Ivana Croghan | Mayo Clinic Graduate School (original) (raw)

Papers by Ivana Croghan

Research paper thumbnail of Developing a clinical trial unit to advance research in an academic institution

Contemporary clinical trials, Jan 7, 2015

Research, clinical care, and education are the three cornerstones of academic health centers in t... more Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trials unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine Clinical Trials Unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a centra...

Research paper thumbnail of Stress, Resilience, and Coping of Healthcare Workers during the COVID-19 Pandemic

Journal of Primary Care & Community Health

Objective To estimate the health care workers (HCWs) self-reported stress, resilience, and coping... more Objective To estimate the health care workers (HCWs) self-reported stress, resilience, and coping during the COVID-19 pandemic, and to determine inter-professional differences. Participants and Methods An email survey was sent to 474 HCW at a Midwestern HealthCare facility between April 9, 2020 and April 30, 2020. A total of 311 (65.6%) responses were received by May 31, 2020. The survey utilized 3 validated instruments: Perceived Stress Scale (PSS), Brief Resilience Scale (BRS), Brief Resilience Coping Scale (BRCS). Results Of the 311 responses, 302 were evaluated: 97 from nonmedical staff with patient contact (NMPC); 86 from nonmedical staff with no patient contact (NMNPC); 62 from medical doctors (MD), physician assistants (PA) and nurse practitioners (NP); and 57 from nurses. Significant differences were noted across job categories for stress and resilience, with nurses reporting highest PSS scores (effect estimates: −2.72, P = .009 for NMNPC; −2.50, P = .015 for NMPC; −3.21, P ...

Research paper thumbnail of Assessing vitamin D and mammographic breast density in Alaskan women

Clinics and Practice

Vitamin D deficiency and high breast density may be associated with increased breast cancer risk.... more Vitamin D deficiency and high breast density may be associated with increased breast cancer risk. We examined a possible association between vitamin D levels and mammographic breast density in a population of Alaskan women. Patients seen in the Mayo Clinic-Alaska Native Medical Center telemedicine program from December 2014 to December 2017 were enrolled in the study. Pearson correlation was used to estimate the association between mammographic breast density and vitamin D levels. Of the 33 women enrolled, 70% of women self-identified as American Indian/Alaskan Native, 12% as White, 6% as Native Hawaiian/Pacific Islander and 12% as other. Nineteen (58%) participants were taking vitamin D supplementation. No correlation was identified between breast density and serum vitamin D levels overall (correlation= –0.03). Larger studies controlling for vitamin supplementation are needed, as this association could potentially impact breast cancer rates in populations at risk for vitamin D defi...

Research paper thumbnail of Family-Based Mindful Eating Intervention in Adolescents with Obesity: A Pilot Randomized Clinical Trial

Children

Mindfulness has gained attention in the treatment of obesity. However, there is a paucity of data... more Mindfulness has gained attention in the treatment of obesity. However, there is a paucity of data on family-based training in mindful eating in children. The objective of this pilot randomized clinical trial was to evaluate the feasibility and acceptability of a family-based mindful eating intervention (MEI) in adolescents with obesity, and to compare the efficacy of the MEI versus standard dietary counseling (SDC) for decreasing weight and improving cardiometabolic risk markers. Twenty-two adolescents (age 14.5-17.9 years) and parent pairs were randomized to the MEI or SDC. The MEI was administered in four 90-min sessions over 10 weeks and SDC was provided at baseline, 12 weeks, and 24 weeks. Despite the requirement of more frequent visits with the MEI, adolescents and parents attended 100% of the sessions and there were no dropouts in that group. High density lipoprotein (HDL) cholesterol increased in the SDC group, but not in the MEI group. Adolescents receiving the MEI demonstrated an increase in awareness at 24 weeks (p = 0.01) and a decrease in distraction during eating at 12 weeks (p = 0.04), when compared with the SDC group. The family-based MEI showed feasibility and acceptability in adolescents with obesity. Future studies with more intense therapy and larger sample sizes are warranted to examine the role of mindful eating in treating pediatric obesity.

Research paper thumbnail of Identifying Opportunities for Advancing Weight Management in Primary Care

Journal of Primary Care & Community Health

Objective: Much has been written about the patients’ perspective concerning weight management in ... more Objective: Much has been written about the patients’ perspective concerning weight management in health care. The purpose of this survey study was to assess perspectives of primary care providers (PCPs) and nurses toward patient weight management and identify possible areas of growth. Patients and Methods: We emailed a weight management–focused survey to 674 eligible participants (437 [64.8%] nurses and 237 [35.2%] PCPs) located in 5 outpatient primary care clinics. The survey focused on opportunities, practices, knowledge, confidence, attitudes, and beliefs. A total of 219 surveys were returned (137 [62.6%] from nurses and 82 [34.4%] from PCPs). Results: Among 219 responders, 85.8% were female and 93.6% were white non-Hispanic. In this study, PCPs and nurses believed obesity to be a major health problem. While PCPs felt more equipped than nurses to address weight management ( P < .001) and reported receiving more training than nurses (50.0% vs 17.6%, respectively), both felt the...

