Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03441451 |
| Other study ID # |
MonashU |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2012 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2022 |
| Source |
Monash University |
| Contact |
Wendy Brown, MBBS |
| Phone |
+61 3 9903 0625 |
| Email |
wendy.brown[@]monash.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Persons with obesity are more likely to suffer from many other serious health conditions and
are more likely to die young. Lifestyle interventions have not been found to be an effective
long-term solution for treating obesity. When usual weight loss measures are not successful,
bariatric, or 'weight loss,' surgery may be considered. Bariatric surgery is performed to
help people with obesity achieve weight loss which they can maintain. Weight loss following
bariatric surgery leads to improvement in health and well-being, and patients have been shown
to live longer. It is invasive surgery which has surgical risks and potential side effects,
including death. Since people are having this surgery to improve their health, it is
important that the surgery is performed with a minimum of side effects, otherwise it cannot
be justified. Information is collected about the surgery, any complications after the
surgery, weight at various time points, and if the patient has diabetes and how it is is
treated. Patient details are needed to be able to identify patients on the registry and track
their progress through data linkages. Participants have information about their bariatric
surgery provided to the registry by their surgeon or hospital. They may also be contacted
directly by the registry staff to see if they had any complications and if the surgery had
any effect on their health (if they have diabetes), weight, and well-being. The Registry will
hold their identifiable information as it aims to follow each patient for ten years after
their first bariatric operation. By systematically collecting information on every procedure
performed in Australia and New Zealand, the registry will help to identify when surgeons,
hospitals or procedures not performing to the expected standard. A Bariatric Surgery 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.
Description:
The Bariatric Surgery Registry (BSR) is a population based observational quality improvement
study of patients with obesity undergoing bariatric surgery and collects identifiable data
obtained from participants' medical records, the participants themselves and from surgeons or
hospitals. When mature, the registry will collect data from all public and private hospitals
in Australia and New Zealand that perform bariatric surgery (estimated to be around 152 sites
in Australia and 12 in NZ). Contributing surgeons or public hospital clinics are required to
make patients who will undergo bariatric procedures aware that information related to their
procedure will be provided to the BSR. Surgeons and public hospital clinics are required to
display a poster that advises their practice/clinic contributes to the Bariatric Surgery
Registry and give all bariatric patients a registry information flyer. Upon the registry
receiving patient demographic and procedure information from the surgeon or the hospital,
bariatric patients are posted a Participant Fact Sheet (PFS) further advising that
participation in the registry is voluntary and their decision not to participate in the
registry or to participate and later opt out, will not affect their relationship with their
treating surgeon or the hospital, and their surgeon will be unaware of their participation
status. After the PFS are posted, bariatric patients have two weeks to contact the Registry
staff via the free call telephone number to opt out. Their participation will be presumed if
no contact is made within that period. There are three options for participation: full
participation; partial opt out - data is included on the registry but registry staff will not
contact the participant during the follow-up period; or, complete opt out - no clinical data
is included on the registry. All participants retain the right to opt out at any time. For
those who choose to opt out, their information is disposed of in accordance with the National
Statement for Ethical Conduct in Human Research 2007 (2015). Data are provided using one of
the following options: web browser with secure authorised entry using the Bariatric Surgery
Registry Interface (BSR-i); paper based data forms securely faxed or posted; or, secure
electronic record transfer from surgeons' or hospitals' electronic medical record. In New
Zealand, data will only be collected through direct entry through the BSR-i. Completeness and
accuracy of the eligible population captured by the Registry will be assessed using hospital
International Classification of Disease 10-Australia Modified (ICD-10-AM) codes.
Cross-checking with ICD-10-AM codes allows for complete data capture at each hospital site
and provides data validation for each procedure submitted by the surgeon. Hospital
Information Services (HIS) at each hospital site or of a private hospital group provide
regular ICD-10-AM coding reports for bariatric procedures performed by surgeons who
participate in the Registry. These reports are sent to the registry at regular intervals by
the administering organising and will only contain data of contributing surgeons. The reports
are sent to the registry using a secure file transfer platform (SFTP). In the case where the
surgeon or hospital had not previously provided information of a bariatric patient, the
reports will be the primary source of data. When ICD-10-AM coding is the primary source,
surgeons are asked to complete the missing data elements not made available from the
hospitals (e.g. device/stapling information, whether it is a primary or revision operation,
height/ weight information and diabetes treatment). If the surgeons are providing the missing
operation data with the ICD-10-AM report verification process, they will also be asked to
provide their perioperative follow-up data at the same time to enable efficiency. Patients
whose details are obtained from ICD-10-AM reports will be sent a PFS and the opt-out approach
is followed. If the surgeons do not supply the missing data elements, registry staff will
contact the patient to confirm whether the procedure was a primary or revision and to
ascertain the participant's height, weight, diabetes status and treatment prior to surgery.
