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Lancet Infect Dis. 2016 Oct;16(10):e202-e213. doi: 10.1016/S1473-3099(16)30082-2. Epub 2016 Sep 12.

Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research.

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MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK.
MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK; The Farr Institute of Health Informatics Research, University College London, London, UK.
Paediatric Infectious Disease Research Group, St George's University of London, London, UK.
Child Health Research Foundation, Department of Microbiology, Dhaka Shishu Hospital, Dhaka, Bangladesh.
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
Department of Paediatrics, College Of Medicine, University of Ibadan and University College Hospital, Ibadan, Nigeria.
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.
Institute for International Programs, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Medical Research Council, The Gambia Unit, Banjul, The Gambia.
Centre for Global Health Research, University of Edinburgh, Edinburgh, UK.
Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
Medical Research Council: Respiratory and Meningeal Pathogens Research Unit & DST/NRF Vaccine Preventable Diseases, Faculty Health Science, University of the Witwatersrand, Johannesburg, South Africa.
Vaccines, Bill & Melinda Gates Foundation, Seattle, WA, USA.
Royal College of Paediatrics and Child Health, London, UK; Department of Medicine, Section of Neonatal Medicine, Imperial College London, London, UK.
Maternal, Newborn, and Child Health, Bill & Melinda Gates Foundation, Seattle, WA, USA.
Department of Maternal Newborn Child and Adolescent Health, WHO, Geneva, Switzerland.
Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.
Saving Newborn Lives, Save the Children, Washington, DC, USA.
Department of Paediatrics, Ahmadu Bello University Teaching Hospital, Ahmadu Bello University, Zaria, Nigeria.
MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK. Electronic address:


Neonatal infections are estimated to account for a quarter of the 2ยท8 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.

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