Research paper thumbnail of Low-level laser therapy for weight reduction: a randomized pilot study

Lasers in Medical Science

Obesity and overweight is a global health crisis and novel methods of treatment are needed to add... more Obesity and overweight is a global health crisis and novel methods of treatment are needed to address it. Low-level laser therapy (LLLT) is a currently available non-invasive procedure for lysing excess fat, but there is a lack of consensus exists on LLLT frequency and limited research from studies of LLLT. The purpose of this pilot study is to compare the effect of three of the most common LLLT frequencies on weight, waist circumference, body fat percentage, and quality of life. Sixty overweight (body mass index (BMI) 25-29.9 kg/m 2) adult participants were randomized to 12 LLLT treatments: (1) three times weekly for 4 weeks, (2) twice weekly for 6 weeks, or (3) once weekly for 12 weeks. All participants attended an in-person visit at baseline and at weeks 4, 6, 12, and 26. Participants were recruited September 30, 2016 through to August 27, 2017. The majority of the 60 participants were female (90%) with an average age of 43.7 years (± 9.2 years). Most participants (98%) completed 10 or more of the 12 LLLT treatments. When comparing across treatment groups, the greatest reductions from baseline were observed in those assigned to twice weekly for 6 weeks in weight (1 ± 1.7 (±SD) kg by week 6), waist circumference (− 2.0 ± 3.2 in. by week 6 and − 1.5 ± 3.2 in. by week 26), body mass index (− 0.4 ± 0.6 kg/m 2), and body fat mass (− 1.1 ± 1.6 kg). This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26). LLLT twice weekly for 6 weeks could be proposed as the optimal frequency and duration for the management of body weight. Trial registration: https://clinicaltrials.gov/ ct2/show/NCT02877004. Registered August 24, 2016.

Research paper thumbnail of Patient perception matters in weight management

Primary Health Care Research & Development

In a survey of 471 patients, we collected self-reported weight and height data and asked about se... more In a survey of 471 patients, we collected self-reported weight and height data and asked about self-perceptions of provider support toward weight loss and other weight management concerns. Multivariable analysis found that respondents with higher body mass index (BMI) were more likely to report that a physician had told them that they were overweight (OR=3.49, 95% CI 2.06–5.89, P<0.001). However, this conversation was less likely to change their personal view of their weight (OR=0.62 per 5 kg/m2, 95% CI 0.45–0.86, P=0.004), or motivate them to lose weight (OR=0.67 per 5 kg/m2, 95% CI 0.50–0.91, P=0.009). Higher BMI was associated with higher weight-loss goals (P<0.001), while anticipated time to achieve those goals was increased (P<0.001). Physician involvement in weight management was important, but the patients’ needs and experiences differed by BMI. Approaches to addressing barriers and identifying resources for weight management should be tailored to individuals by cons...

Research paper thumbnail of The effects of cigarette smoking extracts on cell cycle and tumor spread: novel evidence

Future Science OA

Cigarette smoking is a major preventable risk factor for lung cancer, contributing to lung cancer... more Cigarette smoking is a major preventable risk factor for lung cancer, contributing to lung cancer progression and metastasis. Moreover, cigarette smoking correlates with increased metastasis frequency of pancreatic, breast and bladder cancer. The aim of this review was to examine the role of cigarette smoke extract in cell cycle and cancer progression. Clinical impact and the effects of cigarette smoke extract on carcinogenesis are discussed. 98 of the over 5000 chemicals in tobacco smoke are known carcinogens that can act on cancer genes such as K-RAS and p53. Through various mechanisms these compounds can activate molecules involved in the cell cycle, such as cyclins, and molecules involved in apoptosis and autophagy, such as Beclin-1 or LC3B. A search of the literature, including in vitro and in vivo studies, was carried out and the results summarized. Lay abstract: There is evidence of cancerogenic effects of cigarette smoke compounds. Cigarette smoke extract is a tobacco condensate obtained by filtration processes. Studies have shown that it can modify the cell cycle, inducing uncontrolled cell proliferation. This effect occurs through activation of genetic and epigenetic pathways and increasing the expression of proteins involved in inflammation. The pathways activated by cigarette smoke extract open up opportunities for researchers to develop new targeted therapies toward the specific molecules involved. Furthermore, the effects exerted by cigarette smoke extract on normal epithelial cells hold potential for use in the development of prevention medicine and early cancer diagnosis.

Research paper thumbnail of Needs Assessment for Weight Management: The Learning Health System Network Experience

Mayo Clinic Proceedings: Innovations, Quality & Outcomes

To assess patients&#39; weight management needs and experiences across multiple sites within ... more To assess patients&#39; weight management needs and experiences across multiple sites within the Learning Health System Network. A total of 19,964 surveys were sent to patients identified with overweight or obesity through medical record query at 5 health care systems throughout 11 states. The survey collected patients&#39; experiences with and opinions about weight management in clinical care from October 27, 2017, through March 1, 2018. Among the 2380 responders, being younger, female, nonwhite, and single and having some college education or less were all significantly associated with higher body mass index (BMI). The most frequent weight loss barriers included food cravings (30.7%-49.9%) and having a medical condition limiting physical activity (17.7%-47.1%) (&lt;.001). Higher BMI was associated with a higher frequency of comorbidities and lower health status (&lt;.001). Higher BMI was also associated with a higher belief that primary care providers (PCPs) should be involved in weight loss management (=.01) but lower belief that the PCP had the necessary skills and knowledge to help (&lt;.001). Responders with a higher BMI were more likely to feel judged (&lt;.001) and not always respected (&lt;.001) by their PCP. In addition, those with a higher BMI more frequently reported avoiding health care visits because of weight gain, not wanting to undress or be weighed, and not wanting to discuss their weight with their PCP (&lt;.001). Physician involvement in weight management is important to patients whose needs and experiences differ by BMI. These data may inform clinical weight management efforts and create greater alignment with patient expectations.

