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Purpose: This study examined the extent to which teacher responsivity education affected preschoolers' language and literacy development over an academic year. Additional aims were to determine whether children's initial language abilities and teachers' use of responsivity strategies were associated with language outcomes, in particular. Method: In this randomized controlled trial, preschool centers were assigned to a responsivity education intervention (n = 19 centers, 25 teachers, and 174 children) or a \"business-as-usual\" control condition (n = 19 centers, 24 teachers, and 156 children). Teachers within the intervention centers received training focused on a set of strategies designed to promote children's engagement and participation in extended conversational interactions across the school day. Results: Hierarchical linear models showed no main effects on children's language skills, although moderating effects were observed such that the intervention appeared to have positive effects for children with relatively high initial language abilities. In addition, teacher use of responsivity strategies was positively associated with vocabulary development. With regard to children's literacy skills, there was a significant main effect of the intervention on print-concept knowledge. Conclusions: Although teacher responsivity education is viewed as benefitting children's language and literacy development, the impacts of this type of intervention on children's skills warrant further investigation. (Contains 6 tables and 1 figure.)

A process evaluation was conducted to determine the effectiveness, usability, and barriers and facilitators related to the Better OutcOmes & Successful Transitions for Autism (BOOST-A™), an online transition planning program. Adolescents on the autism spectrum (n = 33) and their parents (n = 39) provided feedback via an online questionnaire. Of these, 13 participants were interviewed to gain in-depth information about their experiences. Data were analyzed using descriptive statistics and thematic analysis. Four themes were identified: (i) taking action to overcome inertia, (ii) new insights that led to clear plans for the future, (iii) adolescent empowerment through strengths focus, and (iv) having a champion to guide the way. The process evaluation revealed why BOOST-A™ was beneficial to some participants more than others.Trial registration #ACTRN12615000119594

Background Verbal autopsy (VA) has been proposed to determine the cause of death (COD) distributions in settings where most deaths occur without medical attention or certification. We develop performance criteria for VA-based COD systems and apply these to the Registrar General of India’s ongoing, nationally-representative Indian Million Death Study (MDS). Methods Performance criteria include a low ill-defined proportion of deaths before old age; reproducibility, including consistency of COD distributions with independent resampling; differences in COD distribution of hospital, home, urban or rural deaths; age-, sex- and time-specific plausibility of specific diseases; stability and repeatability of dual physician coding; and the ability of the mortality classification system to capture a wide range of conditions. Results The introduction of the MDS in India reduced the proportion of ill-defined deaths before age 70 years from 13% to 4%. The cause-specific mortality fractions (CSMFs) at ages 5 to 69 years for independently resampled deaths and the MDS were very similar across 19 disease categories. By contrast, CSMFs at these ages differed between hospital and home deaths and between urban and rural deaths. Thus, reliance mostly on urban or hospital data can distort national estimates of CODs. Age-, sex- and time-specific patterns for various diseases were plausible. Initial physician agreement on COD occurred about two-thirds of the time. The MDS COD classification system was able to capture more eligible records than alternative classification systems. By these metrics, the Indian MDS performs well for deaths prior to age 70 years. The key implication for low- and middle-income countries where medical certification of death remains uncommon is to implement COD surveys that randomly sample all deaths, use simple but high-quality field work with built-in resampling, and use electronic rather than paper systems to expedite field work and coding. Conclusions Simple criteria can evaluate the performance of VA-based COD systems. Despite the misclassification of VA, the MDS demonstrates that national surveys of CODs using VA are an order of magnitude better than the limited COD data previously available.

