Participant Fraud in Virtual Qualitative Substance Use Research: Recommendations and Considerations for Detection and Prevention Based on a Case Study.

Background: The COVID-19 pandemic has accelerated and amplified the use of virtual research methods. While online research has several advantages, it also provides greater opportunity for individuals to misrepresent their identities to fraudulently participate in research for financial gain. Participant deception and fraud have become a growing concern for virtual research. Reports of deception and preventative strategies have been discussed within online quantitative research, particularly survey studies. Though, there is a dearth of literature surrounding these issues pertaining to qualitative studies, particularly within substance use research. Results: In this commentary, we detail an unforeseen case study of several individuals who appeared to deliberately misrepresent their identities and information during participation in a virtual synchronous qualitative substance use study. Through our experiences, we offer strategies to detect and prevent participant deception and fraud, as well as challenges to consider when implementing these approaches. Conclusions: Without general awareness and protective measures, the integrity of virtual research methods remains vulnerable to inaccuracy. As online research continues to expand, it is essential to proactively design innovative solutions to safeguard future studies against increasingly sophisticated deception and fraud.

Identifying appropriate outcomes to help evaluate the impact of the Canadian Guideline for Safe and Effective Use of Opioids for Non-Cancer Pain.

BACKGROUND: The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain (COG) was developed in response to increasing rates of opioid-related hospital visits and deaths in Canada, and uncertain benefits of opioids for chronic non-cancer pain (CNCP). Following publication, we developed a list of evaluable outcomes to assess the impact of this guideline on practice and patient outcomes. METHODS: A working group at the National Pain Centre at McMaster University used a modified Delphi process to construct a list of clinical and patient outcomes important in assessing the uptake and application of the COG. An advisory group then reviewed this list to determine the relevance and feasibility of each outcome, and identified potential data sources. This feedback was reviewed by the National Faculty for the Guideline, and a National Advisory Group that included the creators of the COG, resulting in the final list of 5 priority outcomes. RESULTS: Five outcomes were judged clinically important and feasible to measure: 1) Effects of opioids for CNCP on quality of life, 2) Assessment of patient's risk of addiction before starting opioid therapy, 3) Monitoring patients on opioid therapy for aberrant drug-related behaviour, 4) Mortality rates associated with prescription opioid overdose and 5) Use of treatment agreements with patients before initiating opioid therapy for CNCP. Data sources for these outcomes included patient's medical charts, e-Opioid Manager, prescription monitoring programs and administrative databases. CONCLUSION: Measuring the impact of best practice guidelines is infrequently done. Future research should consider capturing the five outcomes identified in this study to evaluate the impact of the COG in promoting evidence-based use of opioids for CNCP.

Cardiovascular and Neuropsychiatric Events after Varenicline Use for Smoking Cessation.

RATIONALE: Varenicline aids in smoking cessation but has also been associated with serious adverse events. OBJECTIVES: The aim of this study was to determine the risks of cardiovascular and neuropsychiatric events after varenicline receipt in a real-world setting. METHODS: A population-based, self-controlled risk interval study using linked universal health administrative data from the diverse, multicultural population of Ontario, Canada, was conducted. In two separate analyses, new varenicline users between September 1, 2011 and February 15, 2014 were observed from 1 year before to 1 year after varenicline receipt. The relative incidences of cardiovascular and neuropsychiatric hospitalizations and emergency department visits in the 12 weeks after varenicline receipt (the risk interval) compared with the remaining observation period (the control interval) were estimated in two separate fixed-effect conditional Poisson regressions. Sensitivity analyses tested the robustness of the results. MEASUREMENTS AND MAIN RESULTS: Among 56,851 new users of varenicline, 6,317 cardiovascular and 10,041 neuropsychiatric hospitalizations and emergency department visits occurred from 1 year before to 1 year after receipt. The incidence of cardiovascular events was 34% higher in the risk compared with the control interval (relative incidence, 1.34; 95% confidence interval, 1.25-1.44). Findings were consistent in sensitivity analyses, most notably in those without any history of previous cardiovascular disease. The relative incidence of neuropsychiatric events was marginally significant in the primary (relative incidence, 1.06; 95% confidence interval, 1.00-1.13) but not all sensitivity analyses. CONCLUSIONS: Varenicline appears to be associated with an increased risk of cardiovascular but not neuropsychiatric events.

