Symptomatic benefits of testosterone treatment in patient subgroups: a systematic review, individual participant data meta-analysis, and aggregate data meta-analysis.

BACKGROUND: Testosterone replacement therapy is known to improve sexual function in men younger than 40 years with pathological hypogonadism. However, the extent to which testosterone alleviates sexual dysfunction in older men and men with obesity is unclear, despite the fact that testosterone is being increasingly prescribed to these patient populations. We aimed to evaluate whether subgroups of men with low testosterone derive any symptomatic benefit from testosterone treatment. METHODS: We did a systematic review and meta-analysis to evaluate characteristics associated with symptomatic benefit of testosterone treatment versus placebo in men aged 18 years and older with a baseline serum total testosterone concentration of less than 12 nmol/L. We searched major electronic databases (MEDLINE, Embase, Science Citation Index, and the Cochrane Central Register of Controlled Trials) and clinical trial registries for reports published in English between Jan 1, 1992, and Aug 27, 2018. Anonymised individual participant data were requested from the investigators of all identified trials. Primary (cardiovascular) outcomes from this analysis have been published previously. In this report, we present the secondary outcomes of sexual function, quality of life, and psychological outcomes at 12 months. We did a one-stage individual participant data meta-analysis with a random-effects linear regression model, and a two-stage meta-analysis integrating individual participant data with aggregated data from studies that did not provide individual participant data. This study is registered with PROSPERO, CRD42018111005. FINDINGS: 9871 citations were identified through database searches. After exclusion of duplicates and publications not meeting inclusion criteria, 225 full texts were assessed for inclusion, of which 109 publications reporting 35 primary studies (with a total 5601 participants) were included. Of these, 17 trials provided individual participant data (3431 participants; median age 67 years [IQR 60-72]; 3281 [97%] of 3380 aged ≥40 years) Compared with placebo, testosterone treatment increased 15-item International Index of Erectile Function (IIEF-15) total score (mean difference 5·52 [95% CI 3·95-7·10]; τ2=1·17; n=1412) and IIEF-15 erectile function subscore (2·14 [1·40-2·89]; τ2=0·64; n=1436), reaching the minimal clinically important difference for mild erectile dysfunction. These effects were not found to be dependent on participant age, obesity, presence of diabetes, or baseline serum total testosterone. However, absolute IIEF-15 scores reached during testosterone treatment were subject to thresholds in patient age and baseline serum total testosterone. Testosterone significantly improved Aging Males' Symptoms score, and some 12-item or 36-item Short Form Survey quality of life subscores compared with placebo, but it did not significantly improve psychological symptoms (measured by Beck Depression Inventory). INTERPRETATION: In men aged 40 years or older with baseline serum testosterone of less than 12 nmol/L, short-to-medium-term testosterone treatment could provide clinically meaningful treatment for mild erectile dysfunction, irrespective of patient age, obesity, or degree of low testosterone. However, due to more severe baseline symptoms, the absolute level of sexual function reached during testosterone treatment might be lower in older men and men with obesity. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.

A Brief Screening and Assessment Tool for Opioid Use in Adults: Results from a Validation Study of the Tobacco, Alcohol, Prescription Medication, and Other Substances Tool.

OBJECTIVES: This secondary analysis evaluated opioid-specific validation results of the Tobacco, Alcohol, Prescription Medication, and Other Substances (TAPS) tool for screening in primary care. METHODS: This study is a secondary data analysis of the TAPS validation study. Performance of the TAPS tool for screening for unhealthy opioid use (with a score of 1+ for heroin and/or prescription opioids representing a positive screen) was evaluated. Discriminative ability was examined in comparison with reference standard measures across the spectrum of unhealthy opioid use: timeline follow-back with and without oral fluid testing identifying past-month use and the modified Composite International Diagnostic Interview for past-year problem use, opioid use disorder (OUD), and moderate-severe OUD. RESULTS: In a sample of 2000 primary care patients, 114 screened positive for opioids on the TAPS tool. With a TAPS cutoff equal to 1+, the TAPS accurately identified past-month use, problem use, any OUD, and moderate-severe OUD (sensitivities = 68%-85%, specificities = 97%-98%, area under the curve = 0.80-0.91). When past-month use was expanded to include timeline follow-back with oral fluid testing, accuracy declined (52% sensitivity [95% confidence interval, 43%-60%], 98% specific [95% confidence interval, 97%-98%]). CONCLUSIONS: While further testing in a larger population sample may be warranted, given their brevity, simplicity, and accuracy when self-administered, the TAPS opioid items can be used in primary care settings for a spectrum of unhealthy opioid use; however, self-disclosure remains an issue in primary care settings.

