Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial.

AIM: To analyse the effects of albiglutide, a glucagon-like peptide 1 receptor agonist, on cardiovascular outcomes in older adults aged ≥65 years with type 2 diabetes and cardiovascular disease who participated in the Harmony Outcomes trial (NCT02465515). MATERIALS AND METHODS: We conducted a post hoc analysis of the primary endpoint of the Harmony Outcomes trial-time to first occurrence of a major adverse cardiovascular event-in subgroups of participants aged <65 and ≥65 years and <75 and ≥75 years at baseline. Hazard ratios and 95% confidence intervals (CIs) were generated using Cox proportional hazards regression. RESULTS: The analysis population included 9462 Harmony Outcomes participants, including 4748 patients ≥65 and 1140 patients ≥75 years at baseline. Hazard ratios for the prevention of major adverse cardiovascular events were 0.66 (95% CI, 0.53-0.82) in persons <65 and 0.86 (95% CI, 0.71-1.04) in those ≥65 years (age interaction p = .07), and 0.78 (95% CI, 0.67-0.91) in <75 and 0.70 (95% CI, 0.48-1.01) in ≥75 year age groups (interaction p = .6). When analysed as a continuous variable, age did not modify the effect of albiglutide on the primary endpoint. CONCLUSIONS: This post hoc analysis adds to the body of literature showing that glucagon-like peptide 1 receptor agonists added to standard type 2 diabetes therapy safely reduce the incidence of cardiovascular events in older adults with established cardiovascular disease. In this analysis, the risk-benefit profile was similar between younger and older age groups treated with albiglutide.

Randomized clinical trial examining financial incentives for smoking cessation among mothers of young children and possible impacts on child secondhand smoke exposure.

This randomized clinical trial examined whether financial-incentives increase smoking cessation among mothers of young children and potential impacts on child secondhand-smoke exposure (SHSe). 198 women-child dyads were enrolled and assigned to one of three treatment conditions: best practices (BP, N = 68), best practices plus financial incentives (BP + FI, N = 63), or best practices, financial incentives, and nicotine replacement therapy (BP + FI + NRT, N = 67). The trial was completed in Vermont, USA between June 2015 and October 2020. BP entailed staff referral to the state tobacco quitline; financial incentives entailed mothers earning vouchers exchangeable for retail items for 12 weeks contingent on biochemically-verified smoking abstinence; NRT involved mothers receiving 10 weeks of free transdermal nicotine and nicotine lozenges/gum. Baseline, 6-, 12-, 24-, and 48-week assessments were conducted. Primary outcomes were maternal 7-day point-prevalence abstinence and child SHSe through the 24-week assessment with the 48-week assessment exploratory. Results were analyzed using mixed model repeated measures for categorical data. Odds of maternal abstinence were greater among mothers in BP + FI and BP + FI + NRT compared to BP at the 6- and 12-week assessments (ORs ≥ 7.30; 95% CIs: 2.35-22.71); only abstinence in BP + FI remained greater than BP at the 24-week assessment (OR = 2.95; 95% CIs: 1.06-8.25). Abstinence did not differ significantly between treatment conditions at the 48-week assesssment. There was a significant effect of treatment condition (F[2109] = 3.64, P = .029) on SHSe with levels in BP and BP + FI significantly below BP + FI + NRT (ts[109] ≥ -2.30, Ps ≤ 0.023). Financial incentives for smoking abstinence are efficacious for increasing maternal cessation but that alone was insufficient for reducing child SHSe. ClinicalTrials.gov:NCT05740098.

Randomized Controlled Trial Examining the Efficacy of Adding Financial Incentives to Best practices for Smoking Cessation Among pregnant and Newly postpartum Women.

