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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-2019-034367 on 7 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 September 30, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-034367 on 7 June 2020. Downloaded from Clinical outcomes among individuals with a first episode psychosis attending Butabika National mental referral hospital in Uganda- a longitudinal cohort study. A study protocol ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-034367 Article Type: Protocol Date Submitted by the 20-Sep-2019 Author: Complete List of Authors: Akena, Dickens; Makerere University, Psychiatry Semeere, Aggrey; Infectious Diseases Institute Makerere University, Kadama, Philippa ; Makerere University Infectious Diseases Institute Mwesiga, Emanuel ; Makerere University College of Health Sciences Basangwa, David ; Butabika National Referral Hospital Nakku, Juliet; Butabika National Referral and Teaching Mental Hospital, Kampala, Psychiatry Nakasujja, Noeline ; Makerere University College of Health Sciences Schizophrenia & psychotic disorders < PSYCHIATRY, Public health < Keywords: INFECTIOUS DISEASES, Adult psychiatry < PSYCHIATRY http://bmjopen.bmj.com/ on September 30, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 13 BMJ Open 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2019-034367 on 7 June 2020. Downloaded from 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 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 30, 2021 by guest. Protected copyright. 45 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 13 BMJ Open: first published as 10.1136/bmjopen-2019-034367 on 7 June 2020. Downloaded from 1 2 Clinical outcomes among individuals with a first episode psychosis attending Butabika 3 4 National mental referral hospital in Uganda- a longitudinal cohort study. A study protocal 5 1 2 2 1,4 6 Authors: Dickens Akena , Aggrey Semeere , Philippa Kadama , Emanuel Mwesiga , David 3 3 1 7 Basangwa , Juliet Nakku , Noeline Nakasujja 8 9 Affiliations: 1. Department of Psychiatry, Makerere University College of Health Sciences, 2. 10 Infectious Disease Institute, Makerere University College of Health Sciences, 3. Butabika 11 National Mental referral Hospital, 4. Department of Psychiatry and Mental Health, University of 12 Cape Town. 13 14 Author emails: 15 16 Dickens Akena: [email protected] peer review , [email protected] only 17 18 Aggrey Semeere: [email protected] 19 20 : 21 Philippa Kadama [email protected] 22 23 Emanuel Mwesiga: [email protected] 24 25 David Basangwa: [email protected] 26 27 Juliet Nakku: [email protected] 28 29 Noeline Nakasujja: [email protected] 30 31 Corresponding author: Dickens Akena. P.O.Box 7062, Makerere University. email: 32 http://bmjopen.bmj.com/ 33 [email protected] 34 35 36 37 38 39 40 on September 30, 2021 by guest. Protected copyright. 41 42 43 44 45 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 Page 3 of 13 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-034367 on 7 June 2020. Downloaded from 1 2 Abstract 3 4 5 Introduction: Psychotic disorders are a major contributor to high morbidity and mortality and 6 significantly contribute to years lived with disability. Predictors of mortality, relapse and barriers 7 to care among patients with first episode psychoses (FEP) have been studied as a means of 8 tailoring interventions to improve patient outcomes. However, little has been done in sub- 9 Saharan Africa to document the incidence and predictors of relapse in patients with FEP. The 10 objectives of this study will be to (a) estimate the cumulative incidence of clinical relapse of 11 psychotic symptoms in patients with FEP, and (b) determine the factors that predict clinical 12 relapse in patients with FEP who showed clinical response to treatment during hospital 13 admission. 14 15 Methods and analysis: We will assemble a cohort of patients with a FEP seen at the Butabika 16 National Mental ReferralFor Hospital peer in Kampala review over a 4-year period.only Participants will be adults 17 ( ≥18 years old), who have received a diagnosis of a psychosis according to the Mini 18 International Neuropsychiatric Instrument (M.I.N.I), with a demonstrable resolution of active 19 symptoms following the use of antipsychotic medications, and deemed clinically stable for a 20 discharge by the health care practitioner. All participants will be required to provide written 21 informed consent. 22 Trained research assistants (RA) will collect Demographic and clinical parameters, age of onset 23 24 of symptoms, diagnostic data using the MINI, physical examination data, symptom severity, 25 level of social and occupational functioning and household income, during the 4 year study 26 period. We will conduct a verbal audit in the event of loss of life. 27 28 Ethics and Dissemination: All participants will provide written informed consent Ethical 29 approvals for the study has been obtained from the Makerere University School of Medicine 30 Research and Ethics Committee and the Uganda National Council for Science and Technology. 31 We will prepare manuscripts for publication in peer reviewed journals 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39 40 on September 30, 2021 by guest. Protected copyright. 41 42 43 44 45 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 4 of 13 BMJ Open: first published as 10.1136/bmjopen-2019-034367 on 7 June 2020. Downloaded from 1 2 Article summary: 3 4 5 Strengths and limitations of the study 6 7 8 This study will be among the first to examine the incidence of relapse among individuals with a 9 FEP in Uganda. 10 11 Findings from this study will provide us with the building blocks for future intervention studies in 12 the field of psychosis. 13 14 We will be able to examine the feasibility and feasibility of setting up a cohort in resource 15 constrained Uganda. 16 For peer review only 17 Our sample size may limit us from examining multiple predictors to relapse among individuals 18 with a psychosis. 19 20 Our short duration of follow-up may limit us from answering questions about long term 21 predictors of relapse 22 23 24 25 Key words: First episode psychosis, Cohort Study, Incidence, sub-Saharan Africa. 26 27 28 29 30 31 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39 40 on September 30, 2021 by guest.
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