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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2020-044493 on 19 January 2021. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 24, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-044493 on 19 January 2021. Downloaded from Persistent opioid use and opioid-related harm after hospital admissions for surgery and trauma in New Zealand: A Population-based Cohort Study ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-044493 Article Type: Protocol Date Submitted by the 04-Sep-2020 Author: Complete List of Authors: Gong, Jiayi; The University of Auckland Faculty of Medical and Health Sciences, School of Pharmacy; Auckland City Hospital, Pharmacy Merry, Alan; The University of Auckland Faculty of Medical and Health Sciences, Dept of Anaesthesiology; Auckland City Hospital, Department of Anaesthesia and Perioperative Medicine Beyene, Kebede; The University of Auckland Faculty of Medical and Health Sciences, School of Pharmacy Campbell, Doug; The University of Auckland Faculty of Medical and Health Sciences, Department of Anaesthesiology; Auckland City Hospital, Department of Anaesthesia and Perioperative Medicine Frampton, Chris; University of Otago Christchurch, Department of Psychological Medicine Jones, Peter; The University of Auckland Faculty of Medical and Health http://bmjopen.bmj.com/ Sciences, Department of Surgery McCall, John; The University of Auckland Faculty of Medical and Health Sciences, Department of Surgery Moore, Matthew; The University of Auckland Faculty of Medical and Health Sciences, Department of Anaesthesiology Chan, Amy; The University of Auckland Faculty of Medical and Health Sciences, School of Pharmacy; Auckland City Hospital Pain management < ANAESTHETICS, EPIDEMIOLOGY, ORTHOPAEDIC & on September 24, 2021 by guest. Protected copyright. Keywords: TRAUMA SURGERY, PAEDIATRIC SURGERY, SURGERY, ACCIDENT & EMERGENCY MEDICINE For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 69 BMJ Open 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-044493 on 19 January 2021. Downloaded from 4 5 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on September 24, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 69 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-044493 on 19 January 2021. Downloaded from 4 5 6 Study Protocol: 7 8 9 10 11 12 13 14 Persistent opioid use and opioid- 15 16 17 18 related harmFor peer after review hospital only 19 20 21 22 23 admissions for surgery and trauma in 24 25 26 27 New Zealand: A Population-based 28 29 30 31 Cohort Study 32 33 34 35 36 Authors: Jiayi (Jay) Gong,1,2 Alan Merry,3,4 Kebede Beyene,1 Douglas Campbell,3,4 Christopher 37 Frampton,5 Peter Jones,6 John McCall,6 Matthew Moore,3 Amy Chan 1,2 http://bmjopen.bmj.com/ 38 39 40 Corresponding author: Dr Amy Chan ([email protected]) 41 42 Word count: 3896 (excl. abstracts, figs, references, declarations) 43 44 45 on September 24, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Opioid Study ADHB/UoA Study Protocol_BMJOPEN_v9 01/09/2020 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 69 BMJ Open 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-044493 on 19 January 2021. Downloaded from 4 5 6 7 8 9 10 11 12 13 14 Abstract 15 16 17 Introduction: 18 For peer review only 19 Opioid use has increased globally for the management of chronic non-cancer-related pain. There are 20 concerns regarding the misuse of opioids leading to persistent opioid use and subsequent 21 22 hospitalisation and deaths in developed countries. Hospital admissions related to surgery or trauma 23 have been identified as contributing to the increasing opioid use internationally. There are minimal 24 data on persistent opioid use and opioid-related harm in NZ, and how hospital admission for surgery 25 or trauma contributes to this. We aim to describe rates and identify predictors of persistent opioid 26 use among opioid-naïve individuals following hospital discharge for surgery or trauma. 27 28 29 30 Methods and analysis: 31 32 This is a population-based, retrospective cohort study using linked data from national health 33 administrative databases for opioid-naïve patients who have had surgery or trauma in NZ between 34 35 January 2006 to December 2019. Linked data will be used to identify variables of interest including 36 all types of hospital surgeries in NZ, all trauma hospital admissions, opioid dispensing, comorbidities, 37 and sociodemographic variables. The primary outcome of this study will be the prevalence of http://bmjopen.bmj.com/ 38 persistent opioid use. Secondary outcomes will include mortality, opioid-related harms, and 39 hospitalisation. We will compare the secondary outcomes between persistent and non-persistent 40 41 opioid user groups. To compute rates, we will divide the total number of outcome events by total 42 follow-up time. Multivariable logistic regression will be used to identify predictors of persistent 43 opioid use. Multivariable Cox regression models will be used to estimate the risk of opioid-related 44 harms and hospitalisation as well as all-cause mortality among the study cohort in a year following 45 hospital discharge for surgery or trauma. on September 24, 2021 by guest. Protected copyright. 46 47 48 49 Ethics and Dissemination: 50 51 This study has been approved by the Auckland Health Research Ethics Committee (AHREC- AH1159). 52 Results will be reported in accordance with the Reporting of studies Conducted using Observational 53 Routinely collected health data statement (RECORD). 54 55 56 57 58 59 60 Opioid Study ADHB/UoA Study Protocol_BMJOPEN_v9 01/09/2020 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 69 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-044493 on 19 January 2021. Downloaded from 4 5 6 7 8 9 10 11 12 13 14 Article Summary 15 Strength and Limitations of the study 16 17 This will be the first study in New Zealand to examine the relationship between hospital 18 For peer review only 19 admission for surgery or trauma and the incidence of persistent opioid use. 20 The study will include 14 years of opioid usage data, making this one of the largest opioid 21 usage studies to date (2006 to 2019).
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