We report results from a single-blinded randomized controlled trial examining financial incentives for smoking cessation among 249 pregnant and newly postpartum women. Participants included 169 women assigned to best practices (BP) or BP plus financial incentives (BP + FI) for smoking cessation available through 12-weeks postpartum. A third condition included 80 never-smokers (NS) sociodemographically-matched to women who smoked. Trial setting was Burlington, Vermont, USA, January, 2014 through January, 2020. Outcomes included 7-day point-prevalence abstinence antepartum and postpartum, and birth and other infant outcomes during 1st year of life. Reliability and external validity of results were assessed using pooled results from the current and four prior controlled trials coupled with data on maternal-smoking status and birth outcomes for all 2019 singleton live births in Vermont. Compared to BP, BP + FI significantly increased abstinence early- (AOR = 9.97; 95%CI, 3.32-29.93) and late-pregnancy (primary outcome, AOR = 5.61; 95%CI, 2.37-13.28) and through 12-weeks postpartum (AOR = 2.46; CI,1.05-5.75) although not 24- (AOR = 1.31; CI,0.54-3.17) or 48-weeks postpartum (AOR = 1.33; CI,0.55-3.25). There was a significant effect of trial condition on small-for-gestational-age (SGA) deliveries (χ2 [2] = 9.01, P = .01), with percent SGA deliveries (+SEM) greatest in BP, intermediate in BP + FI, and lowest in NS (17.65 + 4.13, 10.81 + 3.61, and 2.53 + 1.77, respectively). Reliability analyses supported the efficacy of financial incentives for increasing abstinence antepartum and postpartum and decreasing SGA deliveries; external-validity analyses supported relationships between antepartum cessation and SGA risk. Adding financial incentives to Best Practice increases smoking cessation among antepartum and postpartum women and improves other maternal-infant outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02210832.

Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study.

Cigarette smoking during pregnancy increases risk for pregnancy complications, growth restriction, and other adverse health outcomes. The most effective intervention for reducing smoking during pregnancy is financial incentives contingent on biochemically-verified smoking abstinence. The present study examined the efficacy of a smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app. If efficacious, this remote intervention would allow pregnant women residing in geographically remote areas to benefit from incentives-based cessation interventions. Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook. Participants were assigned sequentially to one of two treatments: best practices alone (N = 30) or best practices plus financial incentives (N = 30). Outcomes were analyzed using repeated measures analysis based on generalized estimating equations (GEE). Seven-day point prevalence abstinence rates were greater in the incentives versus best practices arms early- (46.7% vs 20.0%, OR = 3.50, 95%CI = 1.11,11.02) and late-antepartum (36.7% vs 13.3%, OR = 3.76, 95%CI = 1.04,13.65), and four- (36.7% vs 10.0%, OR = 5.21, 95%CI = 1.28,21.24) and eight-weeks postpartum (40.0% vs 6.7%, OR = 9.33, 95%CI = 1.87,46.68), although not at the 12- (23.3% vs 10.0%, OR = 2.74, 95%CI = 0.63,11.82) or 24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion. These results support the efficacy of this remote, incentives-based intervention for pregnant smokers. Further research evaluating its efficacy and cost-effectiveness in a well-powered, randomized controlled trial appears warranted.

Pregnancy-Induced Increases in the Nicotine Metabolite Ratio: Examining Changes During Antepartum and Postpartum.

