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
Introduction Traditionally, 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 re...
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2025-05-01
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| author | Suzanne Polinder Erwin Ista Nicole Erler Irene Mathijssen Jolanda Okkerse K Joosten Natalja Bannink Mariët Faasse Sarah Lisa Versnel Pauline Tio Merel van Staalduinen K Dulfer Sjoukje Loudon Marieke Telleman Tareq Abdel-Alim Gennady Roshchupkin Stella Heemskerk Marie-Lise van Veelen Arianne van Driel Jochem Spoor Elin Weissbach Jacoba Kats Mieke Pleumeekers |
| author_facet | Suzanne Polinder Erwin Ista Nicole Erler Irene Mathijssen Jolanda Okkerse K Joosten Natalja Bannink Mariët Faasse Sarah Lisa Versnel Pauline Tio Merel van Staalduinen K Dulfer Sjoukje Loudon Marieke Telleman Tareq Abdel-Alim Gennady Roshchupkin Stella Heemskerk Marie-Lise van Veelen Arianne van Driel Jochem Spoor Elin Weissbach Jacoba Kats Mieke Pleumeekers |
| author_sort | Suzanne Polinder |
| collection | DOAJ |
| description | Introduction Traditionally, 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. |
| format | Article |
| id | doaj-art-cb2a4563f33142f798904b467dcf0b05 |
| institution | OA Journals |
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| language | English |
| publishDate | 2025-05-01 |
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| series | BMJ Open |
| spelling | doaj-art-cb2a4563f33142f798904b467dcf0b052025-08-20T02:15:30ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-094112Comparing 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 hospitalSuzanne Polinder0Erwin Ista1Nicole Erler2Irene Mathijssen3Jolanda Okkerse4K Joosten5Natalja Bannink6Mariët Faasse7Sarah Lisa Versnel8Pauline Tio9Merel van Staalduinen10K Dulfer11Sjoukje Loudon12Marieke Telleman13Tareq Abdel-Alim14Gennady Roshchupkin15Stella Heemskerk16Marie-Lise van Veelen17Arianne van Driel18Jochem Spoor19Elin Weissbach20Jacoba Kats21Mieke Pleumeekers22Department of Public Health, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Neonatal and Pediatric Intensive Care, Erasmus MC Sophia, Rotterdam, The NetherlandsDepartment of Biostatistics, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia, Rotterdam, The NetherlandsDepartment of Neonatal and Pediatric Intensive Care, Erasmus MC Sophia, Rotterdam, The NetherlandsDepartment of Pediatrics, Franciscus Gasthuis en Vlietland, Rotterdam, The NetherlandsDutch Patient and Parent Society for Craniofacial Conditions, Rotterdam, The NetherlandsDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia, Rotterdam, The NetherlandsDepartment of Neonatal and Pediatric Intensive Care, Erasmus MC Sophia, Rotterdam, The NetherlandsDepartment of Ophthalmology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Ophthalmology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Neurosurgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Epidemiology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Public Health, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Neurosurgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Pediatrics, IJsselland Ziekenhuis, Capelle aan den IJssel, The NetherlandsDepartment of Neurosurgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsDepartment of Plastic and Reconstructive Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, The NetherlandsIntroduction Traditionally, 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.https://bmjopen.bmj.com/content/15/5/e094112.full |
| spellingShingle | Suzanne Polinder Erwin Ista Nicole Erler Irene Mathijssen Jolanda Okkerse K Joosten Natalja Bannink Mariët Faasse Sarah Lisa Versnel Pauline Tio Merel van Staalduinen K Dulfer Sjoukje Loudon Marieke Telleman Tareq Abdel-Alim Gennady Roshchupkin Stella Heemskerk Marie-Lise van Veelen Arianne van Driel Jochem Spoor Elin Weissbach Jacoba Kats Mieke Pleumeekers 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/5/e094112.full |
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