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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-2020-038843 on 6 July 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 23, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-038843 on 6 July 2020. Downloaded from The Broad Spectrum Project. Factors determining the quality of antibiotic use in primary care: an observational study protocol from Italy. ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-038843 Article Type: Protocol Date Submitted by the 26-Mar-2020 Author: Complete List of Authors: Kurotschka, Peter; University of Cagliari, Department of Medical Science and Public Health; Istituto Superiore di Sanita, National Centre for pre- clinical and clinical drug research and surveillance (CNRVF) Serafini, Alice; General Practitioner in training, Local Health Trust Modena Massari, Marco; Istituto Superiore di Sanita, National Centre for pre- clinical and clinical drug research and surveillance (CNRVF) Da Cas, Roberto; Istituto Superiore di Sanita, National Centre for pre- clinical and clinical drug research and surveillance (CNRVF) Figueiras, Adolfo; Universidade de Santiago de Compostela, Department of Preventive Medicine and Public Health Forte, Viviana; General Practitioner, Regional Health Trust, Sardinia, http://bmjopen.bmj.com/ Italy Moro, Maria Francesca; Columbia University Mailman School of Public Health Massidda, Matteo; General Practitioner in training, Regional Health Trust, Sardinia, Italy Contu, Federico; General Practitioner in training, Regional Health Trust, Sardinia, Italy Minerba, Luigi; University of Cagliari, Department of Medical Science and Public Health on September 23, 2021 by guest. Protected copyright. Marcias, Maurizio; Health Technology Assessment Unit - Regional Health Trust of Sardinia Nardelli, Marco; Tower Hamlets Primary Care Trust, Brayford Square Surgery Perra, Alessandra; University of Cagliari, Department of Medical Science and Public Health Carta, M; University of Cagliari, Department of Medical Science and Public Health Spila Alegiani, Stefania; Istituto Superiore di Sanita, National Centre for pre-clinical and clinical drug research and surveillance (CNRVF) PRIMARY CARE, PUBLIC HEALTH, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, EPIDEMIOLOGY, Keywords: EDUCATION & TRAINING (see Medical Education & Training), Epidemiology < INFECTIOUS DISEASES For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 14 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-038843 on 6 July 2020. 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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 23, 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 Page 3 of 14 BMJ Open 1 2 3 The Broad Spectrum project. 4 BMJ Open: first published as 10.1136/bmjopen-2020-038843 on 6 July 2020. Downloaded from 5 Factors determining the quality of antibiotic use in primary care: an 6 7 observational study protocol from Italy 8 9 Peter Konstantin Kurotschka1,2,3,4 * & Alice Serafini5*, Marco Massari2, Roberto Da Cas2, Adolfo 10 Figueiras6, Viviana Forte3,7, Maria Francesca Moro8, Matteo Massidda3,4, Federico Contu3,4, Luigi 11 1 9 10 1 1 12 Minerba , Maurizio Marcias , Marco Nardelli , Alessandra Perra , Mauro Giovanni Carta **, Stefania 2 13 Spila Alegiani ** 14 15 * These authors contributed equally to this work (shared first authorship) 16 17 ** These authors also contributed equally to this work (shared last authorship) 18 For peer review only 19 (1) Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy 20 (2) Italian National Institute of Health, National Centre for pre-clinical and clinical drug research and surveillance 21 (CNRVF), Rome, Italy 22 (3) Italian Secretariat of Physician Scientists – SIMeR (SIGM), Italy (4) General Practitioner in training, Regional Health Trust, Sardinia, Italy 23 (5) General Practitioner in training, Local Health Trust Modena, Emilia-Romagna, Italy 24 (6) Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Consortium for 25 Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología y Salud Pública - CIBERESP), 26 Santiago de Compostela, Spain 27 (7) General Practitioner, Regional Health Trust, Sardinia, Italy 28 (8) Mailman School of Public Health, Columbia University, New York City, USA 29 (9) Health Technology Assessment Unit - Regional Health Trust, Sardinia, Italy 30 (10) General Practitioner, Tower Hamlets Primary Care Trust, Brayford Square Surgery, London, United Kingdom 31 32 Correspondence to: 33 Peter Konstantin Kurotschka 34 Via Genovesi 34, 09124 Cagliari 35 E-Mail [email protected] 36 Phone +393924712115 http://bmjopen.bmj.com/ 37 38 KEYWORDS: antibiotic, prescription, general practice, family medicine, appropriate, use, consumption, 39 questionnaire, knowledge, attitudes, factors, determinants. 40 41 WORD COUNT: 4000 42 43 44 on September 23, 2021 by guest. Protected copyright. 45 ABSTRACT 46 47 Introduction. The overuse of antibiotics (ABs) is causing worldwide spread of antimicrobial 48 resistance (AMR). Italy has a high consumption rate of ABs and if compared to other European 49 countries, one of the highest rates of AMR. 50 Due to the fact that around 90% of ABs are prescribed by General Practitioners (GPs), this 51 study aims to measure the impact of knowledge, attitudes and socio-demographic and 52 workplace related factors on the quality of AB prescriptions filled by GPs in the Italian Region 53 54 of Sardinia. 55 Methods and analysis. Knowledge, attitude, socio-demographic and workplace-related 56 factors deemed to influence physicians prescribing behaviour will be evaluated in a cross- 57 sectional study conducted among all GPs of the Italian Region of Sardinia (n~1200). A 58 knowledge and attitudes questionnaire (ITA-KAAR) accompanied by a socio-demographic 59 form will be linked to drug prescription data reimbursed by the National Health System 60 (NHS). European Surveillance of AB Consumption (ESAC) quality indicators for outpatient AB For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 1 BMJ Open Page 4 of 14 1 2 3 use will be calculated from drug prescription records. Every GP will be deemed to have 4 demonstrated an adequate quality of prescriptions of ABs (AQPA) if half of the indicator score BMJ Open: first published as 10.1136/bmjopen-2020-038843 on 6 July 2020.
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