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Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2024年10月23日

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

摘要

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.