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Outcome Measures Reported in Published Clinical Research Studies in Craniosynostosis: A Systematic Review.
Thomas E Pidgeon1, Yasser Al Omran1, Reem Farwana2
1University Hospital Birmingham, Edgbaston, Birmingham.
The Journal of Craniofacial Surgery
|August 3, 2020
Summary
Outcomes for craniosynostosis treatment are inconsistently reported and defined, hindering fair comparisons. Standardizing outcome definitions and prespecification is crucial for improving craniosynostosis care.
Area of Science:
- Craniofacial Surgery
- Pediatric Neurosurgery
- Clinical Trial Methodology
Background:
- Craniosynostosis treatment comparisons are hindered by inconsistent outcome reporting.
- Lack of standardized outcomes complicates the evaluation of different surgical interventions.
Purpose of the Study:
- To assess outcomes reported in craniosynostosis studies.
- To determine if reported outcomes are formally defined and prespecified.
Main Methods:
- Systematic literature search for craniosynostosis interventional studies (2011-2015).
- Independent review of 240 studies involving 18,365 patients.
- Data extraction on reported outcomes, definitions, and prespecification.
Main Results:
- 2192 distinct outcomes were reported; only 38.8% were clearly defined.
- 63.6% of outcomes were prespecified in study methods.
- "Clinical and functional" outcomes were most common; "patient-reported" outcomes were least common.
Conclusions:
- Inconsistent and incomplete outcome definitions impede craniosynostosis research comparability.
- Improved outcome definitions and prespecification are needed to advance craniosynostosis treatment strategies.
- Suboptimal prespecification raises concerns about potential outcome reporting bias.
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