Research paper thumbnail of Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial

Implementation science : IS, Jul 13, 2018

Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability o... more Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability of effective and safe vaccines. Uptake of HPV vaccine has been low and lags behind other adolescent vaccines. This protocol describes a multilevel intervention to improve HPV vaccination rates. Using a cluster randomized trial, we will evaluate the independent and combined impact of two evidence-based implementation strategies with innovative enhancements on HPV vaccination rates for female and male patients. The clusters are six primary care sites providing care to pediatric populations. We will use a stepped-wedge cluster randomized design, including process evaluation, to test the hypothesis that compared with the current course of care and a practice-level intervention using reminder-recall interventions coupled with provider-level audit and feedback with education increases HPV vaccination rates in exposed clusters. The factorial design allows us to use a single trial to test these t...

Research paper thumbnail of Impact of a 12-week wellness coaching on self-care behaviors among primary care adult patients with prediabetes

Preventive medicine reports, 2018

This single arm prospective study assessed the impact of individualized wellness coaching interve... more This single arm prospective study assessed the impact of individualized wellness coaching intervention for primary care patients with prediabetes on self-reported changes in physical activity level and food choices. Five hundred sixty adult patients 18 years and older with prediabetes, seen in primary care clinic, were invited to participate in 12 weeks wellness coaching sessions delivered by certified coaches. Responses from questionnaires at baseline, 6 and 12 weeks were analyzed. Of 168 consented patients, 99 completed at least one coaching session; majority was elderly, female, overweight or obese. At baseline, 50% had <60 min aerobic exercise/week. At 6 and 12 weeks, average aerobic exercise time significantly increased from 117 min to 166 and 199 min respectively. Effect was sustained at 24 weeks. Success in making healthy eating choices also statistically improved from baseline. Significant effects on both activity level and eating behavior persisted even after adjusting f...

Research paper thumbnail of An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial

Trials, Jan 28, 2017

Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (... more Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) ...

Research paper thumbnail of Automated chart review utilizing natural language processing algorithm for asthma predictive index

BMC pulmonary medicine, Jan 13, 2018

Thus far, no algorithms have been developed to automatically extract patients who meet Asthma Pre... more Thus far, no algorithms have been developed to automatically extract patients who meet Asthma Predictive Index (API) criteria from the Electronic health records (EHR) yet. Our objective is to develop and validate a natural language processing (NLP) algorithm to identify patients that meet API criteria. This is a cross-sectional study nested in a birth cohort study in Olmsted County, MN. Asthma status ascertained by manual chart review based on API criteria served as gold standard. NLP-API was developed on a training cohort (n = 87) and validated on a test cohort (n = 427). Criterion validity was measured by sensitivity, specificity, positive predictive value and negative predictive value of the NLP algorithm against manual chart review for asthma status. Construct validity was determined by associations of asthma status defined by NLP-API with known risk factors for asthma. Among the eligible 427 subjects of the test cohort, 48% were males and 74% were White. Median age was 5.3 year...

Research paper thumbnail of Incidental Pulmonary Nodules Reported on CT Abdominal Imaging: Frequency and Factors Affecting Inclusion in the Hospital Discharge Summary

Journal of Hospital Medicine

Research paper thumbnail of Application of a Natural Language Processing Algorithm to Asthma Ascertainment. An Automated Chart Review

American journal of respiratory and critical care medicine, Jan 15, 2017

Difficulty of asthma ascertainment and its associated methodologic heterogeneity have created sig... more Difficulty of asthma ascertainment and its associated methodologic heterogeneity have created significant barriers to asthma care and research. We evaluated the validity of an existing natural language processing (NLP) algorithm for asthma criteria to enable an automated chart review using electronic medical records (EMRs). The study was designed as a retrospective birth cohort study using a random sample of 500 subjects from the 1997-2007 Mayo Birth Cohort who were born at Mayo Clinic and enrolled in primary pediatric care at Mayo Clinic Rochester. Performance of NLP-based asthma ascertainment using predetermined asthma criteria was assessed by determining both criterion validity (chart review of EMRs by abstractor as a gold standard) and construct validity (association with known risk factors for asthma, such as allergic rhinitis). After excluding three subjects whose respiratory symptoms could be attributed to other conditions (e.g., tracheomalacia), among the remaining eligible ...

Research paper thumbnail of A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss

BMC obesity, 2016

Obesity is a significant public health problem and innovative treatments are needed. The purpose ... more Obesity is a significant public health problem and innovative treatments are needed. The purpose of this pilot study was to assess the preliminary efficacy and safety of a combined treatment of low-level laser therapy (LLLT) and lorcaserin on weight loss, health quality of life (QOL) measures, and cardiovascular risk factors. Forty-five overweight and obese adult participants with a body mass index (BMI) >26.9 and <40 were randomized to receive LLLT, lorcaserin, or a combination of the two therapies. All study participants received treatment for 3 months and were followed for 3 months post-treatment. Participants were recruited from June 2014 through September 2014. The majority of the 44 participants accrued to this study were female (84 %) with an average age of 43.9 years (range 22 to 64 years). Most participants (93 % LLLT alone, 87 % LLLT + lorcaserin) completed at least 80 % of the LLLT treatments. From baseline to end of treatment, significant reductions in waist circum...