INTRODUCTION: Pregnancy-induced increases in nicotine metabolism may contribute to difficulties in quitting smoking during pregnancy. However, the time course of changes in nicotine metabolism during early and late pregnancy is unclear. This study investigated how pregnancy alters the nicotine metabolite ratio (NMR), a common biomarker of nicotine metabolism among nonpregnant smokers. METHODS: Urinary NMR (trans-3'-hydroxycotinine [3HC]/cotinine [COT]) was assessed using total (free + glucuronide) and free compounds among women (N = 47) from a randomized controlled trial for smoking cessation who self-reported smoking and provided a urine sample during early pregnancy (M ± SD = 12.5 ± 4.5 weeks' gestation), late pregnancy (28.9 ± 2.0 weeks' gestation), and 6 months postpartum (24.7 ± 1.2 weeks since childbirth). Urine samples were analyzed using liquid chromatography-tandem mass spectrometry and NMR were calculated as Total 3HC/Free COT, Free 3HC/Free COT, and Total 3HC/Total COT. RESULTS: NMR was significantly higher during early and late pregnancy compared to postpartum and significantly increased from early to late pregnancy as measured by Total 3HC/Free COT (0.76, 0.89, 0.60; all p's < .05) and Free 3HC/Free COT (0.68, 0.80, 0.51; all p's < .05). Total 3HC/Total COT did not vary over time (p = .81). CONCLUSIONS: Total 3HC/Free COT and Free 3HC/Free COT increased in the first trimester and continued to increase throughout pregnancy, suggesting a considerable increase in nicotine metabolism over gestation. Future analyses are needed to interpret the changes in NMR in the context of nicotine pharmacokinetics, as well as its impact on changes in smoking behavior and cessation outcomes. IMPLICATIONS: We observed that the NMR was significantly higher as early as 12 weeks' gestation and increased further as a function of gestational age. Among nonpregnant smokers, elevated NMR is associated with smoking phenotypes such as smoking more cigarettes per day and poorer response to nicotine patch; therefore, pregnancy-induced increases in the NMR may contribute to smoking during the first trimester of pregnancy and reducing or quitting smoking may become more challenging as the rate of nicotine metabolism accelerates over the course of pregnancy.

Response to reduced nicotine content cigarettes among smokers differing in tobacco dependence severity.

This study examines whether tobacco dependence severity moderates the acute effects of reducing nicotine content in cigarettes on the addiction potential of smoking, craving/withdrawal, or smoking topography. Participants (N = 169) were daily smokers with mild, moderate, or high tobacco-dependence severity using the Heaviness of Smoking Index. Following brief abstinence, participants smoked research cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg nicotine/g tobacco) in a within-subject design. Results were analyzed using repeated measures analysis of co-variance. No main effects of dependence severity or interactions with nicotine dose were noted in relative reinforcing effects in concurrent choice testing or subjective effects on the modified Cigarette Evaluation Questionnaire. Demand for smoking in the Cigarette Purchase Task was greater among more dependent smokers, but reducing nicotine content decreased demand independent of dependence severity. Dependence severity did not significantly alter response to reduced nicotine content cigarettes on the Minnesota Tobacco Withdrawal Scale nor Questionnaire of Smoking Urges-brief (QSU) Factor-2 scale; dependence severity and dose interacted significantly on the QSU-brief Factor-1 scale, with reductions dependent on dose among highly but not mildly or moderately dependent smokers. Dependence severity and dose interacted significantly on only one of six measures of smoking topography (i.e., maximum flow rate), which increased as dose increased among mildly and moderately but not highly dependent smokers. These results suggest that dependence severity has no moderating influence on the ability of reduced nicotine content cigarettes to lower the addiction potential of smoking, and minimal effects on relief from craving/withdrawal or smoking topography.

Effects of Financial Incentives for Smoking Cessation on Mood and Anxiety Symptoms Among Pregnant and Newly Postpartum Women.

Introduction: Financial incentives for smoking cessation increase smoking abstinence and decrease Beck Depression Inventory (BDI) scores among depression-prone pregnant and postpartum women. The present study is a secondary analysis using the Brief Symptom Inventory (BSI) to examine whether this treatment impacts a broader array of mood and anxiety symptoms. Methods: Participants (N = 253) were pregnant cigarette smokers who participated in four controlled clinical trials examining the efficacy of financial incentives for smoking cessation. Women were assigned to an intervention wherein they earned vouchers exchangeable for retail items contingent on smoking abstinence (Contingent, n = 143) or a control condition wherein they received comparable vouchers independent of smoking status (Noncontingent, n = 110). Participants were categorized as depression-prone (n = 105) or depression-negative (n = 148) based on self-reported history of depression and BDI scores at intake. A prior study demonstrated that financial incentives decreased depressive symptoms among depression-prone women in this sample. The present study examined whether those effects extended to a broader array of mood and anxiety symptoms using the BSI. Effects of treatment, time, and depression status were examined using repeated measures analyses of covariance. Results: In addition to depressive symptoms, financial incentives reduced a multitude of BSI scores among depression-prone women, including the BSI global measure of distress and seven symptom subscales. Treatment effects were discernible by late pregnancy, peaked at 8 weeks postpartum, and dissipated by 24 weeks postpartum. Discussion: In addition to reducing smoking, this financial incentives treatment appears to reduce a range of mood and anxiety symptoms among depression-prone pregnant and postpartum women. Implications: This study adds evidence that providing financial incentives contingent on smoking cessation lowers a broad array of psychiatric symptoms, as measured by the BSI, among depression-prone pregnant and newly postpartum women during a time of heightened risk for peripartum mood disorders.

