Last data update: May 13, 2024. (Total: 46773 publications since 2009)
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Urodynamic characteristics of neurogenic bladder in newborns with myelomeningocele and refinement of the definition of bladder hostility: Findings from the UMPIRE multi-center study
Tanaka ST , Yerkes EB , Routh JC , Tu DD , Austin JC , Wiener JS , Vasquez E , Joseph DB , Ahn JJ , Wallis MC , Williams T , Rose C , Baum MA , Cheng EY . J Pediatr Urol 2021 17 (5) 726-732 INTRODUCTION: Infants with myelomeningocele are at risk for chronic kidney disease caused by neurogenic bladder dysfunction. Urodynamic evaluation plays a key role to risk stratify individuals for renal deterioration. OBJECTIVE: To present baseline urodynamic findings from the Urologic Management to Preserve Initial Renal function for young children with spina bifida (UMPIRE) protocol, to present the process that showed inadequacies of our original classification scheme, and to propose a refined definition of bladder hostility and categorization. STUDY DESIGN: The UMPIRE protocol follows a cohort of newborns with myelomeningocele at nine children's hospitals in the United States. Infants are started on clean intermittent catheterization shortly after birth. If residual volumes are low and there is no or mild hydronephrosis, catheterization is discontinued. Baseline urodynamics are obtained at or before 3 months of age to determine further management. Based on protocol-specific definitions, urodynamic studies were reviewed by the clinical site in addition to a central review team; and if necessary, by all site urologists to achieve 100% concurrence. RESULTS: We reviewed 157 newborn urodynamic studies performed between May 2015 and September 2017. Of these 157 infants, 54.8% were boys (86/157). Myelomeningocele closure was performed in-utero in 18.4% (29/157) and postnatally in 81.5% (128/157) of newborns. After primary review, reviewers agreed on overall bladder categorization in 50% (79/157) of studies. Concurrence ultimately reached 100% with further standardization of interpretation. We found that it was not possible to reliably differentiate a bladder contraction due to detrusor overactivity from a volitional voiding contraction in an infant. We revised our categorization system to group the "normal" and "safe" categories together as "low risk". Additionally, diagnosis of detrusor sphincter dyssynergia (DSD) with surface patch electrodes could not be supported by other elements of the urodynamics study. We excluded DSD from our revised high risk category. The final categorizations were high risk in 15% (23/157); intermediate risk in 61% (96/157); and low risk in 24% (38/157). CONCLUSION: We found pitfalls with our original categorization for bladder hostility. Notably, DSD could not be reliably measured with surface patch of electrodes. The effect of this change on future renal outcomes remains to be defined. |
Tenofovir Alafenamide (TAF) for HIV Prevention: Review of the Proceedings from the Gates Foundation Long Acting (LA) TAF Product Development Meeting
Romano JW , Baum M , Demkovich ZR , Diana F , Dobard C , Feldman PL , Garcia-Lerma JG , Grattoni A , Gunawardana M , Ho DK , Hope TJ , Massud I , Milad M , Moss J , Pons-Faudoa FP , Roller S , van der Straten A , Srinivasan S , Veazey R , Zane D . AIDS Res Hum Retroviruses 2021 37 (6) 409-420 The ability to successfully develop a safe and effective vaccine for the prevention of HIV infection has proven challenging. Consequently, alternative approaches to HIV infection prevention have been pursued, and there have been a number of successes with differing levels of efficacy. Currently, only two oral pre-exposure prophylaxis (PrEP) products are available, Truvada and Descovy. Descovy is a newer product not yet indicated in individuals at risk of HIV-1 infection from receptive vaginal sex, since it still needs to be evaluated in this population. A topical dapivirine vaginal ring is currently under regulatory review, and a long acting (LA) injectable cabotegravir product shows strong promise. Although demonstrably effective, daily oral PrEP presents adherence challenges for many users, particularly adolescent girls and young women, key target populations. This limitation