Teratogenic medication use associated with favourable odds of contraception counselling in a cohort of women with systemic lupus erythematosus at a large tertiary academic medical centre.

OBJECTIVE: SLE primarily affects women of childbearing age, who have an increased risk of pregnancy complications, especially in the setting of active disease. Contraception counselling is particularly important given the teratogenicity of some medications used for SLE treatment. Our study describes the frequency of contraception counselling provided by multiple subspecialties to women with SLE and investigates associations between teratogenic medication use and receiving contraception counselling. METHODS: This was a cross-sectional retrospective study of women (aged 15-46 years) diagnosed with SLE who were seen in various outpatient clinics at a large tertiary academic medical centre over a 2-year period. Demographic data were retrieved via the university-affiliated central data repository, and additional data, including documentation of contraception counselling, were obtained via manual chart abstraction. Univariable associations between variables and contraception counselling were assessed to produce unadjusted ORs and 95% CIs. Multivariable models were generated to evaluate independent associations between variables and contraception counselling. RESULTS: Data from 478 women (52% African American, 25% Caucasian) with SLE were included. Rheumatology was the subspecialty to document contraception counselling most frequently (57%). Nearly 80% of women received counselling from at least one subspecialty, 44% from at least two. Factors associated with having lower odds of receiving contraception counselling were older age and Caucasian race. Women on teratogenic medications (methotrexate, mycophenolate mofetil/mycophenolic acid, cyclophosphamide) had higher odds of receiving contraception counselling from at least one subspecialty (OR 2.01; 95% CI 1.23 to 3.26), from two or more subspecialties (OR 2.18; 95% CI 1.50 to 3.17), and from rheumatology (OR 1.86; 95% CI 1.27 to 2.73). CONCLUSIONS: In this study, women with SLE on teratogenic medications had higher odds of receiving contraception counselling from rheumatology and from at least two subspecialties. Multidisciplinary approaches to enhance contraception counselling should be encouraged.

Perceived Impact of the COVID-19 Pandemic on Physical Activity Among Adult Patients With Rheumatologic Disease.

OBJECTIVE: The objective of this cross-sectional study was to investigate the impact of the COVID-19 pandemic on physical activity (PA) levels of patients with rheumatic and musculoskeletal diseases (RMDs) and to examine factors associated with decreased PA. METHODS: A sample of adult patients with RMDs (n = 7,776) was identified through electronic medical records from an academic health care system in North Carolina. Invitations to participate in an online survey were sent between July 2020 and September 2020 to assess self-reported changes in PA during the COVID-19 pandemic. Descriptive statistics, age-adjusted prevalence odds ratios (PORs), and 95% confidence intervals (CIs) were computed to examine patient characteristics associated with decreased PA. RESULTS: A total of 893 eligible participants completed the survey (mean age 57.8 ± 14.9 years, 75.8% female). The most common primary diagnoses reported among participants included rheumatoid arthritis (27.3%), osteoarthritis (16.0%), and systemic lupus erythematosus (SLE) (13.0%). More than half of participants (56.8%) reported engaging in less PA since the pandemic began. Factors associated with engaging in less PA included lower self-reported general health (POR, 2.21; CI, 1.64-2.97) and a diagnosis of SLE (POR, 1.57; CI, 1.03-2.38). Comorbidities associated with decreased PA included chronic pain (POR, 1.38; CI, 1.04-1.82), depression (POR, 1.48; CI, 1.09-2.01), and hypertension (POR, 1.44; CI, 1.10-1.90). CONCLUSION: The COVID-19 pandemic has exacerbated barriers to PA in patients with RMDs. There is a critical need to provide resources, support, and multifaceted programs to encourage PA in patients with RMDs during the COVID-19 pandemic.

EMBRACE: One Small Story in Lupus-One Giant Challenge in Clinical Trials.

Clinical trials of novel therapeutics in the United States have not been adequately representative of diverse populations, particularly racial and ethnic minorities. The challenges and consequences of underrepresentation in clinical trial recruitment are exemplified by the case of belimumab, a biologic treatment for systemic lupus erythematosus (SLE), a disease that is more prevalent in patients of Black African ancestry and of Hispanic/Latino ethnicity than in other patient populations. Although belimumab was found to be effective in phase 2 and 3 clinical trials in the general population, post hoc analyses of efficacy data in patients of Black African ancestry showed inconsistent results. Consequently, a cautionary statement regarding belimumab use in this population was added to the product label. To alleviate concerns that belimumab may not be safe and effective for patients of Black African ancestry, the Efficacy and Safety of Belimumab in Black Race Patients with SLE (EMBRACE) study was conducted in a post-marketing commitment to the Food and Drug Administration. The study recruited only patients who self-identified as being of Black race; its findings led to the removal of the cautionary labeling of belimumab use in patients of Black African ancestry. Our manuscript highlights the critical lessons learned from the successes and failures of the EMBRACE study. It also provides suggestions for overcoming health disparities, highlighting strategies for conducting well-designed clinical trials to overcome systematic barriers to diversity in recruitment, with a focus on enacting long-term support to ensure equity in the process, products, and benefits from drug development and clinical trials.

