Outpatient-Based Opioid Treatment Engagement and Attendance: A Prospective Cohort Study of Homeless-Experienced Adults.

BACKGROUND: The opioid overdose epidemic disproportionately impacts people experiencing homelessness. Outpatient-based opioid treatment (OBOT) programs have been established in homeless health care settings across the USA, but little is known about the success of these programs in engaging and retaining this highly marginalized patient population in addiction care. OBJECTIVE: To evaluate predictors of initial engagement and subsequent attendance in a homeless-tailored OBOT program. DESIGN: Prospective cohort study with 4 months of follow-up. PARTICIPANTS: A total of 148 homeless-experienced adults (≥18 years) who newly enrolled in the Boston Healthcare for the Homeless Program (BHCHP) OBOT program over a 1-year period (1/6/2022-1/5/2023). MAIN MEASURES: The primary outcomes were (1) initial OBOT program engagement, defined as having ≥2 additional OBOT visits within 1 month of OBOT enrollment, and (2) subsequent OBOT program attendance, measured monthly from months 2 to 4 of follow-up. KEY RESULTS: The average age was 41.7 years (SD 10.2); 23.6% were female, 35.8% were Hispanic, 12.8% were non-Hispanic Black, and 43.9% were non-Hispanic White. Over one-half (57.4%) were initially engaged. OBOT program attendances during months 2, 3, and 4 were 60.8%, 50.0%, and 41.2%, respectively. One-quarter (24.3%) were initially engaged and then attended the OBOT program every month during the follow-up period. Participants in housing or residential treatment programs (vs. unhoused; adjusted odds ratios (aORs) = 2.52; 95% CI = 1.17-5.44) and those who were already on or initiated a medication for opioid use disorder (OUD) (aOR = 6.53; 95% CI = 1.62-26.25) at the time of OBOT enrollment had higher odds of engagement. Older age (aOR = 1.74 per 10-year increment; 95% CI = 1.28-2.38) and initial engagement (aOR = 3.50; 95% CI = 1.86-6.59) conferred higher odds of attendance. CONCLUSIONS: In this study, over half initially engaged with the OBOT program, with initial engagement emerging as a strong predictor of subsequent OBOT program attendance. Interventions aimed at enhancing initial OBOT program engagement, including those focused on housing and buprenorphine initiation, may improve longer-term outcomes in this marginalized population.

HIV-related stigma and psychological distress in a cohort of patients receiving antiretroviral therapy in Nigeria.

Psychological distress is increasingly recognized as a barrier to engagement in HIV care, resulting in poor HIV outcomes. HIV-related stigma is a potential driver of distress in people living with HIV (PLWH). We conducted a prospective cohort study in 288 PLWH who newly initiated ART in a Nigeria. We assessed overall stigma (range 40-160) and four stigma subtypes (personalized, disclosure, negative self-image, and public stigma) at enrollment, and assessed psychological distress at enrollment, 6, and 12-months after ART initiation. We used logistic regression to assess the relationship between stigma and 12-month psychological distress. Overall stigma was high (102.34 ± 5.65) and was higher in both unmarried patients (p < 0.01) and those who had not disclosed their HIV status to anyone at enrollment (p < 0.01). Higher overall stigma (OR: 1.05, 95% CI 1.00-1.09) and personalized stigma (OR:1.08, 95% CI 1.00-1.16) were associated with higher odds of psychological distress at 12-months. Conclusions: Overall stigma levels were high in a cohort of PLWH initiating care in Nigeria. Higher stigma was associated with psychological distress. These data support the need for integration of measures to reduce stigma and psychological distress in the care of PLWH.

Psychological Distress Increases 30-Fold Among People with HIV in the First Year on ART in Nigeria-a Call for Integrated Mental Health Services.

BACKGROUND: Few studies have longitudinally assessed psychological distress among people with HIV (PWH) initiating ART in resource-limited settings. METHOD: Baseline, 6-month, and 12-month psychological distress were measured in a Nigerian cohort newly initiating therapy; the relationship between baseline factors and psychological distress at 12 months was assessed; and the association between psychological distress at 12 months and care retention or immunologic failure was determined. RESULTS: Among 563 patients, median age was 38 years (IQR: 33-46 years), 62% were female, and 51% were married. Psychological distress increased from 3% at baseline to 34% at 12 months. Age (aOR 1.28, 95% CI 1.06-1.56), female sex (aOR 2.89, 95% CI 1.93-4.33), lack of disclosure (aOR 4.32, 95% CI 2.48-7.51), and time on ART (6 months [aOR 6.91, 95% CI 3.14-15.18] and 12 months [aOR 32.63, 95% CI 16.54-64.36]) were associated with psychological distress while being married (OR 0.42, 95% CI 0.30-0.61) was associated with reduced odds. Tweve-month psychological distress was associated with increased risk of immunologic failure (aOR 2.22, 95% CI 1.31-3.82). CONCLUSION: The risk of psychological distress increased 30-fold in the first year on therapy in PWH in Nigeria.