has triggered development efforts in LA HIV prevention options. This article reviews efforts supported by the Bill & Melinda Gates Foundation, as well as similar work by other groups, to identify and develop optimal LA HIV prevention products. Specifically, this article is a summary review of a meeting convened by the foundation in early 2020 that focused on the development of LA products designed for extended delivery of tenofovir alafenamide (TAF) for HIV prevention. The review broadly serves as technical guidance for preclinical development of LA HIV prevention products. The meeting examined the technical feasibility of multiple delivery technologies, in vivo pharmacokinetics, and safety of subcutaneous delivery of TAF in animal models. Ultimately, the foundation concluded that there are technologies available for long-term delivery of TAF. However, due to potentially limited efficacy and possible toxicity issues with subcutaneous (SC) delivery, the foundation will not continue investing in the development of LA, SC delivery of TAF products for HIV prevention. |
Incidence of urinary tract infections in newborns with spina bifida: Is antibiotic prophylaxis necessary
Wallis MC , Paramsothy P , Newsome K , Williams T , Routh JC , Joseph DB , Cheng E , Tu D , Austin JC , Tanaka ST , Walker WO , Smith KA , Baum MA , Wiener JS . J Urol 2021 206 (1) 101097ju0000000000001690 PURPOSE: Urinary tract infections (UTI) commonly occur in patients with spina bifida (SB) and pose a risk for renal scarring. Routine antibiotic prophylaxis has been utilized in newborns with SB to prevent UTI. We hypothesized that prophylaxis can safely be withheld in newborns with SB until clinical assessment allows for risk stratification. MATERIALS AND METHODS: Newborns with myelomeningocele at nine institutions were prospectively enrolled in the UMPIRE study and managed by a standardized protocol with a strict definition for UTI. Patient data were collected regarding details of reported UTI, baseline renal ultrasound findings, vesicoureteral reflux, use of clean intermittent catheterization (CIC), and circumcision status in boys. Risk Ratios (RRs) and corresponding 95% confidence intervals (CIs) were calculated using log-binomial models. RESULTS: From 2/2015 through 8/2019, data were available on 299 newborns (50.5% male). During the first four months of life, 48 (16.1%) newborns were treated for UTI with 23 (7.7%) having positive cultures; however, only 12 (4.0%) met the strict UTI definition. Infants with grade 3-4 hydronephrosis had an increased risk of UTI compared to infants with no hydronephrosis (RR=10.1; 95%CI=2.8, 36.3). Infants on CIC also had an increased risk of UTI (RR=3.3; 95%CI=1.0, 10.5). CONCLUSIONS: The incidence of a culture-positive, symptomatic UTI among newborns with SB in the first 4 months of life was low. Patients with high grades of hydronephrosis or those on CIC had a significantly greater incidence of UTI. Our findings suggest that routine antibiotic prophylaxis may not be necessary for most newborns with SB. |
Changes in provider type and prescription refills among privately insured children and youth with ADHD
Hart LC , Grosse SD , Danielson ML , Baum RA , Kemper AR . J Atten Disord 2020 25 (14) 2028-2036 OBJECTIVE: The aim of this paper is to understand associations between age and health care provider type in medication continuation among transition-aged youth with ADHD. METHOD: Using an employer-sponsored insurance claims database, we identified patients with likely ADHD and receipt of ADHD medications. Among patients who had an outpatient physician visit at baseline and maintained enrollment at follow-up 3 years later, we evaluated which ones continued to fill prescriptions for ADHD medications. RESULTS: Patients who were younger at follow-up more frequently continued medication (77% of 11-12 year-olds vs. 52% of 19-20 year-olds). Those who saw a pediatric provider at baseline and follow-up more frequently continued to fill ADHD medication prescriptions than those who saw a pediatric provider at baseline and non-pediatric providers at follow-up (71% vs. 53% among those ages 15-16 years at follow-up). CONCLUSION: Adolescents and young adults with ADHD who changed from pediatric to exclusively non-pediatric providers less frequently continued to receive ADHD medications. |
