Review of Pharmacologic Weight Loss Medications in a Patient-Centered Medical Home.

Background: Per the Centers for Disease Control, 78 million adults were classified as obese in the United States in 2009 to 2010. Lifestyle modifications and pharmacologic treatment are appropriate options to combat obesity. Objectives: The primary objective of the study was to assess change in body weight after 12 weeks in patients seen at a family medicine patient-centered medical home (PCMH) who were prescribed Food and Drug Administration-approved weight loss medications. Methods: A retrospective medical record review was used to evaluate weight loss in adult patients with office visits at the PCMH. Adult patients were eligible for inclusion in the study if prescribed a Food and Drug Administration approved weight loss medication between July 1, 2013, and March 31, 2014, and had at least one weight documented during a follow-up visit 12 weeks after the initial prescription. Results: Of the 27 patients identified for study inclusion, 22 (81.5%) were prescribed phentermine. The remaining 5 (18.5%) patients were prescribed phentermine/topiramate ER. After 12 weeks of pharmacologic therapy, the median change in body weight was -3.7 kg (range = -16.8 to 5.5 kg) regardless of medication taken. This correlates to a -1.4 kg/m2 (range = -15.7 to 4.2 kg/m2) median change in body mass index. Twelve patients (44.4%) lost at least 5% of their body weight during the study period. Conclusions: In our study population, we observed a median weight loss of 3.7 kg over 12 weeks while utilizing weight loss medications. Unfortunately, other lifestyle-modification services offered through the PCMH were not consistently utilized.

Financial strain and smoking cessation among racially/ethnically diverse smokers.

OBJECTIVES: We evaluated the influence of financial strain on smoking cessation among Latino, African American, and Caucasian smokers of predominantly low socioeconomic status. METHODS: Smokers enrolled in a smoking cessation study (N = 424) were followed from 1 week prequit through 26 weeks postquit. We conducted a logistic regression analysis to evaluate the association between baseline financial strain and smoking abstinence at 26 weeks postquit after control for age, gender, race/ethnicity, educational level, annual household income, marital status, number of cigarettes smoked per day, and time to first cigarette of the day. RESULTS: Greater financial strain at baseline was significantly associated with reduced odds of abstinence at 26 weeks postquit among those who completed the study (odds ratio [OR] = 0.77; 95% confidence interval [CI] = 0.62, 0.94; P = .01). There was a significant association as well in analyses that included those who completed the study in addition to those lost to follow-up who were categorized as smokers (OR = 0.78; 95% CI = 0.64, 0.96; P = .02). CONCLUSIONS: Greater financial strain predicted lower cessation rates among racially/ethnically diverse smokers. Our findings highlight the impact of economic concerns on smoking cessation and the need to address financial strain in smoking cessation interventions.

Breast feeding is associated with postpartum smoking abstinence among women who quit smoking due to pregnancy.

INTRODUCTION: The purpose of this study was to characterize the relationship between breast feeding and postpartum smoking abstinence among women who quit smoking due to pregnancy and who were participating in a randomized clinical trial of an intervention designed to prevent postpartum relapse. METHODS: A total of 251 women were enrolled in the intervention between 30 and 33 weeks postpartum and were followed through 26 weeks postpartum. Participant characteristics were assessed at the prepartum baseline visit, any breast feeding was assessed at 8 weeks postpartum, and smoking abstinence was assessed at 8 and 26 weeks postpartum. RESULTS: Although 79.1% of participants intended to breast feed, only 40.2% reported breast feeding at 8 weeks postpartum. Characteristics associated with breast feeding at 8 weeks postpartum included Caucasian race/ethnicity, greater education, higher household income, and being married/living with a significant other. Logistic regression analysis indicated that breast feeding at 8 weeks postpartum was significantly associated with smoking abstinence at 8 weeks postpartum, odds ratio (OR) = 7.27 (95% CI = 3.27, 16.13), p < .001. Breast feeding at 8 weeks postpartum was also associated with abstinence at 26 weeks postpartum after controlling for smoking status at 8 weeks postpartum, OR = 2.64 (95% CI = 1.14, 6.10), p = .02. DISCUSSION: Encouraging breast feeding among women who quit smoking due to pregnancy may facilitate postpartum smoking abstinence while increasing adherence to current infant feeding guidelines.

