Jmn Duffy1,2, M Hirsch1,3, M Vercoe4, J Abbott5, C Barker6, B Collura7, R Drake8, Jlh Evers9, M Hickey10, A W Horne11, M L Hull12, S Kolekar8, S Lensen4, N P Johnson12,13, V Mahajan8, B W Mol14, A-S Otter15, L Puscasiu16, M B Rodriguez4, L Rombauts14, A Vail17, R Wang12, C M Farquhar4. 1. Institute for Women's Health, University College London, London, UK. 2. King's Fertility, The Fetal Medicine Research Institute, London, UK. 3. University College London Hospitals NHS Foundation Trust, London, UK. 4. Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand. 5. School of Women's and Children's Health, University of New South Wales Sydney, Sydney, New South Wales, Australia. 6. Radcliffe Women's Health Patient Participation Group, University of Oxford, Oxford, UK. 7. Resolve: The National Infertility Association, McLean, Virginia, USA. 8. endo:outcomes Patient and Public Participation Group, University of Auckland, Auckland, New Zealand. 9. Centre for Reproductive Medicine and Biology, University Medical Centre Maastricht, Maastricht, the Netherlands. 10. Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. 11. MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK. 12. Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia. 13. World Endometriosis Society, Vancouver, British Columbia, Canada. 14. Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia. 15. Osakidetza, OSI Bilbao, Basurto, Spain. 16. University of Medicine, Pharmacy, Science, and Technology, Targu Mures, Romania. 17. Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Abstract
OBJECTIVE: To develop a core outcome set for endometriosis. DESIGN: Consensus development study. SETTING: International. POPULATION: One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives. METHODS: Modified Delphi method and modified nominal group technique. RESULTS: The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment. CONCLUSIONS: Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. TWEETABLE ABSTRACT: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.
OBJECTIVE: To develop a core outcome set for endometriosis. DESIGN: Consensus development study. SETTING: International. POPULATION: One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives. METHODS: Modified Delphi method and modified nominal group technique. RESULTS: The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment. CONCLUSIONS: Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. TWEETABLE ABSTRACT: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.
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
Authors: Ana Sofia Pais; Clara Flagothier; Linda Tebache; Teresa Almeida Santos; Michelle Nisolle Journal: J Clin Med Date: 2021-01-22 Impact factor: 4.241
Authors: Mike Armour; Mahmoud A Al-Dabbas; Carolyn Ee; Caroline A Smith; Jane Ussher; Susan Arentz; Kenny Lawson; Jason Abbott Journal: Trials Date: 2021-04-21 Impact factor: 2.279
Authors: Nathan A Pearson; Elizabeth Tutton; Alexander Joeris; Stephen Gwilym; Richard Grant; David J Keene; Kirstie L Haywood Journal: Trials Date: 2021-07-12 Impact factor: 2.279
Authors: Innie Chen; Veerle B Veth; Abdul J Choudhry; Ally Murji; Andrew Zakhari; Amanda Y Black; Carmina Agarpao; Jacques Wm Maas Journal: Cochrane Database Syst Rev Date: 2020-11-18