Current and future options for opioid use disorder: a survey assessing real-world opinion of service users on novel therapies including depot formulations of buprenorphine

Background: Hepatitis C Virus (HCV) treatment in people who inject drugs (PWID) is a key component of elimination models but PWID face substantial barriers to treatment access. Despite data showing treatment outcomes among PWID on medications for opioid use disorder (MOUD) are similar to non-PWID outcomes, few studies examine PWID treatment outcomes with only syringe services support. Objectives: To evaluate the effect of recruitment for HCV treatment with elbasvir/grazoprevir (E/G) in a syringe services program (SSP) as compared to an MOUD program for people with opioid use disorder. Methods: This real-world, multi-site prospective open-label pilot study compares treatment of PWID with aspartate aminotransferase to platelet ratio (APRI) < 0.7 and genotype 1a, 1b, and 4 HCV with E/G, engaged in MOUD (n = 25) or an SSP (n = 25). The MOUD arm was enrolled through a federally qualified community health center and SSP arm through a nearby SSP. Prospective arms were compared to an academic hepatology clinic group (n = 50). Sustained virologic response at 12 weeks (SVR12), medication adherence, and treatment discontinuation were evaluated. Results: In the MOUD vs SSP arms, substance use throughout treatment was found in 36% (9/25) vs 100% (25/25); good adherence (> 90% pills taken) in 100% (25/25) vs 68% (17/25); treatment completion 100% (25/25) vs 64% (16/25); and SVR12 rates were 96% (24/25) vs 60% (15/25). In the community standard comparison group, SVR12 was achieved in 94% (47/50). There were two virologic failures or re-infections in the SSP group; all other non-responders were due to missing SVR12 data. Conclusions: While recruitment and follow-up are challenging in SSPs, preliminary data suggests adherence, treatment completion, and SVR12 are high in PWID treated with E/G engaging in SSP or MOUD. All metrics are comparable to community standards for non-PWID for treatment of HCV with direct-antiviral drugs.

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Factors That Affect Patient Attrition in Buprenorphine Treatment for Opioid Use Disorder: A Retrospective Real-World Study Using Electronic Health Records

Neuropsychiatric Disease and Treatment ◽

10.2147/ndt.s331442 ◽

2021 ◽

Vol Volume 17 ◽

pp. 3229-3244

Author(s):

Sheryl Ker ◽

Jennifer Hsu ◽

Anisha Balani ◽

Sankha Subhra Mukherjee ◽

A John Rush ◽

...

Keyword(s):

Electronic Health Records ◽

Real World ◽

Opioid Use Disorder ◽

Opioid Use ◽

Health Records ◽

Patient Attrition ◽

Electronic Health ◽

Buprenorphine Treatment

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Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic

Expert Review of Pharmacoeconomics & Outcomes Research ◽

10.1080/14737167.2021.1840357 ◽

2020 ◽

pp. 1-8

Author(s):

Fulton F. Velez ◽

Sam Colman ◽

Laura Kauffman ◽

Charles Ruetsch ◽

Kathryn Anastassopoulos

Keyword(s):

Resource Utilization ◽

Real World ◽

Healthcare Resource ◽

Healthcare Resource Utilization ◽

Opioid Use Disorder ◽

Opioid Use

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Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder

Hospital Practice ◽

10.1080/21548331.2021.1956256 ◽

2021 ◽

Author(s):

Fulton F Velez ◽

Sam Colman ◽

Laura Kauffman ◽

Kathryn Anastassopoulos ◽

Sean Murphy ◽

...

Keyword(s):

Health System ◽

Real World ◽

Opioid Use Disorder ◽

Opioid Use

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Identifying Clinical Risk Factors for Opioid Use Disorder using a Distributed Algorithm to Combine Real-World Data from a Large Clinical Data Research Network

10.1101/2020.08.16.20167577 ◽

2020 ◽

Author(s):

Jiayi Tong ◽

Zhaoyi Chen ◽

Rui Duan ◽

Wei-Hsuan Lo-Ciganic ◽

Tianchen Lyu ◽

...

Keyword(s):

Risk Factors ◽

Clinical Data ◽

Real World ◽

Distributed Algorithm ◽

Opioid Use Disorder ◽

Research Network ◽

Patient Privacy ◽

Opioid Use ◽

Real World Data ◽

Level Data

Because they contain detailed individual-level data on various patient characteristics including their medical conditions and treatment histories, electronic health record (EHR) systems have been widely adopted as an efficient source for health research. Compared to data from a single health system, real-world data (RWD) from multiple clinical sites provide a larger and more generalizable population for accurate estimation, leading to better decision making for health care. However, due to concerns over protecting patient privacy, it is challenging to share individual patient-level data across sites in practice. To tackle this issue, many distributed algorithms have been developed to transfer summary-level statistics to derive accurate estimates. Nevertheless, many of these algorithms require multiple rounds of communication to exchange intermediate results across different sites. Among them, the One-shot Distributed Algorithm for Logistic regression (termed ODAL) was developed to reduce communication overhead while protecting patient privacy. In this paper, we applied the ODAL algorithm to RWD from a large clinical data research network-the OneFlorida Clinical Research Consortium and estimated the associations between risk factors and the diagnosis of opioid use disorder (OUD) among individuals who received at least one opioid prescription. The ODAL algorithm provided consistent findings of the associated risk factors and yielded better estimates than meta- analysis.

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Barriers impacting the POINT pragmatic trial: the unavoidable overlap between research and intervention procedures in “real-world” research

Trials ◽

10.1186/s13063-021-05065-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Allyson L. Dir ◽

Dennis P. Watson ◽

Matthew Zhiss ◽

Lisa Taylor ◽

Bethany C. Bray ◽

...

Keyword(s):

Emergency Department ◽

Implementation Science ◽

Real World ◽

Research Team ◽

Pragmatic Trial ◽

Opioid Use Disorder ◽

Opioid Use ◽

Pragmatic Trials ◽

Intervention Delivery ◽

Quality Assurance Mechanism

Abstract Background This manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching intervention for linking patients with opioid use disorder to evidence-based treatment. The research team has encountered a number of challenges related to the “real-world” study setting since the trial began. Using an implementation science lens, we sought to identify and describe barriers impacting both the intervention and research protocols of the POINT study, which are often intertwined in pragmatic trials due to the focus on external validity. Method Qualitative data were collected from 3 peer recovery coaches, 2 peer recovery coach supervisors, and 3 members of the research team. Questions and deductive qualitative analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Results Nine unique barriers were noted, with 5 of these barriers impacting intervention and research protocol implementation simultaneously. These simultaneous barriers were timing of intervention delivery, ineffective communication with emergency department staff, lack of privacy in the emergency department, the fast-paced emergency department setting, and patient’s limited resources. Together, these barriers represent the intervention characteristics, inner setting, and outer setting domains of the CFIR. Conclusion Results highlight the utility of employing an implementation science framework to assess implementation issues in pragmatic trials and how this approach might be used as a quality assurance mechanism given the considerable overlap that exists between research and intervention protocols in real-world trial settings. Previously undocumented changes to the trial design that have been made as a result of the identified barriers are discussed.

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