Preventing postpartum smoking relapse among diverse low-income women: a randomized clinical trial.

INTRODUCTION: Postpartum relapse rates are high among women who spontaneously quit smoking during pregnancy. This randomized clinical trial tested a Motivation and Problem-Solving (MAPS) treatment for reducing postpartum relapse among diverse low-income women who quit smoking during pregnancy (N = 251; 32% Black, 30% Latino, and 36% White; 55% <$30,000/year household income). METHODS: Pregnant women were randomly assigned to MAPS/MAPS+ or Usual Care (UC). Continuation ratio logit models were used to examine differences in biochemically confirmed continuous abstinence at Weeks 8 and 26 postpartum by treatment group and moderators of the treatment effect. Analyses controlled for age, race/ethnicity, partner status, education, smoking rate, and the number of smokers in the participant's environment. RESULTS: MAPS/MAPS+ was more efficacious than UC in the prevention of postpartum relapse (p = .05). An interaction between treatment and the number of cigarettes smoked per day before quitting approached significance (p = .09), suggesting that the MAPS/MAPS+ treatment effect was stronger among women who smoked more cigarettes per day. DISCUSSION: MAPS, a holistic and dynamic approach to changing behavior using a combined motivational enhancement and social cognitive approach, is a promising intervention for postpartum smoking relapse prevention among low-income women, which may have particular relevance for women with higher prequit smoking rates.

The individual's role in maintaining a positive climate.

INTRODUCTION: This commentary adds to the discussion about academic workload challenges raised in the Mothers in Academic Pharmacy article. Outlined here are strategies for individual faculty members to proactively engage in developing a positive climate for all faculty. PERSPECTIVE: Faculty play an important role in building and maintaining a positive culture. This article provides suggestions for individuals to consider their role and impact at their institution. These suggestions focus on communication, building communities, embracing flexibility, and recognizing burnout. IMPLICATIONS: Faculty retention is important for student support and financial efficiency. Faculty who are able to openly discuss their struggles in a positive climate are more likely to identify opportunities to be productive. This helps faculty meet their overall needs and maintain success in teaching, scholarship, and service.

Inter-rater Reliability of a Clinical Documentation Rubric Within Pharmacotherapy Problem-Based Learning Courses.

Objective. To evaluate a clinical documentation rubric for pharmacotherapy problem-based learning (PBL) courses using inter-rater reliability (IRR) among different evaluators. Methods. A rubric was adapted for use in grading student pharmacists' clinical documentation in pharmacotherapy PBL courses. Multiple faculty evaluators used the rubric to assess student pharmacists' clinical documentation. The mean rubric score given by the evaluators and the standard deviation were calculated. Intra-class correlation coefficients (ICC) were calculated to determine the inter-rater reliability (IRR) of the rubric. Results. Three hundred seventeen clinical documentation submissions were scored twice by multiple evaluators using the rubric. The mean initial evaluation score was 9.1 (SD=0.9) and the mean second evaluation score was 9.1 (SD=0.9), with no significant difference found between the two. The overall ICC was 0.7 across multiple graders, indicating good IRR. Conclusion. The clinical documentation rubric demonstrated overall good IRR between multiple evaluators when used in pharmacotherapy PBL courses. The rubric will undergo additional evaluation and continuous quality improvement to ensure that student pharmacists are provided with the formative feedback they need.

The Smoking Consequences Questionnaire: Factor structure and predictive validity among Spanish-speaking Latino smokers in the United States.

