COVID-19 vaccines: a look at the ethics of the clinical research involving children.

Currently, millions of minors are being inoculated against SARS-CoV-2 in many countries in the world. Ethical concerns about clinical research involving children have barely been addressed in the literature, despite the fact that the paediatric population is particularly vulnerable within this context. Children should be included in the research plans for COVID-19 vaccines. Nevertheless, it is necessary to critically assess to what extent clinical trials are being conducted according to methodological and ethical criteria that allow us to conclude that the results are valid and, in consequence, how far the vaccination plans for children are scientifically justified.The principal aim of this article is to analyse critically the process of clinical research on COVID-19 vaccines involving children, highlighting the ethical concerns that arise, including the need to stratify the results from older adolescents separately for analysis before proceeding, if further research is warranted, in descending age order. The development of COVID-19 vaccines is examined, with a special look at the participation of children throughout their clinical development, including a review of the clinical trials registered in three international databases. We also offer some additional considerations about the inclusion of minors in vaccination plans. Finally, we conclude with some recommendations, with particular emphasis on the following ethical duties: research in children should be carried out only once the relevant research in adults has previously been conducted; issues that concern children's needs and rights should be specifically addressed; and, therefore, the highest standards of ethical and scientific quality should be met.

Well-Being and the Lifestyle Habits of the Spanish Population: The Association between Subjective Well-Being and Eating Habits.

The so-called Mediterranean diet is not simply a collection of foodstuffs but an expression of the culture of the countries of the south of Europe, declared Intangible Cultural Heritage by UNESCO. Despite the link between food and culture, little has been studied about how diet contributes to the well-being of the population. This article aims to analyze the association between subjective well-being and the eating habits of the Spanish population in order to gain a better understanding of the subjective well-being that food culture produces. For this study, we used a representative sample of the Spanish adult population from a survey by the Sociological Research Center (CIS 2017). Three indicators of subjective well-being were used: perceived health, life satisfaction, and feeling of happiness. The independent variables relating to eating habits considered in the analysis were, among others, how often meat, fish, vegetables, fruit, and sweets were consumed; how the food was prepared; how often meals were eaten out at restaurants or cafés and how often they were eaten with family or friends. Other independent variables related to lifestyle habits were also included in the analysis, in particular, physical exercise and body mass index. We used ordinal logistic regressions and multiple linear regression models. Our findings coincide in large measure with those obtained in earlier studies where perceived health and income play a key role in evaluating subjective well-being. In turn, several variables related to lifestyle habits, such as consuming sweets and fruits, social interaction around meals, exercising, and body mass index, were also associated with subjective well-being.

[Quality perceived by users of minor surgery according to care level and the professionals that carried it out]. / Calidad percibida por usuarios de cirugía menor según nivel asistencial y profesionales que la realizan.

OBJECTIVE: Nowadays minor surgery is performed by di- fferent professionals at primary as well as specialized care. Being a healthcare technology, minor surgery must be assessed in order to achieve an organizational efficiency. User's satisfaction must be one of the quality criteria. That is why an analysis of the quality perceived by users according to where minor surgery takes place and who carries it out is made. METHODS: This study explores, conducting telephone surveys, the satisfaction of a sample of 275 minor surgery patients of two hospitals and three primary healthcare areas of Asturias. The survey is based on the SERVQUAL model adapting the one used by the Spanish Ministry of Health in 1977. A behavior pattern of satisfaction was established in terms of the variables that increase or diminish it. RESULTS: In every item, satisfaction was perceived as good or very good at least in 84% of the survey users and in the majority was over 95%. There was a significant difference in favour of primary care with respect to waiting time (p less than 0,001), explanations received (p=0,002) and security perceived (p=0,015). The more explanatory variables of excellent satisfaction were the sense of security and the staff attention. The kind of professional did not represent a conditioning factor and the level of healthcare only appeared to be so among those who did not feel safe showing to be less satisfied those treated in primary care. CONCLUSIONS: Good quality perceived by users does not seem to be penalized by the fact that minor surgery can be carried out at different healthcare levels or which specialist performs it.

