Developing an instrument for an early prediction model of long-term functional outcomes in people with acquired injuries

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ORIGINAL ARTICLE

Developing an instrument for an early prediction model of long-term functional outcomes in people with acquired injuries of the central nervous system: protocol and methodological aspects Stefano Masiero 1,2 & Humberto Antonio Cerrel Bazo 3 & Marcello Rattazzi 4,5 & Laura Bernardi 1 & Marina Munari 6 & Elisabetta Faggin 4 & Manuela Cattelan 7 & Paolo Pauletto 8 & Alessandra Del Felice 1,2 Received: 25 March 2020 / Accepted: 10 October 2020 # The Author(s) 2020

Abstract Severe acquired brain injury (ABI) is a major cause of long-term disability and is the main determinant of health and societal costs. Early identification of favourable long-term recovery would allow personalized rehabilitative programs and better health care resources allocation. In light of the higher survival rate from intensive care units (ICU) in recent years, there is a growing need for early prognostication markers of functional recovery; to date, these data have been mainly collected at rehabilitation unit admission and not during the acute phase. We present the protocol and methodology to develop prediction models in people with severe acquired brain injury (GCS at admission to ICU < 8) for the functional and cognitive outcome at 12 months from the event. Predictors will be collected during the acute stage. Participants will be recruited within the first 72 h from the event in the ICUs of two teaching hospitals (Padova and Treviso). Participants will be followed up at discharge from ICU, admission and discharge from Neurorehabilitation and after 12 months from the event. Clinical and functional scales, electroencephalography, evoked potentials, magnetic resonance imaging and serological markers will be entered into a digital registry. Survival will be estimated using the Cox proportional hazard model. A multivariate prediction model will be developed for each of the functional and cognitive outcomes at 12 months from the event. Keywords Coma . Vegetative state . Minimally consciousness state . Disorders of consciousness . Prognosis

Introduction Severe acquired brain injury (ABI) is a major cause of longterm disability and one of the main determinants of health care

and societal costs in terms of DALYs (disability-adjusted life years). Short-term outcome/survival has mainly been investigated in intensive care units (ICUs) but long-term functional outcomes [1, 2], including social, vocational and cognitive

Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10072-020-04821-8) contains supplementary material, which is available to authorized users. * Alessandra Del Felice [email protected]

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Department of Medicine - DIMED, Medicina Generale I^, Ca’ Foncello Hospital, University of Padova, Treviso, Italy

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Department of Neuroscience, Section of Rehabilitation & NEUROMOVE-Rehab Lab, University of Padova, Via Giustiniani n. 3, 35128 Padova, Italy

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Department of Medicine - DIMED, Institute of Anesthesiology and Intensive Care - Neurointensive Care Unit, Padova Unive