INTRODUCTION: Much of the existing research on smoking outcome expectancies has been guided by the Smoking Consequences Questionnaire (SCQ ). Although the original version of the SCQ has been modified over time for use in different populations, none of the existing versions have been evaluated for use among Spanish-speaking Latino smokers in the United States. METHODS: The present study evaluated the factor structure and predictive validity of the 3 previously validated versions of the SCQ--the original, the SCQ-Adult, and the SCQ-Spanish, which was developed with Spanish-speaking smokers in Spain--among Spanish-speaking Latino smokers in Texas. RESULTS: The SCQ-Spanish represented the least complex solution. Each of the SCQ-Spanish scales had good internal consistency, and the predictive validity of the SCQ-Spanish was partially supported. Nearly all the SCQ-Spanish scales predicted withdrawal severity even after controlling for demographics and dependence. Boredom Reduction predicted smoking relapse across the 5- and 12-week follow-up assessments in a multivariate model that also controlled for demographics and dependence. DISCUSSION: Our results support use of the SCQ-Spanish with Spanish-speaking Latino smokers in the United States.

Low-level smoking among Spanish-speaking Latino smokers: relationships with demographics, tobacco dependence, withdrawal, and cessation.

INTRODUCTION: Although recent research indicates that many Latino smokers are nondaily smokers or daily smokers who smoke at a low level ( or =11 cigarettes/day; n = 100). Data were collected prior to the quit attempt and at 5 and 12 weeks postquit. RESULTS: Results yielded three key findings. First, smoking level was positively associated with the total score and 12 of 13 subscale scores on a comprehensive, multidimensional measure of tobacco dependence. Low-level smokers consistently reported the least dependence, and moderate/heavy smokers reported the most dependence on tobacco. Second, low-level smokers reported the least craving in pre- to postcessation longitudinal analyses. Third, despite significant differences on dependence and craving, low-level smoking was not associated with abstinence. Smoking level was not associated with demographic variables. DISCUSSION: This is a preliminary step in understanding factors influencing tobacco dependence and smoking cessation among low-level Spanish-speaking Latino smokers, a subgroup with high prevalence in the Latino population.

Pathways between socioeconomic status and modifiable risk factors among African American smokers.

Although socioeconomic status is a major contributing factor to health disparities, the mechanisms through which socioeconomic status influences health remain unclear. The purpose of the present study was to evaluate an a priori conceptual model of the pathways between socioeconomic status and modifiable health risk factors in a sample of 399 African Americans seeking smoking cessation treatment. A latent variable modeling approach was utilized to characterize the interrelationships among socioeconomic status, neighborhood disadvantage, social support, negative affect/perceived stress, and three specific modifiable risk factors (i.e., overweight/obesity, insufficient physical activity, at-risk drinking). Findings indicated that neighborhood disadvantage, social support, and negative affect/perceived stress function as pathways linking socioeconomic status and modifiable risk factors among African American smokers, and negative affect/perceived stress appears to play a key mediating role. Policy, community, and individual-level interventions may attenuate the impact of socioeconomic status on health by targeting intermediate psychosocial, environmental, and behavioral pathways.

Race/ethnicity and multiple cancer risk factors among individuals seeking smoking cessation treatment.

Smoking in combination with other behavioral risk factors is known to have a negative influence on health, and individuals who smoke typically engage in multiple risk behaviors. However, little is known about the clustering of risk behaviors among smokers of varying race/ethnicity. The purpose of this study was to examine patterns of cancer risk behaviors and to identify predictors of multiple risk behaviors in a racially/ethnically diverse sample of individuals seeking smoking cessation treatment. Overweight/obesity, at-risk alcohol consumption, and insufficient physical activity were measured in 424 smokers (African American, n = 144; Latino, n = 141; and Caucasian, n = 139). Results indicated that 90% of participants reported behavioral cancer risk factors in addition to smoking. Approximately 70% of participants were overweight or obese, 48% engaged in at-risk drinking, and 27% were insufficiently physically active. Univariate analyses indicated that race/ethnicity (P < 0.001), smoking level (P = 0.03), and marital status (P = 0.04) were significant predictors of multiple risk behaviors, although only race/ethnicity remained a significant predictor (P < 0.001), when gender, smoking level, age, education, household income, marital status, and health insurance status were included in a multivariate model. Multivariate analysis indicated that the odds of engaging in multiple risk behaviors were significantly higher among Latinos (odds ratio = 2.85) and African Americans (odds ratio = 1.86) than Caucasians. Our findings highlight the need for research aimed at identifying determinants of racial/ethnic differences in multiple risk behaviors and indicate the importance of developing culturally sensitive interventions that target multiple risk behaviors.

