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• W4296793736 abstract "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). The authors’ contribution has major implications for future research and the OUD cascade of care [2]. However, we raise two concerns in the authors’ study design, which may bias results and affect generalizability of their conclusions. First, input of key stakeholders is absent—a limitation acknowledged but understated by the authors. COMET (Core Outcome Measures in Effectiveness Trials) guidelines—the framework the authors used—specify that distinctive perspectives of different stakeholders, including patients, should be preserved [3]. However, all but two (8%) panel members were identified as PhD/ScD or physician and 21 (84%) identified as researcher or clinician researcher. The primary vehicle for recruitment was the NIDA (National Institute on Drug Abuse) Clinical Trials Network (CTN), which includes diverse clinical disciplines such as social workers, pharmacists, nurse care managers and advanced practice providers, but none of these were included in the e-Delphi panel. The cumulative number of participants who were identified as any race or ethnicity other than Caucasian or Asian was one (4%). Further, the original protocol did not specify any procedure to ensure racial/ethnic diversity [4]. While the authors subsequently distributed their proposed COS items to chairs and co-chairs of CTN special interest groups, it is unclear how many of these chairs/co-chairs responded. Importantly, patients were not represented in the development of OUD-COS. A central tenet of any COS is to ‘promote patient and public involvement in COS development’ [3]. Without more diverse voices, a COS is incomplete [5, 6]. Second, procedures used to govern the steering committee and consensus meeting following the e-Delphi panel potentially limit the scope of this important research. Development of candidate outcomes was derived from approximately 100 extant CTN trials without further literature review, which may miss potentially relevant outcomes from other sources. For example, stigma has at least three validated measures that could be used in effectiveness trials for OUD treatment interventions, yet stigma was not considered in this study [7-9]. Additionally, after the e-Delphi panel completed their selection of three core outcomes, the steering committee subsequently added two additional outcomes to the OUD-COS. The authors justified this post-hoc decision by stating that the added outcomes had ‘initial high rankings’ (i.e. in early rounds) despite ultimately falling short in the e-Delphi process, but other outcomes that had similarly high initial rankings were excluded without additional explanation. Quality of life (QoL)—one of these discarded outcomes—is the primary driver of the economic burden related to OUD [10], suggesting that patients are likely to be sensitive to QoL impacts of OUD treatment interventions [11, 12]. Many (but not all) OUD clinical trials include validated QoL measures [13-16]. If patients and/or other disciplines outside research had been included in the e-Delphi panel, would QoL have been selected for the OUD-COS? This question highlights potential biases inherent in a homogenous group participating in consensus-based research. While we applaud the work the authors have contributed, diverse representation and more objective protocol procedures are necessary to define a truly evidence-based and patient-centered COS. A.T.K. is supported by the Vulnerable Veteran Innovative Patient-aligned Care Team (VIP) Initiative (no award number) at the Department of Veterans Affairs (VA) Salt Lake City Health Care System. None. ATK drafted the initial letter. MAI provided major edits and content revision." @default.
• W4296793736 created "2022-09-24" @default.
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• W4296793736 date "2022-10-06" @default.
• W4296793736 modified "2023-10-11" @default.
• W4296793736 title "The need for a more inclusive and objective approach in developing a core outcomes set for opioid use disorder" @default.
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• W4296793736 doi "https://doi.org/10.1111/add.16054" @default.
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