{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T16:49:46Z","timestamp":1789577386820,"version":"build-2803163510"},"reference-count":23,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T00:00:00Z","timestamp":1748908800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Scleroderma and Related Disorders"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Systemic sclerosis (scleroderma) is associated with functional disability and poor quality of life. Patient-reported outcome measures provide valuable insights into patients\u2019 experiences, symptoms, and perceptions of their health. The Health Assessment Questionnaire\u2013Disability Index (HAQ-DI) and the Scleroderma Health Assessment Questionnaire (S-HAQ) are widely used patient-reported outcome measures in scleroderma research and clinical care. However, there is lack of data to (a) ensure and document patients with systemic sclerosis understand the concepts contained in these measure and (b) demonstrate face, item, and content validity for these items and measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We conducted cognitive debriefing of the S-HAQ in patients with diffuse cutaneous systemc sclerosis (dcSSc). The S-HAQ includes the HAQ-DI, a 20-item questionnaire that assesses functional ability for performing day-to-day activities, four systemic sclerosis\u2013specific items that assess scleroderma symptoms, and one item on overall scleroderma-related limitations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The total sample of patients with dcSSc (N\u2009=\u200920) had a mean age of 57.6\u2009years and average disease duration of 3.4\u2009years. For the HAQ-DI, the participants understood the concepts and the items were clear. In addition, majority (60%\u2013100%) of participants reported using aids and devices to perform activities of daily living and\/or utilizing assistance from another person. The systemic sclerosis-specific items of the S-HAQ were relevant to participants but required revisions to item wording and response options, including a change from the visual analog scales to numerical rating scales.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The HAQ-DI and S-HAQ systemic sclerosis-specific items demonstrated content and item validity, respectively. Several minor modifications were made to the S-HAQ instructions, item wording, and rating scales.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/23971983251334162","type":"journal-article","created":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T07:48:43Z","timestamp":1748936923000},"page":"556-568","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Cognitive debriefing of the Scleroderma Health Assessment Questionnaire in diffuse cutaneous systemic sclerosis"],"prefix":"10.1136","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1412-4453","authenticated-orcid":false,"given":"Dinesh","family":"Khanna","sequence":"first","affiliation":[{"name":"Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA"},{"name":"Scleroderma Program, University of Michigan, Ann Arbor, MI, USA"},{"name":"M-Clinical Trials Support Unit (M-CTSU) and Clinical Research Unit (MCRU), University of Michigan, Ann Arbor, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4620-5840","authenticated-orcid":false,"given":"George J","family":"Greene","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chelsea Rose","family":"Perschon","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzieh","family":"Jamali","sequence":"additional","affiliation":[{"name":"Scleroderma Program, University of Michigan, Ann Arbor, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Steen","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine, Georgetown University, Washington, DC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Medsger","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gurkirpal","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA, USA"},{"name":"Institute of Clinical Outcomes Research and Education (ICORE), Woodside, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cella","sequence":"additional","affiliation":[{"name":"Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,6,3]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)30933-9"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S191418"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-006-0018-8"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200103)44:3<653::AID-ANR114>3.0.CO;2-Q"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh070"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780401110"},{"issue":"7","key":"e_1_3_3_8_2","first-page":"1630","article-title":"Current status of outcome measure development for clinical trials in systemic sclerosis","volume":"30","author":"Merkel PA","year":"2003","unstructured":"Merkel PA, Clements PJ, Reveille JD, et al. Current status of outcome measure development for clinical trials in systemic sclerosis. J Rheumatol 2003; 30(7): 1630\u20131647.","journal-title":"J Rheumatol"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(199911)42:11<2372::AID-ANR16>3.0.CO;2-J"},{"issue":"5","key":"e_1_3_3_10_2","first-page":"832","article-title":"Responsiveness of the SF-36 and the Health Assessment Questionnaire disability index in a systemic sclerosis clinical trial","volume":"32","author":"Khanna D","year":"2005","unstructured":"Khanna D, Furst DE, Clements PJ, et al. Responsiveness of the SF-36 and the Health Assessment Questionnaire disability index in a systemic sclerosis clinical trial. J Rheumatol 2005; 32(5): 832\u2013840.","journal-title":"J Rheumatol"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-219100"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2024-004653"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keae667"},{"key":"e_1_3_3_14_2","unstructured":"Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims 2009 https:\/\/www.fda.gov\/media\/77832\/download"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780230202"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1790040106"},{"key":"e_1_3_3_17_2","doi-asserted-by":"crossref","unstructured":"Willis G. Cognitive Interviewing. 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