Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial.


Journal

The Lancet. Global health
ISSN: 2214-109X
Titre abrégé: Lancet Glob Health
Pays: England
ID NLM: 101613665

Informations de publication

Date de publication:
09 2019
Historique:
received: 11 02 2019
revised: 13 06 2019
accepted: 14 06 2019
entrez: 13 8 2019
pubmed: 14 8 2019
medline: 27 5 2020
Statut: ppublish

Résumé

There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in low-income countries. We did an incremental cost-effectiveness analysis using data from 3412 women recruited to the AIMS trial, a randomised, double-blind, placebo-controlled trial designed to evaluate the effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in Malawi, Pakistan, Tanzania, and Uganda. Economic evaluation was done from a health-care-provider perspective on the basis of the outcome of cost per pelvic infection avoided within 2 weeks of surgery. Pelvic infection was broadly defined by the presence of clinical features or the clinically identified need to administer antibiotics. We used non-parametric bootstrapping and multilevel random effects models to estimate incremental mean costs and outcomes. Decision uncertainty was shown via cost-effectiveness acceptability frontiers. The AIMS trial is registered with the ISRCTN registry, number ISRCTN97143849. Between June 2, 2014, and April 26, 2017, 3412 women were assigned to receive either antibiotic prophylaxis (1705 [50%] of 3412) or placebo (1707 [50%] of 3412) in the AIMS trial. 158 (5%) of 3412 women developed pelvic infection within 2 weeks of surgery, of whom 68 (43%) were in the antibiotic prophylaxis group and 90 (57%) in the placebo group. There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided. In terms of post-surgery antibiotics, the antibiotic prophylaxis group was US$0·27 (95% CI -0·49 to -0·05) less expensive per woman than the placebo group. A secondary analysis, a sensitivity analysis, and all subgroup analyses supported these findings. Antibiotic prophylaxis, if implemented routinely before miscarriage surgery, could translate to an annual total cost saving of up to $1·4 million across the four participating countries and up to $8·5 million across the two regions of sub-Saharan Africa and south Asia. Antibiotic prophylaxis is more effective and less expensive than no antibiotic prophylaxis. Policy makers in various settings should be confident that antibiotic prophylaxis in miscarriage surgery is cost-effective. UK Medical Research Council, Wellcome Trust, and the UK Department for International Development.

Sections du résumé

BACKGROUND
There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in low-income countries.
METHODS
We did an incremental cost-effectiveness analysis using data from 3412 women recruited to the AIMS trial, a randomised, double-blind, placebo-controlled trial designed to evaluate the effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in Malawi, Pakistan, Tanzania, and Uganda. Economic evaluation was done from a health-care-provider perspective on the basis of the outcome of cost per pelvic infection avoided within 2 weeks of surgery. Pelvic infection was broadly defined by the presence of clinical features or the clinically identified need to administer antibiotics. We used non-parametric bootstrapping and multilevel random effects models to estimate incremental mean costs and outcomes. Decision uncertainty was shown via cost-effectiveness acceptability frontiers. The AIMS trial is registered with the ISRCTN registry, number ISRCTN97143849.
FINDINGS
Between June 2, 2014, and April 26, 2017, 3412 women were assigned to receive either antibiotic prophylaxis (1705 [50%] of 3412) or placebo (1707 [50%] of 3412) in the AIMS trial. 158 (5%) of 3412 women developed pelvic infection within 2 weeks of surgery, of whom 68 (43%) were in the antibiotic prophylaxis group and 90 (57%) in the placebo group. There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided. In terms of post-surgery antibiotics, the antibiotic prophylaxis group was US$0·27 (95% CI -0·49 to -0·05) less expensive per woman than the placebo group. A secondary analysis, a sensitivity analysis, and all subgroup analyses supported these findings. Antibiotic prophylaxis, if implemented routinely before miscarriage surgery, could translate to an annual total cost saving of up to $1·4 million across the four participating countries and up to $8·5 million across the two regions of sub-Saharan Africa and south Asia.
INTERPRETATION
Antibiotic prophylaxis is more effective and less expensive than no antibiotic prophylaxis. Policy makers in various settings should be confident that antibiotic prophylaxis in miscarriage surgery is cost-effective.
FUNDING
UK Medical Research Council, Wellcome Trust, and the UK Department for International Development.

Identifiants

pubmed: 31402008
pii: S2214-109X(19)30336-5
doi: 10.1016/S2214-109X(19)30336-5
pmc: PMC6695526
pii:
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1280-e1286

Subventions

Organisme : World Health Organization
ID : 001
Pays : International
Organisme : Medical Research Council
ID : MR/K007408/1
Pays : United Kingdom

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

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Auteurs

Ilias Goranitis (I)

Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

David M Lissauer (DM)

Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.

Arri Coomarasamy (A)

Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.

Amie Wilson (A)

Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Jane Daniels (J)

School of Health Sciences, University of Nottingham, UK.

Lee Middleton (L)

Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Jonathan Bishop (J)

Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Catherine A Hewitt (CA)

Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Andrew D Weeks (AD)

Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

Chisale Mhango (C)

College of Medicine, Department of Obstetrics and Gynaecology, Blantyre, Malawi.

Ronald Mataya (R)

College of Medicine, Department of Obstetrics and Gynaecology, Blantyre, Malawi.

Iffat Ahmed (I)

The Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan.

Olufemi T Oladapo (OT)

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Javier Zamora (J)

Hospital Universitario Ramón y Cajal, CIBER en Epidemiología y Salud Pública (CIBERESP) and Instituto de Investigación Sanitaria (IRYCIS), Madrid, Spain.

Tracy E Roberts (TE)

Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. Electronic address: t.e.roberts@bham.ac.uk.

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Classifications MeSH