{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T16:03:00Z","timestamp":1790697780788,"version":"4.1.0"},"reference-count":19,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T00:00:00Z","timestamp":1783382400000},"content-version":"unspecified","delay-in-days":6,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bristol Myers Squibb"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Lupus Sci Med"],"accepted":{"date-parts":[[2026,4,25]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>SLE is a chronic autoimmune disorder with a range of symptoms. While these are broadly reported in the literature, the symptom impact of SLE on patient health-related quality of life is less well documented. This qualitative interview study aimed to understand the nature and importance of skin symptoms, evaluate the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in SLE and assess what constitutes meaningful change in SLE-associated fatigue and skin symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In August 2023, 60\u2009min individual interviews were conducted virtually with 18 adults in the USA who self-reported a diagnosis of SLE and reported experiencing SLE-related fatigue within the prior 30 days. 17 participants also reported experiencing SLE-related skin symptoms. Participants described their experiences with these symptoms and their perceptions of the smallest meaningful improvement using their own words and using the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales. Cognitive debriefing was conducted to evaluate content validity of the 13-item FACIT-Fatigue scale (V.4) for SLE-related fatigue.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 18 participants interviewed (mean age 51.7 years (range 33\u201367 years)), 17 were female and nine were white. All participants acknowledged that all items of the FACIT-Fatigue scale were relevant to SLE-related fatigue and most could comprehend and answer all items without difficulty. 13 participants indicated that a one-point improvement in fatigue on the PGIS would be meaningful. All participants with skin symptoms understood the skin-specific PGIS and PGIC items without difficulty. A one-point improvement on the PGIS and \u2018a little better\/moderately better\u2019 on the PGIC represented meaningful improvements in skin symptoms by most participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These results support the use of the FACIT-Fatigue scale in SLE trials and suggest that even minimal improvements in fatigue and skin symptoms are meaningful to patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/lupus-2025-001898","type":"journal-article","created":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T11:16:50Z","timestamp":1783423010000},"page":"e001898","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Qualitative interview study in patients with SLE to assess patient perception of fatigue and skin-related symptoms"],"prefix":"10.1136","volume":"13","author":[{"given":"Joseph F","family":"Merola","sequence":"first","affiliation":[{"name":"Department of Medicine and Rheumatology, UT Southwestern Medical Center, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3030-5369","authenticated-orcid":false,"given":"Victoria P","family":"Werth","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiyoon C","family":"Choi","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandon","family":"Becker","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Edwards","sequence":"additional","affiliation":[{"name":"RTI International, Research Triangle Park, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Coburn","family":"Hobar","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Pomponi","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurie","family":"Eliason","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4978-4072","authenticated-orcid":false,"given":"Vibeke","family":"Strand","sequence":"additional","affiliation":[{"name":"Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,7,7]]},"reference":[{"key":"2026092908101573000_13.2.e001898.1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2016.137"},{"key":"2026092908101573000_13.2.e001898.2","unstructured":"Justiz Vaillant AA , Goyal A , Varacallo M . 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Results from a systematic literature review","volume":"22","author":"Basta","year":"2018","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"2026092908101573000_13.2.e001898.12","first-page":"1699","article-title":"Fatigue in systemic lupus erythematosus: contributions of disease activity, pain, depression, and perceived social support","volume":"32","author":"Jump","year":"2005","journal-title":"J Rheumatol"},{"key":"2026092908101573000_13.2.e001898.13","doi-asserted-by":"crossref","DOI":"10.1186\/ar3919","article-title":"Unmet medical needs in systemic lupus erythematosus","volume":"14 Suppl 4","author":"Lateef","year":"2012","journal-title":"Arthritis Res Ther"},{"key":"2026092908101573000_13.2.e001898.14","doi-asserted-by":"crossref","DOI":"10.1136\/lupus-2021-000640","article-title":"Real-world burden of systemic lupus erythematosus in the USA: a comparative cohort study from the Medical Expenditure Panel Survey (MEPS) 2016-2018","volume":"9","author":"Grabich","year":"2022","journal-title":"Lupus Sci Med"},{"key":"2026092908101573000_13.2.e001898.15","unstructured":"Guidance for Industry Systemic Lupus Erythematosis - Developing Medical Products for Treatment. 2010. 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