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Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial

Stevens, Elizabeth R; Lei, Lei; Cleland, Charles M; Vojjala, Mahathi; El-Shahawy, Omar; Berger, Kenneth I; Kirchner, Thomas R; Sherman, Scott E
BACKGROUND:Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD. METHODS:In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms. DISCUSSION/CONCLUSIONS:Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke. Trial Registration ClinicalTrials.gov Identifier: NCT04465318.
PMCID:8734340
PMID: 34991693
ISSN: 1940-0640
CID: 5107362

Understanding Racial and Ethnic Differences in Switching from Combustible Cigarettes to E-Cigarettes in COPD Patients [Meeting Abstract]

Bonafont, Reyes B V; Stevens, E; Nicholson, A; Lei, L; Vojjala, M; Sherman, S
Background: Electronic cigarettes (EC) have been proposed as a harm-reducing alternative in smokers with COPD. Racial and ethnic differences can affect the extent to which smokers in the general population switch from combustible cigarettes (CC) to EC. To help design a targeted intervention for smokers with COPD, we conducted a mixed methods study assessing the relationship between race/ethnicity and switching from CC to EC; and evaluated whether it is mediated by social norms, risk perception, and overall opinions of CC and EC.
Method(s): We recruited patients with COPD, aged 21 to 75, listed as current smokers in the NYU Langone Health electronic health record by phone, mail, and My Chart. Smokers who had moderate COPD (based on the COPD Assessment Test score (CAT)), who smoked >=5 CC a day at least 4 days a week and were interested in quitting were eligible. We randomized participants to EC or nicotine replacement therapy (NRT) for switching from CC. Over 12 weeks, participants received 5 counseling sessions and were asked about their COPD symptoms, CC use, NRT/EC use, and nicotine withdrawal symptoms. We used Ecological Momentary Assessment (four text messages/day) to assess current EC/NRT and CC use. We analyzed the influence of race and ethnicity on switching, considering social norms, risk perception, media influence and overall opinions of tobacco and EC as possible mediators. We conducted in-depth interviews to gain descriptive explanations of study experience and reasons for switching or lack thereof. We used chi squared tests to compare categorical variables and analysis of variance for continuous ones.
Result(s): Among the 48 participants, the average age was 60 (STD 8.2) years and 54% were female. Races/ethnicities were 8% Black; 8% Hispanic/Latino; 81% White; and 3% Other/Not Reported. There was a trend towards decreased dyspnea and COPD symptoms, as well as decreased CC use, in the EC arm compared to the NRT arm. We are still collecting the qualitative data on switching perceptions.
Conclusion(s): Understanding the extent to which racial and ethnic differences in switching from CC to EC can be attributed to social norms, risk perception, media influence, and overall opinions of tobacco and EC; may allow us to design a more effective, more engaging smoking cessation intervention
EMBASE:637954635
ISSN: 1531-5487
CID: 5252392

Exclusive and Dual Cigarette and Hookah Smoking Is Associated with Adverse Perinatal Outcomes among Pregnant Women in Cairo, Egypt

El-Shahawy, Omar; Labib, Kareem; Stevens, Elizabeth; Kahn, Linda G; Anwar, Wagida; Oncken, Cheryl; Loney, Tom; Sherman, Scott E; Mead-Morse, Erin L
This study assessed the prevalence of prenatal smoking, factors associated with prenatal smoking, and its association with birth outcomes in a sample of pregnant women in Egypt. Pregnant women were recruited during their last trimester from antenatal clinics in Cairo from June 2015 to May 2016. Participants completed an interviewer-administered survey that assessed tobacco use and attitudes, and exhaled carbon monoxide (CO) was measured. Gestational age at delivery and offspring birth weight were collected via a postnatal phone interview. Two hundred pregnant women ages 16-37 years participated. More than a quarter (29.0%) of women reported smoking (cigarettes, hookah, or both) during their current pregnancy, and hookah was more popular than cigarettes. Most women who smoked prior to their current pregnancy either maintained their current smoking habits (46.6%) or switched from dual to hookah-only smoking (46.6%). Current smokers during pregnancy had a higher mean (±SD) exhaled CO level (2.97 ± 1.45 vs. 0.25 ± 0.60 ppm, p < 0.001) and had babies with a lower mean birth weight (2583 ± 300 vs. 2991 ± 478 g, p < 0.001) than non-smokers. Smokers during pregnancy had greater odds of premature birth and/or low birth weight babies compared to non-smokers. Dual cigarette-hookah smokers had the highest risk. Additional focused programs are required to prevent women of childbearing age from initiating tobacco use and empower women to stop tobacco use during the preconception and gestational periods.
PMID: 34948585
ISSN: 1660-4601
CID: 5090792

