{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T13:56:00Z","timestamp":1790430960628,"version":"4.1.0"},"reference-count":34,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"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":"publisher","award":["Infrastructure award"],"award-info":[{"award-number":["Infrastructure award"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Trends in Hearing"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:p>Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints (\u201coutcome domains\u201d). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT\u2019ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT\u2019ID recommendations are robust. The COMiT\u2019ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.<\/jats:p>","DOI":"10.1177\/2331216518824827","type":"journal-article","created":{"date-parts":[[2019,1,29]],"date-time":"2019-01-29T23:49:31Z","timestamp":1548805771000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":27,"title":["One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults"],"prefix":"10.1177","volume":"23","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":"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":"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":"Ha\u00fala F.","family":"Haider","sequence":"additional","affiliation":[{"name":"ENT Department, Hospital Cuf Infante Santo \u2013 Nova Medical School, Lisbon, Portugal"}],"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":"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":[[2019,1,29]]},"reference":[{"key":"bibr1-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60142-7"},{"key":"bibr2-2331216518824827","doi-asserted-by":"publisher","DOI":"10.3310\/hta19680"},{"key":"bibr3-2331216518824827","unstructured":"Committee for Medicinal Products for Human Use. (2005).\n                      Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products\n                      (Doc. Ref. EMEA\/CHMP\/EWP\/139391\/2004). London, England: European Medicines Agency."},{"issue":"2008","key":"bibr4-2331216518824827","volume":"337","author":"Craig P.","year":"2008","journal-title":"BMJ"},{"issue":"1","key":"bibr5-2331216518824827","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":"bibr6-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1037\/h0031619"},{"key":"bibr7-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.09.012"},{"key":"bibr8-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1186\/s12955-018-0888-9"},{"key":"bibr9-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1399-9"},{"key":"bibr10-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6963-11-302"},{"key":"bibr11-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1044\/2017_AJA-16-0129"},{"key":"bibr12-2331216518824827","doi-asserted-by":"crossref","unstructured":"Hall, D. A., Smith, H., Hibbert, A., Colley, V., Haider, H. F., Horobin, A. \u2026 Fackrell, K. (2018). 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.\n                      Trends in Hearing\n                      22: 2331216518814384. doi: 10.1177\/2331216518814384.","DOI":"10.1177\/2331216518814384"},{"key":"bibr13-2331216518824827","volume-title":"TQ manual of the tinnitus questionnaire, revised and updated","author":"Hallam R. S.","year":"2009"},{"key":"bibr14-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d5928"},{"issue":"10","key":"bibr15-2331216518824827","first-page":"1","volume":"12","author":"Hsu C. 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Cognitive behavioural therapy for tinnitus.\n                      Cochrane Database of Systematic Reviews\n                      , (9). CD005233. doi:10.1002\/14651858.CD005233.pub3.","DOI":"10.1002\/14651858.CD005233.pub3"},{"key":"bibr24-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1097\/AUD.0b013e31822f67c0"},{"key":"bibr25-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.1996.01890140029007"},{"key":"bibr26-2331216518824827","doi-asserted-by":"crossref","unstructured":"Prinsen, C. A. C., Mokkink, L. B., Bouter, L. M., Alonso, J., Patrick, D. L., de Vet, H. C. W. & Terwee, C. B. (2018). COSMIN guideline for systematic reviews of patientreported outcome measures.\n                      Quality of Life Research\n                      ,\n                      27\n                      (5), 1147\u20131157. doi:10.1007\/s11136-018-1798-3.","DOI":"10.1007\/s11136-018-1798-3"},{"key":"bibr27-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1186\/s40900-018-0091-5"},{"key":"bibr28-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-018-1829-0"},{"key":"bibr29-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1177\/0194599814545325"},{"key":"bibr30-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1016\/S0079-6123(07)66048-8"},{"key":"bibr31-2331216518824827","volume-title":"Guidance for industry on providing clinical evidence of effectiveness for human drugs and biological products","author":"U.S. Department of Health and Human Services Food and Drug Administration","year":"1998"},{"key":"bibr32-2331216518824827","volume-title":"Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims","author":"U.S. Department of Health, Human Services Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, &amp; Center for Devices and Radiological Health","year":"2009"},{"key":"bibr33-2331216518824827","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-017-1978-4"},{"key":"bibr34-2331216518824827","doi-asserted-by":"crossref","unstructured":"Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E. & Tugwell, P. (2012). Developing core outcome sets for clinical trials: Issues to consider.\n                      Trials\n                      ,\n                      13\n                      (1), 132. doi:10.1186\/1745-6215-13-132.","DOI":"10.1186\/1745-6215-13-132"}],"container-title":["Trends in Hearing"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2331216518824827","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2331216518824827","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2331216518824827","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:44:10Z","timestamp":1777596250000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2331216518824827"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1]]},"references-count":34,"alternative-id":["10.1177\/2331216518824827"],"URL":"https:\/\/doi.org\/10.1177\/2331216518824827","relation":{},"ISSN":["2331-2165","2331-2165"],"issn-type":[{"value":"2331-2165","type":"print"},{"value":"2331-2165","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1]]},"article-number":"2331216518824827"}}