Core Outcome Measures in Effectiveness Trials

Core outcome measures for prevention of miscarriage trials

General Information

Summary:
Miscarriage is the commonest complication of pregnancy and occurs in one in five pregnancies. Miscarriage has the potential to cause physical harm to patients including: infection, severe bleeding, perforation of the uterus and even death. Miscarriage also has a psychological impact on patients with research showing that the bereavement associated with miscarriage can be equivalent to those women suffering from a stillbirth at term. There is a great deal of research looking at ways to prevent miscarriage and its associated psychological morbidity and complications. Often, however, studies do not address the same outcomes, making it difficult to draw conclusions when a group of studies is looked at as a whole. The aim of this study will be to develop core outcome measures for trials in the prevention 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
Surgery

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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