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Abstract Background Polycystic ovary syndrome (PCOS) is underdiagnosed, but factors associated with women’s report of diagnosis are not well-understood, particularly social determinants of health. Therefore, in a population-based cohort, we compared the characteristics of women with self-reported PCOS vs. women who have unrecognized PCOS vs. women without PCOS. Methods We performed a secondary data analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study, a population-based, prospective cohort of Black and White women. Participants were women (n = 2028) who responded to the question, “Did a doctor or nurse ever tell you that you had polycystic ovarian syndrome or polycystic ovarian disease?” at the year 15 examination. Women who answered “yes” were defined as having self-reported PCOS. Women who answered “no or not sure” were defined as having unrecognized PCOS if they also had irregular menses and hyperandrogenemia between 20 and 30 years of age. Exposures of interest included social determinants of health, symptoms including irregular menses and hirsutism, and comorbid conditions. Results Forty-three (2.1%) of women had self-reported PCOS, 135 (6.7%) had unrecognized PCOS, and 1850 (91%) women were without PCOS. In logistic regression models adjusting for age, race, and center, women with self-reported PCOS were more likely to have obesity (OR 1.83, 95% CI 1.22, 2.75) and diabetes (OR 2.37, 95% CI 1.05, 5.33) compared to women without PCOS. Women with unrecognized PCOS were more likely to have hypertension (OR 1.68, 95% CI 1.03, 2.74) and food insecurity (OR 1.94, 95% CI 1.25, 3.01) compared to women without PCOS. Conclusions Unrecognized PCOS is common. Self-report of PCOS is not associated with access to healthcare. Women who report PCOS are more often obese and comorbidities may contribute to recognition of PCOS.

Abstract Background The 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) 3rd expert report highlights up-to-date Cancer Prevention Recommendations that may reduce burdens of many chronic diseases, including diabetes. This study examined if following a lifestyle that aligns with the recommendations – assessed via the 2018 WCRF/AICR Score – was associated with lower risk of type 2 diabetes in high-risk adults participating in the Diabetes Prevention Program Outcomes Study (DPPOS). Methods The Diabetes Prevention Program (DPP) randomized adults at high risk for diabetes to receive a lifestyle intervention (ILS), metformin (MET) or a placebo (PLB) (mean: 3.2 years), with additional follow-up in DPPOS for 11 years (mean: 15 years total). 2018 WCRF/AICR Scores included seven components: body weight, physical activity, plant-based foods, fast foods, red and processed meat, sugar-sweetened beverages, and alcohol; the optional breastfeeding component was excluded. Scores ranged 0-7 points (with greater scores indicating greater alignment with the recommendations) and were estimated at years 0, 1, 5, 6, 9, and 15 (N=3,147). Fasting glucose and HbA1c were measured every six months and oral glucose tolerance tests were performed annually. Adjusted Cox proportional hazard ratios (HRs) and 95% confidence intervals (CIs) were used to examine the association of both Score changes from years 0-1 and time-dependent Score changes on diabetes risk through DPP and year 15. Results Scores improved within all groups over 15 years (p

Abstract Background While the United States has the largest number of children with type 1 diabetes mellitus, less is known regarding adult-onset disease. The present study utilizes nationwide data to compare the incidence of type 1 diabetes in youth (0–19 years) to that of adults (20–64 years). Methods In this longitudinal study, the Clinformatics® Data Mart Database was used, which contains information from 61 million commercially insured Americans (years 2001–2015). Incidence rates and exact Poisson 95% confidence intervals were calculated by age group, sex, census division, and year of diagnosis. Changes in rates over time were assessed by negative binomial regression. Results Overall, there were 32,476 individuals who developed type 1 diabetes in the cohort. The incidence rate was greatest in youth aged 10–14 years (45.5 cases/100,000 person-years); however, because adulthood spans over a longer period than childhood, there was a greater number of new cases in adults than in youth (n = 19,174 adults; n = 13,302 youth). Predominance in males was evident by age 10 and persisted throughout adulthood. The male to female incidence rate ratio was 1.32 (95% CI 1.30–1.35). The incidence rate of type 1 diabetes in youth increased by 1.9% annually from 2001 to 2015 (95% CI 1.1–2.7%; P

