Accepted Manuscript Title: Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat prostaglandin gel Author: Michael Beckmann FRANZCOG Katharina Merollini PhD Sailesh Kumar FRCOG FRANZCOG DPhil(Oxon) Vicki Flenady PhD PII: DOI: Reference:
S0301-2115(16)30020-3 http://dx.doi.org/doi:10.1016/j.ejogrb.2016.01.041 EURO 9288
To appear in:
EURO
Received date: Accepted date:
3-1-2016 29-1-2016
Please cite this article as: BECKMANN M, Merollini K, KUMAR S, FLENADY V, Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat prostaglandin gel, European Journal of Obstetrics and Gynecology and Reproductive Biology (2016), http://dx.doi.org/10.1016/j.ejogrb.2016.01.041 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title page Full title Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat
ip t
prostaglandin gel
cr
Author Michael BECKMANN, FRANZCOG 1, 2, 3
Mater Health Services, Department of Obstetrics and Gynecology, Brisbane, Australia
2.
Mater Research Institute – The University of Queensland, Brisbane, Australia
3.
School of Medicine – The University of Queensland, Brisbane, Australia
an
us
1.
Raymond Terrace,
M
South Brisbane
+61 7 3163 1594
Ac ce p
te
[email protected]
d
Queensland 4101, Australia
Co-authors
Katharina Merollini, PhD 4 4.
Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia
Sailesh KUMAR, FRCOG FRANZCOG DPhil(Oxon) 1, 2, 3 1.
Mater Research Institute – The University of Queensland, Brisbane, Queensland, Australia
2.
Mater Health Services, Department of Obstetrics and Gynecology, Brisbane, Queensland, Australia
3.
School of Medicine – The University of Queensland, Brisbane, Australia
Vicki FLENADY, PhD 1 1.
Mater Research Institute – The University of Queensland, Brisbane, Queensland, Australia
1
Page 1 of 24
Conflict of interest The authors report no conflict of interest
Financial support
ip t
The authors gratefully acknowledge receipt of a $30,000 seeding grant from the JP Kelly Foundation
cr
Acknowledgments
us
The authors wish to thank the women and their families who participated in the study; the research midwives (Jackie Chaplin and Anne Tremellen), Tony Albuquerque and the members of the Mater Finance Department,
an
and the midwives and doctors of the Mater Mothers’ Hospitals who supported this study.
M
Word count
Ac ce p
te
Main text: 2661
d
Abstract: 277
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363946
2
Page 2 of 24
Condensation This paper presents the cost analysis of a randomized controlled trial comparing two policies of PGE2 vaginal gel induction of labor.
ip t
Short version of title
Ac ce p
te
d
M
an
us
cr
Cost analysis of PGE2 vaginal gel induction.
3
Page 3 of 24
Abstract Background In a randomized controlled trial of two policies for induction of labor (IOL) using Prostaglandin E2 (PGE2)
ip t
vaginal gel, women who had an earlier amniotomy experienced a shorter IOL-to-birth time. Objective
cr
To report the cost analysis of this trial and determine if there are differences in healthcare costs when an early
us
amniotomy is performed as opposed to giving more PGE2 vaginal gel, for women undergoing IOL at term
an
Study Design
Following an evening dose of PGE2 vaginal gel, 245 women with live singleton pregnancies, ≥37+0 weeks,
M
were randomized into an amniotomy or repeat-PGE2 group. Healthcare costs were a secondary outcome measure, sourced from hospital finance systems and included staff costs, equipment and consumables,
d
pharmacy, pathology, hotel services and business overheads. A decision analytic model, specifically a
te
Markov chain, was developed to further investigate costs, and a Monte Carlo simulation was performed to confirm the robustness of these findings. Mean and median costs and cost differences between the two
Ac ce p
groups are reported, from the hospital perspective.
Results
The healthcare costs associated with IOL were available for all 245 trial participants. A 1000-patient cohort simulation demonstrated that performing an early amniotomy was associated with a cost-saving of $AUD289 ($AUD7094 vs $AUD7338) per woman induced, compared with administering more PGE2. Propagating the uncertainty through the model 10,000 times, early amniotomy was associated with a median cost savings of $AUD487 (IQR -$AUD573, +$AUD1498).