Rapid Methadone Induction in a General Hospital Setting: A Retrospective, Observational Analysis.

BACKGROUND: Outpatient methadone guidelines recommend starting at a low dose and titrating slowly. As fentanyl prevalence and opioid-related mortality increases, there is a need for individuals to rapidly achieve a therapeutic methadone dose. Hospitalization offers a monitored setting for methadone initiation, however dosing practices and safety are not well described. METHODS: Retrospective, observational analysis of hospitalized patients with opioid use disorder seen by an inpatient addiction consult team in an academic medical center who were newly initiated on methadone between 2016 and 2022. We calculated initial daily dose, maximum daily dose, timing interval of dose escalation, whether patients were connected to an opioid treatment program (OTP) prior to discharge, whether adverse effects or safety events occurred during the hospitalization, and whether such events were definitely or probably related versus possibly related or unrelated to methadone. RESULTS: One hundred twelve patients were included. The mean initial daily methadone dose administered was 32 mg (range: 10-90 mg). The mean maximum dose reached was 76.8 mg (range 30-165 mg). The mean number of days from initial to peak dose was 5.6 days (range 1-19 days). Overall, 30% of patients experienced a safety event, most commonly sedation. Only 4 safety events were deemed probably or definitely related to methadone. In regression analyses, there was no significant difference between starting doses among patients with or without sedation but there was a relationship between last dose and the likelihood of any possibly related event, with those ending at a dose of 100 mg or higher having a higher likelihood event, compared to those ending at lower doses (47.8% vs 12.4%, P < .001). Seventy-six percent were connected to OTP before discharge. CONCLUSION: Among hospitalized patients initiating methadone, rapid dose titration was infrequently associated with related safety events and most were connected to community-based methadone treatment before discharge.

Attitudes Toward Injection Practices Among People Who Inject Drugs Utilizing Medical Services: Opportunities for Harm Reduction Counseling in Health Care Settings.

Hospitals are an important setting to provide harm reduction services to people who inject drugs (PWID). This study aimed to characterize PWID's injection practices, the perceived risk and benefits of those practices, and the immediate IDU risk environment among individuals seeking medical care. Surveys were administered to 120 PWID seeking medical services at an urban hospital. Poisson regression was used to examine the effect of perceived risk or importance of injection practices on the rate of engaging in those practices. The mean participant reported "often" reusing syringes and "occasionally" cleaning their hands or skin prior to injection. 78% of participants reported that syringes were extremely risky to share, which was associated with lower likelihood of sharing them (ARR: 0.59; 95% CI: 0.36-0.95). 38% of participants reported it was extremely important to use a new syringe for each injection, and these participants were more likely to report never reusing syringes >5 times (ARR: 1.62, 95% CI: 1.11-2.35). Other factors that may influence injection practices-including fear of arrest, withdrawal, lack of access to supplies, and injecting outdoors-were common among participants. In conclusion, practices that place PWID at risk of injury and infection are common, and risk-benefit perception is associated with some, but not all, injection practices. Injecting in challenging environments and conditions is common. Therefore, harm reduction counseling in medical settings must be accompanied by other strategies to reduce risk, including facilitating access to supplies. Ultimately, structural interventions, such as affordable housing, are needed to address the risk environment.

Interest in Electronic Cigarettes for Smoking Cessation Among Adults With Opioid Use Disorder in Buprenorphine Treatment: A Mixed-Methods Investigation.