Health care use and cost of treatment for adolescents and young adults with opioid use disorder.

BACKGROUND: Few studies have examined the cost of medication for opioid use disorder (MOUD) with counseling for the adolescent and young adult population. This study calculated the health care utilization and cost of MOUD treatment, other substance use disorder treatment, and general health care for adolescents and young adults receiving treatment for opioid use disorder. METHODS: The study randomized youth ages 15 to 21 (N = 288) equally into the two study conditions: extended-release naltrexone (XR-NTX) or treatment as usual (TAU). While participants committed to treatment based on randomization the study observed considerable nonadherence to both randomized conditions. Instead of using the randomly assigned study conditions, we present descriptive costs by the type of MOUD treatment received: XR-NTX only, buprenorphine only, any other combination of MOUD treatments, and no MOUD. Health care use was aggregated over the 6-month period for each participant, and we calculated average/participant utilization for each treatment group. To determine participant costs, we multiplied the unit costs of health care services obtained from the literature by the reported amount of health care utilization for each participant. We then calculated the mean, standard error, median and IQR for MOUD costs, other substance use disorder treatment costs and general healthcare cost from the health care sector perspective. RESULTS: On average, participants in the XR-NTX only group received 2.6 doses of XR-NTX (equivalent to approximately 78 days of treatment). The buprenorphine only group had an average of 97 days of buprenorphine treatment. The XR-NTX only group had higher/patient costs compared to participants in the buprenorphine only group ($10,491 vs. $8765) and higher XR-NTX utilization would further increase costs. Participants in the any other MOUD combination group had the highest total costs ($14,627) while participants in the no MOUD group at the lowest ($3453). DISCUSSION: Our cost analysis calculates the real-world cost of MOUD treatment and, while not generalizable, provides policy makers an estimate of costs for adolescents and young adults. We found that participants in the XR-NTX only group received fewer days of medication compared to the buprenorphine only group, but their medication costs were higher due to the cost of XR-NTX injections. While the buprenorphine only group had the highest number of days of medication utilization of all the groups, the average number of days of medication utilization was considerably shorter than the six-month treatment period.

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population.

BACKGROUND: A randomized clinical trial found that patient navigation for hospital patients with comorbid substance use disorders (SUDs) reduced emergency department (ED) and inpatient hospital utilization compared with treatment-as-usual. OBJECTIVE: To compare the cost and calculate any cost savings from the Navigation Services to Avoid Rehospitalization (NavSTAR) intervention over treatment-as-usual. RESEARCH DESIGN: This study calculates activity-based costs from the health care providers and uses a net benefits approach to calculate the cost savings generated from NavSTAR. NavSTAR provided patient navigation focused on engagement in SUD treatment, starting before hospital discharge and continuing for up to 3 months postdischarge. SUBJECTS: Adult hospitalized medical/surgical patients with comorbid SUD for opioids, cocaine, and/or alcohol. COST MEASURES: Cost of the 3-month NavSTAR patient navigation intervention and the cost of all inpatient days and ED visits over a 12-month period. RESULTS OF BASE CASE ANALYSIS: NavSTAR generated $17,780 per participant in cost savings. Ninety-seven percent of bootstrapped samples generated positive cost savings, and our sensitivity analyses did not change our results. LIMITATIONS: Participants were recruited at one hospital in Baltimore, MD through the hospital's addiction consultation service. Findings may not generalize to the broader population. Outpatient health care cost data was not available through administrative records. CONCLUSION: Our findings show that patient navigation interventions should be considered by payors and policy makers to reduce the high hospital costs associated with comorbid SUD patients.

Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis.

