The Clinical Complication Scale of Fondazione Don Gnocchi (FDG-CCS) for classifying clinical complications in patients with severe acquired brain injury: development and multicentre validation

Anna Estraneo ^1* Maria Rosaria Fiorentino ² Tommaso Cibellis ² Biagio Campana ² Pietro Balbi ³ Valentina Carli ³ Elena Vatteroni ³ Guya Devalle ⁴ Francesco Mantelli ⁴ Mattia Villa ⁴ Alessandra Bianchi ⁵ Maria Concetta Costa ⁵ Marina Rossi ⁵ Angela Comanducci ⁶ Jorge Navarro ⁶ Alessandro Viganò ⁶ Agnese De Nisco ¹ Francesca Draghi ¹ Bahia Hakiki ^1,7 Alfonso Magliacano ¹

• ¹ IRCCS Don Carlo Gnocchi Firenze, Florence, Italy
• ² Polo Specialistico Riabilitativo, Fondazione Don Carlo Gnocchi ONLUS, Sant’Angelo dei Lombardi, Italy
• ³ Polo Riabilitativo del Levante Ligure, Fondazione Don Carlo Gnocchi Onlus (IRCCS), La Spezia, Italy
• ⁴ Istituto Palazzolo Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy
• ⁵ Centro Spalenza Fondazione Don Carlo Gnocchi ONLUS, Rovato, Italy
• ⁶ Santa Maria Nascente, Fondazione Don Carlo Gnocchi Onlus (IRCCS), Milano, Italy
• ⁷ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

Introduction. Patients with severe acquired brain injury have a high risk of developing clinical complications that affect clinical outcome and rehabilitation programme. 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 multicentre 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). Methods. 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 two weeks as an observation time window. Concurrently, a third examiner (C) administered the Comorbidities Coma Scale. The blinded examinations were analysed 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). Results. 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 = .865; p<.05), and the FDG-CCS total score correlated significantly with the total score of the Comorbidities Coma Scale (A, ρ = .356; p = 0.01; B, ρ = .317; p = 0.02). Discussion. The present multicentre 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 programmes.