Doing community-based research during dual public health emergencies (COVID and overdose).

Meaningful engagement and partnerships with people who use drugs are essential to conducting research that is relevant and impactful in supporting desired outcomes of drug consumption as well as reducing drug-related harms of overdose and COVID-19. Community-based participatory research is a key strategy for engaging communities in research that directly affects their lives. While there are growing descriptions of community-based participatory research with people who use drugs and identification of key principles for conducting research, there is a gap in relation to models and frameworks to guide research partnerships with people who use drugs. The purpose of this paper is to provide a framework for research partnerships between people who use drugs and academic researchers, collaboratively developed and implemented as part of an evaluation of a provincial prescribed safer supply initiative introduced during dual public health emergencies (overdose and COVID-19) in British Columbia, Canada. The framework shifts from having researchers choose among multiple models (advisory, partnership and employment) to incorporating multiple roles within an overall community-based participatory research approach. Advocacy by and for drug users was identified as a key role and reason for engaging in research. Overall, both academic researchers and Peer Research Associates benefited within this collaborative partnerships approach. Each offered their expertise, creating opportunities for omni-directional learning and enhancing the research. The shift from fixed models to flexible roles allows for a range of involvement that accommodates varying time, energy and resources. Facilitators of involvement include development of trust and partnering with networks of people who use drugs, equitable pay, a graduate-level research assistant dedicated to ongoing orientation and communication, technical supports as well as fluidity in roles and opportunities. Key challenges included working in geographically dispersed locations, maintaining contact and connection over the course of the project and ensuring ongoing sustainable but flexible employment.

Opioid use disorder Cascade of care framework design: A roadmap.

Unintentional overdose deaths, most involving opioids, have eclipsed all other causes of US deaths for individuals less than 50 years of age. An estimated 2.4 to 5 million individuals have opioid use disorder (OUD) yet a minority receive treatment in a given year. Medications for OUD (MOUD) are the gold standard treatment for OUD however early dropout remains a major challenge for improving clinical outcomes. A Cascade of Care (CoC) framework, first popularized as a public health accountability strategy to stem the spread of HIV, has been adapted specifically for OUD. The CoC framework has been promoted by the NIH and several states and jurisdictions for organizing quality improvement efforts through clinical, policy, and administrative levers to improve OUD treatment initiation and retention. This roadmap details CoC design domains based on available data and potential linkages as individual state agencies and health systems typically rely on limited datasets subject to diverse legal and regulatory requirements constraining options for evaluations. Both graphical decision trees and catalogued studies are provided to help guide efforts by state agencies and health systems to improve data collection and monitoring efforts under the OUD CoC framework.

Cost-Effectiveness Analysis in Implementation Science: a Research Agenda and Call for Wider Application.

PURPOSE OF REVIEW: Cost-effectiveness analysis (CEA) can help identify the trade-offs decision makers face when confronted with alternative courses of action for the implementation of public health strategies. Application of CEA alongside implementation scientific studies remains limited. We aimed to identify areas for future development in order to enhance the uptake and impact of model-based CEA in implementation scientific research. RECENT FINDINGS: Important questions remain about how to broadly implement evidence-based public health interventions in routine practice. Establishing population-level implementation strategy components and distinct implementation phases, including planning for implementation, the time required to scale-up programs, and sustainment efforts required to maintain them, can help determine the data needed to quantify each of these elements. Model-based CEA can use these data to determine the added value associated with each of these elements across systems, settings, population subgroups, and levels of implementation to provide tailored guidance for evidence-based public health action. There is a need to integrate implementation science explicitly into CEA to adequately capture diverse real-world delivery contexts and make detailed, informed recommendations on the aspects of the implementation process that provide good value. We describe examples of how model-based CEA can integrate implementation scientific concepts and evidence to help tailor evaluations to local context. We also propose six distinct domains for methodological advancement in order to enhance the uptake and impact of model-based cost-effectiveness analysis in implementation scientific research.

Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs.