Research paper thumbnail of Weight Concerns Associated With Delay in Quit Date But Not Treatment Outcomes: A Czech Republic Experience

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 11, 2016

Weight concerns are prevalent in smokers and may reduce the success rate of quitting. This concep... more Weight concerns are prevalent in smokers and may reduce the success rate of quitting. This concept has been primarily studied on US populations and it is unknown how weight concerns may differ cross-culturally. This study examined the role of weight concern in European smokers wishing to stop smoking. A sample of 593 smokers (299 men and 294 women, mean age 38 years) utilizing the Centre for Tobacco-Dependent in Prague, Czech Republic, between 2010 and 2013 were studied. Weight concerns were assessed at baseline prior to treatment by evidence-based stop smoking methods. Abstinence was evaluated at 12 months post baseline. Approximately 34% of all patients (204/593) were classified as weight concerned (by indicating on the Weight Concern Scale that they would return to smoking after any weight gain) at the time they sought treatment. Among all men, 19.4% (58/299) were weight concerned and among all women, 49.7% (146/294) were weight concerned. Among females, weight-concerned smokers ...

Research paper thumbnail of High-Dose Nicotine Patch Therapy Percentage of Replacement and Smoking Cessation

To assess the level of nicotine replacement, evidence of nicotine toxicity, and withdrawal sympto... more To assess the level of nicotine replacement, evidence of nicotine toxicity, and withdrawal symptom relief with placebo and 11-, 22-, and 44-mg/d doses of transdermal nicotine. A secondary objective was to assess short- and long-term smoking cessation rates. Randomized, double-blind, placebo-controlled inpatient/outpatient trial. Seventy-one cigarette smokers stratified according to light (n = 23), moderate (n = 24), and heavy (n = 24) smoking rates. After baseline measures were obtained, subjects were randomly assigned to placebo or an 11-, 22-, or 44-mg/d dose of transdermal nicotine and admitted to a special hospital unit for intensive inpatient treatment of nicotine dependence. During the 6-day inpatient stay, daily nicotine and cotinine levels were determined from trough and peak blood samples. Outpatient patch therapy continued for 7 weeks following the hospital stay, and those initially assigned to placebo were randomly assigned to 11 or 22 mg/d. At week 4, the dosage of those initially assigned to 44 mg/d was reduced to 22 mg/d. Percentage of replacement of cotinine was calculated by dividing the steady-state levels attained during patch therapy by the corresponding baseline levels. Abstinence from smoking was verified by expired air carbon monoxide. Withdrawal symptoms and nicotine toxicity were assessed daily through questionnaires during the inpatient stay. Follow-up visits were at 3, 6, 9, and 12 months. There was a statistically significant relationship between baseline smoking rate and baseline trough and peak blood cotinine levels (rs = 0.39, rs = 0.45; P &lt; .001 in both instances). A dose-response relationship was observed with higher patch doses, which produced a higher percentage of cotinine replacement and better withdrawal symptom relief. Only one subject (a light smoker assigned to the 44-mg dose) developed signs of nicotine toxicity. There was a positive association between the week 2 patch dose and the biochemically confirmed abstinence at the end of patch therapy (P = .007) but not for subsequent follow-up times. A higher percentage of cotinine replacement was associated with the higher 8-week smoking abstinence rate (P = .03), an association not found at long-term follow-up. A 44-mg/d dose of nicotine patch therapy appears to be safe for use in heavy smokers. Cigarette smoking rates can be used to estimate the initial nicotine patch dose. Monitoring blood cotinine levels at baseline and steady state can be used for assessing the adequacy of nicotine replacement. Withdrawal symptom relief can be improved with more complete nicotine replacement. Achieving a greater percentage of nicotine replacement may increase the efficacy of nicotine patch therapy.

Research paper thumbnail of Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users

Nicotine Tobacco Research Official Journal of the Society For Research on Nicotine and Tobacco, 2007

No pharmacotherapies have been shown to increase long-term (&amp;amp;amp;amp;amp;amp;amp;amp;... more No pharmacotherapies have been shown to increase long-term (&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;gt; or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to nicotine patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and nicotine toxicity were obtained with an electronic diary. During the first week of nicotine patch therapy, we observed a dose-response relationship such that higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose nicotine patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose nicotine patch therapy is safe and well tolerated in this population of tobacco users.

Research paper thumbnail of Development of depression during placebo-controlled trials of bupropion for smoking cessation: case reports

The Journal of Clinical Psychiatry 1999 60 436 41, Jul 1, 1999

Recent attention has focused on the relationship between depression and smoking cessation. This a... more Recent attention has focused on the relationship between depression and smoking cessation. This article describes 5 cases of severe depression that occurred during 2 multicenter trials using bupropion for smoking cessation. Subjects were participants in 2 randomized, double-blind, placebo-controlled studies investigating the efficacy of bupropion for smoking cessation. Data from both trials were restricted to subjects at the Rochester, Minn., site in order to have access to the medical records for information on depression diagnosis, treatment, and follow-up. The first trial involved 205 smokers who received active bupropion or placebo for 7 weeks. In the second trial, 252 smokers received open-label bupropion therapy for 7 weeks. Those abstinent from smoking at the end of week 7 (N = 148) were randomly assigned to a 45-week, double-blind, relapse-prevention phase. In the first trial, 1 of the 205 participants (0.49%) experienced major depression during the 7-week treatment phase. In the second trial, none of the 252 subjects developed major depression during the 7-week, open-label phase. When results of both trials across the 7-week treatment phase (study 1, N = 205; study 2, N = 252) are combined, the rate of developing major depression was 0.22% (1 of 457). Of the 457 subjects, none of the 51 who received placebo and 1 (0.25%) of the 406 who received active bupropion developed major depression. In the second trial, 4 (2.7%) of the 148 subjects randomly assigned to the 45-week, relapse-prevention phase developed depression. Overall, 4 of the 5 cases from the 2 trials had a past history of major depression prior to study entry, but none had current major depression. Major depression may occur in some individuals during smoking cessation treatment with bupropion.

