Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III
Authors: Rasmussen Marie Isabel Skov , Hansen Mathias Lühr , Peters Colin , Greisen Gorm ,   SafeBoosC-III Trial Group, Pellicer Adelina , El-Kuffash Afif , Bargiel Agata , Alarcon Ana , Hopper Andrew , Truttmann Anita , Hergenhan Anja , Klamer Anja , Curley Anna , Heuchan Anne Marie , Smits Anne , Memisoglu Asli Cinar , Krolak-Olejnik Barbara , Rzepecka Beata , Gonzales Begona Loureiro , Yasa Beril , Urlesberger Berndt , Morales-Betancourt Catalina , Lecart Chantal , Gluud Christian , Knöepfli Claudia , Hagmann Cornelia , Healy David , Ergenekon Ebru , Hatzidaki Eleftheria , Bergon-Sendin Elena , Skylogianni Eleni , Rafinska-Wazny Elzbieta , Mastretta Emmanuele , Dempsey Eugene , Valverde Eva , Papathoma Evangelina , Mosca Fabio , Dimitriou Gabriel , Pichler Gerhard , Vento Giovanni , Hahn Gitte Holst , Naulaers Gunnar , Cheng Guoqiang , Fuchs Hans , Ozkan Hilal , De Las Cuevas Isabel , Serrano-Vinuales Itziar , Sadowska-Krawczenko Iwona , Kucera Jachym , Tkaczyk Jakub , Miletin Jan , Sirc Jan , Jakobsen Janus Christian , Baumgartner Jana , Mintzer Jonathan , De Buyst Julie , McCall Karen , Tsoni Konstantina , Sarafidis Kosmas , Bender Lars , Lopez Laura Serrano , Wang Le , Thewissen Liesbeth , Huijia Lin , Chalak Lina , Yang Ling , Cornette Luc , Arruza Luis , Wilinska Maria , Baserga Mariana , Ybarra Marta Mencia , Palacio Marta Teresa , Stocker Martin , Agosti Massimo , Cetinkaya Merih , Alsina Miguel , Fumagalli Monica , Kadri Munaf M. , Akin Mustafa Senol , Baş Münevver , Koksal Nilgun , Vaccarello Olalla Otero , Baud Olivier , Zafra Pamela , Agergaard Peter , Korcek Peter , Maton Pierre , Sanchez-Salmador Rebeca , del Rio Florentino Ruth , Lauterbach Ryszard , Borregas Salvador Piris , Nesargi Saudamini , Suna Serife , Rao Shashidhar Appaji , Zeng Shujuan , Pisoni Silvia , Hyttel-Sørensen Simon , Kersin Sinem Gulcan , Fredly Siv , Oguz Suna , Marciniak Sylwia , Karen Tanja , Szczapa Tomasz , Nordvik Tone , Karadyova Veronika , Gao Xiaoyan , Xu Xin , Vesoulis Zachary , Peng Zhang , Yin Zhaoqing 
Published: October 2024

Abstract
Background
SafeBoosC-III is a pragmatic, multinational clinical trial evaluating cerebral oximetry-guided treatment for extremely preterm infants. In total, 1601 infants were randomised across 70 sites in Asia, Europe, and USA. To enhance data quality and patient care, a web-based training program was implemented for staff. We now report on the processes.

Methods
All training modules consisted of initial learning material followed by a case-based quiz, with elaborate responses to correct as well as to wrong answers. Modules covered trial introduction, cerebral oximetry monitoring, treatment guidelines, cerebral ultrasound, and Good Clinical Practice. The introduction module was accessible in eight languages on an online platform, while language versions varied for other modules, due to different needs. Certification was earned upon module completion, relevant to the staff category. The training was not mandatory, but for motivational purposes, principal investigators continuously received local certification rate reports.

Results
A total of 926 out of 2347 staff (39%) obtained certification. Amongst 295 staff who completed the evaluation, 83% rated the program as overall good and 94% found it relevant to clinical practice. Sites exhibited varying certification rates, with 10 at 0%, 43 between 0.1 and 79.9%, and 17 exceeding 80%. There was no correlation between the rate of certification in individual sites and how often the clinical management was changed due to cerebral hypoxia nor a correlation to site-specific estimates of the intervention effect.

Conclusion
Despite language barriers and a low budget, our web-based training and certification program proved feasible. Only a minority of sites reached 80% certification of staff and an impact on the trial could not be detected.

Trial registration
The SafeBoosC-III trial is registered at ClinicalTrials.gov NCT03770741. The first participant was randomised in June 2019 and recruitment was completed in December 2021.