Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000783224
Ethics application status
Approved
Date submitted
23/01/2018
Date registered
9/05/2018
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Date results information initially provided
22/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidemiology and estimation of long-term surgical mortality
Scientific title
Validation and extension of a multivariable prediction model of perioperative mortality in
a national perioperative dataset
Secondary ID [1] 293864 0
ADHB A+ 7383
Universal Trial Number (UTN)
Trial acronym
NZRISK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative mortality 306326 0
Condition category
Condition code
Anaesthesiology 305411 305411 0 0
Other anaesthesiology
Surgery 305412 305412 0 0
Other surgery
Public Health 305440 305440 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
NZRISK will provide a multivariate risk model based on data from July 2011 to June 2016 of the New Zealand Ministry of Health National Minimum Dataset (NMDS. Covariates will include age, gender, ASA, acuity, specialty, surgical severity, ethnicity and cancer status.
Intervention code [1] 300125 0
Early Detection / Screening
Intervention code [2] 300155 0
Diagnosis / Prognosis
Comparator / control treatment
Observation - no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304547 0
Postoperative Mortality at 30 days
Timepoint [1] 304547 0
30 days post surgery
Secondary outcome [1] 342925 0
Days Alive out of hospital
Timepoint [1] 342925 0
90 days
Secondary outcome [2] 346657 0
Postoperative Mortality at 90 days
Timepoint [2] 346657 0
90 days post surgery
Secondary outcome [3] 346670 0
Postoperative Mortality at 1 year
Timepoint [3] 346670 0
1 year post surgery
Secondary outcome [4] 346671 0
Postoperative Mortality at 2 year
Timepoint [4] 346671 0
2 years post surgery

Eligibility
Key inclusion criteria
undergoing a surgical procedure of any acuity (elective, expedited, urgent or emergency) in New Zealand
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac Surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis
Data of approximately 300,000 patients fromNational Minimum Dataset (NMDS) and National Mortality Registry. The dataset will be split for derivation and validation. We will use multivariable logistic regression with backward stepwise regression to derive the models.

ASA was handled as a categorical predictor with 5 categories. Operation type was mapped onto surgical grade in 4 categories of minor, intermediate, major and major-complex. Cancer was a bivariate variable for presence or absence of a cancer with potential to affect mortality. Acuity was categorical elective or acute. Age was handled as a continuous predictor.
We will use multivariable logistic regression with backward stepwise regression. Univariate analysis will be performed initially using chi-squared testing to test the relationship between each independent variable and 30-day mortality. All analyses will performed to validate a predictive model of 30-day mortality and then repeated to derive predictive models of 30-day, one-year and two-year mortality respectively. Variables that had more than 10% missing values were excluded from the analysis. Incremental improvements in the extended models by incorporating gender and ethnicity will be assessed by change in AUC and integrated discrimination improvement.
The predictive model will be derived from the full dataset and was then resampled using bootstrapping to evaluate performance. Reporting the results will be according to the TRIPOD statement.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/12/2017
Date of last participant enrolment
Anticipated
Actual
31/12/2017
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
360000
Accrual to date
Final
360000
Recruitment outside Australia
Country [1] 9520 0
New Zealand
State/province [1] 9520 0
Nationally

Funding & Sponsors
Funding source category [1] 298483 0
Other Collaborative groups
Name [1] 298483 0
Precision Driven Health
Country [1] 298483 0
New Zealand
Primary sponsor type
Individual
Name
Dr Douglas Campbell
Address
Dept Anaesthesia and Perioperative Services.
Level 8, Support Building, Auckland City Hospital. Park Rd, Grafton, Auckland 1024
Country
New Zealand
Secondary sponsor category [1] 297627 0
None
Name [1] 297627 0
Address [1] 297627 0
Country [1] 297627 0
Other collaborator category [1] 279911 0
Government body
Name [1] 279911 0
Auckland District Health Board
Address [1] 279911 0
Park Road
Grafton
Auckland 1024
Country [1] 279911 0
New Zealand
Other collaborator category [2] 279912 0
Individual
Name [2] 279912 0
Professor Alan Merry
Address [2] 279912 0
Dept of Anaesthesiology, University of Auckland
Park Road
Grafton
Auckland 1024
Country [2] 279912 0
New Zealand
Other collaborator category [3] 279914 0
Individual
Name [3] 279914 0
Associate Professor Tim Short
Address [3] 279914 0
Department of Anaesthesia and Perioperative Services
Auckland City Hospital
Level 8 Support Building
Park Road
Grafton
Auckland 1024
Country [3] 279914 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299470 0
Health and Disability Ethics Committees
Ethics committee address [1] 299470 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299470 0
New Zealand
Date submitted for ethics approval [1] 299470 0
24/11/2016
Approval date [1] 299470 0
17/01/2017
Ethics approval number [1] 299470 0
16/CEN/200

Summary
Brief summary
Currently, there is no widely used clinical tool for anaesthestists to predict perioperative mortality that has been validated in New Zealand patients. We aim to validate the Surgical Outcome Risk Tool (SORT), a parsimonious, 6 risk factor multivariate model used in the UK, in a New Zealand cohort. We also aim to extend the model to include gender and ethnicity to tailor the model to New Zealand conditions. We will also aim to derive extended models incorporating one and two year mortality as well as 30 day mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80514 0
Dr Douglas Campbell
Address 80514 0
Department Anaesthesia and Perioperative Services
Level 8, Auckland City Hospital
Park Road
Grafton, Auckland 1024
Country 80514 0
New Zealand
Phone 80514 0
+6493757095
Fax 80514 0
+6493754378
Email 80514 0
[email protected]
Contact person for public queries
Name 80515 0
Ms Davina McAllister
Address 80515 0
Anaesthesia and Perioperative Services
Level 8, Auckland City Hospital
Park Road
Grafton, Auckland 1024
Country 80515 0
New Zealand
Phone 80515 0
+6493757095
Fax 80515 0
+6493754378
Email 80515 0
[email protected]
Contact person for scientific queries
Name 80516 0
Dr Douglas Campbell
Address 80516 0
Anaesthesia and Perioperative Services
Level 8, Auckland City Hospital
Park Road
Grafton, Auckland 1024
Country 80516 0
New Zealand
Phone 80516 0
+6493757095
Fax 80516 0
+6493754378
Email 80516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16987Study protocol    374364-(Uploaded-13-04-2021-10-55-36)-Study-related document.pdf
16988Ethical approval    374364-(Uploaded-13-04-2021-10-56-29)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Campbell D, Boyle L, Soakell-Ho M, et al. National... [More Details]
Study results articleYes Stephanie Clark, MBChB, FANZCA, Luke Boyle, MSc, P... [More Details]

Documents added automatically
No additional documents have been identified.