Long-Term Effectiveness of a Clinician-Assisted Digital Cognitive Behavioral Therapy Intervention for Smoking Cessation: Secondary Outcomes From a Randomized Controlled Trial.

INTRODUCTION: This study evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioral therapy (CBT) intervention for smoking cessation. METHODS: Adult smokers (N = 556) were randomly assigned to Quit Genius (n = 277), a digital, clinician-assisted CBT intervention or very brief advice (VBA) to stop smoking, an evidence-based, 30-s intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n = 279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (n = 530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date (QD). The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at 4 weeks post-QD. Consecutive 7-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of <5 parts per million (n = 280). RESULTS: Self-reported consecutive 7-day PPA at weeks 26 and 52 for Quit Genius was 27.2% and 22.6%, respectively, compared with VBA which was 16.6% and 13.2% (RR = 1.70, 95% CI, 1.22-2.37; p = .003, 26 weeks; RR = 1.71, 95% CI, 1.17-2.50; P = .005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p = .03) but not 52 weeks (p = .16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR = 1.71, 95% CI 1.17-2.50; p = .005). CONCLUSIONS: This study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed. IMPLICATIONS: The long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

Physician variation in lung cancer treatment at the end of life.

OBJECTIVES: To determine whether a treating oncologist's characteristics are associated with variation in use of chemotherapy for patients with advanced non-small cell lung cancer (aNSCLC) at the end of life. STUDY DESIGN: Retrospective cohort. METHODS: Using the 2009 Surveillance, Epidemiology, and End Results-Medicare database, we studied chemotherapy receipt within 30 days of death among Medicare enrollees who were diagnosed with aNSCLC between 1999 and 2006, received chemotherapy, and died within 3 years of diagnosis. A multilevel model was constructed to assess the contribution of patient and physician characteristics and geography to receiving chemotherapy within 30 days of death. RESULTS: Among 21,894 patients meeting eligibility criteria, 43.1% received chemotherapy within 30 days of death. In unadjusted bivariate analyses, female sex, Asian or black race, older age, and a greater number of comorbid diagnoses predicted lower likelihood of receiving chemotherapy at the end of life (P ≤.038 for all comparisons). Adjusting for patient and physician characteristics, physicians in small independent practices were substantially more likely than those employed in other practice models, particularly academic practices or nongovernment hospitals, to order chemotherapy for a patient in the last 30 days of life (P <.001 for all comparisons); female physicians were less likely than males to prescribe such treatment (P = .04). CONCLUSIONS: Patients receiving care for aNSCLC in small independent oncology practices are more likely to receive chemotherapy in the last 30 days of life.

Utilizing a Two-stage Design to Investigate the Safety and Potential Efficacy of Monthly Naltrexone Plus Once-daily Bupropion as a Treatment for Methamphetamine Use Disorder.

OBJECTIVES: This 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder. METHODS: The study was conducted in 2 stages of recruitment across 3 sites; 20 participants were enrolled in stage 1 and 29 participants were enrolled in stage 2. Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP; Wellbutrin XL) were provided with a smartphone-assisted medication adherence platform. Participants met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for severe MA use disorder, self-reported ≥20 days of MA use in the 30 days prior to consent, and submitted 3 MA-positive urine drug screens (UDS) out of 4 collected during screening. Participants attended clinic twice weekly for observed BRP dosing, UDS testing, assessments, and medical management; XR-NTX was administered at weeks 1 and 5. A BRP taper and follow-up visit occurred in week 9. RESULTS: Analyses evaluated effects of XR-NTX + BRP to determine the number of "responders" according to a statistically predefined response criterion (6 of 8 MA-negative UDS during the last 4 weeks of medication). The 2-stage design required that stage 1 yield ≥3 responders to continue to stage 2; 11 of the 49 participants met responder criteria across both stages (5 in stage 1, 6 in stage 2). CONCLUSIONS: Under the statistical analysis plan, study "success" required ≥9 responders. With 11 responders, the study demonstrated sufficient potential of naltrexone plus bupropion as a combination pharmacotherapy for MA use disorder to warrant further study.

Racial/Ethnic and Socioeconomic Differences in Colorectal and Breast Cancer Treatment Quality: The Role of Physician-level Variations in Care.

BACKGROUND: Despite a large body of research showing racial/ethnic and socioeconomic disparities in cancer treatment quality, the relative role of physician-level variations in care is unclear. OBJECTIVE: To examine the effect of physicians on disparities in breast and colorectal cancer care. SUBJECTS: Linked SEER Medicare data were used to identify Medicare beneficiaries diagnosed with colorectal and breast cancer during 1995-2007 and their treating physicians. RESEARCH DESIGN: We identified treating physicians from Medicare claims data. We measured the use of NIH guideline-recommended therapies from SEER and Medicare claims data, and used logistic models to examine the relationship between race/ethnicity, socioeconomic status, and cancer quality of care. We used physician fixed effects to account for between-physician variations in treatment. RESULTS: Minority and low socioeconomic status beneficiaries with breast and colorectal cancer were less likely to receive any recommended treatments as compared with whites. Overall, between-physician variation explained <20% of the total variation in quality of care. After accounting for between-physician differences, median household income explained 14.3%, 18.4%, and 13.2% of the variation in use of breast-conserving surgery, chemotherapy, and radiation for breast cancer, and 13.7%, 12.9%, and 12.6% of the within-physician variation in use of colorectal surgery, chemotherapy, and radiation for colorectal cancer, whereas race and ethnicity explained <2% of the within-physician variation in cancer care. CONCLUSIONS: Between-physician variations partially explain racial disparities in cancer care. Residual within-physician disparities may be due to differences in patient-provider communication, patient preferences and treatment adherence, or unmeasured clinical severity.

