Last data update: Sep 16, 2024. (Total: 47680 publications since 2009)
Records 1-7 (of 7 Records) |
Query Trace: Edelman L [original query] |
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Optimizing Provider Preexposure Prophylaxis (PrEP) Training: A Cross-Sectional Analysis of Recommendations from Providers Across the PrEP Implementation Cascade
Rao S , Reed AE , Parchem B , Edelman EJ , Magnus M , Hansen NB , Kershaw TS , Earnshaw VA , Krakower DS , Dovidio JF , Mayer KH , Underhill K , Rosenberger JG , Ogburn DF , Betancourt JR , Calabrese SK . AIDS Behav 2021 26 (1) 1-14 Expanding PrEP access necessitates training that supports healthcare providers' progression along the PrEP implementation cascade, moving from PrEP awareness to prescription. We surveyed 359 USA providers about PrEP training content and format recommendations. We examined the association between cascade location and training recommendations. Most providers were aware of PrEP (100%), willing to prescribe PrEP (97.2%), had discussed PrEP with patients (92.2%), and had prescribed PrEP (79.9%). Latent class regression analysis revealed that cascade location was associated with training recommendations. Although all providers recommended PrEP-specific content (e.g., patient eligibility), providers who were located further along the cascade also recommended more comprehensive content, including sexual history-taking and sexual and gender minority competence training. Providers further along the cascade were also more likely to recommend interactive training formats (e.g., role-playing). These insights from providers furthest along the cascade indicate the importance of including comprehensive content and interactive formats in future PrEP training initiatives. |
White Paper On Antimicrobial Stewardship In Solid Organ Transplant Recipients.
So M , Hand J , Forrest G , Pouch SM , Te H , Ardura MI , Bartash RM , Dadhania D , Edelman J , Ince D , Jorgenson MR , Kabbani S , Lease ED , Levine D , Ohler L , Patel G , Pisano J , Spinner ML , Abbo L , Verna EC , Husain S . Am J Transplant 2021 22 (1) 96-112 Antimicrobial stewardship programs (ASPs) have made immense strides in optimizing antibiotic, antifungal, and antiviral use in clinical settings. However, while ASPs are required institutionally by regulatory agencies in the United States and Canada, they are not mandated for transplant centers or programs specifically. Despite the fact that solid-organ transplant recipients in particular are at increased risk of infections from multi-drug resistant organisms, due to host and donor factors and immunosuppressive therapy - there currently are little rigorous data regarding stewardship practices in solid organ transplant populations, and thus no transplant-specific requirements currently exist. Further complicating matters, transplant patients have a wide range of variability regarding their susceptibility to infection, as factors such as surgery of transplant, intensity of immunosuppression, and presence of drains or catheters in-situ, may modify the risk of infection. As such, it is not feasible to have a 'one-size-fits-all' style of stewardship for this patient population. The objective of this whitepaper is to identify opportunities, risk factors and ASP strategies that should be assessed with SOT recipients to optimize antimicrobial use, while producing an overall improvement in patient outcomes. We hope it may serve as a springboard for development of future guidance, and identification of research opportunities. |
Infants with Congenital Disorders Identified Through Newborn Screening - United States, 2015-2017.
Sontag MK , Yusuf C , Grosse SD , Edelman S , Miller JI , McKasson S , Kellar-Guenther Y , Gaffney M , Hinton CF , Cuthbert C , Singh S , Ojodu J , Shapira SK . MMWR Morb Mortal Wkly Rep 2020 69 (36) 1265-1268 Newborn screening (NBS) identifies infants at risk for congenital disorders for which early intervention has been shown to improve outcomes (1). State public health programs are encouraged to screen for disorders on the national Recommended Uniform Screening Panel (RUSP), which increased from 29 disorders in 2005 to 35 in 2018.* The RUSP includes hearing loss (HL) and critical congenital heart defects, which can be detected through point-of-care screening, and 33 disorders detected through laboratory screening of dried blood spot (DBS) specimens. Numbers of cases for 33 disorders on the RUSP (32 DBS disorders and HL) reported by 50 U.S. state programs were tabulated. The three subtypes of sickle cell disease (SCD) listed as separate disorders on the RUSP (S,S disease; S,beta-thalassemia; and S,C disease) were combined for the current analysis, and the frequencies of the resulting disorders were calculated relative to annual births. During 2015-2017, the overall prevalence was 34.0 per 10,000 live births. Applying that frequency to 3,791,712 live births in 2018,(†) approximately 12,900 infants are expected to be identified each year with one of the disorders included in the study. The most prevalent disorder is HL (16.5 per 10,000), and the most prevalent DBS disorders are primary congenital hypothyroidism (CH) (6.0 per 10,000), SCD (4.9 per 10,000), and cystic fibrosis (CF) (1.8 per 10,000). Notable changes in prevalence for each of these disorders have occurred since the previous estimates based on 2006 births (2). The number of infants identified at a national level highlights the effect that NBS programs are having on infant health through early detection, intervention, and potential improved health, regardless of geographic, racial/ethnic, or socioeconomic differences. |
FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications"
Akbar M , Berry-Bibee E , Blithe DL , Day RS , Edelman A , Hochel J , Jamshidi R , Kim MJ , Li L , Purohit VS , Turpin JA , Scott PE , Strauss DG , Sun H , Tepper NK , Zhang L , Yu C . J Clin Pharmacol 2018 58 (12) 1655-1665 Potential drug interactions with hormonal contraceptives are an important public health concern. A public meeting on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implication" was hosted by the United States Food and Drug Administration (FDA). The meeting endeavored to provide an opportunity for the FDA to seek input from experts on the public health concerns associated with the use of hormonal contraceptives and interacting drugs that might affect efficacy and safety, including pharmacokinetic/pharmacodynamic considerations, in the design of drug interaction studies of hormonal contraceptives for drug development and approaches to translating the results of drug interaction information into informative labeling and communication. The input received could be used to refine FDA's thinking on hormonal contraceptives drug interaction study design and interpretation and labeling communication of drug interaction risk. This meeting benefited from strong and diverse participation from the Center for Drug Evaluation and Research at the FDA, Centers for Disease Control and Prevention, National Institutes of Health, Swedish Medical Products Agency, pharmaceutical industry, and representatives of academia. This report provides a summary of the key discussion based on the presentations and panel discussion. |
Optimizing intradermal administration of cryopreserved Plasmodium falciparum sporozoites in controlled human malaria infection
Lyke KE , Laurens MB , Strauss K , Adams M , Billingsley PF , James E , Manoj A , Chakravarty S , Plowe CV , Li ML , Ruben A , Edelman R , Green M , Dube TJ , Sim BK , Hoffman SL . Am J Trop Med Hyg 2015 93 (6) 1274-1284 Controlled human malaria infection (CHMI) is a powerful tool to evaluate malaria vaccine and prophylactic drug efficacy. Until recently CHMI was only carried out by the bite of infected mosquitoes. A parenteral method of CHMI would standardize Plasmodium falciparum sporozoite (PfSPZ) administration, eliminate the need for expensive challenge facility infrastructure, and allow for use of many P. falciparum strains. Recently, intradermal (ID) injection of aseptic, purified, cryopreserved PfSPZ was shown to induce P. falciparum malaria; however, 100% infection rates were not achieved by ID injection. To optimize ID PfSPZ dosing so as to achieve 100% infection, 30 adults aged 18-45 years were randomized to one of six groups composed of five volunteers each. The parameters of dose (1 x 104 versus 5 x 104 PfSPZ total dose per volunteer), number of injections (two versus eight), and aliquot volume per ID injection (10 muL versus 50 muL) were studied. Three groups attained 100% infection: 1 x 104 PfSPZ in 50 muL/2 doses, 1 x 104 PfSPZ in 10 muL/2 doses, and 5 x 104 PfSPZ in 10 muL/8 doses. The group that received 5 x 104 PfSPZ total dose in eight 10-muL injections had a 100% infection rate and the shortest prepatent period (mean of 12.7 days), approaching the prepatent period for the current CHMI standard of five infected mosquitoes. |
Long-term safety assessment of live attenuated tetravalent dengue vaccines: deliberations from a WHO technical consultation
Bentsi-Enchill AD , Schmitz J , Edelman R , Durbin A , Roehrig JT , Smith PG , Hombach J , Farrar J . Vaccine 2013 31 (23) 2603-9 Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use. |
Reduction in gastroenteritis in United States children and correlation with early rotavirus vaccine uptake from national medical claims databases
Cortese MM , Tate JE , Simonsen L , Edelman L , Parashar UD . Pediatr Infect Dis J 2010 29 (6) 489-94 BACKGROUND: We sought to estimate rotavirus disease reduction among children in hospital and office settings in the 4 US regions following rotavirus vaccine introduction and to estimate vaccine uptake. METHODS: Two national third-party payer medical claims databases were used to examine the number of visits for gastroenteritis per annual nongastroenteritis visits among children aged <5 years during July 2003 to June 2008 in hospital and office settings. The gastroenteritis burden attributable to rotavirus was computed as the excess of all gastroenteritis visits during rotavirus seasons above the baseline of visits during nonrotavirus periods. Rotavirus vaccine uptake was estimated by comparing claims for rotavirus vaccine with those for diphtheria-tetanus-acellular pertussis vaccines. RESULTS: In the South, Northeast, and Midwest, the typical winter-spring gastroenteritis peak due to rotavirus was markedly dampened in 2007-2008. Compared with the mean for 3 prevaccine seasons, the excess gastroenteritis visits that occurred during the 2007-2008 rotavirus season was reduced by >90% among infants in all care settings in 3 regions and by >70% among children aged 1 to 4 years. In the West, disease reductions were lower (53%-63% reduction among hospitalized infants). At the onset of the 2007-2008 season, coverage with ≥1 rotavirus vaccine dose was an estimated 57% among infants, 17% among children aged 1 year, and 0 among those aged 2 to 4 years. CONCLUSIONS: The rotavirus burden in 2007-2008 was markedly reduced in all US regions and exceeded that explained by only direct protection of the youngest vaccinated children. |
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