ACT for Lupus: Pilot Feasibility and Acceptability Study of a Novel Web-Based Acceptance and Commitment Therapy Program for Patients With Lupus.

OBJECTIVE: Acceptance and commitment therapy (ACT) has demonstrated effectiveness in addressing symptoms of anxiety and depression, frequently experienced by patients with systemic lupus erythematosus (SLE). The goal of this pilot study was to develop and assess the feasibility and acceptability of a novel web-based ACT skills training program tailored for patients with lupus: ACT for Lupus. The program served as a complementary approach to support the management of symptoms and stressors during the COVID-19 pandemic. METHODS: This study employed a single-group pretest-posttest design. Participants with a diagnosis of SLE were primarily recruited through an institutional healthcare system between November 25, 2020 and December 17, 2020 and through an online national lupus organization listserv. Participants were invited to attend two 1-hour webinars delivered over a 2-week period. Educational ACT-based content was tailored for patients with lupus and delivered by an experienced clinical psychologist specializing in ACT. Surveys assessed patient-reported outcomes of anxiety, depression, and quality of life and evaluated program feedback, usability, and satisfaction. RESULTS: A total of 83 participants submitted the baseline survey, with 21 participants designated as study completers. The program was well received by participants, who reported feasibility and acceptability of the intervention, as reflected by high usability ratings. Participants reported favorable experiences with the program. Feedback included suggestions to include additional lupus-tailored content, increase the range and scope of sessions and activities, and improve program flexibility and availability to avoid scheduling conflicts. CONCLUSION: This study provides preliminary evidence for an adapted, ACT-based virtual skills training program as a feasible and acceptable intervention to support the well-being of patients with lupus.

Awareness and outcomes of the fruits and veggies (FNV) campaign to promote fruit and vegetable consumption among targeted audiences in California and Virginia: a cross-sectional study.

BACKGROUND: In 2015, the Partnership for a Healthier America launched the branded Fruits & Veggies (FNV) Campaign to apply a unique industry-inspired marketing approach to promote fruit and vegetable sales and intake to moms and teens in two US pilot markets: Fresno, California and Hampton Roads, Virginia. The aims of this cross-sectional study were to: 1) assess brand awareness and fruit- and vegetable-related outcomes among FNV Campaign target audiences in the California and Virginia market locations; and 2) examine whether reported awareness of the FNV Campaign was associated with differences in fruit- and vegetable-related cognitive and behavioral outcomes. METHODS: Data for this cross-sectional study were collected using an online survey administered to a non-probability convenience sample (n = 1604; February-July 2017) of youth aged 14-20 years (n = 744) and moms aged 21-36 years (n = 860) in the two pilot markets. Descriptive statistics were computed and outcomes compared between unaware and aware respondents, controlling for sociodemographic covariates. Multivariate analysis of covariance (MANCOVA) was conducted to assess whether fruit- and vegetable-related attitude, belief, and encouragement outcomes differed by FNV Campaign awareness; logistic regression was used to examine associations between FNV brand awareness and dichotomous variables (fruit- and vegetable-related behavioral intentions, trying new fruits and vegetables); and ANCOVA was used to assess associations with daily fruit and vegetable intake frequency. RESULTS: Approximately 20% (n = 315/1604) of respondents reported awareness of the FNV Campaign. Youth that reported awareness of the FNV Campaign (n = 167, 22.4%) had higher intentions to buy (p = 0.003) and eat (p = 0.009) fruits and vegetables than unaware respondents. Mothers that reported awareness of the FNV Campaign (n = 148, 17.2%) reported greater encouragement for friends and family to eat fruits and vegetables (p = 0.013) and were approximately 1.5 times more likely to report trying a new fruit or vegetable (p = 0.04) than mothers unaware of the Campaign. Daily fruit and vegetable intake frequency did not differ by Campaign awareness. CONCLUSIONS: FNV Campaign awareness was associated with limited but positive short- and intermediate-term cognitive and behavioral outcomes among target audience respondents. These findings can inform future research to enhance understanding and improve the FNV Campaign as it is expanded to new markets nationwide.