OBJETIVO: La cirugía menor es realizada actualmente por diversos profesionales en atención primaria y especializada. Como tecnología sanitaria debe ser evaluada para conseguir una eficiencia organizacional. La satisfacción del usuario es uno de los criterios de calidad. Por ello se plantea un análisis de la calidad percibida por el usuario según dónde y quién realice cirugía menor. METODOS: Se estudió por encuesta telefónica la satisfacción de una muestra de 275 pacientes de cirugía menor pertenecientes a dos hospitales y tres áreas de atención primaria de Asturias. El cuestionario sigue el modelo SERVQUAL adaptando el utilizado por el Ministerio de Sanidad en 1977. Se establece un modelo de comportamiento de la satisfacción en función de las variables que la incrementan o disminuyen. RESULTADOS: En todos los ítems la satisfacción fue buena o muy buena como mínimo en el 84% de los encuestados y en la mayoría estaba por encima del 95%. Había una diferencia significativa, a favor de atención primaria en tiempo de espera (p menor que 0,001), explicaciones recibidas (p=0,002) y seguridad percibida (p=0,015). Las variables más explicativas de una satisfacción excelente fueron la sensación de seguridad y la atención del personal. El tipo de profesional no apareció como condicionante y el nivel asistencial solo apareció entre los que no se sentían muy seguros, en cuyo caso estaban menos satisfechos los atendidos en atención primaria. CONCLUSIONES: La buena calidad percibida por los usuarios no penaliza el que la cirugía menor sea realizada en ninguno de los niveles asistenciales ni por ninguno de los profesionales que la realizan actualmente.

Calidad percibida por usuarios de cirugía menor según nivel asistencial y profesionales que la realizan / Quality perceived by users of minor surgery according to care level and the professionals that carried it out

Fundamentos. La cirugía menor es realizada actualmente por diversos profesionales en atención primaria y especializada. Como tecnología sanitaria debe ser evaluada para conseguir una eficiencia organizacional. La satisfacción del usuario es uno de los criterios de calidad. Por ello se plantea un análisis de la calidad percibida por el usuario según dónde y quién realice cirugía menor. Métodos. Se estudió por encuesta telefónica la satisfacción de una muestra de 275 pacientes de cirugía menor pertenecientes a dos hospitales y tres áreas de atención primaria de Asturias. El cuestionario sigue el modelo SERVQUAL adaptando el utilizado por el Ministerio de Sanidad en 1977. Se establece un modelo de comportamiento de la satisfacción en función de las variables que la incrementan o disminuyen. Resultados. En todos los ítems la satisfacción fue buena o muy buena como mínimo en el 84% de los encuestados y en la mayoría estaba por encima del 95%. Había una diferencia significativa, a favor de atención primaria en tiempo de espera (p<0,001), explicaciones recibidas (p=0,002) y seguridad percibida (p=0,015). Las variables más explicativas de una satisfacción excelente fueron la sensación de seguridad y la atención del personal. El tipo de profesional no apareció como condicionante y el nivel asistencial solo apareció entre los que no se sentían muy seguros, en cuyo caso estaban menos satisfechos los atendidos en atención primaria. Conclusiones. La buena calidad percibida por los usuarios no penaliza el que la cirugía menor sea realizada en ninguno de los niveles asistenciales ni por ninguno de los profesionales que la realizan actualmente

Background. Nowadays minor surgery is performed by different professionals at primary as well as specialized care. Being a healthcare technology, minor surgery must be assessed in order to achieve an organizational efficiency. User’s satisfaction must be one of the quality criteria. That is why an analysis of the quality perceived by users according to where minor surgery takes place and who carries it out is made. Methods. This study explores, conducting telephone surveys, the satisfaction of a sample of 275 minor surgery patients of two hospitals and three primary healthcare areas of Asturias. The sur- vey is based on the SERVQUAL model adapting the one used by the Spanish Ministry of Health in 1977. A behavior pattern of satisfaction was established in terms of the variables that increase or diminish it. Results. In every item, satisfaction was perceived as good or very good at least in 84% of the survey users and in the majority was over 95%. There was a significant difference in favour of primary care with respect to waiting time (p<0,001), explanations received (p=0,002) and security perceived (p=0,015). The more explanatory variables of excellent satisfaction were the sense of security and the staff attention. The kind of professional did not represent a conditioning factor and the level of healthcare only appeared to be so among those who did not feel safe showing to be less satisfied those treated in primary care. Conclusions. Good quality perceived by users does not seem to be penalized by the fact that minor surgery can be carried out at different healthcare levels or which specialist performs it

Analysis of the economic structure of the eating-out sector: The case of Spain.