Impact of large-scale distribution and subsequent use of free nicotine patches on primary care physician interaction.

BACKGROUND: Large-scale distribution efforts of free nicotine replacement therapy (NRT) have been documented to be cost-effective interventions for increasing smoking quit rates. However, despite nearly a dozen studies evaluating their effectiveness, none have examined whether free NRT provision promotes further primary care help-seeking and the impact that it may have on cessation efforts. METHODS: In the context of a randomized controlled trial, a secondary analysis was conducted on 1000 adult regular smokers randomized to be mailed a 5-week supply of nicotine patches or to a no intervention control group. Recipients and users of free nicotine patches at an 8 week follow-up were successfully case matched to controls based on age, gender, baseline level of nicotine dependence and intent to quit (n = 201 per group). Differences in physician interaction between the two groups were evaluated at both 8 week and 6 month follow-ups. The impact of physician interaction on self-reported smoking abstinence at each follow-up was also examined. RESULTS: Although no differences in physician interaction were noted between groups at the 8 week follow-up, at the 6 month follow-up, nicotine patch users reported greater frequency of discussing smoking with their physician (43.9%), as compared to the control group (30.3%) (p = 0.011). Across both groups, over 90% of those that discussed smoking with a physician were encouraged to quit and approximately 70% were provided with additional support. Separate ANOVAs revealed no significant impact of physician interaction on cessation (p > 0.05), regardless of group or follow-up period, however, at the 6 month follow-up, nicotine patch users who discussed cessation with a physician had made serious quit attempts at significantly greater rates (72.6%), compared to controls (49.1%) (p = 0.007). CONCLUSIONS: Irrespective of group, the majority of smokers in the present study did not discuss cessation with their physician. Recipients and users of nicotine patches however, were more likely to discuss smoking with their physician, suggesting that the provision of free NRT particularly to those who are likely to use it may facilitate opportunities for benefits beyond the direct pharmacological effects of the medication. TRIAL REGISTRATION: clinicaltrials.gov , NCT01429129 . Registered: 2 September 2011.

Incorporating sex, gender and vulnerable populations in a large multisite health research programme: The Ontario Pharmacy Evidence Network as a case study.

BACKGROUND: Funders now frequently require that sex and gender be considered in research programmes, but provide little guidance about how this can be accomplished, especially in large research programmes. The purpose of this study is to present and evaluate a model for promoting sex- and gender-based analysis (SGBA) in a large health service research programme, the Ontario Pharmacy Evidence Network (OPEN). METHODS: A mixed method study incorporating (1) team members' critical reflection, (2) surveys (n = 37) and interviews (n = 23) at programme midpoint, and (3) an end-of-study survey in 2016 with OPEN research project teams (n = 6). RESULTS: Incorporating gender and vulnerable populations (GVP) as a cross-cutting theme, with a dedicated team and resources to promote GVP research across the programme, was effective and well received. Team members felt their knowledge was improved, and the programme produced several sex- and gender-related research outputs. Not all resources were well used, however, and better communication of the purposes and roles of the team could increase effectiveness. CONCLUSIONS: The experience of OPEN suggests that dedicating resources for sex and gender research can be effective in promoting SGBA research, but that research programmes should also focus on communicating the importance of SGBA to their members.

Impact of self-reported lifetime depression or anxiety on effectiveness of mass distribution of nicotine patches.

