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Background: Gonorrhea incidence in the United States has risen by nearly 50% in the last decade, while screening rates have increased. Gonorrhea sequelae rates could indicate whether increased gonorrhea incidence is due to better screening. We estimated the association of gonorrhea diagnosis with pelvic inflammatory disease (PID), ectopic pregnancy (EP), and tubal factor infertility (TFI) in women and detected changes in associations over time. Materials and Methods: This retrospective cohort study included 5,553,506 women aged 18–49 tested for gonorrhea in the IBM MarketScan claims administrative database from 2013–2018 in the United States. We estimated incidence rates and hazard ratios (HRs) of gonorrhea diagnosis for each outcome, adjusting for potential confounders using Cox proportional hazards models. We tested the interaction between gonorrhea diagnosis and the initial gonorrhea test year to identify changes in associations over time. Results: We identified 32,729 women with a gonorrhea diagnosis (mean follow-up time in years: PID = 1.73, EP = 1.75, TFI = 1.76). A total of 131,500 women were diagnosed with PID, 64,225 had EP, and 41,507 had TFI. Women with gonorrhea diagnoses had greater incidence per 1000 person-years for all outcomes (PID = 33.5, EP = 9.4, TFI = 5.3) compared to women without gonorrhea diagnoses (PID = 13.9, EP = 6.7, TFI = 4.3). After adjustment, HRs were higher in women with a gonorrhea diagnosis vs. those without [PID = 2.29 (95% confidence interval, CI: 2.15–2.44), EP = 1.57, (95% CI: 1.41–1.76), TFI = 1.70 (95% CI: 1.47–1.97)]. The interaction of gonorrhea diagnosis and test year was not significant, indicating no change in relationship by initial test year. Conclusion: The relationship between gonorrhea and reproductive outcomes has persisted, suggesting a higher disease burden. [ABSTRACT FROM AUTHOR]

Background: Aerobic exercise has shown inconsistent cognitive effects in older adults with Alzheimer's disease (AD) dementia.Objective: To examine the immediate and longitudinal effects of 6-month cycling on cognition in older adults with AD dementia.Methods: This randomized controlled trial randomized 96 participants (64 to cycling and 32 to stretching for six months) and followed them for another six months. The intervention was supervised, moderate-intensity cycling for 20-50 minutes, 3 times a week for six months. The control was light-intensity stretching. Cognition was assessed at baseline, 3, 6, 9, and 12 months using the AD Assessment Scale-Cognition (ADAS-Cog). Discrete cognitive domains were measured using the AD Uniform Data Set battery.Results: The participants were 77.4±6.8 years old with 15.6±2.9 years of education, and 55% were male. The 6-month change in ADAS-Cog was 1.0±4.6 (cycling) and 0.1±4.1 (stretching), which were both significantly less than the natural 3.2±6.3-point increase observed naturally with disease progression. The 12-month change was 2.4±5.2 (cycling) and 2.2±5.7 (control). ADAS-Cog did not differ between groups at 6 (p = 0.386) and 12 months (p = 0.856). There were no differences in the 12-month rate of change in ADAS-Cog (0.192 versus 0.197, p = 0.967), memory (-0.012 versus -0.019, p = 0.373), executive function (-0.020 versus -0.012, p = 0.383), attention (-0.035 versus -0.033, p = 0.908), or language (-0.028 versus -0.026, p = 0.756).Conclusion: Exercise may reduce decline in global cognition in older adults with mild-to-moderate AD dementia. Aerobic exercise did not show superior cognitive effects to stretching in our pilot trial, possibly due to the lack of power. [ABSTRACT FROM AUTHOR]

Background: The Tobacco Longitudinal Care study was a randomized controlled trial for smoking cessation. It demonstrated that longitudinal care for smoking cessation, in which telephone-based counseling and nicotine replacement therapy were offered for 12 months, was more effective than the standard 8-week treatment.Purpose: This study aims to identify for whom and how longitudinal care increased the likelihood of abstinence.Methods: Mediated moderation analyses were utilized across three time points.Results: There was a trend towards smokers who did not respond to treatment (i.e., were still smoking) by 21 days being more likely to be abstinent at 6 months if they received longitudinal care rather than usual care. Similarly, those who did not respond to treatment by 3 months were more likely to be abstinent at 12 months if they received longitudinal care. At both time points, the likelihood of abstinence did not differ across treatment conditions among participants who responded to treatment (i.e., quit smoking). The effect on 6-month outcomes was mediated by satisfaction and readiness to quit. Cessation self-efficacy, satisfaction, and readiness to quit mediated the effect on 12-month outcomes. The effect of treatment condition on the likelihood of abstinence at 18 months was not moderated by response to treatment at 6 months.Conclusions: Smokers who did not respond to initial treatment benefited from longitudinal care. Differential effects of treatment condition were not observed among those who responded to early treatment. Conditional assignment to longitudinal care may be useful. Determining for whom and how interventions work over time will advance theory and practice. [ABSTRACT FROM AUTHOR]