INTRODUCTION: Individuals in treatment for opioid use disorder (OUD) have high smoking rates and limited success with Food and Drug Administration (FDA)-approved cessation aids, suggesting need for novel approaches. Electronic cigarettes (e-cigarettes) might benefit this population, but e-cigarettes' acceptability for tobacco reduction or cessation among smokers in OUD treatment is not known. METHODS: A cross-sectional mixed-methods study of 222 adults in OUD treatment with buprenorphine in the Boston, Massachusetts metropolitan area was conducted in 2020. We used quantitative and qualitative data to investigate individuals' experience with and interest in e-cigarettes and other methods for smoking cessation and assessed factors associated with interest in e-cigarette use. RESULTS: One hundred sixty (72%) of the 222 participants were past 30-day cigarette smokers. They most frequently reported having ever used nicotine replacement therapy (NRT; 83%) and e-cigarettes (71%) for smoking cessation and most often indicated interest in using NRT (71%) and e-cigarettes (44%) for future smoking cessation. In multiple logistic regression analysis, interest in using e-cigarettes for future smoking cessation was independently associated with having ever used e-cigarettes for smoking cessation, current e-cigarette use, and perceiving e-cigarettes to be less harmful than cigarettes (ps < .05). In qualitative data, many current vapers/former smokers reported that e-cigarettes had been helpful for quitting cigarettes. For current smokers who currently or formerly vaped, frequently reported challenges in switching to e-cigarettes were concerns about replacing one addiction with another and e-cigarettes not adequately substituting for cigarettes. CONCLUSIONS: E-cigarettes had a moderate level of acceptability for smoking cessation among cigarette smokers in OUD treatment. More research is warranted to test the efficacy of this approach. IMPLICATIONS: Individuals in treatment for opioid use disorder (OUD) have high smoking rates and limited success with existing smoking cessation tools, suggesting a need for novel cessation treatment approaches. In this mixed-methods study of individuals receiving medication treatment for OUD with buprenorphine in Massachusetts in 2020, we found a moderate level of acceptability of e-cigarettes for smoking cessation.

Longitudinal Electronic Cigarette Use Among Patients Recently Diagnosed With Cancer Enrolled in a Smoking Cessation Trial.

INTRODUCTION: Many cancer patients who smoke report concurrent e-cigarette use. Using a mixed-methods approach, we aimed to (1) describe longitudinal e-cigarette use over 6 months after a cancer diagnosis and (2) assess the association between e-cigarette use and smoking cessation, among cancer patients in a smoking cessation trial. AIMS AND METHODS: Data were from a 2-site randomized controlled trial of Standard (brief counseling) versus Intensive treatment (sustained counseling plus smoking cessation medication) in individuals who smoke recently diagnosed with cancer. Participants (n = 303) reported e-cigarette use at baseline, 3 months, and 6 months. Biochemically-verified past 7-day cigarette abstinence was collected at 6 months. Qualitative interviews at 6 months explored factors related to e-cigarette use. RESULTS: E-cigarette use prevalence was highest between baseline and 3 months (16%) and declined over time. Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily. Multivariable analyses found no significant association between follow-up e-cigarette use and 6-month cigarette abstinence. E-cigarette use at follow-up was higher in the Standard versus Intensive treatment group (p = .003 and .001 at 3 and 6 mo, respectively). Smoking cessation and health concerns were primary reasons for using e-cigarettes. CONCLUSIONS: Among individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence. Individuals who chose to use e-cigarettes were less likely to be receiving intensive cessation support as part of the trial. Further studies are needed to evaluate the association between e-cigarette use and smoking cessation in cancer patients. IMPLICATIONS: E-cigarette use was not associated with cigarette abstinence at 6 months among adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial. Individuals with easier access to evidence-based smoking cessation treatment may be less likely to use e-cigarettes.

Investigating documentation of alcohol and non-medical substance use in oncology treatment: an electronic health record review.

PURPOSE: Little is known about non-tobacco substance use (SU) and its treatment in cancer patients. National guidelines address tobacco only, and assessment of SU in cancer patients is not standardized. It is not clear how oncology clinicians assess, document, and follow-up on SU. METHODS: We conducted an electronic health record review of patients enrolled in a smoking cessation trial at one large hospital site (N = 176). Chart review of oncology treatment notes assessed whether SU assessment was documented, the content of the documentation/assessment (e.g., frequency of use), and details about documentation (e.g., where/who documented). RESULTS: Sixty-nine percent (121/176) of cancer patients had SU documented. Many patients (42%, 74/176) had only one substance documented; 66% (116/176) had alcohol use documented. For a substantial minority of patients (43/176; 24%), the provider did not specify the substance assessed (e.g., "drug use," "illicits"). SU was primarily documented by physicians (84%, 102/121), in routine progress notes (56%, 68/121), in the "social history" section of the note (84%, 102/121). Only 4 patients had a documented SU follow-up plan. When examining the subset of patients who reported problematic alcohol use (N = 27), the content of documentation was inconsistent (e.g., number of drinks/day vs. qualitative descriptors of use). CONCLUSIONS: About 1/3 of oncology patients did not have SU assessment documented. SU other than alcohol use was infrequently documented, many clinicians documented SU but did not specify substance type, and few clinicians documented a follow-up plan for problematic SU. Oncology settings should utilize standardized assessment and referral for SU treatment.

Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0].

BACKGROUND: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings. METHODS/DESIGN: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes. DISCUSSION: This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

Prevalence of Cannabis Use and Cannabis Route of Administration among Massachusetts Adults in Buprenorphine Treatment for Opioid Use Disorder.

BACKGROUND: Recent prevalence estimates of cannabis use among individuals receiving medication treatment for OUD (MOUD) are lacking, and no study has characterized cannabis route of administration (cROA) in this population. These knowledge gaps are relevant because cannabis' effects and health outcomes vary by cROA and the availability and perceptions of cROA (e.g., vaping devices) are changing. METHODS: The Vaping In Buprenorphine-treated patients Evaluation (VIBE) cross-sectional survey assessed the prevalence and correlates of cannabis use and cROA among adults receiving buprenorphine MOUD from 02/20 to 07/20 at five community health centers in Massachusetts, a state with legal recreational and medical cannabis use. RESULTS: Among the 92/222 (41%) respondents reporting past 30-day cannabis use, smoking was the most common cROA (75%), followed by vaping (38%), and eating (26%). Smoking was more often used as a single cROA vs. in combination others (p = 0.01), whereas vaping, eating, and dabbing were more often used in combination with another cROA (all p < 0.05). Of the 39% of participants reporting multiple cROA, smoking and vaping (61%), and smoking and eating (50%), were the most prevalent combinations. Nonwhite race (vs. white) and current cigarette smoking (vs. no nicotine use) were associated with past 30-day cannabis use in multiple logistic regression. CONCLUSIONS: Prevalence of past 30-day cannabis use among individuals receiving buprenorphine MOUD in Massachusetts in 2020 was nearly double the prevalence of cannabis use in Massachusetts' adult general population in 2019 (21%). Our data are consistent with state and national data showing smoking as the most common cROA.

Cigarette Smoking and Risk Perceptions During the COVID-19 Pandemic Reported by Recently Hospitalized Participants in a Smoking Cessation Trial.

BACKGROUND: Cigarette smoking is a risk factor for severe COVID-19 disease. Understanding smokers' responses to the pandemic will help assess its public health impact and inform future public health and provider messages to smokers. OBJECTIVE: To assess risk perceptions and change in tobacco use among current and former smokers during the COVID-19 pandemic. DESIGN: Cross-sectional survey conducted in May-July 2020 (55% response rate) PARTICIPANTS: 694 current and former daily smokers (mean age 53, 40% male, 78% white) who had been hospitalized pre-COVID-19 and enrolled into a smoking cessation clinical trial at hospitals in Massachusetts, Pennsylvania, and Tennessee. MAIN MEASURES: Perceived risk of COVID-19 due to tobacco use; changes in tobacco consumption and interest in quitting tobacco use; self-reported quitting and relapse since January 2020. KEY RESULTS: 68% (95% CI, 65-72%) of respondents believed that smoking increases the risk of contracting COVID-19 or having a more severe case. In adjusted analyses, perceived risk was higher in Massachusetts where COVID-19 had already surged than in Pennsylvania and Tennessee which were pre-surge during survey administration (AOR 1.56, 95% CI, 1.07-2.28). Higher perceived COVID-19 risk was associated with increased interest in quitting smoking (AOR 1.72, 95% CI 1.01-2.92). During the pandemic, 32% (95% CI, 27-37%) of smokers increased, 37% (95% CI, 33-42%) decreased, and 31% (95% CI, 26-35%) did not change their cigarette consumption. Increased smoking was associated with higher perceived stress (AOR 1.49, 95% CI 1.16-1.91). Overall, 11% (95% CI, 8-14%) of respondents who smoked in January 2020 (pre-COVID-19) had quit smoking at survey (mean, 6 months later) while 28% (95% CI, 22-34%) of former smokers relapsed. Higher perceived COVID-19 risk was associated with higher odds of quitting and lower odds of relapse. CONCLUSIONS: Most smokers believed that smoking increased COVID-19 risk. Smokers' responses to the pandemic varied, with increased smoking related to stress and increased quitting associated with perceived COVID-19 vulnerability.

