TY - JOUR
T1 - Core outcome sets for prevention and treatment of postpartum haemorrhage
T2 - an international Delphi consensus study
AU - Meher, S.
AU - Cuthbert, A.
AU - Kirkham, J. J.
AU - Williamson, P.
AU - Abalos, E.
AU - Aflaifel, N.
AU - Bhutta, Z. A.
AU - Bishop, A.
AU - Blum, J.
AU - Collins, P.
AU - Devane, D.
AU - Ducloy-Bouthors, A. S.
AU - Fawole, B.
AU - Gülmezoglu, A. M.
AU - Gutteridge, K.
AU - Gyte, G.
AU - Homer, C. S.E.
AU - Mallaiah, S.
AU - Smith, J. M.
AU - Weeks, A. D.
AU - Alfirevic, Z.
N1 - Funding Information:
This project was funded by the British Medical Association Strutt and Harper Grant. The funders reviewed the application and protocol before awarding the grant, monitored the project progress, and provided financial support to disseminate the COS through international meetings but were not directly involved in any other aspect of the project.
Funding Information:
was felt that the tool was developed through a rigorous process, was feasible to apply in all settings, and there were no better established alternative tools. ADW has a patent pending on the PPH Butterfly device for PPH management. JB reports grants from the Bill and Melinda Gates Foundation during the conduct of the study; PC has grants from CSL Behring and Haemonetics, outside the submitted work; AD-B reports grants, personal fees, and non-financial support from Laboratoire Fractionnement Biotechnologies, grants and non-financial support from French Ministry of Health and Drug Administration ANSM, outside the submitted work; GG has received royalties from John Wiley & Son in respect of A Cochrane Pocketbook – Pregnancy and Childbirth (Hofmeyr GJ et al. 2008). The remaining authors have no disclosures. Completed disclosure of interests form available to view online as supporting information.
Funding Information:
The project was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) initiative4 and funded by the British Medical Association. The protocol was peer-reviewed by the COMET team and funding body. Ethics approval was not required.5The manuscript has been reported in line with the core outcome sets (COS)-STAR guidelines for COS reporting.6 Methods are summarised in Figure S1 and further details are available in Appendix S1.
Publisher Copyright:
© 2018 Royal College of Obstetricians and Gynaecologists
PY - 2019/1
Y1 - 2019/1
N2 - 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.
AB - 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.
KW - Core outcomes
KW - Delphi
KW - postpartum haemorrhage
KW - pregnancy
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U2 - 10.1111/1471-0528.15335
DO - 10.1111/1471-0528.15335
M3 - Article
C2 - 29920912
AN - SCOPUS:85051129306
SN - 1470-0328
VL - 126
SP - 83
EP - 93
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 1
ER -