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
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
Affiliations
Niranjan S. Karnik
Department of Psychiatry & Behavioral Sciences, Rush University Medical Center
Cynthia I. Campbell
Division of Research, Kaiser Permanente Northern California
Megan E. Curtis
Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
David A. Fiellin
Yale School of Medicine, Internal Medicine, Program in Addiction Medicine
Udi Ghitza
National Institute on Drug Abuse, National Institutes of Health, National Institute on Drug Abuse Center for Clinical Trials Network
Kathryn Hefner
Yale School of Medicine, Internal Medicine, Program in Addiction Medicine
Yih-Ing Hser
Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
R. Kathryn McHugh
Division of Alcohol, Drugs and Addiction, McLean Hospital, & Department of Psychiatry, Harvard Medical School
Sean M. Murphy
Department of Population Health Sciences, Weill Cornell Medical College
Sterling M. McPherson
Washington State University Elson S. Floyd College of Medicine
Landhing Moran
National Institute on Drug Abuse, National Institutes of Health, National Institute on Drug Abuse Center for Clinical Trials Network
Larissa J. Mooney
Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
Li-Tzy Wu
Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center
Dikla Shmueli-Blumberg
The Emmes Company, LLC, National Institute on Drug Abuse Data and Statistics Center and Clinical Coordinating Center
Matisyahu Shulman
Department of Psychiatry, Columbia University Irving Medical Center & Department of Psychiatry, New York State Psychiatric Institute
Robert P. Schwartz
Friends Research Institute
Kari A. Stephens
Departments of Family Medicine, Biomedical Informatics & Medical Education, University of Washington
Katherine E. Watkins
RAND Corporation
John Marsden
Addictions Department, Division of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King’s College London
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