Abstract Background Previous reports have noted that dehydroepiandrosterone-sulfate (DHEAS) increases prior to the final menstrual period (FMP) and remains stable beyond the FMP. How DHEAS concentrations correspond with other sex hormones across the menopausal transition (MT) including androstenedione (A4), testosterone (T), estrone (E1), and estradiol (E2) is not known. Our objective was to examine how DHEAS, A4, T, E1, and E2 changed across the MT by White vs. African-American (AA) race/ethnicity. Methods We conducted a longitudinal observational analysis of a subgroup of women from the Study of Women’s Health Across the Nation observed over 4 visits prior to and 4 visits after the FMP (n = 110 women over 9 years for 990 observations). The main outcome measures were DHEAS, A4, T, E1, and E2. Results Compared to the decline in E2 concentrations, androgen concentrations declined minimally over the MT. T (β 9.180, p < 0.0001) and E1 (β 11.365, p < 0.0001) were higher in Whites than in AAs, while elevations in DHEAS (β 28.80, p = 0.061) and A4 (β 0.2556, p = 0.052) were borderline. Log-transformed E2 was similar between Whites and AAs (β 0.0764, p = 0.272). Body mass index (BMI) was not significantly associated with concentrations of androgens or E1 over time. Conclusion This report suggests that the declines in E2 during the 4 years before and after the FMP are accompanied by minimal changes in DHEAS, A4, T, and E1. There are modest differences between Whites and AAs and minimal differences by BMI.

Abstract Background Reproductive age may be a risk factor for vascular disease. Anti-Müllerian hormone (AMH) is produced by viable ovarian follicles and reflects reproductive age. We examined whether AMH concentrations were associated with markers of subclinical cardiovascular disease (CVD) and kidney disease among women with type 1 diabetes. Methods We performed a cross-sectional analysis of the Epidemiology of Diabetes Interventions and Complications Study. Participants included women with type 1 diabetes and ≥1 AMH measurement (n = 390). In multivariable regression models which adjusted for repeated measures, we examined the associations between AMH with CVD risk factors, estimated glomerular filtration rate, and albumin excretion ratio. We also examined whether initial AMH concentrations were associated with the presence of any coronary artery calcification (CAC) or carotid intima media thickness (cIMT). Results After adjustment for age, AMH was not associated with waist circumference, blood pressure, lipid profiles, or renal function. Higher initial AMH concentrations had borderline but non-significant associations with the presence of CAC after adjustment for age (odds ratio [OR] 1.08, 95% confidence interval [CI] 1.00, 1.16) which were minimally altered by addition of other CVD risk factors, although women in the 3rd quartile of AMH had lower odds of CAC than women in the lowest quartile (OR 0.40, 95% CI 0.17, 0.94). After adjustment for age, higher AMH was associated with statistically significant but only slightly higher cIMT (0.005 mm, p = 0.0087) which was minimally altered by addition of other CVD risk factors. Conclusions Among midlife women with type 1 diabetes, AMH has slight but significant associations with subclinical measures of atherosclerosis. Future studies should examine whether these associations are clinically significant. Trial registration NCT00360815 and NCT00360893 Study Start Date April 1994.

Abstract Background Health messages on e-cigarette packs emphasise nicotine addiction or harms using similar wording to warnings on cigarette packs. These may not be appropriate for e-cigarettes which constitute a reduced risk alternative for smokers. This research aimed to (1) develop and test a selection of relative risk messages for e-cigarette products; (2) compare these to the two current EU Tobacco Products Directive (TPD) nicotine addiction messages; and (3) explore differences between smokers, non-smokers and dual users. Method Twenty-six messages focusing on either harm-reduction or cessation were developed and rated by multidisciplinary experts for accuracy, persuasiveness and clarity. The eight highest ranking messages were compared alongside the TPD messages in a sample of 983 European residents (316 smokers, 327 non-smokers, 340 dual users) on understandability, believability and convincingness. Results On all three constructs combined, the two TPD messages rated the highest, closely followed by four relative risk messages “Completely switching to e-cigarettes lowers your risk of smoking related diseases”, “Use of this product is much less harmful than smoking”, “Completely switching to e-cigarettes is a healthier alternative to smoking”, and “This product presents substantially lower risks to health than cigarettes” which did not differ statistically from the TPD messages. Non-smokers rated TPD1 significantly higher overall than dual users. Dual users rated “This product is a safer alternative to smoking” significantly higher than non-smokers. Messages did not differ on understandability. Conclusions These alternative messages provide a useful resource for future research and for policy makers considering updating e-cigarette product labelling.