Socioeconomic status, negative affect, and modifiable cancer risk factors in African-American smokers.

The purpose of the present study was to describe the prevalence, patterns, and predictors of cooccurring modifiable cancer risk factors among African-Americans seeking smoking cessation treatment and to evaluate previously hypothesized models of the relationship between socioeconomic status (SES) and health behavior. Overweight/obesity, at-risk alcohol consumption, and insufficient physical activity were measured in 399 African-American smokers. Analyses indicated that 92.8% of participants had at least one cancer risk factor in addition to smoking. Univariate ordinal logistic regression analyses revealed that female gender, unemployment, lower positive affect, and greater negative affect were associated with having a greater number of cancer risk factors. Multivariate analyses yielded similar findings. A structural equation modeling approach indicated that stress/negative affect may function as one pathway linking SES and modifiable cancer risk factors among African-American smokers and that gender has a direct effect on modifiable cancer risk factors. Thus, risk patterns identified within each gender group may guide the development of multiple risk factor interventions for African-American smokers. Stress and negative affect may be an important treatment target within behavioral interventions for African-American smokers of low SES.

It's no debate, debates are great.

INTRODUCTION: A debate can be a pedagogical method used to instill essential functions in pharmacy students. This non-traditional teaching method may help to further develop a number of skills that are highlighted in the current Accreditation Council for Pharmacy Education Standards 2016 and Center for the Advancement of Pharmacy Education Educational Outcomes 2013. COMMENTARY: Debates have also been used as an educational tool in other health disciplines. Current pharmacy literature does illustrate the use of debates in various areas within the pharmacy curriculum in both required and elective courses; however, the current body of literature would suggest that debates are an underutilized teaching tool in pharmacy experiential education. IMPLICATIONS: With all potential benefits of debates as a teaching tool, pharmacy experiential preceptors should further explore their use in the experiential setting.

A Survey on Data Reproducibility and the Effect of Publication Process on the Ethical Reporting of Laboratory Research.

Purpose: The successful translation of laboratory research into effective therapies is dependent upon the validity of peer-reviewed publications. However, several publications in recent years suggested that published scientific findings could be reproduced only 11% to 45% of the time. Multiple surveys attempted to elucidate the fundamental causes of data irreproducibility and underscored potential solutions, more robust experimental designs, better statistics, and better mentorship. However, no prior survey has addressed the role of the review and publication process on honest reporting.Experimental Design: We developed an anonymous online survey intended for trainees involved in bench research. The survey included questions related to mentoring/career development, research practice, integrity, and transparency, and how the pressure to publish and the publication process itself influence their reporting practices.Results: Responses to questions related to mentoring and training practices were largely positive, although an average of approximately 25% did not seem to receive optimal mentoring. A total of 39.2% revealed having been pressured by a principle investigator or collaborator to produce "positive" data. About 62.8% admitted that the pressure to publish influences the way they report data. The majority of respondents did not believe that extensive revisions significantly improved the manuscript while adding to the cost and time invested.Conclusions: This survey indicates that trainees believe that the pressure to publish affects honest reporting, mostly emanating from our system of rewards and advancement. The publication process itself affects faculty and trainees and appears to influence a shift in their ethics from honest reporting ("negative data") to selective reporting, data falsification, or even fabrication. Clin Cancer Res; 24(14); 3447-55. ©2018 AACR.

