Papers by Babalola Faseru
Journal of Thoracic Oncology, 2019
demonstrated that targeting DNA damage response can activate the anti-tumor immunity and potentia... more demonstrated that targeting DNA damage response can activate the anti-tumor immunity and potentiate the response of immune checkpoint blockade antibodies. This talk will review these recent studies, focusing on opportunities and future directions in investigational therapy for patients with small cell lung cancer.
Addictive Behaviors, Mar 1, 2018
Introduction-The prevalence of smoking among people living with HIV/AIDS (PLWHA) remains higher t... more Introduction-The prevalence of smoking among people living with HIV/AIDS (PLWHA) remains higher than the general population. Life expectancy among PLWHA has increased over the past decade, however, PLWHA who smoke will die younger than their non-smoking peers. The primary aim of this pilot study was to examine the effects of warm handoff versus fax referral to the quitline for smoking cessation among hospitalized smokers living with HIV/AIDS. Methods-25 smokers with a diagnosis of HIV/AIDS hospitalized at a Midwestern academic medical center in 2012-2013 (19 male; mean age = 47.7; 48% African-American) were identified, approached, and randomized to one of two treatment arms. At the bedside for patients in warm handoff, staff telephoned the quitline for on-the-spot enrollment and counseling. Participants randomized to fax were fax-referred to the quitline on the day of discharge. The quitline provided continued outpatient counseling to participants in both conditions. The main outcome was verified tobacco abstinence at 6-months post randomization. Results-Enrollment and participation in quitline counseling was high among both warm handoff (100%) and fax-referred (71.4%) PLWHA participants. Nearly all (24) completed follow up for outcome data collection at 6 months. Verified abstinent rates were 45.5% in warm handoff versus 14.3% in fax referral at 6 months (not significant). Conclusions-Hospitalized smokers living with HIV/AIDS were highly engaged in quitline services. Warm handoff seems a promising intervention for hospitalized PLWHA that requires further exploration.
Trials, Aug 14, 2017
Background: Most health care providers do not treat tobacco dependence routinely. This may in par... more Background: Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment "default." Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to "opt in" to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say "yes." This drastically limits the reach of cessation services because, at any given encounter, only one in three smokers say that they are ready to quit. The objective of this study is to determine the impact of providing all smokers with tobacco-cessation treatment unless they refuse it (OPT OUT) versus current practice-screening for readiness and only offering treatment to smokers who say they are ready to quit (OPT IN). Methods: This individually randomized clinical trial is conducted in a tertiary-care hospital. We will conduct the trial among up to 1000 randomly selected hospitalized smokers to determine the population impact of changing the treatment default, identify mediators of outcome, and determine the cost-effectiveness of this new, highly proactive approach. This is a population-based study that targets an endpoint of vital interest; applies minimal eligibility criteria to broaden generalizability; and utilizes hospital staff for interventions to ensure long-term sustainability. The study employs delayed consent and an innovative Bayesian adaptive design to evaluate a major shift in our approach to care. If effective, this change would expand the reach of tobacco-cessation treatment from 30% to 100% of smokers. Discussion: Regardless of outcome, the trial will provide a model of how to alter and evaluate the impact of health care defaults. If OPT OUT proves to be more effective, it will expand the population eligible for cessation treatment by over 300%. It will also simplify the tobacco-cessation treatment algorithm, and relieve busy health care providers of the burden of evaluating readiness to quit.