The Independent Contribution of Uterine Blood Flow to Birth Weight and Body Composition in Smoking Mothers.

OBJECTIVE: This study aims to evaluate the relationship of maternal smoking to uterine artery hemodynamics and examine independent contributions to birth weight and fetal body composition. STUDY DESIGN: Women were enrolled in a prospective randomized controlled study targeting smoking abstinence. Uterine artery Doppler ultrasound was performed and volumetric blood flow was calculated. Third trimester ultrasound estimates of fetal body composition were performed and birth weight was recorded. RESULTS: Uterine artery volumetric flow and resistance index (RI) were significantly correlated with birth weight adjusted for gestational age (R = 0.35, p = 0.002; R = - 0.27, p = 0.02). Volumetric flow was significantly associated with fetal fat mass (R = 0.30, p = 0.018). Smoking status did not have significant effects on lean body mass (t [61] = 0.60, p = 0.55), fat mass (t [61] = 1.67, p = 0.10), or volumetric flow (t = 0.86, df = 87, p = 0.39). Stepwise regression identified volumetric flow (ß = 0.81, 95% confidence interval [CI]: 0.35-1.27, p < 0.001), maternal prepregnancy body mass index (ß = 16.04, 95% CI: 2.57-29.50, p = 0.02), and fetal sex (ß = 346.28, 95% CI: -532.64 to 159.91, p < 0.001, where male = 0 and female = 1) as independent contributors to birth weight adjusted for gestational age. CONCLUSION: No direct relationship of smoking to uterine artery hemodynamics was demonstrated. Volumetric flow was an independent contributor to birth weight and was associated with fetal fat deposition, while smoking was not independently associated with either outcome.

A Randomized Controlled Trial of Brief Intervention by Interactive Voice Response.

AIMS: To determine the effect of an Interactive Voice Response (IVR) brief intervention (BI) to reduce alcohol consumption among adults seeking primary care. METHODS: Patients (N = 1855) with unhealthy drinking were recruited from eight academic internal medicine and family medicine clinics and randomized to IVR-BI (n = 938) versus No IVR-BI control (n = 917). Daily alcohol consumption was assessed at baseline, 3- and 6-months using the Timeline Followback. RESULTS: The IVR-BI was completed by 95% of the 938 patients randomized to that condition, and 62% of them indicated a willingness to consider a change in their drinking. Participants in both conditions significantly reduced consumption over time, but changes were not different between groups. Regardless of condition, participants with alcohol use disorder (AUD) showed significant decreases in drinking outcomes. No significant changes were observed in patients without AUD, regardless of condition. CONCLUSION: Although the IVR intervention was well accepted by patients, there was no evidence that IVR-BI was superior to No IVR-BI for reducing drinking in the subsequent 6 months. Because both the design and the intervention tested were novel, we cannot say definitively why this particular eHealth treatment lacked efficacy. It could be useful to evaluate the effect of the pre-randomization assessment alone on change in drinking. The high treatment engagement rate and successful implementation protocol are strengths, and can be adopted for future trials. SHORT SUMMARY: We examined the efficacy of a novel BI for patient self-administration by automated telephone. Alcohol consumption decreased over time but there were no between-group changes in consumption. Regardless of treatment condition, participants with alcohol use disorder (AUD) showed significant reduction in drinking but participants without AUD showed no change.

