The Opioid Use Disorder Core Outcomes Set (OUD–COS) for Treatment Research

Findings from a Delphi Consensus Study

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, et al.

ResearchPosted on rand.org Feb 21, 2023Published in: Addiction, Volume 117, Issue 9, pages 2438–2447 (September 2022). doi: 10.1111/add.15875

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.

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Document Details

  • Copyright: 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
  • Publisher: John Wiley & Sons Ltd
  • Availability: Non-RAND
  • Year: 2022
  • Pages: 10
  • Document Number: EP-70002

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