Kidney function surveillance in the National Spina Bifida Patient Registry: A retrospective cohort study
Chu DI , Liu T , Patel P , Routh JC , Ouyang L , Baum MA , Cheng EY , Yerkes EB , Isakova T . J Urol 2020 204 (3) 101097ju0000000000001010 PURPOSE: Chronic kidney disease affects 25-50% of patients with spina bifida. Guidelines recommend kidney function surveillance in these patients, but practice patterns are unknown. Variations in kidney function surveillance were assessed across patients with spina bifida, with the hypothesis that the treating clinic and spina bifida type would be associated with kidney function surveillance. MATERIALS AND METHODS: A retrospective cohort study was conducted from 2013-2018 within the National Spina Bifida Patient Registry in the United States. Follow-up was anchored at the 2013 visit. Participants with either an outcome event within 2 years of follow-up or >2 years of follow-up without an outcome event were included. Primary outcome was kidney function surveillance, defined as at least one renal ultrasound and serum creatinine within 2 years of follow-up. Primary exposures were clinic and spina bifida type, which were analyzed with covariates including sociodemographic and clinical characteristics in logistic regression models for their association with the outcome. Sensitivity analyses were performed using different kidney function surveillance definitions. RESULTS: Of 8351 total patients, 5445 were included, with median 3.0 years' follow-up. Across 23 treating clinics, kidney function surveillance rates averaged 62% (range 6-100%). In multivariable models, kidney function surveillance was associated with clinic, younger age, functional lesion level, non-ambulatory status, and prior bladder augmentation. Treating clinic remained a significant predictor of kidney function surveillance in all sensitivity analyses. CONCLUSIONS: Within the National Spina Bifida Patient Registry, wide variation exists in practice of kidney function surveillance across treating clinics, despite adjustment for key patient characteristics. |
Cost comparison between 2 responses to hepatitis A virus incidents in restaurant food handlers - New York City, 2015 and 2017
Baum SE , Reddy V , Vora NM , Balter S , Daskalakis D , Barbot O , Misener M , Rakeman J , Rojas J , Starr D , Waechter H , Zucker J , Lee D . J Public Health Manag Pract 2020 26 (2) 176-179 CONTEXT: While the New York City Department of Health and Mental Hygiene (DOHMH) can use agency-wide emergency activation to respond to a hepatitis A virus-infected food handler, there is a need to identify alternative responses that conserve scarce resources. OBJECTIVE: To compare the costs incurred by DOHMH of responding to a hepatitis A case in restaurant food handlers using an agency-wide emergency activation (2015) versus the cost of collaborating with a private network of urgent care clinics (2017). DESIGN: We partially evaluate the costs incurred by DOHMH of responding to a hepatitis A case in a restaurant food handler using agency-wide emergency activation (2015) with the cost of collaborating with a private network of urgent care clinics (2017) estimated for a scenario in which DOHMH incurred the retail cost of services rendered. RESULTS: Costs incurred by DOHMH for emergency activation were $65 831 ($238 per restaurant employee evaluated) of which DOHMH personnel services accounted for 85% ($55 854). Costs of collaboration would have totaled $50 914 ($253 per restaurant employee evaluated) of which personnel services accounted for 6% ($3146). CONCLUSIONS: Accounting for incident size, collaborating with the clinic network was more expensive than agency-wide emergency activation, though required fewer DOHMH personnel services. |
Baseline urinary tract imaging in infants enrolled in the UMPIRE Protocol for Children with Spina Bifida