The etiology of childhood cancers remains largely unknown, especially regarding environmental and behavioral risk factors. Unpacking the association between socioeconomic status (SES) and incidence may offer insight into such etiology. We tested associations between SES and childhood cancer incidence in a population-based case-cohort study (source cohort: Minnesota birth registry, 1989-2014). Cases, ages 0-14 years, were linked from the Minnesota Cancer Surveillance System to birth records through probabilistic record linkage. Controls were 4:1 frequency matched on birth year (2,947 cases and 11,907 controls). We tested associations of individual-level (maternal education) and neighborhood-level (census tract composite index) SES using logistic mixed models. In crude models, maternal education was positively associated with incidence of acute lymphoblastic leukemia (odds ratio (OR) = 1.10, 95% confidence interval (CI): 1.02, 1.19), central nervous system tumors (OR = 1.12, 95% CI: 1.04, 1.21), and neuroblastoma (OR = 1.15, 95% CI: 1.02,1.30). Adjustment for established risk factors--including race/ ethnicity, maternal age, and birth weight--substantially attenuated these positive associations. Similar patterns were observed for neighborhood-level SES. Conversely, higher maternal education was inversely associated with hepatoblastoma incidence (adjusted OR = 0.70, 95% CI: 0.51, 0.98). Overall, beyond the social patterning of established demographic and pregnancy-related exposures, SES is not strongly associated with childhood cancer incidence. [ABSTRACT FROM AUTHOR]

Background: Raw bioimpedance parameters (eg, 50-kHz phase angle [PA] and 200-kHz/5-kHz impedance ratio [IR]) have been investigated as predictors of nutrition status and/or clinical outcomes. However, their validity as prognostic measures depends on the availability of appropriate reference data. Using a large and ethnically diverse data set, we aimed to determine if ethnicity influences these measures and provide expanded bioimpedance reference data for the U.S.Population: Methods: The National Health and Nutrition Examination Survey (NHANES) is an ongoing compilation of studies conducted by the U.S. Centers for Disease Control and Prevention designed to monitor nutrition status of the U.S.Population: The NHANES data sets analyzed were from the years 1999-2000, 2001-2002, and 2003-2004.Results: Multivariate analysis showed that PA and IR differed by body mass index (BMI), age, sex, and ethnicity (n = 6237; R2 = 41.2%, P < .0001). Suggested reference cut-points for PA stratified by age decade, ethnicity, and sex are provided.Conclusion: Ethnicity is an important variable that should be accounted for when determining population reference values for PA and IR. We have provided sex-, ethnicity-, and age decade-specific reference values from PA for use by future studies in U.S.Populations: Interdevice differences are likely to be important contributors to variability across published population-specific reference data and, where possible, should be evaluated in future research. Ultimately, further validation with physiologically relevant reference measures (eg, dual-energy x-ray absorptiometry) is necessary to determine if PA/IR are appropriate bedside tools for the assessment of nutrition status in a clinical population. [ABSTRACT FROM AUTHOR]

The article reports findings from 2 segments of a larger project that examined multiple aspects of expedited safety reporting from sponsors to site investigators who were asked to prospectively record the time they spent receiving, interpreting and communicating expedited safety reports from investigational new drug application (IND) sponsors. Topics discussed include the 2 lessons derived from the investigators' experience including the significant engagement of potential survey participants.

Mixed models are commonly used to represent longitudinal or repeated measures data. An additional complication arises when the response is censored, for example, due to limits of quantification of the assay used. While Gaussian random effects are routinely assumed, little work has characterized the consequences of misspecifying the random-effects distribution nor has a more flexible distribution been studied for censored longitudinal data. We show that, in general, maximum likelihood estimators will not be consistent when the random-effects density is misspecified, and the effect of misspecification is likely to be greatest when the true random-effects density deviates substantially from normality and the number of noncensored observations on each subject is small. We develop a mixed model framework for censored longitudinal data in which the random effects are represented by the flexible seminonparametric density and show how to obtain estimates in SAS procedure NLMIXED. Simulations show that this approach can lead to reduction in bias and increase in efficiency relative to assuming Gaussian random effects. The methods are demonstrated on data from a study of hepatitis C virus. [ABSTRACT FROM PUBLISHER]

The Heart of New Ulm Project (HONU), is a population-based project designed to reduce modifiable cardiovascular disease (CVD) risk factors in the rural community of New Ulm, MN. HONU interventions address multiple levels of the social-ecological model. The community is served by one health system, enabling the use of electronic health record (EHR) data for surveillance. The purpose of this study was to assess if trends in CVD risk factors and healthcare utilization differed between a cohort of New Ulm residents age 40-79 and matched controls selected from a similar community, using EHR data from baseline (2008-2009) through three follow up time periods (2010-2011, 2012-2013, 2014-2015). Matching, using covariate balance sparse technique, yielded a sample of 4077 New Ulm residents and 4077 controls. We used mixed effects longitudinal models to examine trends over time between the two groups. Blood pressure, total cholesterol, low-density lipoprotein-cholesterol, and triglycerides showed better management in New Ulm over time compared to the controls. The proportion of residents in New Ulm with controlled blood pressure increased by 6.2 percentage points compared to an increase of 2 points in controls (p < 0.0001). As the cohort aged, 10-year ASCVD risk scores increased less in New Ulm (5.1) than the comparison community (5.9). The intervention and control community did not differ with regard to inpatient stays, smoking, or glucose. Findings suggest efficacy for the HONU project interventions for some outcomes. [ABSTRACT FROM AUTHOR]