BACKGROUND: Government social assistance payments seek to alleviate poverty and address survival needs, but their monthly disbursement may cue increases in illicit drug use. This cue may be magnified when assistance is disbursed simultaneously across the population. Synchronized payments have been linked to escalations in drug use and unintended but severe drug-related harms, including overdose, as well as spikes in demand for health, social, financial and police services. METHODS/DESIGN: The TASA study examines whether changing payment timing and frequency can mitigate drug-related harm associated with synchronized social assistance disbursement. The study is a parallel arm multi-group randomized controlled trial in which 273 participants are randomly allocated for six assistance cycles to a control or one of two intervention arms on a 1:1:1 basis. Intervention arm participants receive their payments: (1) monthly; or (2) semi-monthly, in each case on days that are not during the week when cheques are normally issued. The study partners with a community-based credit union that has developed a system to vary social assistance payment timing. The primary outcome is a 40 % increase in drug use during the 3 days beginning with cheque issue day compared to other days of the month. Bi-weekly follow-up interviews collect participant information on this and secondary outcomes of interest, including drug-related harm (e.g. non-fatal overdose), exposure to violence and health service utilization. Self-reported data will be supplemented with participant information from health, financial, police and government administrative databases. A longitudinal, nested, qualitative parallel process evaluation explores participant experiences, and a cost-effectiveness evaluation of different disbursement scenarios will be undertaken. Outcomes will be compared between control and intervention arms to identify the impacts of alternative disbursement schedules on drug-related harm resulting from synchronized income assistance. DISCUSSION: This structural RCT benefits from strong community partnerships, highly detailed outcome measurement, robust methods of randomization and data triangulation with third party administrative databases. The study will provide evidence regarding the potential importance of social assistance program design as a lever to support population health outcomes and service provision for populations with a high prevalence of substance use. TRIAL REGISTRATION: NCT02457949 Registered 13 May 2015.

Implementation of pharmaceutical alternatives to a toxic drug supply in British Columbia: A mixed methods study.

BACKGROUND: North America has been in an unrelenting overdose crisis for almost a decade. British Columbia (BC), Canada declared a public health emergency due to overdoses in 2016. Risk Mitigation Guidance (RMG) for prescribing pharmaceutical opioids, stimulants and benzodiazepine alternatives to the toxic drug supply ("safer supply") was implemented in March 2020 in an attempt to reduce harms of COVID-19 and overdose deaths in BC during dual declared public health emergencies. Our objective was to describe early implementation of RMG among prescribers in BC. METHODS: We conducted a convergent mixed methods study drawing population-level linked administrative health data and qualitative interviews with 17 prescribers. The Consolidated Framework for Implementation Research (CFIR) informs our work. The study utilized seven linked databases, capturing the characteristics of prescribers for people with substance use disorder to describe the characteristics of those prescribing under the RMG using univariate summary statistics and logistic regression analysis. For the qualitative analysis, we drew on interpretative descriptive methodology to identify barriers and facilitators to implementation. RESULTS: Analysis of administrative databases demonstrated limited uptake of the intervention outside large urban centres and a highly specific profile of urban prescribers, with larger and more complex caseloads associated with RMG prescribing. Nurse practitioners were three times more likely to prescribe than general practitioners. Qualitatively, the study identified five themes related to the five CFIR domains: 1) RMG is helpful but controversial; 2) Motivations and challenges to prescribing; 3) New options and opportunities for care but not enough to 'win the arms race'; 4) Lack of implementation support and resources; 5) Limited infrastructure. CONCLUSIONS: BC's implementation of RMG was limited in scope, prescriber uptake and geographic scale up. Systemic, organizational and individual barriers and facilitators point to the importance of engaging professional regulatory colleges, implementation planning and organizational infrastructure to ensure effective implementation and adaptation to context.

The impact of syringe services program closure on the risk of rebound HIV outbreaks among people who inject drugs: a modeling study.