BACKGROUND: Large-scale public health initiatives providing free nicotine replacement therapy have been shown to increase smoking cessation rates; however, their effectiveness among the highly prevalent population of smokers with depression and anxiety disorders has not been explored. The aim of this study was to investigate the influence of lifetime history of depression or anxiety on smoking cessation success following the free distribution of nicotine patches. METHOD: In the context of a randomised controlled trial, a secondary analysis was conducted on 1000 adult regular smokers randomised to be mailed a 5-week supply of nicotine patches or to a no intervention control group. Participants were divided into subgroups based on the presence of self-reported lifetime diagnosis of depression and anxiety. RESULTS: Irrespective of self-reported lifetime history of depression or anxiety, odds of self-reported cessation at 6 months were significantly greater among groups receiving nicotine patches compared to no intervention control (no history of depression or anxiety: OR 2.20; 95% CI 1.05 to 4.63; history of depression or anxiety present: OR 3.90; 95% CI 1.28 to 11.88). Among nicotine patch recipients only, quit outcomes did not differ between those with and without self-reported lifetime depression or anxiety in models unadjusted and adjusted for differences in demographic and smoking characteristics. CONCLUSIONS: The mass distribution of free nicotine patches (without behavioural support) is effective among smokers with or without lifetime history of depression or anxiety alike, providing further support for the adoption of similar initiatives as a means of promoting tobacco cessation on a population level. TRIAL REGISTRATION NUMBER: NCT01429129, Post-results.

Predictors of Patient-Initiated Discharge From an Inpatient Withdrawal Management Service: A Sex-Based Study.

OBJECTIVES: The purpose of this study was to examine sex-stratified independent predictors of patient-initiated discharge from an inpatient withdrawal management service and to determine whether those predictors differed by sex. METHODS: This study compared people who had self-initiated versus planned discharges and used sex-stratified generalized estimating equations models to identify independent predictors of patient-initiated discharge. Predictors examined included age, ethnicity, substance of concern, tobacco use, mental health comorbidities, day of discharge, referral source, children, and social assistance funds. RESULTS: Among females, there were 722 discharges, 116 of which were patient initiated. Among females, increasing age was associated with lower odds of patient-initiated discharge (OR = 0.97, 95% CI [0.95, 0.98]). Racialized females were nearly 2 times more likely to experience patient-initiated discharge compared with White females (OR = 1.8, 95% CI [1.09, 3.00]). Compared with weekdays, weekends were associated with over 4 times the odds of patient-initiated discharge (OR = 4.77, 95% CI [2.66, 8.56]). Having one or more mental health comorbidities was associated with lower odds of patient-initiated discharge compared with having no mental health comorbidities (OR = 0.51, 95% CI [0.32, 0.82]). Among males, there were 1,244 discharges, 185 of which were patient initiated. Among males, increasing age was associated with decreased odds of patient-initiated discharge (OR = 0.97, 95% CI [0.95, 0.98]). Compared with weekdays, weekends were associated with nearly 15 times the odds of patient-initiated discharge (OR = 14.9, 95% CI [9.11, 24.3]). CONCLUSIONS: Males and females have shared and unique predictors of patient-initiated discharge. Future studies should continue to examine the influence of sex and gender on engagement with addictions care.

Characteristics, treatment patterns and retention with extended-release subcutaneous buprenorphine for opioid use disorder: A population-based cohort study in Ontario, Canada.

BACKGROUND: Uptake and retention for opioid agonist treatment (OAT) remains low. Novel extended-release formulations may improve OAT accessibility by reducing the frequency of healthcare visits. Our aim was to examine uptake, characteristics, treatment patterns and retention of individuals initiating extended-release subcutaneous buprenorphine (BUP-ER), a monthly injectable OAT. METHODS: We conducted a population-based cohort study among adults aged 18+ initiated on BUP-ER between February 3, 2020 and March 31, 2022 in Ontario, Canada. Using administrative health data, we defined continuous BUP-ER use based on repeat injections within a 56-day period and used Kaplan-Meier curves to estimate time on treatment. Among new BUP-ER recipients, we described individual and prescriber characteristics, healthcare utilization and treatment patterns. RESULTS: 2366 individuals initiated BUP-ER. The median time to BUP-ER discontinuation was 183 days (interquartile range: 66-428 days) and 52.0% of individuals were co-prescribed buprenorphine/naloxone at least once throughout the period of BUP-ER receipt. Among individuals who initiated on a dose of 300mg BUP-ER and had three or more injections, 18.8% continued to receive only 300mg doses (N=276 of 1470). Furthermore, 28.6% of those whose dose was reduced to 100mg (N=341 of 1194) had a subsequent dose increase to 300mg. CONCLUSIONS: On average, people initiating BUP-ER discontinue within the first 6 months of treatment. While BUP-ER is likely providing an important OAT option, the high occurrence of discontinuation, supplementation with buprenorphine/naloxone, and frequent dose increases suggest inadequacy of current dosing recommendations among a proportion of individuals.

