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Establishing clinical severity for PROMIS® measures in adult patients with rheumatic diseases

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Abstract

Purpose

Different patient-reported outcome (PRO) measures are used for rheumatic diseases (RD). The aims of this study are—(1) Identify PROMIS® domains most relevant to care of patients with RD, (2) Collect T-Score metrics in patients with RD, and (3) Identify clinically meaningful cut-points for these domains.

Methods

A convenience sample of RD patients was recruited consecutively during clinic visits, and asked to complete computer-adaptive tests on thirteen Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments. Based on discussion with clinical providers, four measures were chosen to be relevant and actionable (from rheumatologists’ perspective) in RD patients. Data from RD patients were used to develop clinical vignettes across a range of symptom severity. Vignettes were created based on most likely item responses at different levels on the T-score metric (mean = 50; SD = 10) and anchored at 5-point intervals (0.5 SDs). Patients with RD (N = 9) and clinical providers (N = 10) participated as expert panelists in separate one-day meetings using a modified educational standard setting method.

Results

Four domains (physical function, pain interferences, sleep disturbance, depression) that are actionable at the point-of-care were selected. For all domains, patients endorsed cut-points at lower levels of impairment than providers by 0.5 to 1 SD (e.g., severe impairment in physical function was defined as a T-score of 35 by patients and 25 by providers).

Conclusions

We used a modified educational method to estimate clinically relevant cut-points to classify severity for PROMIS measures This allows for meaningful interpretation of PROMIS® measures in a clinical setting of RD population.

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Acknowledgements

The authors thank National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases for funding the study and Dr. D. Khanna (NIH/NIAMS K24 AR 063120), and Dr. Young (NIH/NIAMS T32-AR007080-38).

Funding

The study and Dr. D. Khanna were funded by the NIH/NIAMS K24 AR 063120, and Dr. Young by NIH/NIAMS T32-AR007080-38.

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Correspondence to Dinesh Khanna.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study was approved by the University of Michigan Institutional Review Board. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individuals who participated in the phase 2 of the study, and from patients and providers who participated in the panel group discussions.

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Nagaraja, V., Mara, C., Khanna, P.P. et al. Establishing clinical severity for PROMIS® measures in adult patients with rheumatic diseases. Qual Life Res 27, 755–764 (2018). https://doi.org/10.1007/s11136-017-1709-z

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