Deliberative processes in health technology assessment of medicines: the case of Spain.

OBJECTIVES: Spain incorporated in 2020 changes in its health technology assessment (HTA), pricing, and reimbursement system for medicines including publishing reports, development of networks of experts, or consultation with stakeholders. Despite these changes, it is unclear how deliberative frameworks are applied and the process has been criticized for not being sufficiently transparent. This study analyses the level of implementation of deliberative processes in HTA for medicines in Spain. METHODS: We review the grey literature and summarize the Spanish HTA, pricing, and reimbursement process of medicines. We apply the deliberative processes for HTA checklist, developed to assess the overall context of the deliberative process, and identify the stakeholders involved and type of involvement following the framework for evidence-informed deliberative processes, a framework for benefit package design that aims to optimize the legitimacy of decision making. RESULTS: In the Spanish HTA, pricing, and reimbursement process deliberation takes place in order to exchange viewpoints and reach common ground, mainly during the prioritization, assessment, and appraisal steps. It is closed to the public, not clearly summarized in published documents and limited to the Ministry of Health, the regulatory agency, other Ministries, and experts with mostly clinical and/or pharmaceutical background. The views of stakeholders are only represented through consultation. Communication is the most commonly used form of stakeholder engagement. CONCLUSIONS: Despite improvements in transparency of the Spanish HTA process for evaluating medicines, aspects related to stakeholder involvement and implementation of deliberative frameworks need further attention in order to achieve further legitimacy of the process.

Differences in acute ischaemic stroke in-hospital mortality across referral stroke hospitals in Spain: a retrospective, longitudinal observational study.

OBJECTIVE: To assess differences in acute ischaemic stroke (AIS) in-hospital mortality between referral stroke hospitals and provide evidence on the association of those differences with the overtime adoption of effective reperfusion therapies. DESIGN: Retrospective, longitudinal observational study using administrative data for virtually all hospital admissions from 2003 to 2015. SETTING: Thirty-seven referral stroke hospitals in the Spanish National Health System. PARTICIPANTS: Patients aged 18 years and older with a hospital episode with an admission diagnosis of AIS in any referral stroke hospital (196 099 admissions). MAIN ENDPOINTS: (1) Hospital variation in 30-day in-hospital mortality measured in terms of the intraclass correlation coefficient (ICC); and (2) the difference in mortality between the hospital of treatment and the trend of utilisation of reperfusion therapies (including intravenous fibrinolysis and endovascular mechanical thrombectomy) in terms of median OR (MOR). RESULTS: Adjusted 30-day AIS in-hospital mortality decreased over the study period. Adjusted in-hospital mortality after AIS rates varied from 6.66% to 16.01% between hospitals. Beyond differences in patient characteristics, the relative contribution of the hospital of treatment was higher in the case of patients undergoing reperfusion therapies (ICC=0.031 (95% Bayesian credible interval (BCI)=0.017 to 0.057)) than in the case of those who did not (ICC=0.016 (95% BCI=0.010 to 0.026)). Using the MOR, the difference in risk of death was as high as 46% between the hospital with the highest risk and the hospital with the lowest risk of patients undergoing reperfusion therapy (MOR 1.46 (95% BCI 1.32 to 1.68)); in patients not undergoing any reperfusion therapy, the risk was 31% higher (MOR 1.31 (95% BCI 1.24 to 1.41)). CONCLUSIONS: In the referral stroke hospitals of the Spanish National Health System, the overall adjusted in-hospital mortality decreased between 2003 and 2015. However, between-hospital variations in mortality persisted.

Effect of Tourism Pressure on the Mediterranean Diet Pattern.

Despite proposed conceptual frameworks of eating behaviors, little is known about environmental factors contributing to changes in food habits. Few studies have reported the external influence of tourism on the inhabitants' eating patterns. The present study aimed to investigate whether tourism pressure affects Canary Islands inhabitants' adherence to the Mediterranean diet pattern. Data were obtained from a health and lifestyle population-based survey conducted in 2009 and 2015. From the reported intake frequency, a Mediterranean diet score was defined (0 to 11 points). Tourist overnight stays, which were stratified by nationality and area of destination, were used as a proxy variable to measure tourism pressure. A multilevel linear regression analysis by restricted maximum likelihood estimation was performed to examine the relationship between tourism pressure and the Mediterranean diet score. A significant negative association between the Mediterranean diet score and British tourism pressure was observed (ß = -0.0064, p = 0.010), whereas German tourism pressure increased inhabitants' adherence (ß = 0.0092, p = 0.042). The socioeconomic level of tourists seems to play a role in differences in the tourism pressure effect by nationality. Further investigation of other highly touristic destinations is needed to confirm these findings that could contribute to a shift in tourism and public health nutrition policies.

