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

Sarah J Stock; Lisa M Wotherspoon; Kathleen A Boyd; Rachel K Morris; Jon Dorling; Lesley Jackson; Manju Chandiramani; Anna L David; Asma Khalil; Andrew Shennan; Victoria Hodgetts Morton; Tina Lavender; Khalid Khan; Susan Harper-Clarke; Ben W Mol; Richard D Riley; John Norrie; Jane E Norman

doi:10.1136/bmjopen-2017-020796

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

Sarah J Stock, Lisa M Wotherspoon, Kathleen A Boyd, Rachel K Morris, Jon Dorling, Lesley Jackson, Manju Chandiramani, Anna L David, Asma Khalil, Andrew Shennan, Victoria Hodgetts Morton, Tina Lavender, Khalid Khan, Susan Harper-Clarke, Ben W Mol, Richard D Riley, John Norrie, Jane E Norman

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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).

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.

Original language	English
Article number	e020796
Journal	BMJ open
Volume	8
Issue number	4
DOIs	https://doi.org/10.1136/bmjopen-2017-020796
Publication status	Published - 7 Apr 2018

Keywords

Journal Article

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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., & Norman, J. E. (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), Article e020796. https://doi.org/10.1136/bmjopen-2017-020796

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title = "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",

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.",

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author = "Stock, {Sarah J} and Wotherspoon, {Lisa M} and Boyd, {Kathleen A} and Morris, {Rachel K} and Jon Dorling and Lesley Jackson and Manju Chandiramani and David, {Anna L} and Asma Khalil and Andrew Shennan and {Hodgetts Morton}, Victoria and Tina Lavender and Khalid Khan and Susan Harper-Clarke and Mol, {Ben W} and Riley, {Richard D} and John Norrie and Norman, {Jane E}",

note = "{\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",

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Stock, SJ, Wotherspoon, LM, Boyd, KA, Morris, RK, Dorling, J, Jackson, L, Chandiramani, M, David, AL, Khalil, A, Shennan, A, Hodgetts Morton, V, Lavender, T, Khan, K, Harper-Clarke, S, Mol, BW, Riley, RD, Norrie, J & Norman, JE 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, vol. 8, no. 4, e020796. https://doi.org/10.1136/bmjopen-2017-020796

TY - JOUR

T1 - Quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 1

T2 - Individual participant data meta-analysis and health economic analysis

AU - Stock, Sarah J

AU - Wotherspoon, Lisa M

AU - Boyd, Kathleen A

AU - Morris, Rachel K

AU - Dorling, Jon

AU - Jackson, Lesley

AU - Chandiramani, Manju

AU - David, Anna L

AU - Khalil, Asma

AU - Shennan, Andrew

AU - Hodgetts Morton, Victoria

AU - Lavender, Tina

AU - Khan, Khalid

AU - Harper-Clarke, Susan

AU - Mol, Ben W

AU - Riley, Richard D

AU - Norrie, John

AU - Norman, Jane E

PY - 2018/4/7

Y1 - 2018/4/7

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1136/bmjopen-2017-020796

DO - 10.1136/bmjopen-2017-020796

M3 - Article

C2 - 29627817

SN - 2044-6055

VL - 8

JO - BMJ open

JF - BMJ open

IS - 4

M1 - e020796

ER -

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

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