Core Outcome Measures in Effectiveness Trials

Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study

General Information

Abstract:
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

Authors:
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 G├╝lmezoglu
Kathryn Gutteridge
Gill Gyte
Caroline S E Homer
Shuba Mallaiah
Jeffrey M Smith
Andrew D Weeks
Zarko Alfirevic

Publication

Journal:
BJOG: An International Journal of Obstetrics and Gynaecology
Volume:
Issue:
Pages:
-
Year:
2018
DOI:
Further Study Information

Date:
December 2014 - September 2016
Funding source(s):
British Medical Association Strutt and Harper Grant

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Postpartum Haemorrhage

Target Population

Age Range
16 - 100

Sex
Female


Nature / type of Intervention
Any

Method(s)

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.


Stakeholders Involved

Clinical experts
Consumers (patients)
Methodologists
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research

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