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Objectives The Study Participant Feedback Questionnaire (SPFQ) is a patient-completed tool designed to assess patient experiences and satisfaction with aspects associated with being involved in a clinical trial. Originally developed in oncology and among English-speaking participants, the aim of the current study was to evaluate the content and cross-cultural validity of the SPFQ in other indications and non-English-speaking countries. Methods Semi-structured qualitative telephone interviews were conducted with 80 participants across eight non-English-speaking countries (in Europe, South America and Asia) who had received an investigational medicinal product as part of a clinical trial in the past three years. Interviews comprised concept elicitation to identify concepts of importance to participants’ trial experiences, and cognitive debriefing to assess understanding and perceived importance of SPFQ instructions, items and response options. Results Concept elicitation findings supported the content validity of the SPFQ. During cognitive debriefing, SPFQ instructions and the majority of items were well understood by participants. Participants generally considered the SPFQ items important to their clinical trial experience, albeit a handful of items assessed concepts that had not been experienced by trial participants or were redundant with other SPFQ items. The instructions, response options and recall period of the SPFQ were generally well understood. No country-level differences in understanding or importance were apparent. Conclusion Study findings provide evidence for the content and cross-cultural validity of the SPFQ and support implementation of the SPFQ as a means of obtaining participant feedback across global development programmes in a variety of indications.

The chapter provides a comparative-law perspective- specifically the US and Italian models - on legal, civic and legal educational cultures. In particular, it describes the content of a proposed course in Street Law, being taught for the first time in Italy in the spring of 2019 at Roma Tre University. The course will instill law students with the tools and techniques needed to teach high school students the basics of civic education - including concepts such as rule of law, subsidiarity and democracy - largely lacking in the Italian educational system. By partnering with the non-profit volunteer organization Retake Roma, the course participants will organize a cleanup, involving the local Retake neighborhood group and a local high school. Didactic approaches, a best-practices lesson plan and interactive strategies are explored, as well as the challenges such a course will meet in the Italian legal-education system and local context. Other contributers to this volume include: Rebecca Grimes, Lee Arbetman, David McQuoid-Mason, Ulviyya Mikayilova, Lamiya Sharafkanova, Vitaly Radsky, Jeff Giddings, Arpeeta Mizan, Rolf Gollob, Lucia Madlenakova, Harrison Belley, Angeliki Aroni, Rosa Tedjabuwana, Hesti Septianita, Leni Widi Mulyani, John Lunney, Sean Arthurs, Chris Malcolm, Ramona Biholar, Bruce A. Lasky, Wendy Morrish, Stephen A. Rosenbaum, Bebs Chorak, Chigizori Ojiaka, Boubacar Tall, Coline Bruintjies, Nancy Flowers, A Gascón-Cuenca, Rainer Adam, Pimrapaat Dusadeeisariyakul, Ben Fourniotis, Seda Gayreti, Ted Huddlestone, Richard Grimes, Margaret Fisher, Judy Zimmer, Mary C. Larkin