Background: Testosterone is the standard treatment for male hypogonadism, but there is uncertainty about its cardiovascular safety due to inconsistent findings. We aimed to provide the most extensive individual participant dataset (IPD) of testosterone trials available, to analyse subtypes of all cardiovascular events observed during treatment, and to investigate the effect of incorporating data from trials that did not provide IPD. Methods: We did a systematic review and meta-analysis of randomised controlled trials including IPD. We searched MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE Epub Ahead of Print, Embase, Science Citation Index, the Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, and Database of Abstracts of Review of Effects for literature from 1992 onwards (date of search, Aug 27, 2018). The following inclusion criteria were applied: (1) men aged 18 years and older with a screening testosterone concentration of 12 nmol/L (350 ng/dL) or less; (2) the intervention of interest was treatment with any testosterone formulation, dose frequency, and route of administration, for a minimum duration of 3 months; (3) a comparator of placebo treatment; and (4) studies assessing the pre-specified primary or secondary outcomes of interest. Details of study design, interventions, participants, and outcome measures were extracted from published articles and anonymised IPD was requested from investigators of all identified trials. Primary outcomes were mortality, cardiovascular, and cerebrovascular events at any time during follow-up. The risk of bias was assessed using the Cochrane Risk of Bias tool. We did a one-stage meta-analysis using IPD, and a two-stage meta-analysis integrating IPD with data from studies not providing IPD. The study is registered with PROSPERO, CRD42018111005. Findings: 9871 citations were identified through database searches and after exclusion of duplicates and of irrelevant citations, 225 study reports were retrieved for full-text screening. 116 studies were subsequently excluded for not meeting the inclusion criteria in terms of study design and characteristics of intervention, and 35 primary studies (5601 participants, mean age 65 years, [SD 11]) reported in 109 peer-reviewed publications were deemed suitable for inclusion. Of these, 17 studies (49%) provided IPD (3431 participants, mean duration 9·5 months) from nine different countries while 18 did not provide IPD data. Risk of bias was judged to be low in most IPD studies (71%). Fewer deaths occurred with testosterone treatment (six [0·4%] of 1621) than placebo (12 [0·8%] of 1537) without significant differences between groups (odds ratio [OR] 0·46 [95% CI 0·17-1·24]; p=0·13). Cardiovascular risk was similar during testosterone treatment (120 [7·5%] of 1601 events) and placebo treatment (110 [7·2%] of 1519 events; OR 1·07 [95% CI 0·81-1·42]; p=0·62). Frequently occurring cardiovascular events included arrhythmia (52 of 166 vs 47 of 176), coronary heart disease (33 of 166 vs 33 of 176), heart failure (22 of 166 vs 28 of 176), and myocardial infarction (10 of 166 vs 16 of 176). Overall, patient age (interaction 0·97 [99% CI 0·92-1·03]; p=0·17), baseline testosterone (interaction 0·97 [0·82-1·15]; p=0·69), smoking status (interaction 1·68 [0·41-6·88]; p=0.35), or diabetes status (interaction 2·08 [0·89-4·82; p=0·025) were not associated with cardiovascular risk. Interpretation: We found no evidence that testosterone increased short-term to medium-term cardiovascular risks in men with hypogonadism, but there is a paucity of data evaluating its long-term safety. Long-term data are needed to fully evaluate the safety of testosterone. Funding: National Institute for Health Research Health Technology Assessment Programme.

Effect of Collateral Flow on Catheter-Based Assessment of Cardiac Microvascular Obstruction.

Cardiac microvascular obstruction (MVO) associated with acute myocardial infarction (heart attack) is characterized by partial or complete elimination of perfusion in the myocardial microcirculation. A new catheter-based method (CoFI, Controlled Flow Infusion) has recently been developed to diagnose MVO in the catheterization laboratory during acute therapy of the heart attack. A porcine MVO model demonstrates that CoFI can accurately identify the increased hydraulic resistance of the affected microvascular bed. A benchtop microcirculation model was developed and tuned to reproduce in vivo MVO characteristics. The tuned benchtop model was then used to systematically study the effect of different levels of collateral flow. These experiments showed that measurements obtained in the catheter-based method were adversely affected such that collateral flow may be misinterpreted as MVO. Based on further analysis of the measured data, concepts to mitigate the adverse effects were formulated which allow discrimination between collateral flow and MVO.

Costs and Implementation Effectiveness of Generalist Versus Specialist Models for Adolescent Screening and Brief Intervention in Primary Care.

