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

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

Article Commentary: Research Priorities for Expanding access to Methadone Treatment for Opioid use Disorder in the United States: A National Institute on Drug Abuse Clinical Trials Network Task Force Report

“…Conduct mixed-methods and expert consensus techniques (e.g., Delphi) to identify the cogent domains for measurement of patient need for structure and medical, psychiatric, behavioral, and social services during methadone treatment and their impact on OUD treatment outcomes across outpatient general medical, specialty, and OTP settings. 45 Medium term: 3-4 years Create research sites in general medical and other outpatient settings to study components of treatment structure (visit frequency; medication dispensing schedule; toxicology testing; medical, psychiatric, behavioral, and social services) with all MOUDs. Develop and validate strategies to assess patient need for treatment structure and medical, psychiatric, behavioral, and social services during methadone treatment in outpatient general medical, specialty, and OTP settings.…”

The opioid use disorder core outcomes set (OUD–COS) for treatment research: findings from a Delphi consensus study

“…The IRB judged it exempt from formal review because panel members did not meet the definition of research participants. The protocol was then reviewed by the CTN's Research Development Committee and published before commencement of the consensus process [29]. This report has been prepared to align with guidelines for reporting COS research [30].…”

“…This was an on-line (e-Delphi) consensus study. shed before commencement of the consensus process [29]. This report has been prepared to align with guidelines for reporting COS research [30].…”

Commentary Article: Strategic Planning for Addiction Programs within Academic Medical Centers: Examples from the Yale Program in Addiction Medicine

“…This method has been used widely in policymaking and guidelines development, including in the context of addiction medicine. [4][5][6] Figure 1 summarizes our stepwise process. Copies of surveys used during each step of this process are available in a Supplemental Appendix A included with this publication.…”