Core Outcome Measures in Effectiveness Trials

The COBALT Study: Core Outcomes for Broken bones in the arm for application in Trials

General Information

Summary:
The selection of outcomes to measure is of critical importance when designing a trial or study to ensure the outputs are relevant to patients, clinicians and policy makers. Studies become more powerful when they can be combined into meta-analyses, but this can only be performed where studies report the same outcomes.
At present there is no agreement as to the outcomes that need to be reported in studies relating to upper limb fractures. There is a core set for general shoulder problems which has been designed by rheumatology researchers and there is a set being developed for rotator cuff tears. While there may be some overlap, there would be value in developing a core set for upper limb fractures to support future studies in fracture care.

A study related to upper limb fractures will report a range of outcomes. The objective of the COBALT study is to agree a key set of outcomes that should be reported in all studies as a minimum set of results. Researchers are free to add in additional outcomes to compliment this core set

Contributors:
Ben Marson
Ben Ollivere
John Geoghegan
Martin Scott

Further Study Information

Current Stage:
Ongoing
Date:
July 2019 - July 2021
Funding source(s):
None

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Fractures
Upper limb fractures (arm, elbow and shoulder)

Target Population

Age Range
16 - 105

Sex
Either


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

Method(s)

Consensus meeting
Delphi process
Interview
Survey
Systematic review

Broadly, the study is divided into five phases:

• Scope.
• What can be measured?
• What should be measured?
• How should we measure it?
• Implementation.

1. Scope
The scope of the core outcome set will be agreed by the steering group. This group will include a range of stakeholders including clinicians, researchers, therapists and patient representatives.
2. What can be measured?
A systematic review of outcomes reported in previous trials of upper limb fractures will be completed with outcomes mapped to WHO ICF domains.
These outcomes will be supplemented with consultations with patients and experts to generate a long list of outcomes.
3. What should be measured?
The long list of outcomes will be reduced through a Delphi survey of mixed stakeholders.
Finally, a core outcome set of what should be measured will be decided through a consensus meeting.
4. How should we measure it?
Selection of outcome tools requires an analysis of measurement properties of currently available instruments for each of the identified outcomes.
When measurement properties (validity, reliability and responsiveness) are available then a further consensus meeting will be held to agree outcome measures to include in the core outcome set.
5. Implementation
To maximise uptake of the core outcome set the protocol and results will be published in a peer reviewed journal. Collaborations will be sought with BESS, OTS, AOUK, BOA and AAOS to encourage use of the core outcome set in reporting studies relating to these injuries.


Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives
Researchers
Service users

Study Type

COS for clinical trials or clinical research
Recommended outcome measures (measurement)

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