{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,16]],"date-time":"2025-07-16T13:49:01Z","timestamp":1752673741937,"version":"3.37.3"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T00:00:00Z","timestamp":1659052800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T00:00:00Z","timestamp":1659052800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>New treatments are being evaluated for lipodystrophy; however, limited information is available on the patient experience. Results of a prior patient panel showed that hunger and temperature-related symptoms were an issue for participants. Therefore, evaluation of any changes in these symptoms is recommended for inclusion in new treatment options. The objective of this study was to further understand the patient experience and to evaluate newly developed items of hunger and temperature regulation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Individual, in-depth telephone interviews were conducted via semi-structured discussion guide. Telephone interviews were conducted with 21 US patients with generalized lipodystrophy (GLD) or partial lipodystrophy (PLD). Eligibility requirements included self-reported PLD or GLD. Interviews included open-ended concept elicitation followed by a review of newly developed items assessing hunger, temperature sensations, and patient globals. Interviews were conducted in two rounds, with the newly developed items assessing hunger revised after each round of interviews based on participant feedback.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Results indicated that hunger-related symptoms were considered a current issue for greater than half (N\u2009=\u200911) of participants, and all but one reported this as an issue at some point in their lives. Specifically, participants most often reported symptoms of increased appetite and not feeling full. The cognitive debriefing process indicated that the hunger-related symptoms, temperature, and global impression of change and severity items were correctly interpreted and easily completed by the participants. While not a focus of the interviews, the concept elicitation results demonstrated that pain was a frequently reported and bothersome symptom in this patient population.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This qualitative research provided evidence to support the use of clinical outcomes assessments such as hunger and temperature-related items in clinical trials.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-022-00486-3","type":"journal-article","created":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T11:03:59Z","timestamp":1659092639000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Qualitative interviews in patients with lipodystrophy to assess the patient experience: evaluation of hunger and other symptoms"],"prefix":"10.1186","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9594-5036","authenticated-orcid":false,"given":"Susan A.","family":"Martin","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert J.","family":"Sanchez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oyebimpe","family":"Olayinka-Amao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Harris","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sheri","family":"Fehnel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,7,29]]},"reference":[{"issue":"6","key":"486_CR1","doi-asserted-by":"publisher","first-page":"2548","DOI":"10.1210\/jc.2004-0395","volume":"89","author":"EE Kershaw","year":"2004","unstructured":"Kershaw EE, Flier JS (2004) Adipose tissue as an endocrine organ. 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Front Endocrinol (Lausanne) 12:803189. https:\/\/doi.org\/10.3389\/fendo.2021.803189","journal-title":"Front Endocrinol (Lausanne)"},{"key":"486_CR6","doi-asserted-by":"publisher","first-page":"307","DOI":"10.1016\/B978-0-12-800892-8.00022-1","volume-title":"Genetic diagnosis of endocrine disorders","author":"RK Semple","year":"2016","unstructured":"Semple RK, Savage DB, Brierley GV, O\u2019Rahilly S (2016) Chapter 22\u2014syndromes of severe insulin resistance and\/or lipodystrophy. In: Weiss RE, Refetoff S (eds) Genetic diagnosis of endocrine disorders, 2nd edn. Academic Press, San Diego, pp 307\u2013324.","edition":"2"},{"issue":"9","key":"486_CR7","doi-asserted-by":"publisher","first-page":"4258","DOI":"10.1210\/jc.2003-031868","volume":"89","author":"JR McDuffie","year":"2004","unstructured":"McDuffie JR, Riggs PA, Calis KA et al (2004) Effects of exogenous leptin on satiety and satiation in patients with lipodystrophy and leptin insufficiency. 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Informed consent was obtained before any participant\u2019s participation.","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":"S.A.M., O.O.-A., and S.F. are employees of RTI Health Solutions\u2014a unit of RTI International, a not-for-profit research organization that provides consulting and research services to governmental organizations, businesses, and pharmaceutical companies. R.J.S. and C.H. are current employees of Regeneron Pharmaceuticals, Inc.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"84"}}