Objective
To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of PPH, and recommendations on how to report the COS.
Design
A two-round Delphi survey and face-to-face meeting.
Population
Health care 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
Shireen Meher
Anna Cuthbert
Jamie J Kirkham
Paula Williamson
Edgardo Abalos
Nasreen Aflaifel
Zulfiqar A Bhutta
Alina Bishop
Jennifer Blum
Peter Collins
Declan Devane
Anne-Sophie Ducloy-Bouthors
Bukola Fawole
A Metin Gülmezoglu
Kathryn Gutteridge
Gill Gyte
Caroline S E Homer
Shuba Mallaiah
Jeffrey M Smith
Andrew D Weeks
Zarko Alfirevic
Disease Category: Pregnancy & childbirth
Disease Name: Postpartum Haemorrhage
Age Range: 16 - 100
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
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.