Background: There is a concern that patients may answer patient-reported outcome (PRO) questionnaires differently depending on the purpose-clinical care or research (eg, "Hawthorne effect"). We sought to determine whether Patient-Reported Outcomes Management Information System (PROMIS) scores differ at the same clinic visit based on whether a patient was completing the PRO tool for study or clinical care purposes. Methods: Patients presenting to one surgeon at an academic medical center hand clinic were asked to complete PROMIS Physical Function (PF) and Pain Interference (PI) questionnaires as part of routine care. Those diagnosed with carpal tunnel syndrome from February 2015 to April 2017 were then asked to participate in a clinical research project, which had them complete PROMIS PF and PROMIS PI again. Data from those who completed both routine and research PROs at each visit were compared. Between the 2 settings, test-retest reliability was determined using Pearson correlation coefficients (r), and internal consistency was evaluated using Cronbach α. Results: A total of 128 unique office visits representing 67 patients fit our inclusion criteria. There was a strong correlation between PROMIS PF and PI in the research and patient care setting (PF: r = 0.82, P < .01; PI: r = 0.83, P < .01). Both domains had a Cronbach α of 0.90. The PROMIS PF scores were not different between the 2 groups (P = .19), but the PROMIS PI scores were slightly different (P < .01). Conclusions: Patients appear to be consistent when completing PROMIS for both clinical care and research, supporting the idea that data obtained in either setting are generalizable and appropriate for research purposes.
Keywords: PROMIS; bias; hand surgery; patient-reported outcomes; test-retest reliability.