Harold S. Javitz

Prospective assessment after pediatric cardiac ablation: demographics, medical profiles, and initial outcomes.

Introduction: A multicenter prospective study was designed and implemented to assess the short‐ and longer‐term results and risks associated with radiofrequency (RF) ablation in children.

Bupropion SR and counseling for smoking cessation in actual practice: Predictors of outcome

To date, only one study has been published on individual characteristics associated with outcome following standard treatment with bupropion SR for smoking cessation. To investigate treatment outcome beyond the 6-week end-of-treatment point, the present study examined characteristics associated with more clinically relevant smoking endpoints following treatment with bupropion SR in a large health care system. A total of 1,524 smokers (649 men and 875 women) of average age 45.1 years were randomized to receive one of four combinations of bupropion SR (150 or 300 mg) and behavioral counseling (tailored mailings or proactive telephone counseling) and assessed for point-prevalent smoking status at 3 and 12 months. Multiple logistic regression analyses of potential risk factors for 12-month point-prevalent smoking and for persistent smoking (point-prevalent smoking at both follow-ups) following treatment were conducted for men and women combined and separately. Risk factors for smoking at both endpoints in the combined sample included treatment with tailored mailings, female gender, younger age, higher levels of tobacco dependence, shorter previous quit attempts, previous use of nicotine replacement therapy, and report of current depressive symptoms or lifetime depression. Risk factors for smoking following treatment identified in women only included treatment with the lower dose of bupropion SR, younger age, and higher perceived stress, whereas those that were unique to men included the presence of lifetime depression. The results are discussed in terms of their implications for the need for more effective treatments in general, and the role of individual differences in the likelihood of returning to smoking following treatment for quitting.

Behavioral Counseling and Varenicline Treatment for Smoking Cessation

BACKGROUND Smoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence. PURPOSE This study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline. METHODS Current treatment-seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401); proactive telephone-based counseling (PTC; n=402); or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-ups); the number of days varenicline was taken; and treatment-related symptoms. Behavioral measures determined utilization of both the web- and Phone-based counseling. RESULTS Intent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC-web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months (OR=1.48, 95% CI=1.12, 1.96), but no between-group differences in abstinence outcomes were seen at 6 months. CONCLUSIONS Phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.

Nicotinic Acetylcholine Receptor Variation and Response to Smoking Cessation Therapies

Objective To evaluate the association of nicotinic acetylcholine receptor (nAChR) single nucleotide polymorphism (SNP) with 7-day point prevalence abstinence (abstinence) in randomized clinical trials of smoking cessation therapies in individuals grouped by pharmacotherapy randomization to inform the development of personalized smoking cessation therapy. Materials and methods We quantified association of four SNPs at three nAChRs with abstinence in eight randomized clinical trials. Participants were 2633 outpatient treatment-seeking, self-identified European ancestry individuals smoking at least 10 cigarettes/day, recruited through advertisement, prescribed pharmacotherapy, and provided with behavioral therapy. Interventions included nicotine replacement therapy (NRT), bupropion, varenicline, placebo (PLA), or combined NRT and bupropion, and five modes of group and individual behavioral therapy. Outcome measures tested in multivariate logistic regression were end of treatment and 6 month (6MO) abstinence, with demographic, behavioral, and genetic covariates. Results ‘Risk’ alleles previously associated with smoking heaviness were significantly (P<0.05) associated with reduced abstinence in the PLA pharmacotherapy group (PG) at 6MO [for rs588765, odds ratio (95% confidence interval) 0.41 (0.17–0.99)], and at end of treatment and at 6MO [for rs1051730, 0.42 (0.19–0.93) and 0.31 (0.12–0.80)], and with increased abstinence in the NRT PG at 6MO [for rs588765, 2.07 (1.11–3.87) and for rs1051730, 2.54 (1.29–4.99)]. We observed significant heterogeneity in rs1051730 effects (F=2.48, P=0.021) between PGs. Conclusion chr15q25.1 nAChR SNP risk alleles for smoking heaviness significantly increase relapse with PLA treatment and significantly increase abstinence with NRT. These SNP–PG associations require replication in independent samples for validation, and testing in larger sample sizes to evaluate whether similar effects occur in other PGs.