OBJECTIVE: This study analyzed the marginal service and program costs, and conducted a cost-effectiveness analysis (CEA) of two models of implementation of adolescent substance screening, brief intervention, and referral to treatment (SBIRT). METHOD: SBIRT was implemented at seven clinics in a multisite, cluster-randomized trial, through a Specialist model (behavioral health counselor-delivered brief intervention), and a Generalist model (primary care provider-delivered brief intervention). The CEA calculated marginal costs using an activity-based costing methodology for direct SBIRT services, and effectiveness was measured by the proportion of brief interventions delivered among patients who screened positive for alcohol, tobacco, or other drugs. Site-level program costs comprised start-up and maintenance (training and technical assistance). Costs were estimated in 2017 U.S. dollars. RESULTS: The marginal cost of SBIRT per patient with a positive screen for brief intervention was $6.72 in the Specialist model and $6.05 in the Generalist model. Implementation effectiveness was 7.2% (SE = 2.9%) in the Specialist model and 37.7% (SE = 5.6%) in the Generalist model. The program costs to provide SBIRT for 1 year per site were $13,548 for the Specialist site and $12,081 for the Generalist. CONCLUSIONS: The Generalist model was more effective in implementing brief intervention and less expensive than the Specialist model. Results were robust to sensitivity analysis. Brief intervention delivered by primary care providers rather than by handoff to a behavioral health counselor may ensure greater penetration and a lower cost of these services in primary care settings.

Machine Learning Applications in Mental Health and Substance Use Research Among the LGBTQ2S+ Population: Scoping Review.

BACKGROUND: A high risk of mental health or substance addiction issues among sexual and gender minority populations may have more nuanced characteristics that may not be easily discovered by traditional statistical methods. OBJECTIVE: This review aims to identify literature studies that used machine learning (ML) to investigate mental health or substance use concerns among the lesbian, gay, bisexual, transgender, queer or questioning, and two-spirit (LGBTQ2S+) population and direct future research in this field. METHODS: The MEDLINE, Embase, PubMed, CINAHL Plus, PsycINFO, IEEE Xplore, and Summon databases were searched from November to December 2020. We included original studies that used ML to explore mental health or substance use among the LGBTQ2S+ population and excluded studies of genomics and pharmacokinetics. Two independent reviewers reviewed all papers and extracted data on general study findings, model development, and discussion of the study findings. RESULTS: We included 11 studies in this review, of which 81% (9/11) were on mental health and 18% (2/11) were on substance use concerns. All studies were published within the last 2 years, and most were conducted in the United States. Among mutually nonexclusive population categories, sexual minority men were the most commonly studied subgroup (5/11, 45%), whereas sexual minority women were studied the least (2/11, 18%). Studies were categorized into 3 major domains: web content analysis (6/11, 54%), prediction modeling (4/11, 36%), and imaging studies (1/11, 9%). CONCLUSIONS: ML is a promising tool for capturing and analyzing hidden data on mental health and substance use concerns among the LGBTQ2S+ population. In addition to conducting more research on sexual minority women, different mental health and substance use problems, as well as outcomes and future research should explore newer environments, data sources, and intersections with various social determinants of health.

Addiction Medicine Practice-Based Research Network (AMNet): Assessment Tools and Quality Measures.

INTRODUCTION: The need for innovative approaches to address the opioid epidemic in the United States is widely recognized. Many challenges exist to addressing this epidemic, including the obstacles outpatient substance use treatment practices face in implementing measurement-based care (MBC), quality measurement systems, and evidence-based treatments. Also, there are insufficient opportunities for clinicians in these settings to participate in research, resulting in diminished translation of research findings into community-based practice. To address these challenges, the Addiction Medicine Practice-Based Research Network (AMNet) was developed to facilitate the uptake of MBC in outpatient practices via implementation of patient-reported assessments and quality of care performance measures to improve patient outcomes. This network will offer clinicians in outpatient settings (not incuding opioid treatment programs [OTPs]) the opportunity to participate in future substance use disorder treatment research studies. METHODS: A key step in the development of AMNet was the selection of substance use-specific assessment tools and quality of care performance measures for incorporation into the American Psychiatric Association's mental health patient registry, PsychPRO. A scoping review and multi-step consensus-based process were used to identify, review and select candidate assessment tools and quality of care performance measures for opioid use disorders (OUD) and substance use disorders (SUD). RESULTS: Following a consensus-based methodology, 12 standardized assessment tools and 3 quality of care performance measures for OUD and SUD were selected to help facilitate the implementation of MBC and quality improvement for AMNet participants. These tools were further categorized as core and optional. CONCLUSION: By offering a collection of carefully vetted assessment tools and quality measures through PsychPRO, AMNet will help participating clinicians with the systematic uptake of MBC and delivery of evidence-based treatment for patients with SUD. Also, AMNet will act as a centralized repository of data collected from patients and clinicians in non-OTP outpatient addiction medicine practices and serve as a platform for opioid treatment research.