A Randomized Controlled Trial of IVR-Based Alcohol Brief Intervention to Promote Patient-Provider Communication in Primary Care.

BACKGROUND: Brief interventions for unhealthy drinking in primary care settings are efficacious, but underutilized. Efforts to improve rates of brief intervention though provider education and office systems redesign have had limited impact. Our novel brief intervention uses interactive voice response (IVR) to provide information and advice directly to unhealthy drinkers before a physician office visit, with the goals of stimulating in-office dialogue about drinking and decreasing unhealthy drinking. This automated approach is potentially scalable for wide application. OBJECTIVE: We aimed to examine the effect of a pre-visit IVR-delivered brief alcohol intervention (IVR-BI) on patient-provider discussions of alcohol during the visit. DESIGN: This was a parallel group randomized controlled trial with two treatment arms: 1) IVR-BI or 2) usual care (no IVR-BI). PARTICIPANTS: In all, 1,567 patients were recruited from eight university medical center-affiliated internal medicine and family medicine clinics. INTERVENTIONS: IVR-BI is a brief alcohol intervention delivered by automated telephone. It has four components, based on the intervention steps outlined in the National Institute of Alcohol Abuse and Alcoholism guidelines for clinicians: 1) ask about alcohol use, 2) assess for alcohol use disorders, 3) advise patient to cut down or quit drinking, and 4) follow up at subsequent visits. MAIN MEASURES: Outcomes were patient reported: patient-provider discussion of alcohol during the visit; patient initiation of the discussion; and provider's recommendation about the patient's alcohol use. KEY RESULTS: Patients randomized to IVR-BI were more likely to have reported discussing alcohol with their provider (52 % vs. 44 %, p = 0.003), bringing up the topic themselves (20 % vs. 12 %, p < 0.001), and receiving a recommendation (20 % vs. 14 %, p < 0.001). Other predictors of outcome included baseline consumption, education, age, and alcohol use disorder diagnosis. CONCLUSIONS: Providing automated brief interventions to patients prior to a primary care visit promotes discussion about unhealthy drinking and increases specific professional advice regarding changing drinking behavior.

A review of the literature on contingency management in the treatment of substance use disorders, 2009-2014.

This report describes a systematic literature review of voucher and related monetary-based contingency management (CM) interventions for substance use disorders (SUDs) over 5.2years (November 2009 through December 2014). Reports were identified using the search engine PubMed, expert consultations, and published bibliographies. For inclusion, reports had to (a) involve monetary-based CM; (b) appear in a peer-reviewed journal; (c) include an experimental comparison condition; (d) describe an original study; (e) assess efficacy using inferential statistics; (f) use a research design allowing treatment effects to be attributed to CM. Sixty-nine reports met inclusion criteria and were categorized into 7 research trends: (1) extending CM to special populations, (2) parametric studies, (3) extending CM to community clinics, (4) combining CM with pharmacotherapies, (5) incorporating technology into CM, (6) investigating longer-term outcomes, (7) using CM as a research tool. The vast majority (59/69, 86%) of studies reported significant (p<0.05) during-treatment effects. Twenty-eight (28/59, 47%) of those studies included at least one follow-up visit after CM was discontinued, with eight (8/28, 29%) reporting significant (p<0.05) effects. Average effect size (Cohen's d) during treatment was 0.62 (95% CI: 0.54, 0.70) and post-treatment it was 0.26 (95% CI: 0.11, 0.41). Overall, the literature on voucher-based CM over the past 5years documents sustained growth, high treatment efficacy, moderate to large effect sizes during treatment that weaken but remain evident following treatment termination, and breadth across a diverse set of SUDs, populations, and settings consistent with and extending results from prior reviews.

Financial incentives for smoking cessation among depression-prone pregnant and newly postpartum women: effects on smoking abstinence and depression ratings.

