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 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.

Response to Kelley & Incze: there is certainly more work to do for the OUD‐COS

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We thank Drs Kelley and Incze [1] for taking time to offer feedback on our report of defining a core outcomes set for opioid use disorder trials (OUD-COS) [2]. The major points they make are outlined in the paper's limitations, and we concur that the process would have benefited from broader stakeholder input, including most critically that of people who use drugs.We hope that the results of our time-limited work form a version 1 of the OUD-COS. As others consider the next steps toward strengthening this core outcomes set, the availability of resources will be essential to successfully broaden the work and the contribution of diverse stakeholders.

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The need for a more inclusive and objective approach in developing a core outcomes set for opioid use disorder

“…Alan Taylor Kelley 1,2,3 Michael A. Incze 2,3 1 Vulnerable Veteran Innovative Patient Aligned Care Team (VIP) Initiative, Informatics, Decision-Enhancement, and Analytic Sciences (IDEAS) Center, VA Salt Lake City Health Care System, Salt Lake City, UT,…”

“…We read with great interest the study that Karnik et al [1] recently published defining a core outcomes set (COS) for opioid use disorder (OUD) treatment effectiveness research in clinical trials (OUD-COS).…”

Commentary on Karnik et al.: Harmonization now—the need for consistent, validated measures to identify opioid use disorder in observational data

“…Karnik et al . developed an expert consensus, first‐of‐its‐kind core outcome set (COS) for use in clinical trials of individuals with opioid use disorder (OUD) [1]. Their work was motivated by the lack of agreed‐upon outcome sets and the resultant proliferation of measurements and approaches that makes cross‐study comparisons difficult.…”

“…The ‘data harmonization efforts underway globally’ [1] will doubtless benefit from the work conducted by Karnik et al ., and we believe that a particular point of impact could be the application of a COS framework for observational data from administrative claims and electronic health records (EHR). These types of data are more readily available than trial data, often include larger samples, enabling study of rarer but important outcomes such as overdose, and can track patients over years or decades.…”