Core Outcome Measures in Effectiveness Trials

Core outcome measures for medical management of miscarriage

General Information

Summary:
It has been estimated that around 15% of women will suffer from a miscarriage during the reproductive life span. Miscarriage can have a negative effect on both the physical and mental health of the woman and her partner. Medical management, most commonly with misoprostal, mifepristone or both, remains an option for treatment.

There continues to be research interest in the dose, frequency and compounds that give the optimal results for medical management of miscarriage. Although there have been common themes to outcomes measured in trials in this area, such as: success, bleeding, infection, quality of life and cost. There has been incredible variation in how these outcomes have been defined and measured. Research has also been lacking in establishing the most important outcomes for women and their partners. The aim of this study will be to develop core outcome measures for the medical management of miscarriage

Link to protocol: http://bmjopen.bmj.com/content/7/11/e018535

Contributors:
Principle Investigator: Dr Paul Smith, The University of Birmingham
Supervisor: Arri Coomarasamy, The University of Birmingham
Collaborators: Khalid Khan, Queen Mary University of London

Further Study Information

Current Stage:
Ongoing
Date:
October 2015 - October 2017
Funding source(s):
NIHR post doctoral fellowship

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Miscarriage

Target Population

Age Range
16 - 60

Sex
Female


Nature / type of Intervention
Drug

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Systematic review

To develop the core outcome set the methodology will engage all key stakeholders (clinicians, researchers, patients, partners, charities). Systematic reviews of the literature combined with interviews and focus groups with stakeholders will be conducted to identify a list of potential core outcomes. A Delphi survey will then be used to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions.


Stakeholders Involved

Charities
Clinical experts
Consumers (patients)
Families
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research

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