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Mycoplasma genitalium is a sexually transmitted bacterium associated with nongonococcal urethritis (NGU) in men and cervicitis, endometritis, and pelvic inflammatory disease in women. Effective treatment is challenging due to the inherent, and increasingly acquired, antibiotic resistance in this pathogen. In our treatment trial conducted from 2007 to 2011 in Seattle, WA, we demonstrated poor efficacy of azithromycin (AZM) and doxycycline (DOX) against M. genitalium among men with NGU. In the present study, we cultured M. genitalium from 74 of 80 (92.5%) PCR-positive men at enrollment (V-1) and defined the MICs of AZM (N = 56 isolates) of DOX (N = 62 isolates). Susceptibility to AZM was bimodal; MICs were >8 μg/ml (44.6%) and 8 μg/ml (18/18 men) than those with isolates that had AZM MICs of 8 μg/ml (12/18 men) than with AZM MICs of

Background A sensitive and specific serologic test is needed to evaluate the association of Mycoplasma genitalium (MG) infection with serious upper reproductive tract sequelae in women. In this study, we compared the ability of immunoblot and ELISA methods to detect serum antibody reactivity with the immunodominant MgpB and MgpC adherence proteins among MG-infected men with nongonococcal urethritis (NGU). Methods Serum samples collected at two time points (spanning 15–86 days) from 22 MG-infected, PCR-positive men with NGU were assayed for reactivity to MG whole cell lysates by immunoblot, and to the conserved C-terminus of MgpB by ELISA, compared to 19 MG-negative controls. Additionally, we selected six MG(+) men with a variety of immunoblot reactivities and examined their serum specimens for ELISA reactivity to 16 recombinant peptides spanning conserved and variable domains of MgpB and MgpC at two time points. Results Among men with current MG infection, immunoblot detection of MgpB antibodies outperformed an ELISA assay detecting reactivity to the conserved C-terminus of MgpB with 90.9% and 81.8% sensitivity, and 92.3% and 82.3% specificity, respectively. In contrast to immunoblot results, ELISA-reactivity to individual peptides spanning MgpB and MgpC indicated patient antibodies more frequently targeted the C-terminus of MgpC than the C-terminus of MgpB. As expected, most patient sera reacted poorly in ELISAs to recombinant peptides spanning the MgpB and MgpC variable regions as these sequences corresponded to the G37 type strain rather than the infecting strains. Conclusion Our findings suggest that an MG ELISA test could be improved by including conserved portions of both the MgpB and MgpC proteins, providing an alternative to the more labor intensive immunoblot. Such a test will be especially valuable for associating current or past MG infection with serious upper reproductive tract disease in women. Disclosure No significant relationships.

BACKGROUND In 2009, the American Academy of Orthopedic Surgeons published clinical practice guidelines (CPGs) on the treatment of pediatric diaphyseal femur fractures, which recommended a nonaccidental trauma (NAT) evaluation for all patients below 36 months of age. A recent study of these guidelines found

IntroductionRheumatic heart disease causes substantial morbidity in children in low-income countries. School-based echocardiographic screening has been suggested as a means to identify children with latent disease; however, little is known about the experience of children and teachers participating in screenings. The aim of our study was to assess students’ and teachers’ experience of school-based echocardiographic screening and identify areas for improvement.Materials and methodsA school-based echocardiographic screening programme was conducted in five schools in Northern Uganda in 2013. After 8 months, an age- and gender-stratified population that included 5% of the participating students and teachers completed a questionnaire via an in-person interview. Responses were reviewed by question and coded to identify key themes.ResultsA total of 255 students (mean 10.7 years; 48% male) and 35 teachers participated in our study. In total, 95% of the students and 100% of the teachers were happy to have participated in the screening; however, students reported feeling scared (35%) and nervous (48%) during the screening process. Programmatic strengths included the following: knowing one’s health status, opportunity to receive treatment, and staff interactions. Although 43% of the patients did not suggest a change with open-ended questioning, concerns regarding privacy, fear of the screening process, and a desire to include others in the community were noted.DiscussionSchool-based echocardiographic rheumatic heart disease screening was well received by students and teachers. Future programmes would likely benefit from improved pre-screening education regarding the screening process and diagnosis of rheumatic heart disease. Furthermore, education of teachers and students could improve screening perception and establish realistic expectations regarding the scope of screening.

Background Chronic conditions are common and costly for older Americans and for the health system. Adherence to daily maintenance medications may improve patient health and lead to lower health care spending. Methods To identify predictors of adherence and to quantify associations with health care utilization and spending among older adults with chronic conditions, we conducted a longitudinal retrospective analysis using the OptumLabs Data Warehouse. This database of deidentified administrative claims includes medical and eligibility information for more than 200 million commercial and Medicare Advantage enrollees. We identified adults age 50+ years initiating treatment for atrial fibrillation (N = 33,472), chronic obstructive pulmonary disease (COPD; N = 44,130), diabetes (N =76,726), and hyperlipidemia (N= 249,391) between January 2010 and December 2014. We assessed adherence, health care utilization, and spending during the first 2 years of treatment. Results During the first year of treatment, 13%-53% of each condition cohort was adherent (proportion of days covered ≥0.80). White race, Midwest residence, and having fewer comorbidities consistently and independently predicted adherence among enrollees initiating treatment for chronic obstructive pulmonary disease, diabetes, and hyperlipidemia. Male sex and higher net worth were also independently associated with adherence among commercial enrollees with these conditions. Patients in most condition cohorts who were adherent to treatment had significantly lower odds of hospitalization or emergency department use compared to patients who were not adherent. Additional spending on pharmacy claims by patients who were adherent was not consistently offset by lower spending on medical claims over a 2-year horizon. Conclusions Although many patient factors are strongly associated with medication adherence, the problem of non-adherence is common across all groups and may increase risk of adverse health outcomes.

