry is always happy to address any related concerns or issues, especially if they impact on its acceptance and uptake amongst the profession. Timeliness of Data Submission Whilst the Registry will always take operations from previous reporting periods, only data current to the reporting period is analysed. This highlights the need for submission of operation data as soon as practical. For example, if operations are routinely sent six months after they were performed, the registry could only report on six months of data for the period, resulting in a drastically reduced data capture rate for that reporting period. Not only does the practice of late submission affect the Registry’s annual reports, it greatly impacts the surgeons’ personal reports. If you need assistance ensuring all of your data is submitted expeditiously, please contact the Registry. Please note that for consideration of Leading or Valued Contributor status levels, only the number of submitted operations performed within the calendar year are counted. OPT OUT REMINDER It is critical that the Registry’s Protocol is followed. Surgeons who agree to participate in the Bariatric Surgery Registry must: 1. Give every patient a FLYER prior to sending any of their health information to the Registry. 2. Display a poster stating their practice participates in the Bariatric Surgery Registry 3. Follow the OPT OUT process and not consent their patients. 4. If patients state their preference not to participate, they must be advised to contact the BSR themselves to state this decision. Any deviation from this procedure contravenes the Protocol which is approved by the Human Research Ethics Committees that have oversight for the study. The ethics approval given to the project ensures that the opt out process adheres to all Commonwealth and State Privacy legislation. Please contact Dr Jenifer Cottrell, Customer Relationship Manager if you have any questions about this process.
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Newsletter #15 July 2018
End of 2017/2018 Reporting Year The registry was delighted with the response to the call for data as its reporting year drew to a close. We greatly appreciate and thank all surgeons and their teams for the time and effort that was made over the past several weeks. The data for this period has been extracted and currently under-going analysis for the Sixth Annual Report of the Bariatric Surgery Registry. The Report is due to be published in early September.
Anticipating the Next Phase The establishment of the Bariatr ic Surgery Registry is nearing completion in Australia and, is well underway in New Zealand. The capture of NZ participant data has successfully begun, realising the long awaited inclusion of data from across the Tasman. In i ts next phase, the Bariatr ic Surgery Registry wi l l aim for both further exponential growth and improved stakeholder engagement. Plans are also underway to embolden the Registry’s profi le locally and inter-nationally. Eliminating Bias in Reporting Concerns have been raised, on occasion, to the Registry in regard to the potential for reporting bias. Indeed, the perception of trans-parency in reporting is not achiev-able with surgeons self-reporting to the Registry. 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. (Tu JV, Willison DJ, Silver FL, et al. Impracticability of Informed Consent in the Registry of the Canadian Stroke Network. New England Journal of Medicine 2004; 350: 1414-21.) The OPT OUT process can ensure that patients are not “cherry picked” by their surgeons. It is equally important that the OPT OUT decision is reported to the Registry by the patients themselves, NOT the surgeons or their staff. Over 90% of Australian surgeons known to perform bariatric surgery have committed to participating in the Bariatric Surgery Registry. To date, 89% of these surgeons have contributed data. Governance for the project is provided by the Steering Committee with a broadly based membership and is chaired by an independent nonsurgical obesity expert to ensure transparency and maintain impartiality. The Registry is always happy to address any related concerns or issues, especially if they impact on its acceptance and uptake amongst the profession. Timeliness of Data Submission Whilst the Registry will always take operations from previous reporting periods, only data current to the reporting period is analysed. This highlights the need for submission of operation data as soon as practical. For example, if operations are routinely sent six months after they were performed, the registry could only report on six months of data for the period, resulting in a drastically reduced data capture rate for that reporting period.
