Law Jansen1,2, M H Koot1, J Van't Hooft1, C R Dean3, Jmn Duffy4, W Ganzevoort1, N Gauw5, B Y Goes6, J Rodenburg7, T J Roseboom1,8, R C Painter1, I J Grooten1. 1. Department of Obstetrics and Gynaecology, Amsterdam UMC, Academic Medical Centre, Amsterdam, the Netherlands. 2. Department of Obstetrics and Gynaecology, Franciscus Gasthuis, Rotterdam, the Netherlands. 3. Pregnancy Sickness Support, Bodmin, UK. 4. Institute for Women's Health, University College London, London, UK. 5. Dutch Hyperemesis Gravidarum Patient Foundation (ZEHG), Dussen, the Netherlands. 6. Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands. 7. General practice Czaar Peter Medical Centre, Amsterdam, the Netherlands. 8. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Academic Medical Centre, Amsterdam, the Netherlands.
Abstract
OBJECTIVE: To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG). DESIGN: Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round. SETTING: An international web-based survey combined with a consensus development meeting. POPULATION: Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals. METHODS: We used systematic review, semi-structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round. MAIN OUTCOME MEASURES: A core outcome set for research on HG. RESULTS: Fifty-six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short- and long-term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death). CONCLUSIONS: This core outcome set will help standardise outcome reporting in HG trials. TWEETABLE ABSTRACT: A core outcome set for treatment of hyperemesis gravidarum in order to create high-quality evidence.
OBJECTIVE: To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG). DESIGN: Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round. SETTING: An international web-based survey combined with a consensus development meeting. POPULATION: Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals. METHODS: We used systematic review, semi-structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round. MAIN OUTCOME MEASURES: A core outcome set for research on HG. RESULTS: Fifty-six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short- and long-term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death). CONCLUSIONS: This core outcome set will help standardise outcome reporting in HG trials. TWEETABLE ABSTRACT: A core outcome set for treatment of hyperemesis gravidarum in order to create high-quality evidence.
Authors: J M N Duffy; S Bhattacharya; S Bhattacharya; M Bofill; B Collura; C Curtis; J L H Evers; L C Giudice; R G Farquharson; S Franik; M Hickey; M L Hull; V Jordan; Y Khalaf; R S Legro; S Lensen; D Mavrelos; B W Mol; C Niederberger; E H Y Ng; L Puscasiu; S Repping; I Sarris; M Showell; A Strandell; A Vail; M van Wely; M Vercoe; N L Vuong; A Y Wang; R Wang; J Wilkinson; M A Youssef; C M Farquhar; Ahmed M. Abou-Setta; Juan J. Aguilera; Hisham AlAhwany; Oluseyi O. A. Atanda; Eva M. E. Balkenende; Kurt T. Barnhart; Yusuf Beebeejaun; Georgina M. Chambers; Abrar A. Chughtai; Irene Cuevas-Sáiz; Cate Curtis; Arianna D'Angelo; Danielle D. Dubois; Kirsten Duckitt; Carlos Encinas; Marie-Odile Gerval; Nhu H. Giang; Ahmed Gibreel; Lynda J. Gingel; Elizabeth J. Glanville; Demian Glujovsky; Ingrid Granne; Georg Griesinger; Devashana Gupta Repromed; Zeinab Hamzehgardeshi; Martin Hirsch; Marcos Horton; Shikha Jain; Marta Jansa Perez; Claire A. Jones; Mohan S. Kamath; José Knijnenburg; Elena Kostova; Antonio La Marca; Tien Khac Le; Arthur Leader; Brigitte Leeviers; Jian Li Chinese; Olabisi M. Loto; Karen L. Marks; Rodrigo M. Martinez-Vazquez; Alison R. McTavish; David J. Mills; Raju R. Nair; Dung Thi Phuong Nguyen; Anne-Sophie Otter; Allan A. Pacey; Satu Rautakallio-Hokkanen; Lynn C. Sadler; Peggy Sagle; Juan-Enrique Schwarze; Heather M. Shapiro; Joe L. Simpson; Charalampos S. Siristatidis; Akanksha Sood; Catherine Strawbridge; Helen L. Torrance; Cam Tu Tran; Emma L. Votteler; Chi Chiu Wang; Andrew Watson; Menem Yossry Journal: Hum Reprod Date: 2020-12-01 Impact factor: 6.918
Authors: J M N Duffy; H AlAhwany; S Bhattacharya; B Collura; C Curtis; J L H Evers; R G Farquharson; S Franik; L C Giudice; Y Khalaf; J M L Knijnenburg; B Leeners; R S Legro; S Lensen; J C Vazquez-Niebla; D Mavrelos; B W J Mol; C Niederberger; E H Y Ng; A S Otter; L Puscasiu; S Rautakallio-Hokkanen; S Repping; I Sarris; J L Simpson; A Strandell; C Strawbridge; H L Torrance; A Vail; M van Wely; M A Vercoe; N L Vuong; A Y Wang; R Wang; J Wilkinson; M A Youssef; C M Farquhar Journal: Hum Reprod Date: 2020-12-01 Impact factor: 6.918
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