The effectiveness of post-discharge navigation added to an inpatient addiction consultation for patients with substance use disorder; a randomized controlled trial.

Background: It is unknown whether post-discharge navigation enhances the impact of hospital-initiated addiction care. This study tested the incremental benefit of telephonic linkage to a post-discharge navigator for patients who received an addiction consultation during hospitalization. Methods: A two-arm, randomized controlled trial of 395 hospitalized adults with substance use disorder who received an addiction consultation. The intervention group received post-discharge phone calls from a navigator to review the recommended treatment plan and address barriers to engagement on days 3, 7, 14, and 21. The primary outcome was days of alcohol or drug use in the past 30 assessed by Timeline Follow-back at 1 month. Results: Follow-up assessment completion rates were 46% at 1 month, and 41%, at 2 months. At baseline, intervention and control groups did not differ in substance use patterns; 45% reported primary alcohol use, 43% drugs, and 12% both. Heroin was the most common drug. At baseline, mean days of past 30-day alcohol or drug use were 13.6 in the intervention and 14.9 in the control group. The median number of navigation calls completed was 3 out of 4. At 1 month, both groups reported less use (decrease of 4.8 in intervention vs. 4.2 days in control group, p = 0.49). There were no differences between groups at 2 months. Compared to controls, participants who received all four calls had a greater decrease in use with a mean 8.6 days decrease from baseline (difference of 4.4 days, p = 0.0009). Conclusion: Post-discharge telephonic patient navigation did not further improve substance use outcomes following addiction consultation.

A hospital-wide initiative to redesign substance use disorder care: Impact on pharmacotherapy initiation.

Background: Substance use disorder (SUD) treatment in general medical settings remains underutilized. We evaluated 5 years of a hospital-wide SUD initiative which included an inpatient addiction consult team (ACT), low-threshold Bridge Clinic, recovery coaches, and office-based addiction treatment (OBAT) nurses. Methods: Naturalistic registry study. We calculated frequencies of patient contacts, types of substance use diagnoses, and medication treatment initiation and duration. Results: From 2014 to 2019, 7,036 unique patients were seen, including 4,959 by ACT, 1,197 in Bridge Clinic, 2,250 by a recovery coach, and 979 by an OBAT nurse. The median age was 47, 31% were women, 80% were white, 7% were black, 6% were Hispanic/Latinx, and 25% were experiencing homelessness. Alcohol use disorder was seen in 62%, opioid use disorder in 54%, cocaine use disorder in 29%, benzodiazepine use disorder in 14%, and stimulant use disorder in 7%. Co-occurring medical and psychiatric illnesses were common; 35% had hepatitis C, 59% depression, 66% anxiety, and 13% schizophrenia. 1,623 patients received a prescription for buprenorphine during the study period (42% of patients with OUD), 877 for oral naltrexone, and 163 for extended-release naltrexone. The mean length of continuous treatment was 178.4 days for buprenorphine, 47.7 days for oral naltrexone, and 1.29 injections for extended-release naltrexone. Conclusion: A hospital SUD initiative effectively initiated SUD pharmacotherapy with naltrexone and buprenorphine. Medication treatment episodes were longer with buprenorphine.

Real-world use of chemotherapy for Kaposi's sarcoma in a large community-based HIV primary care system in Kenya.

