German Cranial Reconstruction Registry (GCRR): protocol for a prospective, multicentre, open registry

Introduction: Owing to increasing numbers of decompressive craniectomies in patients with malignant middle cerebral artery infarction, cranioplastic surgery becomes more relevant. However, the current literature mainly consists of retrospective single-centre (evidence class III) studies. This leads to a wide variability of technical approaches and clinical outcomes. To improve our knowledge about the key elements of cranioplasty, which may help optimising clinical treatment and long-term outcome, a prospective multicentre registry across Germany, Austria and Switzerland will be established. Methods: All patients undergoing cranioplastic surgery in participating centres will be invited to join the registry. Technical methods, materials, medical history, adverse events and clinical outcome measures, including modified Rankin scale and EQ-5D, will be assessed at several time points. Patients will be accessible to inclusion either at initial decompressive surgery or when cranioplasty is planned. Scheduled monitoring will be carried out at time of inclusion and subsequently at time of discharge, if any readmission is necessary, and at follow-up presentation. Cosmetic results and patient satisfaction will also be assessed. Collected data will be managed and statistically analysed by an independent biometric institute. The primary endpoint will be mortality, need for operative revision and neurological status at 3 months following cranioplasty. Ethics and dissemination: Ethics approval was obtained at all participating centres. The registry will provide reliable prospective evidence on surgical techniques, used materials, adverse events and functional outcome, to optimise patient treatment. We expect this study to give new insights in the treatment of skull defects and to provide a basis for future evidence-based therapy regarding cranioplastic surgery. Trial registration number: This trial is indexed in the German Clinical Trials Register (DRKS-ID: DRKS00007931). The Universal Trial Number (UTN) is U1111-1168-7425

Fluoroscopic radiation exposure of the kyphoplasty patient

Kyphoplasty (KP) is a minimally invasive technique for the percutaneous stabilisation of vertebral fractures. As such, this technique is highly dependent upon intraoperative fluoroscopic visualisation. In order to assess the range of radiation doses that patients are typically subjected to, 60 consecutive procedures using simultaneous bilateral fluoroscopy were analysed with respect to exposure time (ET). In a subset of 16 of these patients, a theoretical entrance skin dose (ESD) and effective dose was additionally calculated from intraoperatively measured dose area product. Average fluoroscopy time for single level cases reached 2.2 min (range 0.6–4.3) in the lateral plane and 1.6 min (range 0.5–3.0) in the anterior–posterior plane. For multiple level cases the corresponding ET per level was 1.7 min (range 0.6–2.9) per level in the lateral and 1.1 min (range 0.5–2.0) in the anterior-posterior plane. ESD was estimated as an average 0.32 Gy (range 0.05–0.86) in the anterior–posterior and 0.68 Gy (range 0.10–1.43) in the lateral plane. Effective dose (cumulative from both planes) averaged 4.28 mSv (range 0.47–10.14). Safety margins for the development of early transient erythema are respected within the presented fluoroscopy times. Longer ET in the lateral plane may however breach the 2 Gy threshold. Use of large c-arms and judiciously operating the exposure is recommended. With regard to effective dose, a single fluoroscopy guided KP performed for osteoporotic or traumatic vertebral fractures is a safe procedure

Development and assessment of competency-based neurotrauma course curriculum for international neurosurgery residents and neurosurgeons

Traumatic brain injuries (TBIs) are a significant disease burden worldwide. It is imperative to improve neurosurgeons’ training during and after their medical residency with appropriate neurotrauma competencies. Unfortunately, the development of these competencies during neurosurgeons’ careers and in daily practice is very heterogeneous. This article aimed to describe the development and evaluation of a competency-based international course curriculum designed to address a broad spectrum of needs for taking care of patients with neurotrauma with basic and advanced interventions in different scenarios around the world. METHODS A committee of 5 academic neurosurgeons was involved in the task of building this course curriculum. The process started with the identification of the problems to be addressed and the subsequent performance needed. After this, competencies were defined. In the final phase, educational activities were designed to achieve the intended learning outcomes. In the end, the entire process resulted in competency and outcomes-based education strategy, including a definition of all learning activities and learning outcomes (curriculum), that can be integrated with a faculty development process, including training. Further development was completed by 4 additional academic neurosurgeons supported by a curriculum developer specialist and a project manager. After the development of the course curriculum, template programs were developed with core and optional content defined for implementation and evaluation. RESULTS The content of the course curriculum is divided into essentials and advanced concepts and interventions in neurotrauma care. A mixed sample of 1583 neurosurgeons and neurosurgery residents attending 36 continuing medical education activities in 30 different cities around the world evaluated the course. The average satisfaction was 97%. The average usefulness score was 4.2, according to the Likert scale. CONCLUSIONS An international competency-based course curriculum is an option for creating a well-accepted neurotrauma educational process designed to address a broad spectrum of needs that a neurotrauma practitioner faces during the basic and advanced care of patients in different regions of the world. This process may also be applied to other areas of the neurosurgical knowledge spectrum. Moreover, this process allows worldwide standardization of knowledge requirements and competencies, such that training may be better benchmarked between countries regardless of their income level