Rounding up the usual suspects: confirmation bias in epidemiological research

Braithwaite, R Scott; Ban, Kaoon Francois; Stevens, Elizabeth R; Caniglia, Ellen C
PMID: 33928375
ISSN: 1464-3685
CID: 4873822

The Influence of Community and Leadership Support on Implementation Research Behaviors

Stevens, Elizabeth R
ORIGINAL:0016522
ISSN: 2662-9275
CID: 5428842

Barriers to engagement in implementation science research: a national survey

Stevens, Elizabeth R; Shelley, Donna; Boden-Albala, Bernadette
Low levels of engagement in implementation science (IS) among health researchers is a multifaceted issue. With the aim of guiding efforts to increase engagement in IS research, we sought to identify barriers to engagement in IS within the health research community. We performed an online survey of health researchers in the United States in 2018. Basic science researchers were excluded from the sample. IS engagement was measured by self-reported conduct of or collaboration on an IS study in the past 5 years. Potential barriers tested were (a) knowledge and awareness of IS, (b) attitudes about IS research, (c) career benefits of IS, (d) research community support, and (e) research leadership support. We performed simple logistic regressions and tested multivariable logistic regression models of researcher characteristics and potential barriers as predictors of IS engagement. Of the 1,767 health researchers, 49.7% indicated they engaged in an implementation study. Being able to define IS (aOR 3.42, 95%CI 2.68-4.36, p < .001) and having attended IS training (aOR 3.77, 95%CI 2.96-4.81, p < .001) were associated with engaging in IS research. Among other potential barriers tested, perceptions that engaging in IS would not be good for their career (aOR 0.29, 95%CI 0.2-0.41, p < .001) was strongly associated with decreased engagement in IS research. Efforts to increase researcher familiarity with IS methods and foster support for IS within research communities, along with decreasing barriers to funding and publishing, are likely to be most effective for increasing engagement in IS research.
PMID: 31958137
ISSN: 1613-9860
CID: 4273762

Does Reducing Drinking in Patients with Unhealthy Alcohol Use Improve Pain Interference, Use of Other Substances, and Psychiatric Symptoms?

Caniglia, Ellen C; Stevens, Elizabeth R; Khan, Maria; Young, Kailyn E; Ban, Kaoon; Marshall, Brandon D L; Chichetto, Natalie E; Gaither, Julie R; Crystal, Stephen; Edelman, Eva Jennifer; Fiellin, David A; Gordon, Adam J; Bryant, Kendall J; Tate, Janet; Justice, Amy C; Braithwaite, Ronald Scott
BACKGROUND:We aimed to investigate the impact of reducing drinking in patients with unhealthy alcohol use on improvement of chronic pain interference, substance use, and psychiatric symptoms. METHODS:We analyzed longitudinal data from 2003 to 2015 in the Veterans Aging Cohort Study, a prospective, multisite observational study of US veterans, by emulating a hypothetical randomized trial (a target trial). Alcohol use was assessed using the AUDIT questionnaire, and outcome conditions were assessed via validated survey items. Individuals were followed from the first time their AUDIT score was ≥ 8 (baseline), a threshold consistent with unhealthy alcohol use. We compared individuals who reduced drinking (AUDIT < 8) at the next follow-up visit with individuals who did not (AUDIT ≥ 8). We fit separate logistic regression models to estimate odds ratios for improvement of each condition 2 years postbaseline among individuals who had that condition at baseline: moderate or severe pain interference symptoms, tobacco smoking, cannabis use, cocaine use, depressive symptoms, and anxiety symptoms. Inverse probability weighting was used to account for potential selection bias and confounding. RESULTS:Adjusted 2-year odds ratios (95% confidence intervals) for associations between reducing drinking and improvement or resolution of each condition were as follows: 1.49 (0.91, 2.42) for pain interference symptoms, 1.57 (0.93, 2.63) for tobacco smoking, 1.65 (0.92, 2.95) for cannabis use, 1.83 (1.03, 3.27) for cocaine use, 1.11 (0.64, 1.92) for depressive symptoms, and 1.33 (0.80, 2.22) for anxiety symptoms. CONCLUSIONS:We found some evidence for improvement of pain interference symptoms and substance use after reducing drinking among US veterans with unhealthy alcohol use, but confidence intervals were wide.
PMID: 33030753
ISSN: 1530-0277
CID: 4627062