4
Page 4 of 24
Conclusions After an initial dose of PGE2 vaginal gel, a policy of administering more PGE2 when the Modified Bishop’s score is
S0301-2115(16)30020-3 http://dx.doi.org/doi:10.1016/j.ejogrb.2016.01.041 EURO 9288
To appear in:
EURO
Received date: Accepted date:
3-1-2016 29-1-2016
Please cite this article as: BECKMANN M, Merollini K, KUMAR S, FLENADY V, Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat prostaglandin gel, European Journal of Obstetrics and Gynecology and Reproductive Biology (2016), http://dx.doi.org/10.1016/j.ejogrb.2016.01.041 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title page Full title Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat
ip t
prostaglandin gel
cr
Author Michael BECKMANN, FRANZCOG 1, 2, 3
Mater Health Services, Department of Obstetrics and Gynecology, Brisbane, Australia
2.
Mater Research Institute – The University of Queensland, Brisbane, Australia
3.
School of Medicine – The University of Queensland, Brisbane, Australia
an
us
1.
Raymond Terrace,
M
South Brisbane
+61 7 3163 1594
Ac ce p
te
[email protected]
d
Queensland 4101, Australia
Co-authors
Katharina Merollini, PhD 4 4.
Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia
Sailesh KUMAR, FRCOG FRANZCOG DPhil(Oxon) 1, 2, 3 1.
Mater Research Institute – The University of Queensland, Brisbane, Queensland, Australia
2.
Mater Health Services, Department of Obstetrics and Gynecology, Brisbane, Queensland, Australia
3.
School of Medicine – The University of Queensland, Brisbane, Australia
Vicki FLENADY, PhD 1 1.
Mater Research Institute – The University of Queensland, Brisbane, Queensland, Australia
1
Page 1 of 24
Conflict of interest The authors report no conflict of interest
Financial support
ip t
The authors gratefully acknowledge receipt of a $30,000 seeding grant from the JP Kelly Foundation
cr
Acknowledgments
us
The authors wish to thank the women and their families who participated in the study; the research midwives (Jackie Chaplin and Anne Tremellen), Tony Albuquerque and the members of the Mater Finance Department,
an
and the midwives and doctors of the Mater Mothers’ Hospitals who supported this study.
M
Word count
Ac ce p
te
Main text: 2661
d
Abstract: 277
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363946
2
Page 2 of 24
Condensation This paper presents the cost analysis of a randomized controlled trial comparing two policies of PGE2 vaginal gel induction of labor.
ip t
Short version of title
Ac ce p
te
d
M
an
us
cr
Cost analysis of PGE2 vaginal gel induction.
3
Page 3 of 24
Abstract Background In a randomized controlled trial of two policies for induction of labor (IOL) using Prostaglandin E2 (PGE2)
ip t
vaginal gel, women who had an earlier amniotomy experienced a shorter IOL-to-birth time. Objective
cr
To report the cost analysis of this trial and determine if there are differences in healthcare costs when an early
us
amniotomy is performed as opposed to giving more PGE2 vaginal gel, for women undergoing IOL at term
an
Study Design
Following an evening dose of PGE2 vaginal gel, 245 women with live singleton pregnancies, ≥37+0 weeks,
M
were randomized into an amniotomy or repeat-PGE2 group. Healthcare costs were a secondary outcome measure, sourced from hospital finance systems and included staff costs, equipment and consumables,
d
pharmacy, pathology, hotel services and business overheads. A decision analytic model, specifically a
te
Markov chain, was developed to further investigate costs, and a Monte Carlo simulation was performed to confirm the robustness of these findings. Mean and median costs and cost differences between the two
Ac ce p
groups are reported, from the hospital perspective.
Results
The healthcare costs associated with IOL were available for all 245 trial participants. A 1000-patient cohort simulation demonstrated that performing an early amniotomy was associated with a cost-saving of $AUD289 ($AUD7094 vs $AUD7338) per woman induced, compared with administering more PGE2. Propagating the uncertainty through the model 10,000 times, early amniotomy was associated with a median cost savings of $AUD487 (IQR -$AUD573, +$AUD1498).
4
Page 4 of 24
Conclusions After an initial dose of PGE2 vaginal gel, a policy of administering more PGE2 when the Modified Bishop’s score is