Research paper thumbnail of Developing a clinical trial unit to advance research in an academic institution

Contemporary clinical trials, Jan 7, 2015

Research, clinical care, and education are the three cornerstones of academic health centers in t... more Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trials unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine Clinical Trials Unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a centra...

Research paper thumbnail of Stress, Resilience, and Coping of Healthcare Workers during the COVID-19 Pandemic

Journal of Primary Care & Community Health

Objective To estimate the health care workers (HCWs) self-reported stress, resilience, and coping... more Objective To estimate the health care workers (HCWs) self-reported stress, resilience, and coping during the COVID-19 pandemic, and to determine inter-professional differences. Participants and Methods An email survey was sent to 474 HCW at a Midwestern HealthCare facility between April 9, 2020 and April 30, 2020. A total of 311 (65.6%) responses were received by May 31, 2020. The survey utilized 3 validated instruments: Perceived Stress Scale (PSS), Brief Resilience Scale (BRS), Brief Resilience Coping Scale (BRCS). Results Of the 311 responses, 302 were evaluated: 97 from nonmedical staff with patient contact (NMPC); 86 from nonmedical staff with no patient contact (NMNPC); 62 from medical doctors (MD), physician assistants (PA) and nurse practitioners (NP); and 57 from nurses. Significant differences were noted across job categories for stress and resilience, with nurses reporting highest PSS scores (effect estimates: −2.72, P = .009 for NMNPC; −2.50, P = .015 for NMPC; −3.21, P ...

Research paper thumbnail of Assessing vitamin D and mammographic breast density in Alaskan women

Clinics and Practice

Vitamin D deficiency and high breast density may be associated with increased breast cancer risk.... more Vitamin D deficiency and high breast density may be associated with increased breast cancer risk. We examined a possible association between vitamin D levels and mammographic breast density in a population of Alaskan women. Patients seen in the Mayo Clinic-Alaska Native Medical Center telemedicine program from December 2014 to December 2017 were enrolled in the study. Pearson correlation was used to estimate the association between mammographic breast density and vitamin D levels. Of the 33 women enrolled, 70% of women self-identified as American Indian/Alaskan Native, 12% as White, 6% as Native Hawaiian/Pacific Islander and 12% as other. Nineteen (58%) participants were taking vitamin D supplementation. No correlation was identified between breast density and serum vitamin D levels overall (correlation= –0.03). Larger studies controlling for vitamin supplementation are needed, as this association could potentially impact breast cancer rates in populations at risk for vitamin D defi...

Research paper thumbnail of Family-Based Mindful Eating Intervention in Adolescents with Obesity: A Pilot Randomized Clinical Trial

Children

Mindfulness has gained attention in the treatment of obesity. However, there is a paucity of data... more Mindfulness has gained attention in the treatment of obesity. However, there is a paucity of data on family-based training in mindful eating in children. The objective of this pilot randomized clinical trial was to evaluate the feasibility and acceptability of a family-based mindful eating intervention (MEI) in adolescents with obesity, and to compare the efficacy of the MEI versus standard dietary counseling (SDC) for decreasing weight and improving cardiometabolic risk markers. Twenty-two adolescents (age 14.5-17.9 years) and parent pairs were randomized to the MEI or SDC. The MEI was administered in four 90-min sessions over 10 weeks and SDC was provided at baseline, 12 weeks, and 24 weeks. Despite the requirement of more frequent visits with the MEI, adolescents and parents attended 100% of the sessions and there were no dropouts in that group. High density lipoprotein (HDL) cholesterol increased in the SDC group, but not in the MEI group. Adolescents receiving the MEI demonstrated an increase in awareness at 24 weeks (p = 0.01) and a decrease in distraction during eating at 12 weeks (p = 0.04), when compared with the SDC group. The family-based MEI showed feasibility and acceptability in adolescents with obesity. Future studies with more intense therapy and larger sample sizes are warranted to examine the role of mindful eating in treating pediatric obesity.

Research paper thumbnail of Identifying Opportunities for Advancing Weight Management in Primary Care

Journal of Primary Care & Community Health

Objective: Much has been written about the patients’ perspective concerning weight management in ... more Objective: Much has been written about the patients’ perspective concerning weight management in health care. The purpose of this survey study was to assess perspectives of primary care providers (PCPs) and nurses toward patient weight management and identify possible areas of growth. Patients and Methods: We emailed a weight management–focused survey to 674 eligible participants (437 [64.8%] nurses and 237 [35.2%] PCPs) located in 5 outpatient primary care clinics. The survey focused on opportunities, practices, knowledge, confidence, attitudes, and beliefs. A total of 219 surveys were returned (137 [62.6%] from nurses and 82 [34.4%] from PCPs). Results: Among 219 responders, 85.8% were female and 93.6% were white non-Hispanic. In this study, PCPs and nurses believed obesity to be a major health problem. While PCPs felt more equipped than nurses to address weight management ( P < .001) and reported receiving more training than nurses (50.0% vs 17.6%, respectively), both felt the...