Organic acidemias and urea cycle disorders are ultra-rare inborn errors of metabolism characterized by episodic acute decompensation, often associated with hyperammonemia, resulting in brain edema and encephalopathy. Retrospective reports and translational studies suggest that N-carbamylglutamate (NCG) may be effective in reducing ammonia levels during acute decompensation in two organic acidemias, propionic and methylmalonic acidemia (PA and MMA), and in two urea cycle disorders, carbamylphosphate synthetase 1 and ornithine transcarbamylase deficiency (CPSD and OTCD). We established the 9-site N-carbamylglutamate Consortium (NCGC) in order to conduct two randomized double-blind, placebo-controlled trials of NCG in acute hyperammonemia of PA, MMA, CPSD and OTCD. Conducting clinical trials is challenging in any disease, but poses unique barriers and risks in the ultra-rare disorders. As the number of clinical trials in orphan diseases increases, evaluating the successes and opportunities for improvement in such trials is essential. We summarize herein the design, methods, experiences, challenges and lessons from the NCGC-conducted trials.

BACKGROUND: This study compares a Pediatric Early Warning Score (PEWS) to physician opinion in identifying patients at risk for deterioration. METHODS: Maximum PEWS recorded during each admission was retrospectively ascertained from electronic medical record data. Physician opinion regarding risk of subsequent deterioration was determined by assignment to an institutional “senior sign-out” (SSO) list that highlights patients whom senior pediatric residents have identified as at risk. Deterioration events were defined as intubation, initiation of high flow nasal cannula, inotropes, noninvasive mechanical ventilation, or aggressive fluid resuscitation within 12 hours of transfer to the PICU. We assessed the relationships of sociodemographic variables, PEWS, and SSO assignment with subsequent deterioration events using multivariate regression analysis to control for a number of covariates. RESULTS: There were 97 patients with nonelective transfers to the PICU who were eligible for placement on the SSO lists before transfer, 51 of whom experienced qualifying deterioration events. Maximum recorded PEWS was significantly higher for patients with a subsequent deterioration event during the first 12 hours after transfer, compared with those who were transferred but did not experience a deterioration event in the first 12 hours (mean [SD]: 3.9 [2.0] vs 2.9 [2.0]; P = .01). This association persisted even after multivariate adjustment. SSO assignment was only marginally associated with risk of deterioration among this patient population, with or without adjustment for covariates. CONCLUSIONS: The PEWS was significantly associated with ICU deterioration, whereas physician opinion was not. Used alone or in conjunction with physician assessment, PEWS is a valuable tool for identifying patients vulnerable to acute deterioration.

Objective To examine missed opportunities to administer an eligible vaccination (MOs) and their contribution to underimmunization in contemporary pediatric practices. Study design This study was a retrospective analysis from 42 diverse pediatric practices located throughout the US. Medical records of 50 randomly selected children 3-18 months of age per practice were reviewed in Spring 2013. Immunization status for age and MOs were assessed as of each encounter and as of March 1, 2013. Results Of 2076 eligible patients, 72.7% (95% CI 67.6-77.9) were up-to-date with receipt of standard vaccines. Most children (82.4%; 95% CI 78.3-85.9) had at least 1 MO, and 37.8% (95% CI 30.0-46.2) had at least one MO to administer an overdue vaccination. After adjustment, risk of underimmunization was 3.5 times greater for patients who had ever experienced an MO for an overdue vaccination compared with those who had not (adjusted relative risk = 3.5; 95% CI 2.8-4.3). If all age-appropriate vaccinations had been administered at the last recorded encounter, 45.5% (95% CI 36.8-54.5) of the underimmunized patients would have been up to date at the time of assessment. Conclusion MOs were common and contributed substantially to underimmunization in this contemporary sample of diverse primary care practice settings.

Background Adolescents and young adults with congenital heart disease (CHD) are often restricted from physical activity and sports participation, which may have adverse effects. Objectives To determine the amount of physical activity, type of sports participation, and reasons for sports restrictions, and to evaluate the effect of sports participation on quality of life (QoL) in a cohort of patients with CHD. Methods Individuals with CHD aged 13–30 years were recruited at outpatient visits or via mailings. They completed a questionnaire addressing physical activity, sports participation, sports restrictions, and QoL (Pediatric Quality of Life Inventory). We also reviewed the patient's medical record. Results Of the 177 patients who responded (mean age 20 years), 31% have mild CHD, 40% have moderate CHD, and 29% have severe CHD. In the cohort, 52% participate in competitive sports, 25% recreational sports, and 23% no sports. Among patients with severe CHD, 29% participate in competitive sports that would be restricted by published guidelines (36th Bethesda Conference). After controlling for age, sex, CHD severity, residual hemodynamic disease, and comorbidities, participation in competitive sports and increased frequency of physical activity are independently associated with a higher QoL (P = .003 and P = .001, respectively). In an identical model, competitive sports participation and frequency of physical activity are associated with higher maximum predicted oxygen consumption (VO2) (n = 40; P = .002 and .02) and slightly lower body mass index (BMI) (P = .02 and .01). All findings were similar when analyses were stratified by recruitment method. Conclusions Patients with CHD commonly participate in competitive sports, and such participation is associated with higher QoL, improved exercise capacity, and lower BMI.

We evaluated 236 asymptomatic men for urethritis, assessed sexual behaviors, and tested urine for pathogens. Asymptomatic urethritis was present in 38 (16.1%). Of these, nearly half (42.1%) had a previously unrecognized discharge on examination; only 18.4% had a known pathogen. Correlates included black race, anal intercourse, and number of sex partners.

Timely identification and treatment of osteoporosis following hip fracture is recommended to mitigate future fracture risk, yet prior work has demonstrated a disconnect between evidence-based recommendations and real-world implementation. We sought to describe contemporary patterns of osteoporosis screening and initiation of pharmacotherapy following hip fracture based on medical and pharmacy claims in the OptumLabs™ Data Warehouse. From a national sample, we identified 8349 women aged 50+ years enrolled in private commercial or Medicare Advantage plans with no prior history of osteoporosis diagnosis, osteoporosis pharmacotherapy, or hip fracture who experienced a hip fracture between 2008 and 2013. Just 17.1% and 23.1% of these women had evidence of osteoporosis assessment and/or treatment within 6 or 12 months of their fractures, respectively. Women aged 80+ years were one-third less likely to utilize recommended services within 6 months, compared to those aged 50 to 79 years (13.8% versus 20.8%; p 0.001). Utilization of bone mass measurement increased significantly among women aged 65+ years over the study period (p 0.001) while declining among those aged 50 to 64 years (p = 0.2). In contrast, rates of osteoporosis pharmacotherapy remained steady among women aged 50 to 64 years (p = 0.8) yet declined among women aged 65 to 79 years and aged 80+ years (p = 0.07 and p = 0.004, respectively). Accounting for differences in all measured characteristics, receipt of primary care was the strongest and most consistent predictor of osteoporosis assessment or treatment following fracture. © 2017 American Society for Bone and Mineral Research.