Not only does the practice of late submission affect the Registry’s annual reports, it greatly impacts the surgeons’ personal reports. If you need assistance ensuring all of your data is submitted expeditiously, please contact the Registry. Please note that for consideration of Leading or Valued Contributor status levels, only the number of submitted operations performed within the calendar year are counted. OPT OUT REMINDER It is critical that the Registry’s Protocol is followed. Surgeons who agree to participate in the Bariatric Surgery Registry must:
1. Give every patient a FLYER prior to sending any of their health information to the Registry.
2. Display a poster stating their practice participates in the Bariatric Surgery Registry
3. Follow the OPT OUT process and not consent their patients.
4. If patients state their preference not to participate, they must be advised to contact the BSR themselves to state this decision.
Any deviation from this procedure contravenes the Protocol which is approved by the Human Research Ethics Committees that have oversight for the study. The ethics approval given to the project ensures that the opt out process adheres to all Commonwealth and State Privacy legislation. Please contact Dr Jenifer Cottrell, Customer Relationship Manager if you have any questions about this process.
Newsletter #15 July 2018
Recognising Star Staff The last edition of newsletter called for the nomination of staff who give outstanding support to the Bariatric Surgery Registry. Heartfelt nominations were put forth by surgeons who truly valued their staff. The following staff have been nominated by their employers in the period 1 April-30 June 2018.
Certificates of Outstanding Merit
awarded to
Sharon Rochester (Drs I Martin & R Adib QLD) Lisa Driscoll (Dr N Williams and R Harrison NSW) Kahlia Wilksch (Dr J Bessell SA) Natalie Pizzichetta-Studwick (Mr K Bhatia VIC) Kim Hearn (Dr J Chau NSW) Sara Bowles (Dr C Taylor NSW) These staff are well to Registry staff who fully supported their nominations. The following was taken from two of the letters received. Dr Ian Martin wrote: “I would like to nominate Sharon Rochester, our fabulous dietician, who is integral in our management of information with respect to your database. She…is thorough and caring and personally ensures that all follow-up for the bariatric surgery registry and information is correct prior to sending. She is also involved in sending forms to…ensure they are prompt, up to date and accurate. She attends…Dr Reza Adib and myself, and…we highly value her service…’ Dr Nick Williams nominated Lisa Driscoll saying that since joining
their practice 3 years ago as a typist, she “quickly showed commitment and initiative well beyond her usual job description. Lisa is responsible for the submission of all our data to the BSDR, allowing us [Dr Williams and Dr Richard Harrison] to enjoy ‘gold contributor status.’ Lisa chases up missing data in the database, prompting nurse practitioners to phone relevant patients. With her statistical analysis skills, Lisa “aided in the submission of no less than three abstracts to ANZMOSS over the years. Lisa is an enthusiastic and invaluable member of the the team at Riverina Bariatrics, without her help we would not have been able to commit data to the BSR so consistently and accurately.
Kahlia Wilksch is the lucky recipient of the $100 VISA Gift card. The draw took place at the July Steering Committee on July 26. Each nominee receives a Certificate for Outstanding Merit and is sincerely congratulated. Surgeons are encouraged to Surgeons are encouraged to nominate their BSR Star Staff for next quarter’s Newsletter. All nominees receive a Certificate of Outstanding Merit will be mentioned and go into a draw for a $100 VISA gift card. NEW STAFF? Please remember that they may require training about the BSR as part of their induction at the start of their employment. Contact the Registry for any materials or assistance required.
GDPR Precautionary Measures The EU General Data Protection Regulation (GDPR) is a regulation on data protection and privacy for all individuals within the European Union and European Economic Area. These new regulations were enforced as of 25th May 2018. Whilst the chance of data that breach by the Bariatric Surgery Registry is very slight, measures will be implemented to ensure that the possibility of a breach occurring is minimised. Contin- gency plans are in place to rectify the situation in the event of a breach. The Bariatric Surgery Registry protocol adheres to recognised ethical standards. These standards reduce the risks of a breach and the risks of involvement in research for participants. New Data Forms An email was sent in June with pdf of the current data forms. Please ensure that you are using the current Patient and Operation Data Form (‘Pink Form’) to submit your bariatric procedures. In this Newsletter: The new operation data form, a brief instruction sheet for completing the operation data form and 'Notes on Submitting Patient & Operation Information' are included to help clarify the data collection process. Improving the Safety and Quality of Bariatric Surgery MDA National Insurance’s Defense Update published an article by Prof Wendy Brown, Clinical Lead, and Prof Ian Caterson, Steering Committee Chair, in its June 2018 edition.