INTRODUCTION: We examined whether pregnant and newly postpartum smokers at risk for postpartum depression respond to an incentive-based smoking-cessation treatment and how the intervention impacts depression ratings. METHODS: This study is a secondary data analysis. Participants (N = 289; data collected 2001-2013) were smokers at the start of prenatal care who participated in 4 controlled clinical trials on the efficacy of financial incentives for smoking cessation. Women were assigned either to an intervention wherein they earned vouchers exchangeable for retail items contingent on abstaining from smoking or to a control condition wherein they received vouchers of comparable value independent of smoking status. Treatments were provided antepartum through 12-weeks postpartum. Depression ratings (Beck Depression Inventory [BDI]-1A) were examined across 7 antepartum/postpartum assessments. Women who reported a history of prior depression or who had BDI scores ≥ 17 at the start of prenatal care were categorized as depression-prone (Dep+), while those meeting neither criterion were categorized as depression-negative (Dep-). RESULTS: The intervention increased smoking abstinence independent of depression status (p < .001), and it decreased mean postpartum BDI ratings as well as the proportion of women scoring in the clinical range (≥17 and >21) compared with the control treatment (ps ≤ .05). Treatment effects on depression ratings were attributable to changes in Dep+ women. CONCLUSIONS: These results demonstrate that depression-prone pregnant and newly postpartum women respond well to this incentive-based smoking-cessation intervention in terms of achieving abstinence, and the intervention also reduces the severity of postpartum depression ratings in this at-risk population.

Feasibility of automated pre-screening for lifestyle and behavioral health risk factors in primary care.

BACKGROUND: Screening of primary care patients for unhealthy behaviors and mental health issues is recommended by numerous governing bodies internationally, yet evidence suggests that provider-initiated screening is not routine practice. The objective of this study was to implement systematic pre-screening of primary care patients for common preventive health issues on a large scale. METHODS: Patients registered for non-acute visits to one of 40 primary care providers from eight clinics in an Academic Medical Center health care network in the United States from May, 2012 to May, 2014 were contacted one- to three-days prior to their visit. Patients were invited to complete a questionnaire using an Interactive Voice Response (IVR) system. Six items assessed pain, smoking, alcohol use, physical activity, concern about weight, and mood. RESULTS: The acceptance rate among eligible patients reached by phone was 65.6 %, of which 95.5 % completed the IVR-Screen (N = 8,490; mean age 57; 57 % female). Sample demographics were representative of the overall primary care population from which participants were drawn on gender, race, and insurance status, but participants were slightly older and more likely to be married. Eighty-seven percent of patients screened positive on at least one item, and 59 % endorsed multiple problems. The majority of respondents (64.2 %) reported being never or only somewhat physically active. Weight concern was reported by 43.9 % of respondents, 36.4 % met criteria for unhealthy alcohol use, 23.4 % reported current pain, 19.6 % reported low mood, and 9.4 % reported smoking. CONCLUSIONS: The percent endorsement for each behavioral health concern was generally consistent with studies of screening using other methods, and contrasts starkly with the reported low rates of screening and intervention for such concerns in typical PC practice. Results support the feasibility of IVR-based, large-scale pre-appointment behavioral health/ lifestyle risk factor screening of primary care patients. Pre-screening in this population facilitated participation in a controlled trial of brief treatment for unhealthy drinking, and also could be valuable clinically because it allows for case identification and management during routine care.

Effect of occult metastases on survival in node-negative breast cancer.

BACKGROUND: Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking. METHODS: We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension. RESULTS: Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P=0.03), disease-free survival (P=0.02), and distant-disease-free interval (P=0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively. CONCLUSIONS: Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.).

Examining two different schedules of financial incentives for smoking cessation among pregnant women.