Background The United States Preventive Services Task Force recommends universal osteoporosis screening among women ages 65+ and targeted screening of younger women, but historically, adherence to these evidence-based recommendations has been suboptimal. Methods To describe contemporary patterns of osteoporosis screening, we conducted a retrospective analysis using the OptumLabs ™ Data Warehouse, a database of de-identified administrative claims, which includes medical and eligibility information for over 100 million Medicare Advantage and commercial enrollees. Study participants included 1,638,454 women ages 50+ with no prior history of osteoporosis diagnosis, osteoporosis drug use, or hip fracture. Osteoporosis screening during the most recent 2-year period of continuous enrollment was assessed via medical claims. Patient sociodemographics, comorbidities, and utilization of other services were also determined using health insurance files. Results Overall screening rates were low: 21.1%, 26.5%, and 12.8% among women ages 50-64, 65-79, and 80+ years, respectively. Secular trends differed significantly by age ( P Conclusions Despite significant changes in utilization of osteoporosis screening among women ages 50-64 and 80+, in line with national recommendations, tremendous deficiencies among women 65+ remain.

OBJECTIVE:New emphasis on and requirements for demonstrating health care quality have increased the need for evidence-based methods to disseminate practice guidelines. With regard to impact on pediatric immunization coverage, we aimed to compare a financial incentive program (pay-for-performance [P4P]) and a virtual quality improvement technical support (QITS) learning collaborative.METHODS:This single-blinded (to outcomes assessor), cluster-randomized trial was conducted among unaffiliated pediatric practices across the United States from June 2013 to June 2014. Practices received either the P4P or QITS intervention. All practices received a Vaccinator Toolkit. P4P practices participated in a tiered financial incentives program for immunization coverage improvement. QITS practices participated in a virtual learning collaborative. Primary outcome was percentage of all needed vaccines received (PANVR). We also assessed immunization up-to-date (UTD) status.RESULTS:Data were analyzed from 3,147 patient records from 32 practices. Practices in the study arms reported similar QI activities (∼6 to 7 activities). We found no difference in PANVR between P4P and QITS (mean ± SE, 90.7% ± 1.1% vs 86.1% ± 1.3%, P = 0.46). Likewise, there was no difference in odds of being UTD between study arms (adjusted odds ratio 1.02, 95% confidence interval 0.68 to 1.52, P = .93). In within-group analysis, patients in both arms experienced nonsignificant increases in PANVR. Similarly, the change in adjusted odds of UTD over time was modest and nonsignificant for P4P but reached significance in the QITS arm (adjusted odds ratio 1.28, 95% confidence interval 1.02 to 1.60, P = .03).CONCLUSIONS:Participation in either a financial incentives program or a virtual learning collaborative led to self-reported improvements in immunization practices but minimal change in objectively measured immunization coverage.

Background. Azithromycin or doxycycline is recommended for nongonococcal urethritis (NGU); recent evidence suggests their efficacy has declined. We compared azithromycin and doxycycline in men with NGU, hypothesizing that azithromycin was more effective than doxycycline. Methods. From January 2007 to July 2011, English-speaking males ≥16 years, attending a sexually transmitted diseases clinic in Seattle, Washington, with NGU (visible urethral discharge or ≥5 polymorphonuclear leukocytes per high-power field [PMNs/HPF]) were eligible for this double-blind, parallel-group superiority trial. Participants received active azithromycin (1 g) + placebo doxycycline or active doxycycline (100 mg twice daily for 7 days) + placebo azithromycin. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Ureaplasma urealyticum biovar 2 (UU-2), and Trichomonas vaginalis (TV) using nucleic acid amplification tests. Clinical cure (

Timely identification and treatment of osteoporosis following hip fracture is recommended to mitigate future fracture risk, yet prior work has demonstrated a disconnect between evidence-based recommendations and real-world implementation. We sought to describe contemporary patterns of osteoporosis screening and initiation of pharmacotherapy following hip fracture based on medical and pharmacy claims in the OptumLabs™ Data Warehouse. From a national sample, we identified 8349 women aged 50+ years enrolled in private commercial or Medicare Advantage plans with no prior history of osteoporosis diagnosis, osteoporosis pharmacotherapy, or hip fracture who experienced a hip fracture between 2008 and 2013. Just 17.1% and 23.1% of these women had evidence of osteoporosis assessment and/or treatment within 6 or 12 months of their fractures, respectively. Women aged 80+ years were one-third less likely to utilize recommended services within 6 months, compared to those aged 50 to 79 years (13.8% versus 20.8%; p

Uneven adherence to immunization guidelines might leave some communities vulnerable to outbreaks of vaccine-preventable diseases. To examine factors related to implementation of immunization delivery best practices, we analyzed responses to monthly surveys and debriefing interviews from 16 diverse pediatric practices engaged in a year-long virtual learning collaborative. The collaborative provided a toolkit, online learning sessions, performance feedback, and conference calls with a quality improvement coach. Participants used iterative plan-do-study-act cycles to implement self-selected changes in immunization practices. Descriptive statistics were applied to quantitative data; qualitative data were analyzed using a framework approach. Impediments to implementing guidelines included difficulties with electronic record systems, rigid management structures, competing priorities, and parental resistance. Facilitators included linkage with regional immunization registries, positive social interactions, and performance feedback. Findings suggest that improving immunization delivery requires not only awareness of recommendations and training in improvement methods but also efforts to ameliorate contextual factors that impede immunization delivery.

