Assessment of the 2021 AASLD Practice Guidance for Albumin Infusion in Elective Therapeutic Paracentesis: A Regression Discontinuity Design.

INTRODUCTION: The 2021 American Association for the Study of Liver Disease (AASLD) Practice Guidance recommends albumin infusion when removing ≥5 L of ascites to prevent post-paracentesis circulatory dysfunction. However, the optimal criteria and scenarios for initiating albumin infusion subsequent to therapeutic paracentesis (TP) have been subject to limited scientific inquiry. METHODS: We conducted a retrospective cohort study at a US academic healthcare center. Participants received elective, outpatient TP between July 2019 and December 2022. Patients with spontaneous bacterial peritonitis, post-TP clinical adjustments, and/or hospitalization were excluded. The institution strictly followed the AASLD Guidance. We used a sharp regression discontinuity (RD) design to estimate the effect of albumin infusion at the AASLD Guidance-recommended cutoff of 5 L on serum creatinine and sodium trajectory after TP. RESULTS: Over the study period, 1,457 elective TPs were performed on 235 unique patients. Albumin infusion at the threshold of 5 L of ascites removal reduced serum creatinine levels by 0.046 mg/dL/d (95% confidence interval 0.003-0.116, P = 0.037) and increased serum sodium levels by 0.35 mEq/L/d (95% confidence interval 0.15-0.55, P = 0.001) compared with those who did not receive albumin infusion. The RD plots indicated worsened serum creatine/sodium levels after draining 3 L of fluid, approaching levels similar to or worse than with albumin infusion at 5 L or more. DISCUSSION: Our RD models supported the 2021 AASLD Guidance with robust estimation of causal effect sizes at the cutoff level of 5 L. Nevertheless, the findings also highlight the need to further evaluate the efficacy of albumin infusion in patients who undergo elective TP and have 3-5 L of ascites removed.

The "dirty work" of last responders: Occupational stigma risk and protective factors.

Last responders constitute an occupational category that includes all those who are involved in the postmortem care of deceased persons and their families. The work of last responders is often considered "dirty work" and, as a result, stigmatized. Last responders are aware of this stigma, and stigma consciousness has been associated with negative health outcomes. Despite the wide acknowledgment of stigma among last responders, specific risk, or protective factors for experiencing stigma have not been investigated. This paper aims to identify determinants of stigma among last responders in the United States. The data for this study were obtained from a national cross-sectional survey of last responders. The survey included a measure of stigma and multiple sociodemographic characteristics. A hurdle model was used to assess the association between the characteristics of last responders and their perceived stigma. Respondents were predominantly male (55.1%), White non-Hispanic (90.2%), and employed full-time (96%). Seventy-seven percent reported having experienced at least one form of occupation-related stigma. There was no significant association between the experience of stigma and any socio-demographic variables. The experience of stigma is nearly ubiquitous among last responders->75% of last responders in the sample experienced at least one form of stigma. Another aspect of its ubiquitous nature is the lack of evidence that stigma was experienced differentially across sex, race/ethnicity, employment type, and length of years as a last responder. Interventions are needed to decrease stigma among last responders and to support last responders in managing the consequences of the stigma they experience.

Differential Impact of the UNOS Simultaneous Liver-kidney Transplant Policy Change Among Patients With Sustained Acute Kidney Injury.

BACKGROUND: Simultaneous liver-kidney transplant (SLK) allocation policy in the United States was revised in August 2017, reducing access for liver transplant candidates with sustained acute kidney injury (sAKI) and potentially adversely impacting vulnerable populations whose true renal function is overestimated by commonly used estimation equations. METHODS: We examined national transplant registry data containing information for all liver transplant recipients from June 2013 to December 2021 to assess the impact of this policy change using instrumental variable estimation based on date of listing. RESULTS: Posttransplant survival was compared for propensity-matched patients with sAKI who were only eligible for liver transplant alone (LTA_post; n = 638) after the policy change but would have been SLK-eligible before August 2017, with similar patients who were previously able to receive an SLK (SLK; n = 319). Overall posttransplant patient survival was similar at 3 y (81% versus 80%; P = 0.9). However, receiving an SLK versus LTA increased survival among African Americans (87% versus 61% at 3 y; P = 0.029). A trend toward survival benefit from SLK versus LTA, especially later in the follow-up period, was observed in recipients ≥ age 60 (3-y survival: 84% versus 76%; P = 0.2) and women (86% versus 80%; P = 0.2). CONCLUSIONS: The 2017 United Network for Organ Sharing SLK Allocation Policy was associated with reduced survival of African Americans with end-stage liver disease and sAKI and, potentially, older patients and women. Our study suggested the use of race-neutral estimation of renal function would ameliorate racial disparities in the SLK arena; however, further studies are needed to reduce disparity in posttransplant outcomes among patients with liver and kidney failure.