Addictive Behaviors, Mar 1, 2013
BackgroundThis is the first study to examine predictors of successful cessation in African Americ... more BackgroundThis is the first study to examine predictors of successful cessation in African American (AA) light smokers treated within a placebo-controlled trial of bupropion.MethodsWe analyzed data from a randomized, double-blind, placebo-controlled trial of bupropion and health education for 540 African American light smokers. African American light smokers (≤ 10 cigarettes per day, cpd) were randomly assigned to receive 150mg bid bupropion SR (n=270) or placebo (n=270) for 7 weeks. All participants received health education counseling at Weeks 0, 1, 3, 5 and 7. Using chi-square tests, two sample t-tests, and multiple logistic regression analyses, we examined baseline psychosocial and smoking characteristics as predictors of cotinine-verified 7-day point prevalence smoking abstinence among study participants at the end treatment (week 7) and at the end of follow up (week 26).ResultsParticipants who received bupropion were significantly more likely to quit smoking compared to those who received placebo (OR = 2.72, 95% CI = 1.60–4.62, P = 0.0002). Greater study session attendance (OR = 2.47, 95% CI = 1.76–3.46, P = 0.0001), and smoking non-menthol cigarettes increased the likelihood of quitting (OR = 1.84, 95% CI = 1.01–3.36, P = 0.05); while longer years of smoking (OR = 0.98, 95% CI = 0.96–1.00, P = 0.05) and higher baseline cotinine (OR = 0.97, 95% CI = 0.95–0.99, P = 0.002) significantly reduced the odds of quitting at Week 7. Conversely, at the end of follow-up (week 26), treatment with bupropion vs. placebo (OR =1.14, 95% CI = 0.65–2.02, P = 0.64) was not significantly associated with quitting and type of cigarette smoked (menthol vs. non-menthol) did not appear in the final logistic regression model. Greater study session attendance (OR = 1.96, 95% CI = 1.44–2.66, P = 0.0001); BMI (OR = 1.03, 95% CI = 1.00–1.07, P = 0.04); and weight efficacy (OR = 1.03, 95% CI = 1.01–1.05, P = 0.01) increased the likelihood of quitting at Week 26. Similar to our findings at Week 7, longer years of smoking (OR = 0.96, 95% CI = 0.94–0.99, P = 0.01) and higher baseline cotinine (OR = 0.97, 95% CI = 0.95–0.99, P = 0.02) significantly reduced the odds of quitting at Week 26.ConclusionsBaseline cotinine levels, number of years smoked and study session attendance are associated with both short- and long-term smoking cessation, while bupropion and the type of cigarette smoked were associated with quitting on short term only.
Journal of Biopharmaceutical Statistics, Jul 7, 2023
Annals of Behavioral Medicine, Jun 4, 2013
Background-African Americans are at risk for inadequate adherence to smoking cessation treatment ... more Background-African Americans are at risk for inadequate adherence to smoking cessation treatment yet little is known about what leads to treatment discontinuation. Purpose-Examine the factors associated with discontinuation of treatment in African American light smokers (≤10 cigarettes per day). Methods-Bupropion plasma levels and counseling attendance were measured among 540 African American light smokers in a placebo-controlled randomized trial of bupropion. Results-By Week 3, 28.0% of subjects in the bupropion arm had discontinued bupropion and only moderate associations were found between plasma levels and self-reported bupropion use (r s =0.38). By Week 16, 36.9% of all subjects had discontinued counseling. Males had greater odds of discontinuing medication (OR=2.02, 95% CI, 1.10-3.71, p=0.02) and older adults had lower odds of discontinuing counseling (OR=0.96, 95% CI, 0.94-0.97, p<0.0001).
Clinical Pharmacology & Therapeutics, Nov 14, 2012
Bupropion is indicated to promote smoking cessation. Animal studies suggest that bupropion's majo... more Bupropion is indicated to promote smoking cessation. Animal studies suggest that bupropion's major metabolite hydroxybupropion can mediate bupropion's pharmacologic activity. We measured plasma bupropion and metabolite levels in a double-blind, placebo controlled, randomized smoking cessation trial. Among the treatment adherent individuals, higher hydroxybupropion concentrations (per µg/mL) resulted in better smoking cessation outcomes (Week 3, 7 and 26 OR=2.82, 2.96 and 2.37, P=0.005-0.040), this was not observed with bupropion levels (OR=1.00-1.03, P=0.59-0.90). Genetic variation in CYP2B6, the enzyme that metabolizes bupropion to hydroxybupropion, was identified as a significant source of variability in hydroxybupropion formation. Our data indicate that hydroxybupropion contributes to the pharmacologic effects of bupropion for smoking cessation, and that variability in response to bupropion treatment is related to variability in CYP2B6-mediated hydroxybupropion formation. These findings suggest dosing bupropion to achieve a hydroxybupropion level of 0.7 µg/ml or increasing bupropion dose for CYP2B6 slow metabolizers, could improve bupropion's cessation outcomes.