The objective of this article is to analyse the structure of the Spanish eating-out sector from an economic point of view, and more specifically, from the supply perspective. This aspect has been studied less than the demand side, almost certainly due to the gaps which exist in available official statistics in Spain, and which have been filled basically with consumer surveys. For this reason, focus is also placed on the economic relevance of the sector and attention is drawn to the serious shortcomings regarding official statistics in this domain, in contrast to the priority that hotel industry statistics have traditionally received in Spain. Based on official statistics, a descriptive analysis was carried out, focused mainly, though not exclusively, on diverse structural aspects of the sector. Special emphasis was placed on issues such as business demography (for instance, number and types of enterprises, survival rates, size distribution, and age structure), market concentration and structure of costs. Among other conclusions, the analysis allowed us to conclude that: part of the sector is more concentrated than it may at first appear to be; the dual structure of the sector described by the literature in relation to other countries is also present in the Spanish case; and the impact of ICTs (Information and Communication Technologies) on the sector are, and will foreseeably continue to be, particularly relevant. The main conclusion of this study refers to the fact that consumers have gained prominence in their contribution to shaping the structure of the sector.

A propósito de la excepcionalidad de las innovaciones farmacológicaspara el cáncer / Apropos of the exceptionality of new cancer drugs

El objetivo de este artículo es analizar cómo las innovaciones farmacológicas para el cáncer son objeto defrecuentes excepciones al proceso habitual de evaluación económica de tecnologías, así como su impactoen la regulación de estos procesos y de los contratos de riesgo compartido, particularmente utilizadosen este ámbito. Con este fin se seleccionaron dos agentes representativos de los primeros tratamientosdirigidos, el trastuzumab y el imatinib, y se procedió a la revisión de algunas experiencias internacionales (Australia, Gales e Inglaterra, pioneros en la aplicación de estudios de evaluación económica detecnologías), en especial, aunque no exclusivamente, centradas en estos dos casos. De la revisión de lasexperiencias se desprende que, aparte de la eficiencia, otros criterios pueden resultar particularmenterelevantes en los procesos de evaluación de este tipo de innovaciones. En Inglaterra y Gales (donde, adiferencia de Australia, no se aplica la «regla de rescate»), los controvertidos procesos de toma de decisiones han llevado a la regulación de nuevos enfoques en la evaluación de estos tratamientos. Asimismo,el solapamiento de los contratos de riesgo compartido o su aplicación secuencial han llamado la atenciónsobre posibles problemas de inconsistencia en la toma de decisiones y de equidad en el acceso, resultando en su regulación para el conjunto del sistema. Se concluye con una referencia específica al casoespañol, centrada en el riesgo de profundizar en la aplicación de fórmulas micro (como los contratos de riesgo compartido) frente a macro, y se sugiere una estrategia de actuación apoyada en el recientementeaprobado Real Decreto-ley 9/2011 (AU)

Given that new oncology drugs are frequently involved in departures from the normal technology appraisal processes, the main objective of this article is to analyze these decision-making processes, as well astheir impact on the regulation of new approaches to selecting novel drugs and the regulatory steps to dealwith risk-sharing arrangements. This analysis was carried out by selecting two drugs, trastuzumab andimatinib, both agents being representive examples of the innovative targeted therapies introduced in thelast decade, and by reviewing some international experiences (particularly those of Australia, England,and Wales, pioneers in the application of technology appraisals), centered mainly - but not exclusively - on these two drugs. The review of these experiences indicated that other concerns apart from efficiencyare especially important in the evaluation of this type of innovations. In England and Wales (where,in contrast to Australia, the “rule of rescue” has not been adopted) the controversial decision-makingprocesses have resulted in new approaches to the appraisal of end-of-life treatments. Moreover, overlapping or sequential risk-sharing arrangements have led to regulatory steps, paying attention to possibleproblems of inconsistencies in decision-making and inequalities of access. The case of Spain is critically discussed, with special emphasis on the risk of favoring the application of micro formulae (such asrisk-sharing arrangements) over macro formulae. Finally, a strategy is suggested, based on the recentlyapproved Royal Decree-law 9/2011 (AU)

[Apropos of the exceptionality of new cancer drugs]. / A propósito de la excepcionalidad de las innovaciones farmacológicas para el cáncer.