OBJECTIVE: Despite their effectiveness in preventing the transmission of HIV among people who inject drugs (PWID), syringe services programs (SSPs) in many settings are hampered by social and political opposition. We aimed to estimate the impact of closure and temporary interruption of SSP on the HIV epidemic in a rural United States setting. METHODS: Using an agent-based model (ABM) calibrated to observed surveillance data, we simulated HIV risk behaviors and transmission in adult populations who inject and do not inject drugs in Scott County, Indiana. We projected HIV incidence and prevalence between 2020 and 2025 for scenarios with permanent closure, delayed closure (one additional renewal for 24 months before closure), and temporary closure (lasting 12 months) of an SSP in comparison to persistent SSP operation. RESULTS: With sustained SSP operation, we projected an incidence rate of 0.15 per 100 person-years among the overall population (95% simulation interval: 0.06-0.28). Permanently closing the SSP would cause an average of 58.4% increase in the overall incidence rate during 2021-2025, resulting in a higher prevalence of 60.8% (50.9-70.6%) (18.7% increase) among PWID by 2025. A delayed closure would increase the incidence rate by 38.9%. A temporary closure would cause 12 (35.3%) more infections during 2020-2021. CONCLUSION: Our analysis suggests that temporary interruption and permanent closure of existing SSPs operating in rural United States may lead to 'rebound' HIV outbreaks among PWID. To reach and sustain HIV epidemic control, it will be necessary to maintain existing and implement new SSPs in combination with other prevention interventions.

Advancing virtual primary care for people with opioid use disorder (VPC OUD): a mixed-methods study protocol.

INTRODUCTION: The emergence of COVID-19 introduced a dual public health emergency in British Columbia, which was already in the fourth year of its opioid-related overdose crisis. The public health response to COVID-19 must explicitly consider the unique needs of, and impacts on, communities experiencing marginalisation including people with opioid use disorder (PWOUD). The broad move to virtual forms of primary care, for example, may result in changes to healthcare access, delivery of opioid agonist therapies or fluctuations in co-occurring health problems that are prevalent in this population. The goal of this mixed-methods study is to characterise changes to primary care access and patient outcomes following the rapid introduction of virtual care for PWOUD. METHODS AND ANALYSIS: We will use a fully integrated mixed-methods design comprised of three components: (a) qualitative interviews with family physicians and PWOUD to document experiences with delivering and accessing virtual visits, respectively; (b) quantitative analysis of linked, population-based administrative data to describe the uptake of virtual care, its impact on access to services and downstream outcomes for PWOUD; and (c) facilitated deliberative dialogues to co-create educational resources for family physicians, PWOUD and policymakers that promote equitable access to high-quality virtual primary care for this population. ETHICS AND DISSEMINATION: Approval for this study has been granted by Research Ethics British Columbia. We will convene PWOUD and family physicians for deliberative dialogues to co-create educational materials and policy recommendations based on our findings. We will also disseminate findings via traditional academic outputs such as conferences and peer-reviewed publications.

Characteristics and response to treatment among Aboriginal people receiving heroin-assisted treatment.

BACKGROUND: Medically prescribed diacetylmorphine, the active ingredient of heroin, has been shown to be effective for the treatment of severe opioid addiction. However, there are no data regarding its effectiveness among Aboriginal heroin injectors. METHODS: The present analyses were performed using data from the NAOMI study (North American Opiate Maintenance Initiative), an open-label randomized controlled trial that compared the effectiveness of injectable diacetylmorphine (45.8%) and hydromorphone (10%) vs. oral methadone (44.2%) among long-term treatment-refractory opioid-dependent individuals. Rates of retention and response to treatment were analyzed among participants from the Vancouver site (n = 192). RESULTS: Baseline profiles were similar among Aboriginal (n = 60) and non-Aboriginal (n = 132) participants except for higher HIV positive rates among Aboriginal people (23.3% vs. 8.3%). Among Aboriginal participants in the injection and methadone groups, retention rates at 12 months were 84.4% vs. 57.1% and response rates were 68.8% vs. 53.4%, respectively. Aboriginal and non-Aboriginal rates were not significantly different. DISCUSSION: Offering treatment assisted with medically prescribed diacetylmorphine or hydromorphone to long-term treatment-refractory opioid-dependent Aboriginal people could be an effective way to attract them into and retain them in treatment as well as dramatically reduce the risk of HIV infection.

A historical review of HIV prevention and care initiatives in British Columbia, Canada: 1996-2015.

