{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T19:03:14Z","timestamp":1785351794980,"version":"3.55.0"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,1,28]],"date-time":"2021-01-28T00:00:00Z","timestamp":1611792000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,1,28]],"date-time":"2021-01-28T00:00:00Z","timestamp":1611792000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000026","name":"National Institute on Drug Abuse","doi-asserted-by":"publisher","award":["UG1-DA049467"],"award-info":[{"award-number":["UG1-DA049467"]}],"id":[{"id":"10.13039\/100000026","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods\/design<\/jats:title>\n                <jats:p>Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.comet-initiative.org\/Studies\/Details\/1579\">http:\/\/www.comet-initiative.org\/Studies\/Details\/1579<\/jats:ext-link><\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05051-9","type":"journal-article","created":{"date-parts":[[2021,1,28]],"date-time":"2021-01-28T13:06:26Z","timestamp":1611839186000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7650-3008","authenticated-orcid":false,"given":"Niranjan S.","family":"Karnik","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia I.","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan E.","family":"Curtis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Fiellin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Udi","family":"Ghitza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Hefner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yih-Ing","family":"Hser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. 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All panel members will complete a consent and declaration of interests form. These materials and all data gathered by the study will be kept at the offices of the CTN Great Lakes Node at Rush University on password-encrypted electronic storage. Only researchers named on the protocol approved by the IRB will have access to study data. Study data will be kept for 5\u00a0years in accordance with the NIH policy and then archived.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All workgroup members and co-authors have given consent for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"NK, in addition to the support outlined above, is supported by grants from the National Center for Advancing Translational Science (UL1-TR002389, KL2-TR002387), the National Institute on Drug Abuse (R01-DA041071, R01-DA051464), the Substance Abuse Mental Health Services Administration (H79-SM082299), and the National Institute on Mental Health (R01-MH117168).MC is supported by a grant from the National Institute on Drug Abuse (UG1DA049435).CC is supported by grants and contracts from the National Institute on Drug Abuse (UG1DA040314, R01DA047405) and the Food and Drug Administration. Dr. Campbell has received support through her institution from the Industry PMR Consortium, a consortium of companies working together to conduct postmarketing studies required by the Food and Drug Administration that assess known risks related to opioid analgesic use.DF is supported by a grant from the National Institute on Drug Abuse (5UG1DA015831).UG is an employee of the Center for the Clinical Trials Network of NIDA, the funding agency for the CTN. The opinions in this manuscript are those of the authors and do not represent the official position of the National Institutes of Health.KH is supported by the Emmes Data and Statistics Center, which is funded by a contract from the National Institute on Drug Abuse (75N95019D00013).YH is supported by grants from the National Institute on Drug Abuse (UG1DA049435, R21\/R33 DA042280, R21\/R33 DA045844).KMcH is supported by grants from the National Institute on Drug Abuse (R21DA046937, R21DA046521, R01 DA045632, UG1DA015831).SMM is supported by grants and contracts from the National Institute on Drug Abuse (R01DA046721, P30DA040500, R01DA044878, R01DA046527, R01DA045042, UG1DA040314, U01DA047408, UG1DA013732, UG1DA013035, UG1DA015831, UM1DA049412, UG1DA050071, UG1DA050077, UG1DA050067), the National Institute of Mental Health (R01MH118107), the National Institute on Alcohol Abuse and Alcoholism (R01AA020248), the Centers for Disease Control and Prevention (R01CE002999), and the California Department of Health Care Services.SMcP is supported by NIH grants P20MD006871, UG1DA013714, R01EY027476, N44DA162246, R01AA022070, R01AA020248, P60AA026112, R41AA026793, N44DA171210, and R01AG042467; VA grant I01HX002518; and CDC grant 75D301-19-Q-69877.LJM is supported by grants from the National Institute on Drug Abuse (UG1DA049435, R21\/R33DA042280, R21\/R33DA045844, R01DA045162).LM is an employee of the Center for the Clinical Trials Network of NIDA, the funding agency for the CTN. The opinions in this manuscript are those of the authors and do not represent the official position of the National Institutes of Health.LW is supported by grants and contract from the National Institute on Drug Abuse (UG1DA040317), National Institute on Minority Health and Health Disparities (R01MD007658), Patient-Centered Outcomes Research Institute, and Centers for Disease Control and Prevention.DSB is supported by the Emmes Clinical Coordinating Center, which is funded by a contract from the National Institute on Drug Abuse HHSN271201500065C.MS is supported by grants from the National Institute on Drug Abuse (UG1 DA013035-18, 1UM3 1DA049415-01) and SAMSHA (H79 TI080816-01).RPS is supported by grants from the National Institute on Drug Abuse (UG1DA013034, 1U01DA046910, 1U01DA047982, 3U01DA046910, 1R01DA043476-02S1). He has served as a consultant for Verily Life Sciences, Ltd.KS is supported by the National Institute of Drug Abuse\u2019s National Drug Abuse Treatment Clinical Trials Network (CTN) Pacific Northwest Node (3 UG1DA013714).KW is supported by grants from the National Institute of Drug Use: R34DA046950, R34DA047492, 1R01DA046226, 1UG1DA049435; NIAAA: R34AA025480; PCORI: OBOT-2018C2-1287; NIMH: 1UF1MH121954-01.JM is supported by the Center for the Clinical Trials Network. He is senior academic advisor at the Alcohol, Drugs, Tobacco and Justice Division of Health Improvement at Public Health England. He declares an unrestricted research grant from Indivior at King\u2019s College London and South London and Maudsley NHS Trust, UK, for a multi-center, randomized controlled trial study of injectable depot buprenorphine for OUD.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"102"}}