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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.

Amy RiddellAislinn CookNathalie KhavessianSally EllisDavide BilardiErika CorreiaTomislav KostyanevAlessandra NardoneNeal RussellTuba VilkenWolfgang StöhrBethou AdhisivamIana Rosa Alves de MoraesNawshad Uddin AhmedAdrie BekkerEitan Naaman BerezinSuppawat BoonkasidechaCristina Gardonyi CarvalheiroPrachi ChauhanSara ChiurchiùElisavet ChorafaAngela DramowskiMadhusudhan DsJinxing FengShengnan JiaYuan KongMary KyohereAngeliki KontouSorasak LochindaratMaia De LucaAripfani MphaphuliMarisa Márcia Mussi-PinhataSheila MurungaFirdose Lambey NakwaDebasish NandaErinah NassoloNgoc Thi Bin HoangChristina W ObieroLinus OlsonWang PingNishad PlakkalPriyanka PrasadKanchana PreedisripipatSheikh Wasik RahmanTiffany SeefPra-Ornsuda SukrakanchanaReenu ThomasZhang YuQiaoru ZhangA Sarah WalkerJulia BielickiPaul T HeathMichael SharlandTatiana Munera-Huertas
Published in: Antibiotics (Basel, Switzerland) (2023)
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.
Keyphrases
  • healthcare
  • randomized controlled trial
  • cardiovascular disease
  • electronic health record
  • emergency department
  • coronary artery disease
  • artificial intelligence
  • current status
  • cardiovascular events
  • septic shock