OBJECTIVE: To examine whether an efficacious voucher-based incentives intervention for decreasing smoking during pregnancy and increasing fetal growth could be improved without increasing costs. The strategy was to redistribute the usual incentives so that higher values were available early in the quit attempt. METHOD: 118 pregnant smokers in greater Burlington, Vermont (studied December, 2006-June, 2012) were randomly assigned to the revised contingent voucher (RCV) or usual contingent voucher (CV) schedule of abstinence-contingent vouchers, or to a non-contingent voucher (NCV) control condition wherein vouchers were provided independent of smoking status. Smoking status was biochemically verified; serial sonographic estimates of fetal growth were obtained at gestational weeks 30-34. RESULTS: RCV and CV conditions increased point-prevalence abstinence above NCV levels at early (RCV: 40%, CV: 46%, NCV: 13%, p=.007) and late-pregnancy (RCV: 45%; CV: 36%; NCV, 18%; p=.04) assessments, but abstinence levels did not differ between the RCV and CV conditions. The RCV intervention did not increase fetal growth above control levels while the CV condition did so (p<.05). CONCLUSION: This trial further supports the efficacy of CV for increasing antepartum abstinence and fetal growth, but other strategies (e.g., increasing overall incentive values) will be necessary to improve outcomes further.

Maternal body mass index moderates the influence of smoking cessation on breast feeding.

INTRODUCTION: Smoking cessation is associated with greater breast feeding in newly postpartum women, while being overweight or obese is associated with lower rates of breast feeding. The purpose of this study is to examine whether the increases in breast feeding associated with smoking cessation are moderated by maternal body mass index (BMI). To our knowledge, the interaction of maternal smoking status and overweight/obesity on breast feeding has not been previously reported. METHODS: Participants (N = 370) were current or recent smokers at the start of prenatal care who participated in controlled trials on smoking cessation or relapse prevention during/after pregnancy. Study participants were followed from the start of prenatal care through 24 weeks postpartum. Smoking status was biochemically verified, and maternal reports of breast feeding were collected at 2-, 4-, 8-, 12-, and 24-week postpartum assessments. RESULTS: Women who reported postpartum smoking abstinence or had a normal/underweight prepregnancy BMI (<25) were more likely to be breast feeding at the time that smoking status was ascertained (odds ratio [OR] = 3.02, confidence interval [CI] = 2.09-4.36, and OR = 2.07, CI = 1.37-3.12, respectively). However, smoking status and BMI interacted such that (a) normal/underweight women showed a stronger association between smoking abstinence and breast feeding (OR = 4.58, CI = 2.73-7.66) than overweight/obese women (OR = 1.89, CI = 1.11-3.23), and (b) abstainers showed an association between normal/underweight BMI and breast feeding (OR = 3.53, CI = 1.96-6.37), but smokers did not (OR = 1.46, CI = 0.88-2.44). CONCLUSIONS: Overweight/obesity attenuates the positive relationship between smoking abstinence and greater breast feeding among newly postpartum women.

Examining the latent factor structure of a hypothetical cigarette purchase task among pregnant women.

The cigarette purchase task (CPT) is a valid behavioral-economic measure of demand that has smokers estimate hypothetical cigarette consumption under a range of escalating prices. The task involves no experimenter exposure of participants to smoking. CPT demand is measured in terms of five indices: intensity (cigarettes consumed at $0), Omax (largest expenditure), Pmax (price associated with peak expenditure), breakpoint (the first price at which consumption is 0), and elasticity (rate at which consumption changes as a function of increasing price). Out of concern for collinearity, prior studies investigated a more parsimonious CPT latent-factor structure for these derived indices consisting of two factors. The present study examined whether the same two latent-factor solutions extend to pregnant women who smoke. Six hundred sixty-five women completed the CPT as part of recruitment for a clinical trial examining the efficacy of a remote contingency-management intervention to promote smoking cessation during pregnancy. Factor analysis confirmed a two-factor solution to the CPT accounting for 87% of the variance in the five indices with demand intensity and Omax loading onto amplitude and Omax, Pmax, breakpoint, and elasticity loading onto persistence. Backward elimination regression revealed a significant negative relationship between amplitude and persistence (i.e., lower amplitude and persistence scores predicted a higher likelihood of making at least one quit attempt upon learning of pregnancy). These results further support the utility of the CPT for experimentally examining individual differences in smoking among pregnant women in an efficient and ethical manner that does not involve exposing them to cigarette smoke. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Reproducibility of BI-RADS breast density measures among community radiologists: a prospective cohort study.

