Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations]
Sepsis and meningitis due to invasive group B Streptococcus (iGBS) disease during early infancy is a leading cause of child mortality. Recent systematic estimates of the worldwide burden of GBS suggested that there are 319,000 cases of infant iGBS disease each year, and an estimated 147,000 stillbir...
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F1000 Research Ltd
2021-07-01
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Series: | Gates Open Research |
Online Access: | https://gatesopenresearch.org/articles/4-138/v2 |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Proma Paul Simon R. Procter Ziyaad Dangor Quique Bassat Amina Abubakar Sridhar Santhanam Romina Libster Bronner P. Gonçalves Shabir A. Madhi Azucena Bardají Eva Mwangome Adam Mabrouk Hima B. John Clara Sánchez Yanotti Jaya Chandna Pamela Sithole Humberto Mucasse Patrick V. Katana Artemis Koukounari Lois M. Harden Celine Aerts Azra Ghoor Shannon Leahy Sibongile Mbatha Sarah Lowick Sanjay G. Lala Justina Bramugy Charles Newton A. K. M. Tanvir Hossain Qazi Sadeq-ur Rahman Philipp Lambach Mark Jit Joy E. Lawn |
spellingShingle |
Proma Paul Simon R. Procter Ziyaad Dangor Quique Bassat Amina Abubakar Sridhar Santhanam Romina Libster Bronner P. Gonçalves Shabir A. Madhi Azucena Bardají Eva Mwangome Adam Mabrouk Hima B. John Clara Sánchez Yanotti Jaya Chandna Pamela Sithole Humberto Mucasse Patrick V. Katana Artemis Koukounari Lois M. Harden Celine Aerts Azra Ghoor Shannon Leahy Sibongile Mbatha Sarah Lowick Sanjay G. Lala Justina Bramugy Charles Newton A. K. M. Tanvir Hossain Qazi Sadeq-ur Rahman Philipp Lambach Mark Jit Joy E. Lawn Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations] Gates Open Research |
author_facet |
Proma Paul Simon R. Procter Ziyaad Dangor Quique Bassat Amina Abubakar Sridhar Santhanam Romina Libster Bronner P. Gonçalves Shabir A. Madhi Azucena Bardají Eva Mwangome Adam Mabrouk Hima B. John Clara Sánchez Yanotti Jaya Chandna Pamela Sithole Humberto Mucasse Patrick V. Katana Artemis Koukounari Lois M. Harden Celine Aerts Azra Ghoor Shannon Leahy Sibongile Mbatha Sarah Lowick Sanjay G. Lala Justina Bramugy Charles Newton A. K. M. Tanvir Hossain Qazi Sadeq-ur Rahman Philipp Lambach Mark Jit Joy E. Lawn |
author_sort |
Proma Paul |
title |
Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations] |
title_short |
Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations] |
title_full |
Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations] |
title_fullStr |
Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations] |
title_full_unstemmed |
Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations] |
title_sort |
quantifying long-term health and economic outcomes for survivors of group b streptococcus invasive disease in infancy: protocol of a multi-country study in argentina, india, kenya, mozambique and south africa [version 2; peer review: 1 approved, 2 approved with reservations] |
publisher |
F1000 Research Ltd |
series |
Gates Open Research |
issn |
2572-4754 |
publishDate |
2021-07-01 |
description |
Sepsis and meningitis due to invasive group B Streptococcus (iGBS) disease during early infancy is a leading cause of child mortality. Recent systematic estimates of the worldwide burden of GBS suggested that there are 319,000 cases of infant iGBS disease each year, and an estimated 147,000 stillbirths and young-infant deaths, with the highest burden occurring in Sub-Saharan Africa. The following priority data gaps were highlighted: (1) long-term outcome data after infant iGBS, including mild disability, to calculate quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs) and (2) economic burden for iGBS survivors and their families. Geographic data gaps were also noted with few studies from low- and middle- income countries (LMIC), where the GBS burden is estimated to be the highest. In this paper we present the protocol for a multi-country matched cohort study designed to estimate the risk of long-term neurodevelopmental impairment (NDI), socioemotional behaviors, and economic outcomes for children who survive invasive GBS disease in Argentina, India, Kenya, Mozambique, and South Africa. Children will be identified from health demographic surveillance systems, hospital records, and among participants of previous epidemiological studies. The children will be aged between 18 months to 17 years. A tablet-based custom-designed application will be used to capture data from direct assessment of the child and interviews with the main caregiver. In addition, a parallel sub-study will prospectively measure the acute costs of hospitalization due to neonatal sepsis or meningitis, irrespective of underlying etiology. In summary, these data are necessary to characterize the consequences of iGBS disease and enable the advancement of effective strategies for survivors to reach their developmental and economic potential. In particular, our study will inform the development of a full public health value proposition on maternal GBS immunization that is being coordinated by the World Health Organization. |