Adherence to Varenicline in the COMPASS Smoking Cessation Intervention Trial

INTRODUCTION Patient adherence to smoking cessation medications can impact their effectiveness. It is important to understand the extent to which prescribed medications are actually taken by smokers, how this influences smoking cessation outcomes, and what factors may influence adherence. METHODS Smokers recruited from a large health plan were randomized to receive different modes of cessation counseling in combination with varenicline (Swan, G. E., McClure, J. B., Jack, L. M., Zbikowski, S. M., Javitz, H. S., Catz, S. L., et al. 2010.Behavioral counseling and varenicline treatment for smoking cessation. American Journal of Preventive Medicine, 38, 482-490). One thousand one hundred and sixty-one participants were mailed a 28-day varenicline supply when they set a quit date and were able to request up to two refills from the health plan pharmacy at no cost. Pharmacy fill records were obtained and telephone surveys completed at baseline, 21 days, 12 weeks, and 6 months post target quit date. RESULTS Good adherence to varenicline (≥80% of days taken) was associated with a twofold increase in 6-month quit rates compared with poor adherence (52% vs. 25%). Smokers were more likely than nonsmokers to stop varenicline early. Purposeful nonadherence was associated with smoking at 12 weeks and was predicted in multivariate analyses by age, gender, adherence self-efficacy, and initial medication side effect severity. CONCLUSIONS Innovative methods for increasing adherence to smoking cessation medications are needed, particularly early in the quit process. Simple metrics of adherence such as number of days cessation medication is taken can and should be routinely incorporated in effectiveness trials and reported to advance future attempts to understand and reduce nonadherence.

A National Picture of Parent and Youth Participation in IEP and Transition Planning Meetings

Two prospective longitudinal studies of nationally representative samples of students with disabilities—the Special Education Elementary Longitudinal Study and the National Longitudinal Transition Study–2—are used to provide a broad look at the participation of parents of 11- through 19-year-old students with disabilities in Individualized Education Plan/transition planning meetings and their satisfaction with their involvement in them. Students’ attendance and the roles played in their transition planning meetings are also examined. Logistic regression analyses identify disability characteristics; demographics; aspects of parents’ involvement, expectations, and perceptions; experiences in students’ educational histories; and features of their instructional programs that help explain variations in parent and student participation, parent satisfaction, and student roles.

Reliability of Adult Retrospective Recall of Lifetime Tobacco Use

Retrospective assessment of tobacco use underlies much of the data collected in epidemiological and genetic epidemiological research. Although individuals are asked to report lifetime tobacco use for periods spanning months to decades, the test-retest reliability intervals of the instruments often span only a few weeks to several months. The present analyses examined the test-retest reliability of retrospective tobacco use measures, including details of first use, circumstances of first use, and initial subjective reactions. The questions were part of the Lifetime Tobacco Use Questionnaire (LTUQ), a Web-based questionnaire designed to assess use of most forms of tobacco or nicotine retrospectively across the lifespan. A convenience sample of 236 men and women with history of tobacco use (Time 1 mean age, 44.9 years; 74.2% females; 75.1% regular monthly tobacco use) responded verifiably to invitations to self-administer the LTUQ two times, 2 years apart. Test-retest reliability analyses reflected high reliability for salient tobacco-use questions. Acceptable levels of reliability were observed for initial subjective reactions to smoking, if the scaled response options were dichotomized. Few differences in the reliability of recall were apparent between sexes and between age groups. These results indicate that recall of important tobacco use information can form a reliable basis for research.

Resequencing of nicotinic acetylcholine receptor genes and association of common and rare variants with the Fagerström test for nicotine dependence.

