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

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

143 Downloads (Pure)

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

Access to Document

10.1136/bmjopen-2017-020796Licence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

Stock_et_al_Quantitative_fibronectin_BMJ_OpenFinal published version, 659 KBLicence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

Cite this

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

@article{417f2be264534e2886279141636f3c55,

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.",

keywords = "Journal Article",

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.",

year = "2018",

month = apr,

day = "7",

doi = "10.1136/bmjopen-2017-020796",

language = "English",

volume = "8",

journal = "BMJ open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "4",

}

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

Abstract

Keywords

Access to Document

Fingerprint

Cite this