A core outcome set for future endometriosis research: an international consensus development study.

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Tytuł:: A core outcome set for future endometriosis research: an international consensus development study.
Autorzy:: Duffy J; Institute for Women's Health, University College London, London, UK.; King's Fertility, The Fetal Medicine Research Institute, London, UK.
Hirsch M; Institute for Women's Health, University College London, London, UK.; University College London Hospitals NHS Foundation Trust, London, UK.
Vercoe M; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
Abbott J; School of Women's and Children's Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.
Barker C; Radcliffe Women's Health Patient Participation Group, University of Oxford, Oxford, UK.
Collura B; Resolve: The National Infertility Association, McLean, Virginia, USA.
Drake R; endo:outcomes Patient and Public Participation Group, University of Auckland, Auckland, New Zealand.
Evers J; Centre for Reproductive Medicine and Biology, University Medical Centre Maastricht, Maastricht, the Netherlands.
Hickey M; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.
Horne AW; MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
Hull ML; Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
Kolekar S; endo:outcomes Patient and Public Participation Group, University of Auckland, Auckland, New Zealand.
Lensen S; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
Johnson NP; Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.; World Endometriosis Society, Vancouver, British Columbia, Canada.
Mahajan V; endo:outcomes Patient and Public Participation Group, University of Auckland, Auckland, New Zealand.
Mol BW; Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.
Otter AS; Osakidetza, OSI Bilbao, Basurto, Spain.
Puscasiu L; University of Medicine, Pharmacy, Science, and Technology, Targu Mures, Romania.
Rodriguez MB; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
Rombauts L; Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.
Vail A; Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Wang R; Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
Farquhar CM; Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
Corporate Authors:: endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research
Źródło:: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2020 Jul; Vol. 127 (8), pp. 967-974. Date of Electronic Publication: 2020 Mar 30.
Typ publikacji:: Journal Article; Systematic Review
Język:: English
Imprint Name(s):: Publication: : Oxford : Wiley-Blackwell
Original Publication: Oxford [England] : Blackwell Science, [2000]-
MeSH Terms:: Biomedical Research*
Endometriosis*
Consensus ; Delphi Technique ; Endpoint Determination ; Female ; Health Personnel ; Humans ; Prospective Studies ; Research Design ; Research Personnel
References:: Duffy JMN, Ziebland S, von Dadelszen P, McManus RJ. Tackling poorly selected, collected, and reported outcomes in obstetrics and gynecology research. Am J Obstet Gynecol 2019;220:71.e1-.e4.
Johnson NP, Hummelshoj L, Abrao MS, Adamson GD, Allaire C, Amelung V, et al. Consensus on current management of endometriosis. Hum Reprod 2013;28:1552-68.
Hirsch M, Duffy JMN, Kusznir JO, Davis CJ, Plana MN, Khan KS, et al. Variation in outcome reporting in endometriosis trials: a systematic review. Am J Obstet Gynecol 2016;214:452-64.
Duffy J, Bhattacharya S, Herman M, Mol B, Vail A, Wilkinson J, et al. Reducing research waste in benign gynaecology and fertility research. BJOG 2017;124:366-9.
Hirsch M, Duffy JMN, Barker C, Hummelshoj L, Johnson NP, Mol B, et al. Protocol for developing, disseminating and implementing a core outcome set for endometriosis. BMJ Open. 2016;6:e013998.
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National Institute for Health Research. Jargon Buster. http://www.invo.org.uk/resource-centre/jargon-buster/ (Accessed 10 March 2015).
Royal College of Obstetricians and Gynaecologists. Medical terms explained. https://www.rcog.org.uk/en/patients/medical-terms/ (Accessed 10 December 2014).
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Henderson B, Dorsey J. Medical Terminology for Dummies. Indianapolis, IN: Wiley Publishing; 2012.
Murphy M, Sanderson C, Black N, Askham J, Lamping D, Marteau T, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess 1998;2:1-88.
Giannarou L, Zervas E. Using Delphi technique to build consensus in practice. Int J Business Sci Appl Manage 2014;9:65-82.
Skulmoski GJ, Hartman FT, Krahn J. The Delphi method for graduate research. J Inform Technol Educ: Res 2007;6:1-21.
Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64:395-400.
Gallagher M, Hares TIM, Spencer J, Bradshaw C, Webb IAN. The nominal group technique: a research tool for general practice? Fam Pract 1993;10:76-81.
Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core outcome Set-STAndards for development: The COS-STAD recommendations. PLoS Medicine 2017;14:e1002447.
Duffy JMN, Rolph R, Gale C, Hirsch M, Khan KS, Ziebland S, et al. Core outcome sets in women's and newborn health: a systematic review. BJOG 2017;124:1481-9.
Horne AW, Saunders PTK, Abokhrais IM, Hogg L. Top ten endometriosis research priorities in the UK and Ireland. Lancet 2017;389:2191-2.
Chan A, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
Khan KS, Romero R. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health. Am J Obstet Gynecol 2014;211:575-6.
Grant Information:: DRF-2014-07-051 United Kingdom DH_ Department of Health; TCS/18/43 United Kingdom CSO_ Chief Scientist Office; Catalyst Fund; Endometriosis Millennium Fund
Contributed Indexing:: Investigator: JP Daniels; AC Lim; K Edmonds; CE MacLean; AC Appleton; S Skelton; DL Byrne; RK White; M Sardo; RC Fowles; B Ata; SA Richatd; CC Puig Ybanez; MC Peterson; JL Elms; A Parks; BLF De Bie Rocks; JC Roe; R Doran; M Ceccaroni; CA Ferreira; S Dias; T Pinnington; P Laupa-Santiago; MC Turner; AMF Schreurs; E Baggot; RV Socolov; M Yossry; TM Hodges; MWP Barbossa; T Mures; TL Lytwyn; SEL Egan-Reid; SCL Devlin; KS Crees; BC Baldwin; JR Scott; AK Gravolin; EF Chapman; SN Bartley; AJ Hamilton; KJ Thorpe; DM Carmody; J Eyeson; MD Davis; J Henry; M Armour; PYFV Cummings; LA Cook
Keywords: Consensus development study; core outcome set; endometriosis; modified Delphi method; modified nominal group technique
Entry Date(s):: Date Created: 20200401 Date Completed: 20200630 Latest Revision: 20220323
Update Code:: 20240105
DOI:: 10.1111/1471-0528.16157
PMID:: 32227676
: Czasopismo naukowe

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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.
(© 2020 Royal College of Obstetricians and Gynaecologists.)

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