Newsletter #15 July 2018
The article can be read here https://defenceupdate.mdanational.com.au/en/Articles/anz-bariatric-surgery-registry
Will you catch up with your colleagues at ANZMOSS 2018? ANZMOSS 2018 offers outstanding opportunities for learning, sharing, networking and socialising.
ANZMOSS 2018 offers outstanding opportunities for learning, sharing, networking and socialising. The conference will feature two international keynote speakers: President of IFSO, Professor Jacques Himpens- Thursday ple-nary “Long term outcomes of the gastric sleeve … so far” and, Registered Dietitian and Secretary of the American Society of Metabolic and Bariatric Surgery, Ms Sue Cummings - Friday plenary “Much ado about nutrition. Prevention and management of the nutritional consequences in bariatric surgery”. With an impressive list of close to 50 local and international speakers, you are invited to peruse the two day program and pre and post conference workshop programs. Remember to register for the various social functions and Hosted Education Sessions. Whilst there, please ensure that you visit the Bariatric Surgery Registry team at the Trade Exhibition. Already registered Let your col- leagues know you are attending ANZMOSS 2018 and encourage them to join you. Visit the website www.anzmoss2018. com.au to learn more and to register.
Steering Committee Meeting Dates of 2018 Friday 16 March Friday 27 July Friday 21 September to be confirmed Friday 23 November to be confirmed
The Bariatric Surgery Registry launches a vibrant new logo Fostering engagement is vital to the success of the Bariatric Surgery Registry. With this objective, the Bariatric Surgery Registry 'brand' has been revitalised.
Design consultant Hayley Cottrell was engaged at the start of the year to rebrand the study. Her brief was to design a new logo that should be “clear and reflective of the Registry and its purpose.”
Whilst retaining the image of the stomach, its refinement reflects the impact of bariatric surgery. This impact, its safety and quality, is what the Bariatric Surgery Registry aims to demonstrate.
Replacing the BSR acronym, emphasis is on the study name: the Bariatric Surgery Registry.
Incorporating the full name within the logo aims to strengthen the connection that is felt by all who are involved in the Registry: patients, surgeons and their teams, the hospitals, and all stakeholders.
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FuturaT H E Q U I C K B R O W N F O XJ U M P S O V E RT H E L A Z YD O G
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I M A G E R Y , T Y P O G R A P H Y A N D C O L O U R S
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Highlight
Newsletter #15 July 2018
Current Surgeon Status on the CRM (Insightly) Database
At Sites with Ethics Approval Enlisted Not Enlisted Not
Australian Hospitals with Ethics and Governance 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 (North Sydney) Mater Private Hospital Pimlico Mater Private Hospital (Redland) Mater Private Hospital (Springfield) Mater Private Hospital Rockhampton Mildura Base Hospital Mildura Private Hospital Mitcham Private Hospital Monash Medical Centre Mount 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 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 Valley 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 and Locality Approval Auckland City Hospital Gisborne Hospital Middlemore Hospital St George’s Hospital Southern Cross Hospital Christchurch Southern Cross Hospital Hamilton Southern Cross Hospital North Harbour Southern Cross Hospital Wellington
Place label with Patient Details here or complete below
PATIENT & OPERATION FORM v9.0 6/2018
ID: ____________
Patient Details
Surname________________________________________
First name_______________________________________
Female Male Intersex/Indeterminate
Date of Birth ____________________________________
Address _______________________________________