A smoking cessation intervention for rural veterans tailored to individual risk factors: A multicenter randomized clinical trial.

INTRODUCTION: Rates of cigarette use remain elevated among those living in rural areas. Depressive symptoms, risky alcohol use, and weight concerns frequently accompany cigarette smoking and may adversely affect quitting. Whether treatment for tobacco use that simultaneously addresses these issues affects cessation outcomes is uncertain. METHODS: The study was a multicenter, two-group, randomized controlled trial involving mostly rural veterans who smoke (N = 358) receiving treatment at one of five Veterans Affairs Medical Centers. The study randomly assigned participants to a tailored telephone counseling intervention or referral to their state tobacco quitline. Both groups received guideline-recommended smoking cessation pharmacotherapy, selected using a shared decision-making approach. The primary outcome was self-reported seven-day point prevalence abstinence (PPA) at three and six months. The study used salivary cotinine to verify self-reported quitting at six months. RESULTS: Self-reported PPA was significantly greater in participants assigned to Tailored Counseling at three (OR = 1.66; 95 % CI: 1.07-2.58) but not six (OR = 1.35; 95 % CI: 0.85-2.15) months. Post hoc subgroup analyses examining treatment group differences based on whether participants had a positive screen for elevated depressive symptoms, risky alcohol use, and/or concerns about weight gain indicated that the cessation benefit of Tailored Counseling at three months was limited to those with ≥1 accompanying concern (OR = 2.02, 95 % CI: 1.20-3.42). Biochemical verification suggested low rates of misreporting. CONCLUSIONS: A tailored smoking cessation intervention addressing concomitant risk factors enhanced short-term abstinence but did not significantly improve long-term quitting. Extending the duration of treatment may be necessary to sustain treatment effects.

"It Is A Carrot-Stick Model": A Qualitative Study of Rural-Serving Clinician and Rural-Residing Veteran Perceptions of Requirements to Quit Smoking prior to Elective Surgery.

Introduction: Some medical centers and surgeons require patients to stop smoking cigarettes prior to elective orthopaedic surgeries in an effort to decrease surgical complications. Given higher rates of smoking among rural individuals, rural patients may be disproportionately impacted by these requirements. We assessed the perceptions and experiences of rural-residing Veterans and clinicians related to this requirement. Methods: We conducted qualitative semistructured one-on-one interviews of 26 rural-residing veterans, 10 VA orthopaedic surgery staff (from two Veterans Integrated Services Networks), 24 PCPs who serve rural veterans (14 VA; 10 non-VA), and 4 VA pharmacists. Using the knowledge, attitudes, and behavior framework, we performed conventional content analysis. Results: We found three primary themes across respondents: (1) knowledge of and the evidence base for the requirement varied widely; (2) strong personal attitudes toward the requirement; and (3) implementation and possible implications of this requirement. All surgery staff reported knowledge of requirements at their institution. VA PCPs reported knowledge of requirements but typically could not recall specifics. Most patients were unaware. The majority of respondents felt this requirement could increase motivation to quit smoking. Some PCPs felt a more thorough explanation of smoking-related complications would result in increased quit attempts. About half of all patients reported belief that the requirement was reasonable regardless of initial awareness. Respondents expressed little concern that the requirement might increase rural-urban disparities. Most PCPs and patients felt that there should be exceptions for allowing surgery, while surgical staff disagreed. Discussion. Most respondents thought elective surgery was a good motivator to quit smoking; but patients, PCPs, and surgical staff differed on whether there should be exceptions to the requirement that patients quit preoperatively. Future efforts to augment perioperative smoking cessation may benefit from improving coordination across services and educating patients more about the benefits of quitting.

Determinants of smoking related weight-concern in smokers participating in a community-based cessation program.

BACKGROUND: Concern about weight gain is a barrier to smoking-cessation, but determinants of postcessation weight-concern have not been comprehensively assessed in the context of community-based cessation programs. METHODS: This cross-sectional analysis used baseline data from a cessation trial of 392 adults randomized to physical activity (PA) or general wellness counseling as adjunctive treatment for smoking. Outcomes were 1) smoking behaviors to control weight and 2) anticipating relapse due to weight gain. Independent variables were PA and perceptions, sociodemographics, psychosocial measures, smoking behavior and perceptions, diet, and BMI. From bivariable models examining main and sex interaction effects, significant variables were entered into a linear (control) or logistic (relapse) regression model to identify key determinants. RESULTS: For both measures, weight-concern was greater (p < .05) for female smokers (standardized b = 0.52, SE = 0.10; OR = 0.29, 95 % CI = 0.17-0.49), White (b = 0.12, SE = 0.05; OR = 0.39, 95 % CI = 0.23-0.66), and less motivated to quit (b = -0.14, SE = 0.05; OR = 0.77, 95 % CI = 0.59-1.0). Higher scores for smoking to control weight were associated with less PA (b = -0.10, SE = 0.05) and higher BMI (b = 0.21, SE = 0.05). For men, higher BMI was associated with greater anticipation of relapse (OR = 2.54, 95 % CI = 1.42-4.56). CONCLUSIONS: Among adults attempting cessation, women, White smokers, and those less motivated to quit were more likely to smoke for weight control and to relapse due to weight gain. Higher BMI was associated with greater anticipation of relapse for men, but not women. Weight-concerns, for both measures, were not related to smoking history, psychosocial functioning, PA engagement or attitudes, or dietary variables. Results suggest potential cessation intervention targets for weight-concerned smokers.

Ignored and distressed: a cross-sectional study of the impact of COVID-19 on last responders.

BACKGROUND: Last responders constitute an occupational category that includes all those that are involved in the postmortem care of deceased persons and their families. Last responders are exposed to several categories of work-related stressors that affect their health and well-being. COVID-19 exacerbated these stressors. Research to understand the consequences of COVID-19 on the health and wellbeing of last responders is nascent. This study aimed to assess COVID-19 related stress, coping and wellbeing among last responders in the United States. METHODS: We conducted a national cross-sectional survey of last responders in July through September of 2020. The survey measured wellbeing, stress, coping, and stigma; COVID-19 experiences, and socio-demographics. A ridge regression model was fit for the outcome variables. RESULTS: Analysis was conducted on 366 respondents from 43 states. Respondents were male (55.4%), age 50 + (57.4%), and White non-Hispanic (90.3%); 54% reported moderate-high stress and 41% endorsed mild-severe anxiety. Seventy-seven percent had experienced at least one form of stigma related to their occupation. Variables associated with higher perceived stress and anxiety included gender (female), shorter length of employment, perceiving a higher impact from COVID-19 on everyday life, and increased perceived stigma. CONCLUSIONS: Last responders are a critical part of the health care system. Throughout this pandemic, last responders have been frequently ignored and not prioritized for protection and support. Interventions to support last responders cope with stress, and to decrease anxiety are urgently needed. There is also a critical need to challenge community stigma towards last responders.

The Efficacy of Individualized, Community-Based Physical Activity to Aid Smoking Cessation: A Randomized Controlled Trial.

Objective: The efficacy of individualized, community-based physical activity as an adjunctive smoking cessation treatment to enhance long-term smoking cessation rates was evaluated for the Lifestyle Enhancement Program (LEAP). Methods: The study was a two-arm, parallel-group, randomized controlled trial. All participants (n = 392) received cessation counseling and a nicotine patch and were randomized to physical activity (n = 199; YMCA membership and personalized exercise programming from a health coach) or an equal contact frequency wellness curriculum (n = 193). Physical activity treatment was individualized and flexible (with each participant selecting types of activities and intensity levels and being encouraged to exercise at the YMCA and at home, as well as to use "lifestyle" activity). The primary outcome (biochemically verified prolonged abstinence at 7-weeks (end of treatment) and 6- and 12-months postcessation) and secondary outcomes (7-day point prevalent tobacco abstinence (PPA), total minutes per week of leisure time physical activity and strength training) were assessed at baseline, 7 weeks, 6 months, and 12 months. Results: Prolonged abstinence in the physical activity and wellness groups was 19.6% and 25.4%, respectively, at 7-weeks, 15.1% and 16.6% at 6-months, and 14.1% and 17.1% at 12 months (all between-group P values >0.18). Similarly, PPA rates did not differ significantly between groups at any follow-up. Change from baseline leisure-time activity plus strength training increased significantly in the physical activity group at 7 weeks (P = 0.04). Across treatment groups, an increase in the number of minutes per week in strength training from baseline to 7 weeks predicted prolonged abstinence at 12 months (P ≤ 0.001). Further analyses revealed that social support, fewer years smoked, and less temptation to smoke were associated with prolonged abstinence over 12 months in both groups. Conclusions: Community-based physical activity programming, delivered as adjunctive treatment with behavioral/pharmacological cessation treatment, did not improve long-term quit rates compared to adjunctive wellness counseling plus behavioral/pharmacological cessation treatment. This trial is registered with https://beta.clinicaltrials.gov/study/NCT00403312, registration no. NCT00403312.

Sociodemographic and Clinical Factors Associated with Nonattendance at the Hepatology Clinic.

BACKGROUND: Absenteeism from clinic appointments reduces efficiency, wastes resources, and contributes to longer wait times. There are limited data regarding factors associated with nonattendance in hepatology clinics. Identifying factors related to appointment nonattendance may help in the design of interventions for reducing absenteeism. METHODS: We aim to identify sociodemographic, clinical, and appointment-related factors associated with absenteeism following referral to a liver clinic in a tertiary academic center located in the US Midwest. We designed a case-control study using data from electronic medical records of patients scheduled for appointments between January 2016 and December 2021. Cases were defined as patients who canceled appointments on the same day or resulting in no-shows, and controls were those who completed the referral visit. Information about patients' sociodemographic characteristics, appointment details, and etiology of liver disease were recorded. Hierarchical logistic regression was used to analyze factors related to nonattendance. RESULTS: Of 3404 scheduled appointments, 460 (13.5%) missed visits were recorded. In the multivariable logistic regression models, hepatitis C and alcohol-associated liver disease were associated with greater odds of nonattendance [odds ratio (OR) 4.0 (95% CI 3.2-4.9), OR 2.7 (1.7-4.2), respectively] compared to those with other liver disease. Sociodemographic characteristics associated with risk of nonattendance included being Black [OR 2.6, (1.8-3.7)], Medicaid insurance or no insurance [OR 2.3 (1.7-2.9), OR 2.5 (1.6-3.7), respectively], non-English speaking [OR 1.8 (1.1-3.1)], being unmarried [OR 1.8 (1.4-2.2)], and longer wait time (> 30 days) until appointments [OR 1.8 (1.5-2.2)]. CONCLUSION: Several sociodemographic and administrative characteristics, as well as hepatitis C and alcohol-associated liver disease were associated with appointment nonattendance. Targeted future interventions may help to decrease nonattendance.

Obesity treatment initiation, retention, and outcomes in the Veterans Affairs MOVE! Program among rural and urban veterans.

Objective: Rural veterans have high obesity rates. Yet, little is known about this population's engagement with the Veterans Affairs (VA) weight management program (MOVE!). The study objective is to determine whether MOVE! enrollment, anti-obesity medication use, bariatric surgery use, retention, and outcomes differ by rurality for veterans with severe obesity. Methods: This is a retrospective cohort study using Veterans Health Administration patient databases, including VA patients with severe obesity during 2015-2017. Patients were categorized using Rural-Urban Commuting Area codes. Primary outcomes included proportion of patients and risk-adjusted likelihood of initiating VA MOVE!, anti-obesity medication, or bariatric surgery and risk-adjusted highly rural|Hazard Ratio (HR) of any obesity treatment. Secondary outcomes included treatment retention (≥12 weeks) and successful weight loss (5%) among patients initiating MOVE!, and risk-adjusted odds of retention and successful weight loss. Results: Among 640,555 eligible veterans, risk-adjusted relative likelihood of MOVE! treatment was significantly lower for rural and HR veterans (HR = 0.83, HR = 0.67, respectively). Initiation rates of anti-obesity medication use were significantly lower as well, whereas bariatric surgery rates, retention, and successful weight loss did not differ. Conclusions: Overall treatment rates with MOVE!, bariatric surgery, and anti-obesity medications remain low. Rural veterans are less likely to enroll in MOVE! and less likely to receive anti-obesity medications than urban veterans.

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use.

BACKGROUND: Total joint arthroplasties are common orthopedic surgeries that carry risk for developing chronic post-surgical pain. In addition to pre- and post-operative pain severity, psychological distress (e.g., anxiety, pain catastrophizing) is a risk factor for chronic postsurgical pain. Cognitive behavioral therapy (CBT) for chronic pain is an empirically supported approach to managing chronic pain, functional impairment, and related distress. While CBT has been used extensively in patients with established chronic pain, using it as a preventive intervention targeting the transition from acute to chronic postsurgical pain is a novel application. OBJECTIVES: The Perioperative Pain Self-Management (PePS) program is a pain self-management intervention based on the principles of CBT. This innovative intervention is brief, flexible, and is delivered remotely. The current study aims to determine the efficacy of PePS compared to standard care on reducing the incidence of significant surgical site pain at 6-months post-surgery. The current study also aims to evaluate the context for subsequent implementation. METHODS: This study is a hybrid type I efficacy-preparing for implementation trial. It is a two-site, single-blind, two-arm, parallel, randomized control trial. Surgical patients will be randomized to either receive: 1) PePS plus standard care, or 2) Standard care. The primary end point will be surgical site pain severity at 6-months post-surgery. CONCLUSION: Results from this study are expected to result in support for a brief scalable intervention (PePS) that can prevent the development of chronic pain and prolonged post-surgical opioid use, as well as key details to inform subsequent implementation. CLINICALTRIALS: govIdentifier:NCT04979429.

The Impact of Preoperative Distress: A Qualitative analysis of the Perioperative Pain Self-Management Intervention.

PURPOSE: Preoperatively distressed patients are at elevated risk for chronic postsurgical pain. Active psychological interventions show promise for mitigating chronic postsurgical pain. This study describes experiences of preoperatively distressed (elevated depressive symptom, anxious symptoms, or pain catastrophizing) and non-distressed participants who participated in the psychologically based Perioperative Pain Self-management (PePS) intervention. DESIGN: This is a qualitative study designed to capture participants' perspectives and feedback about their experiences during the PePS intervention. METHODS: Interviews were semi-structured, conducted by telephone, audio-recorded, transcribed, and audited for accuracy. Coded interviews were analyzed using a quote matrix to discern possible qualitative differences in what preoperatively distressed and non-distressed participants found most and least helpful about the intervention. RESULTS: Twenty-one participants completed interviews, 7 of whom were classified as distressed. Distressed participants identified learning how to reframe their pain as the most helpful part of the intervention. Non-distressed participants focused on the benefit of relaxation skill-building to manage post-surgical pain. Distressed and non-distressed participants both emphasized the importance of the social support aspects of PePS and- identified goal-setting as challenging. CONCLUSIONS: Distressed and non-distressed participants emphasized different preferences for pain management strategies offered by PePS. Most participants emphasized the importance of social support that PePS provided. CLINICAL IMPLICATIONS: Our results indicate that post-operative patients may benefit from interpersonal interaction with a trained interventionist. Our findings also suggest that distressed and non-distressed patients may benefit from varied intervention approaches. How to build flexibility into a manualized intervention or whether these subsets of patients would benefit more from different interventions is a direction for future research.

Enhancing the Biopsychosocial Approach to Perioperative Care: A Pilot Randomized Trial of the Perioperative Pain Self-management (PePS) Intervention.

OBJECTIVE: The current study aimed to pilot the PePS intervention, based on principles of cognitive behavioral therapy (CBT), to determine feasibility and preliminary efficacy for preventing chronic pain and long-term opioid use. SUMMARY BACKGROUND DATA: Surgery can precipitate the development of both chronic pain and long-term opioid use. CBT can reduce distress and improve functioning among patients with chronic pain. Adapting CBT to target acute pain management in the postoperative period may impact longer-term postoperative outcomes. METHODS: This was a mixed-methods randomized controlled trial in a mixed surgical sample with assignment to standard care or PePS, with primary outcomes at 3-months postsurgery. The sample consisted of rural-dwelling United States Military Veterans. RESULTS: Logistic regression analyses found a significant effect of PePS on odds of moderate-severe pain (on average over the last week) at 3-months postsurgery, controlling for preoperative moderate-severe pain: Adjusted odds ratio = 0.25 (95% CI: 0.07-0.95, P < 0.05). At 3-months postsurgery, 15% (6/39) of standard care participants and 2% (1/45) of PePS participants used opioids in the prior seven days: Adjusted Odds ratio = 0.10 (95% CI: 0.01-1.29, P = .08). Changes in depression, anxiety, and pain catastrophizing were not significantly different between arms. CONCLUSIONS: The findings from this study support the feasibility and preliminary efficacy of the PePS intervention.

Time to put it out - nurse-facilitated tobacco treatment in a comprehensive cancer center.

Few cancer patients receive guideline-concordant care for treatment of tobacco dependence. The purpose of this pilot trial was to obtain preliminary estimates of effectiveness of an evidence-based practice intervention on the delivery of tobacco treatment and cessation outcomes in cancer patients. We conducted a pragmatic implementation trial with a before-after design in 119 current or recently quit adult smokers with cancer who met with a clinician at a single National Cancer Institute designated comprehensive cancer center (CCC) (n = 61 pre-implementation, n = 58 post-implementation). We used a multi-component strategy based on the Chronic Care Model to implement National Comprehensive Cancer Network (NCCN) guidelines for smoking cessation. Smoking cessation counseling during the index visit was assessed by exit interview and patients were interviewed by phone to assess cessation outcomes at 3-month follow-up. Performance of cessation counseling and 7-day point prevalence abstinence (PPA) were compared across the pre- and post-implementation periods using log-logistic regression, accounting for clustering by nursing staff. More patients had received assistance in quitting at the index visit during the post-implementation period compared to the pre-implementation period (30 vs. 10%, p < .01). At 3-month follow-up, 38 and 14% of participants had discussed smoking cessation medication with a CCC healthcare professional and 57 and 27% of participants had used pharmacotherapy, respectively (p < .01 for both comparisons). Seven-day PPA at 3-month follow-up was similar in both periods, however (14 vs. 12%, respectively). A multi-component tobacco treatment intervention increased the proportion of smokers who received assistance in quitting smoking during usual cancer care but did not improve cessation outcomes.

Few patients with cancer receive help in quitting smoking. We conducted a pilot before-after trial to determine the effectiveness of an evidence-based practice intervention, including brief cessation counseling during the clinic visit and referral to an onsite tobacco treatment specialist, on the delivery of stop smoking services and cessation outcomes at a NCI-designated Comprehensive Cancer Center. During the post-implementation period, cancer patients who smoke were more likely to have received assistance in quitting in clinic and during 3-month follow-up. This change in process of care did not translate into improved short-term abstinence from tobacco, however. Greater and more sustained participation in tobacco treatment will be needed to improve cessation outcomes in this population.

Smoking Cessation among Pregnant and Postpartum Women from Low-Income Groups in the United States.

INTRODUCTION: Pregnancy creates a unique window of opportunity for smoking cessation. However, pregnant women from underserved groups can face personal, social, and environmental challenges that impede quitting. This study draws upon the socioecological framework to explore perspectives on smoking cessation among pregnant and postpartum women from low-income groups in the mid-South of the United States. METHODS: Semistructured interviews were conducted with 60 women who were pregnant or postpartum. Data were analyzed in Dedoose qualitative software using the directed content analysis approach. RESULTS: Findings reveal that at the individual level, motivations for smoking cessation included the fact of being pregnant, risks associated with the infant's health, and desire to breastfeed. However, some pregnant women perceived that slowing down on smoking during pregnancy was adequate to prevent harm to their fetuses. Individual-level factors that made smoking cessation difficult included nicotine addiction and habit, boredom, stressful life circumstances, fear of weight gain, and perceived lack of willpower. At the interpersonal level, living in a smoke-free environment where loved ones do not smoke and emotional and practical support from social network members including partners and family members were thought to facilitate smoking cessation. At the organizational level, access to nicotine replacement therapies and counseling aided in their abilities to quit smoking. At the policy level, pregnant women viewed increase in cigarette prices, warning labels on the cigarette pack, and the potential for a ban on cigarette sales as having some effect in helping them quit smoking. DISCUSSION: This study offers theoretical insights into factors that function as barriers or facilitators of smoking cessation among pregnant and postpartum women from low-income groups in the United States. Designing multilevel smoking cessation interventions while considering the interplay of individual, interpersonal, organizational, and policy level factors may lead to better cessation outcomes.

A cluster randomized trial to evaluate a centralized remote clinical pharmacy service in large, health system primary care clinics.

Background: We developed a remote cardiovascular risk service (CVRS) managed by clinical pharmacists to support primary care teams. The purpose of this study was to examine whether the CVRS could improve guideline adherence in primary care clinics with diverse geographic and patient characteristics. Methods: This study was a cluster-randomized trial initiated in 20 primary care clinics across the US. Clinics were stratified as high or low minority and then randomized to receive the intervention or maintain usual care for 12 months. The primary outcome was adherence to relevant The Guideline Advantage (TGA) criteria met. TGA is a compilation of criteria from practice guidelines intended to improve the quality of primary care. Post-hoc outcomes included changes in individual TGA measures. Results: A total of 401 study subjects were included in the analysis. Mean TGA scores remained the same in the intervention group (n=193, 0.72) and slightly decreased in the usual care group (n=208, 0.67 to 0.66) over the 12-month study period. There was no significant difference between the mean TGA scores in intervention and usual care groups for the overall population at 12 months (0.72 versus 0.66 respectively, p=0.10). For under-represented minority subjects, there was no significant difference between TGA scores at 12 months (n=186; 0.70 versus 0.67, respectively, p=0.50). In a post-hoc analysis of subjects uncontrolled at baseline, there was a significant improvement in systolic BP at 12 months in the intervention group versus usual care (model-based difference of -8.03mmHg, p=0.03). Conclusions: Improvements in individual TGA measures were limited, in part, due to higher than expected baseline TGA scores. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02215408; https://clinicaltrials.gov/ct2/show/NCT02215408?id=NCT02215408.

The Reversion of cg05575921 Methylation in Smoking Cessation: A Potential Tool for Incentivizing Healthy Aging.

Smoking is the largest preventable cause of mortality and the largest environmental driver of epigenetic aging. Contingency management-based strategies can be used to treat smoking but require objective methods of verifying quitting status. Prior studies have suggested that cg05575921 methylation reverts as a function of smoking cessation, but that it can be used to verify the success of smoking cessation has not been unequivocally demonstrated. To test whether methylation can be used to verify cessation, we determined monthly cg05575921 levels in a group of 67 self-reported smokers undergoing biochemically monitored contingency management-based smoking cessation therapy, as part of a lung imaging protocol. A total of 20 subjects in this protocol completed three months of cotinine verified smoking cessation. In these 20 quitters, the reversion of cg05575921 methylation was dependent on their initial smoking intensity, with methylation levels in the heaviest smokers reverting to an average of 0.12% per day over the 3-month treatment period. In addition, we found suggestive evidence that some individuals may have embellished their smoking history to gain entry to the study. Given the prominent effect of smoking on longevity, we conclude that DNA methylation may be a useful tool for guiding and incentivizing contingency management-based approaches for smoking cessation.