Given that new oncology drugs are frequently involved in departures from the normal technology appraisal processes, the main objective of this article is to analyze these decision-making processes, as well as their impact on the regulation of new approaches to selecting novel drugs and the regulatory steps to deal with risk-sharing arrangements. This analysis was carried out by selecting two drugs, trastuzumab and imatinib, both agents being representive examples of the innovative targeted therapies introduced in the last decade, and by reviewing some international experiences (particularly those of Australia, England, and Wales, pioneers in the application of technology appraisals), centered mainly - but not exclusively - on these two drugs. The review of these experiences indicated that other concerns apart from efficiency are especially important in the evaluation of this type of innovations. In England and Wales (where, in contrast to Australia, the "rule of rescue" has not been adopted) the controversial decision-making processes have resulted in new approaches to the appraisal of end-of-life treatments. Moreover, overlapping or sequential risk-sharing arrangements have led to regulatory steps, paying attention to possible problems of inconsistencies in decision-making and inequalities of access. The case of Spain is critically discussed, with special emphasis on the risk of favoring the application of micro formulae (such as risk-sharing arrangements) over macro formulae. Finally, a strategy is suggested, based on the recently approved Royal Decree-law 9/2011.

Desigualdades territoriales en materia sanitaria en el SNS: entre la diversidad deseable y las desigualdades evitables (1) / No disponible

No disponible

Economía y Medicina personalizada: allegro ma non troppo / No disponible

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Atención farmacéutica en personas que han sufrido episodios coronarios agudos (estudio TOMCOR) / Pharmaceutical care in people who have had acute coronary episodes (TOMCOR Study)

Fundamento: Este estudio valora los efectos de un nuevo modelo de trabajo en las farmacias, denominado Atención Farmacéutica, frente al modelo tradicional. Se pretende conocer su factibilidad y las diferencias, potencialmente debidas a la Atención Farmacéutica, respecto de los resultados de salud de la farmacoterapia usada, en una muestra de pacientes que han sufrido episodios coronarios agudos. Métodos: Es un estudio prospectivo con un grupo de intervención (330 personas) y un grupo control (405 personas), realizado en 83 farmacias de Asturias, Barcelona, Madrid y Vizcaya, en las que se hizo seguimiento durante un año del uso de medicamentos en 735 personas, de las cuales finalizaron el estudio 600.Resultados: Hubo diferencias favorables al grupo intervención, respecto de: a) uso de servicios sanitarios indicativos de mayor morbilidad, tales como la frecuencia de consultas hospitalarias urgentes por paciente 1,27Interv. (IC95 por ciento:1,10 a 1,44) y 1,63Contr.(IC95 por ciento:1,36 a 1,90) o los días promedio de UCI por paciente hospitalizado: 2,46Interv.(IC95 por ciento:1,56 a 3,36) y 5,87Contr.(IC95 por ciento: 3,57 a 8,17), por causa cardiológica; b) calidad de vida con diferencia de 4,7 (p < 0,05) en la dimensión de función física; c) conocimiento de factores de riesgo de enfermedad coronaria, promedio de +10 por ciento (p < 0,02 - 0,07, según dimensión); d) identificación nominal de los medicamentos usados +10 por ciento (p < 0,01); importancia subjetiva otorgada a los antiagregantes + 12 por ciento (p < 0,009), los beta-bloqueantes, así como sus efectos +25 por ciento (p < 0,02); y e) satisfacción con la AF y percepción de la competencia profesional, promedio de + 12 por ciento (p < 0,000 - 0,05, según dimensión).Conclusiones: Los valores menores de: demanda individual urgente coronaria, frecuencia de hospitalizaciones y número de días de Unidad de Cuidados Intensivos coronaria por hospitalización, sugerirían que los pacientes que tras un episodio coronario agudo reciben Atención Farmacéutica tienden a estar menos enfermos en los doce meses del seguimiento realizado. Bajo el modelo de Atención Farmacéutica los pacientes conocen mejor las razones de su farmacoterapia y, por ello, utilizan mejor los servicios sanitarios del sistema, alcanzando un mayor nivel de salud (AU)