Using data from the Vermont Breast Cancer Surveillance System (VBCSS), we studied the reproducibility of Breast Imaging Reporting and Data System (BI-RADS) breast density among community radiologists interpreting mammograms in a cohort of 11,755 postmenopausal women. Radiologists interpreting two or more film-screen screening or bilateral diagnostic mammograms for the same woman within a 3- to 24-month period during 1996-2006 were eligible. We observed moderate-to-substantial overall intra-rater agreement for use of BI-RADS breast density in clinical practice, with an overall intra-radiologist percent agreement of 77.2% (95% confidence interval (CI), 74.5-79.5%), an overall simple kappa of 0.58 (95% CI, 0.55-0.61), and an overall weighted kappa of 0.70 (95% CI, 0.68-0.73). Agreement exhibited by individual radiologists varied widely, with intra-radiologist percent agreement ranging from 62.1% to 87.4% and simple kappa ranging from 0.19 to 0.69 across individual radiologists. Our findings underscore the need for additional evaluation of the BI-RADS breast density categorization system in clinical practice.

Trends and costs of stereotactic body radiation therapy in metastatic non-small cell lung cancer.

Background: The purpose of this study is to describe stereotactic body radiation therapy (SBRT) use, outcomes, hospitalizations and costs compared to patients receiving chemotherapy among patients with metastatic non-small cell lung cancer (NSCLC). Methods: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we identified patients aged ≥66 with metastatic NSCLC treated with SBRT as first-line treatment between 2004 and 2014. Multivariable logistic regression identified covariates associated with SBRT. Overall survival (OS) between SBRT and chemotherapy was compared using the Kaplan-Meier estimator and Cox proportional hazards regression. To compare hospitalizations and associated costs, we matched patients treated with SBRT to those with comparable prognostic factors receiving chemotherapy. Results: We identified 215 patients with metastatic NSCLC who received SBRT and 12,486 patients who received chemotherapy as first-line treatment. SBRT use increased from 0.5% to 3% and was associated with older age, female sex, poor disability status, and lower T- and N-stage. OS increased with SBRT, female sex, higher income and decreased with higher Charlson Comorbidity Score ≥2, poor disability status, higher T-stage and higher N-stage. Among a matched sample, SBRT patients underwent fewer hospitalizations vs. chemotherapy patients (73% vs. 81%, P=0.02). Among those hospitalized, SBRT patients incurred higher hospitalization costs ($33,063 vs. $23,865, P<0.001) but costs per month of survival were similar. Conclusions: SBRT is increasing among Medicare patients with metastatic NSCLC. Our findings suggest that SBRT may play a role in management of select metastatic NSCLC patients in addition to standard-of-care chemotherapy.

Breast cancer risk assessment in women aged 70 and older.

Although the benefit of screening mammography for women over 69 has not been established, it is generally agreed that screening recommendations for older women should be individualized based on health status and breast cancer risk. However, statistical models to assess breast cancer risk have not been previously evaluated in this age group. In this study, the original Gail model and three more recent models that include mammographic breast density as a risk factor were applied to a cohort of 19,779 Vermont women aged 70 and older. Women were followed for an average of 7.1 years and 821 developed breast cancer. The predictive accuracy of each risk model was measured by its c-statistic and associations between individual risk factors and breast cancer risk were assessed by Cox regression. C-statistics were 0.54 (95% CI = 0.52-0.56) for the Gail model, 0.54 (95% CI = 0.51-0.56) for the Tice modification of the Gail model, 0.55 (95% CI = 0.53-0.58) for a model developed by Barlow and 0.55 (95% CI = 0.53-0.58) for a Vermont model. These results indicate that the models are not useful for assessing risk in women aged 70 and older. Several risk factors in the models were not significantly associated with outcome in the cohort, while others were significantly related to outcome but had smaller relative risks than estimated by the models. Age-related attenuation of the effects of some risk factors makes the prediction of breast cancer in older women particularly difficult.