Randomized trial of methadone treatment of arrestees: 24-month post-release outcomes.

BACKGROUND: We report on the 24-month post-release outcomes of arrestees with opioid use disorder (OUD) enrolled in a randomized trial comparing three treatment approaches initiated in jail. METHODS: Adults (N = 225) receiving medically supervised withdrawal from opioids in the Baltimore Detention Center within a few days of arrest were randomly assigned to: (1) interim methadone treatment plus patient navigation (IM + PN) started in the Detention Center; (2) IM; or (3) Enhanced Treatment-as-Usual (ETAU) consisting of detoxification with methadone and referral to treatment in the community. Participants in both methadone conditions could transfer to standard methadone treatment following release. Participants were interviewed at baseline, and 1, 3, 6, 12, and 24 months post-release. Urine was drug tested at follow-up and official arrest records were obtained. RESULTS: On an intention-to-treat basis, there were no significant differences among the three conditions over the 24-month post-release period in terms of opioid- or cocaine-positive urine test results or self-reported opioid or cocaine use, meeting opioid or cocaine use disorder criteria, self-reported criminal behavior, or the number of official arrests. There were 9 fatal overdoses, none occurring during methadone treatment, and 109 hospitalizations unrelated to the study. CONCLUSIONS: Given the high morbidity and mortality found in this population of arrestees and costs to society associated with their health care utilization and continued crime and arrests, research aimed at finding more effective interventions should be continued. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02334215.

Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.

BACKGROUND: Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group. METHODS: We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective. RESULTS: The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs. CONCLUSIONS: IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.

Insurance status and level of education predict disparities in receipt of treatment and survival for anal squamous cell carcinoma.

INTRODUCTION: Anal squamous cell carcinoma (ASCC) is relatively rare, but its incidence and mortality have been steadily climbing in marginalized populations. We explored the impact of insurance status, education, and income on survival and receipt of chemoradiation therapy. METHODS: We included patients with ASCC from the Surveillance, Epidemiology, and End Results Program database from 2004 to 2016. Socioeconomic variables included insurance status, level of education, income, and unemployment rate. Cox proportional hazards and multivariate logistic regression were used to determine predictors of survival and receipt of chemoradiation. RESULTS: We included a total of 10,868 cases of ASCC. The median age was 55, 10.4 % were black, and 65.4 % were female. Overall, 74.1 % of patients received combination chemoradiation. In multivariate analysis, poorer survival was found for Medicaid (HR 1.52, 95 % CI 1.34-1.74) and uninsured (HR 1.68, 95 % CI 1.35-2.10) patients, and for communities with the lowest rates of high school education (HR 1.17, 95 % CI 1.02-1.38), lowest income (HR 1.29, 95 % CI 1.08-1.54), and highest unemployment (HR 1.21, 95 % CI 1.03-1.40). Patients were less likely to receive combination treatment if they were black (OR 0.76, 95 % CI 0.55-0.92), had Medicaid insurance (OR 0.54, 95 % CI 0.33-0.88) or lower education (OR 0.59, 95 % CI 0.46-0.76). CONCLUSION: Insurance status, level of education, income, and employment impact survival and receipt of treatment in patients with ASCC. Identifying high risk patients and developing targeted interventions to improve access to treatment is integral to reducing these disparities and improving cancer survival.

Navigation Services to Avoid Rehospitalization among Medical/Surgical Patients with Comorbid Substance Use Disorder: Rationale and Design of a Randomized Controlled Trial.