The purpose of this study is to describe recruitment and retention experiences from three behavioral randomized controlled trials conducted among youth with type 1 diabetes. Eligibility, recruitment, and retention data were examined. Study-specific differential study participation and loss-to-follow-up analyses assessed the relations of patient characteristics with treatment completion and 6-month retention. Multivariable logistic regression identified factors independently associated with 6-month retention among all participants. Approximately 70-92 % of randomized participants completed treatment and 58-90 % were retained for follow-up. Older patients and non-Caucasian patients were less likely to enroll. Treatment completion and 6-month retention were less likely among youth who were older, had worse baseline glycemic control, lower household income, and/or unmarried parents. Some subgroups of patients are less likely to participate in research and are more susceptible to loss-to-follow-up. More work is needed to understand the facilitators and barriers to research participation.

This study examined whether overweight and obesity are pretreatment comorbidities and predictors of short-term drug response in newly diagnosed untreated childhood absence epilepsy (CAE). We also examined whether dietary intake accounts for observed pretreatment body mass index (BMI) distribution.Pretreatment height and weight were available for 445 of 446 participants in the NIH-funded CAE comparative effectiveness trial (NCT00088452). Twenty-four-hour dietary recalls were collected. Calculated BMI and dietary intake were standardized for age, sex, and race/ethnicity and compared to age-matched US population from the National Health and Nutrition Examination Survey (NHANES). Logistic regression models tested BMI as a predictor of treatment response. Pharmacokinetic variables were explored as contributors to differential drug response.After standardizing for demographic differences, children with CAE were more likely to be overweight (19.3% vs 13.8%; p0.001) or obese (14.5% vs 11.5%; p0.001) than NHANES controls. The combined prevalence of overweight and obesity was 33.8% in the CAE cohort and 25.3% among controls (p0.001). Mean daily energy intake (difference -79.5 kcal/day, p = 0.04) and daily carbohydrate intake (difference -10.7 g/day, p = 0.04) were lower in the CAE group than in NHANES controls. With increasing baseline BMI z score, the efficacy and effectiveness of ethosuximide and valproic acid over lamotrigine became more pronounced, despite no significant differences in drug exposure and trough levels.Overweight and obesity are more prevalent in children with newly diagnosed CAE than in age-matched peers, despite lower caloric and carbohydrate intake. Baseline BMI may also predict differential drug response, which cannot be attributed to pharmacokinetic differences.

Background Health has improved markedly in Mesoamerica, the region consisting of southern Mexico and Central America, over the past decade. Despite this progress, there remain substantial inequalities in health outcomes, access, and quality of medical care between and within countries. Poor, indigenous, and rural populations have considerably worse health indicators than national or regional averages. In an effort to address these health inequalities, the Salud Mesoamérica 2015 Initiative (SM2015), a results-based financing initiative, was established. Methods For each of the eight participating countries, health targets were set to measure the progress of improvements in maternal and child health produced by the Initiative. To establish a baseline, we conducted censuses of 90,000 households, completed 20,225 household interviews, and surveyed 479 health facilities in the poorest areas of Mesoamerica. Pairing health facility and household surveys allows us to link barriers to care and health outcomes with health system infrastructure components and quality of health services. Results Indicators varied significantly within and between countries. Anemia was most prevalent in Panama and least prevalent in Honduras. Anemia varied by age, with the highest levels observed among children aged 0 to 11 months in all settings. Belize had the highest proportion of institutional deliveries (99%), while Guatemala had the lowest (24%). The proportion of women with four antenatal care visits with a skilled attendant was highest in El Salvador (90%) and the lowest in Guatemala (20%). Availability of contraceptives also varied. The availability of condoms ranged from 83% in Nicaragua to 97% in Honduras. Oral contraceptive pills and injectable contraceptives were available in just 75% of facilities in Panama. IUDs were observed in only 21.5% of facilities surveyed in El Salvador. Conclusions These data provide a baseline of much-needed information for evidence-based action on health throughout Mesoamerica. Our baseline estimates reflect large disparities in health indicators within and between countries and will facilitate the evaluation of interventions and investments deployed in the region over the next three to five years. SM2015’s innovative monitoring and evaluation framework will allow health officials with limited resources to identify and target areas of greatest need. Electronic supplementary material The online version of this article (doi:10.1186/s12963-015-0034-4) contains supplementary material, which is available to authorized users.

Objective Ureaplasma urealyticum biovar 2 (UU-2), but not Ureaplasma parvum (UP), has been associated with non-gonococcal urethritis (NGU), but little is known about species-specific responses to standard therapies. We examined species-specific treatment outcomes and followed men with treatment failure for 9 weeks. Methods From May 2007 to July 2011, men aged ≥16 attending a sexually transmitted disease (STD) clinic in Seattle, Washington, with NGU (urethral discharge or urethral symptoms plus ≥5 polymorphonuclear leucocytes /high-powered field) enrolled in a double-blind, randomised trial. Participants received active azithromycin (1 g) + placebo doxycycline or active doxycycline (100 mg twice a day ×7 days) + placebo azithromycin. Ureaplasma were detected in culture followed by species-specific PCR. Outcomes were assessed at 3, 6 and 9 weeks. At 3 weeks, men with persistent Ureaplasma detection received ‘reverse therapy’ (eg, active doxycycline if they first received active azithromycin). At 6 weeks, persistently positive men received moxifloxacin (400 mg×7 days). Results Of 490 men, 107 (22%) and 60 (12%) were infected with UU-2 and UP, respectively, and returned at 3 weeks. Persistent detection was similar for UU-2-infected men initially treated with azithromycin or doxycycline (25% vs 31%; p=0.53), but differed somewhat for men with UP (45% vs 24%; p=0.11). At 6 weeks, 57% of UU-2-infected and 63% of UP-infected men who received both drugs had persistent detection. Failure after moxifloxacin occurred in 30% and 36%, respectively. Persistent detection of UU-2 or UP was not associated with signs/symptoms of NGU. Conclusions Persistent detection after treatment with doxycycline, azithromycin and moxifloxacin was common for UU and UP, but not associated with persistent urethritis. Trial registration number NCT00358462.