With the increased number of schools adopting social-emotional learning (SEL) programming, there is increased emphasis on the role of implementation in obtaining desired outcomes. Despite this, the current knowledge of the active ingredients of SEL programming is lacking, and there is a need to move from a focus on “whether” implementation matters to “what” aspects of implementation matter. To address this gap, the current study utilizes a latent class approach with data from year 1 of a randomized controlled trial of Second Step® (61 schools, 321 teachers, over 7300 students). Latent classes of implementation were identified, then used to predict student outcomes. Teachers reported on multiple dimensions of implementation (adherence, dosage, competency), as well as student outcomes. Observational data were also used to assess classroom behavior (academic engagement and disruptive behavior). Results suggest that a three-class model fits the data best, labeled as high-quality, low-engagement, and low-adherence classes. Only the low-engagement class showed significant associations with poorer outcomes, when compared to the high-quality class (not the low-adherence class). Findings are discussed in terms of implications for program development and implementation science more broadly.

Training efforts in disaster education need to provide updated knowledge, skills and expertise to nurses through evidence-based interventions. The purpose of the study was the development, implementation and evaluation of an educational programme for nurses regarding the provision of health care during disasters. A randomized controlled trial using Switching Replications design was conducted for the evaluation of the programme. 207 hospital-based nurses were randomly assigned into intervention (n = 112) and original control (n = 95) groups. Changes between groups and over time were measured by questionnaire and used as the outcome measure to demonstrate effectiveness of the training intervention. The intervention improved nurses' knowledge and self-confidence levels while no significant changes were detected in behavioral intentions. A significant increase in the mean knowledge score was observed in both groups in times 2 and 3 compared to time 1 [pre-test: 6.43 (2.8); post-test: 16.49 (1.7); follow-up test: 13.5 (2.8)], (P < 0.002). Changes in knowledge between intervention and control group were significantly different (P < 0.001) with a large effect size (eta-squared = 0.8). The training programme was feasible and effective in improving nurses' knowledge concerning disaster response.

Probiotics have been defined as “Live microorganisms that when administered in adequate amounts confer a health benefit on the host”. This definition covers a wide range of applications, target populations and (combinations of) microorganisms. Improved knowledge on the importance of the microbiota in terms of health and disease has further diversified the potential scope of a probiotic intervention, whether intended to reach the market as a food, a food supplement or a drug, depending on the intended use. However, the increased interest in the clinical application of probiotics may require specific attention given their administration in a diseased population. In addition to safety, the impact of the type of product, in terms of quality, production method and, e.g., the acceptance of side effects, is now part of the current regulatory constraints for developers. In the European Union, foods are regulated by the European Food Safety Authority and drugs by the European Medicines Agency; in the United States, the Food and Drug Administration (FDA) deals with both categories. More recently, the FDA has defined a new “live biotherapeutic products” (LBP) category, clarifying pharmaceutical expectations. Since 2019, the quality requirements for this category of drug products have also been clarified by the European Pharmacopoeia (Ph. Eur.). Similar to all products intended to prevent or treat diseases, LBPs will have to be registered as medicinal products to reach the market in the US and in Europe. In this area, regulatory authorities and the pharmaceutical industry will routinely use guidelines of the “International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use” (ICH). Although ICH guidelines are not legally binding, they provide very important recommendations, recognized by almost all drug authorities in the world. In this review, we discuss some aspects of this regulatory framework, especially focusing on products with an intended use in a diseased or vulnerable target population.Prevention and treatment: When living microbes become medicinesRegulatory frameworks must be stretched to include microbe-based medicines such as “live biotherapeutic products” (LBPs). Some LBPs are similar by nature to probiotics, health-enhancing living microbes, except that they are meant to treat or prevent disease in sick or vulnerable individuals. Bruno Pot at the Vrije Universiteit Brussel in Belgium and co-workers have reviewed how current food and drug regulations in the United States and the European Union apply to living microorganisms. As for all drugs, in the case of LBPs, quality, safety, and efficacy must be demonstrated, but LBPs pose extra challenges because they contain live organisms, raising issues of stability over time and batch-to-batch variation. Differences in patients’ microbiomes and diets add further complications. This review helps to outline a way forward in this new and developing field of medicinal products.