_______________________Post code________
Mobile Ph ________________Home Ph _____________
Email ________________________________________
Hospital UR (MRN) Number -________________________
Medicare Number______________________ Ref No____
DVA Number __________________________
Indigenous Status-Tick box Neither Aboriginal or Torres Strait Islander Aboriginal Torres Strait Islander Both Aboriginal and Torres Strait Islander Unknown/Not stated
Hospital _______________________________________
Surgeon _______________________________________
Operation Date _________________
Height ___________ Pre-Op Weight ____________kg
Operation Weight _______________kg
Diabetes Yes (select treatment below) or No Diet/exercise Insulin Non-insulin therapy (single Non-insulin therapy (multiple)
Gastric Banding Gastroplasty R-Y Gastric Bypass One Anastomosis Gastric Bypass Sleeve Gastrectomy Bilio Pancreatic Bypass/Duodenal Switch Gastric Imbrication Gastric Imbrication, Plus Gastric Band (iBand) Port Revision Surgical reversal of gastric band Surgical reversal of bypass Lavage/washout + Drainage Stent (insertion or removal) Dilatation of Stricture Division of adhesions Control of Post Op Bleeding Sub-total gastrectomy Other (Specify)________________________
Planned Revision Unplanned RevisionState reason for Unplanned Revision
_________________________________ Tick box for Previous Operation
Gastric Banding Gastroplasty R-Y Gastric Bypass One Anastomosis Gastric Bypass Sleeve Gastrectomy Bilio Pancreatic Bypass/Duodenal Switch Gastric Imbrication Gastric Imbrication, Plus Gastric Band Other_____________________
Device/Staple Tracking Attach sticker(s) or complete below Type ______________________ Model _______________________ Serial number _________________
Buttress Yes (answer below) or No Type ______________________ Model _____________________
Concurrent Transplant Renal Liver
Notes
Please return form to the BSR Data Manager Fax 03 9903 0717 Post: Bariatric Surgery Registry
Level 6, the Alfred Centre 99 Commercial Road Melbourne VIC 3004
Please DO NOT email form unless encrypted
How to Complete the PATIENT & OPERATION DATA FORM
Smith
1. Attach label/sticker with patient information in top left cornerof page, OR, complete Patient Details in box.
2. Select Indigenous Status.3. Write Hospital Name and Surgeon.4. State date of operation.5. Write the patient’s height and weight.6. Indicate if the patient has diabetes and the type of
treatment.7. Tick if the operation was completed or abandoned. If
abandoned, please state reason.8. Tick the box for the type of operation.9. Choose if the operation was a Primary (patient’s first
bariatric operation) or a Revision (any subsequentprocedure following the primary bariatric operation).
10. If the operation was a Revision:1. indicate if it was planned or unplanned2. state reason if it was an unplanned procedure3. tick the previous major bariatric operation.
Refer to Notes for Submitting Patient and Operation Information.
**Ensure that you have provided the BSR with your Staple and Device Preference Form.
Notes for Submitting Patient and Operation Information
Patient Details Please complete the following fields: Full Name Gender Date of Birth Patient’s Postal Address Phone Numbers (Mobile/Home) Medicare Number and Reference Number Hospital UR Number Indigenous Status – If you do not know your patient’s indigenous status, select Unknown. Hospital for Operation Operating Surgeon Operation Date Start Weight: Enter the patient’s weight at the initial consultation. This is only a required field for
patients having primary bariatric surgery. Operation Weight: Enter the patient’s weight at the time of the operation. Diabetes Status: If the patient has diabetes, select the type of treatment.
Operation Details 1. Select if the procedure was completed or abandoned (and give reason for why the procedure was
abandoned). If the patient’s operation was abandoned, it must still be recorded in the BSR.
