Hernández-Gallego Jesús, Llamas-Velasco Sara, Bermejo-Pareja Felix, Vega Saturio, Tapias-Merino Ester, Rodríguez-Sánchez Emiliano, Boycheva Elina, Serrano José Ignacio, Gil-García Juan-Francisco, Trincado Rocio, Sánchez-Rodrigo José-María Vizcaino, Cacho Jesús, Contador Israel, Garcia-Ptacek Sara, Sierra-Hidalgo Fernando, Cubo Esther, Carro Eva, Villarejo-Galende Alberto, García García-Patino Rosalía, Benito-León Julián
Department of Neurology, University Hospital "12 de Octubre", Madrid, Spain.
Spanish Network for Biomedical Research in Neurodegenerative Diseases, Carlos III Research Institute, Madrid, Spain.
JMIR Res Protoc. 2019 Jan 10;8(1):e10941. doi: 10.2196/10941.
The Neurological Disorders in Central Spain, second survey (NEDICES-2) is a population-based, closed-cohort study that will include over 8000 subjects aged ≥55 years. It will also include a biobank.
The objective of this study was to evaluate all major aspects of the NEDICES-2 (methods, database, screening instruments, and questionnaires, as well as interexpert rating of the neurological diagnoses) in each one of the planned areas (all of them in central Spain) and to test the possibility of obtaining biological samples from each participant.
A selection of patients and participants of the planned NEDICES-2 underwent face-to-face interviews including a comprehensive questionnaire on demographics, current medications, medical conditions, and lifestyle habits. Biological samples (blood, saliva, urine, and hair) were also obtained. Furthermore, every participant was examined by a neurologist.
In this pilot study, 567 study participants were enrolled (196 from hospitals and 371 from primary care physician lists). Of these 567, 310 completed all study procedures (questionnaires and the neurological evaluation). The study was time-consuming for several primary care physicians. Hence, a few primary care physicians from some areas refused to participate, which led to a reconfiguration of study areas. In addition, the central biobank needed to be supplemented by the biobanks of local Spanish National Health System hospitals.
Population-based epidemiological surveys, such as the NEDICES-2, require a pilot study to evaluate the feasibility of all aspects of a future field study (population selection, methods and instruments to be used, neurological diagnosis agreement, and data collection).
西班牙中部神经系统疾病第二次调查(NEDICES - 2)是一项基于人群的封闭队列研究,将纳入8000多名年龄≥55岁的受试者。该研究还将包括一个生物样本库。
本研究的目的是评估NEDICES - 2的所有主要方面(方法、数据库、筛查工具和问卷,以及神经学诊断的专家间评级)在每个计划区域(均位于西班牙中部)的情况,并测试从每位参与者获取生物样本的可能性。
对计划参与NEDICES - 2的患者和参与者进行面对面访谈,包括一份关于人口统计学、当前用药情况、医疗状况和生活习惯的综合问卷。还获取了生物样本(血液、唾液、尿液和毛发)。此外,每位参与者都接受了神经科医生的检查。
在这项试点研究中,招募了567名研究参与者(196名来自医院,371名来自初级保健医生名单)。在这567名参与者中,310名完成了所有研究程序(问卷和神经学评估)。该研究对几位初级保健医生来说耗时较长。因此,一些地区的几位初级保健医生拒绝参与,这导致了研究区域的重新规划。此外,中央生物样本库需要由西班牙国家卫生系统当地医院的生物样本库进行补充。
像NEDICES - 2这样基于人群的流行病学调查需要进行试点研究,以评估未来实地研究各方面的可行性(人群选择、使用的方法和工具、神经学诊断一致性以及数据收集)。