{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T01:09:19Z","timestamp":1790903359167,"version":"4.1.0"},"update-to":[{"DOI":"10.12688\/gatesopenres.13185.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2021,7,19]],"date-time":"2021-07-19T00:00:00Z","timestamp":1626652800000}}],"reference-count":27,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2021,7,19]],"date-time":"2021-07-19T00:00:00Z","timestamp":1626652800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1180644"],"award-info":[{"award-number":["OPP1180644"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["gatesopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Gates Open Res"],"abstract":"<ns4:p>\n                    Sepsis and meningitis due to invasive group B\n                    <ns4:italic>Streptococcus<\/ns4:italic>\n                    (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.\u00a0 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.\n                  <\/ns4:p>","DOI":"10.12688\/gatesopenres.13185.2","type":"journal-article","created":{"date-parts":[[2021,7,19]],"date-time":"2021-07-19T04:20:11Z","timestamp":1626668411000},"page":"138","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":2,"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"],"prefix":"10.12688","volume":"4","author":[{"given":"Proma","family":"Paul","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0380-1503","authenticated-orcid":false,"given":"Simon 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T03:40:16Z","timestamp":1659066016000},"score":1,"resource":{"primary":{"URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,19]]},"references-count":27,"URL":"https:\/\/doi.org\/10.12688\/gatesopenres.13185.2","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/gatesopenres.14539.r30894","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/gatesopenres.14539.r30894","asserted-by":"object"}]},"ISSN":["2572-4754"],"issn-type":[{"value":"2572-4754","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,19]]},"assertion":[{"value":"Indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.14539.r30894, David Kaslow, Essential Medicines and Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA, 26 Jul 2021, version 2, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2#referee-response-30894","order":0,"name":"referee-response-30894","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.14390.r30610, Tina Perme, Department of Perinatology, University Medical Centre Ljubljana, Ljubljana, Slovenia, 26 Apr 2021, version 1, 3 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v1#referee-response-30610","order":1,"name":"referee-response-30610","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Simon Procter<\/b>; \n<i>Posted: 26 May 2021<\/i>; We thank the reviewer for their comments. Our response to the specific points raised are below.  \n<b>(1) However, there are some ambiguities regarding inclusion and exclusion criteria which need addressing if they have not yet been sufficiently provided in the full study protocol. The researchers state that the comparison group will be matched to GBS survivors based on sex and birth month and year. However, especially in low-income settings, there are many other potentially threatening infections or diseases that can influence socio-emotional, behavioral and economic outcomes for survivors. That needs to be considered and control group potentially adjusted to account for this other possible confounding factor.<\/b>  Response: Thank you. For all study participants we collect data on prior medical history but this does not include the history of other neonatal infections. We agree that clarity on the inclusion\/exclusion criteria is fundamental, we have clarified this by revising table 2 to include definitions for unexposed (non-GBS) children and additional exclusion criteria related to gestational age. We also added the following sentence to the manuscript after the case definition:  \u201c\n<b>In Argentina, India, Kenya, and Mozambique iGBS children and GBS unexposed children born earlier than 32 weeks of gestation are excluded.&nbsp; In South Africa, gestational age is not an exclusion criterion.<\/b>\u201d  NDI that may result from other infections and disease will form part of the background risk of NDI in our study settings. While we are not collecting data on these other aetiological causes of NDI, if numbers allow we will examine the influence of other potential confounders such as prematurity, SES and maternal education using multivariable regression.  \n<b>(2) Additionally, as neurodevelopmental impairment is so differently assessed throughout the different centres, care must be taken to ensure that the outcomes provided are comparable between different study sites.<\/b>  Response: This is indeed a challenge in our study, and for most studies that aim to assess and compare diverse neurodevelopmental outcomes across settings. We highlight this in our discussion, where we say: \u201cA major challenge of this study is the use of different developmental assessment tools in each country, and the complexity of combining multi-domain and neurodevelopmental outcomes for different age bands and multiple tests.\u201d To ensure comparability as far as possible we will work with clinical experts in the individual country teams to map the different neurodevelopmental outcomes across the different tools for greater comparability. As described in the protocol, domain definitions (e.g., cognition, motor, language) will be defined following the definitions used in the Global Burden of Disease (GBD). Then clinical experts will review each of the tools to determine how the full tool or subscales within the tool best aligns with the GBD definitions. For our our analysis where we will combine data on the severity and across domains of impairments we are following a similar approach to the GBD (\n<i>Blencowe H, Vos T, Lee AC, Philips R, Lozano R, Alvarado MR, Cousens S, Lawn JE. Estimates of neonatal morbidities and disabilities at regional and global levels for 2010: introduction, methods overview, and relevant findings from the Global Burden of Disease study. Pediatr Res. 2013 Dec;74 Suppl 1(Suppl 1):4-16. doi: 10.1038\/pr.2013.203).&nbsp;<\/i>","URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v2#referee-comment-3441","order":2,"name":"referee-comment-3441","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.14390.r30611, Robert Simon Heyderman, NIHR Global Health Mucosal Pathogens Research Unit @UCL, University College London, London, UK, 28 May 2021, version 1, 3 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/4-138\/v1#referee-response-30611","order":3,"name":"referee-response-30611","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by a grant (OPP1180644) from the Bill & Melinda Gates Foundation to the London School of Hygiene & Tropical Medicine (PI, Joy Lawn). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}