2. Select Operation PerformedOperations collected by the BSR as a PRIMARY or REVISION Operation: Gastric band Gastroplasty R-Y Gastric Bypass One Anastomosis Gastric Bypass Sleeve Gastrectomy Bilio Pancreatic Bypass/Duodenal Switch Gastric Imbrication Gastric Imbrication, Plus Gastric Band (iBand)
Operations collected by the BSR as REVISION Operations Only Cardiopexy Control of post-op bleeding Dilatation of Strictures Division of Adhesions Gastropexy Incisional Hernia Repair Laparoscopic cholecystectomy - only if caused by an operative injury Lavage/Washout, Drainage Port Revision Refashion of Gastric Pouch Stent (Insertion/Removal) Sub-total/Partial Gastrectomy Surgical Reversal continued next page…
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Therapeutic Endoscopy/ Gastroscopy/ Laparoscopy (NOTE: The BSR does not collect
these procedures done for diagnostic reasons; or, if routine surgical protocol.) VAC Dressing Other (Specify)
3. Indicate whether the operation was a Primary or Revision Primary Operation: A patient's initial bariatric operation. Revision Operation: Any subsequent bariatric operation.
4. For Revision Bariatric Operations:
Indicate if the need for the revision operation was Planned or Unplanned. (Refer to NOTE).
operative injury • Hiatus Hernia Repair--unless caused by an operative injury
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6. Select Previous Operation
Gastric Band
Gastroplasty
R-Y Gastric Bypass
One Anastomosis Gastric Bypass
Sleeve Gastrectomy
Bilio Pancreatic Bypass/Duodenal Switch
Gastric Imbrication
Gastric Imbrication, Plus Gastric Band
Other
Device and Staple Tracking
This does not need to be completed if you have submitted the Device and Staple Preference Form.
Device or Staple Cartridge Stickers can be attached to the form if you have not advised the BSR of your preference or if a different device from previously stated preference was used.
Buttress Indicate if a staple line reinforcement material was used and the type/brand of material.
Concurrent Transplant Indicate if the bariatric operation occurred with a liver or renal transplant procedure.
How to Enter More Than One Operation Performed on the Same Day If the operation you are recording had two concurrent procedures, enter ONLY the main procedure. Use the chart below ‘Which Procedure Trumps?‘ Include the additional procedure(s) in the Notes box. Do not enter two operations on the same day, UNLESS the patient returned to theatre.
Example: A patient undergoes an operation that includes a surgical reversal of a gastric band and a sleeve gastrectomy. Principle Procedure – Sleeve Gastrectomy should be checked Additional Procedure – Included in ‘Notes’ as: Surgical Reversal of Gastric Band Procedure
Which Procedure Trumps? Procedure Combination Trump
(Major Operation) Surgical Reversal and Sleeve gastrectomy Sleeve gastrectomy
RYGB and division of adhesions RYGB
Division of adhesions and Gastroplasty Gastroplasty
Lavage and stent Lavage
Lavage and feeding tube Lavage
Dilatation of stricture and stent Stent
Dilatation of stricture and Division of adhesions Dilatation
Lavage and removal of fixed ring Lavage
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Further Help & Information
If you are unsure how to correctly document a procedure or for any further information, please email [email protected] or call T: 03 9903 0725. Aileen Heal, Data Manager Email: [email protected] Phone: 03 9903 0722 Jenifer Cottrell, Customer Relationship Manager Email: [email protected] Phone: 03 9903 0721
The BSR staff are always happy to help!
Commonly Used Nomenclature for Operations The following operations are often entered incorrectly. They should be entered as the corresponding field.
Nomenclature for Operation Enter in the BSR i as:
Omega loop bypass One anastomosis gastric bypass
Band removal Surgical reversal
Gastric band revision Gastric banding
Reposition of band Gastric banding
Sleeve gastrectomy with minimiser ring Sleeve gastrectomy, add ring as an additional device
Bypass and ring R-Y bypass, add ring and staples as devices
Vagal block upgrade Operation not included
Procedure abandoned Not an operation - check the box for Procedure Abandoned