Rise and Fall: Hydroxychloroquine and COVID-19 Global Trends: Interest, Political Influence, and Potential Implications.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic has led to rapid research and reporting on potential preventatives and treatments for the disease, including the drug hydroxychloroquine (HCQ). Despite a lack of robust evidence to support the use of HCQ for treatment of COVID-19, it was publicly endorsed and received widespread media coverage and public interest. The purpose of this report is to describe and contextualize the surges in public interest, demand, and adoption of HCQ for treatment of COVID-19 and outline implications for future public health policy and practice. METHODS: Using national and global events and Google Trends data as a measure of public interest, we describe the timeline and trends in the emergence of, interest in, and adoption of HCQ as a treatment of COVID-19. We additionally review reports on public demand for HCQ for treatment of COVID-19 and impacts on medication access among patients with indicated uses. RESULTS: Public interest and demand for HCQ surged in the United States and globally following endorsements from public officials and enaction of policies to facilitate off-label use of HCQ for treatment of COVID-19. Surges in demand for HCQ led to multiple documented shortages and barriers to accessing HCQ treatment for patients with indicated uses for HCQ. Although there have been reversals in policies to support HCQ use for treatment of COVID-19 in some regions, others have continued or expanded recommended uses. CONCLUSION: Insights from the global response to HCQ and COVID-19 can be used to inform prudent decision-making in the future to prevent premature action and promote informed and equitable responses to promote public health.

A Qualitative Study to Understand Stakeholders' Views About the Fruits & Veggies (FNV) Social Marketing Campaign to Promote Fruit and Vegetable Consumption in the United States.

BACKGROUND: In 2015, the Partnership for a Healthier America (PHA) piloted a branded social marketing communications initiative called the FNV (Fruits & Veggies) Campaign to promote the sale and consumption of fruits and vegetables among mom and teen target audiences in 2 California and Virginia pilot markets. After the first year, FNV was expanded to multiple markets across the United States through diverse partnerships. Factors, resources, and strategies that contribute to the effectiveness and sustainability of the campaign need to be identified. OBJECTIVE: The purpose of this qualitative study was to explore diverse stakeholders' views and expectations about the FNV Campaign design, reach, effectiveness, and impact and prospects for expansion, scale-up, and sustainability. DESIGN: Semistructured interviews were conducted between July and October 2016 with stakeholders to elicit their perspectives and expectations of the FNV Campaign. PARTICIPANTS/SETTING: A purposive sample of diverse stakeholders (n = 22) affiliated with national, state, and local industry and government and nongovernmental organizations. ANALYSIS: Data were recorded, transcribed, input into NVivo 11 software (QSR International. Melbourne, Australia), coded and organized thematically using a conceptual framework that examined campaign design, reach, effectiveness, adoption, implementation, expansion, scaling up, and sustainability. RESULTS: Opportunities, challenges, and expectations of stakeholders were reported for the FNV Campaign related to engaging future partners from different levels of community, government, and industry; conducting and disseminating findings from multifaceted evaluations; ensuring campaign effectiveness; and developing and improving campaign elements for target audiences and partner adoption. Conducting formative research, partner, and audience engagement, implementation, and evaluation are essential to the ensure effectiveness and sustainability of the FNV Campaign. CONCLUSIONS: Insights from this study can inform the strategic use of social marketing campaign elements to facilitate the effectiveness and sustainability of the FNV Campaign as it expands and is scaled up across markets nationwide.

Evaluation of integrated marketing communication strategies used for the Fruits & Veggies Campaign in California and Virginia.

