Janneke van 't Hooft1, James M N Duffy, Mandy Daly, Paula R Williamson, Shireen Meher, Elizabeth Thom, George R Saade, Zarko Alfirevic, Ben Willem J Mol, Khalid S Khan. 1. Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, the Netherlands; the Irish Neonatal Health Alliance, Wicklow, Ireland; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, and Liverpool Women's Hospital, Liverpool, and Imperial College Health Care NHS Trust, Queen Charlotte's and Chelsea Hospital, and the Women's Health Research Unit, the Blizard Institute, Barts and the London School of Medicine and Dentistry, London, United Kingdom; the George Washington University Biostatistics Center, Rockville, Maryland; the Department of Obstetrics and Gynecology, University of Texas Medical Branch Hospitals, Galveston, Texas; and the Department of Obstetrics and Gynaecology, the Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
Abstract
OBJECTIVE: To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. METHODS: A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect on total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as "critical" and less than 15% as "limited." RESULTS: A total of 228 participants from five stakeholder groups from three lower middle-income countries, seven upper middle-income countries, and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine were related to offspring: gestational age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention. CONCLUSION: This core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined. DATABASE REGISTRATION: COMET Initiative, http://www.comet-initiative.org/studies/details/603, REGISTRATION NUMBER: 603.
OBJECTIVE: To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. METHODS: A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect on total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as "critical" and less than 15% as "limited." RESULTS: A total of 228 participants from five stakeholder groups from three lower middle-income countries, seven upper middle-income countries, and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine were related to offspring: gestational age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention. CONCLUSION: This core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined. DATABASE REGISTRATION: COMET Initiative, http://www.comet-initiative.org/studies/details/603, REGISTRATION NUMBER: 603.
Authors: John P A Ioannidis; Jeffrey D Horbar; Colleen M Ovelman; Yolanda Brosseau; Kristian Thorlund; Madge E Buus-Frank; Edward J Mills; Roger F Soll Journal: BMJ Date: 2015-01-26
Authors: Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell Journal: Trials Date: 2012-08-06 Impact factor: 2.279
Authors: Nicola L Harman; Iain A Bruce; Peter Callery; Stephanie Tierney; Mohammad Owaise Sharif; Kevin O'Brien; Paula R Williamson Journal: Trials Date: 2013-03-12 Impact factor: 2.279
Authors: Cecilia A C Prinsen; Sunita Vohra; Michael R Rose; Susanne King-Jones; Sana Ishaque; Zafira Bhaloo; Denise Adams; Caroline B Terwee Journal: Trials Date: 2014-06-25 Impact factor: 2.279
Authors: Paula R Williamson; Douglas G Altman; Heather Bagley; Karen L Barnes; Jane M Blazeby; Sara T Brookes; Mike Clarke; Elizabeth Gargon; Sarah Gorst; Nicola Harman; Jamie J Kirkham; Angus McNair; Cecilia A C Prinsen; Jochen Schmitt; Caroline B Terwee; Bridget Young Journal: Trials Date: 2017-06-20 Impact factor: 2.279
Authors: Alison E Turnbull; Kristin A Sepulveda; Victor D Dinglas; Caroline M Chessare; Clifton O Bingham; Dale M Needham Journal: Crit Care Med Date: 2017-06 Impact factor: 7.598
Authors: Karine E Manera; Allison Tong; Jonathan C Craig; Edwina A Brown; Gillian Brunier; Jie Dong; Tony Dunning; Rajnish Mehrotra; Sarala Naicker; Roberto Pecoits-Filho; Jeffrey Perl; Angela Y Wang; Martin Wilkie; Martin Howell; Benedicte Sautenet; Nicole Evangelidis; Jenny I Shen; David W Johnson Journal: Perit Dial Int Date: 2017-08-01 Impact factor: 1.756
Authors: Simen Vergote; Felix De Bie; Jan Bosteels; Holly Hedrick; James Duffy; Beverley Power; Alexandra Benachi; Paolo De Coppi; Caraciolo Fernandes; Kevin Lally; Irwin Reiss; Jan Deprest Journal: Trials Date: 2021-02-23 Impact factor: 2.279
Authors: George U Eleje; Ahizechukwu C Eke; Joseph I Ikechebelu; Ifeanyichukwu U Ezebialu; Princeston C Okam; Chito P Ilika Journal: Cochrane Database Syst Rev Date: 2020-09-24
Authors: Allison Tong; Susan Samuel; Michael Zappitelli; Allison Dart; Susan Furth; Allison Eddy; Jaap Groothoff; Nicholas J A Webb; Hui-Kim Yap; Detlef Bockenhauer; Aditi Sinha; Stephen I Alexander; Stuart L Goldstein; Debbie S Gipson; Camilla S Hanson; Nicole Evangelidis; Sally Crowe; Tess Harris; Brenda R Hemmelgarn; Braden Manns; John Gill; Peter Tugwell; Wim Van Biesen; David C Wheeler; Wolfgang C Winkelmayer; Jonathan C Craig Journal: Trials Date: 2016-08-12 Impact factor: 2.279