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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
- Source :
- Stock, S, Wotherspoon, L, Boyd, K, Morris, R K, Jon, D, Jackson, L, Chandiramani, M, David, A, Khalil, A, Shennan, A, Victoria, H M, Lavender, T, Khalid, K, Susan, H-C, Mol, B, Richard, R, John, N & Norman, J 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 . https://doi.org/10.1136/bmjopen-2017-020796
- Publication Year :
- 2018
- Publisher :
- BMJ Publishing Group, 2018.
-
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). 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.
- Subjects :
- R1
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Database :
- OpenAIRE
- Journal :
- Stock, S, Wotherspoon, L, Boyd, K, Morris, R K, Jon, D, Jackson, L, Chandiramani, M, David, A, Khalil, A, Shennan, A, Victoria, H M, Lavender, T, Khalid, K, Susan, H-C, Mol, B, Richard, R, John, N & Norman, J 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 . https://doi.org/10.1136/bmjopen-2017-020796
- Accession number :
- edsair.dedup.wf.001..592aa34781f914bbe5ca56b46a2090e5