Predictors of Continued Use of Extended-Released Naltrexone (XR-NTX) for Opioid-Dependence: An Analysis of Heroin and Non-Heroin Opioid Users in Los Angeles County.

Extended-release naltrexone (XR-NTX) is associated with an increased number of opioid-free days, improved adherence rates in substance use disorder treatment programs, and reduced cravings and drug-seeking behaviors. There is little evidence on the predictive associations between baseline characteristics of opioid-dependent patients and XR-NTX utilization. Some studies have demonstrated better pharmacotherapy adherence and/or retention rates among non-heroin opioid users compared to heroin users. This study examines predictive associations between characteristics of patients and XR-NTX utilization, as well as participants' urge to use opiates. Our findings suggest that XR-NTX may contribute to decreases in urges to use among both heroin and non-heroin opioid users. Non-heroin opioid users and heroin users were retained in XR-NTX treatment for comparable periods of time. However, those who identified as homeless, injected opioids (regardless of opioid-type), or were diagnosed with a mental illness were less likely to be retained in treatment with XR-NTX.

Buprenorphine pharmacotherapy and behavioral treatment: comparison of outcomes among prescription opioid users, heroin users and combination users.

Most research examining buprenorphine has been conducted with heroin users. Few studies have examined buprenorphine pharmacotherapy for prescription opioid users. Data were from a randomized controlled trial of behavioral treatment provided for 16weeks on a platform of buprenorphine pharmacotherapy and medication management. We compared heroin (H, n=54), prescription opioid (PO, n=54) and combination heroin+prescription opioid (POH, n=71) users to test the hypothesis that PO users will have better treatment outcomes compared with heroin users. The PO group provided more opioid-negative urine drug screens over the combined treatment period (PO:70%, POH:40%, H:38%, p<0.001) and at the end of the combined treatment period (PO:65%, POH:31%, H:33%, p<0.001). Retention was lowest in the H group (PO:80%, POH:65%, H:57%, p=0.039). There was no significant difference in buprenorphine dose between the groups. PO users appear to have better outcomes in buprenorphine pharmacotherapy compared to those reporting any heroin use, confirming that buprenorphine pharmacotherapy is effective in PO users.

Adherence to World Cancer Research Fund/American Institute for Cancer Research lifestyle recommendations reduces prostate cancer aggressiveness among African and Caucasian Americans.

The effect of adherence to the World Cancer Research Fund (WCRF) lifestyle recommendations on cancer aggressiveness is unknown. We examined associations between adherence to recommendations and risk of highly aggressive prostate cancer in research subjects enrolled in the North Carolina-Louisiana Prostate Cancer Project (PCaP). We examined associations between adherence to WCRF recommendations and risk of highly aggressive prostate cancer among 2212 newly diagnosed African Americans (AA) or Caucasian Americans (CA) aged 40-70 years in PCaP. Prostate cancer aggressiveness was based on Gleason scores, serum prostate-specific antigens, and TNM stage. Adherence to WCRF recommendations was based on point scores and odds ratios estimated. Results showed that adherence to recommendations was significantly and negatively associated with risk of a highly aggressive prostate cancer. Each additional point in the total adherence score corresponded to a 13% risk reduction. Total adherence score <4 predicted increased risk in both AA (OR = 1.36; 95% CI = 1.01-1.85) and CA (OR = 1.41; 95% CI = 1.01-1.98). Consumption of <500 g red meat per week or ≤125 total kcal/100 g solid food per day is a statistically significant protective factor in the overall cohort. Recommendations aimed at preventing all cancers also may reduce risk of highly aggressive prostate cancer.

Buprenorphine/naloxone and methadone maintenance treatment outcomes for opioid analgesic, heroin, and combined users: findings from starting treatment with agonist replacement therapies (START).