Research paper thumbnail of Low-level laser therapy for weight reduction: a randomized pilot study

Lasers in Medical Science

Obesity and overweight is a global health crisis and novel methods of treatment are needed to add... more Obesity and overweight is a global health crisis and novel methods of treatment are needed to address it. Low-level laser therapy (LLLT) is a currently available non-invasive procedure for lysing excess fat, but there is a lack of consensus exists on LLLT frequency and limited research from studies of LLLT. The purpose of this pilot study is to compare the effect of three of the most common LLLT frequencies on weight, waist circumference, body fat percentage, and quality of life. Sixty overweight (body mass index (BMI) 25-29.9 kg/m 2) adult participants were randomized to 12 LLLT treatments: (1) three times weekly for 4 weeks, (2) twice weekly for 6 weeks, or (3) once weekly for 12 weeks. All participants attended an in-person visit at baseline and at weeks 4, 6, 12, and 26. Participants were recruited September 30, 2016 through to August 27, 2017. The majority of the 60 participants were female (90%) with an average age of 43.7 years (± 9.2 years). Most participants (98%) completed 10 or more of the 12 LLLT treatments. When comparing across treatment groups, the greatest reductions from baseline were observed in those assigned to twice weekly for 6 weeks in weight (1 ± 1.7 (±SD) kg by week 6), waist circumference (− 2.0 ± 3.2 in. by week 6 and − 1.5 ± 3.2 in. by week 26), body mass index (− 0.4 ± 0.6 kg/m 2), and body fat mass (− 1.1 ± 1.6 kg). This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26). LLLT twice weekly for 6 weeks could be proposed as the optimal frequency and duration for the management of body weight. Trial registration: https://clinicaltrials.gov/ ct2/show/NCT02877004. Registered August 24, 2016.

Research paper thumbnail of Patient perception matters in weight management

Primary Health Care Research & Development

In a survey of 471 patients, we collected self-reported weight and height data and asked about se... more In a survey of 471 patients, we collected self-reported weight and height data and asked about self-perceptions of provider support toward weight loss and other weight management concerns. Multivariable analysis found that respondents with higher body mass index (BMI) were more likely to report that a physician had told them that they were overweight (OR=3.49, 95% CI 2.06–5.89, P<0.001). However, this conversation was less likely to change their personal view of their weight (OR=0.62 per 5 kg/m2, 95% CI 0.45–0.86, P=0.004), or motivate them to lose weight (OR=0.67 per 5 kg/m2, 95% CI 0.50–0.91, P=0.009). Higher BMI was associated with higher weight-loss goals (P<0.001), while anticipated time to achieve those goals was increased (P<0.001). Physician involvement in weight management was important, but the patients’ needs and experiences differed by BMI. Approaches to addressing barriers and identifying resources for weight management should be tailored to individuals by cons...

Research paper thumbnail of The effects of cigarette smoking extracts on cell cycle and tumor spread: novel evidence

Future Science OA

Cigarette smoking is a major preventable risk factor for lung cancer, contributing to lung cancer... more Cigarette smoking is a major preventable risk factor for lung cancer, contributing to lung cancer progression and metastasis. Moreover, cigarette smoking correlates with increased metastasis frequency of pancreatic, breast and bladder cancer. The aim of this review was to examine the role of cigarette smoke extract in cell cycle and cancer progression. Clinical impact and the effects of cigarette smoke extract on carcinogenesis are discussed. 98 of the over 5000 chemicals in tobacco smoke are known carcinogens that can act on cancer genes such as K-RAS and p53. Through various mechanisms these compounds can activate molecules involved in the cell cycle, such as cyclins, and molecules involved in apoptosis and autophagy, such as Beclin-1 or LC3B. A search of the literature, including in vitro and in vivo studies, was carried out and the results summarized. Lay abstract: There is evidence of cancerogenic effects of cigarette smoke compounds. Cigarette smoke extract is a tobacco condensate obtained by filtration processes. Studies have shown that it can modify the cell cycle, inducing uncontrolled cell proliferation. This effect occurs through activation of genetic and epigenetic pathways and increasing the expression of proteins involved in inflammation. The pathways activated by cigarette smoke extract open up opportunities for researchers to develop new targeted therapies toward the specific molecules involved. Furthermore, the effects exerted by cigarette smoke extract on normal epithelial cells hold potential for use in the development of prevention medicine and early cancer diagnosis.

Research paper thumbnail of Needs Assessment for Weight Management: The Learning Health System Network Experience

Mayo Clinic Proceedings: Innovations, Quality & Outcomes

To assess patients&#39; weight management needs and experiences across multiple sites within ... more To assess patients&#39; weight management needs and experiences across multiple sites within the Learning Health System Network. A total of 19,964 surveys were sent to patients identified with overweight or obesity through medical record query at 5 health care systems throughout 11 states. The survey collected patients&#39; experiences with and opinions about weight management in clinical care from October 27, 2017, through March 1, 2018. Among the 2380 responders, being younger, female, nonwhite, and single and having some college education or less were all significantly associated with higher body mass index (BMI). The most frequent weight loss barriers included food cravings (30.7%-49.9%) and having a medical condition limiting physical activity (17.7%-47.1%) (&lt;.001). Higher BMI was associated with a higher frequency of comorbidities and lower health status (&lt;.001). Higher BMI was also associated with a higher belief that primary care providers (PCPs) should be involved in weight loss management (=.01) but lower belief that the PCP had the necessary skills and knowledge to help (&lt;.001). Responders with a higher BMI were more likely to feel judged (&lt;.001) and not always respected (&lt;.001) by their PCP. In addition, those with a higher BMI more frequently reported avoiding health care visits because of weight gain, not wanting to undress or be weighed, and not wanting to discuss their weight with their PCP (&lt;.001). Physician involvement in weight management is important to patients whose needs and experiences differ by BMI. These data may inform clinical weight management efforts and create greater alignment with patient expectations.