Protocol for a qualitative study exploring the pharmacist's role in supporting postsecondary students with psychotropic medication management.

INTRODUCTION: Findings from the National College Health Assessment (2019) stated that anxiety and depression are the most prevalent diagnosed mental illnesses among Canadian postsecondary students with one-fifth of students self-reporting a lifetime diagnosis. Psychotropic medications can be an important component of a multifaceted approach to the management and treatment of mental illness and are the most commonly dispensed via community pharmacies. Community pharmacies provide an opportunity for pharmacists to have a prominent role in supporting patients' psychotropic medication management. However, there has been limited exploration of how pharmacists can address patients' psychotropic medication management needs, experiences and opportunities for improvements especially for emerging adults. METHODS AND ANALYSIS: This qualitative study will incorporate Thorne's approach to interpretative description. Purposeful snowball sampling will be used to identify students (18-25 years) taking psychotropic medication(s) to manage their mental health. Participants will be interviewed one on one using a semistructured interview guide virtually. Inductive thematic analysis is underway with data analysis being iterative and reflexive using NVivo. Information provided from the interviews will be reviewed and summarised into key themes. ETHICS AND DISSEMINATION: This study was approved by the University of Toronto Health Sciences Research Ethics Board (REB #43185). It is expected that there will be a very low risk for mild psychological and social harm for participants as they will have the ability to stop the interview at any time and will be aware of confidentiality. The results from this study will be used to create or adapt healthcare team services including the role of pharmacists within the healthcare ecosystem at the university and contribute to developing the next stage of research to evaluate feasibility and effectiveness of programmes at the university that help postsecondary students to manage psychotropic medication.

Physician and nurse practitioner perspectives of a modified Routine Opioid Outcome Monitoring (ROOM) Tool.

Introduction The Routine Opioid Outcome Monitoring (ROOM) Tool was developed for use in community pharmacies in Australia. It facilitates pharmacists' screening and brief interventions regarding an individual's opioid use for chronic pain. At our academic teaching hospital, the ROOM Tool was adapted to incorporate a communication tool that includes a pharmacist's assessment and recommendations for primary care providers. This modified ROOM Tool was implemented as part of usual care in our outpatient pharmacies; however, the value to primary care providers is unknown. Aim The aim of this study was to determine primary care provider perspectives on the modified ROOM Tool. Methods Focus groups were conducted with primary care providers from an Academic Family Health Team. The focus group encompassed topics related to the positive and negative aspects of the modified ROOM Tool in supporting the care of patients using opioids for chronic pain. Qualitative content analysis of transcripts was performed to identify themes. Results Three focus groups were conducted with a total of six participants. Four themes emerged: (i) Facilitators to using the tool, (ii) Barriers to using the tool, (iii) Recommendations for improvement, (iv) Impact of the tool on patient care and safety. Discussion The ROOM Tool paired with the communication tool supports collaboration between pharmacists and primary care providers. The communication tool standardises the approach for communicating the pharmacist's assessment and recommendations. Recommendations to refine this modified ROOM Tool may increase its utility to primary care providers and enhance the impact on patient care and safety.

Assessing the impact of the slow-release oral morphine drug shortages in Ontario, Canada: A population-based time series analysis.

BACKGROUND: Slow-release oral morphine (SROM) is used to manage pain, and as opioid agonist treatment (OAT). Between 2017 and 2021 in Canada, several drug shortages occurred for Kadian© (SROM-24). The purpose of this study was to evaluate the impact of these shortages on people's ability to remain on this medication. METHODS: We conducted a retrospective population-based time series analysis of SROM-24 dispensed between January 1, 2014, and December 31, 2021, in Ontario, Canada. Using interventional autoregressive integrated moving average models (ARIMA) models, we evaluated the association between SROM-24 drug shortages and treatment discontinuation. Analyses were also stratified by the SROM-24 indication (pain or OAT). RESULTS: We identified 22,479 SROM-24 recipients, of which one-third (33.9%) were aged 65 or above and just over half (51.9%) were female. In our primary analysis of monthly SROM-24 discontinuation, we observed a significant sustained monthly increase following the shortages in November 2019 (+0.29%/month; 95% CI: 0.16%, 0.43%; p < .001) with significant sudden, temporary changes following the shortages in March 2020 (+2.00%; 95% CI: 0.95%, 3.05%; p < .001), July 2021 (+3.53%; 95% CI: 2.20%, 4.86%; p < .001), and August 2021 (+4.98%; 95% CI: 3.49%, 6.47%; p < .001). Similar results were observed in our stratified analyses, with sustained high rates of discontinuation among people accessing SROM-24 as OAT. CONCLUSIONS: The SROM-24 shortages resulted in significant treatment disruptions across all recipients. These findings have important implications for those with few treatment alternatives, including people using SROM-24 as OAT who are at risk of adverse outcomes following treatment disruptions.

