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Standardizing Cranioplasty Outcomes Following Stroke or Traumatic Brain Injury: Protocol for the Development of a
Harry Mee1,2,3, Ana M Castaño-Leon4, Ivan Timofeev5
1Division of Rehabilitation Medicine and Neurosurgery, Department of Clinical Neurosciences, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom.
JMIR Research Protocols
|June 27, 2022
Summary
This study will develop a core outcome set (COS) for cranioplasty after traumatic brain injury (TBI) or stroke. This will standardize reporting in future research, improving understanding and evidence for patient recovery.
Area of Science:
- Neurosurgery
- Clinical Research Methodology
Background:
- Core outcome sets (COSs) standardize research reporting.
- Cranioplasty for TBI and stroke is common, but outcome reporting is inconsistent.
- Inconsistent reporting limits meta-analyses and risks bias.
Purpose of the Study:
- Define a standardized COS for all future TBI and stroke cranioplasty studies.
- Collate current outcome measures via systematic review.
- Gather stakeholder perspectives through qualitative study and Delphi survey.
Main Methods:
- Systematic review of cranioplasty literature.
- Qualitative study with clinicians and patient relatives.
- Delphi survey and consensus meeting for COS development.
- Adherence to COMET and OMERACT guidelines.
Main Results:
- Phase 1 (data collection) commenced in late 2019.
- Project completion is anticipated by late 2022/early 2023.
- Consensus definitions will be established prior to the Delphi survey.
Conclusions:
- Establish a consensus COS for cranioplasty following TBI or stroke.
- Standardize outcome reporting to enhance future research and clinical services.
- Improve understanding of cranioplasty's impact on patient function and recovery.