Tanaka ST , Paramsothy P , Thibadeau J , Wiener JS , Joseph DB , Cheng EY , Tu D , Austin C , Koh CJ , Wallis MC , Walker WO , Smith KA , Routh JC , Baum MA . J Urol 2019 201 (6) 1193-1198 PURPOSE: The lifetime risk of renal damage in children with spina bifida is high but only limited baseline imaging data are available for this population. We evaluated a large prospective cohort of infants with spina bifida to define their baseline imaging characteristics. MATERIALS AND METHODS: The UMPIRE Protocol for Young Children with Spina Bifida is an iterative quality improvement protocol that follows a cohort of newborns at 9 United States centers. Using descriptive statistics, we report the initial baseline imaging characteristics, specifically regarding renal bladder ultrasound, cystogram and dimercaptosuccinic acid nuclear medicine scan. RESULTS: Data on 193 infants from 2015 to 2018 were analyzed. Renal-bladder ultrasound was normal in 55.9% of infants, while 40.4% had Society for Fetal Urology grade 1 to 2 hydronephrosis in at least 1 kidney, 3.7% had grade 3 to 4 hydronephrosis in either kidney and 21.8% had grade 1 or higher bilateral hydronephrosis. There was no vesicoureteral reflux in 84.6% of infants. A third of enrolled infants underwent dimercaptosuccinic acid nuclear medicine renal scan, of whom 92.4% had no renal defects and 93.9% had a difference in differential function of less than 15%. CONCLUSIONS: The majority of infants born with spina bifida have normal baseline imaging characteristics and normal urinary tract anatomy at birth. This proactive protocol offers careful scheduled surveillance of the urinary tract with the goal of lifelong maintenance of normal renal function and healthy genitourinary development. |
Mean mid-arm circumference and blood pressure cuff sizes for US children, adolescents and adults: National Health and Nutrition Examination Survey, 2011-2016
Ostchega Y , Hughes JP , Nwankwo T , Zhang G . Blood Press Monit 2018 23 (6) 305-311 BACKGROUND: Measuring blood pressure (BP) requires an appropriate BP cuff size given measured mid-arm circumference (mid-AC). OBJECTIVE: To provide mid-AC means and percentiles for US population aged more than 3 years and examine the frequency distribution of mid-AC cuffed by Baum and Welch Allyn cuff systems. PATIENTS AND METHODS: The 2011-2016 National Health and Nutrition Examination Survey, a cross-sectional survey, was used to estimate mean mid-AC (n=24 723). RESULTS: Mean mid-AC did not differ from 2011 to 2016 (31.0 vs. 31.3 cm, P>0.05). During 2011-2016, mean mid-AC was greater for males than females (32.0 vs. 30.4 cm, P<0.001) and was largest among adults 40-49 years (34.0 cm). Non-Hispanic Black persons had the largest mean mid-AC (32.0 cm) and non-Hispanic Asian persons the smallest (28.4 cm). Increased BMI was associated with increased mean mid-AC for those 3-19 years (normal, 22.0 cm and obese, 31.5 cm, P<0.001) and more than 20 years (normal, 28.2 cm and obese, 37.8 cm, P<0.001). Among those aged 8-17 years, high BP status was associated with a larger mean mid-AC (normotensive 26.1 cm vs. high BP 28.2 cm, P=0.001). Among adults aged 18 years and older, hypertension status was associated with a larger mean mid-AC (normotensive 32.4 cm vs. hypertensive 34.2 cm, P<0.001). Among those aged 12-19 years, 13.0% required a Baum large cuff (35-46.9 cm mid-AC) and 21.7% required a Welch Allyn large cuff (32-39.9 cm mid-AC). Among those aged more than 20 years, 33.2% required a Baum large cuff, 48.2% required a Welch Allyn large cuff, 1.3% required a Baum extra-large cuff (44-66 cm mid-AC), and 9.5% required a Welch Allyn extra-large cuff (40-55 cm mid-AC). CONCLUSION: Currently, BP is obtained in clinic, pharmacy, home, and ambulatory setting using single or multiple cuffs. National Health and Nutrition Examination Survey mid-AC data should be considered for accurate cuffing avoiding cuff hypertension or hypotension. |
Novel multipurpose pod-intravaginal ring for the prevention of HIV, HSV, and unintended pregnancy: Pharmacokinetic evaluation in a macaque model
