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

Stock, S. J. et al. (2018) 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. (doi: 10.1136/bmjopen-2017-020796) (PMID:29627817) (PMCID:PMC5892771)

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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 and analysis: 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).

Item Type:Articles
Additional Information: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).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Boyd, Dr Kathleen
Authors: Stock, S. J., Wotherspoon, L. M., Boyd, K. A., Morris, R. K., Dorling, J., Jackson, L., Chandiramani, M., David, A. L., Khalil, A., Shennan, A., Hodgetts Morton, V., Lavender, T., Khan, K., Harper-Clarke, S., Mol, B. W., Riley, R. D., Norrie, J., and Norman, J. E.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:07 April 2018
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in BMJ Open 8(4):e020796
Publisher Policy:Reproduced under a Creative Commons License

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