Cost-effectiveness of direct anti-viral agents for hepatitis C virus infection and a combined intervention of syringe access and medication assisted therapy for opioid use disorders in an injection drug use population

Stevens, Elizabeth R; Nucifora, Kimberly A; Hagan, Holly; Jordan, Ashly E; Uyei, Jennifer; Khan, Bilal; Dombrowski, Kirk; des Jarlais, Don; Braithwaite, R Scott
BACKGROUND:There are too many plausible permutations and scale-up scenarios of combination hepatitis C (HCV) interventions for exhaustive testing in experimental trials. Therefore, we used computer simulation to project the health and economic impact of alternative combination intervention scenarios for people who inject drugs (PWID), focusing on direct anti-viral agents (DAA) and medication-assisted treatment combined with syringe access programs (MAT+). METHODS:We performed an allocative efficiency study using a mathematical model simulating the progression of HCV in PWID and its related consequences. Two previously validated simulations were combined to estimate the cost-effectiveness of intervention strategies that included a range of coverage levels. Analyses were performed from a health sector and societal perspective with a 15-year time horizon and a discount rate of 3%. RESULTS:From a health-sector perspective (excluding criminal justice system-related costs), four potential strategies fell on the cost-efficiency frontier. DAA at 20% coverage had an ICER of $27,251/QALY. Combinations of DAA 20% with MAT+ at 20%, 40%, and 80% coverage had ICERs of $165,985/QALY, $325,860/QALY, and $399,189/QALY, respectively. When analyzed from a societal perspective (including criminal justice system-related costs), DAA 20% with MAT+ 80% was most effective and was cost saving. While DAA 20% with MAT+ 80% was more expensive (e.g., less cost-saving) than MAT+ 80% alone without DAA, it offered favorable value compared to MAT+ 80% alone ($23,932/QALY). CONCLUSION/CONCLUSIONS:When considering health sector costs alone, DAA alone was the most cost-effective intervention. However, with criminal justice system-related costs, DAA and MAT+ implemented together become the most cost-effective interventions.
PMID: 31400755
ISSN: 1537-6591
CID: 4034552

Association of Alcohol Screening Scores With Adverse Mental Health Conditions and Substance Use Among US Adults

