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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-2020-040944 on 30 November 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 26, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. Downloaded from Study protocol: The Philippine COVID-19 Outcomes: a Retrospective study Of Neurological manifestations and Associated symptoms (The Philippine CORONA Study) ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-040944 Article Type: Protocol Date Submitted by the 27-May-2020 Author: Complete List of Authors: Espiritu, Adrian; University of the Philippines Manila College of Medicine, Neurosciences Sy, Marie Charmaine; University of the Philippines Manila College of Medicine, Neurosciences Anlacan, Veeda Michelle; University of the Philippines Manila College of Medicine, Neurosciences Jamora, Roland Dominic; University of the Philippines Manila College of Medicine, Neurosciences Keywords: NEUROLOGY, Adult neurology < NEUROLOGY, EPIDEMIOLOGY http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 22 BMJ Open 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. 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 26, 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 22 BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. Downloaded from 1 2 3 4 5 6 Study protocol: The Philippine COVID-19 Outcomes: a Retrospective study Of Neurological 7 manifestations and Associated symptoms (The Philippine CORONA Study) 8 9 10 a,b, ,† a,† a,‡ 11 Adrian I. Espiritu * , Marie Charmaine C. Sy , Veeda Michelle M. Anlacan , Roland 12 Dominic G. Jamoraa,*, ‡ 13 14 aDepartment of Neurosciences, College of Medicine and Philippine General Hospital, University 15 of the Philippines Manila, Manila, Philippines 16 b For peer review only 17 Department of Clinical Epidemiology, College of Medicine, University of the Philippines 18 Manila, Manila, Philippines 19 20 *Corresponding author; †Joint co-principal investigators; ‡Joint senior investigators 21 22 23 24 25 Contact information: 26 27 ADRIAN I. ESPIRITU, MD 28 E-mail address: [email protected] 29 Contact number: (+63) 925 852 0341 30 ORCID iD: 0000-0001-5621-1833 31 32 MARIE CHARMAINE C. SY, MD, MBA 33 http://bmjopen.bmj.com/ 34 E-mail address: [email protected] 35 Contact number: (+63) 917 843 6444 36 ORCID iD: 0000-0003-1135-6400 37 38 VEEDA MICHELLE M. ANLACAN, MD, FPNA 39 40 E-mail address: [email protected] Contact number: (+63) 917 832 7340 41 on September 26, 2021 by guest. Protected copyright. 42 ORCID iD: 0000-0002-1241-8805 43 44 ROLAND DOMINIC G. JAMORA, MD, FPNA 45 E-mail address: [email protected] 46 Contact number: (+63) 998 543 8062 47 48 ORCID iD: 0000-0001-5317-7369 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 22 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. Downloaded from 1 2 3 ABSTRACT 4 5 6 Introduction: 7 The SARS-CoV-2, virus which caused the coronavirus disease (COVID-19) global pandemic, 8 may possess a neuroinvasive potential. It is hypothesized that patients with COVID-19 disease 9 may also present with neurological signs and symptoms aside from the usual respiratory 10 affectation. Moreover, it appears that COVID-19 may be associated with several neurological 11 diseases and complications, which may eventually affect clinical outcomes. 12 13 14 Objectives: 15 The Philippine CORONA study investigators will conduct a nationwide, multicenter study 16 involving 31 institutionsFor that aimspeer to determine review the neurological only manifestations and factors 17 associated with clinical outcomes in COVID-19 infection. 18 19 Methodology and analysis: 20 21 This is a retrospective cohort study (comparative between patients with and without neurological 22 manifestations) via medical chart review involving adult patients with COVID-19 infection. 23 Sample size was determined at 1,342 patients. Demographic, clinical and neurological profiles 24 will be obtained and summarized using descriptive statistics. Student’s t-test for two independent 25 samples and chi-squared test will be used to determine differences between distributions. Hazard 26 ratios (HR) and 95% confidence interval will be used as an outcome measure. Kaplan-Meier 27 curves will be constructed to plot the time to onset of mortality (survival), respiratory failure, 28 29 ICU admission, duration of ventilator dependence, length of ICU stay, and length of hospital 30 stay. The log-rank test will be employed to compare the Kaplan-Meier curves. Stratified analysis 31 will be performed to identify confounders and effects modifiers. To compute for adjusted HR 32 with 95% CI, crude HR of outcomes will be adjusted according to the prespecified possible 33 confounders. Cox-proportional regression models will be used to determine significant factors of http://bmjopen.bmj.com/ 34 outcomes. Testing for goodness-of-fit will also be done using Hosmer-Lemeshow test. Subgroup 35 analysis will be performed for proven prespecified effect modifiers. The effects of missing data 36 37 and outliers will also be evaluated in this study. 38 39 Ethical consideration: 40 This protocol was approved by the Single Joint Research Ethics Board of the Philippine 41 Department of Health (SJREB-2020-24) and the institutional review board of the different study on September 26, 2021 by guest. Protected copyright. 42 sites. 43 44 45 Registration number: NCT04386083 46 47 Keywords: COVID-19, Neurologic manifestations; Outcomes; Cohort study 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 1 BMJ Open Page 4 of 22 BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. Downloaded from 1 2 3 ARTICLE SUMMARY 4 5 Strengths and limitations: 6 7 8 9 CORONA is a nationwide, multicenter, retrospective, cohort study with 31 Philippine 10 11 sites. 12 13 Full spectrum of neurological manifestations of COVID-19 will be collected. 14 15 16 RetrospectiveFor gathering peer of data offers review virtually no risk only of COVID-19 infection to data 17 18 collectors. 19 20 21 Data from COVID-19 patients who did not go to the hospital are unobtainable.
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