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The opioid use disorder core outcomes set (OUD-COS) for treatment research: findings from a Delphi consensus study
Niranjan S Karnik1, John Marsden2, Connor McCluskey1
1Institute for Juvenile Research, Department of Psychiatry, University of Illinois Chicago, Chicago, IL, USA.
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.
Insights
Researchers developed a core outcomes set for opioid use disorder (OUD) treatments. This standardized set includes patient-reported, clinician-reported, and administrative outcomes for OUD research.
Area of Science:
- Addiction Medicine
- Clinical Research Methodology
- Public Health
Background:
- Significant heterogeneity exists in outcome measures for opioid use disorder (OUD) treatments.
- A standardized approach is needed to evaluate OUD treatment efficacy and effectiveness.
Purpose of the Study:
- 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).
Main Methods:
- A four-round e-Delphi expert panel consensus study was conducted.
- A panel of 25 experts, including practitioners and researchers, participated.
- Candidate items were ranked on a 9-point scale, with a 70% consensus criterion.
Main Results:
- Consensus was reached on five core outcomes for OUD treatment.
- These include two patient-reported outcomes: global impression of improvement and incident non-fatal overdose.
- One clinician-reported outcome (illicit/non-medical drug toxicology) and two administrative outcomes (duration of treatment, fatal opioid poisoning) were identified.
Conclusions:
- The e-Delphi study successfully produced the NIDA CTN OUD-COS version 1.
- This core outcomes set will standardize research on OUD treatment efficacy and effectiveness.
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