Benchmarking against the MOMS Trial: Zurich Results of Open Fetal Surgery for Spina Bifida.
Benchmarking
/ standards
Female
Fetal Therapies
/ adverse effects
Gestational Age
Humans
Male
Meningomyelocele
/ diagnostic imaging
Program Evaluation
Prospective Studies
Randomized Controlled Trials as Topic
/ standards
Registries
Spina Bifida Cystica
/ diagnostic imaging
Switzerland
Treatment Outcome
Myelomeningocele
Benchmark comparison
Fetal repair
Fetal surgery
Fetus
In utero surgery
Myeloschisis
Neural tube defect
Spina bifida
Journal
Fetal diagnosis and therapy
ISSN: 1421-9964
Titre abrégé: Fetal Diagn Ther
Pays: Switzerland
ID NLM: 9107463
Informations de publication
Date de publication:
2020
2020
Historique:
received:
13
01
2019
accepted:
01
04
2019
pubmed:
6
6
2019
medline:
18
11
2020
entrez:
6
6
2019
Statut:
ppublish
Résumé
The Management of Myelomeningocele Study, a.k.a. the MOMS trial, was published in 2011 in the New England Journal of Medicine. This prospective randomized controlled trial proved to be a milestone publication that provided definitive evidence that fetal surgery is a novel standard of care for select fetuses with spina bifida aperta (SB). The goal of our study is to assess whether our center can match these benchmark results. Our study was conducted according to the MOMS protocol using the same inclusion and exclusion criteria and looked at the same outcome parameters that were used in the MOMS trial. Zurich and MOMS results were compared. We enrolled 20 patients between December 2010 and May 2015 all of whom underwent fetal surgery for SB. Among 51 different outcome variables, there were only 3 favorable (multiplicity-adjusted) significant differences (gestational age at birth, hindbrain herniation, and psychomotor development). There were no statistically significant differences regarding any other parameters. Our findings confirm that rigorous apprenticeship, training, and comprehensive prospective data collection enable centers like the Zurich Center for Fetal Diagnosis and Therapy to achieve benchmark results for open fetal surgery for myelomeningocele and myeloschisis. These results justify the existence and continuation of our program. Outcome documentation is an essential element of quality management. It is medically and ethically fundamental for fetal medicine and surgery centers offering high-end innovative medical care.
Identifiants
pubmed: 31167195
pii: 000500049
doi: 10.1159/000500049
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
91-97Informations de copyright
© 2019 S. Karger AG, Basel.