Adolescents and young adults with congenital heart disease (CHD) are often restricted from physical activity and sports participation, which may have adverse effects.To determine the amount of physical activity, type of sports participation, and reasons for sports restrictions, and to evaluate the effect of sports participation on quality of life (QoL) in a cohort of patients with CHD.Individuals with CHD aged 13-30 years were recruited at outpatient visits or via mailings. They completed a questionnaire addressing physical activity, sports participation, sports restrictions, and QoL (Pediatric Quality of Life Inventory). We also reviewed the patient's medical record.Of the 177 patients who responded (mean age 20 years), 31% have mild CHD, 40% have moderate CHD, and 29% have severe CHD. In the cohort, 52% participate in competitive sports, 25% recreational sports, and 23% no sports. Among patients with severe CHD, 29% participate in competitive sports that would be restricted by published guidelines (36th Bethesda Conference). After controlling for age, sex, CHD severity, residual hemodynamic disease, and comorbidities, participation in competitive sports and increased frequency of physical activity are independently associated with a higher QoL (P = .003 and P = .001, respectively). In an identical model, competitive sports participation and frequency of physical activity are associated with higher maximum predicted oxygen consumption (VO2 ) (n = 40; P = .002 and .02) and slightly lower body mass index (BMI) (P = .02 and .01). All findings were similar when analyses were stratified by recruitment method.Patients with CHD commonly participate in competitive sports, and such participation is associated with higher QoL, improved exercise capacity, and lower BMI.

To determine if a health communication intervention targeting parents of high-risk, urban, minority children with asthma could (i) improve parental perceptions of connectedness to and communication with their child's primary care providers (PCP) and (ii) decrease reliance on emergency departments (EDs) and other urgent care services for their child's asthma-related care.The design was a single blind, parallel groups, randomized controlled trial. Parents were recruited from an ED-based asthma clinic serving primarily low-income, minority children in Washington, DC. The intervention involved face-to-face education on effective communication followed by a single booster call. Standardized instruments were administered to assess primary care connectedness and healthcare utilization at baseline and 2- and 6-months post-enrollment.A total of 150 parents of children 1-12 years old were randomized (77 intervention and 73 usual care), and 137 (91%) were successfully followed for six months. Only at the two-month follow-up time-point, parents in the intervention group were significantly more likely to identify a PCP as the main source of their child's asthma care (adjusted odds ratio: 12.6, 95% confidence interval: 1.1-142.1) and to report a significant reduction in ED visits for asthma care (adjusted incidence rate ratio: 0.3, 95% confidence interval: 0.1-0.8). There was no significant effect on parent communication self-efficacy or number of PCP visits.A brief, in-person health communication intervention for parents of high-risk children with asthma resulted in improved identification of PCPs as the usual source of asthma care and reduced reliance on EDs for asthma care, albeit only for two months post-intervention.

Background Modifiable risks account for a large fraction of disease and death, but clinicians and patients lack tools to identify high risk populations or compare the possible benefit of different interventions. Methods We used data on the distribution of exposure to 12 major behavioral and biometric risk factors inthe US population, mortality rates by cause, and estimates of the proportional hazards of risk factor exposure from published systematic reviews to develop a risk prediction model that estimates an adult’s 10 year mortality risk compared to a population with optimum risk factors. We compared predicted risk to observed mortality in 8,241 respondents in NHANES 1988-1994 and NHANES 1999-2004 with linked mortality data up to the end of 2006. Results Predicted risk showed good discrimination with an area under the receiver operating characteristic (ROC) curve of 0.84 (standard error 0.01) for women and 0.84 (SE 0.01) for men. Across deciles of predicted risk, mortality was accurately predicted in men ((Χ2 statistic = 12.3 for men, p=0.196) but slightly overpredicted in the highest decile among women (Χ2 statistic = 22.8, p=0.002). Mortality risk was highly concentrated; for example, among those age 30-44 years, 5.1 % (95 % CI 4.1 % - 6.0 %) of the male and 5.9 % (95 % CI 4.8 % - 6.9 %) of the female population accounted for 25 % of the risk of death. Conclusion The risk model accurately predicted mortality in a representative sample of the US population and could be used to help inform patient and provider decision-making, identify high risk groups, and monitor the impact of efforts to improve population health. Electronic supplementary material The online version of this article (doi:10.1186/s12963-015-0059-8) contains supplementary material, which is available to authorized users.

Tetralogy of Fallot with absent pulmonary valve (TOF/APV) is associated with high rates of perinatal morbidity/mortality. This study aimed to identify fetal characteristics in TOF/APV associated with clinical presentation/outcome. Fetuses with TOF/APV from 2002-2012 were retrospectively identified

Urethritis is the most common male reproductive tract syndrome and is caused primarily by Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT). However, up to 50% of cases have neither GC nor CT detected1 and are referred to simply as nonchlamydial nongonococcal urethritis (NGU). Clinically defined as symptoms of urethral irritation (dysuria, pruritis) or visible urethral discharge and 5 or more polymorphonuclear leukocytes per high-power field (PMNs/HPF) in urethral exudates, nonchlamydial NGU has been associated with a number of known pathogens; Mycoplasma genitalium (MG) in 15% to 25%, Trichomonas vaginalis (TV) in 5% to 15%, and, less commonly, herpes simplex virus (HSV) and adenovirus in 2% to 4%.1 The differentiated Ureaplasma urealyticum (UU) has been associated with urethritis in some2–4 but not all studies.4,5 However, in a recent case-control study, 45% of NGU cases had no known pathogen,4 even after testing for CT, MG, TV, and UU. Although noninfectious causes of male urethritis exist, most cases are likely caused by sexually transmitted pathogens. Therefore, bacteria involved in female reproductive tract disease are reasonable candidates for involvement in NGU. Bacterial vaginosis (BV) is the most prevalent genital tract syndrome in women, affecting 29% of reproductive-aged women,6 and has been associated with increased risk for perinatal complications,7 pelvic inflammatory disease,8 and HIV acquisition9 and transmission.10 Although there is debate as to whether BV can be sexually transmitted, the protective effect of condoms11 and the concordance of infection in lesbian couples12 support this concept. The syndrome is characterized by a shift in the vaginal microbiota from a predominance of lactobacilli to a predominance of anaerobic bacteria13 and does not seem to be caused by a single organism, but rather represents a change in the vaginal microbiota from one with several predominant Lactobacillus species to one marked by increased species richness and diversity.14–16 Several recently identified bacteria have been highly predictive of and specific for BV, including Leptotrichia/Sneathia spp., Atopobium spp., Megasphaera spp. and BVAB-1, BVAB-2, and BVAB-3 (all Clostridiales order bacteria)17 Most of these organisms, with the exception of BVAB-1, were also more common in women with than in those without cervicitis in a pilot study we conducted (unpublished data), suggesting that their presence in men may be associated with similar inflammation in the male urethra. To assess the role of these newly described bacteria in male urethritis, we conducted a case-control study of men with and without idiopathic NGU. All men were tested for 5 recently identified bacteria associated with BV in women, and we estimated the risk of urethritis associated with detection of each bacterial species.

