Estraneo Anna, Fiorentino Maria Rosaria, Cibellis Tommaso, Campana Biagio, Balbi Pietro, Carli Valentina, Vatteroni Elena, Devalle Guya, Mantelli Francesco, Villa Mattia, Bianchi Alessandra, Costa Maria Concetta, Rossi Marina, Comanducci Angela, Navarro Jorge, Viganò Alessandro, De Nisco Agnese, Draghi Francesca, Hakiki Bahia, Magliacano Alfonso
IRCCS Fondazione Don Carlo Gnocchi ONLUS, Florence, Italy.
Polo Specialistico Riabilitativo, Fondazione Don Carlo Gnocchi ONLUS, Sant'Angelo dei Lombardi, Italy.
Front Neurol. 2025 Mar 12;16:1537093. doi: 10.3389/fneur.2025.1537093. eCollection 2025.
Patients with severe acquired brain injury have a high risk of developing clinical complications that affect clinical outcome and rehabilitation program. Early identification of clinical complications would allow to treat them appropriately and to prevent their worsening. However, available clinical scales for recording clinical complications are not appropriately tailored for this population. The present multicenter study aimed at developing and validating a new scale to categorize the clinical complications: the Clinical Complication Scale of the Fondazione Don Gnocchi (FDG-CCS).
Six Intensive Neurorehabilitation Units enrolled consecutively admitted patients with severe brain injury. Demographic, anamnestic, and clinical data were collected at study entry. For each enrolled patient, two independent examiners (A and B) administered the FDG-CCS considering 2 weeks as an observation time window. Concurrently, a third examiner (C) administered the Comorbidities Coma Scale. The blinded examinations were analyzed to assess the inter-rater agreement (A vs. B) and the concurrent validity of the FDG-CCS with respect to the Comorbidities Coma Scale (C).
A total of 42 patients (22 patients with and 20 emerged from prolonged disorder of consciousness) were enrolled. The FDG-CCS total score did not differ in the two subgroups of patients. Metabolic (examiner A = 33%; examiner B = 43%), gastro-intestinal (A = 31%; B = 26%), cardio-vascular (A = 26%; B = 29%), respiratory (A = 21%; B = 21%), and musculo-skeletal disorders (A = 19%; B = 14%) were the most frequent complications. Inter-rater agreement for the total score of the FDG-CCS resulted to be good (intra-class correlation coefficient = 0.865; < 0.05), and the FDG-CCS total score correlated significantly with the total score of the Comorbidities Coma Scale (A, = 0.356; = 0.01; B, ρ = 0.317; = 0.02).
The present multicenter study proposed and validated a novel clinical tool for the categorization of clinical complications of patients with severe brain injury. This clinical tool could help the rehabilitation team for planning tailored treatment and prevention of clinical complications that negatively impact patients' outcomes and hamper rehabilitation programs.
重度获得性脑损伤患者发生临床并发症的风险很高，这些并发症会影响临床结局和康复计划。早期识别临床并发症有助于进行适当治疗并防止其恶化。然而，现有的用于记录临床并发症的临床量表并不适合该人群。本多中心研究旨在开发并验证一种用于对临床并发症进行分类的新量表：唐·诺基基金会临床并发症量表（FDG-CCS）。
六个强化神经康复单元连续纳入重度脑损伤患者。在研究开始时收集人口统计学、既往史和临床数据。对于每个纳入的患者，两名独立检查者（A和B）以两周为观察时间窗应用FDG-CCS。同时，第三名检查者（C）应用共病昏迷量表。对盲法检查进行分析，以评估检查者间一致性（A与B）以及FDG-CCS相对于共病昏迷量表（C）的同时效度。
共纳入42例患者（22例有意识障碍延长情况，20例已从意识障碍延长中恢复）。两组患者的FDG-CCS总分无差异。代谢性并发症（检查者A为33%；检查者B为43%）、胃肠道并发症（A为31%；B为26%）、心血管并发症（A为26%；B为29%）、呼吸并发症（A为21%；B为21%）和肌肉骨骼疾病（A为19%；B为14%）是最常见的并发症。FDG-CCS总分的检查者间一致性良好（组内相关系数=0.865；<0.05），且FDG-CCS总分与共病昏迷量表总分显著相关（A，=0.356；=0.01；B，ρ=0.317；=0.02）。
本多中心研究提出并验证了一种用于对重度脑损伤患者临床并发症进行分类的新型临床工具。该临床工具可帮助康复团队制定针对性治疗方案，并预防对患者结局产生负面影响且阻碍康复计划的临床并发症。
