S Meher1,2, A Cuthbert1, J J Kirkham3, P Williamson3, E Abalos4, N Aflaifel1, Z A Bhutta5,6, A Bishop7, J Blum8, P Collins9, D Devane10, A-S Ducloy-Bouthors11, B Fawole12, A M Gülmezoglu13, K Gutteridge14, G Gyte7, Cse Homer15, S Mallaiah16, J M Smith17, A D Weeks1, Z Alfirevic1. 1. Department of Women's and Children's Health, University of Liverpool, Liverpool, UK. 2. Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK. 3. Department of Biostatistics, University of Liverpool, Liverpool, UK. 4. Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina. 5. Division of Women and Child Health, Aga Khan University, Karachi, Pakistan. 6. The Hospital for Sick Children, Toronto, Canada. 7. Cochrane Pregnancy and Childbirth Group, University of Liverpool, Liverpool, UK. 8. Gynuity Health Projects, New York, NY, USA. 9. Institute of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK. 10. HRB-Trials Methodology Research Network, School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland. 11. Centre Hospitalier Regional Universitaire de Lille, Lille, France. 12. Department of Obstetrics and Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria. 13. The UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland. 14. Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK. 15. Centre for Midwifery, Child and Family Health, University of Technology Sydney, Sydney, NSW, Australia. 16. Liverpool Women's Hospital, Liverpool, UK. 17. Jhpiego/Johns Hopkins University, Baltimore, MD, USA.
Abstract
OBJECTIVE: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. DESIGN: A two-round Delphi survey and face-to-face meeting. POPULATION: Healthcare professionals and women's representatives. METHODS: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. MAIN OUTCOME MEASURES: Outcomes from systematic reviews and consultations. RESULTS: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. CONCLUSIONS: These COS will help standardise outcome reporting in PPH trials. TWEETABLE ABSTRACT: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.
OBJECTIVE: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. DESIGN: A two-round Delphi survey and face-to-face meeting. POPULATION: Healthcare professionals and women's representatives. METHODS: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. MAIN OUTCOME MEASURES: Outcomes from systematic reviews and consultations. RESULTS: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. CONCLUSIONS: These COS will help standardise outcome reporting in PPH trials. TWEETABLE ABSTRACT: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.
Authors: Cecily M Begley; Gillian Ml Gyte; Declan Devane; William McGuire; Andrew Weeks; Linda M Biesty Journal: Cochrane Database Syst Rev Date: 2019-02-13
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