Smith JM , Moss JA , Srinivasan P , Butkyavichene I , Gunawardana M , Fanter R , Miller CS , Sanchez D , Yang F , Ellis S , Zhang J , Marzinke MA , Hendrix CW , Kapoor A , Baum MM . PLoS One 2017 12 (10) e0185946 Globally, women bear an uneven burden for sexual HIV acquisition. Results from two clinical trials evaluating intravaginal rings (IVRs) delivering the antiretroviral agent dapivirine have shown that protection from HIV infection can be achieved with this modality, but high adherence is essential. Multipurpose prevention technologies (MPTs) can potentially increase product adherence by offering protection against multiple vaginally transmitted infections and unintended pregnancy. Here we describe a coitally independent, long-acting pod-IVR MPT that could potentially prevent HIV and HSV infection as well as unintended pregnancy. The pharmacokinetics of MPT pod-IVRs delivering tenofovir alafenamide hemifumarate (TAF2) to prevent HIV, acyclovir (ACV) to prevent HSV, and etonogestrel (ENG) in combination with ethinyl estradiol (EE), FDA-approved hormonal contraceptives, were evaluated in pigtailed macaques (N = 6) over 35 days. Pod IVRs were exchanged at 14 days with the only modification being lower ENG release rates in the second IVR. Plasma progesterone was monitored weekly to determine the effect of ENG/EE on menstrual cycle. The mean in vivo release rates (mg d-1) for the two formulations over 30 days ranged as follows: TAF2 0.35-0.40; ACV 0.56-0.70; EE 0.03-0.08; ENG (high releasing) 0.63; and ENG (low releasing) 0.05. Mean peak progesterone levels were 4.4 +/- 1.8 ng mL-1 prior to IVR insertion and 0.075 +/- 0.064 ng mL-1 for 5 weeks after insertion, suggesting that systemic EE/ENG levels were sufficient to suppress menstruation. The TAF2 and ACV release rates and resulting vaginal tissue drug concentrations (medians: TFV, 2.4 ng mg-1; ACV, 0.2 ng mg-1) may be sufficient to protect against HIV and HSV infection, respectively. This proof of principle study demonstrates that MPT-pod IVRs could serve as a potent biomedical prevention tool to protect women's sexual and reproductive health and may increase adherence to HIV PrEP even among younger high-risk populations. |
Blood pressure cuff comparability study
Ostchega Y , Nwankwo T , Zhang G , Chiappa M . Blood Press Monit 2016 21 (6) 345-351 BACKGROUND: Manufacturer-supplied blood pressure (BP) cuffs are part of the automatic oscillometric BP devices algorithm. MATERIALS AND METHODS: This study assessed the differences in BP values using the Omron HEM 907-XL (Omron) device with two types of cuffs: the Baum cuff (BC) and the supplied Omron cuff (OC). A sample of 102 adults participated in the study, 34 per cuff size (adult, large, and extra-large). After a 5-min resting period, three pairs of BP determinations (systolic and diastolic) were taken simultaneously on both arms. One arm was cuffed with a BC and the other arm was cuffed with an OC. The cuffs were switched to opposite arms after 5 min of rest. The order was decided randomly as to which cuff was applied to which arm first. RESULTS: The BP readings were highly correlated between the cuffs (systolic BP, r=0.98; diastolic BP, r=0.98). The overall mean differences (BC-OC) were 2.66 mmHg (SD=3.9 mmHg) for systolic BP (P<0.05) and 0.33 mmHg (SD=2.03 mmHg) for diastolic BP (P>0.05). Increased cuff size corresponded to increased differences in systolic BP values (adult: 1.51 mmHg; large: 2.56 mmHg; and extra-large: 3.9 mmHg; P<0.05). For diastolic BP values, a statistically significant difference was observed only for adult cuff size (difference=1.31 mmHg, SD=1.34 mmHg, P<0.05). CONCLUSION: Using a BC with the Omron could result in higher systolic BP readings and higher diastolic BP readings with the adult cuff size. |
Design and Methodological Considerations of the Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida
Routh JC , Cheng EY , Austin JC , Baum MA , Gargollo PC , Grady RW , Herron AR , Kim SS , King SJ , Koh CJ , Paramsothy P , Raman L , Schechter MS , Smith KA , Tanaka ST , Thibadeau JK , Walker WO , Wallis MC , Wiener JS , Joseph DB . J Urol 2016 196 (6) 1728-1734 INTRODUCTION: Care of children with spina bifida (SB) has significantly advanced over the last half-century, resulting in gains in longevity and quality of life for affected children and caregivers. Bladder dysfunction is the norm in SB patients and may result in infection, renal scarring, and chronic kidney disease. However, the optimal urologic management for SB-related bladder dysfunction is unknown. METHODS: In 2012, Centers for Disease Control and Prevention (CDC) convened a working group composed of pediatric urologists, nephrologists, epidemiologists, methodologists, community advocates, and CDC personnel to develop a protocol to