OBJECTIVE: The objective of this secondary analysis was to explore differences in baseline clinical characteristics and opioid replacement therapy treatment outcomes by type (heroin, opioid analgesic [OA], or combined [heroin and OA]) and route (injector or non-injector) of opioid use. METHOD: A total of 1,269 participants (32.2% female) were randomized to receive one of two study medications (methadone or buprenorphine/naloxone [BUP]). Of these, 731 participants completed the 24-week active medication phase. Treatment outcomes were opioid use during the final 30 days of treatment (among treatment completers) and treatment attrition. RESULTS: Non-opioid substance dependence diagnoses and injecting differentiated heroin and combined users from OA users. Non-opioid substance dependence diagnoses and greater heroin use differentiated injectors from non-injectors. Further, injectors were more likely to be using at end of treatment compared with non-injectors. OA users were more likely to complete treatment compared with heroin users and combined users. Non-injectors were more likely than injectors to complete treatment. There were no interactions between type of opioid used or injection status and treatment assignment (methadone or BUP) on either opioid use or treatment attrition. CONCLUSIONS: Findings indicate that substance use severity differentiates heroin users from OA users and injectors from non-injectors. Irrespective of medication, heroin use and injecting are associated with treatment attrition and opioid misuse during treatment. These results have particular clinical interest, as there is no evidence of superiority of BUP over methadone for treating OA users versus heroin users.

Coffee consumption and prostate cancer aggressiveness among African and Caucasian Americans in a population-based study.

This study evaluated the relationship between caffeinated and decaffeinated coffee and prostate cancer (CaP) aggressiveness using data from a population-based incident CaP study within the North Carolina-Louisiana Prostate Cancer Project (PCaP). Classification of CaP aggressiveness at diagnosis was based on clinical criteria for 1,049 African-American (AA) and 1,083 Caucasian-American (CA) research subjects. Coffee consumption was measured using a modified NCI Dietary History Questionnaire. No significant associations were found between CaP aggressiveness and consumption of either caffeinated or decaffeinated coffee. The OR for high aggressive CaP among consumers of more than 4 cups per day was 0.92 (95%CI = 0.61, 1.39), compared to non-coffee-drinkers. Results stratified by race found no significant associations and no noticeable trends in either AAs (P for trend = 0. 62) or CAs (P for trend = 0.42). In contrast to a recent report on a select population that has less complete information on CaP aggressiveness suggesting that coffee prevents aggressive CaP, this rapid case ascertainment population-based study, in a biracial population with differing risks of CaP did not demonstrate a protective relationship between high coffee consumption and risk of high aggressive CaP.

Validity of a multipass, web-based, 24-hour self-administered recall for assessment of total energy intake in blacks and whites.

To date, Web-based 24-hour recalls have not been validated using objective biomarkers. From 2006 to 2009, the validity of 6 Web-based DietDay 24-hour recalls was tested among 115 black and 118 white healthy adults from Los Angeles, California, by using the doubly labeled water method, and the results were compared with the results of the Diet History Questionnaire, a food frequency questionnaire developed by the National Cancer Institute. The authors performed repeated measurements in a subset of 53 subjects approximately 6 months later to estimate the stability of the doubly labeled water measurement. The attenuation factors for the DietDay recall were 0.30 for blacks and 0.26 for whites. For the Diet History Questionnaire, the attenuation factors were 0.15 and 0.17 for blacks and whites, respectively. Adjusted correlations between true energy intake and the recalls were 0.50 and 0.47 for blacks and whites, respectively, for the DietDay recall. For the Diet History Questionnaire, they were 0.34 and 0.36 for blacks and whites, respectively. The rate of underreporting of more than 30% of calories was lower with the recalls than with the questionnaire (25% and 41% vs. 34% and 52% for blacks and whites, respectively). These findings suggest that Web-based DietDay dietary recalls offer an inexpensive and widely accessible dietary assessment alternative, the validity of which is equally strong among black and white adults. The validity of the Web-administered recall was superior to that of the paper food frequency questionnaire.

Racial differences in correlations between reported dietary intakes of carotenoids and their concentration biomarkers.

BACKGROUND: The predictive ability of dietary assessment methods to estimate specific circulating plasma carotenoid concentrations has been compared between African Americans and whites in only one study to date. OBJECTIVE: The predictive abilities of 24-h dietary recalls and a food-frequency questionnaire in reporting dietary carotenoids when measured against concentration biomarkers were assessed in African Americans and compared with the findings in whites. DESIGN: Data were collected from 250 generally healthy, nonsmoking white and African American participants aged 21-69 y, who completed 8 self-administered online 24-h dietary recalls and one National Cancer Institute diet-history questionnaire in the University of California Los Angeles (UCLA) Energetics Study. Mean intakes from 4-d dietary recalls were correlated with plasma xanthophyll concentrations (lutein + zeaxanthin and ß-cryptoxanthin) and hydrocarbon carotenoids (lycopene, α-carotene, and ß-carotene). RESULTS: Adjusted correlations of plasma carotenoids with reported dietary intakes for African Americans in the 24-h dietary recall ranged from 0.03 for ß-carotene to 0.40 for ß-cryptoxanthin. For whites, the correlations ranged from 0.13 for lycopene to 0.51 for ß-cryptoxanthin. CONCLUSIONS: Despite stronger validity in reported energy intakes for African Americans than for whites in the 24-h dietary recall in the Energetics Study, both recalls and food-frequency dietary assessment methods yielded lower correlations in African Americans than in whites. This finding might be attributable to reporting differences in both dietary sources and food preparation or to racially related genetic variants influencing circulating concentrations. The current findings support the need to account for differences in race, age, sex, and body mass index in regression calibrations of dietary reports and measurement error adjustments.