Challenges in the Implementation of the NeoOBS Study, a Global Pragmatic Observational Cohort Study, to Investigate the Aetiology and Management of Neonatal Sepsis in the Hospital Setting.

Autor: Riddell A; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK., Cook A; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK., Khavessian N; GARDP, 1202 Geneva, Switzerland., Ellis S; GARDP, 1202 Geneva, Switzerland., Bilardi D; Fondazione Penta ETS, 35127 Padova, Italy., Correia E; GARDP, 1202 Geneva, Switzerland., Kostyanev T; Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerpen, Belgium., Nardone A; Fondazione Penta ETS, 35127 Padova, Italy., Russell N; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK., Vilken T; Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerpen, Belgium., Stohr W; MRC Clinical Trials Unit, University College London, London WC1V 6LJ, UK., Adhisivam B; Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry 605006, India., Moraes IRA; Santa Casa de São Paulo, Sao Paulo 01221-010, Brazil., Ahmed NU; Child Health Research Foundation, Dhaka 1207, Bangladesh., Bekker A; Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town 8000, South Africa., Berezin EN; Santa Casa de São Paulo, Sao Paulo 01221-010, Brazil., Boonkasidecha S; Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand., Carvalheiro CG; Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, Brazil., Chauhan P; Department of Neonatology, Lady Hardinge Medical College and Kalawati Saran Children's Hospital, New Delhi 110001, India., Chiurchiù S; Academic Department of Pediatrics (DPUO), Infectious Disease Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy., Chorafa E; Infectious Diseases Unit, 3rd Dept Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University and Hippokration General Hospital, 546 43 Thessaloniki, Greece., Dramowski A; Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town 8000, South Africa., Ds M; Seth G. S. Medical College & KEM Hospital, Mumbai 400012, India., Feng J; Department of Neonatology, Shenzhen Children's Hospital, Shenzhen 518048, China., Jia S; Department of Neonatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100051, China., Kong Y; Clinical Laboratory, Shenzhen Children's Hospital, Shenzhen 518048, China., Kyohere M; MUJHU Research Collaboration, Kampala P.O. Box 23491, Uganda., Kontou A; 1st Neonatology Department and Neonatal Intensive Care Unit, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Hippokration General Hospital, 546 42 Thessaloniki, Greece., Lochindarat S; Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand., De Luca M; Academic Department of Pediatrics (DPUO), Infectious Disease Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy., Mphaphuli A; School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa AND Department of Paediatrics and Child Health, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg 2193, South Africa., Mussi-Pinhata MM; Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, Brazil., Murunga S; Clinical Research Department, KEMRI-Wellcome Trust Research Programme, Kilifi P.O. Box 230, Kenya., Nakwa FL; Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa., Nangia S; Department of Neonatology, Lady Hardinge Medical College and Kalawati Saran Children's Hospital, New Delhi 110001, India., Nassolo E; MUJHU Research Collaboration, Kampala P.O. Box 23491, Uganda., Hoang NTB; Department of Microbiology, Vietnam National Children's Hospital, Hanoi 100000, Vietnam., Obiero CW; Clinical Research Department, KEMRI-Wellcome Trust Research Programme, Kilifi P.O. Box 230, Kenya.; Amsterdam UMC, University of Amsterdam, Emma Children's Hospital, Department of Global Health, 1081 Amsterdam, The Netherlands., Olson L; Department of Women's and Children's Health, Karolinska institutet, Stockholm, Sweden and Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden., Ping W; Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.; Beijing Maternal and Child Health Care Hospital, Beijing 100026, China., Plakkal N; Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry 605006, India., Prasad P; Seth G. S. Medical College & KEM Hospital, Mumbai 400012, India., Preedisripipat K; Chiangrai Prachanukroh Hospital, Chiang Rai 57000, Thailand., Rahman SW; Child Health Research Foundation, Dhaka 1207, Bangladesh., Seef T; School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa AND Department of Paediatrics and Child Health, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg 2193, South Africa., Sukrakanchana PO; AMS-PHPT Research Collaboration, Chiang Mai University, Chiang Mai 50200, Thailand., Thomas R; Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa., Yu Z; Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.; Beijing Maternal and Child Health Care Hospital, Beijing 100026, China., Zhang Q; Department of Neonatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100051, China., Walker AS; MRC Clinical Trials Unit, University College London, London WC1V 6LJ, UK., Bielicki J; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK., Heath PT; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK., Sharland M; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK., Munera-Huertas T; Centre for Neonatal and Paediatric Infection, St. George's University of London, London SW17 0RE, UK.
Jazyk: angličtina
Zdroj: Antibiotics (Basel, Switzerland) [Antibiotics (Basel)] 2023 May 17; Vol. 12 (5). Date of Electronic Publication: 2023 May 17.
DOI: 10.3390/antibiotics12050923
Abstrakt: Neonatal sepsis is a significant cause of mortality and morbidity in low- and middle-income countries. To deliver high-quality data studies and inform future trials, it is crucial to understand the challenges encountered when managing global multi-centre research studies and to identify solutions that can feasibly be implemented in these settings. This paper provides an overview of the complexities faced by diverse research teams in different countries and regions, together with actions implemented to achieve pragmatic study management of a large multi-centre observational study of neonatal sepsis. We discuss specific considerations for enrolling sites with different approval processes and varied research experience, structures, and training. Implementing a flexible recruitment strategy and providing ongoing training were necessary to overcome these challenges. We emphasize the attention that must be given to designing the database and monitoring plans. Extensive data collection tools, complex databases, tight timelines, and stringent monitoring arrangements can be problematic and might put the study at risk. Finally, we discuss the complexities added when collecting and shipping isolates and the importance of having a robust central management team and interdisciplinary collaborators able to adapt easily and make swift decisions to deliver the study on time and to target. With pragmatic approaches, appropriate training, and good communication, these challenges can be overcome to deliver high-quality data from a complex study in challenging settings through a collaborative research network.
Databáze: MEDLINE