Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study

被引:56
作者
Dos Santos, F. [1 ]
Drymiotou, S. [2 ]
Martin, A. Antequera [3 ]
Mol, B. W. [4 ]
Gale, C. [5 ]
Devane, D. [6 ]
van't Hooft, J. [7 ]
Johnson, M. J. [8 ,9 ]
Hogg, M. [10 ]
Thangaratinam, S. [11 ]
机构
[1] Barts Hlth NHS Trust, Obstet & Gynaecol, Hlth Educ England London, Royal London Hosp, Ward 6F,Whitechapel Rd, London E1 1BB, England
[2] Barts Hlth NHS Trust, Obstet & Gynaecol ST2, Hlth Educ England London, Royal London Hosp, London, England
[3] Princesa Hosp, Dept Internal Med, Madrid, Spain
[4] Monash Univ, Obstet & Gynaecol, Clayton, Vic, Australia
[5] Imperial Coll London, Neonatal Med, London, England
[6] Natl Univ Ireland Galway, Midwifery, HRB Trials Methodol Res Network, Sch Nursing & Midwifery, Galway, Ireland
[7] Acad Med Ctr, Obstet & Gynaecol, Amsterdam, Netherlands
[8] Univ Hosp Southampton NHS Fdn Trust, Dept Neonatal Med, Princess Anne Hosp, Southampton, Hants, England
[9] Univ Southampton, Natl Inst Hlth Res, Southampton Biomed Res Ctr, Univ Hosp Southampton NHS Fdn Trust, Southampton, Hants, England
[10] Barts Hlth NHS Trust, Royal London Hosp, London, England
[11] Queen Mary Univ London, Maternal & Perinatal Hlth, Womens Hlth Res Unit, Barts & London Sch Med & Dent,Barts Hlth NHS Trus, London, England
基金
澳大利亚国家健康与医学研究理事会;
关键词
Core outcome set; CROWN; induction of labour;
D O I
10.1111/1471-0528.15397
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Objective Design To develop a set of core outcomes to be minimally reported in trials on induction of labour. Two-round Delphi survey and consensus meeting. Population Methods Four stakeholder groups: midwives, obstetricians, neonatologists, and women's representatives. Protocol registered with COMET (Registration Number: 695). Stakeholders rated reported outcomes for importance (1-limited to 9-critical). The median rating of each outcome was calculated. The consensus criteria to include outcomes were as follows: >= 70% participants rated outcomes as critical and <15% rated outcomes as limited importance. Outcomes that did not achieve consensus were taken to round two and, if there was still no consensus, to the final consensus meeting. Main outcome measures Results Outcomes in trials of induction of labour. Of the 159 invited participants, 54% (86/159) completed the first round, and 83% completed the second round (71/86). The core outcome set included 28 core outcomes in four domains: Short-term maternal outcomes (n = 18)-cardiorespiratory arrest, damage to internal organs, death, haemorrhage, hysterectomy, infection, intensive care admission, length of hospital stay, mode of delivery, need for more than one induction agent, oxytocin augmentation, postnatal depression, pulmonary embolus, satisfaction with care, stroke, time from induction to delivery, uterine hyperstimulation, uterine scar dehiscence/rupture; short-term offspring outcomes (n = 8)-admission to the neonatal unit, birth trauma, death, hypoxic ischaemic encephalopathy/need for therapeutic hypothermia, meconium aspiration syndrome, need for respiratory support, infection, and seizures; long-term ma bbternal outcomes (n = 1)-operative pelvic floor repair; long-term offspring outcomes (n = 1)-disability including neurodevelopmental delay. Conclusion Tweetable abstract Trials on induction of labour should include this core outcome set to standardise reporting. International multistakeholder Delphi study identifies a core outcome set for trials on induction of labour.
引用
收藏
页码:1673 / 1680
页数:8
相关论文
共 26 条
  • [11] Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO)
    Khan, Khalid S.
    Moore, Philip A. S.
    Wilson, Matthew J.
    Hooper, Richard
    Allard, Shubha
    Wrench, Ian
    Beresford, Lee
    Roberts, Tracy E.
    McLoughlin, Carol
    Geoghegan, James
    Daniels, Jane P.
    Catling, Sue
    Clark, Vicki A.
    Ayuk, Paul
    Robson, Stephen
    Gao-Smith, Fang
    Hogg, Matthew
    Lanz, Doris
    Dodds, Julie
    [J]. PLOS MEDICINE, 2017, 14 (12)
  • [12] Core Outcome Set-STAndards for Reporting: The COS-STAR Statement
    Kirkham, Jamie J.
    Gorst, Sarah
    Altman, Douglas G.
    Blazeby, Jane M.
    Clarke, Mike
    Devane, Declan
    Gorgon, Elizabeth
    Moher, David
    Schmitt, Jochen
    Tugwell, Peter
    Tunis, Sean
    Williamson, Paula R.
    [J]. PLOS MEDICINE, 2016, 13 (10)
  • [13] Kirwan J, 2003, J RHEUMATOL, V30, P868
  • [14] Kirwan John R, 2005, J Rheumatol, V32, P2250
  • [15] McColl E, 2001, Health Technol Assess, V5, P1
  • [16] Outcomes reported in trials of methods for the induction of labour
    Medley, Nancy
    Alfirevic, Zarko
    Caldwell, Deborah M.
    Dias, Sofia
    Dowswell, Therese
    Keeney, Edna
    Jones, Leanne
    Navaratnam, Kate
    Welton, Nicky
    [J]. TRIALS, 2015, 16
  • [17] Choice of primary outcomes in randomised trials and systematic reviews evaluating interventions for preterm birth prevention: a systematic review
    Meher, S.
    Alfirevic, Z.
    [J]. BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2014, 121 (10) : 1188 - 1194
  • [18] National Institute for Health and Clinical Excellence, 2008, IND LAB
  • [19] The Delphi method as a research tool: an example, design considerations and applications
    Okoli, C
    Pawlowski, SD
    [J]. INFORMATION & MANAGEMENT, 2004, 42 (01) : 15 - 29
  • [20] How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline
    Prinsen, Cecilia A. C.
    Vohra, Sunita
    Rose, Michael R.
    Boers, Maarten
    Tugwell, Peter
    Clarke, Mike
    Williamson, Paula R.
    Terwee, Caroline B.
    [J]. TRIALS, 2016, 17