BACKGROUND: Kaposi's sarcoma (KS) is one of the most common HIV-associated malignancies in sub-Saharan Africa. Worldwide, the availability of antiretroviral therapy (ART) has improved KS survival. In resource-rich settings, survival has also benefited from chemotherapy, which is widely available. Little is known, however, about the epidemiology of chemotherapy use for HIV-associated KS in resource-limited regions such as sub-Saharan Africa. METHODS: We identified all patients newly diagnosed with HIV-related KS from 2009 to 2012 in the 26-clinic AMPATH network, a large community-based care network in Kenya. We ascertained disease severity at diagnosis, frequency of initiation of chemotherapy, and distribution of chemotherapeutic regimens used. Indications for chemotherapy included AIDS Clinical Trial Group T1 stage and/or "severe" disease defined by WHO KS treatment guidelines. RESULTS: Of 674 patients diagnosed with KS, charts were available for 588; 61% were men, median age was 35 years, and median CD4 at KS diagnosis was 185 cells/µl. At time of diagnosis, 58% had at least one chemotherapy indication, and 22% had more than one indication. For patients with a chemotherapy indication, cumulative incidence of chemotherapy initiation (with death as a competing event) was 37% by 1 month and 56% by 1 year. Median time from diagnosis to chemotherapy initiation was 25 days (IQR 1-50 days). In multivariable regression, patients with > 3 chemotherapy indications at time of diagnosis had a 2.30 (95% CI 1.46-3.60) increased risk of rapid chemotherapy initiation (within 30 days of diagnosis) compared to those with only one chemotherapy indication (p < 0.001). Initial regimens were bleomycin-vincristine (78%), adriamycin-bleomycin-vincristine (11%), etoposide (7%), and gemcitabine (4%). CONCLUSIONS: A substantial fraction of patients with KS in East Africa are diagnosed at advanced disease stage. For patients with chemotherapy indications, nearly half did not receive chemotherapy by one year. Liposomal anthracyclines, often used in resource-rich settings, were not first line. These findings emphasize challenges in East Africa cancer care, and highlight the need for further advocacy for improved access to higher quality chemotherapy in this setting.

Different associations of tumor PIK3CA mutations and clinical outcomes according to aspirin use among women with metastatic hormone receptor positive breast cancer.

INTRODUCTION: The relationships among PIK3CA mutations, medication use and tumor progression remains poorly understood. Aspirin use post-diagnosis may modify components of the PI3K pathway, including AKT and mTOR, and has been associated with lower risk of breast cancer recurrence and mortality. We assessed time to metastasis (TTM) and survival with respect to aspirin use and tumor PIK3CA mutations among women with metastatic breast cancer. METHODS: Patients with hormone receptor positive, HER2 negative (HR+/HER2-) metastatic breast cancer treated in 2009-2016 who received tumor genotyping were included. Aspirin use between primary and metastatic diagnosis was extracted from electronic medical records. TTM and survival were estimated using Cox proportional hazards regression. RESULTS: Among 267 women with metastatic breast cancer, women with PIK3CA mutated tumors had longer TTM than women with PIK3CA wildtype tumors (7.1 vs. 4.7 years, p = 0.008). There was a significant interaction between PIK3CA mutations and aspirin use on TTM (p = 0.006) and survival (p = 0.026). PIK3CA mutations were associated with longer TTM among aspirin non-users (HR = 0.60 95% CI:0.44-0.82 p = 0.001) but not among aspirin users (HR = 1.57 0.86-2.84 p = 0.139). Similarly, PIK3CA mutations were associated with reduced mortality among aspirin non-users (HR = 0.70 95% CI:0.48-1.02 p = 0.066) but not among aspirin users (HR = 1.75 95% CI:0.88-3.49 p = 0.110). CONCLUSIONS: Among women who develop metastatic breast cancer, tumor PIK3CA mutations are associated with slower time to progression and mortality only among aspirin non-users. Larger studies are needed to confirm this finding and examine the relationship among aspirin use, tumor mutation profile, and the overall risk of breast cancer progression.

Enhancing employer coverage of smoking cessation treatment: A randomized trial of the Partners in Helping You Quit (PiHQ) program.

The workplace is a key channel for delivering tobacco cessation treatment to a population. Employers can provide workplace-based programs and/or financial incentives such as health insurance benefits that cover the cost of treatment accessed outside the workplace. Little is known about the effect of combining these strategies. We tested the benefit of adding a workplace cessation program, Partners in Helping You Quit (PiHQ), to comprehensive health insurance coverage of smoking cessation medications by Partners HealthCare, a large Boston-based healthcare delivery system. PiHQ offers biweekly telephone-based behavioral support, additional automated calls, and medication care coordination for 3 months then monthly telephone monitoring for 9 months. In a pragmatic randomized trial, employees who smoked were informed about the insurance benefit, then randomly assigned (2:1) to PiHQ or to active referral to a free 3-month phone-based community program, Massachusetts Quitline (QL). Outcomes were assessed at 3, 6, and 12 months. During 2015-2018, 106 smokers (n = 73 PiHQ, n = 33 QL) enrolled (64% female; 75% white, 21% black; mean age 46 years, mean cigarettes/day = 13). More PiHQ than QL participants made a quit attempt by 3 months (82 vs. 61%, p < .02) and achieved the primary outcome, verified past 7-day cigarette abstinence at 6 months (31 vs. 12%, odds ratio 3.34, 95% CI, 1.05-10.60). Among participants using behavioral support, PiHQ participants completed more scheduled calls and rated counseling helpfulness higher than did QL participants. These results suggest that employers can enhance the impact of providing comprehensive health insurance coverage of smoking cessation medication by adding a phone-based worksite cessation program.

Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers.

INTRODUCTION: Smoking is a key determinant of mortality among people living with HIV (PLWH). METHODS: To better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH. RESULTS: Among 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01). CONCLUSIONS: HIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences. IMPLICATIONS: PLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking. TRIAL REGISTRATION: (1) Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.

The prevalence of unhealthy alcohol and drug use among inpatients in a general hospital.

Background: Unhealthy substance use is a growing public health issue. Intersections with the health care system offer an opportunity for intervention; however, recent estimates of prevalence for unhealthy substance use among all types of hospital inpatients are unknown. Methods: Universal screening for unhealthy alcohol or drug use was implemented across a 999-bed general hospital between January 1 and December 31, 2015. Nurses completed alcohol screening using the Alcohol Use Disorders Identification Test alcohol consumption questions (AUDIT-C) with a cutoff of ≥5 for moderate risk and ≥8 for high risk and drug screening using the single-item screening question with ≥1 episode of use considered positive. Results: Out of 35,288 unique inpatients, screens were completed on 21,519. There were 3,451 positive screens (16% of all completed screens), including 1,291 (6%) moderate risk and 1,111 (5%) high risk screens for alcohol and 1,657 (8%) positive screens for drug use. Among screens that were positive for moderate- or high-risk alcohol use, 221 (17%) and 297 (27%), respectively, were concurrently positive for drug use. The majority (61%) of patients with unhealthy alcohol use was on the medical services. Men, those who were white or Hispanic, middle-aged, single, unemployed, or screened positive for drug use were more likely to screen positive for high-risk alcohol use. Those who were younger, single, worked less than full time, or screened high risk for alcohol were more likely to screen positive for drug use. Discordance between diagnosis coding and screening results was noted: 29% of high-risk alcohol use screens had no alcohol diagnosis coding associated with that admission, and 51% of patients with a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis code of alcohol dependence had AUDIT-C scores of <8. Conclusions: Across a general hospital, 16% of patients screened positive for unhealthy substance use, with the highest volume on medical floors. Nursing-led screening may offer an opportunity to identify and engage patients with unhealthy substance use during hospitalization.

Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.

Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care. Objective: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. Design, Setting, and Participants: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018. Interventions: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). Main Outcome and Measures: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. Results: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2). Conclusions and Relevance: Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research. Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.

Reversal strategies and outcomes in patients with atrial fibrillation and warfarin-associated intracranial hemorrhage.

PURPOSE: Evaluate reversal strategies in atrial fibrillation (AF) patients with warfarin-associated intracranial hemorrhage (ICH) in clinical care. MATERIALS AND METHODS: Observational cohort of AF patients with warfarin-associated ICH at two referral hospitals (2007-2010), with patient features, reversal agents, and outcomes collected from medical records. RESULTS: Among 498 ICH patients 403 received fresh frozen plasma (FFP) without 3-factor prothrombin complex concentrates (PCCs) or recombinant factor VIIa (rFVIIa), 65 received PCCs or rFVIIa, mostly with FFP, and 30 received no acute reversal agents. Median time from presentation to reversal agent administration was 3.4 h (IQR 2.3-5.3). INR was reversed to ≤1.4 by 6 h post-presentation in 46% of patients receiving PCCs/rFVIIa versus 15% receiving FFP alone (p<0.0001). Among PCCs/rFVIIa recipients, 31% died in-hospital vs. 24% receiving FFP alone (p=0.27). Adjusted OR for death accounting for age and Glasgow Coma Score was 0.78 (0.36-1.69) for PCCs/rFVIIa vs FFP only and 1.16 (0.59-2.27) comparing those reaching vs. not reaching INR ≤ 1.4 at 6 h. CONCLUSIONS: Treatment with PCCs/rFVIIa led to faster INR reversal than treatment with FFP alone. Neither treatment with PCCs/rFVIIa nor rapid INR reversal was associated with improved survival. Delays receiving PCCs may largely eliminate the benefit of treatment.