Psychosocial and pharmacologic interventions for problematic methamphetamine use: Findings from a scoping review of the literature.

RATIONALE: Methamphetamine use and related harms have risen at alarming rates. While several psychosocial and pharmacologic interventions have been described in the literature, there is uncertainty regarding the best approach for the management of methamphetamine use disorder (MUD) and problematic methamphetamine use (PMU). We conducted a scoping review of recent systematic reviews (SR), clinical practice guidelines (CPG), and primary controlled studies of psychosocial and pharmacologic treatments for MUD/PMU. METHODS: Guided by an a priori protocol, electronic database search updates (e.g., MEDLINE, Embase) were performed in February 2022. Screening was performed following a two-stage process, leveraging artificial intelligence to increase efficiency of title and abstract screening. Studies involving individuals who use methamphetamine, including key subgroups (e.g. those with mental health comorbidities; adolescents/youths; gay, bisexual, and other men who have sex with men) were sought. We examined evidence related to methamphetamine use, relapse, use of other substances, risk behaviors, mental health, harms, and retention. Figures, tables and descriptive synthesis were used to present findings from the identified literature. RESULTS: We identified 2 SRs, one CPG, and 54 primary studies reported in 69 publications that met our eligibility criteria. Amongst SRs, one concluded that psychostimulants had no effect on methamphetamine abstinence or treatment retention while the other reported no effect of topiramate on cravings. The CPG strongly recommended psychosocial interventions as well as self-help and family support groups for post-acute management of methamphetamine-related disorders. Amongst primary studies, many interventions were assessed by only single studies; contingency management was the therapy most commonly associated with evidence of potential effectiveness, while bupropion and modafinil were analogously the most common pharmacologic interventions. Nearly all interventions showed signs of potential benefit on at least one methamphetamine-related outcome measure. DISCUSSION: This scoping review provides an overview of available interventions for the treatment of MUD/PMU. As most interventions were reported by a single study, the effectiveness of available interventions remains uncertain. Primary studies with longer durations of treatment and follow-up, larger sample sizes, and of special populations are required for conclusive recommendations of best approaches for the treatment of MUD/PMU.

Predictors of and reasons for early discharge from inpatient withdrawal management settings: A scoping review.

ISSUES: Early discharges, also known as 'against medical advice' discharges, frequently occur in inpatient withdrawal management settings and can result in negative outcomes for patients. The purpose of this scoping review is to identify what is known about predictors of and reasons for the early discharge among adults accessing inpatient withdrawal management settings. APPROACH: MEDLINE, CINAHL, PsycINFO, ASSIA and EMBASE were searched, resulting in 2587 articles for screening. Title and abstract screening and full-text review were completed by two independent reviewers. Results were synthesised in quantitative and qualitative formats. KEY FINDINGS: Sixty-two studies were included in this scoping review. All studies focused on predictors of early discharge, except one which only described reasons for the early discharge. Forty-eight percent of studies involved retrospective review of health records data. The most frequently examined variables were demographics. Variables related to the treatment setting, such as referral source and treatment received, were examined less frequently but were more consistently associated with early discharge compared to demographics. Only six studies described patient reasons for the early discharge, which were retrieved via clinical documentation. The most common reasons for early discharge were dissatisfaction with treatment and family issues. IMPLICATIONS AND CONCLUSIONS: Most demographic variables do not consistently predict early discharge, and reasons for early discharge are not well understood. Future studies should focus on the predictive value of non-patient-level variables, or conduct analyses to account for predictors of early discharge among different subgroups of people (e.g. by gender or ethnicity). Qualitative research exploring patient perspectives is needed.