Substance use disorders (SUDs) are associated with significant morbidity and mortality and contribute to inefficient use of healthcare services. Hospitalized medical/surgical patients with comorbid SUD are at elevated risk of hospital readmission and poor outcomes. Thus, effective interventions are needed to help such patients during hospitalization and post-discharge. This article reports the rationale, methodological design, and progress to date on a randomized trial comparing the effectiveness of Navigation Services to Avoid Rehospitalization (NavSTAR) vs Treatmentas-Usual (TAU) for hospital medical/surgical patients with comorbid SUD (N = 400). Applying Andersen's theoretical model of health service utilization, NavSTAR employed Patient Navigation and motivational interventions to promote entry into SUD treatment, facilitate adherence to recommendations for medical follow-up and self-care, address basic needs, and prevent the recurrent use of hospital services. As part of the NavSTAR service model, Patient Navigators embedded within the SUD consultation service at a large urban hospital delivered patient-centered, proactive navigation and motivational services initiated during the hospital stay and continued for up to 3 months post-discharge. Participants randomized to TAU received usual care from the hospital and the SUD consultation service, which included referral to SUD treatment but no continued contact post-hospital discharge. Hospital service utilization will be determined via review of electronic health records and the regional Health Information Exchange. Participants were assessed at baseline and again at 3-, 6-, and 12-month follow-up on various measures of healthcare utilization, substance use, and functioning. The primary outcome of interest is time-to-rehospitalization through 12 months. In addition, a range of secondary outcomes spanning the medical and SUD service areas will be assessed. The study will include a health economic evaluation of NavSTAR. If NavSTAR proves to be effective and cost-effective in this high-risk patient group, it would have important implications for addressing the needs of hospital patients with comorbid SUD, designing hospital discharge planning services, informing cost containment initiatives, and improving public health.

Electronic self-administered screening for substance use in adult primary care patients: feasibility and acceptability of the tobacco, alcohol, prescription medication, and other substance use (myTAPS) screening tool.

BACKGROUND: The TAPS Tool is a substance use screening and brief assessment instrument that was developed for use in primary care medical settings. It is one of the first screening instruments to provide rapid assessment of all commonly used substance classes, including illicit and prescription opioids, and is one of the only available screeners designed and validated in an electronic self-administered format (myTAPS). This secondary analysis of data from the TAPS Tool validation study describes the feasibility and acceptability of the myTAPS among primary care patients. METHODS: Adult patients (N = 2000) from five primary care clinics completed the TAPS Tool on a tablet computer (myTAPS), and in an interviewer-administered format. Requests for assistance and time required were tracked, and participants completed a survey on ease of use, utilization of audio guidance, and format preference. Logistic regression was used to examine outcomes in defined subpopulations, including groups that may have greater difficulty completing an electronic screener, and those that may prefer an electronic self-administered approach. RESULTS: Almost all participants (98.3%) reported that the myTAPS was easy to use. The median time to complete myTAPS screening was 4.0 min (mean 4.48, standard deviation 2.57). More time was required by participants who were older, Hispanic, Black, or reported non-medical prescription drug use, while less time was required by women. Assistance was requested by 25% of participants, and was more frequently requested by those who with lower education (OR = 2.08, 95% CI 1.62-2.67) or age > 65 years (OR = 2.79, 95% CI 1.98-3.93). Audio guidance was utilized by 18.3%, and was more frequently utilized by participants with lower education (OR = 2.01, 95% CI 1.54-2.63), age > 65 years (OR = 1.79, 95% CI 1.22-2.61), or Black race (OR = 1.30, 95% 1.01-1.68). The myTAPS format was preferred by women (OR = 1.29, 95% CI 1.00-1.66) and individuals with drug use (OR = 1.43, 95% CI 1.09-1.88), while participants with lower education preferred the interviewer-administered format (OR = 2.75, 95% CI 2.00-3.78). CONCLUSIONS: Overall, myTAPS screening was feasible and well accepted by adult primary care patients. Clinics adopting electronic screening should be prepared to offer assistance to some patients, particularly those who are older or less educated, and should have the capacity to use an interviewer-administered approach when required.

Knowledge and risk perceptions of Israelis towards combustible cigarettes: the need for immediate remedial action.