optimize urologic care of children with SB from the newborn period through 5 years of age. RESULTS: An iterative quality-improvement protocol was selected; in this model, participating institutions agree to prospectively treat all newborns with SB using a single consensus-based protocol. Over the course of the 5-year study period, study outcomes are routinely assessed and the protocol adjusted as needed in order to optimize patient and process outcomes. Primary study outcomes include urinary tract infections (UTI), renal scarring, renal function, and bladder characteristics. The protocol specifies the timing and use of testing (e.g., ultrasonography, urodynamics) and interventions (e.g., intermittent catheterization, prophylactic antibiotics, antimuscarinic medications). Starting in 2014, the CDC began funding nine study sites to implement and evaluate the protocol. CONCLUSIONS: The CDC Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida began accruing patients in 2015. Assessment in the first 5 years will focus on UTIs, renal function, renal scarring, and clinical process improvements. |
Topical delivery of tenofovir disoproxil fumarate and emtricitabine from pod-intravaginal rings protects macaques from multiple SHIV exposures
Srinivasan P , Moss JA , Gunawardana M , Churchman SA , Yang F , Dinh CT , Mitchell JM , Zhang J , Fanter R , Miller CS , Butkyavichene I , McNicholl JM , Smith TJ , Baum MM , Smith JM . PLoS One 2016 11 (6) e0157061 Topical preexposure prophylaxis (PrEP) against HIV has been marginally successful in recent clinical trials with low adherence rates being a primary factor for failure. Controlled, sustained release of antiretroviral (ARV) drugs may help overcome these low adherence rates if the product is protective for extended periods of time. The oral combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is currently the only FDA-approved ARV drug for HIV PrEP. A novel pod-intravaginal ring (IVR) delivering TDF and FTC at independently controlled rates was evaluated for efficacy at preventing SHIV162p3 infection in a rigorous, repeat low-dose vaginal exposure model using normally cycling female pigtailed macaques. Six macaques received pod-IVRs containing TDF (65 mg) and FTC (68 mg) every two weeks, and weekly vaginal exposures to 50 TCID50 of SHIV162p3 began one week after the first pod-IVR insertion. All pod-IVR-treated macaques were fully protected throughout the study (P = 0.0002, Log-rank test), whereas all control animals became infected with a median of 4 exposures to infection. The topical, sustained release of TDF and FTC from the pod-IVR maintained protective drug levels in macaques over four months of virus exposures. This novel and versatile delivery system has the capacity to deliver and maintain protective levels of multiple drugs and the protection observed here warrants clinical evaluation of this pod-IVR design. |
Antibody levels and protection after hepatitis B vaccine: Results of a 30-year follow-up study and response to a booster dose
Bruce MG , Bruden D , Hurlburt D , Zanis C , Thompson G , Rea L , Toomey M , Townshend-Bulson L , Rudolph K , Bulkow L , Spradling PR , Baum R , Hennessy T , McMahon BJ . J Infect Dis 2016 214 (1) 16-22 BACKGROUND: The duration of protection in children and adults resulting from hepatitis B vaccination is unknown. In 1981, we immunized a cohort of 1578 Alaska Native adults and children from 15 Alaska communities aged ≥6 months using 3 doses of plasma-derived hepatitis B vaccine. METHODS: Persons were tested for antibody to hepatitis B surface antigen (anti-HBs) levels 30 years after receiving the primary series. Those with levels <10 mIU/mL received 1 booster dose of recombinant hepatitis B vaccine 2-4 weeks later and were then evaluated on the basis of anti-HBs measurements 30 days after the booster. RESULTS: Among 243 persons (56%) who responded to the original primary series but received no subsequent doses during the 30-year period, 125 (51%) had an anti-HBs level ≥10 mIU/mL. Among participants with anti-HBs levels <10 mIU/mL who were available for follow-up, 75 of 85 (88%) responded to a booster dose with an anti-HBs level ≥10 mIU/mL at 30 days. Initial anti-HBs level after the primary series was correlated with higher anti-HBs levels at 30 years. CONCLUSIONS: Based on anti-HBs level ≥10 mIU/mL at 30 years and an 88% booster dose response, we estimate that ≥90% of participants had evidence of protection 30 years later. Booster doses are not needed. |
