title: Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research.
abstract: Neonatal infections are estimated to account for a quarter of the 2·8 million annual neonatal deaths, as well as approximately 3% of all disability-adjusted life-years. Despite this burden, few data are available on incidence, aetiology, and outcomes, particularly regarding impairment. We aimed to develop guidelines for improved scientific reporting of observational neonatal infection studies, to increase comparability and to strengthen research in this area. This checklist, Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE- NI), is an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement. STROBE-NI was developed following systematic reviews of published literature (1996-2015), compilation of more than 130 potential reporting recommendations, and circulation of a survey to relevant professionals worldwide, eliciting responses from 147 professionals from 37 countries. An international consensus meeting of 18 participants (with expertise in infectious diseases, neonatology, microbiology, epidemiology, and statistics) identified priority recommendations for reporting, additional to the STROBE statement. Implementation of these STROBE-NI recommendations, and linked checklist, aims to improve scientific reporting of neonatal infection studies, increasing data utility and allowing meta-analyses and pathogen-specific burden estimates to inform global policy and new interventions, including maternal vaccines.
authors.affiliation: MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Elizabeth J A
authors.initials: EJA
authors.lastname: Fitchett
authors.affiliation: MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK; The Farr Institute of Health Informatics Research, University College London, London, UK.
authors.forename: Anna C
authors.initials: AC
authors.lastname: Seale
authors.affiliation: Paediatric Infectious Disease Research Group, St George's University of London, London, UK.
authors.forename: Stefania
authors.initials: S
authors.lastname: Vergnano
authors.affiliation: Paediatric Infectious Disease Research Group, St George's University of London, London, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Sharland
authors.affiliation: Paediatric Infectious Disease Research Group, St George's University of London, London, UK.
authors.forename: Paul T
authors.initials: PT
authors.lastname: Heath
authors.affiliation: Child Health Research Foundation, Department of Microbiology, Dhaka Shishu Hospital, Dhaka, Bangladesh.
authors.forename: Samir K
authors.initials: SK
authors.lastname: Saha
authors.affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Agarwal
authors.affiliation: Department of Paediatrics, College Of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria.
authors.forename: Adejumoke I
authors.initials: AI
authors.lastname: Ayede
authors.affiliation: Center of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan; Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada.
authors.forename: Zulfiqar A
authors.initials: ZA
authors.lastname: Bhutta
authors.affiliation: Institute for International Programs, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Black
authors.affiliation: Medical Research Council, The Gambia Unit, Banjul, The Gambia.
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
authors.affiliation: Centre for Global Health Research, University of Edinburgh, Edinburgh, UK.
authors.forename: Harry
authors.initials: H
authors.lastname: Campbell
authors.affiliation: MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Cousens
authors.affiliation: Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Gary L
authors.initials: GL
authors.lastname: Darmstadt
authors.affiliation: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit & DST/NRF Vaccine Preventable Diseases, Faculty Health Science, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Shabir A
authors.initials: SA
authors.lastname: Madhi
authors.affiliation: Vaccines, Bill & Melinda Gates Foundation, Seattle, WA, USA.
authors.forename: Ajoke Sobanjo-Ter
authors.initials: AS
authors.lastname: Meulen
authors.affiliation: Royal College of Paediatrics and Child Health, London, UK; Department of Medicine, Section of Neonatal Medicine, Imperial College London, London, UK.
authors.forename: Neena
authors.initials: N
authors.lastname: Modi
authors.affiliation: Maternal, Newborn, and Child Health, Bill & Melinda Gates Foundation, Seattle, WA, USA.
authors.forename: Janna
authors.initials: J
authors.lastname: Patterson
authors.affiliation: Department of Maternal Newborn Child and Adolescent Health, WHO, Geneva, Switzerland.
authors.forename: Shamim
authors.initials: S
authors.lastname: Qazi
authors.affiliation: Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Schrag
authors.affiliation: Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Stoll
authors.affiliation: Saving Newborn Lives, Save the Children, Washington, DC, USA.
authors.forename: Stephen N
authors.initials: SN
authors.lastname: Wall
authors.affiliation: Department of Paediatrics, Ahmadu Bello University Teaching Hospital, Ahmadu Bello University, Zaria, Nigeria.
authors.forename: Robinson D
authors.initials: RD
authors.lastname: Wammanda
authors.affiliation: MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: joy.lawn@lshtm.ac.uk.
authors.forename: Joy E
authors.initials: JE
authors.lastname: Lawn
mesh_terms: D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D057189:Checklist; D015340:Epidemiologic Research Design; D016021:Epidemiologic Studies; D014943:Global Health; D007226:Infant Mortality; D007232:Infant, Newborn, Diseases; D019370:Observation / Q000379:methods