Core Outcome Measures in Effectiveness Trials

Core outcomes and common data elements for cervical degenerative myelopathy (CODE-CDH)

General Information

Summary:
Cervical degenerative myelopathy [CDM] is an umbrella term for a number of conditions that cause progressive cervical cord compression. It is the leading spinal disorder in the over 55s, and with an aging population its incidence is set to rise. Disability can range from mild neck pain to tetraplegia. Although the field is rich in research, the heterogeneous reporting of variables has plagued cross-study comparison and optimisation of treatment. This is due to variation in reported outcome measures, but also other data elements, such as baseline characteristics. Such additional data elements are of significance in CDM, given the varied pathology and current lack of treatment consensus.

Core Outcome Sets (COS) have emerged to allow effective cross-study comparison. A combined consensus of core outcome and other data elements, alongside their manner of reporting, would support CDM research in the future.

Protocol: https://journals.sagepub.com/doi/10.1177/2192568219832855

Contributors:
PI: Mark Kotter (University of Cambridge, UK; Dep. Neurosurgery, Addenbrookes University Hospital, UK)

BM.Davies (University of Cambridge, UK; Dep. Neurosurgery, Addenbrookes University Hospital, UK)
A.Kolias (University of Cambridge, UK; Dep. Neurosurgery, Addenbrookes University Hospital, UK)
PJ.Hutchinson (University of Cambridge, UK; Dep. Neurosurgery, Addenbrookes University Hospital, UK)
Prof. M.G Fehlings (Toronto Western Hospital, University Health Network & University of Toronto, Toronto, Canada)

Further Study Information

Current Stage:
Ongoing
Date:
August 2015 - May 2019
Funding source(s):
NIHR

Health Area

Disease Category
Neurology

Disease Name
Cervical degenerative myelopathy (CDM)
Spinal disorders

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Literature review
Semi structured discussion

All key stakeholders (clinicians, patients, researchers, charities) will be used to develop the core outcome set. A Delphi process, will lead to eventual consensus meeting. Following an opening round, Delphi participants will be supported by findings of a literature review.

Consensus on the manner for reporting outcome variables will be reached by consensus meeting alone.

The final core outcome set will be disseminated via publication and advertising. The uptake of the core outcome dissemination will be evaluated after 5 years.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Researchers
Service providers

Study Type

Minimum dataset

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