Research paper thumbnail of Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial

Implementation science : IS, Jul 13, 2018

Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability o... more Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability of effective and safe vaccines. Uptake of HPV vaccine has been low and lags behind other adolescent vaccines. This protocol describes a multilevel intervention to improve HPV vaccination rates. Using a cluster randomized trial, we will evaluate the independent and combined impact of two evidence-based implementation strategies with innovative enhancements on HPV vaccination rates for female and male patients. The clusters are six primary care sites providing care to pediatric populations. We will use a stepped-wedge cluster randomized design, including process evaluation, to test the hypothesis that compared with the current course of care and a practice-level intervention using reminder-recall interventions coupled with provider-level audit and feedback with education increases HPV vaccination rates in exposed clusters. The factorial design allows us to use a single trial to test these t...

Research paper thumbnail of Impact of a 12-week wellness coaching on self-care behaviors among primary care adult patients with prediabetes

Preventive medicine reports, 2018

This single arm prospective study assessed the impact of individualized wellness coaching interve... more This single arm prospective study assessed the impact of individualized wellness coaching intervention for primary care patients with prediabetes on self-reported changes in physical activity level and food choices. Five hundred sixty adult patients 18 years and older with prediabetes, seen in primary care clinic, were invited to participate in 12 weeks wellness coaching sessions delivered by certified coaches. Responses from questionnaires at baseline, 6 and 12 weeks were analyzed. Of 168 consented patients, 99 completed at least one coaching session; majority was elderly, female, overweight or obese. At baseline, 50% had <60 min aerobic exercise/week. At 6 and 12 weeks, average aerobic exercise time significantly increased from 117 min to 166 and 199 min respectively. Effect was sustained at 24 weeks. Success in making healthy eating choices also statistically improved from baseline. Significant effects on both activity level and eating behavior persisted even after adjusting f...

Research paper thumbnail of An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial

Trials, Jan 28, 2017

Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (... more Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) ...

Research paper thumbnail of Automated chart review utilizing natural language processing algorithm for asthma predictive index

BMC pulmonary medicine, Jan 13, 2018

Thus far, no algorithms have been developed to automatically extract patients who meet Asthma Pre... more Thus far, no algorithms have been developed to automatically extract patients who meet Asthma Predictive Index (API) criteria from the Electronic health records (EHR) yet. Our objective is to develop and validate a natural language processing (NLP) algorithm to identify patients that meet API criteria. This is a cross-sectional study nested in a birth cohort study in Olmsted County, MN. Asthma status ascertained by manual chart review based on API criteria served as gold standard. NLP-API was developed on a training cohort (n = 87) and validated on a test cohort (n = 427). Criterion validity was measured by sensitivity, specificity, positive predictive value and negative predictive value of the NLP algorithm against manual chart review for asthma status. Construct validity was determined by associations of asthma status defined by NLP-API with known risk factors for asthma. Among the eligible 427 subjects of the test cohort, 48% were males and 74% were White. Median age was 5.3 year...

Research paper thumbnail of Incidental Pulmonary Nodules Reported on CT Abdominal Imaging: Frequency and Factors Affecting Inclusion in the Hospital Discharge Summary

Journal of Hospital Medicine

Research paper thumbnail of Application of a Natural Language Processing Algorithm to Asthma Ascertainment. An Automated Chart Review

American journal of respiratory and critical care medicine, Jan 15, 2017

Difficulty of asthma ascertainment and its associated methodologic heterogeneity have created sig... more Difficulty of asthma ascertainment and its associated methodologic heterogeneity have created significant barriers to asthma care and research. We evaluated the validity of an existing natural language processing (NLP) algorithm for asthma criteria to enable an automated chart review using electronic medical records (EMRs). The study was designed as a retrospective birth cohort study using a random sample of 500 subjects from the 1997-2007 Mayo Birth Cohort who were born at Mayo Clinic and enrolled in primary pediatric care at Mayo Clinic Rochester. Performance of NLP-based asthma ascertainment using predetermined asthma criteria was assessed by determining both criterion validity (chart review of EMRs by abstractor as a gold standard) and construct validity (association with known risk factors for asthma, such as allergic rhinitis). After excluding three subjects whose respiratory symptoms could be attributed to other conditions (e.g., tracheomalacia), among the remaining eligible ...

Research paper thumbnail of A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss

BMC obesity, 2016

Obesity is a significant public health problem and innovative treatments are needed. The purpose ... more Obesity is a significant public health problem and innovative treatments are needed. The purpose of this pilot study was to assess the preliminary efficacy and safety of a combined treatment of low-level laser therapy (LLLT) and lorcaserin on weight loss, health quality of life (QOL) measures, and cardiovascular risk factors. Forty-five overweight and obese adult participants with a body mass index (BMI) >26.9 and <40 were randomized to receive LLLT, lorcaserin, or a combination of the two therapies. All study participants received treatment for 3 months and were followed for 3 months post-treatment. Participants were recruited from June 2014 through September 2014. The majority of the 44 participants accrued to this study were female (84 %) with an average age of 43.9 years (range 22 to 64 years). Most participants (93 % LLLT alone, 87 % LLLT + lorcaserin) completed at least 80 % of the LLLT treatments. From baseline to end of treatment, significant reductions in waist circum...

