{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:11:04Z","timestamp":1777543864425,"version":"3.51.4"},"reference-count":19,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2012,12,14]],"date-time":"2012-12-14T00:00:00Z","timestamp":1355443200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2013,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The completeness of self-reported serious adverse events (SAEs) in clinical trials can be reduced by inaccuracies in subject reporting and lost to follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This study assesses the usefulness of a health data linkage system in obtaining SAE data in a randomised controlled study of oral and implant naltrexone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>SAEs were collected from 68 heroin-dependent subjects during a randomised controlled trial of oral and implant naltrexone with follow-up to 26 weeks. Patient self-report data were cross-matched against hospital and emergency department (ED) attendances for the same period using a health data linkage system.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 29 hospital admissions and 74 ED attendances were identified using health data linkage. Of these, 12 (41.4%) hospital admissions and 50 (67.7%) of ED attendances had not been reported as SAE in the randomised controlled trial. In subjects participating in the trial at the time of the event, there was a 1.25-fold increase in the number of hospital admissions and a 2.25-fold increase in the number of ED attendances recorded using data linkage. Overall (including withdrawn subjects or those lost to follow-up), there was a 1.71-fold increase in hospital admission and a 3.09-fold increase in ED attendance recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Limitations<\/jats:title>\n                    <jats:p>The use of data linkage should not be used as a replacement for thorough follow-up, as the datasets can take substantial periods to update, making them a poor substitute for real-time follow-up. Additionally, some SAEs such as life-threatening events that do not involve ED or hospital attendance may be overlooked as would SAEs that occurred outside the dataset\u2019s range, for example, interstate or overseas.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Health data linkage can be used to effectively reduce the extent of missing health data in a clinical trial.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1740774512467237","type":"journal-article","created":{"date-parts":[[2012,12,15]],"date-time":"2012-12-15T20:45:39Z","timestamp":1355604339000},"page":"170-180","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Assessing the usefulness of health data linkage in obtaining adverse event data in a randomised controlled trial of oral and implant naltrexone in the treatment of heroin dependence"],"prefix":"10.1177","volume":"10","author":[{"given":"Erin","family":"Kelty","sequence":"first","affiliation":[{"name":"School of Psychiatry and Clinical Neuroscience, The University of Western Australia, Perth, WA, Australia"},{"name":"Fresh Start Recovery Programme, Perth, WA, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanh","family":"Ngo","sequence":"additional","affiliation":[{"name":"School of Psychiatry and Clinical Neuroscience, The University of Western Australia, Perth, WA, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Hulse","sequence":"additional","affiliation":[{"name":"School of Psychiatry and Clinical Neuroscience, The University of Western Australia, Perth, WA, 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