Patient-Reported Outcome Measurement Information System (PROMIS) Scores Are Not Biased When Gathered in a Study Scenario Compared to a Patient Care Setting
Warren C. Hammert, MD1; David N Bernstein, MBA, MA2; Constantinos Ketonis, MD, PhD2;
1Department of Orthopaedics, University of Rochester, Rochester, NY, 2University of Rochester Medical Center, Rochester, NY
Introduction: PROMIS, a universal PRO instrument, is an outcome instrument that can be used as the healthcare paradigm shifts towards value-based medicine. PROMIS may be more advantageous to use than traditional PRO tools, and may be used in select situations to predict clinical benefit preoperatively. However, such research is only as valuable as the accuracy of the preoperative and postoperative PROMIS scores collected. There is concern that patients may answer PROMIS questionnaires differently depending on the purpose. We aimed to determine if PROMIS scores differed at the same clinic visit based on whether a patient was completing the PRO tool for study purposes or for clinical care purposes.
Methods: Patients presenting to a single hand clinic at an urban tertiary care center were asked to complete PROMIS PI and PF questionnaires. Those diagnosed with carpal tunnel syndrome from 2/2015-4/2017 were asked to participate in a clinical research project with those agreeing completing PROMIS Physical Function (PF), PROMIS Pain Interference (PI), Michigan Hand Questionnaire (MHQ), and Boston Carpal Tunnel Questionnaire (BCTQ). Data from those who completed both routine and research PROs at each visit were compared. Test-restest reliability was determined using Pearson correlation coefficients (r) and calculating the change in scores from one setting to the other. Significance was set at p<0.05.
Results: A total of 128 unique office visits representing 67 patients fit our inclusion criteria. A majority were women (79; 62%) and the average age was 58 years (range, 36-86 years). There was a strong correlation between PROMIS PF in the study and patient care setting (r = 0.82, p<0.01), as well as between PROMIS PI in the study and patient care setting (r = 0.83, p<0.01). On average, there was a very slight decrease in PROMIS PF scores in the patient care setting compared to the study setting (average delta PROMIS PF = -0.51, Standard Deviation (SD): 4.34). On average, there were slightly worse PROMIS PI scores in the patient care setting compared to the study setting (average delta PROMIS PI = 2.09, SD: 4.85).
Conclusions: Patients appear to be consistent when completing PROMIS for both clinical care and research, supporting the idea that data obtained as part of routine care can be used for clinical research.
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