Pressure Injury Data Reconciliation in a Randomized Controlled Trial

Objective: To advance pressure injury (PrI) research in individuals with spinal cord injury (SCI) by describing lessons learned and recommendations for future research, ultimately promoting PrI prevention and more effective wound care. This paper describes the detailed procedures under-taken to collect and reconcile PrI data and summarizes the types of discrepancies identified. Design: Secondary analyses of PrI data collected between 2009 and 2014 in a randomized controlled trial (parent study). Setting: Participants in the parent study were recruited from a large rehabilitation center in the Los Angeles area that serves primarily individuals with limited resources. Participants: 232 participants with SCI and a history of 1 or more medically serious PrI (MSPrI) in the previous 5 years. Interventions: Participants in the parent study were randomized to a 12-month PrI prevention intervention led by an occupational therapist, or to usual care. Main Outcome Measures: Relations among PrI characteristics, data sources (phone interviews, skin checks, paper and electronic medical records [MRs]), and treatment condition, and sensitivity of 6 different data sources in detecting MSPrIs. Results: The majority (62%) of MSPrIs were in the pelvic region. MRs detected 82% of the MSPrIs overall, making it the most sensitive data source, and scheduled skin checks were the second-most sensitive data source, finding 37% of the MSPrIs. Conclusions: MR review is the preferred method for ascertaining MSPrIs in clinical trials of interventions designed to reduce the incidence of these injuries. When multiple sources of information are used, careful reconciliation of reports is necessary to ensure accuracy. Archives of Physical Medicine and Rehabilitation 2023;104:1833-9 (c) 2023 by the American Congress of Rehabilitation Medicine.