url |
https://gatesopenresearch.org/articles/4-138/v2 |
work_keys_str_mv |
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doaj-56e43a91edb541a49cb16da0c9cd57232021-08-02T16:41:48ZengF1000 Research LtdGates Open Research2572-47542021-07-01410.12688/gatesopenres.13185.214539Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa [version 2; peer review: 1 approved, 2 approved with reservations]Proma Paul0Simon R. Procter1Ziyaad Dangor2Quique Bassat3Amina Abubakar4Sridhar Santhanam5Romina Libster6Bronner P. Gonçalves7Shabir A. Madhi8Azucena Bardají9Eva Mwangome10Adam Mabrouk11Hima B. John12Clara Sánchez Yanotti13Jaya Chandna14Pamela Sithole15Humberto Mucasse16Patrick V. Katana17Artemis Koukounari18Lois M. Harden19Celine Aerts20Azra Ghoor21Shannon Leahy22Sibongile Mbatha23Sarah Lowick24Sanjay G. Lala25Justina Bramugy26Charles Newton27A. K. M. Tanvir Hossain28Qazi Sadeq-ur Rahman29Philipp Lambach30Mark Jit31Joy E. Lawn32Maternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UKMaternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UKMedical Research Council: Vaccines and Infectious Diseases Analytical Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, SpainNeuroscience Research Group, Department of Clinical Sciences, KEMRI-Wellcome Trust, Kilifi, KenyaNeonatology Department, Christian Medical College, Vellore, IndiaFundación INFANT, Buenos Aires, ArgentinaMaternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UKMedical Research Council: Vaccines and Infectious Diseases Analytical Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, SpainNeuroscience Research Group, Department of Clinical Sciences, KEMRI-Wellcome Trust, Kilifi, KenyaNeuroscience Research Group, Department of Clinical Sciences, KEMRI-Wellcome Trust, Kilifi, KenyaNeonatology Department, Christian Medical College, Vellore, IndiaFundación INFANT, Buenos Aires, ArgentinaMaternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UKMedical Research Council: Vaccines and Infectious Diseases Analytical Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaCentro de Investigação em Saúde de Manhiça (CISM), Maputo, MozambiqueNeuroscience Research Group, Department of Clinical Sciences, KEMRI-Wellcome Trust, Kilifi, KenyaMaternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UKBrain Function Research Group, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, SpainDepartment of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaDepartment of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaCentro de Investigação em Saúde de Manhiça (CISM), Maputo, MozambiqueNeuroscience Research Group, Department of Clinical Sciences, KEMRI-Wellcome Trust, Kilifi, KenyaMaternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, BangladeshMaternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, BangladeshDepartment of Immunization, Vaccines and Biologicals (IVB), World Health Organization, Geneva, SwitzerlandDepartment of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UKMaternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UKSepsis and meningitis due to invasive group B Streptococcus (iGBS) disease during early infancy is a leading cause of child mortality. Recent systematic estimates of the worldwide burden of GBS suggested that there are 319,000 cases of infant iGBS disease each year, and an estimated 147,000 stillbirths and young-infant deaths, with the highest burden occurring in Sub-Saharan Africa. The following priority data gaps were highlighted: (1) long-term outcome data after infant iGBS, including mild disability, to calculate quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs) and (2) economic burden for iGBS survivors and their families. Geographic data gaps were also noted with few studies from low- and middle- income countries (LMIC), where the GBS burden is estimated to be the highest. In this paper we present the protocol for a multi-country matched cohort study designed to estimate the risk of long-term neurodevelopmental impairment (NDI), socioemotional behaviors, and economic outcomes for children who survive invasive GBS disease in Argentina, India, Kenya, Mozambique, and South Africa. Children will be identified from health demographic surveillance systems, hospital records, and among participants of previous epidemiological studies. The children will be aged between 18 months to 17 years. A tablet-based custom-designed application will be used to capture data from direct assessment of the child and interviews with the main caregiver. In addition, a parallel sub-study will prospectively measure the acute costs of hospitalization due to neonatal sepsis or meningitis, irrespective of underlying etiology. In summary, these data are necessary to characterize the consequences of iGBS disease and enable the advancement of effective strategies for survivors to reach their developmental and economic potential. In particular, our study will inform the development of a full public health value proposition on maternal GBS immunization that is being coordinated by the World Health Organization.https://gatesopenresearch.org/articles/4-138/v2 |