Duration of use and outcomes among people with opioid use disorder initiating methadone and buprenorphine in Ontario: a population-based propensity-score matched cohort study.

AIMS: To characterize comparative risks and benefits of methadone versus buprenorphine/naloxone in a contemporary cohort where the unregulated drug supply is dominated by fentanyl. DESIGN, SETTING AND PARTICIPANTS: Population-based propensity-score matched cohort study conducted in Ontario, Canada among people aged 18+ initiating opioid agonist therapy (OAT) for an opioid use disorder between October 2016 and December 2018 (n = 18 880). INTERVENTION: Initiation of methadone versus buprenorphine/naloxone. MEASUREMENTS: The primary outcome was opioid overdose (fatal and non-fatal) while on treatment, with secondary outcomes including opioid overdose (first 30 days of treatment), treatment discontinuation, health-care interactions related to treatment of opioid use disorder, receiving a weekly supply of take-home doses and opioid overdose within 30 days of treatment discontinuation. Outcomes were assessed over 1 year. FINDINGS: Overall, 7517 people initiating buprenorphine were matched to an equal number of methadone-treated individuals. Risk of opioid overdose while on treatment [hazard ratio (HR) = 0.50; 95% confidence interval (CI) = 0.37-0.68] or within the first 30 days of treatment (HR = 0.51, 95% CI = 0.31-0.85) was lower among buprenorphine recipients compared to methadone recipients. In secondary analyses, people initiating buprenorphine had a higher risk of treatment discontinuation within the first year (median time to discontinuation 104 versus 265 days, HR = 1.43, 95% CI = 1.37-1.49), had lower rates of health-care interactions for OUD (186.4 versus 254.3 per person-year; rate ratio = 0.73; 95% CI = 0.72-0.75), and a higher rate of receiving weekly take-home doses (HR = 2.33; 95% CI = 2.20-2.46). Overdose rates in the period following OAT discontinuation were higher than those observed while on treatment, but did not differ significantly by OAT type. CONCLUSIONS: Although treatment retention is higher among methadone recipients, overdose risk is also elevated compared to buprenorphine recipients. These findings demonstrate the benefits of any OAT on avoidance of overdose, particularly following treatment discontinuation and with the increasingly unpredictable drug supply in North America.

Impact of changes in opioid funding and clinical policies on rapid tapering of opioids in Ontario, Canada.

ABSTRACT: Reports have emerged of abrupt tapering among recipients of long-term prescription opioids to conform new prescribing guidelines. We conducted a population-based, repeated cross-sectional time-series study among very high-dose (≥200 MME) opioid recipients in Ontario, Canada, to examine changes in the monthly prevalence of rapid tapering from 2014 to 2018, defined as recipients experiencing either a ≥50% reduction in daily doses or abrupt discontinuation sustained for 30 days. Interventional autoregressive integrated moving average models were used to test for significant changes following key guidelines and drug policies and programs. A sensitivity analysis examined rapid tapering sustained for 90 days. The monthly prevalence of rapid tapering events was stable from January 2014 to September 2016 (average monthly prevalence: 1.4%) but increased from 1.4% in October 2016 to 1.8% in April 2017 (P = 0.001), coincident with Ontario's Fentanyl Patch-for-Patch Return Program implementation. Transient spikes in the prevalence of rapid tapering also occurred 2 months after Ontario's delisting of publicly funded high-strength opioids and the release of updated Canadian Opioid Prescribing Guideline for Chronic Pain, reaching 2.3% in March 2017 and July 2017, respectively. However, this prevalence decreased to 1.2% in December 2018 (P < 0.0001). Although the prevalence of abrupt opioid discontinuation was lower, similar trends were observed. Our sensitivity analysis examining long-lasting rapid tapering found similar trends but lower prevalence, with no changes in complete discontinuation. These temporary increases in rapid tapering events highlight the need for improved communication and evidence-based resources for prescribers to minimize negative consequences of evolving policies and guidelines.