TY - JOUR
T1 - Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM):
T2 - a trial-based and model-based cost-effectiveness analysis from a stepped wedge, cluster-randomised trial
AU - Camacho, Elizabeth M
AU - Whyte, Sonia
AU - Stock, Sarah J E
AU - Weir, Christopher J
AU - Norman, Jane Elizabeth
AU - Heazell, Alexander E P
N1 - Funding Information:
The authors would like to acknowledge the support of the electronic Data Research and Innovation Service (eDRIS) Team (Public Health Scotland) for their involvement in obtaining approvals, provisioning and linking data and the use of the secure analytical platform within the National Safe Haven. We thank the Trial Steering Committee, Principal Investigators, Midwives, R&D offices, and trial participants from each site.
Funding Information:
The AFFIRM economic evaluation was funded by SANDS (grant number: RF 515/18) and Tommy’s charities. The funder had no direct involvement in conducting the research or writing the paper. CJW was also supported in this work by NHS Lothian via the Edinburgh Clinical Trials Unit.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/3/22
Y1 - 2022/3/22
N2 - BACKGROUND: The AFFIRM intervention aimed to reduce stillbirth and neonatal deaths by increasing awareness of reduced fetal movements (RFM) and implementing a care pathway when women present with RFM. Although there is uncertainty regarding the clinical effectiveness of the intervention, the aim of this analysis was to evaluate the cost-effectiveness.METHODS: A stepped-wedge, cluster-randomised trial was conducted in thirty-three hospitals in the United Kingdom (UK) and Ireland. All women giving birth at the study sites during the analysis period were included in the study. The costs associated with implementing the intervention were estimated from audits of RFM attendances and electronic healthcare records. Trial data were used to estimate a cost per stillbirth prevented was for AFFIRM versus standard care. A decision analytic model was used to estimate the costs and number of perinatal deaths (stillbirths + early neonatal deaths) prevented if AFFIRM were rolled out across Great Britain for one year. Key assumptions were explored in sensitivity analyses.RESULTS: Direct costs to implement AFFIRM were an estimated £95,126 per 1,000 births. Compared to standard care, the cost per stillbirth prevented was estimated to be between £86,478 and being dominated (higher costs, no benefit). The estimated healthcare budget impact of implementing AFFIRM across Great Britain was a cost increase of £61,851,400/year.CONCLUSIONS: Perinatal deaths are relatively rare events in the UK which can increase uncertainty in economic evaluations. This evaluation estimated a plausible range of costs to prevent baby deaths which can inform policy decisions in maternity services.TRIAL REGISTRATION: The trial was registered with www.CLINICALTRIALS: gov , number NCT01777022 .
AB - BACKGROUND: The AFFIRM intervention aimed to reduce stillbirth and neonatal deaths by increasing awareness of reduced fetal movements (RFM) and implementing a care pathway when women present with RFM. Although there is uncertainty regarding the clinical effectiveness of the intervention, the aim of this analysis was to evaluate the cost-effectiveness.METHODS: A stepped-wedge, cluster-randomised trial was conducted in thirty-three hospitals in the United Kingdom (UK) and Ireland. All women giving birth at the study sites during the analysis period were included in the study. The costs associated with implementing the intervention were estimated from audits of RFM attendances and electronic healthcare records. Trial data were used to estimate a cost per stillbirth prevented was for AFFIRM versus standard care. A decision analytic model was used to estimate the costs and number of perinatal deaths (stillbirths + early neonatal deaths) prevented if AFFIRM were rolled out across Great Britain for one year. Key assumptions were explored in sensitivity analyses.RESULTS: Direct costs to implement AFFIRM were an estimated £95,126 per 1,000 births. Compared to standard care, the cost per stillbirth prevented was estimated to be between £86,478 and being dominated (higher costs, no benefit). The estimated healthcare budget impact of implementing AFFIRM across Great Britain was a cost increase of £61,851,400/year.CONCLUSIONS: Perinatal deaths are relatively rare events in the UK which can increase uncertainty in economic evaluations. This evaluation estimated a plausible range of costs to prevent baby deaths which can inform policy decisions in maternity services.TRIAL REGISTRATION: The trial was registered with www.CLINICALTRIALS: gov , number NCT01777022 .
KW - Awareness
KW - Cost-Benefit Analysis
KW - Critical Pathways
KW - Decision Support Techniques
KW - Female
KW - Fetal Movement
KW - Health Care Costs
KW - Health Personnel/education
KW - Humans
KW - Ireland
KW - Northern Ireland
KW - Patient Education as Topic
KW - Perinatal Death/prevention & control
KW - Pregnancy
KW - Pregnant Women/education
KW - Prenatal Care/economics
KW - Stillbirth
KW - United Kingdom
U2 - 10.1186/s12884-022-04563-9
DO - 10.1186/s12884-022-04563-9
M3 - Article
C2 - 35317772
SN - 1471-2393
VL - 22
JO - BMC pregnancy and childbirth
JF - BMC pregnancy and childbirth
M1 - 235
ER -