Characteristics and survival of end stage renal disease (ESRD) patients with spina bifida in the United States Renal Data System (USRDS)
Ouyang L , Bolen J , Valdez R , Joseph D , Baum MA , Thibadeau J . J Urol 2014 193 (2) 558-64 PURPOSE: We described the characteristics, treatments, and survival of persons with spina bifida (SB) who developed end stage renal disease (ESRD) from 2004 through 2008 in the United States Renal Data System (USRDS). MATERIALS AND METHODS: We used ICD-9-CM code 741.* to identify persons with SB from hospital inpatient data (1977-2010) and physician and facility claims (2004-2008). We constructed a 5:1 comparison group of ESRD patients without SB matched by age at first ESRD service, gender, and race/ethnicity. We assessed their risk of mortality and of renal transplant while on dialysis using multivariate cause-specific proportional hazards survival analyses. We also compared their survival after their first renal transplant from first ESRD service to August 2011. RESULTS: We identified 439 ESRD patients with SB, who on average developed ESRD at younger ages than patients without SB (41 vs. 62 years, P<0.001) and urological issues were the most common primary cause of their ESRD. Compared to ESRD patients without SB, patients with SB had similar mortality hazard on dialysis and after a transplant. But ESRD patients without SB were more likely to undergo renal transplantation than patients with SB (hazard ratio=1.51, 95% CI=1.13-2.03). Hospitalizations related to urinary tract infections (UTIs) were positively associated with risk of death on dialysis for ESRD patients with SB (hazard ratio=1.42, 95% CI=1.33-1.53). CONCLUSIONS: SB was not associated with elevated mortality among ESRD patients on dialysis or after a renal transplant. Proper urological and bladder management for patients with SB, particularly for adults, is imperative. |
Pharmacokinetics and preliminary safety study of pod-intravaginal rings delivering antiretroviral combinations for HIV prophylaxis in a macaque model
Moss JA , Srinivasan P , Smith TJ , Butkyavichene I , Lopez G , Brooks AA , Martin A , Dinh CT , Smith JM , Baum MM . Antimicrob Agents Chemother 2014 58 (9) 5125-35 Pre-exposure prophylaxis using oral regimens of the HIV nucleoside reverse transcriptase inhibitors tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has demonstrated efficacy in three clinical trials. Adherence was determined to be a key parameter for success. Incorporation of the TDF-FTC combination into intravaginal rings (IVRs) for sustained mucosal delivery could increase product adherence and efficacy when compared with oral and vaginal gel formulations. A novel pod-IVR technology capable of delivering multiple drugs is described and constitutes the first report of an IVR delivering TDF and FTC, as well as a triple combination IVR delivering TDF, FTC and the entry inhibitor maraviroc (MVC). The pharmacokinetics and preliminary local safety of the two combination pod-IVRs were evaluated in the pig-tailed macaque model. The devices exhibited sustained release at controlled rates over the 28-day study. Median steady-state drug levels in vaginal tissues were: TDF-FTC group; tenofovir (TFV, in vivo hydrolysis product of TDF), 30 mug g-1; FTC, 500 mug g-1; and TDF-FTC-MVC group; TFV, 10 mug g-1; FTC, 150 mug g-1; MVC, 20 mug g-1. No adverse events were observed and there were no toxicological findings. Mild to moderate increases in inflammatory infiltrates were observed in the vaginal tissues of some animals in both the presence and absence of the IVRs. The IVRs did not disturb the vaginal microbiota and levels of proinflammatory cytokines remained stable throughout the study. Pod-IVR candidates based on the TDF-FTC combination have potential for the prevention of vaginal HIV acquisition and merit clinical investigation. |
Characteristics of health impact assessments reported in Australia and New Zealand 2005-2009
