Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study.
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2021-01-28
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Abstract
Background
A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.Methods/design
Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.Discussion
This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.Trial registration
http://www.comet-initiative.org/Studies/Details/1579.Type
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Publication Info
Karnik, Niranjan S, Cynthia I Campbell, Megan E Curtis, David A Fiellin, Udi Ghitza, Kathryn Hefner, Yih-Ing Hser, R Kathryn McHugh, et al. (2021). Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study. Trials, 22(1). p. 102. 10.1186/s13063-021-05051-9 Retrieved from https://hdl.handle.net/10161/22276.
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Scholars@Duke
Li-Tzy Wu
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)
R01: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults (Subaward PI, Investigator).
R01: Understanding the short- and long-term effects of the COVID-19 pandemic on the overdose crisis (Subaward PI, Investigator).
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