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Herein, we aimed to (i) investigate patients\u2019 perspectives on and experience with SLE; (ii) identify meaningful aspects of health (MAHs) and concepts of interest (COIs) in SLE that could be evaluated using digital clinical measures (DCMs); and (iii) identify target DCMs for their assessment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A mixed-methods, multistep approach was deployed for (i) exploring patients\u2019 experience with SLE through a social media listening study and focused group discussions with patients; (ii) mapping patients\u2019 experiences to define MAHs and identify COIs measurable using DCMs; (iii) selecting DCMs for the target COIs; and (iv) identifying types of wearable sensors for measuring COIs in the patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Six MAHs related to physical behavior and sleep were identified: difficulty in ambulating, lack of energy, inability to perform activities of daily living, difficulty engaging in sustained walking, inability to perform leisure activities and exercise, and lack of restful sleep. Measurable COIs represented walking (fatigue and pain) and sleep (sleep and pain) characteristics. Five and six DCMs related to stepping behavior and sleep quality, respectively, were identified. Several wearable sensors are available to derive DCMs for physical behavior and sleep; however, patients showed a strong preference for a wrist-worn actigraphy sensor.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>We identified DCMs for physical behavior and sleep that are relevant and meaningful to patients with SLE, measurable in a real-world environment with wearable sensors, and have the potential to aid personalized patient care.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-024-00832-7","type":"journal-article","created":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T09:19:36Z","timestamp":1735031976000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Identifying meaningful aspects of health and concepts of interest for assessment in systemic lupus erythematosus: implications for digital clinical measure development"],"prefix":"10.1186","volume":"8","author":[{"given":"Paul","family":"Kamudoni","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kate","family":"Lyden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver","family":"G\u00fcnther","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vikas","family":"Jaitely","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thiago Dantas","family":"Araujo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erica","family":"Spies","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josephine","family":"Park","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erik","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joy","family":"Buie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer M.","family":"Blankenship","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurent","family":"Arnaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,12,24]]},"reference":[{"key":"832_CR1","doi-asserted-by":"publisher","first-page":"2332","DOI":"10.1016\/S0140-6736(19)30237-5","volume":"393","author":"L Durcan","year":"2019","unstructured":"Durcan L, O\u2019Dwyer T, Petri M (2019) Management strategies and future directions for systemic lupus erythematosus in adults. 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The data analyzed in this study were obtained from publicly available sources. Identities of the patient posts were appropriately anonymized while ensuring that the data answered specific research questions. To ensure personal data protection, a strict General Data Protection Regulation-compliant process was adopted. This study was exempt from ethical review because it examined retrospective publicly available data from a sizeable number of patients. The focused group discussions (FGDs) plan was submitted to a central IRB and was exempt from ethical review because the research involved only interview procedures. All participants provided written informed consent prior to their participation in the FGDs. The sessions were recorded, and anonymized transcripts were made available for analysis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"PK, OG, VJ, TDA, ES, JP, and ET are employees of the healthcare business of Merck KGaA, Darmstadt, Germany or EMD Serono, Billerica, MA, USA. KL and JMB are employees of VivoSense, Newport Coast, CA, USA, who was contracted to perform some of the research associated with this manuscript. Joy B is the Director of Research at the Lupus Foundation of America and have nothing to disclose. LA has received consulting fees\/honoraria from: Alexion, Alpine, Amgen, Astra-Zeneca, Abbvie, Biogen, BMS, Boehringer-Ingelheim, C\u00eamka, GSK, Grifols, Janssen, LFB, Lilly, Menarini France, Medac, the healthcare business of Merck KGaA, Darmstadt, Germany, Novartis, Pfizer, Roche-Chuga\u00ef, S\u00eameia, UCB.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"154"}}