Haigh F , Harris E , Chok HNG , Baum F , Harris-Roxas B , Kemp L , Spickett J , Keleher H , Morgan R , Harris M , Wendel AM , Dannenberg AL . Aust N Z J Public Health 2013 37 (6) 534-546 OBJECTIVE: To describe the use and reporting of Health Impact Assessment (HIA) in Australia and New Zealand between 2005 and 2009. METHODS: We identified 115 HIAs undertaken in Australia and New Zealand between 2005 and 2009. We reviewed 55 HIAs meeting the study's inclusion criteria to identify characteristics and appraise the quality of the reports. RESULTS: Of the 55 HIAs, 31 were undertaken in Australia and 24 in New Zealand. The HIAs were undertaken on plans (31), projects (12), programs (6) and policies (6). Compared to Australia, a higher proportion of New Zealand HIAs were on policies and plans and were rapid assessments done voluntarily to support decision-making. In both countries, most HIAs were on land use planning proposals. Overall, 65% of HIA reports were judged to be adequate. CONCLUSION: This study is the first attempt to empirically investigate the nature of the broad range of HIAs done in Australia and New Zealand and has highlighted the emergence of HIA as a growing area of public health practice. It identifies areas where current practice could be improved and provides a baseline against which future HIA developments can be assessed. IMPLICATIONS: There is evidence that HIA is becoming a part of public health practice in Australia and New Zealand across a wide range of policies, plans and projects. The assessment of quality of reports allows the development of practical suggestions on ways current practice may be improved. The growth of HIA will depend on ongoing organisation and workforce development in both countries. |
Long-term immunogenicity of hepatitis A vaccine in Alaska 17 years after initial childhood series
Raczniak GA , Bulkow L , Bruce MG , Zanis C , Baum R , Snowball M , Byrd KK , Sharapov UM , Hennessy TW , McMahon BJ . J Infect Dis 2012 207 (3) 493-6 CDC recommends hepatitis A vaccination for all children at age 1 year and high risk adults. The vaccine is highly effective; however, protection duration is unknown. We report hepatitis A antibody concentrations 17 years after childhood immunization, demonstrating protective antibody levels remain and have stabilized over the past 7 years. |
Microbial biofilms on the surface of intravaginal rings worn in non-human primates
Gunawardana M , Moss JA , Smith TJ , Kennedy S , Kopin E , Nguyen C , Malone AM , Rabe L , Schaudinn C , Webster P , Srinivasan P , Sweeney ED , Smith JM , Baum MM . J Med Microbiol 2011 60 828-37 Millions of intravaginal rings (IVRs) are used by women worldwide for contraception and for the treatment of vaginal atrophy. These devices also are suitable for local and systemic sustained release drug delivery, notably for antiviral agents in human immunodeficiency virus pre-exposure prophylaxis. Despite the widespread use of IVRs, no studies have examined whether surface-attached bacterial biofilms develop in vivo, an important consideration when determining the safety of these devices. The present study used scanning electron microscopy, fluorescence in situ hybridization and confocal laser scanning microscopy to study biofilms that formed on the surface of IVRs worn for 28 days by six female pig-tailed macaques, an excellent model organism for the human vaginal microbiome. Four of the IVRs released the nucleotide analogue reverse transcriptase inhibitor tenofovir at a controlled rate and the remaining two were unmedicated. Large areas of the ring surfaces were covered with monolayers of epithelial cells. Two bacterial biofilm phenotypes were found to develop on these monolayers and both had a broad diversity of bacterial cells closely associated with the extracellular material. Phenotype I, the more common of the two, consisted of tightly packed bacterial mats approximately 5 microm in thickness. Phenotype II was much thicker, typically 40 microm, and had an open architecture containing interwoven networks of uniform fibres. There was no significant difference in biofilm thickness and appearance between medicated and unmedicated IVRs. These preliminary results suggest that bacterial biofilms could be common on intravaginal devices worn for extended periods of time. |
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