Patients and clinicians define symptom levels and meaningful change for PROMIS pain interference and fatigue in RA using bookmarking

Objectives Using patient-reported outcomes to inform clinical decision-making depends on knowing how to interpret scores. Patient-Reported Outcome Measurement Information System((R)) (PROMIS (R)) instruments are increasingly used in rheumatology research and care, but there is little information available to guide interpretation of scores. We sought to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspective of RA patients and clinicians. Methods We developed patient vignettes using the PROMIS item banks representing a continuum of Pain Interference and Fatigue levels. During a series of face-to-face 'bookmarking' sessions, patients and clinicians identified thresholds for mild, moderate and severe levels of symptoms and identified change deemed meaningful for making treatment decisions. Results In general, patients selected higher cut points to demarcate thresholds than clinicians. Patients and clinicians generally identified changes of 5-10 points as representing meaningful change. The thresholds and meaningful change scores of patients were grounded in their lived experiences having RA, approach to self-management, and the impacts on function, roles and social participation. Conclusion Results offer new information about how both patients and clinicians view RA symptoms and functional impacts. Results suggest that patients and providers may use different strategies to define and interpret RA symptoms, and select different thresholds when describing symptoms as mild, moderate or severe. The magnitude of symptom change selected by patients and clinicians as being clinically meaningful in interpreting treatment efficacy and loss of response may be greater than levels determined by external anchor and statistical methods.

Automated summary

This study aimed to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspectives of RA patients and clinicians. Results showed that patients generally selected higher cut points to demarcate symptom thresholds than clinicians, and both patients and clinicians considered changes of 5-10 points as meaningful. Patients' thresholds and meaningful change scores were influenced by their personal experiences with RA and impacts on function, roles, and social participation, suggesting potential differences in how patients and providers interpret RA symptoms.