Niranjan S Karnik1, Cynthia I Campbell2, Megan E Curtis3, David A Fiellin4, Udi Ghitza5, Kathryn Hefner4,6, Yih-Ing Hser3, R Kathryn McHugh7, Sean M Murphy8, Sterling M McPherson9, Landhing Moran5, Larissa J Mooney3, Li-Tzy Wu10, Dikla Shmueli-Blumberg6, Matisyahu Shulman11, Robert P Schwartz12, Kari A Stephens13, Katherine E Watkins14, John Marsden15. 1. Department of Psychiatry & Behavioral Sciences, Rush University Medical Center, 1645 West Jackson Blvd., Suite 600, Chicago, IL, 60612, USA. Niranjan_Karnik@rush.edu. 2. Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA. 3. Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, 11075 Santa Monica Blvd., Suite 200, Los Angeles, CA, 90025, USA. 4. Yale School of Medicine, Internal Medicine, Program in Addiction Medicine, PO Box 208056, 333 Cedar Street, New Haven, CT, 06520-8056, USA. 5. National Institute on Drug Abuse, National Institutes of Health, National Institute on Drug Abuse Center for Clinical Trials Network, 6001 Executive Blvd, Bethesda, MD, 20892, USA. 6. The Emmes Company, LLC, National Institute on Drug Abuse Data and Statistics Center and Clinical Coordinating Center, 401 N Washington St, Rockville, MD, 20850, USA. 7. Division of Alcohol, Drugs and Addiction, McLean Hospital, & Department of Psychiatry, Harvard Medical School, McLean Hospital, Proctor House 3, 115 Mill St, Belmont, MA, 02478, USA. 8. Department of Population Health Sciences, Weill Cornell Medical College, 1300 York Avenue, New York, NY, 10065, USA. 9. Washington State University Elson S. Floyd College of Medicine, 412 E. Spokane Falls Blvd., Spokane, WA, 99202-2131, USA. 10. Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 3903, Durham, NC, 27710, USA. 11. Department of Psychiatry, Columbia University Irving Medical Center & Department of Psychiatry, New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY, USA. 12. Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201-5633, USA. 13. Departments of Family Medicine, Biomedical Informatics & Medical Education, University of Washington, Seattle, WA, 98195, USA. 14. RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401-3208, USA. 15. Addictions Department, Division of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, DeCrespigny Park, Denmark Hill, London, SE5 8AF, UK.
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.
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.
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