Objective Doxycycline, one of two recommended therapies for non-gonococcal urethritis (NGU), consists of a 7-day course of therapy (100 mg BID). Since suboptimal adherence may contribute to poor treatment outcomes, we examined the association between self-reported imperfect adherence to doxycycline and clinical and microbiologic failure among men with NGU. Methods Men aged ≥16 years with NGU attending a Seattle, WA, sexually transmitted diseases clinic were enrolled in a double-blind, parallel-group superiority trial from January 2007 to July 2011. Men were randomised to active doxycycline/placebo azithromycin or placebo doxycycline/active azithromycin. Imperfect adherence was defined as missing ≥1 dose in 7 days. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), and Ureaplasma urealyticum -biovar 2 (UU-2) using nucleic acid amplification tests. Clinical failure (symptoms and ≥5 PMNs/HPF or discharge) and microbiologic failure (positive tests for CT, MG, and/or UU-2) were determined after 3 weeks. Results 184 men with NGU were randomised to active doxycycline and provided data on adherence. Baseline prevalence of CT, MG and UU-2 was 26%, 13% and 27%, respectively. 28% of men reported imperfect adherence, and this was associated with microbiologic failure among men with CT (aRR=9.33; 95% CI 1.00 to 89.2) and UU-2 (aRR=3.08; 95% CI 1.31 to 7.26) but not MG. Imperfect adherence was not significantly associated with clinical failure overall or for any specific pathogens, but it was more common among imperfectly adherent men with CT (aRR=2.63; 0.93–7.41, p=0.07). Conclusions Adherence may be important for microbiologic cure of select pathogens. Factors other than adherence should be considered for CT-negative men with persistent NGU.

Background Little is known about the relationship between cardiovascular risk, disease and actual use of aspirin in the community. Methods The Measuring Disparities in Chronic Conditions (MDCC) study is a community and health facility-based survey designed to track disparities in the delivery of health interventions for common chronic diseases. MDCC includes a survey instrument designed to collect detailed information about aspirin use. In King County, WA between 2011 and 2012, we surveyed 4633 white, African American, or Hispanic adults (45% home address-based sample, 55% health facility sample). We examined self-reported counseling on, frequency of use and risks of aspirin for all respondents. For a subgroup free of CAD or cerebral infarction that underwent physical examination, we measured 10-year coronary heart disease risk and blood salicylate concentration. Results Two in five respondents reported using aspirin routinely while one in five with a history of CAD or cerebral infarction and without contraindication did not report routine use of aspirin. Women with these conditions used less aspirin than men (65.0% vs. 76.5%) and reported more health problems that would make aspirin unsafe (29.4% vs. 21.2%). In a subgroup undergoing phlebotomy a third of respondents with low cardiovascular risk used aspirin routinely and only 4.6% of all aspirin users had no detectable salicylate in their blood. Conclusions In this large urban county where health care delivery should be of high quality, there is insufficient aspirin use among those with high cardiovascular risk or disease and routine aspirin use by many at low risk. Further efforts are needed to promote shared-decision making between patients and clinicians as well as inform the public about appropriate use of routine aspirin to reduce the burden of atherosclerotic vascular disease.

Objective: Little is known about the sodium intake of heart failure (HF) patients in the community. We used data from the Measuring Disparities in Chronic Conditions Study to examine the receipt of advice on dietary sodium and its relationship with sodium intake among adults in a large urban county. Method: We recruited adults in King County, WA using a home-address based sample as well as sampling from health facilities using medical record billing codes for key cardiovascular conditions. Survey questions addressed past medical history as well as receipt of advice and behavior related to dietary sodium. Diet history was assessed using the National Cancer Institute Diet History Questionnaire II (DHQ) for intake in the past year. We also compared responses and estimated sodium intake for those who did and did not report a diagnosis of HF. As a sensitivity analysis, we repeated our analysis using the subset of individuals who had a medical record with an ICD9 code for HF in the previous two years. Result: Our results are based on 3357 respondents from the address-based sample and 3477 from the medical record-based sample. The DHQ was completed by 940 and 1291 of these respondents, respectively. HF was reported by 290 respondents (median age 66 years, 57% male, 6.6% black race, 85% from medical record sample, 43% with a DHQ). Among those reporting a diagnosis of HF, 61% (112 of 183) reported being advised to decrease dietary sodium and 37% (67 of 183) reported being told to buy food items labeled as low salt. These rates were 30% (755 of 2515) and 13% (337 of 2515) respectively among individuals without reported HF. Estimated daily dietary sodium intake over the prior year was lower among those with HF completing a DHQ if they reported receiving counseling (mean 2.5 vs 2.8 gm if advised to cut down on salt and 2.3 vs 2.8 gm if advised to buy low salt labeled products). However, these differences were not statistically significant. Only 65% of respondents with HF (183 of 282) said they buy low salt labeled foods and 26% (61 of 290) reported eating processed, fast, or canned food at least 5 times in the prior month. Overall mean estimated daily dietary sodium intake over the prior year was 2.7 gm for respondents both with and without HF. Results were similar for those with an ICD9 code for HF. Conclusion: Our findings revealed that a large percentage of HF patients report no receipt of medical advice to reduce dietary sodium or purchase foods labeled as low salt. Moreover, the dietary intake of salt was similar for HF patients and the general population. These results point to a need for dietary interventions in HF that are both widely adopted and can actually change behavior.