BACKGROUND: Devastation from the tobacco epidemic continues, with strong government tobacco control policy absent in most countries. Knowledge of the full scope of tobacco harm in populations may form the basis for healthier behavior, de-normalization of smoking, and a consensus about necessary public policy. However, many populations may be poorly-informed about the risks, and this ignorance may undermine both effective policy-making and implementation of tobacco control policies. We present knowledge and risk perceptions about smoking tobacco smoke exposure in Israel. METHODS: A nationally-representative phone survey was conducted in Israel (n = 505; response rate = 61%). We assessed knowledge about active and passive smoking using four questions, three of which addressed knowledge about harm, and one of which addressed knowledge of tobacco-related harm relative to knowledge of harm due to traffic accidents. The three questions which addressed knowledge of harm were combined into a composite score. We also asked four risk perception questions concerning tobacco smoke exposure, which were measured on a 7-point Likert scale and then combined. Multivariable logistic regression and linear models were used to identify whether smoking status or socio-demographic variables were associated with knowledge of harm, comparative knowledge of harm, and risk perceptions. RESULTS: Just two in five respondents, and one in five respondents who were current smokers, accurately answered three simple questions about harms of smoking. Fewer than three in ten respondents, and fewer than one in five smokers, knew that smoking causes more damage than traffic accidents. Many (30.3%) were unaware that tobacco smoke exposure causes both lung cancer and heart disease, 27.7% did not know that smoking both shortens life and injures quality of life, and 31.1% did not know that smoking-attributable health problems will afflict all or most heavy smokers. Overall, risk perceptions regarding tobacco smoke exposure were high (mean = 24.5, SD:4.5, on a scale of 7-28, with 28 the indicating highest level). Smoking status was consistently associated with lower levels of knowledge, comparative knowledge, and risk perceptions, with current smokers having the lowest levels of knowledge and the lowest risk perceptions. CONCLUSIONS: Like many others, Israelis, and particularly Israeli smokers, do not fully grasp tobacco's true dangers. Effective communication of the full range of tobacco risks to the public, with a focus on communication with smokers, is an essential component of comprehensive tobacco control policy.

Association of flavoured cigar regulations with wholesale tobacco volumes in Canada: an interrupted time series analysis.

INTRODUCTION: This study examines the association of Federal Canadian regulations passed in 2009 addressing flavours (excluding menthol) in small cigars with changes in cigar sales. METHODS: Quarterly wholesale unit data as reported to Health Canada from 2001 through 2016 were analysed using interrupted time series analysis. Changes in sales of cigars with and without flavour descriptors were estimated. Analyses were seasonally adjusted. Changes in the flavour types were assessed over time. RESULTS: The Federal flavour regulations were associated with a reduction in the sales of flavoured cigars by 59 million units (95% CI -86.0 to -32.4). Increases in sales of cigars with descriptors other than flavours (eg, colour or other ambiguous terms) were observed (9.6 million increase (95% CI -1.3 to 20.5), but the overall level (decline of 49.6 million units (95% CI -73.5 to -25.8) and trend of sales of cigars (6.9 million units per quarter (95% CI -8.1 to -5.7)) declined following the ban. Sensitivity analysis showed that there was no substantial difference in effect over time comparing Ontario and British Columbia, suggesting that other provincial tobacco control legislation was not associated with the changes in levels. Analyses suggested that the level change was sensitive to the specification of the date. CONCLUSION: This study demonstrates that flavour regulations have the potential to substantially impact tobacco sales. However, exemptions for certain flavours and product types may have reduced the effectiveness of the ban, indicating the need for comprehensive, well-designed regulations.

How patient navigators view the use of financial incentives to influence study involvement, substance use, and HIV treatment.

BACKGROUND AND AIMS: While patient navigation has been shown to be an effective approach for linking persons to HIV care, and contingency management is effective at improving substance use-related outcomes, Project HOPE combined these two interventions in a novel way to engage HIV-positive patients with HIV and substance use treatment. The aims of this paper are to examine patient navigator views regarding how contingency management interacted with and affected their navigation process. DESIGN: Semi-structured qualitative interviews. PARTICIPANTS: 22 patient navigators from the original 10 Project HOPE study sites. MEASUREMENTS: Individual, semi-structured interviews lasting approximately 60 min addressed the patient navigator's professional background, descriptions of the participant population, substance use disorder versus HIV treatment entry and engagement issues, and the use of contingency management within the navigation service delivery protocol. FINDINGS: Patient navigators believed that financial incentives helped motivate participant attendance at navigation sessions, particularly early in study involvement, which helped them to establish rapport and develop relationships with participants. Patient navigators often noted that financial incentives positively influenced targeted HIV health-related behaviors, such as attending medical appointments, which provided a rapid pay-off with an escalating sum. Contingency management was more complex when used by the patient navigators for substance use-related behaviors, particularly when incentives revolved around negative urine screening. Patient navigators noted that not all participants responded the same way to the contingency management and that the incentives were particularly helpful when participants were financially strained with limited resources or when internal motivation was lacking. CONCLUSIONS: Overall patient navigators found the inclusion of contingency management to be helpful and affective at influencing participant behaviors, particularly concerning navigation session attendance and HIV healthcare-related participation. However, issues and concerns surrounding the inclusion of contingency management for drug-related behaviors as delivered in Project HOPE were noted. CLINICAL TRIALS REGISTRATION: NCT01612169.