Khan, Maria R; Young, Kailyn E; Caniglia, Ellen C; Fiellin, David A; Maisto, Stephen A; Marshall, Brandon D L; Edelman, E Jennifer; Gaither, Julie R; Chichetto, Natalie E; Tate, Janet; Bryant, Kendall J; Severe, MacRegga; Stevens, Elizabeth R; Justice, Amy; Braithwaite, Scott R
Importance/UNASSIGNED:Alcohol screening may be associated with health outcomes that cluster with alcohol use (ie, alcohol-clustering conditions), including depression, anxiety, and use of tobacco, marijuana, and illicit drugs. Objective/UNASSIGNED:To quantify the extent to which alcohol screening provides additional information regarding alcohol-clustering conditions and to compare 2 alcohol use screening tools commonly used for this purpose. Design, Setting, and Participants/UNASSIGNED:This longitudinal cohort study used data from the Veterans Aging Cohort Study. Data were collected at 8 Veterans Health Administration facilities from 2003 through 2012. A total of 7510 participants were enrolled, completed a baseline survey, and were followed up. Veterans with HIV were matched with controls without HIV by age, race, sex, and site of care. Data were analyzed from January 2019 to December 2019. Exposures/UNASSIGNED:The Alcohol Use Disorders Identification Test (AUDIT) and Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) were used to assess alcohol use, with 4 risk groups delineated for each test: score 0 to 7 (reference), score 8 to 15, score 16 to 19, and score 20 to 40 (maximum score) for the full AUDIT and score 0 to 3 (reference), score 4 to 5, score 6 to 7, and score 8 to 12 (maximum score) for the AUDIT-C. Main Outcomes and Measures/UNASSIGNED:Alcohol-clustering conditions, including self-reported symptoms of depression and anxiety and use of tobacco, marijuana, cocaine, other stimulants, opioids, and injection drugs. Results/UNASSIGNED:A total of 6431 US patients (6104 [95%] men; median age during survey years 2003-2004, 50 years [range, 28-86 years; interquartile range, 44-55 years]) receiving care in the Veterans Health Administration completed 1 or more follow-up surveys when the AUDIT was administered and were included in the present analyses. Of the male participants, 4271 (66%) were African American, 1498 (24%) were white, and 590 (9%) were Hispanic. The AUDIT and AUDIT-C scores were associated with each alcohol-clustering condition. In particular, an AUDIT score of 20 or higher (vs <8, the reference) was associated with symptoms of depression (odds ratio [OR], 8.37; 95% CI, 6.20-11.29) and anxiety (OR, 8.98; 95% CI, 6.39-12.60) and with self-reported use of tobacco (OR, 14.64; 95% CI, 8.94-23.98), marijuana (OR, 12.41; 95% CI, 8.61-17.90), crack or cocaine (OR, 39.47; 95% CI, 27.38-56.90), other stimulants (OR, 21.31; 95% CI, 12.73-35.67), and injection drugs (OR, 8.67; 95% CI, 5.32-14.13). An AUDIT score of 20 or higher yielded likelihood ratio (sensitivity / 1 - specificity) values greater than 3.5 for depression, anxiety, crack or cocaine use, and other stimulant use. Associations between AUDIT-C scores and alcohol-clustering conditions were more modest. Conclusions and Relevance/UNASSIGNED:Alcohol screening can inform decisions about further screening and diagnostic assessment for alcohol-clustering conditions, particularly for depression, anxiety, crack or cocaine use, and other stimulant use. Future studies using clinical diagnoses rather than screening tools to assess alcohol-clustering conditions may be warranted.
PMID: 32163167
ISSN: 2574-3805
CID: 4349832

Insights Provided by Depression Screening Regarding Pain, Anxiety, and Substance use in a Veteran Population

Stevens, Elizabeth R; Mazumdar, Medha; Caniglia, Ellen C; Khan, Maria R; Young, Kailyn E; Edelman, E Jennifer; Gordon, Adam J; Fiellin, David A; Maisto, Stephen A; Chichetto, Natalie E; Crystal, Stephan; Gaither, Julie R; Justice, Amy C; Braithwaite, R Scott
OBJECTIVE/UNASSIGNED:We sought to quantify the extent to which a depression screening instrument commonly used in primary care settings provides additional information regarding pain interference symptoms, anxiety, and substance use. METHODS/UNASSIGNED:Veterans Aging Cohort Study (VACS) data collected from 2003 through 2015 was used to calculate odds ratios (OR) for associations between positive depression screening result cutoffs and clustering conditions. We assessed the test performance characteristics (likelihood ratio value, positive predictive value, and the percentage of individuals correctly classified) of a positive Patient Health Questionnaire (PHQ-9 & PHQ-2) depression screen for the identification of pain interference symptoms, anxiety, and substance use. RESULTS/UNASSIGNED:A total 7731 participants were included in the analyses. The median age was 50 years. The PHQ-9 threshold of ≥20 was strongly associated with pain interference symptoms (OR 21.6, 95% CI 17.5-26.7) and anxiety (OR 72.1, 95% CI 52.8-99.0) and yielded likelihood ratio values of 7.5 for pain interference symptoms and 21.8 for anxiety and positive predictive values (PPV) of 84% and 95%, respectively. A PHQ-9 score of ≥10 still showed significant associations with pain interference symptoms (OR 6.1, 95% CI 5.4-6.9) and symptoms of anxiety (OR 11.3, 95% CI 9.7-13.1) and yet yielded lower likelihood ratio values (4.36 & 8.24, respectively). The PHQ-9 was less strongly associated with various forms of substance use. CONCLUSION/UNASSIGNED:Depression screening provides substantial additional information regarding the likelihood of pain interference symptoms and anxiety and should trigger diagnostic assessments for these other conditions.
PMCID:7418233
PMID: 32772883
ISSN: 2150-1327
CID: 4576332