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Using routinely collected data to understand and predict adverse outcomes in opioid agonist treatment: Protocol for the Opioid Agonist Treatment Safety (OATS) Study
  1. Sarah Larney1,
  2. Matthew Hickman2,
  3. David A Fiellin3,
  4. Timothy Dobbins1,
  5. Suzanne Nielsen4,
  6. Nicola R Jones1,
  7. Richard P Mattick1,
  8. Robert Ali5,
  9. Louisa Degenhardt1
  1. 1 National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia
  2. 2 Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
  3. 3 Schools of Medicine and Public Health, Yale University, New Haven, Connecticut, USA
  4. 4 Monash Addiction Research Centre, Monash University, Melbourne, Victoria, Australia
  5. 5 Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
  1. Correspondence to Dr Sarah Larney; s.larney{at}


Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

  • opiate substitution treatment
  • methadone
  • buprenorphine
  • data linkage

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  • Contributors This study idea was conceived by SL, LD and MH. SL, LD, MH, DAF, TD, SN, NRJ, RPM and RA provided input to the study design and research questions. TD, SL, MH and NRJ developed the statistical analysis plan. SL completed the first draft of the manuscript. MH, DAF, TD, SN, NRJ, RPM, RA ad LD reviewed the manuscript and provided input to the final draft.

  • Funding This publication was supported by the National Institute on Drug Abuse grant number R01DA044170. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute on Drug Abuse. SL is supported by an Australian National Health and Medical Research Council (NHMRC) Career Development Fellowship (GNT1140938). LD is supported by an Australian NHMRC Senior Principal Research Fellowship (GNT1135991). SN is supported by an Australian NHMRC Translating Research Into Practice Fellowship (GNT1132433). MH acknowledges support from NIHR HPRU in Evaluation. The National Drug and Alcohol Research Centre at UNSW Sydney is supported by the Australian Government Department of Health and Ageing.

  • 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.

  • Patient consent Not required.

  • Ethics approval Population and Health Services Research Ethics Committee, received in April 2018 (2018/HRE0205), valid for 5 years.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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