Capacity Building for Primary Stroke Prevention Teams in Children Living With Sickle Cell Anemia in Africa - 27/10/21

Abstract |
Background |
Nigeria has the highest proportion of children with sickle cell anemia (SCA) globally; an estimated 150,000 infants with SCA are born annually. Primary stroke prevention in children with SCA must include Nigeria. We describe capacity-building strategies in conjunction with two National Institutes of Health–funded primary stroke prevention trials (a feasibility trial and phase III randomized controlled trial) with initial hydroxyurea treatment for children with SCA and abnormal transcranial Doppler (TCD) velocities in Nigeria. We anticipated challenges to conducting clinical trials in a low-resource setting with a local team that had not previously been involved in clinical research and sought a sustainable strategy for primary stroke prevention.
Methods |
This is a descriptive, prospective study of challenges, solutions, and research teams in two trials that enrolled a total of 679 children with SCA.
Results |
As part of the capacity-building component of the trials, over eight years, 23 research personnel (physicians, nurses, research coordinators, a statistician, and a pharmacist) completed a one-month research governance and ethics training program at Vanderbilt University Medical Center, USA. A lead research coordinator for each site completed the Society of Clinical Research Professionals certification. TCD machines were donated; radiologists and nonradiologists were trained and certified to perform TCD. A scalable E-prescription was implemented to track hydroxyurea treatment. We worked with regional government officials to support ongoing TCD-based screening and funding for hydroxyurea for children with SCA at a high risk of stroke.
Conclusions |
Our trials and capacity building demonstrate a sustainable strategy to initiate and maintain pediatric SCA primary stroke prevention programs in Africa.
Le texte complet de cet article est disponible en PDF.Keywords : Stroke prevention, Low-resource setting, Clinical research, Sickle cell anemia, Global health
Plan
| Funding: Research reported in this publication was supported by the National Institute of Neurological Disorders, United States and Stroke of the National Institutes of Health, United States Grants R21NS080639, R01NS094041, K24-HL147017, Vanderbilt Endowed Chair Funds, and philanthropic awards from the Phillips Family and Afolabi Family. The findings and conclusions in this report are those of the authors and do not necessarily represent the National Institutes of Health's official position. |
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| Author's Contributions: M.R.D., D.L.G., and L.C.J., had full access to all the data in the study and take responsibility for the integrity of the data and the data analyses' accuracy. The trials were designed by M.R.D, B.C.G., S.A., and L.C.J. The transcranial Doppler training was completed by H.B.-M., A.S., B.J.W., S.G., H.B.-M., S.A., A.S., and K.N.; L.C.J. and F.J.K. verified the strokes with video of neurological examinations; B.C.G. and D.L.G. collected and audited data integrity; M.G. and M.R.D. developed and initiated the e-prescription system at all sites; H.C., B.C.G., H.B.M., A.G., and M.R.D. were responsible for all VIRDE activities; A.A.K., A.G., and S.G. monitored the safety of the participants; B.C.G. and B.J.W. performed the analyses; M.R.D., B.C.G., S.A., L.C.J., and M.H.A. interpreted the results; and D.L.G., B.C.G., A.A.K., L.C.J., and M.R.D. wrote the manuscript. Prior to submission, all authors reviewed the manuscript. |
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| Consent for Publication: The authors agree to sign a statement attesting authorship, disclosing all potential conflicts of interest, and releasing copyright. |
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| Competing Interests: The authors declare no competing financial interests. |
Vol 125
P. 9-15 - décembre 2021 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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