Evaluation of the Live-Attenuated Intranasal Respiratory Syncytial Virus (RSV) Vaccine RSV/6120/ΔNS2/1030s in RSV-Seronegative Young Children.

BACKGROUND: Respiratory syncytial virus (RSV) is the leading cause of pediatric lower respiratory illness (LRI) and a vaccine for immunization of children is needed. RSV/6120/ΔNS2/1030s is a cDNA-derived live-vaccine candidate attenuated by deletion of the interferon antagonist NS2 gene and the genetically stabilized 1030s missense polymerase mutation in the polymerase, conferring temperature sensitivity. METHODS: A single intranasal dose of RSV/6120/ΔNS2/1030s was evaluated in a double-blind, placebo-controlled trial (vaccine to placebo ratio, 2:1) at 105.7 plaque-forming units (PFU) in 15 RSV-seropositive 12- to 59-month-old children, and at 105 PFU in 30 RSV-seronegative 6- to 24-month-old children. RESULTS: RSV/6120/ΔNS2/1030s infected 100% of RSV-seronegative vaccinees and was immunogenic (geometric mean RSV plaque-reduction neutralizing antibody titer [RSV-PRNT], 1:91) and genetically stable. Mild rhinorrhea was detected more frequently in vaccinees (18/20 vaccinees vs 4/10 placebo recipients, P = .007), and LRI occurred in 1 vaccinee during a period when only vaccine virus was detected. Following the RSV season, 5 of 16 vaccinees had ≥4-fold rises in RSV-PRNT with significantly higher titers than 4 of 10 placebo recipients with rises (1:1992 vs 1:274, P = .02). Thus, RSV/6120/ΔNS2/1030s primed for substantial anamnestic neutralizing antibody responses following naturally acquired RSV infection. CONCLUSIONS: RSV/6120/ΔNS2/1030s is immunogenic and genetically stable in RSV-seronegative children, but the frequency of rhinorrhea in vaccinees exceeded that in placebo recipients. CLINICAL TRIALS REGISTRATION: NCT03387137.

Live-attenuated Vaccines Prevent Respiratory Syncytial Virus-associated Illness in Young Children.

Rationale: Active immunization is needed to protect infants and young children against respiratory syncytial virus (RSV). Rationally designed live-attenuated RSV vaccines are in clinical development.Objectives: Develop preliminary estimates of vaccine efficacy, assess durability of antibody responses to vaccination and "booster" responses after natural RSV infection, and determine sample sizes needed for more precise estimates of vaccine efficacy.Methods: We analyzed data from seven phase 1 trials of live-attenuated RSV vaccines in 6- to 24-month-old children (n = 239).Measurements and Main Results: The five vaccine regimens that induced neutralizing antibody responses in ≥80% of vaccinees (defined post hoc as "more promising") protected against RSV-associated medically attended acute respiratory illness (RSV-MAARI) and medically attended acute lower respiratory illness (RSV-MAALRI) and primed for potent anamnestic responses upon natural exposure to wild-type RSV. Among recipients of "more promising" RSV vaccines, efficacy against RSV-MAARI was 67% (95% confidence interval [CI], 24 to 85; P = 0.008) and against RSV-MAALRI was 88% (95% CI, -9 to 99; P = 0.04). A greater than or equal to fourfold increase in RSV serum neutralizing antibody following vaccination was strongly associated with protection against RSV-MAARI (odds ratio, 0.26; 95% CI, 0.09 to 0.75; P = 0.014) and RSV-MAALRI; no child with a greater than or equal to fourfold increase developed RSV-MAALRI. Rates of RSV-MAARI and RSV-MAALRI in placebo recipients were 21% and 7%, respectively. Given these rates, a study of 540 RSV-naive children would have 90% power to demonstrate ≥55% efficacy against RSV-MAARI and ≥80% efficacy against RSV-MAALRI; if rates were 10% and 3%, a study of 1,300 RSV-naive children would be needed.Conclusions: Rapid development of a live-attenuated RSV vaccine could contribute substantially to reducing the global burden of RSV disease.

Simulated patients in audiology education: student reports.

