Development of a novel neurogenic bowel patient reported outcome measure: the Spinal Cord Injury Patient Reported Outcome Measure of Bowel Function & Evacuation (SCI-PROBE)

Study design Outcome measure item generation and reduction. Objectives To develop a patient reported outcome measure (PROM) addressing the impact of neurogenic bowel dysfunction (NBD) on individuals living with traumatic or nontraumatic spinal cord injury (SCI). Setting Tertiary rehabilitation center in Toronto, Canada. Methods A PROM based on the International Classification of Functioning, Disability and Health (ICF) framework was developed using the following steps: (a) item generation, (b) item refinement through iterative review, (c) completion of items by individuals living with SCI and NBD followed by cognitive interviewing, and (d) further item refinement, item reduction, and construction of the preliminary PROM. Results Following initial item generation and iterative review, the investigative team agreed on 55 initial items. Cognitive interviewing, additional revisions, and item reduction yielded an instrument comprised of 35 items; while ensuring at least two items were retained for each of the 16 previously identified challenges of living with NBD following the onset of a SCI. Scoring for the preliminary PROM ranges from 0 to 140. Conclusions A preliminary PROM informed by the ICF for assessing the impact of NBD post-SCI has been devised, which can be used to inform clinicians and decision-makers on optimal ways to treat this serious secondary health complication. Future work will assess the validity and clinimetric properties of the PROM.