Core Outcome Measures in Effectiveness Trials

Recommendations for the use of core outcome measures following Cranioplasty

General Information

Summary:
A cranioplasty is a neurosurgical procedure undertaken to restore the integrity of the skull following a craniectomy - removal of a piece of the skull for often life-saving reasons. The cranioplasty is an elective procedure that often occurs many months after the original craniectomy. There is a building body of evidence suggesting that earlier cranioplasty procedures may improve neurological recovery - both functionally and cognitively.

The main reason for a core outcome measure dataset for cranioplasty procedures is to standardise the outcome measures to help ensure clinical trials capture a standardised, necessary functional and cognitive data to try and improve the reporting of cranioplasty clinical trials within these domains.

Contributors:
Professor Peter Hutchinson, Cambridge University Neurosciences Department
Mr Angelos Kolias, Cambridge University Neurosciences Department
Dr Harry Mee, Cambridge Clinical Neurosciences

Further Study Information

Current Stage:
Ongoing
Date:
September 2018 - April 2021
Funding source(s):
None

Health Area

Disease Category
Neurology
Rehabilitation

Disease Name
Brain injury (traumatic)
Middle cerebral infarct

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review
Systematic review

Stakeholders Involved

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

Study Type

COS for clinical trials or clinical research
COS for practice

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