ArticleBMJ open2025
Comparing effectiveness of conservative policy to craniofacial surgery in children with metopic synostosis: protocol for an observational cohort study on clinical outcomes, psychosocial well-being and costs in a Dutch academic hospital.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06069479 (Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
Who cites it
1 citing paper in PubMed.
- Head Growth and Fundoscopy as Proxies for Intracranial Pressure in Metopic Synostosis Treated Surgically vs Conservatively.JAMA network open · 2026Article
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Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTraditionally, surgical intervention has been the standard treatment for children with metopic synostosis, assuming that it reduces the risk of raised intracranial pressure, thereby preventing vision and cognitive impairment, and also restores the abnormal head shape. However, recent research suggests a sporadic occurrence of raised intracranial pressure in patients with metopic synostosis. In addition, following surgery, an overall tendency to have worse cognitive and behavioral outcomes and more refractive errors compared to healthy peers is observed. Research on conservative (non-surgical) treatment in metopic synostosis is limited and lacks a comparative design. The purpose of this study is to compare the (cost-)effectiveness of conservative and surgical treatment in patients with metopic synostosis. METHODS AND ANALYSIS: This is the protocol for an observational cohort study with a duration of 8 years. A total of 450 patients with metopic synostosis will be included. The primary outcome is head growth as a predictor for increased intracranial pressure. Non-inferiority with regard to head growth from 0 to 8 years (yearly difference in SD) is determined using a linear mixed model adjusted for potential confounders. Secondary outcomes include papilledema, orthoptic outcomes; forehead shape; cognitive, behavioural and psychological outcomes; and societal costs. A cost-effectiveness analysis will be performed. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Center Rotterdam (MEC-2022-0142). Written informed consent will be obtained from both parents of each participant. The results will be disseminated by publication in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06069479.
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