PMID- 30082370 OWN - NLM STAT- MEDLINE DCOM- 20191024 LR - 20231115 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 8 IP - 8 DP - 2018 Aug 5 TI - Using routinely collected data to understand and predict adverse outcomes in opioid agonist treatment: Protocol for the Opioid Agonist Treatment Safety (OATS) Study. PG - e025204 LID - 10.1136/bmjopen-2018-025204 [doi] LID - e025204 AB - 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. CI - (c) Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Larney, Sarah AU - Larney S AUID- ORCID: 0000-0002-5602-4963 AD - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia. FAU - Hickman, Matthew AU - Hickman M AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Fiellin, David A AU - Fiellin DA AD - Schools of Medicine and Public Health, Yale University, New Haven, Connecticut, USA. FAU - Dobbins, Timothy AU - Dobbins T AD - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia. FAU - Nielsen, Suzanne AU - Nielsen S AD - Monash Addiction Research Centre, Monash University, Melbourne, Victoria, Australia. FAU - Jones, Nicola R AU - Jones NR AD - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia. FAU - Mattick, Richard P AU - Mattick RP AD - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia. FAU - Ali, Robert AU - Ali R AD - Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia. FAU - Degenhardt, Louisa AU - Degenhardt L AD - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia. LA - eng GR - 12/136/105/DH_/Department of Health/United Kingdom GR - MR/K006525/1/MRC_/Medical Research Council/United Kingdom GR - R01 DA044170/DA/NIDA NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20180805 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Analgesics, Opioid) RN - 0 (Receptors, Opioid) RN - 40D3SCR4GZ (Buprenorphine) RN - UC6VBE7V1Z (Methadone) SB - IM MH - Analgesics, Opioid/*adverse effects MH - Buprenorphine/*adverse effects MH - Drug Overdose/mortality MH - Emergency Service, Hospital/statistics & numerical data MH - Hospitalization/statistics & numerical data MH - Humans MH - Methadone/*adverse effects MH - New South Wales/epidemiology MH - Opioid-Related Disorders/*drug therapy MH - Patient Dropouts/statistics & numerical data MH - Receptors, Opioid/*agonists MH - Regression Analysis MH - Research Design MH - Retrospective Studies MH - Risk Factors PMC - PMC6078240 OTO - NOTNLM OT - buprenorphine OT - data linkage OT - methadone OT - opiate substitution treatment COIS- 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. EDAT- 2018/08/08 06:00 MHDA- 2019/10/28 06:00 PMCR- 2018/08/05 CRDT- 2018/08/08 06:00 PHST- 2018/08/08 06:00 [entrez] PHST- 2018/08/08 06:00 [pubmed] PHST- 2019/10/28 06:00 [medline] PHST- 2018/08/05 00:00 [pmc-release] AID - bmjopen-2018-025204 [pii] AID - 10.1136/bmjopen-2018-025204 [doi] PST - epublish SO - BMJ Open. 2018 Aug 5;8(8):e025204. doi: 10.1136/bmjopen-2018-025204.