Journal of Immigrant and Minority Health, Nov 3, 2012
African immigrant and refugee communities remain medically underserved in the United States. Form... more African immigrant and refugee communities remain medically underserved in the United States. Formative efforts are being directed to address the local needs of communities by researchers, community agencies, and local populations. However, there is a paucity of data and sparse documentation regarding these efforts. The objectives for this pilot study were to identify the health priorities of the Kansas City Somali community and to establish a working relationship between an academic medical university and the local Somali community. Our team used community-based participatory research principles and interviewed Somali community members (n = 11). Participants stated that chronic and mental health conditions were of primary concern. Medical system navigation and literacy struggles were identified as barriers. Participants offered possible solutions to some health issues, e.g., using community health workers and Qur&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;anic readers. Preliminary findings will help guide future research and inform strategies to improve the health and well-being of this community.
American Journal of Preventive Medicine, Oct 1, 2016
Introduction-Few hospitals treat patients' tobacco dependence. To be effective, hospitalinitiated... more Introduction-Few hospitals treat patients' tobacco dependence. To be effective, hospitalinitiated cessation interventions must provide at least 1 month of supportive contact postdischarge. Study design-Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015. Setting/participants-The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish. Intervention-Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge. Main outcome measures-Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness.
Addictive Behaviors, Dec 1, 2011
Background-Smoking menthol cigarettes is more prevalent among African Americans (AA) compared to ... more Background-Smoking menthol cigarettes is more prevalent among African Americans (AA) compared to Whites. Menthol has been found to be inversely related to smoking cessation among AA, yet little is known about the factors associated with menthol smoking among AA light smokers. This study examines baseline demographic, psychological, and smoking factors associated with smoking menthol cigarettes among AA light smokers (≤10 cigarettes per day). Methods-Participants (n=540) were enrolled in a double blind, placebo-controlled randomized trial of bupropion in combination with health education counseling for smoking cessation. Bivariate differences between menthol and non-menthol smokers were explored and baseline factors associated with smoking menthol cigarettes were identified. Results-Participants averaged 46.5 years in age, predominantly female (66.1%), and smoked an average of 8.0 cpd (SD=2.5). The majority (83.7%) smoked menthol cigarettes. In bivariate analysis, menthol cigarette smokers were younger (mean age: 45 vs. 52 years p<0.0001), were more likely to be female (68% vs. 52% p=0.003) and had smoked for shorter duration (28 vs. 34 years p<0.0001) compared to non-menthol smokers. While depression and withdrawal scores were slightly higher and exhaled carbon monoxide values were lower among menthol smokers, the differences were not statistically significant. Conclusions-Among AA light smokers, younger individuals and females were more likely to smoke menthol cigarettes and may be more susceptible to the health effects of smoking.
Addiction Science & Clinical Practice, Oct 1, 2012
Journal of smoking cessation, Mar 26, 2014
Introduction-Despite smoking fewer cigarettes per day, African American smokers have greater diff... more Introduction-Despite smoking fewer cigarettes per day, African American smokers have greater difficulty quitting compared to Caucasian smokers. Further elucidating the impact of smoking motivations on smoking behavior would contribute to understanding the factors that maintain smoking. Aims-This study examined the factor structure of a brief assessment examining smoking dependence motives among a sample of African American light smokers Methods-Data from a double-blind, placebo-controlled randomized smoking cessation trial involving 540 participants. Results were analyzed using an exploratory factor analysis (EFA) and a randomly split EFA. Results/Findings-Findings from the initial EFA analysis produced an 8-factor model, explaining 69% of the variation in responses. The overall Measure of Sampling Adequacy (MSA) was 0.88 with item level MSA ranging 0.68-0.94 across the 30 items. Results from the randomly
Patient Preference and Adherence, Sep 1, 2011
Background: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to be... more Background: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials. Objectives: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy. Research design: Secondary data analysis of a randomized pilot study. Participants: 46 moderate-to-heavy (.10 cigarettes per day) African-American smokers. Main measures: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded. Results: Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% , $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (r s = 0.94, P , 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P , 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P , 0.0004) than participants with matching phone and in-person counts (n = 39). Conclusion: Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy.
