Core Outcome Measures in Effectiveness Trials

COSTIL Study: Core outcomes in Stillbirth Trials

General Information

Summary:
Stillbirth is one of the most devastating adverse pregnancy outcomes a parent can experience. A decline in the stillbirth rate has slowed in recent years in high-income countries (Flenady et al. 2011). A substantial proportion of stillbirth is the result of modifiable risk factors, which indicates potential for further reduction in the rates.

One limiting factor in stillbirth research has been that clinical studies evaluating diagnostic and therapeutic interventions have reported different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual trials, limiting the usefulness of research to inform clinical practice. Moreover, stillbirth is often not reported separately in studies reporting on other diseases such as hypertension and maternal diabetes that have been associated with increase in the odds of stillbirth (Flenady et al. 2011). The COSTIL study aims to develop a core outcome set from a process of a systematic review, interviews and Delphi surveys involving all stakeholders including parents for future clinical studies evaluating interventions to prevent stillbirth.

Contributors:
Miss Bobae Kim, University of Adelaide
Prof. Ben Mol, University of Adelaide
Dr Edoardo Aromataris, University of Adelaide
Prof. Shakila Thangaratinam, Women’s Health Research Unit at Barts and the London School of Medicine and Dentistry, QMUL
Prof. Khalid Khan, Women’s Health Research Unit at Barts and the London School of Medicine and Dentistry, QMUL
Dr Janneke van ‘t Hooft, Maastricht University
Prof Vicki Flenady, University of Queensland
Dr Philippa Middleton, University of Adelaide

Further Study Information

Current Stage:
Ongoing
Date:
December 2016 - January 2018
Funding source(s):
Stillbirth Foundation Australia, University of Adelaide

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Stillbirth

Target Population

Age Range
15 - 65

Sex
Female


Nature / type of Intervention
Dietary
Exercise
Management of care
Physical
Screening
Prevention of risk factors

Method(s)

Delphi process
Focus group(s)
Interview
Systematic review

1. Conduct a systematic review of outcome measures used in studies evaluating stillbirth prevention to identify reported outcomes.
2. Run a focus group/interviews with parents who have suffered stillbirth to identify outcomes important to them
3. Using the identified outcomes from step 1 and 2 and develop an outcome inventory to be used in Delphi survey
4. Use Delphi method to reach consensus on elements of the inventory with the involvement of all stakeholders.
5. Determine how the outcomes should be defined and measured with consultations with stakeholders.


Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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