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https://www.readbyqxmd.com/read/28077675/post-hoc-assessment-of-the-immunogenicity-of-bioengineered-factor-viia-demonstrates-the-use-of-preclinical-tools
#1
Kasper Lamberth, Stine Louise Reedtz-Runge, Jonathan Simon, Ksenia Klementyeva, Gouri Shankar Pandey, Søren Berg Padkjær, Véronique Pascal, Ileana R León, Charlotte Nini Gudme, Søren Buus, Zuben E Sauna
Immunogenicity is an important consideration in the licensure of a therapeutic protein because the development of neutralizing anti-drug antibodies (ADAs) can affect both safety and efficacy. Neoantigens introduced by bioengineering of a protein drug are a particular cause for concern. The development of a bioengineered recombinant factor VIIa (rFVIIa) analog was discontinued after phase 3 trials because of the development of ADAs. The unmodified parent molecule (rFVIIa), on the other hand, has been successfully used as a drug for more than two decades with no reports of immunogenicity in congenital hemophilia patients with inhibitors...
January 11, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28066693/society-of-pediatric-psychology-workforce-survey-development-of-survey-methods-sample-characteristics-and-lessons-learned
#2
Tim Wysocki, Cheryl L Brosig, Marisa E Hilliard
There are few detailed workforce studies of specialty fields within professional psychology, and none have been reported for pediatric psychology since 2006. Availability of such data could facilitate more-informed decision making by students and trainees, psychologists pursuing employment opportunities, and psychologists involved in employment or compensation negotiations. This article describes the work of a task force of the American Psychological Association (APA) Division 54 (Society of Pediatric Psychology) in the design, construction, pretesting, distribution, and data management for the Society of Pediatric Psychology (SPP) Workforce Survey...
March 2016: Clinical Practice in Pediatric Psychology
https://www.readbyqxmd.com/read/28053335/an-fda-perspective-on-the-assessment-of-proposed-biosimilar-therapeutic-proteins-in-rheumatology
#3
REVIEW
Nikolay P Nikolov, Marjorie A Shapiro
Biologic products have revolutionized the management of many rheumatic diseases, but access to these products might be limited by their relatively high costs. The US Biologics Price Competition and Innovation Act of 2009, which is contained within the Patient Protection and Affordable Care Act, established an abbreviated pathway for licensure by the FDA of biologic products that are demonstrated to be biosimilar to or interchangeable with FDA-licensed biologic products, termed reference products. This law allows for the approval of biosimilar biologic products, which are expected to increase access to treatment for patients, and ensuring the implementation of this Act is a high priority for the FDA...
January 5, 2017: Nature Reviews. Rheumatology
https://www.readbyqxmd.com/read/28049678/the-relationship-between-mock-boards-and-clinical-board-examinations-in-dental-hygiene-education
#4
Victoria M Martin, Ellen J Rogo, Kathleen O Hodges, Neill F Piland, Sharon E Osborn Popp
Research on the effectiveness of clinical mock boards for future oral health professionals is conflicting and limited. Despite this, U.S. dental hygiene programs rely on clinical mock board experiences as essential components for preparing students for their clinical board examinations. Differences in programs' mock board characteristics may relate to board exam outcomes. The validity and reliability of mock boards can be questioned when deviations from exam criteria and procedures are made and grading mechanisms are not consistent...
January 2017: Journal of Dental Education
https://www.readbyqxmd.com/read/28049673/dental-students-reflections-on-quality-of-periodontal-care-in-dental-school-clinics
#5
Sangeetha Chandrasekaran, Charles Powell, Laurice De la Rosa, Anuj Mittal, Lonnie Johnson
The aim of this study was to analyze dental students' descriptions of and reflections on the periodontal care they provided for their patients in dental school clinics. All students enrolled in the final year of the DDS program in 2011-14 at the University of Colorado School of Dental Medicine were required to complete a self-assessment of the periodontal care they provided for patients. Assessments from 263 students were compiled and qualitatively analyzed. The key reasons given for not providing good care were identified and then stratified as student/school-dependent or patient-dependent factors...
January 2017: Journal of Dental Education
https://www.readbyqxmd.com/read/28049672/exploring-how-u-s-dental-schools-teach-removal-of-carious-tissues-during-cavity-preparations
#6
Marcelle M Nascimento, Linda S Behar-Horenstein, Xiaoying Feng, Sandra Guzmán-Armstrong, Margherita Fontana
Approaches for managing carious tissues during cavity preparations vary considerably among clinicians, which may reflect inconsistencies in the teaching of this subject by dental schools. The aims of this study were to investigate practices related to the preclinical and clinical teaching of caries removal at U.S. dental schools and the relationship between that teaching and requirements for U.S. dental licensure examinations. The electronic survey included questions about terminology, methods, instruments and materials, treatment planning, criteria for clinical exams, faculty calibration sessions, and licensure exams...