BACKGROUND: Despite increased attention in recent years to audiology counseling education, students remain concerned about their abilities to interact with patients in challenging situations, such as when breaking difficult news. Simulated patients, or actors trained to portray patients in clinical scenarios, have been used for many years in medical schools to teach and assess students' interpersonal skills, and are just beginning to be used in audiology programs. Although research suggests that medical students value simulated patient experiences, little is known about whether the same is true for audiology students. PURPOSE: The purpose of this study was to survey audiology students who had completed a simulated patient counseling experience as part of their graduate coursework at Central Michigan University, to learn about their experiences and views of this instructional format. RESEARCH DESIGN: This study used descriptive and comparative statistics to report student observations and to determine if student responses to evaluative questions differed from chance. STUDY SAMPLE: Study participants included 29 audiology students who had completed a "breaking difficult news" simulated patient experience as part of their required graduate coursework in patient counseling. DATA COLLECTION AND ANALYSIS: Participants completed an online survey that included seven evaluative five-point Likert-scale questions about their simulated patient counseling experience. Participants also completed one multiple-choice question on suggestions for future simulated-patient sessions. RESULTS: For each of the seven evaluative questions, a majority of participants (76-100%) responded positively, agreeing or strongly agreeing that the experience was helpful to their learning. For each of these evaluative questions, a χ² analysis revealed that the distribution of positive (i.e., strongly agree and agree) to nonpositive (i.e., neutral, disagree, and strongly disagree) responses differed significantly from chance (p < .0001, df = 1). The results also indicated that when asked which of several suggested clinical scenarios would be helpful for future sessions, simulations of challenging patient types (i.e., hostile, rambling, and noncommunicative patients) were supported by most (62-90%) respondents. CONCLUSIONS: The results of the present study are consistent with findings of medical students' positive perceptions of simulated patient experiences as well as those previously reported for audiology students. Together, these data support the continued use of simulated patients as a method of instruction for audiology counseling education for breaking difficult news, and suggest a potential value of using simulated patient interactions for training counseling skills in other clinical situations and scenarios.

Developing Content for Pediatric Hospital Medicine Certification Examination Using Practice Analysis.

OBJECTIVES: The American Board of Pediatrics (ABP) and the Pediatric Hospital Medicine (PHM) subboard developed a content outline to serve as a blueprint for the inaugural certification examination through practice analysis. The systematic approach of practice analyses process is described in the study. METHODS: A diverse, representative panel of 12 pediatric hospitalists developed the draft content outline using multiple resources (publications, textbooks, PHM Core Competencies, PHM fellow's curriculum, etc). The panel categorized practice knowledge into 13 domains and 202 subdomains. By using the ABP database self-defined practicing pediatric hospitalists were identified. Participants rated the frequency and criticality of content domains and subdomains along with providing open-ended comments. RESULTS: In total, 1449 (12.1%) generalists in the ABP database self-identified as pediatric hospitalists, and 800 full-time pediatric hospitalists responded. The content domains that were rated as highly critical and frequently required in practice were weighted more heavily (ie, the percentage of examination questions associated with a domain) than the less critical and less frequently rated. Both community and noncommunity pediatric hospitalists rated domains similarly (P = .943). Subdomain and preliminary weights were rated with similar means and SDs in the majority of topics. CONCLUSIONS: There was concordance in the rating of domain and universal tasks among both community and noncommunity hospitalists. The areas of significant differences, although minor, could be explained by difference in practice settings. The practice analysis approach was structured, engaged the PHM community, reflected the breadth and depth of knowledge required for PHM practice, and used an iterative process to refine the final product.

Global Health Opportunities in Pediatric Fellowships.

BACKGROUND: Interest in global health (GH) among pediatric residents continues to grow. GH opportunities in pediatric fellowship programs in the United States are poorly described. We aimed to evaluate GH offerings among accredited general and subspecialty pediatric fellowship programs and identify implementation barriers. METHODS: This was a cross-sectional study by pediatric GH educators from the Association of Pediatric Program Directors Global Health Learning Community and the American Board of Pediatrics Global Health Task Force. Fellowship program directors and GH educators at accredited US pediatric fellowship programs were surveyed. Data were analyzed by using descriptive and comparative statistics. RESULTS: Data were obtained from 473 of 819 (57.8%) fellowship programs, representing 111 institutions. Nearly half (47.4%) offered GH opportunities as GH electives only (44.2%) or GH tracks and/or fellowships (3.2%) (GHT/Fs). Pretravel preparation and supervision were variable. Programs offering GH opportunities, compared to those without, were more likely to report that GH training improves fellow education (81.9% vs 38.3%; P < .001) and recruitment (76.8% vs 35.9%; P < .001). Since 2005, 10 programs with GHT/Fs have graduated 46 fellows, most of whom are working in GH. Of those with GHT/Fs, 71% believe national accreditation of GH fellowships would define minimum programmatic standards; 64% believe it would improve recruitment and legitimize GH as a subspecialty. CONCLUSIONS: GH experiences are prevalent in accredited US pediatric fellowship programs, and programs offering GH perceive that these opportunities improve fellow education and recruitment. Responses suggest that standards for GH opportunities during fellowship would be useful, particularly regarding pretravel preparation and mentorship for trainees.

