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BMJ Open. 2018 Aug 5;8(8):e025204. doi: 10.1136/bmjopen-2018-025204.

Using routinely collected data to understand and predict adverse outcomes in opioid agonist treatment: Protocol for the Opioid Agonist Treatment Safety (OATS) Study.

Author information

National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Schools of Medicine and Public Health, Yale University, New Haven, Connecticut, USA.
Monash Addiction Research Centre, Monash University, Melbourne, Victoria, Australia.
Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.



North America is amid an opioid use epidemic. Opioid agonist treatment (OAT) effectively reduces extramedical opioid use and related harms. As with all pharmacological treatments, there are risks associated with OAT, including fatal overdose. There is a need to better understand risk for adverse outcomes during and after OAT, and for innovative approaches to identifying people at greatest risk of adverse outcomes. The Opioid Agonist Treatment and Safety study aims to address these questions so as to inform the expansion of OAT in the USA.


This is a retrospective cohort study using linked, routinely collected health data for all people seeking OAT in New South Wales, Australia, between 2001 and 2017. Linked data include hospitalisation, emergency department presentation, mental health diagnoses, incarceration and mortality. We will use standard regression techniques to model the magnitude and risk factors for adverse outcomes (eg, mortality, unplanned hospitalisation and emergency department presentation, and unplanned treatment cessation) during and after OAT, and machine learning approaches to develop a risk-prediction model.


This study has been approved by the Population and Health Services Research Ethics Committee (2018HRE0205). Results will be reported in accordance with the REporting of studies Conducted using Observational Routinely-collected health Data statement.


buprenorphine; data linkage; methadone; opiate substitution treatment

Conflict of interest statement

Competing interests: SL has received an untied educational grant from Indivior. LD has received untied educational grants from Indivior, Seqiris, and Mundipharma. MH reports honoraria for speaking at meetings from Gilead, Abbvie and MSD. SN has been an investigator on untied investigator-driven educational grants funded by Indivior and Reckitt-Benckiser, and has had travel costs covered and honoraria paid to her institution to provide training on identification and management of codeine dependence by Indivior.

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