Adolescents and young adults with congenital heart disease (CHD) are often restricted from physical activity and sports participation. Our goal was to determine the amount of physical activity, type of sports participation, reasons for sports restrictions and quality of life (QoL) in a cohort of

Background Antibiotic resistance profiles of recent Mycoplasma genitalium (MG) isolates have not been extensively evaluated nor correlated with treatment outcomes for NGU. Urine specimens from men with NGU enrolled in a treatment trial in Seattle, WA were used to culture MG strains and assess the association of their susceptibility to azithromycin and doxycycline with treatment outcomes. Methods Urines from all MG-positive (by PCR) men were co-cultured with VERO cells. MG growth was detected by an increase in genomes using an MG-specific quantitative PCR (qPCR); minimum inhibitory concentrations (MICs) were defined by the antibiotic concentration that resulted in 99% growth inhibition. MICs were measured at baseline (V1), 3-week (V2) and 6-week follow-up (V3). Clinical cure (V2, V3) was defined Results Viable MG strains were recovered from 141 (92%) of 153 MG PCR-positive specimens; MICs were determined on 103 isolates. Azithromycin MICs were clearly bimodal; 46% (48/103) were ≤ 0.001–0.5 μg/ml, considered susceptible, and 54% (55/103) were ≥ 8 μg/ml considered resistant. Except for two strains with MICs of ≥ 8 μg/ml doxycycline, MICs were Conclusion Approximately 60% of MG strains were resistant to azithromycin at baseline; azithromycin treatment failures occurred in 90–100% of men who received azithromycin. Development of new antimicrobial therapies for MG is essential.

Background Recent treatment trials have demonstrated low efficacy of doxycycline against Mycoplasma genitalium (MG) and increasing resistance to azithromycin. Treatment with azithromycin is recommended for persistent NGU if not used for the initial episode. We evaluated microbiologic cure rates for men with NGU and persistent detection of MG. Methods English-speaking men aged 16 years attending the STD clinic in Seattle, WA with NGU (urethral discharge or urethral symptoms plus ≥ 5 PMNs/HPF) were enrolled in a randomised trial of NGU therapy between January 2007 and July 2011. Urine was tested for MG by PCR. Men received 1g azithromycin plus placebo doxycycline or doxycycline (100mg bid x 7d) plus placebo azithromycin. Treatment failures after 3 weeks received ‘reverse therapy’ (active doxycycline if they first received active azithromycin and vice versa). Persistent failures after 6 weeks received moxifloxacin (400mg x 7d). After September 2010, microbiologic failures at 3 weeks received moxifloxacin. Results Of 606 enrolled men, 65 were positive for MG at enrollment and returned after 3 weeks. Microbiologic failure (positive MG test) occurred in 23/38 (60.5%) who received azithromycin and 19/27 (70.4%) who received doxycycline (p = 0.41). Of the 37 men with microbiologic treatment failure who received ‘reverse therapy’ and returned after 6 weeks, 19 (51.4%) had persistent detection of MG, including 14/20 (70.0%) retreated with doxycycline and 5/17 (29.4%) retreated with azithromycin (p = 0.02). All 19 men were prescribed moxifloxacin; 16 returned at 9 weeks and 2 (12.5%) had microbiologic failure, despite clinical cure. Four men received moxifloxacin after initial failure; 1 had microbiologic failure at 6 weeks, was retreated with moxifloxacin and microbiologically cured at 9 weeks. Conclusion One half of MG-positive men retreated with a second standard NGU treatment regimen experienced microbiologic treatment failure. Moxifloxacin treatment failure, while not common, did occur, suggesting antimicrobial susceptibility in MG merits careful monitoring.

Background Traditional cultivation approaches have not identified additional pathogens responsible for the 45% of non-gonococcal urethritis (NGU) cases with no identified aetiology. Cultivation-independent methods have identified novel bacteria associated with female reproductive tract disease, particularly bacterial vaginosis (BV). We evaluated the association of NGU and 5 newly described BV-associated bacteria (BVAB). Methods English-speaking, heterosexual men aged 16 years attending the STD clinic in Seattle, WA between May 2007 and July 2011 were eligible if PCR tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, and Ureaplasma urealyticum-biovar2 were negative. Cases were men with visible urethral discharge or 5 PMNs/HPF in urethral exudates. Controls were men with no visible urethral discharge and Results Cases (n = 157) and controls (n = 191) were similar with respect to age, education, and income. Mean age was 34.7 (SD ±9.9) and most were white. Leptotrichia/Sneathia was significantly associated with NGU (25/157 (15.3%) vs. 6/102 (5.9%), p = 0.03) and BVAB-2 was detected more often in cases than controls (7/157 (4.5%) vs. 1/102 (1.0%), p = 0.15). BVAB-3 (n = 2) and Megasphaera (n = 1) were uncommon, but only detected in men with NGU. In contrast, Atopobium was not associated with NGU (8.3% vs. 7.8%, p = 1.0). Quantity of bacteria did not differ between cases and controls for any of the 5 candidate pathogens. Among treated cases, doxycycline was somewhat more effective than azithromycin for clinical cure of men with Leptotrichia/Sneathia(9/10 (90%) vs. 7/12 (58%), p = 0.16), and BVAB-2 (3/3 (100%) vs. 0/3 (0%), p = 0.10). Conclusion Leptotrichia/Sneathia was significantly associated with NGU. BVAB-2, BVAB-3, and Megasphaera were less commonly detected, but most often identified in men with NGU and rarely or never in men without NGU. Doxycycline may be more effective against these newly identified bacteria than azithromycin.

