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. |
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| Authors: | 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 |
| Source: | PLoS ONE; 3/15/2021, p1-20, 20p |
| Subject Terms: | COST control, BACTERIAL diseases, CLINICAL trial registries, INVESTIGATIONAL therapies, NEONATAL infections, NEONATAL mortality, MEDICAL communication |
| Geographic Terms: | KENYA, NIGERIA |
| Abstract: | 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. [ABSTRACT FROM AUTHOR] |
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| Database: | Complementary Index |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Garg%2C+Charu+C%2E%22">Garg, Charu C.</searchLink><br /><searchLink fieldCode="AR" term="%22Tshefu%2C+Antoinette%22">Tshefu, Antoinette</searchLink><br /><searchLink fieldCode="AR" term="%22Longombe%2C+Adrien+Lokangaka%22">Longombe, Adrien Lokangaka</searchLink><br /><searchLink fieldCode="AR" term="%22Kila%2C+Jean-Serge+Ngaima%22">Kila, Jean-Serge Ngaima</searchLink><br /><searchLink fieldCode="AR" term="%22Esamai%2C+Fabian%22">Esamai, Fabian</searchLink><br /><searchLink fieldCode="AR" term="%22Gisore%2C+Peter%22">Gisore, Peter</searchLink><br /><searchLink fieldCode="AR" term="%22Ayede%2C+Adejumoke+Idowu%22">Ayede, Adejumoke Idowu</searchLink><br /><searchLink fieldCode="AR" term="%22Falade%2C+Adegoke+Gbadegesin%22">Falade, Adegoke Gbadegesin</searchLink><br /><searchLink fieldCode="AR" term="%22Adejuyigbe%2C+Ebunoluwa+A%2E%22">Adejuyigbe, Ebunoluwa A.</searchLink><br /><searchLink fieldCode="AR" term="%22Anyabolu%2C+Chineme+Henry%22">Anyabolu, Chineme Henry</searchLink><br /><searchLink fieldCode="AR" term="%22Wammanda%2C+Robinson+D%2E%22">Wammanda, Robinson D.</searchLink><br /><searchLink fieldCode="AR" term="%22Hyellashelni%2C+Joshua+Daba%22">Hyellashelni, Joshua Daba</searchLink><br /><searchLink fieldCode="AR" term="%22Yoshida%2C+Sachiyo%22">Yoshida, Sachiyo</searchLink><br /><searchLink fieldCode="AR" term="%22Gram%2C+Lu%22">Gram, Lu</searchLink><br /><searchLink fieldCode="AR" term="%22Nisar%2C+Yasir+Bin%22">Nisar, Yasir Bin</searchLink><br /><searchLink fieldCode="AR" term="%22Qazi%2C+Shamim+Ahmad%22">Qazi, Shamim Ahmad</searchLink><br /><searchLink fieldCode="AR" term="%22Bahl%2C+Rajiv%22">Bahl, Rajiv</searchLink> – Name: TitleSource Label: Source Group: Src Data: PLoS ONE; 3/15/2021, p1-20, 20p – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22COST+control%22">COST control</searchLink><br /><searchLink fieldCode="DE" term="%22BACTERIAL+diseases%22">BACTERIAL diseases</searchLink><br /><searchLink fieldCode="DE" term="%22CLINICAL+trial+registries%22">CLINICAL trial registries</searchLink><br /><searchLink fieldCode="DE" term="%22INVESTIGATIONAL+therapies%22">INVESTIGATIONAL therapies</searchLink><br /><searchLink fieldCode="DE" term="%22NEONATAL+infections%22">NEONATAL infections</searchLink><br /><searchLink fieldCode="DE" term="%22NEONATAL+mortality%22">NEONATAL mortality</searchLink><br /><searchLink fieldCode="DE" term="%22MEDICAL+communication%22">MEDICAL communication</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22KENYA%22">KENYA</searchLink><br /><searchLink fieldCode="DE" term="%22NIGERIA%22">NIGERIA</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of PLoS ONE is the property of Public Library of Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1371/journal.pone.0247977 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 20 StartPage: 1 Subjects: – SubjectFull: KENYA Type: general – SubjectFull: NIGERIA Type: general – SubjectFull: COST control Type: general – SubjectFull: BACTERIAL diseases Type: general – SubjectFull: CLINICAL trial registries Type: general – SubjectFull: INVESTIGATIONAL therapies Type: general – SubjectFull: NEONATAL infections Type: general – SubjectFull: NEONATAL mortality Type: general – SubjectFull: MEDICAL communication Type: general Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Garg, Charu C. – PersonEntity: Name: NameFull: Tshefu, Antoinette – PersonEntity: Name: NameFull: Longombe, Adrien Lokangaka – PersonEntity: Name: NameFull: Kila, Jean-Serge Ngaima – PersonEntity: Name: NameFull: Esamai, Fabian – PersonEntity: Name: NameFull: Gisore, Peter – PersonEntity: Name: NameFull: Ayede, Adejumoke Idowu – PersonEntity: Name: NameFull: Falade, Adegoke Gbadegesin – PersonEntity: Name: NameFull: Adejuyigbe, Ebunoluwa A. – PersonEntity: Name: NameFull: Anyabolu, Chineme Henry – PersonEntity: Name: NameFull: Wammanda, Robinson D. – PersonEntity: Name: NameFull: Hyellashelni, Joshua Daba – PersonEntity: Name: NameFull: Yoshida, Sachiyo – PersonEntity: Name: NameFull: Gram, Lu – PersonEntity: Name: NameFull: Nisar, Yasir Bin – PersonEntity: Name: NameFull: Qazi, Shamim Ahmad – PersonEntity: Name: NameFull: Bahl, Rajiv IsPartOfRelationships: – BibEntity: Dates: – D: 15 M: 03 Text: 3/15/2021 Type: published Y: 2021 Identifiers: – Type: issn-print Value: 19326203 Titles: – TitleFull: PLoS ONE Type: main |
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