The Opioid Use Disorder Core Outcomes Set (OUD-COS) for treatment research: findings from a Delphi consensus study.

Abstract

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

USA.

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 online 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.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1111/add.15875

Publication Info

Karnik, Niranjan S, John Marsden, Connor McCluskey, Randy A Boley, Katharine A Bradley, Cynthia I Campbell, Megan E Curtis, David Fiellin, et al. (2022). The Opioid Use Disorder Core Outcomes Set (OUD-COS) for treatment research: findings from a Delphi consensus study. Addiction (Abingdon, England). 10.1111/add.15875 Retrieved from https://hdl.handle.net/10161/24998.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Wu

Li-Tzy Wu

Professor in Psychiatry and Behavioral Sciences

Education/Training: Pre- and post-doctoral training in mental health service research, psychiatric epidemiology (NIMH T32), and addiction epidemiology (NIDA T32) from Johns Hopkins University School of Public Health (Maryland); Fellow of the NIH Summer Institute on the Design and Conduct of Randomized Clinical Trials.

Director: Duke Community Based Substance Use Disorder Research Program.

Research interests: COVID-19, Opioid misuse, Opioid overdose, Opioid use disorder, Opioid addiction prevention and treatment, Pain and addiction, Chronic diseases and substance use disorders, diabetes, pharmacy-based care models and services, medication treatment for opioid use disorder (MOUD), Drug overdose, Polysubstance use and disorders, cannabis, alcohol, tobacco, hallucinogens, stimulants, e-cigarette, SBIRT (substance use Screening, Brief Intervention, Referral to Treatment), EHR-based research and intervention, data science, psychometric analysis (IRT), epidemiology of addictions and comorbidity, behavioral health care integration, health services research (mental health disorders, substance use disorders, chronic diseases), nosology, research design, HIV risk behavior. 

FUNDED Research projects (Principal Investigator [PI], Site PI, or Sub-award PI): 
R03: Substance use/dependence (PI).
R21: Treatment use for alcohol use disorders (PI).
R21: Inhalant use & disorders (PI).
R01: MDMA/hallucinogen use/disorders (PI).
R01: Prescription pain reliever (opioids) misuse and use disorders (PI).
R01: Substance use disorders in adolescents (PI).
R21: CTN Substance use diagnoses & treatment (PI).
R33: CTN Substance use diagnoses & treatment (PI).
R01: Evolution of Psychopathology in the Population (ECA Duke site PI).
R01: Substance use disorders and treatment use among Asian Americans and Pacific Islanders (PI).
UG1: SBIRT in Primary Care (NIDA, PI).
UG1: TAPS Tool, Substance use screening tool validation in primary care (NIDA, PI).
UG1: NIDA CTN Mid-Southern Node (Clinical Trials Network, PI).
UG1: EHR Data Element Study (NIDA, PI).
UG1: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder (NIDA, PI).
PCORI: INSPIRE-Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain (Site PI).
CDC R01: Evaluation of state-mandated acute and post-surgical pain-specific CDC opioid prescribing (Site PI).
Pilot: Measuring Opioid Use Disorders in Secondary Electronic Health Records Data (Carolinas Collaborative Grant: Duke PI).
R21: Developing a prevention model of alcohol use disorder for Pacific Islander young adults (Subaward PI, Investigator).
UG1: Subthreshold Opioid Use Disorder Prevention Trial (NIH HEAL Initiative) (NIDA supplement, CTN-0101, Investigator).
NIDA: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone through Community Pharmacies for their Stable Methadone Patients (NIDA/FRI: Study PI).
UG1: Integrating pharmacy-based prevention and treatment of opioid and other substance use disorders: A survey of pharmacists and stakeholder (NIH HEAL Initiative, NIDA, PI).
UG1: NorthStar Node of the Clinical Trials Network (NIDA, Site PI).
R34: Intervention Development and Pilot Study to Reduce Untreated Native Hawaiian and Pacific Islander Opioid Use Disorders (Subaward PI, Investigator).
UG1: Optimal Policies to Improve Methadone Maintenance Adherence Longterm (OPTIMMAL Study) (NIDA, Site PI).
R01: Increasing access to opioid use disorder treatment by opening pharmacy-based medication units of opioid treatment programs (NIDA, PI)


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