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BMJ Open: first published as 10.1136/bmjopen-2019-034946 on 11 June 2020. 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 October 1, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-034946 on 11 June 2020. Downloaded from Protocol for the development and validation of a measure of persistent psychological and emotional distress in cardiac patients: The Cardiac Distress Inventory ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-034946 Article Type: Protocol Date Submitted by the 12-Oct-2019 Author: Complete List of Authors: Jackson, Alun; Australian Centre for Heart Health,; Deakin University Faculty of Health Rogerson, Michelle; Australian Centre for Heart Health Le Grande , Michael; Australian Centre for Heart Health; University of Melbourne, Centre for Behaviour Change, Melbourne School of Psychological Sciences Thompson, David; Queen's University Belfast, School of Nursing and Midwifery; Australian Centre for Heart Health Ski, Chantal; Queen’s University, Belfast, School of Nursing and Midwifery; Australian Centre for Heart Health Alvarenga, Marlies; Federation University Australia - Berwick Campus, School of Health and Life Sciences; MonashHeart, Monash Cardiovascular Research Centre http://bmjopen.bmj.com/ Amerena, John; Barwon Health, Cardiac Services; Deakin School of Medicine Higgins, Rosemary; Australian Centre for Heart Health; Deakin University, Faculty of Health Raciti, Michela; Australian Centre for Heart Health Murphy, Barbara; Australian Centre for Heart Health; Deakin University Faculty of Health Adult cardiology < CARDIOLOGY, Protocols & guidelines < HEALTH Keywords: SERVICES ADMINISTRATION & MANAGEMENT, Cardiology < INTERNAL on October 1, 2021 by guest. 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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 15 1 2 3 Protocol for the development and validation of a measure of persistent psychological and 4 emotional distress in cardiac patients: The Cardiac Distress Inventory BMJ Open: first published as 10.1136/bmjopen-2019-034946 on 11 June 2020. Downloaded from 5 6 7 8 Alun C Jackson PhD (Corresponding author), Director, Australian Centre for Heart Health, 9 Melbourne, Victoria, Australia; Honorary Professor, Faculty of Health, Deakin University, Geelong, 10 11 Australia; Honorary Professor, Centre on Behavioural Health, University of Hong Kong, Pokfulam, 12 Hong Kong. Address: PO Box 2137, The Royal Melbourne Hospital, Victoria 3050 Australia; Ph: +61 3 13 9326 8544; Email: [email protected] 14 15 Michelle Rogerson PhD, Research Fellow, Australian Centre for Heart Health, Melbourne, Australia. 16 17 Michael R Le Grande MPH, Senior Research Fellow, Australian Centre for Heart Health, Melbourne, 18 Australia; Research Fellow,For Centre peer for Behaviour review Change, Melbourne only School of Psychological 19 Sciences, University of Melbourne, Melbourne, Australia. 20 21 David R Thompson PhD, Professor, School of Nursing and Midwifery, Queen’s University Belfast, UK; 22 Honorary Professorial Fellow, Australian Centre for Heart Health, Melbourne, Australia; Honorary 23 24 Professor, Department of Psychiatry, University of Melbourne, Melbourne, Australia. 25 Chantal F Ski PhD, Reader, School of Nursing and Midwifery, Queen’s University Belfast, UK; 26 27 Honorary Principal Research Fellow, Australian Centre for Heart Health, Melbourne, Australia; 28 Honorary Associate Professor, Department of Psychiatry, University of Melbourne, Melbourne, 29 Australia. 30 31 Marlies E Alvarenga PhD, Lecturer in Psychology, School of Health and Life Sciences, Federation 32 University Australia, Berwick, Australia; Consultant Clinical Psychologist, Monash Cardiovascular 33 Research Centre, MonashHEART, Melbourne, Australia & Monash Health & Department of Medicine, 34 Monash University, Melbourne, Australia & Australian Centre for Heart Health, Melbourne, Australia 35 36 John Amerena MB BS, Director of Cardiac Services, Barwon Health, Geelong, Australia; Clinical 37 http://bmjopen.bmj.com/ 38 Associate Professor, Deakin School of Medicine, University Hospital Geelong, Geelong, Australia. 39 Rosemary O Higgins DPsych, Clinical Consultant (Health Psychology), Australian Centre for Heart 40 41 Health, Melbourne, Australia; Honorary Associate Professor, Department of Psychology, Deakin 42 University, Geelong, Australia; Honorary Associate Professor, Department of Physiotherapy, 43 University of Melbourne, Melbourne, Australia. 44 45 Michela Raciti BPsych, Research Intern, Australian Centre for Heart Health, Melbourne, Australia on October 1, 2021 by guest. Protected copyright. 46 47 Barbara M Murphy PhD, Principal Researcher, Australian Centre for Heart Health, Melbourne, 48 Australia; Honorary Associate Professor, Faculty of Health, Deakin University, Geelong, Australia; 49 Honorary Senior Research Fellow, Department of Psychology, University of Melbourne, Melbourne, 50 Australia. 51 52 Key words: cardiac distress, anxiety, depression, psychometrics, instrument development 53 54 Word count: 4371 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 15 BMJ Open 1 2 3 ABSTRACT 4 5 Introduction Distress is experienced by the majority of cardiac patients, yet no cardiac-specific BMJ Open: first published as 10.1136/bmjopen-2019-034946 on 11 June 2020. Downloaded from 6 measure of distress exists. The aim of this project is to develop and validate the Cardiac Distress 7 Inventory (CDI). Using the CDI, health professionals will be able to identify key clusters of 8 psychological, emotional and social concern to address with patients, post-cardiac event. 9 Psychometric testing of a long form questionnaire will also result in the development of a short form 10 screening version. 11 12 Methods and analysis An item pool will be generated through: identification of items by a 13 multidisciplinary group of clinician researchers; review of generic and condition-specific distress 14 measures; focus group testing with cardiac rehabilitation professionals; feedback from patients. The 15 COSMIN criteria will be used to inform the development of the methodology for determining the 16 17 CDI’s psychometric properties. The item pool will be tested with 400 cardiac patients and responses 18 subjected to exploratoryFor factor peer analysis, Rasch review analysis, test-retest only reliability, construct validity 19 testing, and latent class analysis. ROC analysis will be used to identify the optimal CDI cut off score 20 for distinguishing whether a person experiences clinically significant distress. The study will take 21 place over a 15 to 18-month period. 22 23 Ethics and dissemination This protocol has been approved by the Monash Health Human Research 24 Ethics Committee (Approval number – RES-19-0000631L-55979 0). The CDI will be made available to 25 clinicians and researchers without charge.