Core Outcome Measures in Effectiveness Trials

Core outcome measures for surgical management of miscarriage

General Information

Summary:
Miscarriage is the failure of pregnancy before 23 weeks, which is common in early pregnancy occurring in around one in five pregnancies. Miscarriage can have a negative effect on both the physical and mental health of the woman and her partner. Sometimes it is necessary for doctors to suggest surgical treatment. Unfortunately, this can be associated with various problems such as causing a hole in the womb, infection, scarring and bleeding.

Clinical trials, systematic reviews and guidelines have compared beneficial and non-beneficial outcomes following surgical management of miscarriage. 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. Increasingly, it is being realized that what is needed is an agreed standardised collection of outcomes (a ‘core outcomes set’) for all trials in a specific area. The aim of this study will be to develop core outcome measures for the surgical 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: Justin Clark, The University of Birmingham
Khalid Ismail, The University of Birmingham
Khalid Khan, Queen Mary University of London

Further Study Information

Current Stage:
Ongoing
Date:
October 2015 - October 2017
Funding source(s):
Applying to NIHR for a post doctoral fellowship award

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Miscarriage

Target Population

Age Range
16 - 60

Sex
Female


Nature / type of Intervention
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, 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.

Patients (women who have had miscarriage)
Partners of women who have suffered miscarriage
Specialist early pregnancy nurses and midwives
Doctors with an interest in early pregnancy
Leaders of support groups in early pregnancy


Stakeholders Involved

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

Study Type

COS for clinical trials or clinical research

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