Research paper thumbnail of Weight Concerns Associated With Delay in Quit Date But Not Treatment Outcomes: A Czech Republic Experience

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 11, 2016

Weight concerns are prevalent in smokers and may reduce the success rate of quitting. This concep... more Weight concerns are prevalent in smokers and may reduce the success rate of quitting. This concept has been primarily studied on US populations and it is unknown how weight concerns may differ cross-culturally. This study examined the role of weight concern in European smokers wishing to stop smoking. A sample of 593 smokers (299 men and 294 women, mean age 38 years) utilizing the Centre for Tobacco-Dependent in Prague, Czech Republic, between 2010 and 2013 were studied. Weight concerns were assessed at baseline prior to treatment by evidence-based stop smoking methods. Abstinence was evaluated at 12 months post baseline. Approximately 34% of all patients (204/593) were classified as weight concerned (by indicating on the Weight Concern Scale that they would return to smoking after any weight gain) at the time they sought treatment. Among all men, 19.4% (58/299) were weight concerned and among all women, 49.7% (146/294) were weight concerned. Among females, weight-concerned smokers ...

Research paper thumbnail of High-Dose Nicotine Patch Therapy Percentage of Replacement and Smoking Cessation

To assess the level of nicotine replacement, evidence of nicotine toxicity, and withdrawal sympto... more To assess the level of nicotine replacement, evidence of nicotine toxicity, and withdrawal symptom relief with placebo and 11-, 22-, and 44-mg/d doses of transdermal nicotine. A secondary objective was to assess short- and long-term smoking cessation rates. Randomized, double-blind, placebo-controlled inpatient/outpatient trial. Seventy-one cigarette smokers stratified according to light (n = 23), moderate (n = 24), and heavy (n = 24) smoking rates. After baseline measures were obtained, subjects were randomly assigned to placebo or an 11-, 22-, or 44-mg/d dose of transdermal nicotine and admitted to a special hospital unit for intensive inpatient treatment of nicotine dependence. During the 6-day inpatient stay, daily nicotine and cotinine levels were determined from trough and peak blood samples. Outpatient patch therapy continued for 7 weeks following the hospital stay, and those initially assigned to placebo were randomly assigned to 11 or 22 mg/d. At week 4, the dosage of those initially assigned to 44 mg/d was reduced to 22 mg/d. Percentage of replacement of cotinine was calculated by dividing the steady-state levels attained during patch therapy by the corresponding baseline levels. Abstinence from smoking was verified by expired air carbon monoxide. Withdrawal symptoms and nicotine toxicity were assessed daily through questionnaires during the inpatient stay. Follow-up visits were at 3, 6, 9, and 12 months. There was a statistically significant relationship between baseline smoking rate and baseline trough and peak blood cotinine levels (rs = 0.39, rs = 0.45; P &lt; .001 in both instances). A dose-response relationship was observed with higher patch doses, which produced a higher percentage of cotinine replacement and better withdrawal symptom relief. Only one subject (a light smoker assigned to the 44-mg dose) developed signs of nicotine toxicity. There was a positive association between the week 2 patch dose and the biochemically confirmed abstinence at the end of patch therapy (P = .007) but not for subsequent follow-up times. A higher percentage of cotinine replacement was associated with the higher 8-week smoking abstinence rate (P = .03), an association not found at long-term follow-up. A 44-mg/d dose of nicotine patch therapy appears to be safe for use in heavy smokers. Cigarette smoking rates can be used to estimate the initial nicotine patch dose. Monitoring blood cotinine levels at baseline and steady state can be used for assessing the adequacy of nicotine replacement. Withdrawal symptom relief can be improved with more complete nicotine replacement. Achieving a greater percentage of nicotine replacement may increase the efficacy of nicotine patch therapy.

Research paper thumbnail of Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users

Nicotine Tobacco Research Official Journal of the Society For Research on Nicotine and Tobacco, 2007

No pharmacotherapies have been shown to increase long-term (&amp;amp;amp;amp;amp;amp;amp;amp;... more No pharmacotherapies have been shown to increase long-term (&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;gt; or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to nicotine patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and nicotine toxicity were obtained with an electronic diary. During the first week of nicotine patch therapy, we observed a dose-response relationship such that higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose nicotine patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose nicotine patch therapy is safe and well tolerated in this population of tobacco users.

Research paper thumbnail of Development of depression during placebo-controlled trials of bupropion for smoking cessation: case reports

The Journal of Clinical Psychiatry 1999 60 436 41, Jul 1, 1999

Recent attention has focused on the relationship between depression and smoking cessation. This a... more Recent attention has focused on the relationship between depression and smoking cessation. This article describes 5 cases of severe depression that occurred during 2 multicenter trials using bupropion for smoking cessation. Subjects were participants in 2 randomized, double-blind, placebo-controlled studies investigating the efficacy of bupropion for smoking cessation. Data from both trials were restricted to subjects at the Rochester, Minn., site in order to have access to the medical records for information on depression diagnosis, treatment, and follow-up. The first trial involved 205 smokers who received active bupropion or placebo for 7 weeks. In the second trial, 252 smokers received open-label bupropion therapy for 7 weeks. Those abstinent from smoking at the end of week 7 (N = 148) were randomly assigned to a 45-week, double-blind, relapse-prevention phase. In the first trial, 1 of the 205 participants (0.49%) experienced major depression during the 7-week treatment phase. In the second trial, none of the 252 subjects developed major depression during the 7-week, open-label phase. When results of both trials across the 7-week treatment phase (study 1, N = 205; study 2, N = 252) are combined, the rate of developing major depression was 0.22% (1 of 457). Of the 457 subjects, none of the 51 who received placebo and 1 (0.25%) of the 406 who received active bupropion developed major depression. In the second trial, 4 (2.7%) of the 148 subjects randomly assigned to the 45-week, relapse-prevention phase developed depression. Overall, 4 of the 5 cases from the 2 trials had a past history of major depression prior to study entry, but none had current major depression. Major depression may occur in some individuals during smoking cessation treatment with bupropion.