INTRODUCTION: British Columbia has made significant progress in the treatment and prevention of HIV since 1996, when Highly Active Antiretroviral Therapy (HAART) became available. However, we currently lack a historical summary of HIV prevention and care interventions implemented in the province since the introduction of HAART and how they have shaped the HIV epidemic. Guided by a socio-ecological framework, we present a historical review of biomedical and health services, community and structural interventions implemented in British Columbia from 1996-2015 to prevent HIV transmission or otherwise enhance the cascade of HIV care. METHODS: We constructed a historical timeline of HIV interventions implemented in BC between 1996 and 2015 by reviewing publicly available reports, guidelines and other documents from provincial health agencies, community organizations and AIDS service organizations, and by conducting searches of peer-reviewed literature through PubMed and Ovid MEDLINE. We collected further programmatic information by administering a data collection form to representatives from BC's regional health authorities and an umbrella agency representing 45 AIDS Service organizations. Using linked population-level health administrative data, we identified key phases of the HIV epidemic in British Columbia, as characterized by distinct changes in HIV incidence, HAART uptake and the provincial HIV response. RESULTS AND DISCUSSION: In total, we identified 175 HIV prevention and care interventions implemented in BC from 1996 to 2015. We identify and describe four phases in BC's response to HIV/AIDS: the early HAART phase (1996-1999); the harm reduction and health service scale-up phase (2000-2005); the early Treatment as Prevention phase (2006-2009); and the STOP HIV/AIDS phase (2010-present). In doing so, we provide an overview of British Columbia's universal and centralized HIV treatment system and detail the role of community-based and provincial stakeholders in advancing innovative prevention and harm reduction approaches, as well as "seek, test, treat and retain" strategies. CONCLUSIONS: The review provides valuable insight into British Columbia's HIV response, highlights emerging priorities, and may inform future efforts to evaluate the causal impact of interventions.

Quality of life as an outcome of opioid use disorder treatment: A systematic review.

BACKGROUND AND AIMS: The recent opioid epidemic has prompted renewed interest in opioid use disorder treatment, but there is little evidence regarding health-related quality-of-life (HRQoL) outcomes in treatment programs. Measuring HRQoL represents an opportunity to consider outcomes of opioid use disorder treatment that are more patient-centered and more relevant to overall health than abstinence alone. We conducted a systematic literature review to explore the extent to which the collection of HRQoL by opioid treatment programs is documented in the treatment program literature. MATERIALS AND METHODS: We searched PubMed, Embase PsycINFO and Web of Science for papers published between 1965 and 2015 that reported HRQoL outcome measures from substance abuse treatment programs. RESULTS: Of the 3014 unduplicated articles initially identified for screening, 99 articles met criteria for further review. Of those articles, 7 were unavailable in English; therefore 92 articles were reviewed. Of these articles, 44 included any quality-of-life measure, 17 of which included validated HRQoL measures, and 10 supported derivation of quality-adjusted life year utility weights. The most frequently used validated measure was the Addiction Severity Index (ASI). Non-U.S. and more recent studies were more likely to include a measure of HRQoL. CONCLUSIONS: HRQoL measures are rarely used as outcomes in opioid treatment programs. The field should incorporate HRQoL measures as standard practice, especially measures that can be used to derive utility weights, such as the SF-12 or EQ-5D. These instruments provide policy makers with evidence on the impact of programs on patients' lives and with data to quantify the value of investing in opioid use disorder treatments.

Utilization and outcomes of detoxification and maintenance treatment for opioid dependence in publicly-funded facilities in California, USA: 1991-2012.

BACKGROUND: California treats the largest population of opioid dependent individuals in the USA and is among a small group of states that applies regulations for opioid treatment that are more stringent than existing federal regulations. We aim to characterize changes in patient characteristics and treatment utilization over time, and identify determinants of successful completion of detoxification and MMT retention in repeated attempts. METHODS: State-wide administrative data was obtained from California Outcome Measurement System during the period: January 1st, 1991-March 31st, 2012. Short-term detoxification treatment and long-term maintenance treatment, primarily with methadone, was available to study participants. Mixed effects regression models were used to define determinants of successful completion of the detoxification treatment protocol (as classified by treatment staff) and duration of maintenance treatment. RESULTS: The study sample consisted of 237,709 unique individuals and 885,971 treatment episodes; 837% were detoxification treatment episodes in 1994, dropping to 40.5% in 2010. Among individuals accessing only detoxification, the adjusted odds of success declined with each successive attempt (vs. 1st attempt: 2nd: OR: 0.679; 95% CI (0.610, 0.755); 3rd: 0.557 (0.484, 0.641); 4th: 0.526 (0.445, 0.622); 5th: 0.407 (0.334, 0.497); ≥6th: 0.339 (0.288, 0.399). For those ever accessing maintenance treatment, later subsequent attempts were longer in duration, and those with two or more prior attempts at detoxification had marginally longer subsequent maintenance episodes (hazard ratio: 0.97; 95% CI: 0.95, 0.99). Finally, only 10.9% of all detoxification episodes were followed by admission into maintenance treatment within 14 days. CONCLUSIONS: This study has revealed high rates of detoxification treatment for opioid dependence in California throughout the study period, and decreasing odds of success in repeated attempts at detoxification.