The Impact of Health Literacy Level on Inhaler Technique in Patients With Chronic Obstructive Pulmonary Disease.

BACKGROUND: Inhaled medications are recommended as first-line treatment for chronic obstructive pulmonary disease (COPD) and can reduce exacerbations and hospitalizations. Low health literacy is associated with poor inhaler technique. OBJECTIVE: This study examined whether handouts written specifically for patients with low health literacy are more effective in showing patients how to use their medications when compared to standard education materials. METHODS: A prospective, experimental study was performed at a community-based hospital. Patients included in the study were admitted to the hospital with a diagnosis of COPD, taking at least 1 inhaled medication and identified as having low health literacy based on a Rapid Estimate of Adult Literacy in Medicine-Short Form. Low health literacy handouts were compared against the standard hospital educational materials for inhalers. Correct technique during each demonstration was evaluated using a standardized checklist. RESULTS: Mean baseline scores for inhaler technique were 12.2 ± 2.2 steps correct for the control group and 13.4 ± 1.3 for the low health-literacy group of the 18 maximum points ( P = nonsignificant). The mean change in inhaler technique score for the control group was 1.0 ± 1.8, while the mean change in inhaler technique score for the low health-literacy group was 2.1 ± 2.7 ( P = .03).

Comparison of Time to First Dose of Oral Morphine in the Treatment of Neonatal Abstinence Syndrome.

OBJECTIVE: To compare time to first dose of oral morphine used in the treatment of neonatal abstinence syndrome (NAS) in a neonatal intensive care unit (NICU) versus a special care nursery (SCN) setting. METHODS: A retrospective chart review was completed of patient data from two community hospitals in a single health network. Infants born at either facility between January 2013 and August 2015 were eligible for inclusion in the study if treated for NAS with a course of oral morphine. The primary outcome was time from birth to first dose of oral morphine. Secondary outcomes included details about the morphine treatment course, length of stay, and complications from NAS. RESULTS: A total of 54 patients (19 NICU patients and 35 SCN patients) fulfilled inclusion criteria for the study. The primary outcome of median time from birth to first dose of oral morphine did not differ between the two groups (42.5 hrs [NICU] vs 43 hrs [SCN], p=0.53). No significant differences were found between the morphine regimens used in the two units. The median length of hospital stay (27 days [NICU] vs 26 days [SCN], p=0.66) and median length of NICU/SCN stay (26 days [NICU] vs 23 days [SCN], p=0.75) were not statistically significantly different. Time between transfer to the NICU or SCN and administration of the first dose of oral morphine was significantly shorter in the SCN setting (28 hrs [NICU] vs 4 hrs [SCN], p=0.009). CONCLUSIONS: This study found that infants treated for NAS had similar treatment in an NICU and an SCN. No difference was observed in time from birth to initiation of medication therapy. In addition, no differences were seen in all but one marker for quality of care including length of stay and cumulative morphine dose. Infants treated for NAS, whether in an NICU or SCN setting, can receive similar treatment and comparable outcomes.

An updated meta-analysis approach for genetic linkage.

We present a meta-analysis procedure for genome-wide linkage studies (MAGS). The MAGS procedure combines genome-wide linkage results across studies with possibly distinct marker maps. We applied the MAGS procedure to the simulated data from the Genetic Analysis Workshop 14 in order to investigate power to detect linkage to disease genes and power to detect linkage to disease modifier genes while controlling for type I error. We analyzed all 100 replicates of the four simulated studies for chromosomes 1 (disease gene), 2 (modifier gene), 3 (disease gene), 4 (no disease gene), 5 (disease gene), and 10 (modifier gene) with knowledge of the simulated disease gene locations. We found that the procedure correctly identified the disease loci on chromosomes 1, 3, and 5 and did not erroneously identify a linkage signal on chromosome 4. The MAGS procedure provided little to no evidence of linkage to the disease modifier genes on chromosomes 2 and 10.