In 2015, the Partnership for a Healthier America launched the branded Fruits & Veggies (FNV) Campaign to promote fruit and vegetable sales and intake to moms and teens in two California and Virginia pilot markets. The FNV Campaign used a novel, creative approach to promote fruits and vegetables through integrated marketing communication (IMC) strategies. Findings from a mixed-methods process evaluation conducted between 2016 and 2017 were used to explore congruence between stakeholders' expectations of IMC strategy potential and FNV brand awareness and reach among target audiences. Awareness and recall of IMC strategies were assessed through a cross-sectional survey of target audience respondents (n = 1604) from the pilot markets. Qualitative data regarding IMC strategy potential and influential factors were gathered from stakeholder interviews (n = 22). Approximately 19.6% (n = 315) of respondents were aware of the FNV Campaign. Stakeholders' perspectives regarding IMC potential aligned with findings that the proportion of aware respondents was significantly (p = 0.008) higher among teens (22%) than moms (17%). Qualitative results also converged with higher proportions of survey respondents recalling brand exposure through social media (46%) and retail settings (30%) than community activities (18%), word of mouth (17.5%), and traditional media advertisements (9.5%). IMC recall did not differ between mom and teen respondents except for significantly (p = 0.02) higher word of mouth recall among teen respondents. Findings support using selected IMC strategies and future involvement of diverse stakeholders. Evaluation results can inform future research and practice to improve IMC strategy reach and influence as the FNV Campaign expands to new markets nationwide.

How Branded Marketing and Media Campaigns Can Support a Healthy Diet and Food Well-Being for Americans: Evidence for 13 Campaigns in the United States.

This report summarizes the available evidence for strategies used in large-scale, branded marketing campaigns to promote healthy dietary behaviors to Americans between 1990 and 2016. An adapted health-branding framework guided the 3-step mixed-methods approach to identify evidence for campaigns using a scoping review, comprehensive literature review, and key-informant interviews (n = 11). Results show that industry, government, and nongovernmental organizations supported 13 campaigns that used various health-branding strategies. The authors suggest opportunities that may inform the design and evaluation of diet-related campaigns to improve understanding and application of health-branding strategies to promote a healthy diet and to advance consumer health and well-being.

Probiotic supplementation and trimethylamine-N-oxide production following a high-fat diet.

OBJECTIVE: The objective of this study was to test the hypothesis that the multi-strain probiotic VSL#3 would attenuate the increase in fasting plasma concentrations of trimethylamine-N-oxide (TMAO) following a high-fat diet. METHODS: Nineteen healthy, non-obese males (18-30 years) participated in the present study. Following a 2-week eucaloric control diet, subjects were randomized to either VSL#3 (900 billion live bacteria) or placebo (cornstarch) during the consumption of a hypercaloric (+1,000 kcal day(-1) ), high-fat diet (55% fat) for 4 weeks. Plasma TMAO, L-carnitine, choline, and betaine (UPLC-MS/MS) were measured at baseline and following a high-fat diet. RESULTS: Plasma TMAO significantly increased 89% ± 66% vs. 115% ± 61% in both the VSL#3 and placebo groups, respectively; however, the magnitude of change in plasma TMAO was not different (P > 0.05) between them. Plasma L-carnitine, choline, and betaine concentrations did not increase following the high-fat diet in either group. CONCLUSIONS: A high-fat diet increases plasma TMAO in healthy, normal-weight, young males. However, VSL#3 treatment does not appear to influence plasma TMAO concentrations following a high-fat diet. Future studies are needed to determine whether other therapeutic strategies can attenuate the production of TMAO.

Short-term high-fat diet increases postprandial trimethylamine-N-oxide in humans.

The gut microbiota plays an obligatory role in the metabolism of nutrients containing trimethylamine moieties, such as L-carnitine and choline, leading to the production of the proatherogenic trimethylamine-N-oxide (TMAO). We hypothesized that a short-term, high-fat diet would increase fasting and postprandial plasma concentrations of TMAO in response to a high-fat meal challenge. Following a 2-week eucaloric control diet, 10 nonobese men (18-30 years) consumed a eucaloric, high-fat diet (55% fat) for 5 days. Plasma TMAO was measured after a 12-hour fast and each hour after for 4 hours following a high-fat meal (63% fat) at baseline and after the high-fat diet using ultraperformance liquid chromatography/ tandem mass spectrometry. Fasting plasma TMAO did not increase significantly following the high-fat diet (1.83 ± 0.21 vs 1.6 ± 0.24 µmol/L). However, plasma TMAO was higher at hour 1 (2.15 ± 0.28 vs 1.7 ± 0.30 µmol/L), hour 2 (2.3 ± 0.29 vs 1.8 ± 0.32 µmol/L), hour 3 (2.4 ± 0.34 vs 1.58 ± 0.19 µmol/L), and hour 4 (2.51 ± 0.33 vs 1.5 ± 0.12 µmol/L) (all P < .05) following the high-fat diet as compared with the baseline postprandial response. In conclusion, a short-term, high-fat diet does not increase fasting plasma TMAO concentrations but appears to increase postprandial TMAO concentrations in healthy, nonobese, young men. Future studies are needed to determine the mechanisms responsible for these observations.