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.
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
Disease Category: Mental health, Tobacco, drugs, & alcohol dependence
Disease Name: Opioid use disorder
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Drug, Nonpharmacological
- Clinical experts
- Methodologists
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
Modified, stepwise, e-Delphi methodology to achieve consensus among a panel of clinical practitioners and researchers involved in the treatment of opioid use disorder and who are members of the US National Institute on Drug Abuse Clinical Trials Network and coordinating centre.