Increasing compliance with national quality measures for stroke through use of a standard order set.

PURPOSE: Results of a study to determine the impact of physician use of a medication order set on compliance with national quality standards for acute stroke treatment are presented. METHODS: The medical records of adult patients treated for ischemic stroke at three certified primary stroke centers within a large healthcare system were retrospectively reviewed to assess compliance with eight mandatory standards of care. Overall adherence to the standards and rates of compliance with individual standards were compared in random samples of patients treated with or without physician use of an order set providing guidance on acute stroke pharmacotherapy and other aspects of stroke management. RESULTS: Treatment records indicated use of the acute stroke order set in 58% of the 120 patient cases reviewed. Individual patients who were treated without physician use of the order set were more than twice as likely as those in the comparator group to receive care that was not in compliance with at least one of the eight mandatory quality standards (odds ratio, 2.4; 95% confidence interval, 1.43-4.05; p < 0.001). Use of the order set was associated with significantly improved adherence to three standards: venous thromboembolism prophylaxis, stroke education, and statin therapy at discharge. CONCLUSION: A retrospective review of the treatment records of patients hospitalized for acute stroke showed that adherence to national guidelines was increased when providers used a standard order set.

Use of tree-based models to identify subgroups and increase power to detect linkage to cardiovascular disease traits.

BACKGROUND: Our goal was to identify subgroups of sib pairs from the Framingham Heart Study data set that provided higher evidence of linkage to particular candidate regions for cardiovascular disease traits. The focus of this method is not to claim identification of significant linkage to a particular locus but to show that tree models can be used to identify subgroups for use in selected sib-pair sampling schemes. RESULTS: We report results using a novel recursive partitioning procedure to identify subgroups of sib pairs with increased evidence of linkage to systolic blood pressure and other cardiovascular disease-related quantitative traits, using the Framingham Heart Study data set provided by the Genetic Analysis Workshop 13. This procedure uses a splitting rule based on Haseman-Elston regression that recursively partitions sib-pair data into homogeneous subgroups. CONCLUSIONS: Using this procedure, we identified a subgroup definition for use as a selected sib-pair sampling scheme. Using the characteristics that define the subgroup with higher evidence for linkage, we have identified an area of focus for further study.

Mediators of the association of major depressive syndrome and anxiety syndrome with postpartum smoking relapse.

OBJECTIVE: Based on conceptual models of addiction and affect regulation, this study examined the mechanisms linking current major depressive syndrome (MDS) and anxiety syndrome (AS) to postpartum smoking relapse. METHOD: Data were collected in a randomized clinical trial from 251 women who quit smoking during pregnancy. Simple and multiple mediation models of the relations of MDS and AS with postpartum relapse were examined using linear regression, continuation ratio logit models, and a bootstrapping procedure to test the indirect effects. RESULTS: Both MDS and AS significantly predicted postpartum smoking relapse. After adjusting for MDS, AS significantly predicted relapse. However, after adjusting for AS, MDS no longer predicted relapse. Situationally based self-efficacy, expectancies of controlling negative affect by means other than smoking, and various dimensions of primary and secondary tobacco dependence individually mediated the effect of both MDS and AS on relapse. In multiple mediation models, self-efficacy in negative/affective situations significantly mediated the effect of MDS and AS on relapse. CONCLUSIONS: The findings underscore the negative impact of depression and anxiety on postpartum smoking relapse and suggest that the effects of MDS on postpartum relapse may be largely explained by comorbid AS. The current investigation provided mixed support for affect regulation models of addiction. Cognitive and tobacco dependence-related aspects of negative and positive reinforcement significantly mediated the relationship of depression and anxiety with relapse, whereas affect and stress did not. The findings emphasize the unique role of low agency with respect to abstaining from smoking in negative affective situations as a key predictor of postpartum smoking relapse.