Greek Registry of Cerebral Aneurysms
We are writing to announce the official launch of the Greek Registry of Cerebral Aneurysms (GRECA). This is a national project that our team has been working on for the past couple of years. It involves an online, prospective, and continuous database that will be operated on behalf of the Greek Neurosurgical Society and will collect national-level data on both ruptured and unruptured cerebral aneurysms.
The worldwide prevalence of cerebral aneurysms is ∼3% with an overall female-to-male ratio close to 1.6:1. However, the exact regional patterns of the disease, reflecting different risk factor profiles, remain unknown. Detailed nationwide reports are produced regularly only in a few countries (e.g., Finland and Japan) with all other similar datasets being essentially estimates.
The primary purpose of our registry is to serve as a tool for disease monitoring. Providing data on epidemiology, presentation, and treatment of aneurysms, and also subarachnoid hemorrhage (SAH), throughout the country, it will help us evaluate our everyday practice and shape future public health policies. This is extremely important when taking into consideration the relevant high treatment costs, Greece's aging population, and the constant pressure put on the Greek social security funds. Similar difficulties and challenges are posed in all other European countries.
Apart from its value as a health policy-making tool, GRECA will also offer insights into the disease itself. Real-time observational studies based on patient registries are increasingly recognized as an invaluable source of information. Propensity analysis allows for them—if properly designed—to mimic randomized controlled trials (RCTs). In this context, patient registries provide a naturalistic approach to medical research. With many questions still open to debate when it comes to cerebral aneurysms, GRECA has been designed in such a way as to facilitate statistical analysis of input data and extrapolation of correlations. An obvious example of such a question relates to the natural history and best management of unruptured aneurysms. Other fields of research will include aneurysm and SAH risk factors, optimal follow-up regimes, and vasospasm.
One last area of interest where GRECA could be proven useful is assessment and validation of different endovascular devices out on the market today. In an ever-changing field, and with companies trying to provide solutions for embolization of even the most complex lesions, novel devices are released constantly. GRECA will offer real-world data on the efficacy, safety, and potential complications associated with such devices providing a useful tool for not only physicians but also the industry itself.
GRECA is, as already mentioned, a web-based, prospective, and continuous database on cerebral aneurysms. Its software has been developed by RISA Ltd in accordance to General Data Protection Regulation (GDPR) provisions, while funding comes from the Greek Neurosurgical Society itself. RISA Ltd will also provide support on statistical analysis of data. Access to the registry is password protected and will be granted to all neurosurgical departments in Greece, both in the public and in the private sector. Each department is required to appoint a designated operator—preferably a senior member of staff—who will be supervising data collection and submission. Structured training of operators through online short courses (including the Good Clinical Practices course), continuous feedback, and a 24/7 running helpdesk will assure data quality and consecutiveness. Incentives provided to designated operators include free registration to annual conferences of the Greek Neurosurgical Society as well as the opportunity to participate in any research that will come out of the data collected. Monitoring of the whole process will be based on random case controls conducted by the scientific coordinator's team as well as comparison of numbers going in the registry with those expected by what we already know on the epidemiology of the disease. Designated operators and members of the Board of the Greek Neurosurgical Society will be able to propose dataset modifications. If deemed of value, such modifications will be handled by the scientific coordinator with relevant instructions provided to all operators. Of note, data access will be granted to appropriately designed and approved research projects with the permission of the Board of the Greek Neurosurgical Society.
Data collected in our registry include most of the SAH and unruptured aneurysm-associated NIH Common Data Elements (CDEs). Appropriate coding (CDE ID) will be used. Details on (1) epidemiology, (2) associated comorbidities, (3) mode of presentation, (4) treatment, (5) complications, (6) outcome (modified Rankin score [mRS]), and (7) follow-up will form the main bulk of data, while the operators will be also able to introduce any information they deem appropriate in the form of free notes. The registry's design has also incorporated multiple lesions or interventions in the form of different tabs available to the operator. The platform is both interactive and intuitive, allowing for DICOM or JPEG images to be uploaded depending on the operator's wishes. Keep in mind that the current article is a mere announcement of GRECA's official launch of our registry and has no ambition to serve as a detailed presentation of the project. There will be an original article to follow with details on the dataset and preliminary data.
After an initial 4-month trial period, the registry will become fully operational. Future prospects include expansion of the database to other vascular pathologies such as stroke and arteriovenous malformations (AVMs) as well as collaboration with any similar projects in other countries (e.g., the Swiss SOS initiative). Although difficulties will arise, we hope that our project will bring together neurosurgeons from all over Greece and that our whole community will embrace it.
04 February 2021 (online)
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