{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:42:21Z","timestamp":1791830541988,"version":"4.3.4"},"reference-count":32,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"European Cooperation in Science and Technology (COST) Action","award":["BM1306"],"award-info":[{"award-number":["BM1306"]}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"crossref","award":["Nottingham Biomedical Research Centre"],"award-info":[{"award-number":["Nottingham Biomedical Research Centre"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Trends in Hearing"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:p>Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints (\u201coutcome domains\u201d) are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. \u201cTinnitus intrusiveness\u201d was voted in for all three interventions. For sound-based interventions, the minimum set included \u201cability to ignore,\u201d \u201cconcentration,\u201d \u201cquality of sleep,\u201d and \u201csense of control.\u201d For psychology-based interventions, the minimum set included \u201cacceptance of tinnitus,\u201d \u201cmood,\u201d \u201cnegative thoughts and beliefs,\u201d and \u201csense of control.\u201d For pharmacology-based interventions, \u201ctinnitus loudness\u201d was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.<\/jats:p>","DOI":"10.1177\/2331216518814384","type":"journal-article","created":{"date-parts":[[2018,11,29]],"date-time":"2018-11-29T05:52:23Z","timestamp":1543470743000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":62,"title":["The COMiT\u2019ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults"],"prefix":"10.1177","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3804-1452","authenticated-orcid":false,"given":"Deborah A.","family":"Hall","sequence":"first","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"},{"name":"Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, UK"},{"name":"Nottingham University Hospitals National Health Service Trust, Queens Medical Centre, UK"},{"name":"University of Nottingham Malaysia, Semeniyh, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harriet","family":"Smith","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"},{"name":"Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Hibbert","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"},{"name":"Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronica","family":"Colley","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ha\u00fala F.","family":"Haider","sequence":"additional","affiliation":[{"name":"ENT Department, Hospital Cuf Infante Santo\u2014Nova Medical School, Lisbon, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7120-4612","authenticated-orcid":false,"given":"Adele","family":"Horobin","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"},{"name":"Nottingham University Hospitals National Health Service Trust, Queens Medical Centre, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Londero","sequence":"additional","affiliation":[{"name":"Service ORL et CCF, Consultation Acouph\u00e8ne et Hyperacousie, H\u00f4pital Europ\u00e9en G. Pompidou, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birgit","family":"Mazurek","sequence":"additional","affiliation":[{"name":"Tinnitus Center, Charite University Hospital, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Thacker","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Fackrell","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK"},{"name":"Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Core Outcome Measures in Tinnitus (COMiT) initiative","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,11,29]]},"reference":[{"key":"bibr1-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60142-7"},{"key":"bibr2-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60329-9"},{"key":"bibr3-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-016-0188-6"},{"key":"bibr4-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9780511996214"},{"key":"bibr5-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0066844"},{"key":"bibr6-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2009.11.003"},{"issue":"1","key":"bibr7-2331216518814384","doi-asserted-by":"crossref","first-page":"388","DOI":"10.1186\/s13063-017-2123-0","volume":"18","author":"Fackrell K.","year":"2017","journal-title":"Trials"},{"key":"bibr8-2331216518814384","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyg.2017.00206"},{"key":"bibr9-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.09.012"},{"key":"bibr10-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1177\/2331216517736689"},{"key":"bibr11-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1186\/s12955-018-0888-9"},{"key":"bibr12-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1177\/2331216515580272"},{"key":"bibr13-2331216518814384","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1399-9"},{"key":"bibr14-2331216518814384","author":"Hall D. 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