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Abstract Number: 0317

Patient and Physician Perspectives on EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI): A Qualitative Interview Study

Samantha Wratten1, Carl Cooper2, Jessica Flynn2, Natasha Griffiths2, Rebecca Hall3, Linda Abetz-Webb2, Simon J Bowman4, Wolfgang Hueber5, Briana Ndife6 and Pushpendra Goswami5, 1Adelphi Values, Macclesfield, United Kingdom, 2Adelphi Values, Bollington, United Kingdom, 3Adelphi Values Ltd, Bollington, United Kingdom, 4Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom, 5Novartis Pharma AG, Basel, Switzerland, 6Novartis, East Hanover, NJ

Meeting: ACR Convergence 2021

Keywords: autoimmune diseases, Disease Activity, Measurement Instrument, Sjögren's syndrome

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Session Information

Date: Saturday, November 6, 2021

Session Title: Sjögren's Syndrome – Basic & Clinical Science Poster (0296–0322)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: The aim of this research was to gain qualitative patient and physician feedback on the EULAR Sjögren’s syndrome patient reported index (ESSPRI) and the EULAR Sjögren’s syndrome disease activity index (ESSDAI). ESSPRI is a 3-item Patient-Reported Outcome measure of Sjögren’s symptom severity (dryness, fatigue, joint/muscle pain). ESSDAI is a 12-domain Clinician-Reported Outcome measure of Sjögren’s disease activity. Each domain is rated using pre-defined descriptions for each disease activity level (No/Low/Moderate/High). ESSPRI and ESSDAI have been psychometrically validated using data from over 700 patients and with input from over 50 experts (Seror et al., 2016), however qualitative confirmation of the content validity has not been documented.

Methods: Qualitative, semi-structured, cognitive, telephone interviews were conducted with US adult patients with Sjögren’s (N=12) and expert Sjögren’s physicians in the US, UK and Germany (N=10). These samples are typical of qualitative research and are supplementary to the numerous patients and expert physicians previously involved in the validation of these measures. ESSPRI was tested with patients to explore understanding, relevance, and appropriateness of the 2-week recall period, and obtain patient perspectives of meaningful change in relation to their ESSPRI total score. ESSDAI was tested with physicians to explore the appropriateness of ESSDAI domain weightings, domain-level clinically meaningful improvement, and meaningful change in ESSDAI total scores. Physicians were also asked about the clinical relevance of the ESSPRI 2-week recall period.

Results: ESSPRI items were generally relevant to and well-understood by patients; however, there was some variation in interpretation of the locations of dryness considered when answering the dryness item (most frequent: eye dryness, n=9/12). Most patients (n=11/12) reported that it was easy to remember their symptoms over the past two weeks, as specified by the ESSPRI recall period. Patient-reported meaningful improvement in relation to ESSPRI total scores varied from 1-point to 6-points (mean: 2.4 points; mode: 2 points).

Physicians generally reported that the ESSDAI domain weightings were appropriate. Some physicians suggested that some weightings could be adjusted, with Articular (n=6/10), Haematological (n=5/10), and Biological domains (n=5/10) reported as under-weighted, and Muscular reported as over-weighted by most physicians (n=7/10). Most physicians considered a 1-level change in domain-level disease activity (e.g. from ‘High’ to ‘Moderate’) as clinically meaningful for most domains, and improvements of between 2-6 points in total ESSDAI scores were also considered meaningful. Most physicians (n=7/10) reported that the ESSPRI 2-week recall period was appropriate.

Conclusion: These results support the use of ESSPRI and ESSDAI as fit-for-purpose in their current formats, with some suggestions for optimization if desired. Perceptions of meaningful changes on these measures can be useful in interpreting psychometrically-derived responder definitions and informing clinical trial endpoints.


Disclosures: S. Wratten, None; C. Cooper, None; J. Flynn, None; N. Griffiths, None; R. Hall, None; L. Abetz-Webb, None; S. Bowman, Novartis, 1, 2, Astrazeneca, 2, Biogen, 2, BMS, 2, Celgene, 2, Medimmune, 2, MTPharma, 2, Ono, 2, UCB, 2, xtlbio, 2; W. Hueber, Novartis, 3, 11; B. Ndife, Novartis, 3, 11; P. Goswami, Novartis Pharma AG, 3.

To cite this abstract in AMA style:

Wratten S, Cooper C, Flynn J, Griffiths N, Hall R, Abetz-Webb L, Bowman S, Hueber W, Ndife B, Goswami P. Patient and Physician Perspectives on EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI): A Qualitative Interview Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/patient-and-physician-perspectives-on-eular-sjogrens-syndrome-patient-reported-index-esspri-and-eular-sjogrens-syndrome-disease-activity-index-essdai-a-qualitative-interview-stu/. Accessed May 15, 2022.
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