Browsing by Author "Marsden, John"

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    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, 2021-01-28) Karnik, Niranjan S; Campbell, Cynthia I; Curtis, Megan E; Fiellin, David A; Ghitza, Udi; Hefner, Kathryn; Hser, Yih-Ing; McHugh, R Kathryn; Murphy, Sean M; McPherson, Sterling M; Moran, Landhing; Mooney, Larissa J; Wu, Li-Tzy; Shmueli-Blumberg, Dikla; Shulman, Matisyahu; Schwartz, Robert P; Stephens, Kari A; Watkins, Katherine E; Marsden, John

    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.
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    Measurement-based care using DSM-5 for opioid use disorder: can we make opioid medication treatment more effective?
    (Addiction (Abingdon, England), 2019-08) Marsden, John; Tai, Betty; Ali, Robert; Hu, Lian; Rush, A John; Volkow, Nora

    Context and purpose

    Measurement-based care (MBC) is an evidence-based health-care practice in which indicators of disease are tracked to inform clinical actions, provide feedback to patients and improve outcomes. The current opioid crisis in multiple countries provides a pressing rationale for adopting a basic MBC approach for opioid use disorder (OUD) using DSM-5 to increase treatment retention and effectiveness.

    Proposal

    To stimulate debate, we propose a basic MBC approach using the 11 symptoms of OUD (DSM-5) to inform the delivery of medications for opioid use disorder (MOUD; including methadone, buprenorphine and naltrexone) and their evaluation in office-based primary care and specialist clinics. Key features of a basic MBC approach for OUD using DSM-5 are described, with an illustration of how clinical actions are guided and outcomes communicated. For core treatment tasks, we propose that craving and drug use response to MOUD should be assessed after 2 weeks, and OUD remission status should be evaluated at 3, 6 and 12 months (and exit from MOUD treatment) and beyond. Each of the 11 DSM-5 symptoms of OUD should be discussed with the patient to develop a case formulation and guide selection of adjunctive psychological interventions, supplemented with information on substance use, and optionally extended with information from other clinical instruments. A patient-reported outcome measure should be recorded and discussed at each remission assessment.

    Conclusions

    MBC can be used to tailor and adapt MOUD treatment to increase engagement, retention and effectiveness. MBC practice principles can help promote patient-centred care in OUD, personalized addiction therapeutics and facilitate communication of outcomes.
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    Response to commentaries.
    (Addiction (Abingdon, England), 2019-08) Marsden, John; Tai, Betty; Ali, Robert; Hu, Lian; Rush, Agustus John; Volkow, Nora D
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    The Opioid Use Disorder Core Outcomes Set (OUD-COS) for treatment research: findings from a Delphi consensus study.
    (Addiction (Abingdon, England), 2022-03-16) Karnik, Niranjan S; Marsden, John; McCluskey, Connor; Boley, Randy A; Bradley, Katharine A; Campbell, Cynthia I; Curtis, Megan E; Fiellin, David; Ghitza, Udi; Hefner, Kathryn; Hser, Yih-Ing; McHugh, R Kathryn; McPherson, Sterling M; Mooney, Larissa J; Moran, Landhing M; Murphy, Sean M; Schwartz, Robert P; Shmueli-Blumberg, Dikla; Shulman, Matisyahu; Stephens, Kari A; Watkins, Katherine E; Weiss, Roger D; Wu, Li-Tzy

    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.