Common single-nucleotide polymorphisms (SNPs) at nicotinic acetylcholine receptor (nAChR) subunit genes have previously been associated with measures of nicotine dependence. We investigated the contribution of common SNPs and rare single-nucleotide variants (SNVs) in nAChR genes to Fagerström test for nicotine dependence (FTND) scores in treatment-seeking smokers. Exons of 10 genes were resequenced with next-generation sequencing technology in 448 European-American participants of a smoking cessation trial, and CHRNB2 and CHRNA4 were resequenced by Sanger technology to improve sequence coverage. A total of 214 SNP/SNVs were identified, of which 19.2% were excluded from analyses because of reduced completion rate, 73.9% had minor allele frequencies <5%, and 48.1% were novel relative to dbSNP build 129. We tested associations of 173 SNP/SNVs with the FTND score using data obtained from 430 individuals (18 were excluded because of reduced completion rate) using linear regression for common, the cohort allelic sum test and the weighted sum statistic for rare, and the multivariate distance matrix regression method for both common and rare SNP/SNVs. Association testing with common SNPs with adjustment for correlated tests within each gene identified a significant association with two CHRNB2 SNPs, eg, the minor allele of rs2072660 increased the mean FTND score by 0.6 Units (P=0.01). We observed a significant evidence for association with the FTND score of common and rare SNP/SNVs at CHRNA5 and CHRNB2, and of rare SNVs at CHRNA4. Both common and/or rare SNP/SNVs from multiple nAChR subunit genes are associated with the FTND score in this sample of treatment-seeking smokers.

Utilization of Services in a Randomized Trial Testing Phone- and Web-Based Interventions for Smoking Cessation

INTRODUCTION Phone counseling has become standard for behavioral smoking cessation treatment. Newer options include Web and integrated phone-Web treatment. No prior research, to our knowledge, has systematically compared the effectiveness of these three treatment modalities in a randomized trial. Understanding how utilization varies by mode, the impact of utilization on outcomes, and predictors of utilization across each mode could lead to improved treatments. METHODS One thousand two hundred and two participants were randomized to phone, Web, or combined phone-Web cessation treatment. Services varied by modality and were tracked using automated systems. All participants received 12 weeks of varenicline, printed guides, an orientation call, and access to a phone supportline. Self-report data were collected at baseline and 6-month follow-up. RESULTS Overall, participants utilized phone services more often than the Web-based services. Among treatment groups with Web access, a significant proportion logged in only once (37% phone-Web, 41% Web), and those in the phone-Web group logged in less often than those in the Web group (mean = 2.4 vs. 3.7, p = .0001). Use of the phone also was correlated with increased use of the Web. In multivariate analyses, greater use of the phone- or Web-based services was associated with higher cessation rates. Finally, older age and the belief that certain treatments could improve success were consistent predictors of greater utilization across groups. Other predictors varied by treatment group. CONCLUSIONS Opportunities for enhancing treatment utilization exist, particularly for Web-based programs. Increasing utilization more broadly could result in better overall treatment effectiveness for all intervention modalities.

Cardiovascular reactivity as a predictor of relapse in male and female smokers.

This study examined the role of psychophysiological reactivity to general stressors measured before smoking cessation as a predictor of relapse in individuals who quit for a minimum of 12 hr and were then followed for a 12-month interval. The study group consisted of 132 (56.9%) female and 100 (43.1%) male participants in a formal smoking cessation program. The reactivity measures were taken while the Ss were still smoking. Heart rate and blood pressure measurements were taken while Ss were resting, performing mental arithmetic, and delivering a speech and after Ss had been standing for 2 min. In the sample as a whole and for women, a higher level of systolic blood pressure reactivity to the cognitive challenge was associated with a shorter time to relapse (p < .05). In men, greater systolic blood pressure decline to standing was significantly associated with a shorter time to relapse (p < .05).