January 2017: Journal of Dental Education
https://www.readbyqxmd.com/read/28034906/fda-s-approach-to-regulating-biosimilars
#7
Steven J Lemery, M Stacey Ricci, Patricia Keegan, Amy E McKee, Richard Pazdur
The Biosimilar Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between products in terms of safety, purity, and potency...
December 29, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28027053/sample-size-and-probability-threshold-considerations-with-the-tailored-data-method
#8
Adam E Wyse
This article discusses sample size and probability threshold considerations in the use of the tailored data method with the Rasch model. In the tailored data method, one performs an initial Rasch analysis and then reanalyzes data after setting item responses to missing that are below a chosen probability threshold. A simple analytical formula is provided that can be used to check whether or not the application of the tailored data method with a chosen probability threshold will create situations in which the number of remaining item responses for the Rasch calibration will or will not meet minimum sample size requirements...
2016: Journal of Applied Measurement
https://www.readbyqxmd.com/read/28024436/international-consensus-statement-on-the-assessment-of-interprofessional-learning-outcomes
#9
Gary D Rogers, Jill E Thistlethwaite, Elizabeth S Anderson, Madeleine Abrandt Dahlgren, Ruby E Grymonpre, Monica Moran, Dujeepa D Samarasekera
Regulatory frameworks around the world mandate that health and social care professional education programs graduate practitioners who have the competence and capability to practice effectively in interprofessional collaborative teams. Academic institutions are responding by offering interprofessional education (IPE); however, there is as yet no consensus regarding optimal strategies for the assessment of interprofessional learning (IPL). The Program Committee for the 17th Ottawa Conference in Perth, Australia in March, 2016, invited IPE champions to debate and discuss the current status of the assessment of IPL...
December 26, 2016: Medical Teacher
https://www.readbyqxmd.com/read/28017431/who-consultation-on-group-b-streptococcus-vaccine-development-report-from-a-meeting-held-on-27-28-april-2016
#10
Miwako Kobayashi, Stephanie J Schrag, Mark R Alderson, Shabir A Madhi, Carol J Baker, Ajoke Sobanjo-Ter Meulen, David C Kaslow, Peter G Smith, Vasee S Moorthy, Johan Vekemans
Globally, group B Streptococcus (GBS) remains a leading cause of sepsis and meningitis in infants in the first 90days of life. Intrapartum antibiotic prophylaxis (IAP) for women at increased risk of transmitting GBS to their newborns has been effective in reducing part, but not all, of the GBS disease burden in many high income countries (HICs). In low- and middle-income countries (LMICs), IAP use is low. Immunization of pregnant women with a GBS vaccine represents an alternative strategy to protecting newborns and young infants, through transplacental antibody transfer and potentially by reducing new vaginal colonization...
December 22, 2016: Vaccine
https://www.readbyqxmd.com/read/28012981/the-impact-of-instituting-process-oriented-guided-inquiry-learning-pogil-in-a-fundamental-nursing-course
#11
Maureen C Roller, Susan Zori
BACKGROUND: POGIL, using small groups of students, who assume the roles of leader, manager, recorder, and reflector to complete problem based activities in science courses, has demonstrated significant improvement in students' grades and course satisfaction in science courses and a nursing Fundamentals course. Using POGIL with nursing students in fundamentals nursing courses could help to improve final grades and course satisfaction while promoting active learning, critical thinking, and teamwork...
December 16, 2016: Nurse Education Today
https://www.readbyqxmd.com/read/28011136/emerging-adults-without-a-driver-s-license-engage-in-more-transportation-related-physical-activity-to-school-work-in-certain-environmental-contexts
#12
Indra Neal Kar, Kaigang Li, Denise L Haynie, Bruce G Simons-Morton
The aim was to examine the moderation effect of driving licensure status on the association between different environmental contexts and transportation-related physical activity to and from school and/or work (TPA-SW) among emerging adults. The data were from Wave 4 (n=2026, year 2013) of the NEXT Generation Health Study, an annual assessment of a nationally representative cohort across the nine U.S. Census Divisions. The outcome variable, TPA-SW, was derived from walking or cycling as modes of travel to and from school and/or work...
December 20, 2016: Preventive Medicine
https://www.readbyqxmd.com/read/28009600/the-detection-analysis-and-significance-of-physician-clustering-in-medical-malpractice-lawsuit-payouts
#13
Robert E Oshel, Philip Levitt
OBJECTIVES: There is evidence that most adverse events result from individual errors and that most malpractice suits with payouts reflect both patient injury and error. HYPOTHESIS: There are outlier physicians with regard to the frequency and total amount of malpractice payouts. METHODS: Using the public use file of the National Practitioner Data Bank (NPDB), we sought the percentage of physicians who lay above several cutoff points with regard to total amounts of payments and number of payments...
