Article
Proposal for a multicentre paediatric craniectomy & cranioplasty registry (PedCCR) – a European contribution to evidence-based treatment of children
Studienprotokoll für ein multizentrisches pädiatrisches Kraniektomie und Kranioplastie-Register (PedCCR) – Vorschlag für ein europäisches Projekt zur Verbesserung der evidenzbasierten Therapie bei Kindern
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Published: | May 8, 2019 |
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Objective: In children only limited data is available regarding decompressive craniectomy (DC) and no real evidence-based guidance can be provided. Compared to DC, literature on cranioplasty and its complications is even more limited. The relevance of both DC and subsequent cranioplasty and the need for accurate and systematic data have led to establishment of multicenter registries enrolling only adults. Thus, we propose a Pediatric Craniectomy & Cranioplasty Registry (PedCCR).
Methods: After thorough literature review, gaps in knowledge and evidence were identified and the following aims for PedCCR were defined:
- 1.
- Compare surgical practices regarding indication, timing and operative technique in a large multicenter cohort.
- 2.
- Provide outcome data in a large multicenter cohort.
- 3.
- Establish risk factors for complications and cranioplasty failure based on systematic data reaching back as far as the initial injury.
Results: The PedCCR will be a prospective, multicenter, open registry enrolling children (≤16 years) undergoing DC and/or cranioplasty for any pathology. The study will be performed in accordance to the Declaration of Helsinki after ethical review board approval. A steering committee will assure good scientific practice. Standardized questionnaires were designed and data will be collected online and transmitted into an electronic joint database. The study protocol distinguishes three clinical phases: 1) decompressive craniectomy phase, 2) cranioplasty phase and 3) follow up phase. The core set of data for each patient will comprise six case report forms in the first year after the initial insult and subsequent DC. Beyond the first year, annual visits with routine follow up forms are recommended until adulthood. Additionally, incident reporting forms can be submitted at any stage for any incident or unscheduled operation deemed relevant by the individual center. All forms allow reporting of basic data even in the absence of the patient, i.e. by telephone interview or written contact to parents/carers/treating physicians/rehabilitation clinic.
Conclusion: The PedCCR sets out to answer highly relevant open questions regarding pediatric DC and cranioplasty by using a high-quality prospective approach. The registry proposal was designed to maximize scientific yield at reasonable effort for participating centers. Collaboration at all levels, including optimizing the study design, is highly appreciated to advance this project together.