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

Abstract

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 con-sortium. 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.

Time to Completion of Pediatric PROMIS Computerized Adaptive Testing Measures and the SRS-22r in an Adolescent Idiopathic Scoliosis Population

“…To our knowledge, no other studies have evaluated the test-taker burden of Pediatric PROMIS CATs in a similar pediatric orthopaedic population. However, several studies have found similar TTCs in adults 16. In a cross-sectional study of completion time for 4 PROMIS CATs in adults (Pain Interference, Physical Function [lower extremity], Upper Extremity, and Depression) at a single sports medicine clinic, Omar Kadri et al12 found a mean TTC of 0.83 minutes per PROMIS CAT.…”

“…However, several studies have found similar TTCs in adults. 16 In a cross-sectional study of completion time for 4 PROMIS CATs in adults (Pain Interference, Physical Function [lower extremity], Upper Extremity, and Depression) at a single sports medicine clinic, Omar Kadri et al 12 found a mean TTC of 0.83 minutes per PROMIS CAT. Similarly, Bernstein et al 3 found a mean TTC of 0.86 minutes when evaluating the same 4 PROMIS CATs for 20,489 unique visits at a single academic medical center hand clinic.…”