Quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 1: Individual participant data meta-analysis and health economic analysis.
BMJ Open
; 8(4): e020796, 2018 04 07.
Article
en En
| MEDLINE
| ID: mdl-29627817
ABSTRACT
INTRODUCTION:
The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (qfFN) concentration, in combination with clinical risk factors. METHODS ANDANALYSIS:
The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts) which quantifies fFN in a vaginal swab. In part 1 of the study, we will develop and internally validate a prognostic model using an individual participant data (IPD) meta-analysis of existing studies containing women with symptoms of preterm labour alongside fFN measurements and pregnancy outcome. An economic analysis will be undertaken to assess potential cost-effectiveness of the qfFN prognostic model. The primary endpoint will be the ability of the prognostic model to rule out spontaneous preterm birth within 7 days. Six eligible studies were identified by systematic review of the literature and five agreed to provide their IPD (n=5 studies, 1783 women and 139 events of preterm delivery within 7 days of testing). ETHICS AND DISSEMINATION The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068). PROSPERO REGISTRATION NUMBER CRD42015027590. VERSION Protocol version 2, date 1 November 2016.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fibronectinas
/
Sistemas de Apoyo a Decisiones Clínicas
/
Feto
/
Trabajo de Parto Prematuro
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Health_economic_evaluation
/
Health_technology_assessment
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
/
Systematic_reviews
Aspecto:
Ethics
Límite:
Female
/
Humans
/
Newborn
/
Pregnancy
País/Región como asunto:
America do norte
/
Europa
Idioma:
En
Revista:
BMJ Open
Año:
2018
Tipo del documento:
Article
País de afiliación:
Reino Unido