Streamlining Trauma Research Evaluation with Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox within an Orthopaedic Trauma Clinical Trials Consortium

Abstract

The Patient-Reported Outcomes Measurement Information System (PROMIS) has developed item banks, short forms, and computer-adaptive tests (CATs) to help standardize measurement for important patient-reported outcome domains. These tools have the potential to revolutionize outcome measurement in clinical research through greater assessment precision while reducing response burden. Perceived implementation challenges include the need for CAT software, mobile technology, and Internet access. Here, we present preliminary results examining the feasibility of using PROMIS tools within a large, multicenter clinical trials consortium. The assessment of 10 PROMIS domains was incorporated into the longitudinal data collection of 6 ongoing orthopaedic trauma clinical trials for participants being evaluated at 3, 6, and 12 months after an orthopaedic injury. Twelve-month assessments included both CAT assessments and completion of full item banks for a subset of domains. Data were collected for 1000 trauma patients at 43 trauma centers using a custom-built application which included an interface with our primary data capture system. Paper short forms were available as backup instruments and used infrequently. Six- and 12-month study assessments were conducted for 83% and 77% of patients, respectively. It was feasible to use PROMIS tools in a large multicenter, trauma orthopaedics research setting. The ability to efficiently assess a wide spectrum of domains is critically important to the successful completion of future large-scale trials.