Meta-Analysis

. 2018 Apr 7;8(4):e020796.

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^{1

2}, Lisa M Wotherspoon¹, Kathleen A Boyd³, Rachel K Morris⁴, Jon Dorling⁵, Lesley Jackson⁶, Manju Chandiramani⁷, Anna L David⁸, Asma Khalil⁹, Andrew Shennan¹⁰, Victoria Hodgetts Morton⁴, Tina Lavender¹¹, Khalid Khan¹², Susan Harper-Clarke¹³, Ben W Mol¹⁴, Richard D Riley¹⁵, John Norrie¹⁶, Jane E Norman¹

Affiliations

¹ Tommy's Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
² School of Women's and Infants' Health, University of Western Australia, Crawley, Western Australia, Australia.
³ Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.
⁴ School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
⁵ Neonatal Unit, Queen's Medical Centre, Nottingham, UK.
⁶ Neonatal Unit, Royal Hospital for Children Glasgow, Glasgow, UK.
⁷ Imperial College Healthcare NHS Trust, Queen Charlotte's and Chelsea Hospital, London, UK.
⁸ Institute for Women's Health, University College London Medical School, London, UK.
⁹ St. George's Medical School, University of London, London, UK.
¹⁰ Maternal and Fetal Research Unit, King's College London, London, UK.
¹¹ Centre for Global Women's Health, School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
¹² Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
¹³ N/A, Patient and Public Involvement Representative, London, UK.
¹⁴ Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.
¹⁵ Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
¹⁶ Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.

PMID: 29627817
PMCID: PMC5892771
DOI: 10.1136/bmjopen-2017-020796

Meta-Analysis

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 et al. BMJ Open. 2018.

. 2018 Apr 7;8(4):e020796.

doi: 10.1136/bmjopen-2017-020796.

Authors

Affiliations

¹ Tommy's Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
² School of Women's and Infants' Health, University of Western Australia, Crawley, Western Australia, Australia.
³ Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.
⁴ School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
⁵ Neonatal Unit, Queen's Medical Centre, Nottingham, UK.
⁶ Neonatal Unit, Royal Hospital for Children Glasgow, Glasgow, UK.
⁷ Imperial College Healthcare NHS Trust, Queen Charlotte's and Chelsea Hospital, London, UK.
⁸ Institute for Women's Health, University College London Medical School, London, UK.
⁹ St. George's Medical School, University of London, London, UK.
¹⁰ Maternal and Fetal Research Unit, King's College London, London, UK.
¹¹ Centre for Global Women's Health, School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
¹² Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
¹³ N/A, Patient and Public Involvement Representative, London, UK.
¹⁴ Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.
¹⁵ Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
¹⁶ Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.

PMID: 29627817
PMCID: PMC5892771
DOI: 10.1136/bmjopen-2017-020796

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: fetal fibronectin; health economics; individual patient data meta-analysis; pregnancy; preterm birth.

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Conflict of interest statement

Competing interests: SJS and JEN work at the University of Edinburgh, who received £1000 sponsorship from Hologic to support a meeting (Scientific Symposium Targeting Inflammation to Improve Reproductive Health across the Lifecourse (August 2017) in collaboration with The Society for Reproductive Investigation and MRC Centre for Reproductive Health). AS has in the past (over last 5 years; not in the last 3 years) received funding for expenses related to advisory board and internal staff education from Hologic. MC received sponsorship from Hologic to organise an educational teaching focusing on prediction of preterm birth at the 2017 annual meeting of the British Maternal and Fetal Medicine Society. Hologic, the makers of fFN, provided analysers and technical support for their use to sites participating in the QUIDS prospective cohort study. They have no access to the data, or other involvement in the conduct, analysis, interpretation or decision to publish the results of the study.

Figures

**Figure 1**
Flow chart illustrating the design of QUIDS study and conceptual division into part 1 and part 2. qfFN, quantitative fetal fibronectin.

See this image and copyright information in PMC

References

1. Stock SJ, Wotherspoon L, Boyd K, et al. . Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part two- prospective cohort study. BMJ Open 2018. doi: 10.1136/bmjopen-2017-020795 [Epub ahead of print]. - PMC - PubMed
1. Office for National Statistics. ONS gestation-specific infant mortality in England and Wales 2011. 2013. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/... (accessed 23 Nov 2017).
1. Information Services Division. “Births in scottish hospitals 2012”. Edinburgh national services Scotland. 2013. http://www.isdscotland.org/Health-Topics/Maternity-and-Births/Publicatio... (accessed 23 Nov 2017).
1. Kenyon SL, Taylor DJ, Tarnow-Mordi W, et al. . Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group. Lancet 2001;357:989–94. 10.1016/S0140-6736(00)04234-3 - DOI - PubMed
1. Peaceman AM, Andrews WW, Thorp JM, et al. . Fetal fibronectin as a predictor of preterm birth in patients with symptoms: a multicenter trial. Am J Obstet Gynecol 1997;177:13–18. 10.1016/S0002-9378(97)70431-9 - DOI - PubMed

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical