GSM and Quality of Life Measures.

The impact of bothersome vulvovaginal symptoms related to hypoestrogenism on quality of life (QOL) has been evaluated in large international surveys and qualitative studies of vulvovaginal atrophy, most of which were completed before the introduction of the term genitourinary syndrome of menopause (GSM) and focus primarily on vulvovaginal atrophy. The QOL domain most affected in these studies is sexual function, although women also report impacts on self-confidence, self-esteem, sleep, and general enjoyment of life. Health-related QOL measures are available that evaluate the impact of some symptoms associated with GSM on QOL; new measures are in development that assess the full range of symptoms associated with GSM.

Abnormal cervical cancer screening results among US Veteran and non-Veteran participants in the National Health Interview Survey (NHIS).

Female Veterans report cervical cancer risk factors at higher rates than non-Veterans. Using data from the National Health Interview Survey (NHIS), we tested whether Veterans with a recent cervical cancer screening test were more likely than non-Veterans to have received an abnormal result. NHIS is a population-based cross-sectional household survey with a stratified, multistage sampling design. We pooled screening data from 2010, 2015, and 2018, and restricted the sample to female participants without a hysterectomy who had a cervical cancer screening test in the prior 3 years. The primary outcome was self-reported abnormal result on a Pap and/or HPV test in the prior 3 years. Our main predictor was Veteran status. We used survey-weighted multivariable logistic regression to estimate odds of an abnormal screening result in the prior 3 years as a function of Veteran status, controlling first for age and survey year, then adding sociodemographic and health factors in subsequent models. The sample included 380 Veterans and 25,102 non-Veterans (weighted total population 104.9 million). Overall, 19.0% of Veterans and 13.7% of non-Veterans reported an abnormal cervical cancer screening test result in the prior 3 years (unadjusted p = 0.03). In the adjusted regression model, the previously observed association between Veteran status and abnormal screening result was explained by differences in sociodemographic and health factors between Veterans and non-Veterans (aOR 1.21, 95%CI 0.78-1.87). Nearly 1 in 5 Veterans with a recent cervical cancer screening test received an abnormal result. Clinicians should address modifiable risk factors and provide evidence-based follow-up for abnormal results.

Factors Associated with Military Sexual Trauma (MST) Disclosure During VA Screening Among Women Veterans.

BACKGROUND: Capturing military sexual trauma (MST) exposure is critical for Veterans' health equity. For many, it improves access to VA services and allows for appropriate care. OBJECTIVE: Identify factors associated with nondisclosure of MST in VA screening among women. DESIGN: Cross-sectional telephone survey linked with VA electronic health record (EHR) data. PARTICIPANTS: Women Veterans using primary care or women's health services at 12 VA facilities in nine states. MAIN MEASURES: Survey self-reported MST (sexual assault and/or harassment during military service), socio-demographics and experiences with VA care, as well as EHR MST results. Responses were categorized as "no MST" (no survey or EHR MST), "MST captured by EHR and survey," and "MST not captured by EHR" (survey MST but no EHR MST). We used stepped multivariable logistic regression to examine "MST not captured by EHR" as a function of socio-demographics, patient experiences, and screening method (survey vs. EHR). KEY RESULTS: Among 1287 women (mean age 50, SD 15), 35% were positive for MST by EHR and 61% were positive by survey. Approximately 38% had "no MST," 34% "MST captured by EHR and survey," and 26% "MST not captured by EHR". In fully adjusted models, odds of "MST not captured by EHR" were higher among Black and Latina women compared to white women (Black: OR = 1.6, 1.2-2.2; Latina: OR = 1.9, 1.0-3.6). Women who endorsed only sexual harassment in the survey (vs. sexual harassment and sexual assault) had fivefold higher odds of "MST not captured by EHR" (OR = 4.9, 3.2-7.3). Women who were screened for MST in the EHR more than once had lower odds of not being captured (OR = 0.3, 0.2-0.4). CONCLUSIONS: VA screening for MST may disproportionately under capture patients from historically minoritized ethnic/racial groups, creating inequitable access to resources. Efforts to mitigate screening disparities could include re-screening and reinforcing that MST includes sexual harassment.

Development and use of a novel tool for assessing and improving researcher embeddedness in learning health systems and applied system improvements.

This paper outlines the development, deployment and use, and testing of a tool for measuring and improving healthcare researcher embeddedness - i.e., being connected to and engaged with key leverage points and stakeholders in a health system. Despite the widely acknowledged importance of embeddedness for learning health systems and late-stage translational research, we were not aware of useful tools for addressing and improving embeddedness in scholar training programs. We developed the MN-LHS Embeddedness Tool covering connections to committees, working groups, leadership, and other points of contact across four domains: patients and caregivers; local practice (e.g., operations and workflows); local institutional research (e.g., research committees and agenda- or initiative-setting groups); and national (strategic connections within professional groups, conferences, etc.). We used qualitative patterns and narrative findings from 11 learning health system training program scholars to explore variation in scholar trajectories and the embeddedness tool's usefulness in scholar professional development. Tool characteristics showed moderate evidence of construct validity; secondarily, we found significant differences in embeddedness, as a score, from baseline through program completion. The tool has demonstrated simple, practical utility in making embeddedness an explicit (rather than hidden) part of applied and learning health system researcher training, alongside emerging evidence for validity.

The Relationship Between Sexual Assault History and Cervical Cancer Screening Completion Among Women Veterans in the Veterans Health Administration.

Background: Sexual assault affects one in three U.S. women and may have lifelong consequences for women's health, including potential barriers to completing cervical cancer screening and more than twofold higher cervical cancer risk. The objective of this study was to determine whether a history of sexual assault is associated with reduced cervical cancer screening completion among women Veterans. Materials and Methods: We analyzed data from a 2015 survey of women Veterans who use primary care or women's health services at 12 Veterans Health Administration facilities (VA's) in nine states. We linked survey responses with VA electronic health record data and used logistic regression to examine the association of lifetime sexual assault with cervical cancer screening completion within a guideline-concordant interval. Results: The sample included 1049 women, of whom 616 (58.7%) reported lifetime sexual assault. Women with a history of sexual assault were more likely to report a high level of distress related to pelvic examinations, and to report ever delaying a gynecologic examination due to distress. However, in the final adjusted model, lifetime sexual assault was not significantly associated with reduced odds of cervical cancer screening completion (OR 1.35, 95% CI 0.93-1.97). Conclusions: Contrary to our expectations, sexual assault was not significantly associated with gaps in cervical cancer screening completion. Three- to five-year screening intervals may provide sufficient time to complete screening, despite barriers. Trauma-sensitive care practices promoted in the VA may allow women to overcome the distress and discomfort of pelvic examinations to complete needed screening. ClinicalTrials.gov (#NCT02039856).

Reactions to Recommendations and Evidence About Prostate Cancer Screening Among White and Black Male Veterans.

U.S. clinical guidelines recommend that prior to screening for prostate cancer with Prostate Specific Antigen (PSA), men should have an informed discussion about the potential benefits and harms of screening. Prostate cancer disproportionately affects Black men. To understand how White and Black men reacted to a draft educational pamphlet about the benefits and harms of PSA screening, we conducted race-specific focus groups at a midwestern VA medical center in 2013 and 2015. White and Black men who had been previously screened reviewed the draft pamphlet using a semistructured focus group facilitator guide. Forty-four men, ages 55-81, participated in four White and two Black focus groups. Three universal themes were: low baseline familiarity with prostate cancer, surprise and resistance to the recommendations not to test routinely, and negative emotions in response to ambiguity. Discussions of benefits and harms of screening, as well as intentions for exercising personal agency in prevention and screening, diverged between White and Black focus groups. Discussion in White groups highlighted the potential benefits of screening, minimized the harms, and emphasized personal choice in screening decisions. Participants in Black groups devoted almost no discussion to benefits, considered harms significant, and emphasized personal and collective responsibility for preventing cancer through diet, exercise, and alternative medicine. Discussion in Black groups also included the role of racism and discrimination in healthcare and medical research. These findings contribute to our understanding of how men's varied perspectives and life experiences affect their responses to prostate cancer screening information.

Proactive tobacco treatment for veterans with posttraumatic stress disorder.

OBJECTIVE: Individuals with posttraumatic stress disorder (PTSD) smoke at higher rates compared to the general population and experience significant barriers to initiating cessation treatment. Proactive outreach addresses these barriers by directly engaging with smokers and facilitating access to treatment. The objective of the present study was to evaluate a proactive outreach intervention for increasing rates of treatment utilization and abstinence among veteran smokers with and without PTSD. METHOD: This is a secondary analysis of a randomized controlled trial conducted from 2013 to 2017 that demonstrated the effectiveness of proactive outreach among veterans using Veterans Affairs mental health care services. Electronic medical record data were used to identify participants with (n = 355) and without (n = 1,583) a diagnosis of PTSD. Logistic regressions modeled cessation treatment utilization (counseling, nicotine replacement therapy [NRT], and combination treatment) and abstinence (7-day point prevalence and 6-month prolonged at 6- and 12-month follow-ups) among participants randomized to proactive outreach versus usual care in the PTSD and non-PTSD subgroups, respectively. RESULTS: Compared to usual care, proactive outreach increased combined counseling and NRT utilization among participants with PTSD (odds ratio [OR] = 26.25, 95% confidence interval [3.43, 201.17]) and without PTSD (OR = 10.20, [5.21, 19.98]). Proactive outreach also increased 7-day point prevalence abstinence at 12 months among participants with PTSD (OR = 2.62, [1.16, 5.91]) and without PTSD (OR = 1.61, [1.11, 2.34]). CONCLUSIONS: Proactive outreach increased treatment utilization and abstinence among smokers with and without PTSD. Smokers with PTSD may need additional facilitation to initiate cessation treatment but are receptive when it is offered proactively. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Evidence Map: Reporting of Results by Sex or Gender in Randomized, Controlled Trials with Women Veteran Participants (2008 to 2018).

BACKGROUND: Higher participation of women in randomized, controlled trials (RCTs) has not led to significantly improved reporting of sex-stratified results. A recent evidence map of research on women veterans revealed that many studies did not report results by sex or gender. This study's objectives were to compare characteristics of RCTs with women veteran participants that did or did not report results by sex or gender and to assess how sex and gender are addressed in research with women veterans. METHODS: We extended the prior evidence map with a systematic search for RCTs with women veterans, published between 2008 and 2018. We compared the characteristics of RCTs that reported results by sex or gender with those of RCTs that did not, and reviewed methodology and reporting of sex/gender analyses. RESULTS: In addition to 11 studies from the prior evidence map, we assessed 1,820 abstracts for relevance and ultimately included 45 unique RCTs. Five trials included only women and 40 included both men and women (median, 14.3% women). Ten studies reported results by sex or gender. These trials were larger (median study size of n = 343.5 vs. n = 125.5) and included a higher median proportion of women participants (16.8% vs. 11.2%) than studies without sex/gender results. Ten of 11 trials that tested pharmacologic or device interventions did not report results by sex or gender. CONCLUSIONS: Reporting of results by sex or gender remains low in veteran research, but may improve with larger studies and increased recruitment of women veterans into trials. Trials of pharmacologic or device interventions may be targets for future reporting requirements. Standardization could improve attention to sex and gender in methodology and reporting.

Smoking Cessation among Female and Male Veterans before and after a Randomized Trial of Proactive Outreach.

INTRODUCTION: Female veterans smoke cigarettes at high rates compared with both male veterans and nonveteran women. Proactive outreach to smokers may reduce gender disparities in cessation care. The objectives of this study were to compare baseline experiences with VA smoking cessation care for men and women and to assess for gender differences in response to a proactive outreach intervention. METHODS: We conducted a post hoc subgroup analysis of a pragmatic, multisite randomized, controlled trial comparing proactive outreach with usual care (UC). Baseline experiences included physician advice to quit, satisfaction with care, and past-year treatment use. At the 1-year follow-up, treatment use, quit attempts, and 6-month prolonged abstinence for women and men randomized to proactive outreach versus UC were compared using logistic regression. RESULTS: Baseline and follow-up surveys were returned by 138 women and 2,516 men. At baseline, women were less likely than men to report being very or somewhat satisfied with the process of obtaining smoking cessation medications in the VA (47% of women vs. 62% of men), but no less likely to report having used cessation medications from the VA in the past year (39% of women vs. 34% of men). After the intervention, phone counseling and combined therapy increased among both women and men in proactive outreach as compared with UC. At the 1-year follow-up, men in proactive outreach were significantly more likely to report prolonged abstinence than those in UC (odds ratio, 1.65; 95% CI, 1.28-2.14); results for women were in the same direction but not statistically significant (odds ratio, 1.39; 95% CI, 0.48-3.99). CONCLUSIONS: Satisfaction with cessation care in VA remains low. Proactive outreach to smokers was associated with an increased use of cessation therapies, and increased odds of achieving prolonged abstinence. A subgroup analysis by gender did not reveal significant differences in the treatment effect.

Gender differences in rates and predictors of individual psychotherapy initiation and completion among Veterans Health Administration users recently diagnosed with PTSD.

OBJECTIVE: Most veterans with posttraumatic stress disorder (PTSD) who receive care from the Veterans Health Administration (VHA) do not receive individual psychotherapy. The purpose of this study was to explore gender differences in initiation and completion of a sufficient course (defined as attending 8 or more sessions) of individual psychotherapy among male and female VHA users recently diagnosed with PTSD. METHOD: Participants (N = 7,218) were veterans in a prospective national cohort survey of VHA users diagnosed with PTSD; oversampling was used to increase representation of women and minority veterans. RESULTS: Forty-two percent of the sample (40.1% of men, 52.3% of women) initiated individual psychotherapy within 6 months of their index PTSD diagnosis. Of those who initiated, 12.1% (10.8% of men, 17.7% of women) completed a sufficient course of individual psychotherapy. Women were generally more likely than men to initiate individual psychotherapy. However, we found an interaction between gender and age, such that younger men were more likely to initiate psychotherapy than older men; age was not significantly associated with initiation among women. Regarding completion of individual psychotherapy, an interaction between gender and beliefs about psychotherapy was found, such that men were less likely to complete individual psychotherapy when they held more negative beliefs about psychotherapy; these beliefs did not significantly impact female veterans' likelihood of completing psychotherapy. CONCLUSIONS: Overall, while female veterans are more likely than male veterans with PTSD to initiate individual psychotherapy, rates of initiation and completion of individual psychotherapy for both genders remain relatively low. Interventions are needed to increase engagement in individual psychotherapy, particularly for male veterans with PTSD. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

The Equity Impact of Proactive Outreach to Smokers: Analysis of a Randomized Trial.

INTRODUCTION: Population-based smoking-cessation services tend to preferentially benefit high-SES smokers, potentially exacerbating disparities. Interventions that include proactive outreach, telephone counseling, and free or low-cost cessation medications may be more likely to help low-SES smokers quit. This analysis evaluated the role of SES in smokers' response to a population-based proactive smoking-cessation intervention. METHODS: This study, conducted in 2016 and 2017, was a secondary analysis of the Veterans Victory Over Tobacco Study, a multicenter pragmatic RCT of a proactive smoking-cessation intervention conducted from 2009 to 2011. Logistic regression modeling was used to test the effect of income or education level on 6-month prolonged abstinence at 1-year follow-up. RESULTS: Of the 5,123 eligible, randomized participants, 2,565 (50%) reported their education level and 2,430 (47%) reported their income level. The interactions between education (p=0.07) or income (p=0.74) X treatment arm were not statistically significant at the 0.05 level. The largest effect sizes for the intervention were found among smokers in the lowest education category (≤11th grade), with a quit rate of 17.3% as compared with 5.7% in usual care (OR=3.5, 95% CI=1.4, 8.6) and in the lowest income range (<$10,000), with a quit rate of 18.7% as compared with 9.4% in usual care (OR=2.2, 95% CI=1.2, 4.0). CONCLUSIONS: In a large, multicenter smoking-cessation trial, proactive outreach was associated with higher rates of prolonged abstinence among smokers at all SES levels. Proactive outreach interventions that integrate telephone-based care and facilitated cessation medication access have the potential to reduce socioeconomic disparities in quitting. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT00608426.

Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach.

BACKGROUND: Accurate smoking status is key for research purposes, but can be costly and difficult to measure. Within the Veteran's Health Administration (VA), smoking status is recorded as part of routine care as "health factors" (HF)-fields that researchers can query through the electronic health record (EHR). Many researchers are interested in using these fields to track changes in smoking status over time, however the validity of this measure for assessing change is unknown. The primary goal of this project was to examine whether HFs can be used to accurately measure change in tobacco status over time, with secondary goals of assessing the optimum timeframe for assessment and variation in accuracy by site. METHODS: Secondary analysis of the Veterans VICTORY study, a pragmatic smoking cessation randomized controlled trial conducted from 2009 to 2011. Eligible subjects were identified via the EHR using a past 90-day HF indicating current tobacco use (for example: "CURRENT SMOKER", "CURRENTLY USES TOBACCO"). Participants were surveyed at 1 year to determine prolonged smoking abstinence. We identified HFs for tobacco status within +/- 120 days of the follow-up survey mailing date and recorded the temporally closest HF. Among subjects with both measures, we compared the two for agreement using kappa statistics and concordance. RESULTS: 1713 subjects (33%) had both follow-up survey and HF data, 1594 (31%) had only a survey response, 790 (15%) had only HF and 1026 (20%) had neither. For subjects with both measures, there was 90% concordance and moderate agreement (Kappa 0.48, 95%CI 0.41-0.55, Sensitivity 54.4, 95%CI 41.1-67.7, Specificity 94.3, 95%CI 87.5-100.0). CONCLUSIONS: We found high concordance but only moderate agreement by kappa statistics between HFs and survey data. The difference is likely accounted for by the natural history of quit attempts, in which patients cycle in and out of quit attempts. HFs appear to provide an accurate measure of population level quit behavior utilizing data collected in the course of clinical care.

A Proactive Smoking Cessation Intervention for Socioeconomically Disadvantaged Smokers: The Role of Smoking-Related Stigma.

Introduction: Smoking denormalization has been paralleled by reduced smoking prevalence, but smoking rates among socioeconomically disadvantaged populations remain high. The social unacceptability of smoking has also led to increased perceptions of smoking-related stigma. By examining how smoking stigma influences cessation intervention effectiveness, we can better tailor interventions to socioeconomically disadvantaged smokers. Aims and Methods: Data are from a randomized controlled trial evaluating the effectiveness of a proactive cessation intervention on abstinence. Current smokers enrolled in Minnesota Health Care Programs were randomized to proactive outreach (n = 1200) or usual care (n = 1206). The intervention included mailings, telephone outreach, counseling, and access to free cessation treatments. Using baseline measurements, groups with lower (n = 1227) and higher (n = 1093) perceived stigma were formed. Intervention, stigma, and their interaction term were added to a logistic regression modeling abstinence at 12 months. Results: Lower perceived smoking-related stigma was associated with less support for quitting, lower rates of physician quitting advice, and less motivation for quitting. A logistic regression modeling abstinence found a significant intervention × stigma interaction. The proactive intervention was more effective among smokers with lower perceived smoking-related stigma (odds ratio 1.94, 95% confidence interval, 1.29 to 2.92) than those with higher perceived smoking-related stigma (odds ratio 1.04, 95% confidence interval, 0.70 to 1.55). Discussion: Smokers with lower perceived smoking-related stigma had social environments that were conducive to smoking, received less physician advice to quit, and were less motivated to quit than higher stigma smokers. Despite these barriers, the intervention was more effective for lower stigma smokers, suggesting that proactive outreach is an efficient treatment for these hard-to-reach smokers. Implications: Smoking denormalization has led to increased perceptions of smoking-related stigma among many smokers; however, little is known about how this stigma influences the cessation process. In the present study, smokers with lower levels of perceived smoking-related stigma lived in social environments that were more conducive to smoking and were less motivated to quit than higher stigma smokers. Despite these barriers, our proactive outreach cessation intervention was more effective for lower stigma smokers, suggesting that interventions which utilize proactive outreach to stimulate interest in quitting and offer facilitated access to free cessation treatments are an effective treatment approach for these hard-to-reach smokers. These strategies may be particularly effective for motivating smokers enrolled in government-subsidized health insurance programs to take advantage of cessation resources.

Proactive tobacco treatment for individuals with and without a mental health diagnosis: Secondary analysis of a pragmatic randomized controlled trial.

INTRODUCTION: Individuals with (vs. without) mental illness use tobacco at higher rates and have more difficulty quitting. Treatment models for smokers with mental illness are needed. METHODS: This secondary analysis of the Victory Over Tobacco study [a pragmatic randomized clinical trial (N=5123) conducted in 2009-2011 of Proactive Care (proactive outreach plus connection to smoking cessation services) vs. Usual Care] tests the effectiveness of treatment assignment in participants with and without a mental health diagnosis on population-level, 6month prolonged abstinence at one year follow-up. RESULTS: Analyses conducted in 2015-6 found that there was no interaction between treatment group and mental health group on abstinence (F(1,3300=1.12, p=0.29)). Analyses stratified by mental health group showed that those without mental illness, assigned to Proactive Care, had a significantly higher population-level abstinence rate than those assigned to Usual Care (OR=1.40, 95% CI=1.17-1.67); in those with mental illness, assignment to Proactive Care produced a non-significant increase in abstinence compared to Usual Care (OR=1.18, 95% CI=0.98-1.41). Those with mental illness reported more medical visits, cessation advice and treatment (p<0.001), similar levels of abstinence motivation (p>0.05), but lower abstinence self-efficacy (p<0.001). CONCLUSIONS: Those with a mental health diagnosis benefitted less from proactive outreach regarding tobacco use. VA primary care patients with mental illness may not need additional outreach because they are connected to cessation resources during medical appointments. This group may also require more intensive cessation interventions targeting self-efficacy to improve cessation rates. Clinicaltrials.gov registration # NCT00608426.

An Evidence Map of the Women Veterans' Health Research Literature (2008-2015).

BACKGROUND: Women comprise a growing proportion of Veterans seeking care at Veterans Affairs (VA) healthcare facilities. VA initiatives have accelerated changes in services for female Veterans, yet the corresponding literature has not been systematically reviewed since 2008. In 2015, VA Women's Health Services and the VA Women's Health Research Network requested an updated literature review to facilitate policy and research planning. METHODS: The Minneapolis VA Evidence-based Synthesis Program performed a systematic search of research related to female Veterans' health published from 2008 through 2015. We extracted study characteristics including healthcare topic, design, sample size and proportion female, research setting, and funding source. We created an evidence map by organizing and presenting results within and across healthcare topics, and describing patterns, strengths, and gaps. RESULTS: We identified 2276 abstracts and assessed each for relevance. We excluded 1092 abstracts and reviewed 1184 full-text articles; 750 were excluded. Of 440 included articles, 208 (47%) were related to mental health, particularly post-traumatic stress disorder (71 articles), military sexual trauma (37 articles), and substance abuse (20 articles). The number of articles addressing VA priority topic areas increased over time, including reproductive health, healthcare organization and delivery, access and utilization, and post-deployment health. Three or fewer articles addressed each of the common chronic diseases: diabetes, hypertension, depression, or anxiety. Nearly 400 articles (90%) used an observational design. Eight articles (2%) described randomized trials. CONCLUSIONS: Our evidence map summarizes patterns, progress, and growth in the female Veterans' health and healthcare literature. Observational studies in mental health make up the majority of research. A focus on primary care delivery over clinical topics in primary care and a lack of sex-specific results for studies that include men and women have contributed to research gaps in addressing common chronic diseases. Interventional research using randomized trials is needed.

Does Motivation Matter? Analysis of a Randomized Trial of Proactive Outreach to VA Smokers.

BACKGROUND: Current guidelines advise providers to assess smokers' readiness to quit, then offer cessation therapies to smokers planning to quit and motivational interventions to smokers not planning to quit. OBJECTIVES: We examined the relationship between baseline stage of change (SOC), treatment utilization, and smoking cessation to determine whether the effect of a proactive smoking cessation intervention was dependent on smokers' level of motivation to quit. DESIGN: Secondary analysis of a multicenter randomized controlled trial. PARTICIPANTS: A total of 3006 current smokers, aged 18-80 years, at four Veterans Affairs (VA) medical centers. INTERVENTIONS: Proactive care included proactive outreach (mailed invitation followed by telephone outreach), offer of smoking cessation services (telephone or face-to-face), and access to pharmacotherapy. Usual care participants had access to VA smoking cessation services and state telephone quitlines. MAIN MEASURES: Baseline SOC measured with Readiness to Quit Ladder, and 6-month prolonged abstinence self-reported at 1 year. KEY RESULTS: At baseline, 35.8 % of smokers were in preparation, 38.2 % in contemplation, and 26.0 % in precontemplation. The overall interaction between SOC and treatment arm was not statistically significant (p = 0.30). Among smokers in preparation, 21.1 % of proactive care participants achieved 6-month prolonged abstinence, compared to 13.1 % of usual care participants (OR, 1.8 [95 % CI, 1.2-2.6]). Similarly, proactive care increased abstinence among smokers in contemplation (11.0 % vs. 6.5 %; OR, 1.8 [95 % CI, 1.1-2.8]). Smokers in precontemplation quit smoking at similar rates (5.3 % vs. 5.6 %; OR, 0.9 [95 % CI, 0.5-1.9]). Within each stage, uptake of smoking cessation treatments increased with higher SOC and with proactive care as compared with usual care. LIMITATIONS: Mostly male participants limits generalizability. Randomization was not stratified by SOC. CONCLUSIONS: Proactive care increased treatment uptake compared to usual care across all SOC. Proactive care increased smoking cessation among smokers in preparation and contemplation but not in precontemplation. Proactively offering cessation therapies to smokers at all SOC will increase treatment utilization and population-level smoking cessation.

Randomized study of the safety and efficacy of fish oil (omega-3 fatty acid) supplementation with dietary and exercise counseling for the treatment of antiretroviral therapy-associated hypertriglyceridemia.

BACKGROUND: Omega-3 fatty acids (fish oils) reduce fasting serum triglyceride levels and cardiovascular disease risk in individuals without HIV infection. Whether omega-3 fatty acid supplementation can reduce hypertriglyceridemia associated with antiretroviral therapy is not known. METHODS: We conducted an open-label, randomized trial that enrolled 52 patients receiving > or =3 active antiretrovirals who had fasting triglyceride levels of >200 mg/dL and were randomized to receive nutritionist-administered dietary and exercise counseling with or without fish oil supplementation for 16 weeks. RESULTS: Patients assigned to receive fish oil experienced a 25% mean decline in fasting triglyceride levels at week 4 (95% CI, -34.6% to -15.7% change), compared with a 2.8% mean increase among patients assigned to receive counseling alone (95% CI, -17.5% to +23.1% change) (P=.007). By week 16, the mean reduction in triglyceride levels in the fish oil arm remained significant, at 19.5% (95% CI, -34.9% to -4.0% change), whereas the mean decrease in the diet and exercise only arm was 5.7% (95% CI, -24.6% to +13.2% change); however, the difference between study arms was no longer statistically significant (P=.12). Low-density lipoprotein cholesterol levels had increased by 15.6% (95% CI, +4.8% to +26.4% change) at week 4 and by 22.4% (95% CI, +7.91% to +36.8% change) at week 16 in the fish oil arm but did not change in the diet and exercise only group. Fish oil was well tolerated; only 1 patient experienced treatment-limiting toxicity. Patients assigned to receive fish oil experienced a 25% mean decline in fasting triglyceride levels at week 4 (95% CI, -34.6% to -15.7% change), compared with a 2.8% mean increase in patients assigned to receive counseling alone (95% CI, -17.5% to 23.1% change) (P=.007). By week 16, the mean reduction in triglyceride levels in the fish oil arm remained significant, at 19.5% (95% CI, -34.9% to -4.0% change), whereas the mean decrease in the diet and exercise only arm was 5.7% (95% CI, -24.6% to 13.2% change); however, the difference between study arms was no longer statistically significant (P=.12). Low-density lipoprotein cholesterol levels had increased by 15.6% (95% CI, 4.8%-26.4% change) at week 4 and by 22.4% (95% CI, 7.91%-36.8% change) at week 16 in the fish oil arm but did not change in the diet and exercise only group. Fish oil was well tolerated; only 1 patient experienced treatment-limiting toxicity. CONCLUSIONS: Supplementation with omega-3 fatty acids in combination with dietary and exercise counseling was well tolerated and reduced fasting triglyceride levels in patients receiving antiretrovirals. To what extent the increase in low-density lipoprotein cholesterol levels observed in patients assigned this intervention is attributable to omega-3 fatty acid supplementation and whether this increase attenuates any benefit in lowering triglyceride levels is unclear. Given these results, further investigation of omega-3 fatty acid supplementation for the treatment of hypertriglyceridemia in HIV-infected patients is warranted.