BMC Medical Research Methodology, Jan 19, 2010
Background: African-Americans remain underrepresented in clinical research despite experiencing a... more Background: African-Americans remain underrepresented in clinical research despite experiencing a higher burden of disease compared to all other ethnic groups in the United States. The purpose of this article is to describe the study design and discuss strategies used to recruit and retain African-American smokers in a pharmacokinetic study. Methods: The parent study was designed to evaluate the differences in the steady-state concentrations of bupropion and its three principal metabolites between African-American menthol and non-menthol cigarette smokers. Study participation consisted of four visits at a General Clinical Research Center (GCRC) over six weeks. After meeting telephone eligibility requirements, phone-eligible participants underwent additional screening during the first two GCRC visits. The last two visits (pharmacokinetic study phase) required repeated blood draws using an intravenous catheter over the course of 12 hours. Results: Five hundred and fifteen African-American smokers completed telephone screening; 187 were phoneeligible and 92 were scheduled for the first GCRC visit. Of the 81 who attended the first visit, 48 individuals were enrolled in the pharmacokinetic study, and a total of 40 individuals completed the study (83% retention rate). Conclusions: Although recruitment of African-American smokers into a non-treatment, pharmacokinetic study poses challenges, retention is feasible. The results provide valuable information for investigators embarking on nontreatment laboratory-based studies among minority populations.
Trials, Jan 25, 2011
Background: African Americans experience significant tobacco-related health disparities despite t... more Background: African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤10 cigarettes per day). African Americans have been under-represented in smoking cessation research, and few studies have evaluated treatment for light smokers. This paper describes the study design, measures, and baseline characteristics from Kick It at Swope III (KIS-III), the first treatment study of bupropion for African American light smokers. Methods: Five hundred forty African American light smokers were randomly assigned to receive bupropion (150mg bid) (n = 270) or placebo (n = 270) for 7 weeks. All participants received written materials and health education counseling. Participants responded to survey items and provided blood samples for evaluation of phenotype and genotype of CYP2A6 and CYP2B6 enzymes involved in nicotine and bupropion metabolism. Primary outcome was cotinine-verified 7-day point prevalence smoking abstinence at Week 26 follow-up. Results: Of 2,628 individuals screened, 540 were eligible, consented, and randomized to treatment. Participants had a mean age of 46.5 years and 66.1% were women. Participants smoked an average of 8.0 cigarettes per day, had a mean exhaled carbon monoxide of 16.4ppm (range 1-55) and a mean serum cotinine of 275.8ng/ml. The mean Fagerström Test for Nicotine Dependence was 3.2, and 72.2% of participants smoked within 30 minutes of waking. The average number of quit attempts in the past year was 3.7 and 24.2% reported using pharmacotherapy in their most recent quit attempt. Motivation and confidence to quit were high. Conclusion: KIS-III is the first study designed to examine both nicotine and bupropion metabolism, evaluating CYP2A6 and CYP2B6 phenotype and genotype in conjunction with psychosocial factors, in the context of treatment of African American light smokers. Of 1629 smokers screened for study participation, only 18 (1.1%) were ineligible to participate in the study because they refused blood draws, demonstrating the feasibility of recruiting and enrolling African American light smokers into a clinical treatment trial involving biological data collection and genetic analyses. Future evaluation of individual factors associated with treatment outcome will contribute to advancing tailored tobacco use treatment with the goal of enhancing treatment and reducing health disparities for African American light smokers. Trial Registration: ClinicalTrials.gov: NCT00666978
JAMA Internal Medicine
ImportanceTobacco use causes 7 million deaths per year; most national guidelines require people w... more ImportanceTobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries.ObjectiveTo evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco.Design, Setting, and ParticipantsIn Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021.InterventionsAt bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medica...
