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The opioid use disorder core outcomes set (OUD–COS) for treatment research: findings from a Delphi consensus study
journal contributionposted on 11.11.2022, 22:09 authored by Niranjan S Karnik, John Marsden, Connor McCluskey, Randy A Boley, Katharine A Bradley, Cynthia I Campbell, Megan E Curtis, David Fiellin, Udi Ghitza, Kathryn Hefner, Yih‐Ing Hser, R Kathryn McHugh, Sterling M McPherson, Larissa J Mooney, Landhing M Moran, Sean M Murphy, Robert P Schwartz, Dikla Shmueli‐Blumberg, Matisyahu Shulman, Kari A Stephens, Katherine E Watkins, Roger D Weiss, Li‐Tzy Wu
BACKGROUND AND AIM: There is no gold-standard and considerable heterogeneity in outcome measures used to evaluate treatments for opioid use disorder (OUD) along the opioid treatment cascade. The aim of this study was to develop the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder core outcomes set (OUD-COS). DESIGN: Four-round, e-Delphi expert panel consensus study and plenary research group discussion and targeted consultation. SETTING: United States. PARTICIPANTS: A panel of 25 members including clinical practitioners, clinical researchers and administrative staff from the CTN, the network's affiliated clinical and community sites and the NIDA Centre for the CTN. MEASUREMENTS: From a pool of 24 candidate items in four domains (biomedical/disease status; behaviors, symptoms and functioning; opioid treatment cascade; and morbidity and mortality), the panel completed an on-line questionnaire to rank items with defined specification on a 9-point scale for importance, with a standard 70% consensus criterion. FINDINGS: After the fourth round of the questionnaire and subsequent discussion, consensus was reached for five outcomes: two patient-reported (global impression of improvement and incident non-fatal overdose); one clinician-reported (illicit/non-medical drug toxicology); and two from administrative records (duration of treatment and fatal opioid poisoning). CONCLUSIONS: An e-Delphi consensus study has produced the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network opioid use disorder core outcomes set (version 1) for opioid use disorder treatment efficacy and effectiveness research.
Great Lakes Node of the Drug Abuse Clinical Trials Network | Funder: National Institutes of Health (National Institute on Drug Abuse) | Grant ID: UG1DA049467
CitationKarnik, N. S., Marsden, J., McCluskey, C., Boley, R. A., Bradley, K. A., Campbell, C. I., Curtis, M. E., Fiellin, D., Ghitza, U., Hefner, K., Hser, Y., McHugh, R. K., McPherson, S. M., Mooney, L. J., Moran, L. M., Murphy, S. M., Schwartz, R. P., Shmueli‐Blumberg, D., Shulman, M.Wu, L. (2022). The opioid use disorder core outcomes set (OUD–COS) for treatment research: findings from a Delphi consensus study. Addiction, 117(9), 2438-2447. https://doi.org/10.1111/add.15875
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Brain DisordersSubstance AbuseClinical Trials and Supportive ActivitiesDrug Abuse (NIDA Only)Clinical ResearchGeneric health relevanceMental health3 Good Health and Well BeingCore outcomes setDelphi consensusefficacy and effectiveness researchopioid treatment cascadeopioid use disorderUS National Institute on Drug AbuseAnalgesics, OpioidConsensusDelphi TechniqueHumansOpioid-Related DisordersOutcome Assessment, Health CareResearch DesignUnited StatesMedical and Health SciencesPsychology and Cognitive Sciences