December 21, 2016: Journal of Patient Safety
https://www.readbyqxmd.com/read/27989900/ebola-virus-vaccines-where-do-we-stand
#14
REVIEW
Vincent Pavot
The recent outbreak of Ebola virus disease in West Africa has led to more than 11,000 deaths, with a peak in mortality from August through December of 2014. A meeting convened by the World Health Organization (WHO) in September 2014, concluded that an urgent unmet need exists for efficacy and safety testing of the Ebola virus vaccine candidates and that clinical trials should be expedited. These vaccines could be used both in an outbreak setting and to provide long-term protection in populations at risk of sporadic outbreaks...
October 28, 2016: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/27974397/assignment-of-opsonic-values-to-pneumococcal-reference-serum-007sp-for-use-in-opsonophagocytic-assays-for-13-serotypes
#15
R L Burton, J Antonello, D Cooper, D Goldblatt, K H Kim, B D Plikaytis, L Roalfe, D Wauters, F Williams, G L Xie, M H Nahm, M Akkoyunlu
Opsonophagocytic assays (OPAs) are routinely used for assessing the immunogenicity of pneumococcal vaccines, with OPA data often utilized for licensure of new vaccine formulations. However, no reference serum for pneumococcal OPAs is available, making evaluation of data among different laboratories difficult. This international collaboration was initiated to: 1) assign consensus opsonic indexes (OIs) to Pneumococcal Reference Serum Lot 007sp ("007sp") and a panel of calibration sera; and 2) determine if normalization with 007sp decreases the OPA variability among laboratories...
December 14, 2016: Clinical and Vaccine Immunology: CVI
https://www.readbyqxmd.com/read/27960595/meningococcal-serogroup-b-vaccines-estimating-breadth-of-coverage
#16
Robert G K Donald, Julio Cesar Hawkins, Li Hao, Paul Liberator, Thomas R Jones, Shannon L Harris, John L Perez, Joseph J Eiden, Kathrin U Jansen, Annaliesa S Anderson
Neisseria meningitidis serogroup B (MenB) is an important cause of invasive meningococcal disease. The development of safe and effective vaccines with activity across the diversity of MenB strains has been challenging. While capsular polysaccharide conjugate vaccines have been highly successful in the prevention of disease due to meningococcal serogroups A, C, W, and Y, this approach has not been possible for MenB owing to the poor immunogenicity of the MenB capsular polysaccharide. Vaccines based on outer membrane vesicles have been successful in the prevention of invasive MenB disease caused by the single epidemic strain from which they were derived, but they do not confer broad protection against diverse MenB strains...
December 14, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/27936811/parental-influence-on-driver-licensure-in-adolescence-a-randomized-controlled-trial
#17
Jessica H Mirman, Allison E Curry, Flaura K Winston, Megan C Fisher Thiel, Melissa R Pfeiffer, Rachel Rogers, Michael R Elliott, Dennis R Durbin
OBJECTIVE: Newly licensed adolescent drivers have skill deficits that increase risk for motor vehicle crashes. Development of programs targeted to prelicensed adolescents has been hindered by concerns about encouraging overconfidence and early licensure. The study had 2 primary objectives: (a) determine whether an Internet-based intervention designed to improve parent-supervised practice (TeenDrivingPlan [TDP]) influenced adolescents' time to licensure and parents' perceptions of adolescents' driving skill, expertise, and safety and (b) evaluate the association of these perceptions and practice diversity (number of different environments where practiced occurred) with time to licensure...
December 12, 2016: Health Psychology: Official Journal of the Division of Health Psychology, American Psychological Association
https://www.readbyqxmd.com/read/27928182/state-licensure-requirements-for-students-seeking-postgraduate-residency-training-may-limit-options
#18
EDITORIAL
Luis S Gonzalez, Marissa Romanish
No abstract text is available yet for this article.
November 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27922899/nursing-students-intrinsic-motivation-and-performance-on-the-licensure-examination
#19
Michele G Hackney
Unsuccessful attempts at licensure adversely affect graduates, prelicensure nursing education programs, health care agencies, and ultimately, patient safety. The purpose of this quantitative, correlational study was to investigate the relationship between nursing students' intrinsic motivation and performance on the licensure examination. Nursing students responded to 12 questions related to reasons for learning as indicators of motivation type. Results indicated no statistically significant correlations between variables...
December 5, 2016: Nurse Educator
https://www.readbyqxmd.com/read/27922180/going-domestic-importing-the-study-abroad-experience-the-development-of-a-multicultural-new-york-city-study-away-program
#20
Susan Hayes Lane, Carolyn Huffman, Dana E Brackney, Alyssa Cuddy
PROBLEM: Significant off-campus domestic study away experiences have been shown to be a transformative active learning environment for students and achieve similar learning outcomes as study abroad programs. METHODS: This manuscript describes the conception, development, and pedagogical approach of a faculty-led domestic study away experience in New York City for pre-licensure and post-licensure nursing students as an active learning strategy for developing cultural competence...
December 6, 2016: Nursing Forum
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