{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:14:54Z","timestamp":1777544094324,"version":"3.51.4"},"reference-count":17,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2025,4,22]],"date-time":"2025-04-22T00:00:00Z","timestamp":1745280000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01 DK094157"],"award-info":[{"award-number":["U01 DK094157"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01 DK094176"],"award-info":[{"award-number":["U01 DK094176"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background\/Aims<\/jats:title>\n                    <jats:p>Data integrity in multicenter and longitudinal studies requires implementation of standardized reproducible methods throughout the data collection, analysis, and reporting process. This requirement is heightened when results are shared with participants that may influence health care decisions. A quality assurance plan provides a framework for ongoing monitoring and mitigation strategies when errors occur.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The Diabetes Control and Complications Trial (1983\u20131993) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (1994\u2013present), have characterized risk factors and long-term complications in a type 1 diabetes cohort followed for over 40\u2009years. An ancillary study to assess bone mineral density was implemented across 27 sites, using one of two dual x-ray absorptiometry scanner types. Centrally generated reports were distributed to participants by the sites. A query from a site about results that were incongruent with a single participant\u2019s clinical history prompted reevaluation of this scan, revealing a systematic error in the reading of hip scans from one of the two scanner types. A mitigation plan was implemented to correct and communicate the errors to ensure participant safety, particularly among those originally identified as having low bone mineral density scores for whom antiresorptive treatment may have been initiated based on these results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The error in the analysis of hip scans from the identified scanner type resulted in lower bone mineral density scores in scans requiring manual deletion of the ischium bone. Hip scans with original T-score\u2009\u2264\u2009\u22122.5 (n\u2009=\u200984) acquired on either scanner were reviewed, and reanalyzed if the error was detected. Fourteen scans were susceptible to this error and reanalyzed: nine scans were reclassified from osteoporosis to low bone mineral density, one from low to normal bone mineral density, and four were unchanged. All errors occurred on one scanner type. An integrated communication and intervention plan was implemented. The nine participants whose scans were reclassified from osteoporosis to low bone mineral density were contacted; five were using antiresorptive treatment, all of whom had other risk factors for fracture beyond these scan results. Review of all hip scans with a T-score\u2009&gt;\u2009\u22122.5 (n\u2009=\u2009371) using this scanner type identified 27 additional hip scans that required reanalysis and potential reclassification: 1 scan was reclassified from osteoporosis to low bone mineral density, 11 from low to normal bone mineral density, and 15 were unchanged.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The impact of an analysis error on participant safety, specifically when the initiation of unnecessary treatment may result, necessitated implementation of a coordinated communication and mitigation plan across all clinical centers to ensure consistent messaging and accurate results are provided to participants and their local care providers. This framework may serve as a resource for other clinical studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745251328257","type":"journal-article","created":{"date-parts":[[2025,4,22]],"date-time":"2025-04-22T05:48:06Z","timestamp":1745300886000},"page":"538-546","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Identification and mitigation of a systematic analysis error in a multicenter dual-energy x-ray absorptiometry study"],"prefix":"10.1177","volume":"22","author":[{"given":"Gayle M","family":"Lorenzi","sequence":"first","affiliation":[{"name":"University of California San Diego, La Jolla, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2184-9754","authenticated-orcid":false,"given":"Barbara H","family":"Braffett","sequence":"additional","affiliation":[{"name":"Biostatistics Center, The George Washington University, Rockville, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ionut","family":"Bebu","sequence":"additional","affiliation":[{"name":"Biostatistics Center, The George Washington University, Rockville, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victoria R","family":"Trapani","sequence":"additional","affiliation":[{"name":"Biostatistics Center, The George Washington University, Rockville, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jye-Yu C","family":"Backlund","sequence":"additional","affiliation":[{"name":"Biostatistics Center, The George Washington University, Rockville, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaleigh","family":"Farrell","sequence":"additional","affiliation":[{"name":"UH Rainbow Babies &amp; Children\u2019s Hospital, Case Western Reserve University, Cleveland, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rose A","family":"Gubitosi-Klug","sequence":"additional","affiliation":[{"name":"UH Rainbow Babies &amp; Children\u2019s Hospital, Case Western Reserve University, Cleveland, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann V","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the DCCT\/EDIC Research Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,4,22]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0141286"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.4103\/2229-3485.76288"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1177\/1740774507087554"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.epirev.a017973"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(94)00095-K"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(92)90021-Q"},{"key":"e_1_3_3_8_2","doi-asserted-by":"crossref","DOI":"10.1016\/0197-2456(89)90044-5","article-title":"Quality assurance and monitoring in the Hypertension Prevention Trial","volume":"10","author":"Prud\u2019homme GJ","year":"1989","unstructured":"Prud\u2019homme GJ, Canner PL, Cutler JA. Quality assurance and monitoring in the Hypertension Prevention Trial. Control Clin Trials 1989; 10(3 suppl): 84S\u201394S.","journal-title":"Control Clin Trials"},{"issue":"2","key":"e_1_3_3_9_2","first-page":"249","article-title":"Assessing agreement on classification tasks: the kappa statistic","volume":"22","author":"Carletta J.","year":"1996","unstructured":"Carletta J. Assessing agreement on classification tasks: the kappa statistic. arXiv 1996; 22(2): 249\u2013254.","journal-title":"arXiv"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291401"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.2337\/diab.35.5.530"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.1.99"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(22)00103-6"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgac099"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-011-1632-z"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.5650080915"},{"key":"e_1_3_3_17_2","volume-title":"20th Northeast SAS users group 2007 conference proceedings","author":"Lu L","unstructured":"Lu L, Shara N. Reliability analysis: calculate and compare intra-class correlation coefficients (ICC) in SAS. In: 20th Northeast SAS users group 2007 conference proceedings. Baltimore, MD, 11\u201314 November 2007."},{"key":"e_1_3_3_18_2","first-page":"1","volume-title":"Proceedings of the Thirtieth annual SAS users group international conference","author":"Stein CR","unstructured":"Stein CR, Devore RB, Wojcik BE. Calculation of the kappa statistic for inter-rater reliability: the case where raters can select multiple responses from a large number of categories, SUGI30, Paper 180. In: Proceedings of the Thirtieth annual SAS users group international conference. Cary, NC, 10\u201313 April 2005, pp. 1\u20138. Cary, NC: SAS Institute Inc."}],"container-title":["Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745251328257","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17407745251328257","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745251328257","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T17:29:23Z","timestamp":1777397363000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17407745251328257"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,22]]},"references-count":17,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1177\/17407745251328257"],"URL":"https:\/\/doi.org\/10.1177\/17407745251328257","relation":{},"ISSN":["1740-7745","1740-7753"],"issn-type":[{"value":"1740-7745","type":"print"},{"value":"1740-7753","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,22]]}}}