The temporal relationship between drug supply indicators: an audit of international government surveillance systems.

OBJECTIVES: Illegal drug use continues to be a major threat to community health and safety. We used international drug surveillance databases to assess the relationship between multiple long-term estimates of illegal drug price and purity. DESIGN: We systematically searched for longitudinal measures of illegal drug supply indicators to assess the long-term impact of enforcement-based supply reduction interventions. SETTING: Data from identified illegal drug surveillance systems were analysed using an a priori defined protocol in which we sought to present annual estimates beginning in 1990. Data were then subjected to trend analyses. MAIN OUTCOME MEASURES: Data were obtained from government surveillance systems assessing price, purity and/or seizure quantities of illegal drugs; systems with at least 10 years of longitudinal data assessing price, purity/potency or seizures were included. RESULTS: We identified seven regional/international metasurveillance systems with longitudinal measures of price or purity/potency that met eligibility criteria. In the USA, the average inflation-adjusted and purity-adjusted prices of heroin, cocaine and cannabis decreased by 81%, 80% and 86%, respectively, between 1990 and 2007, whereas average purity increased by 60%, 11% and 161%, respectively. Similar trends were observed in Europe, where during the same period the average inflation-adjusted price of opiates and cocaine decreased by 74% and 51%, respectively. In Australia, the average inflation-adjusted price of cocaine decreased 14%, while the inflation-adjusted price of heroin and cannabis both decreased 49% between 2000 and 2010. During this time, seizures of these drugs in major production regions and major domestic markets generally increased. CONCLUSIONS: With few exceptions and despite increasing investments in enforcement-based supply reduction efforts aimed at disrupting global drug supply, illegal drug prices have generally decreased while drug purity has generally increased since 1990. These findings suggest that expanding efforts at controlling the global illegal drug market through law enforcement are failing.

Safety and clinical effectiveness of midazolam versus propofol for procedural sedation in the emergency department: a systematic review.

OBJECTIVES: To synthesize the evidence comparing the adverse event (AE) profile and clinical effectiveness of midazolam and propofol for procedural sedation (PS) in adults in the emergency care setting. METHODS: The authors conducted a systematic review of randomized controlled trials (RCTs) and observational studies reporting the use of either midazolam and/or propofol for adult PS in the emergency department (ED). A systematic search strategy was developed and applied to six bibliographic reference databases. Three emergency medicine journals, the Canadian Adverse Drug Reaction Newsletter, and conference proceedings were hand-searched. Retrieved articles were reviewed and data were abstracted using standardized data collection. Trial quality was assessed using the Jadad score. The outcomes assessed were the proportion of patients with AEs and the pooled mean difference in the proportion of patients with successful PS. RESULTS: Of 229 articles identified, 28 met the inclusion criteria for the analysis of AEs. Only one major AE to PS was found, resulting in no statistically significant difference in the proportion of major AEs between agents. Four studies were RCTs that met the inclusion criteria for the analysis of clinical effectiveness. Two trials met criteria for good quality. The RCTs enrolled between 32 and 86 patients, and the most common indications for PS were orthopedic reductions and cardioversions. There was a nonsignificant difference in the proportion of patients with successful PS in favor of propofol (effect difference 2.9%, 95% confidence interval (CI) = -6.5 to 15.2). CONCLUSIONS: The authors found no significant difference in the safety profile and the proportion of successful PS between midazolam and propofol for adults in the ED.