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
Year: 2021
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: http://www.comet-initiative.org/Studies/Details/1579.
Source: Trials
Authors: Niranjan S. Karnik, Cynthia I. Campbell, Megan E. Curtis, David A. Fiellin, Udi Ghitza, Kathryn Hefner, Yih-Ing Hser, R. Kathryn McHugh, Sean M. Murphy, Sterling M. McPherson, Landhing Moran, Larissa J. Mooney, Li-Tzy Wu, Dikla Shmueli-Blumberg, Matisyahu Shulman, Robert P. Schwartz, Kari A. Stephens, Katherine E. Watkins, John Marsden
Institutions: Rush University Medical Center, Kaiser Permanente, Kaiser Permanente Northern California, University of California, Los Angeles, Yale University, National Institutes of Health, National Institute on Drug Abuse, Emmes (United States), Harvard University, McLean Hospital, Weill Cornell Medicine, Washington State University Spokane, Duke University, Duke Medical Center, Columbia University Irving Medical Center, New York State Psychiatric Institute, Friends Research Institute, University of Washington, RAND Corporation, King's College London
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,290
Awards: Health and Economic Outcomes of Treatment with Extended-Release Naltrexone Among Pre-Release Prisoners with Opioid Use Disorder, IMPROVING NALOXONE ACCESS AND ITS EFFECTS ON DRUG ABUSE AND OVERDOSES, Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder, Clinical Trials Network: Mid-Atlantic Integrated Care Research Collaborative, Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness, Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth, Great Lakes & Mid-Atlantic Node (GLMN) of the NIDA CTN, Health Systems Node of the NIDA Clinical Trials Network, Health Economics of Substance Use Disorder, HCV, and HIV Treatment: Supporting Financial Sustainability, Advanced Methods, and Knowledge Translation, Greater Southern California Node of the Clinical Trials Network, Yale Clinical and Translational Science Award, Clinical Trials Network: Pacific Northwest Node
OpenAlex ID: W3124902931