In the current context of the pandemic triggered by SARS-COV-2, the immunization of the population through vaccination is recognized as a public health priority. In the case of SARS-COV-2, the genetic sequencing was done quickly, in one month. Since then, worldwide research has focused on obtaining a vaccine. This has a major economic impact because new technological platforms and advanced genetic engineering procedures are required to obtain a COVID-19 vaccine. The most difficult scientific challenge for this future vaccine obtained in the laboratory is the proof of clinical safety and efficacy. The biggest challenge of manufacturing is the construction and validation of production platforms capable of making the vaccine on a large scale.

Background Team-based interventions are effective for improving safety and quality of healthcare. However, contextual factors, such as team functioning, leadership, and organizational support, can vary significantly across teams and affect the level of implementation success. Yet, the science for measuring context is immature. The goal of this study is to validate measures from a short instrument tailored to track dynamic context and progress for a team-based quality improvement (QI) intervention. Methods Design: Secondary cross-sectional and longitudinal analysis of data from a clustered randomized controlled trial (RCT) of a team-based quality improvement intervention to reduce central line-associated bloodstream infection (CLABSI) rates in intensive care units (ICUs). Setting: Forty-six ICUs located within 35 faith-based, not-for-profit community hospitals across 12 states in the U.S. Population: Team members participating in an ICU-based QI intervention. Measures: The primary measure is the Team Check-up Tool (TCT), an original instrument that assesses context and progress of a team-based QI intervention. The TCT is administered monthly. Validation measures include CLABSI rate, Team Functioning Survey (TFS) and Practice Environment Scale (PES) from the Nursing Work Index. Analysis: Temporal stability, responsiveness and validity of the TCT. Results We found evidence supporting the temporal stability, construct validity, and responsiveness of TCT measures of intervention activities, perceived group-level behaviors, and barriers to team progress. Conclusions The TCT demonstrates good measurement reliability, validity, and responsiveness. By having more validated measures on implementation context, researchers can more readily conduct rigorous studies to identify contextual variables linked to key intervention and patient outcomes and strengthen the evidence base on successful spread of efficacious team-based interventions. QI teams participating in an intervention should also find data from a validated tool useful for identifying opportunities to improve their own implementation.

The world has entered the second wave of the COVID-19 pandemic, and its intensity is significantly higher than that of the first wave of early 2020. Many countries or regions have been forced to start the second round of lockdowns. To respond rapidly to this global pandemic, dozens of COVID-19 vaccine candidates have been developed and many are undergoing clinical testing. Evaluating and defining effective vaccine candidates for human use is crucial for prioritizing vaccination programs against COVID-19. In this review, we have summarized and analyzed the efficacy, immunogenicity and safety data from clinical reports on different COVID-19 vaccines. We discuss the various guidelines laid out for the development of vaccines and the importance of biological standards for comparing the performance of vaccines. Lastly, we highlight the key remaining challenges, possible strategies for addressing them and the expected improvements in the next generation of COVID-19 vaccines.

Dr Mohammad Nurunnabi examines the factors that affect the implementation of International Financial Reporting Standards (IFRS) in developing countries and answers these specific research questions: - What is the relative impact of accounting regulatory frameworks and politico-institutional factors on the implementation of IFRS in developing countries? - How do cultural factors affect said implementation? - How does a study of implementing IFRS help to build an understanding of a theory of the role of the state in accounting change in developing countries? This follows a mixed methodology approach, in which interviews are conducted, IFRS-related enforcement documents and annual reports are evaluated. More than 138 countries have adopted IFRS, yet the International Accounting Standards Board (IASB) does not provide an implementation index. Financial reporting varies by country, even within the area of the world that has apparently adopted IFRS and Nurunnabi offers an important viewpoint that considers the issues of IFRS implementation from various perspectives. This is an invaluable resource for Undergraduate, Masters and PhD students, policy makers (at local, regional and international level) namely the IASB, World Bank, IMF, practitioners and users, giving them the necessary insight into the financial reporting environment and the state's attitude towards accounting transparency. Most importantly, this book contributes to military and democratic political regimes and the Max Weberian view of the theory of the role of the state's attitude towards accounting transparency.