If surgeons or public data collectors indicate they have not seen the participant for
follow-up and are unable to provide post-operative data, registry staff will contact the
participant for a brief phone call to collect the information related to the perioperative
period and/or 12 month intervals after surgery. This call may also include the missing data
elements about their procedure if the surgeon or data collector had not provided them. Five
attempts will be made to contact the patient before they are allocated to "Lost to
Follow-Up." A waiver of consent has been granted by 40 ethics committees for the time during
the data acquisition process when patients' data may be held without providing them the
opportunity to opt out. The waiver covers from the time when the surgeons and hospitals
provide patients' information before the PFS is posted and two weeks have passed; and, from
the time when the BSR receives the Health Information Services discharge coding (ICD-10-AM
reports) and when patients are identified whose data was not provided by surgeons or
hospitals until the PFS is posted and two weeks has passed. Further, a waiver of consent has
been also granted by the same ethics committees in the event that the patient dies following
bariatric surgery so as not to burden next of kin. Information related to a mortality is
essential to determine if the death is likely to have been caused by the bariatric surgery.
Data collected are defined in the BSR'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 Identifiers-full name, address, date of birth, unit
record (UR) number/hospital, Individual Healthcare Identifier (IHI) number when available,
email address; Patient Demographic Information-Medicare, or Department of Veterans' Affairs
(DVA) number, National Health Index number (NHI) in New Zealand, phone numbers, gender, and
indigenous status/ethnicity; Procedural information-surgeon name, procedure date, procedure
type, primary or planned/unplanned revision status, reason for revision, bariatric procedure
prior to revision, procedure abandoned or not, length of hospital stay, mortality status and
if death likely related to bariatric procedure; Clinical details: start weight (for primary
patients only), day-of-surgery (DOS) weight, height, diabetes status and treatment, and
whether there was a concurrent renal and liver transplant; Device or staple details: type,
brand, model, port fixation method, and buttressing; Peri-operative (up to 90 days
:post-surgery) outcome data: date patient examined for follow-up; defined adverse events
(unplanned return to theatre, unplanned admission to an intensive care unit, unplanned
re-admission to hospital, prolonged hospital stay and reason or complication that caused the
adverse event); mortality status and if death likely related to bariatric procedure; Annual
Outcome data (for primary patients only) up to 10 years after surgery: weight, diabetes
status and treatment, re-operation and reason; mortality status and if death likely related
to bariatric procedure; and, Participant Feedback For quality assurance purposes, and as a
basis for the potential 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 to advise how the BSR could better support their journey as bariatric patients.
Perioperative follow-up data refers to the period between 20 and 90 days post-surgery. Annual
follow-up refers to the period between 9 months prior to anniversary or 3 months following.
Participants are identified as "primary" if they are entered the Registry with their first
bariatric procedure or as "legacy" if they are entered with a revision bariatric procedure.
The Bariatric Surgery Registry data dictionary defines each of the items on which data is
collected and provides information on how the required data is sourced and entered in the
database. The dictionary consists of a contents page that groups data items according to data
that is collected from same source and refers to a particular phase of patient's care. Data
completeness and accuracy are optimized through 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; the use of built in edit checks to ensure data meet
required formats and ranges; accuracy enhanced by the use of exhaustive drop down lists
providing all possible answers to minimize free text entry where applicable; the 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 checks for duplicate data, missing data, and data consistency. 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 or sites for review.
Case ascertainment as well as both brief and comprehensive audit processes will be performed
on site by Monash University registry staff (Australia only). Registry staff will perform
regular remote audit checks to verify the accuracy of data received from surgeons. This will
be done during the course of a follow-up phone call from the call centre or by registry staff
directly contacting surgeons' rooms. In Australia, it is intended that the BSR will
periodically link to other repositories, or datasets, of health information which can
validate registry data. This is to verify critical quality data such as patient mortality,
defined adverse events and other outcome measures are completely captured, minimising the
risk of surgeons selectively choosing whom they enter on the BSR. Requests to link New
Zealand BSR 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 ethics committee will be sought when required. All statistical analyses of this registry
will be undertaken with the support of the Biostatistics unit at Monash University.
Non-identifiable data for both Australia and New Zealand will be provided to an independent
biostatistician employed by the Monash University, Department of Epidemiology and Preventive
Medicine by secure file transfer for review on at least a six monthly basis. Participants,
hospitals and surgeons will not be identified in this dataset. The results will be provided
to the Monash by the registry's Project Manager. Only non-clinical registry staff will have
access to identifiable data. All data to be used in reports or publications are to be cleaned
and verified prior to analysis. Routine, re-analysis of data will be undertaken by the
Project Manager to ensure findings are reproducible. The governance of how the data
activities are undertaken lies with the Steering Committee. The Terms of Reference of the BSR
Steering Committee outline specific roles of the Steering Committee in relation to data as
follows- 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; and review all research
and data requests for identifiable data.
