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Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa

INTRODUCTION: Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries...

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Autores principales: Garg, Charu C., Tshefu, Antoinette, Longombe, Adrien Lokangaka, Kila, Jean-Serge Ngaima, Esamai, Fabian, Gisore, Peter, Ayede, Adejumoke Idowu, Falade, Adegoke Gbadegesin, Adejuyigbe, Ebunoluwa A., Anyabolu, Chineme Henry, Wammanda, Robinson D., Hyellashelni, Joshua Daba, Yoshida, Sachiyo, Gram, Lu, Nisar, Yasir Bin, Qazi, Shamim Ahmad, Bahl, Rajiv
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959374/
https://www.ncbi.nlm.nih.gov/pubmed/33720960
http://dx.doi.org/10.1371/journal.pone.0247977
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author Garg, Charu C.
Tshefu, Antoinette
Longombe, Adrien Lokangaka
Kila, Jean-Serge Ngaima
Esamai, Fabian
Gisore, Peter
Ayede, Adejumoke Idowu
Falade, Adegoke Gbadegesin
Adejuyigbe, Ebunoluwa A.
Anyabolu, Chineme Henry
Wammanda, Robinson D.
Hyellashelni, Joshua Daba
Yoshida, Sachiyo
Gram, Lu
Nisar, Yasir Bin
Qazi, Shamim Ahmad
Bahl, Rajiv
author_facet Garg, Charu C.
Tshefu, Antoinette
Longombe, Adrien Lokangaka
Kila, Jean-Serge Ngaima
Esamai, Fabian
Gisore, Peter
Ayede, Adejumoke Idowu
Falade, Adegoke Gbadegesin
Adejuyigbe, Ebunoluwa A.
Anyabolu, Chineme Henry
Wammanda, Robinson D.
Hyellashelni, Joshua Daba
Yoshida, Sachiyo
Gram, Lu
Nisar, Yasir Bin
Qazi, Shamim Ahmad
Bahl, Rajiv
author_sort Garg, Charu C.
collection PubMed
description INTRODUCTION: Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0–59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens. METHODS: Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made. RESULTS: The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4–25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4–23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs. CONCLUSION: Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality. CLINICAL TRIAL REGISTRATION: The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.
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spelling pubmed-79593742021-03-25 Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa Garg, Charu C. Tshefu, Antoinette Longombe, Adrien Lokangaka Kila, Jean-Serge Ngaima Esamai, Fabian Gisore, Peter Ayede, Adejumoke Idowu Falade, Adegoke Gbadegesin Adejuyigbe, Ebunoluwa A. Anyabolu, Chineme Henry Wammanda, Robinson D. Hyellashelni, Joshua Daba Yoshida, Sachiyo Gram, Lu Nisar, Yasir Bin Qazi, Shamim Ahmad Bahl, Rajiv PLoS One Research Article INTRODUCTION: Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0–59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens. METHODS: Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made. RESULTS: The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4–25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4–23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs. CONCLUSION: Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality. CLINICAL TRIAL REGISTRATION: The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044. Public Library of Science 2021-03-15 /pmc/articles/PMC7959374/ /pubmed/33720960 http://dx.doi.org/10.1371/journal.pone.0247977 Text en © 2021 World Health Organization http://creativecommons.org/licenses/by/3.0/igo/ Licensee Public Library of Science. This is an open access article distributed under the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Garg, Charu C.
Tshefu, Antoinette
Longombe, Adrien Lokangaka
Kila, Jean-Serge Ngaima
Esamai, Fabian
Gisore, Peter
Ayede, Adejumoke Idowu
Falade, Adegoke Gbadegesin
Adejuyigbe, Ebunoluwa A.
Anyabolu, Chineme Henry
Wammanda, Robinson D.
Hyellashelni, Joshua Daba
Yoshida, Sachiyo
Gram, Lu
Nisar, Yasir Bin
Qazi, Shamim Ahmad
Bahl, Rajiv
Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa
title Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa
title_full Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa
title_fullStr Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa
title_full_unstemmed Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa
title_short Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa
title_sort costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: results from randomized trials in africa
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959374/
https://www.ncbi.nlm.nih.gov/pubmed/33720960
http://dx.doi.org/10.1371/journal.pone.0247977
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