To assess the relevance and generalizability across countries of concepts of the impact of Dravet syndrome beyond seizures, as recognized by families.Caregivers of children with Dravet syndrome in four countries (Australia [n=8]; USA, UK, and Italy [all n=4]) participated in 1-hour qualitative telephone interviews, identifying key Dravet syndrome concepts. Interviews were recorded, transcribed, and, where necessary, translated into English for thematic analysis. Conceptual saturation was assessed and findings compared to the previously developed French conceptual disease model.The most common seizure types reported by caregivers were tonic-clonic, absence, or focal-impaired awareness (localized/partial). Fever and physical activity were the most commonly reported triggers. Patient-relevant impacts included impairment in cognition, motor skills, communication, social skills, and behavioural functioning. Caregivers consistently reported negative social, physical, and family impacts. Concepts identified in the interviews showed similarity with the French conceptual model. Minor differences between countries are likely to reflect variations in health care systems.Findings in Italy, Australia, UK, and USA confirm that the key impacts of Dravet syndrome on children and caregivers identified in France are generalizable across countries. Key symptom and impact concepts relevant to children and parents should be targeted as critical outcomes in new therapy evaluations.Relevance of the impact of Dravet syndrome on children and caregivers was confirmed across countries. Patient and caregiver-relevant Dravet syndrome impacts contribute to poorer health-related quality of life. Indirect seizure impacts were reported to be as important as direct impacts. Country-specific differences in concepts probably reflect differences in health care systems.PERCEPCIÓN DEL IMPACTO DEL SÍNDROME DE DRAVET EN NIÑOS Y CUIDADORES EN MÚLTIPLES PAÍSES: UNA OBSERVACIÓN MÁS ALLÁ DE LAS CONVULSIONES: OBJETIVO: Evaluar la relevancia y la generalización de los conceptos del impacto del síndrome de Dravet, más allá de las convulsiones, en distintos países y como lo reconocen las familias. METODO: Cuidadores de niños con síndrome de Dravet en cuatro países (Australia [n=8], EEUU, Reino Unido e Italia [todos n=4]) participaron de una entrevista cualitativa de una hora de duración, identificando conceptos claves en el síndrome de Dravet. Las entrevistas fueron grabadas, transcriptas, y si era necesario, traducidas al inglés para análisis temáticos. Se evaluó la saturación conceptual y los resultados se compararon con el modelo conceptual de enfermedad francés, desarrollado previamente. RESULTADOS: Los tipos más comunes de convulsión reportados por los cuidadores fueron la tónico-clónica, las ausencias o las focales con alteración de la conciencia (localizadas/parciales). La fiebre y las actividades físicas fueron los desencadenantes más comúnmente reportados. Los impactos reportados en los pacientes fueron alteraciones en la cognición, habilidades motrices, comunicación, habilidades sociales y funcionamiento conductual. Los cuidadores informaron sistemáticamente sobre los impactos negativos a nivel social, físico y familiar. Los conceptos identificados en las entrevistas mostraron similitud con el modelo conceptual francés. Es probable que las diferencias menores entre países reflejen variaciones en los sistemas de atención de salud. INTERPRETACIÓN: Los hallazgos en Italia, Australia, Reino Unido y EEUU confirman que las alteraciones claves del síndrome de Dravet en niños y cuidadores identificados en Francia son generalizables en todos los países. Los síntomas claves y las alteraciones relevantes para los niños y los padres deben ser considerados como objetivos críticos de evolución cuando se evalúan el diseño de nuevas terapias.PERCEPÇÃO DO IMPACTO DA SÍNDROME DE DRAVET EM CRIANÇAS E CUIDADORES EM MÚLTIPLOS PAÍSES: OLHANDO PARA ALÉM DAS CONVULSÕES: OBJETIVO: Avaliar a relevância e generalizabilidade entre países dos conceitos sobre o impacto da síndrome de Dravet para além das convulsões, com base no reconhecimento das famílias. MÉTODO: Cuidadores de crianças com síndrome de Dravet em quatro países (Australia [n=8]; EUA, Reino Unido, e Itália [all n=4]) participaram de entrevistas qualitativas por telefone com duração de 1 hora, identificando conceitos chave da síndrome de Dravet. As entrevistas foram gravadas, transcritas, e quando necessário, traduzidas para o inglês para análise temática. A saturação conceitual foi avaliada e os resultados comparados com o modelo conceitual francês da doença desenvolvido previamente. RESULTADOS: Os tipos mais comuns de convulsões reportados pelos cuidadores eram tônico-clônico, ausência, ou redução focal da consciência (localizada/parcial). Febre e atividade física foram os gatilhos mais comumente reportados. Os impactos relevantes para os pacientes incluíram deficiências na cognição, habilidades motoras, comunicação, habilidades sociais, e funcionamento comportamental. Os cuidadores reportaram impactos negativos sociais, físicos e familares. Os conceitos identificados nas entrevistas mostraram similaridades com o modelo conceitural francês. Diferenças pequenas entre países provavelmente refletem variações nos sistemas de cuidado à saúde. INTERPRETAÇÃO: Achados na Itália, Austrália, Reino unido e EUA confirmam que os impactos principais da síndrome de Dravet em crianças e cuidadores identificados na Franca são generalizáveis entre países. Os principais sintomas e conceitos de impacto relevantes para crianças e pais devem ser visados como desfechos críticos na avaliação de novas terapias.

Within the field of crystal growth it is recognized that secondary species can sometimes be occluded within a growing crystal according to the crystallization conditions and pairing of the additive and host crystal. This article takes inspiration from this phenomenon to create multifunctional inorganic nanocomposites with unique structures: inorganic single crystals containing embedded inorganic nanoparticles. Using magnetite (Fe3O4)/ZnO as a suitable test system, ZnO crystals are precipitated from aqueous solution at 90 °C and atmospheric pressure in the presence of Fe3O4 nanoparticles functionalized with anionic diblock copolymers. Analysis of product nanocomposite crystals using atomic absorption spectroscopy shows that the Fe3O4 nanoparticles are embedded within the ZnO single crystal hosts at levels of approximately 10 wt %, and TEM analysis shows that there is no apparent discontinuity between the nanoparticles and host crystal matrix. Importantly, we then demonstrate that this occlusion approach ca...

South Africa has been the home of a vibrant public legal education (PLE) programme for many years. Indeed its Street Law initiative has been described as one of the strategic responses to and a catalyst for change during the apartheid era. The focus on democracy and human rights for all in the lead up to and following the 1994 election has aided the transition from the old regime to the new. Ignorance of the law and legal process is of course a problem in many developing and developed countries and an international conference was therefore planned last year to bring the ever-expanding international legal literacy scene to Durban in order to identify and share best practice - an attempt to promote and support a better understanding of rights and responsibilities under the law. The untimely death of the Street Law co-founder, Ed O'Brien, in July 2015 gave the event even greater poignancy. The conference was not only a global sharing of experience but also an important reminder of how this movement began and of Ed's (and others') role in that process.