Abstract Background Article 20 of the EU Tobacco Products Directive [TPD] stipulates that e-cigarette packets and refill products must carry a nicotine addiction health warning. Although previous studies conducted in North America have found that perceived harm, addictiveness and intention to use declined following exposure to e-cigarette health warnings, possible effects of the TPD health warnings on smokers and non-smokers has not been studied. This study will investigate the effects of the EU TPD e-cigarette health warnings and a comparative harm message (COMP; developed specifically for this study) on smokers’ and non-smokers’ perceptions of harm, addictiveness and social acceptability of e-cigarettes. Additionally, the potential effects of the TPD warnings and the COMP on smokers’ intentions to purchase and use e-cigarettes will be explored. Methods/design A sample of 2400 UK residents will be recruited in this experimental, randomised design, with Smoking status (Smoker vs. Non-smoker), TPD presence (TPD1 vs. TPD2 vs. No-TPD) and COMP presence (Presence vs. Absence) as between subjects independent variables, and Time (pre-post exposure of images) as a within subjects factor. Dependent variables comprise self-reported perceived harm, addictiveness, social acceptability, e-cigarettes’ effectiveness, intentions to purchase and use e-cigarettes. Cigarette dependence, previous e-cigarette exposure, and baseline intentions to quit will be measured as covariates. Discussion Health warnings, such as those implemented by the TPD, may help to prevent non-smokers from e-cigarettes use, but it is possible that they may inadvertently deter smokers from initiating use and substituting their tobacco smoking for e-cigarettes use if their content is deemed too negative. It is hoped that this study will help identify the most effective message or combination of messages that encourage use among smokers without promoting use among non-smokers. Trial registration ISRCTN registry ISRCTN76967031; date of registration: 23/10/18.

Abstract Background Contrary to intuition, use of lower strength nicotine e-liquids might not offer reduced health risk if compensatory puffing behaviour occurs. Compensatory puffing (e.g. more frequent, longer puffs) or user behaviour (increasing the wattage) can lead to higher temperatures at which glycerine and propylene glycol (solvents used in e-liquids) undergo decomposition to carbonyl compounds, including the carcinogens formaldehyde and acetaldehyde. This study aims to document puffing patterns and user behaviour associated with using high and low strength nicotine e-liquid and associated toxicant/carcinogen exposure in experienced e-cigarette users (known as vapers herein). Methods/design A counterbalanced repeated measures design. Participants: Non-tobacco smoking vapers; have used an e-cigarette for ≥3 months; currently using nicotine strength e-liquid ≥12mg/mL and a second or third generation device. Intervention: This study will measure puffing patterns in vapers whilst they use high and low strength nicotine e-liquid under fixed and user-defined settings, each for a week. The 4 counterbalanced conditions are: i) low strength (6mg/mL), fixed settings; ii) low strength user-defined settings; iii) high strength (18mg/mL) fixed settings; iv) high strength user-defined settings. Biomarkers of exposure to toxicants and carcinogens will be measured in urine. In the second phase of this study, toxicant yields will be measured in aerosol generated using a smoking machine operated to replicate the puffing behaviours of each participant. Primary outcomes: i) Puffing patterns (mean puff number, puff duration, inter-puff interval and mL of liquid consumed) and user behaviour (changes to device settings: voltage and air-flow) associated with using high and low strength nicotine e-liquid. ii) Toxicant/carcinogen exposure associated with the puffing patterns/device settings used by our participants. Secondary outcomes: i) Subjective effects. ii) comparisons with toxicant exposure from tobacco smoke (using documented evidence) and with recommended safety limits. Sample size: Twenty participants. Discussion The findings will have important implications for public health messaging regarding the relative risks and subjective effects associated with using high and low strength nicotine e-liquid, and for policy makers regarding regulations on nicotine concentrations in e-liquids.