Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for induced abortion

General Information

Summary:
Approximately 43.8 million abortions are performed annually worldwide. Nearly half of those abortions are performed unsafely. Complications of unsafe abortion are one of the main causes of maternal mortality globally. Studies addressing safe abortion practices report heterogeneous outcomes resulting in bias and making it difficult to draw meaningful conclusions across studies. Development and use of core outcome sets would help to improve the applicability of results and better address one of the most common procedures performed on women worldwide.

Protocol: "Standardizing abortion research outcomes (STAR): a protocol for developing, disseminating and implementing a core outcome set for medical and surgical abortion" http://www.sciencedirect.com/science/article/pii/S001078241730001X

Contributors:
World Health Organization
Dr. Katherine Whitehouse
Dr. Metin Gulmezoglu

Further Study Information

Current Stage:
Ongoing
Date:
October 2015 - October 2017
Funding source(s):

Health Area

Disease Category
Gynaecology
Pregnancy & childbirth

Disease Name
Abortion

Target Population

Age Range
10 - 60

Sex
Female


Nature / type of Intervention
Management of care
Operative and non-operative management
Postoperative management
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

Stage 1: Identify possible outcomes
• Systematic review: randomised controlled trials evaluating safe induced abortion practices
• Qualitative patient interviews: Recruitment of patients via patient representative groups in at least one developed country and one developing country. Patients to take part in semi-structured interviews to identify common themes and identify possible outcomes of abortion.
• Outcome inventory: create comprehensive list of outcomes gleaned from review and patient interviews

Stage 2: Determine Core Outcomes
• Delphi process: Invite key stakeholders to participate in survey assessment of possible outcomes to refine list and work towards consensus
• Consensus meeting: key stakeholders and experts convene to deliberate on final core outcome set, including in this discussion is quality assessment to determine how outcomes should be measured.


Stakeholders Involved

Clinical experts
Consumers (patients)
Epidemiologists
Governmental agencies
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice

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