Background U. urealyticum (UU) but not U. parvum (UP) is associated with non-gonococcal urethritis (NGU), while UP may be associated with adverse pregnancy outcomes. Treatment failure may differ byspecies; therefore, we examined the efficacy of CDC-recommended therapies for NGU against UU and UP separately. Methods From May 2007 to July 2011, men aged ≥ 16 years attending an STD clinic in Seattle, Washington with NGU (urethral discharge or urethral symptoms plus ≥ 5 PMNs/HPF) were enrolled in a randomised treatment trial. Participants received active azithromycin (1g) and placebo doxycycline or active doxycycline (100 mg bid × 7d) and placebo azithromycin. Ureaplasma species were detected in broth urine culture followed by species-specific PCR. Microbiologic failure (detected by PCR) was determined at 3, 6, and 9 weeks. At 3 weeks, men who failed initial treatment received the alternate therapy (active doxycycline if they first received active azithromycin and vice versa). Persistent failures received moxifloxacin at 6 weeks. Results Of 479 enrolled men, 107 (22.3%) and 59 (12.3%) were infected with UU and UP, respectively, and returned at 3 weeks. Among men who received azithromycin, microbiologic failure at 3 weeks occurred in 46.7% (14/30) of UP-infected men and 25.0% (13/52) of UU-infected men (P = 0.04). Among doxycycline-treated men, failure occurred in 24.1% (7/29) and 30.9% (17/55), respectively (P = 0.64). At 6 weeks, 80% (4/5) of UP and 58% (7/12) of UU-infected men originally treated with doxycycline and re-treated with azithromycin were failures; failure among men originally treated with azithromycin and re-treated with doxycycline was 57% (8/14) and 55% (6/11), respectively. At 9 weeks, failure after treatment with moxifloxacin occurred in 27.3% (3/11) of UP and 36.4% (4/11) of UU-infected men. Conclusion Azithromycin was less effective against UP than UU. Failure after re-treatment with alternate therapy and moxifloxacin was common for both UU and UP.

Background Existing health risk measures are narrow in scope, often limited to specific diseases or clinical subpopulations. Modifiable risks account for a large fraction of death, but existing health risk measures do not produce estimates of the fraction of an individual's risk that is potentially avoidable by clinical or behavioural intervention. The aim of this work is to develop and validate a risk prediction model to measure the modifiable risk of all-cause mortality for patients and populations. Methods We used data on the exposure distributions to 12 behavioural and biometric risks in the US population, mortality rates by cause, and estimates of the proportional hazards of risk factor exposure from systematic reviews to develop a risk model to estimate an adult's 10-year total and avoidable mortality risk compared with an optimal population with no excess risk. We then compared predicted risk to observed mortality in 8253 National Health and Nutrition Examination Survey participants (1988–1994 and 1999–2004) aged 30 years and older with linked mortality data through 2006 to validate the model. Findings Predicted risk showed good discrimination; the area under the curve was 0·84 (SE 0·01) for both sexes. Preliminary results show that across deciles of predicted risk, mortality was accurately predicted in men (χ 2 12·3, p=0·196) but slightly over predicted in the highest decile among women (χ 2 22·8, p=0·002). Mortality risk was highly concentrated: among those aged 30–44 years, 5·1% (95% CI 4·1–6·0) of men and 5·9% (4·8–6·9) of women accounted for 25% of mortality risk. Interpretation The risk model accurately predicted individual all-cause mortality in a representative sample of the US population. It can be used to (a) counsel patients on what actions to take to protect their health, (b) identify patients at high risk of avoidable death, (c) quantify individual providers' success at reducing the risk of populations served, and (d) monitor the impact of broad efforts to improve population health. Funding Institute for Health Metrics and Evaluation at the University of Washington.

Background Due to the high risk of influenza-related complications, including severe illness and premature death, WHO recommends that pregnant women receive influenza vaccination. However, current seasonal influenza vaccination rates among pregnant women in the USA are still below the Healthy People 2020 target of 80%. We identified the predictors of the uptake of influenza vaccination among pregnant women. Methods Self-reported survey data from the 2011 Behavioral Risk Factor Surveillance System (BRFSS) were analysed. The study sample included 1931 pregnant women aged 18–44 years surveyed during seasonal influenza seasons from January to May and October to December, 2011. We examined three categories of predictors: sociodemographics, health status, and health-care access. We used stratified, weighted, multivariable logistic regression to compute the odds of receiving the influenza vaccine in the past 12 months and to adjust for potential confounders. Findings The influenza vaccination coverage level among pregnant women was 37·1% (95% CI 33·4–40·9). Those not college educated were less likely to report vaccination (adjusted odds ratio [aOR] 0·63, 95% CI 0·40–0·997). Adjusting for sociodemographics and health status, an indicator of health-care access, not seeing a doctor due to cost in the past year was significantly associated with lower odds of vaccine uptake (aOR 0·47, 95% CI 0·29–0·75). Reporting not having a general physical exam in the past year was marginally associated with lower odds of receipt of influenza vaccine (aOR 0·70, 95% CI 0·48–1·02). Age, ethnic origin, marital status, living with children less than 18 years of age, employment status, and physical and mental health status were not significantly associated with influenza vaccination among pregnant women. Interpretation Our results showed that health-care access and utilisation are strong predictors of influenza vaccination among pregnant women. Counselling on the importance of influenza vaccination should be routinely performed as part of prenatal care. Funding None.

Background Individual income and poverty are associated with poor health outcomes. The poor face unique challenges related to access, education, financial capacity, environmental effects, and other factors that threaten their health outcomes. Methods We examined the variation in the health outcomes and health behaviors among the poorest quintile in eight countries of Mesoamerica using data from the Salud Mesomérica 2015 baseline household surveys. We used multivariable logistic regression to measure the association between delivering a child in a health facility and select household and maternal characteristics, including education and measures of wealth. Results Health indicators varied greatly between geographic segments. Controlling for other demographic characteristics, women with at least secondary education were more likely to have an in-facility delivery compared to women who had not attended school (OR: 3.20, 95 % confidence interval [CI]: 2.56-3.99, respectively). Similarly, women from households with the highest expenditure were more likely to deliver in a health facility compared to those from the lowest expenditure households (OR 3.06, 95 % CI: 2.43-3.85). Household assets did not impact these associations. Moreover, we found that commonly-used definitions of poverty do not align with the disparities in health outcomes observed in these communities. Conclusions Although poverty measured by expenditure or wealth is associated with health disparities or health outcomes, a composite indicator of health poverty based on coverage is more likely to focus attention on health problems and solutions. Our findings call for the public health community to define poverty by health coverage measures rather than income or wealth. Such a health-poverty metric is more likely to generate attention and mobilize targeted action by the health communities than our current definition of poverty.