Validity of an Interview and Online Version of the ISNCSCI

The International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) is recognized as the standard for the examination and classification of neurological impairment after spinal cord injury (SCI). It is the only biomarker currently considered to be a core Common Data Element to be used in all acute clinical SCI trials. Reliable, accurate performance of the ISNCSCI requires standardized examiner training and an in-person assessment of the unclothed subject in supine position. These ISNCSCI prerequisites can lead to poor access to reliable assessment in areas not close to a hub SCI center, especially during the COVID-19 pandemic. Multiple large SCI longitudinal databases and registries include ISNCSCI neurological data. The percentage of missing ISNCSCI data is much higher at follow-up than at initial enrollment due to the difficulties enrollees face returning to centers for the in-person exam. We propose to develop valid and reliable interview and online versions of the ISNCSCI (I- and O-ISNCSCI) that can be used when it is not possible to perform the standard ISNCSCI, such as using telehealth; it is not meant to replace the standard ISNCSCI. The I- and O-ISNCSCI, developed with branching logic, will include 11 dermatomal and 10 myotomal groupings and utilize collapsed motor and sensory grading. The wording and language of the I- and O-ISNCSCI will be refined with cognitive interviews for getting input from persons with SCI. The I- and O-ISNCSCI will be tested at SCI outpatient settings at Mount Sinai Hospital and Kessler Institute. The I- and O-ISNCSCI will be administered prior to a standard ISNCSCI in an assessor blinded fashion. Assessment of reliability and validity will be tested in standard manner. It is expected that a validated I- and O-ISNCSCI will have a wide impact in the assessment of outcomes after SCI, from virtual evaluation/telehealth, screening for clinical trials, to long term and remote follow-up of neurological changes. (CHN: SCIRTS chn:wdg)