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

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.



Amy Riddell, Aislinn Cook, Nathalie Khavessian, Sally Ellis, Davide Bilardi, Erika Correia, Tomislav Kostyanev, Alessandra Nardone, Neal Russell, Tuba Vilken, Wolfgang Stohr, Bethou Adhisivam, Iana Rosa Alves de Moraes, Nawshad Uddin Ahmed, Adrie Bekker , Eitan Naaman Berezin, Suppawat Boonkasidecha, Cristina G. Carvalheiro, Prachi Chauhan, Sara Chiurchiù, Elisavet Chorafa, Angela Dramowski, Madhusudhan DS, Jinxing Feng, Shengnan Jia, Yuan Kong, Mary Kyohere, Angeliki Kontou, Sorasak Lochindarat, Maia De Luca, Aripfani Mphaphuli, Marisa M. Mussi-Pinhata, Sheila Murunga, Firdose Lambey Nakwa, Sushma Nangia, Erinah Nassolo, Ngoc Thi Bin Hoang, Christina W. Obiero, Linus Olson, Wang Ping, Nishad Plakkal, Priyanka Prasad, Kanchana Preedisripipat, Sheikh Wasik Rahman, Tiffany Seef, Pra-ornsuda Sukrakanchana, Reenu Thomas, Zhang Yu, Qiaoru Zhang, A. Sarah Walker, Julia Bielicki, Paul T. Heath, Michael Sharland and Tatiana Munera-Huertas


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