Cancer Epidemiology, Biomarkers & Prevention
Background: Food insecurity (FI) has been associated with poor access to health care. It is uncle... more Background: Food insecurity (FI) has been associated with poor access to health care. It is unclear whether this association is beyond that predicted by income, education, and health insurance. FI may serve as a target for intervention given the many programs designed to ameliorate FI. We examined the association of FI with being up-to-date to colorectal cancer and breast cancer screening guidelines. Methods: Nine NCI-designated cancer centers surveyed adults in their catchment areas using demographic items and a two-item FI questionnaire. For the colorectal cancer screening sample (n = 4,816), adults ages 50–75 years who reported having a stool test in the past year or a colonoscopy in the past 10 years were considered up-to-date. For the breast cancer screening sample (n = 2,449), female participants ages 50–74 years who reported having a mammogram in the past 2 years were up-to-date. We used logistic regression to examine the association between colorectal cancer or breast cancer...
Substance Abuse
Background: In the U.S., excessive drinking accounts for one in 10 deaths among adults aged 20-64... more Background: In the U.S., excessive drinking accounts for one in 10 deaths among adults aged 20-64 years old. Binge drinking is a common form of excessive alcohol consumption that contributes to this chilling statistic. Binge drinking is defined as women consuming four or more drinks or men consuming five or more drinks within a 2-h time span. Examining existing data on risk factors for binge drinking can inform strategies to prevent this deadly practice. Methods: The 2019 Kansas Behavioral Risk Factor Surveillance System (BRFSS) dataset consists of data collected from 11,368 non-institutionalized adults aged 18 years and older with landline or cell phones. The dependent variable in this study was binge drinking status. The independent variables included several sociodemographic variables and risk factors. Data were analyzed using descriptive statistics, bivariate analysis, single logistic regression, and multivariable logistic regression. Results: In the population, 1,447 (17.4%) were reported to be binge drinkers. Significant factors associated with binge drinking in the final model included sex (aOR = 0.53 (0.45-0.63)), age (18-24 years old aOR = 8.77 (6.02-12.79); 25-34 years old aOR = 7.10 (5.35-9.42); 35-44 years old aOR = 6.23 (4.73-8.19); 45-54 years old aOR = 3.87 (2.92-5.14); and 55-64 years old aOR = 2.58 (1.96-3.38)), income ($15,000-$24,999 aOR = 1.00 (0.63-1.58); $25,000-$34,999 aOR = 1.61 (1.04-2.50); $35,000-$49,999 aOR = 1.69 (1.13-2.55); ≥$50,000 aOR = 1.97 (1.34-2.89)), smokeless tobacco use (aOR = 2.09 (1.55-2.82)), and smoking/e-cigarette use (Cigarette user only aOR = 2.11 (1.69-2.65); E-cigarette user only aOR = 2.67 (1.62-3.17); dual cigarette and e-cigarette user = 3.43 (2.21-5.33)). Conclusion: Developing interventions that take into account elevated risk for binge drinking amongst demographic characteristics (i.e., age, sex, income) and lifestyle factors (i.e., smokeless tobacco use, and smoking/e-cigarette use) is crucial to lowering morbidity and mortality related to this form of excessive alcohol consumption.
Cancer Epidemiology, Biomarkers & Prevention, 2022
Background: Rural populations experience a disproportionate cancer burden relative to urban popul... more Background: Rural populations experience a disproportionate cancer burden relative to urban populations. One possibility is that rural populations are more likely to hold counterproductive cancer beliefs such as fatalism and information overload that undermine prevention and screening behaviors. Methods: Between 2016 and 2020, 12 U.S. cancer centers surveyed adults in their service areas using online and in-person survey instruments. Participants (N = 10,362) were designated as rural (n = 3,821) or urban (n = 6,541). All participants were 18 and older (M = 56.97, SD = 16.55), predominately non-Hispanic White (81%), and female (57%). Participants completed three items measuring cancer fatalism (“It seems like everything causes cancer,” “There's not much you can do to lower your chances of getting cancer,” and “When I think about cancer, I automatically think about death”) and one item measuring cancer information overload (“There are so many different recommendations about preven...
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Papers by Babalola Faseru