Keratomalacia in a Patient With Psychogenic Vitamin A Deficiency.

PURPOSE: To report the clinical and histopathological findings of a patient with bilateral keratomalacia arising from severe vitamin A deficiency from panic disorder-related malnutrition. METHODS: Case report. RESULTS: A 47-year-old male with panic disorder presented with 1 month of painful vision loss sequentially affecting the right and left eyes. He exhibited bilateral conjunctival xerosis with complete corneal melt in the right eye and a large corneal epithelial defect with underlying anterior chamber inflammation in the left eye. Laboratory investigation revealed undetectable serum vitamin A levels attributed to self-induced vomiting and starvation. He was treated with high-dose vitamin A, but the right eye required enucleation. The histological findings are reported. CONCLUSIONS: Vitamin A deficiency in the absence of organic gastrointestinal abnormalities is exceedingly rare in the developed world. A strong index of suspicion and thorough review of systems are invaluable in evaluating patients with unexplained corneal melt.

Ratings of speech naturalness of children ages 8-16 years.

The focus of this cross-sectional study was the investigation of Speech Naturalness (speech that sounds normal or natural to the listener) of 60 normal speaking children and adolescents between the ages of 8 and 16 years. 26 naive adult listeners rated the naturalness of videotaped and computer-presented speech samples, using a 9-point-Likert rating scale (1: highly natural sounding speech and 9: highly unnatural sounding speech). The children and adolescents who participated as speakers were distributed among 5 age groups (8, 10, 12, 14, and 16 yr.) with 6 boys and 6 girls in each group. Each child demonstrated normal articulation, language, voice, and speech fluency skills. Age and sex comparisons indicated boys' and girls' speech was rated comparably; however, 8-yr.-olds' speech was rated as significantly less natural than those of 12-, 14-, and 16-yr.-olds. Preliminary ratings of Speech Naturalness for normal speaking children were presented. Suggestions for the clinical application of the findings as a target criterion in treatment programs with communicatively impaired children were suggested. Replication with a larger and more representative sample is in order.

The validity and reliability of the Interprofessional Socialization and Valuing Scale for therapy professionals.

BACKGROUND: Published in Work, the Interprofessional Socialization and Valuing Scale (ISVS) [1] was initially validated with 124 Canadian health profession students. The authors stated that the ISVS was useful to evaluate beliefs, behaviors, and attitudes about interprofessional practice among health profession students and professionals. OBJECTIVE: While the primary purpose of this study was to identify attitudes and behaviors in occupational, physical, and recreational therapists, and speech-language pathologists, the study also evaluated the validity and reliability of the ISVS. METHODS: The ISVS was completed by occupational, physical, and recreational therapists, and speech-language pathologists in Michigan, United States of America to examine beliefs, behaviors, and attitudes towards interprofessional collaboration. Kruskal-Wallis one-way analysis of variance by ranks test was used to analyze and compare responses across disciplines. Principle component analysis identified factors from the ISVS related to attitudes and behaviors. RESULTS: While no differences were found between therapy discipline and beliefs, behaviors, and attitudes, there was a significant finding related to the validity and reliability of the ISVS for use with health professionals. CONCLUSIONS: It was found that the ISVS is valid and reliable to use with health professionals but may yield different factors than with health students.

Defining the roles of advisors and mentors in postgraduate medical education: faculty perceptions, roles, responsibilities, and resource needs.

BACKGROUND: Residency program directors rely on an informal network of faculty mentors to provide guidance for residents. Faced with increasingly sophisticated competency-based evaluation systems and scrutiny of patient safety and resident well-being in today's environment, residency programs need more structured mechanisms for mentoring. OBJECTIVE: To clarify the role of resident advisors and mentors so that residents receive the right combination of direction and oversight to ensure their successful transition to the next phase of their careers. METHODS: The Duke Internal Medicine Residency Program undertook a formal assessment of the roles, responsibilities, and resource needs of its key faculty through a focus group made up of key faculty. A follow-up focus group of residents and chief residents was held to validate the results of the faculty group assessment. RESULTS: The distinction between advising and mentoring was our important discovery and is supported by literature that identifies that mentors and advisors differ in multiple ways. A mentor is often selected to match resources and expertise with a resident's needs or professional interests. An advisor is assigned with a role to counsel and guide the resident through the residency processes, procedures, and key learning milestones. CONCLUSION: The difference between the role of advisor and that of mentor is of critical importance and allowed for the evolution of faculty participants' role as resident advisors, including the formulation of expectations for advisors, and the creation of an advisor toolkit. Our modifiable toolkit can enhance the advising process for residents in many disciplines. We saw an improvement in resident satisfaction from 2006 to 2009.