Impacto sobre el consumo en bares, cafeterías y restaurantes de la modificación de la ley del tabaco española / Impact of new Spanish smoke-free legislation on the business activity of bars, cafes and restaurants

Objetivo. analizar el impacto sobre el consumo en bares, cafeterías y restaurantes de la Ley 42/2010 de modificación de medidas sanitarias frente al tabaquismo. Métodos. explotación de los microdatos de la Encuesta de Presupuestos Familiares en 2010 y 2011. Los ficheros de enlace nos permiten hacer un seguimiento a un amplio número de hogares que permanecen en la muestra 2 años consecutivos. Tomando como referencia el año 2010 se cuantifica cómo han cambiado las pautas de consumo en los establecimientos hosteleros, diferenciando entre hogares fumadores y no fumadores. Resultados. los efectos marginales en la primera etapa del modelo en dos partes muestran una probabilidad media de realizar algún gasto del 96% en las familias fumadoras,frente al 86% de las no fumadoras, sin variaciones significativas entre 2010 y 2011. En lo que respecta a la proporción sobre el gasto total del hogar, las familias fumadoras gastaron en establecimientos hosteleros un 7,961% en 2010 y un 7,796% en 2011, frente al 7,25% y el 7,272%, respectivamente, de las familias no fumadoras. El estimador de dobles diferencias, entre años y entre familias, no resulta estadísticamente significativo. Conclusiones. la Ley 42/2010 no ha tenido influencia en los cambios de los hábitos de consumo de las familias españolas en los establecimientos de hostelería. Las decisiones de consumo están más relacionadas con las características sociodemográficas (como el número de hijos del hogar) y con el impacto de la crisis económica (desempleo y reducción de los ingresos) (AU)

Objective. to analyze the impact of Spanish smoke-free legislation (Law 42/2010) on the business activity of bars, cafés, and restaurants. Methods. we used the micro-data from the Household Budget Survey for 2010 and 2011. The linking files allowed close follow-up of the households that remained in the sample for 2 consecutive years. Taking the year 2010 as the base reference for our analyses, we quantified how levels of consumption expenses on hospitality venues have changed over the years, differentiating between smoking households and non-smoking households. Results. the marginal effects of the first stage of the two-part model showed that the mean probability of expenditure on hospitality venues was 96% in smoking households and was 86% in non-smoking households. There were no statistically significant variations in the probability of expenditure between 2010 and 2011. The proportion of expenditure on hospitality venues in total household consumption expenditure in smoking households was 7.961% and 7.796% in 2010 and 2011, respectively. These proportions were 7.25% in 2010 and 7.272% in 2011 for non-smoking households. The difference in differences estimator, which takes into account both differences between years and households, showed no statistically significant differences in levels of household consumption. Conclusions. the introduction of the Law 42/2010 has had noimpact on the levels of household consumption expenses on hospitality venues. Changes in consumption expenses could be explained by sociodemographic characteristics (such as the number of children per household) and the impact of the economic crisis (unemployment and a decrease in household income) (AU)

[Impact of new Spanish smoke-free legislation on the business activity of bars, cafes and restaurants]. / Impacto sobre el consumo en bares, cafeterías y restaurantes de la modificación de la ley del tabaco española.

OBJECTIVE: to analyze the impact of Spanish smoke-free legislation (Law 42/2010) on the business activity of bars, cafés, and restaurants. METHODS: we used the micro-data from the Household Budget Survey for 2010 and 2011. The linking files allowed close follow-up of the households that remained in the sample for 2 consecutive years. Taking the year 2010 as the base reference for our analyses, we quantified how levels of consumption expenses on hospitality venues have changed over the years, differentiating between smoking households and non-smoking households. RESULTS: the marginal effects of the first stage of the two-part model showed that the mean probability of expenditure on hospitality venues was 96% in smoking households and was 86% in non-smoking households. There were no statistically significant variations in the probability of expenditure between 2010 and 2011. The proportion of expenditure on hospitality venues in total household consumption expenditure in smoking households was 7.961% and 7.796% in 2010 and 2011, respectively. These proportions were 7.25% in 2010 and 7.272% in 2011 for non-smoking households. The difference in differences estimator, which takes into account both differences between years and households, showed no statistically significant differences in levels of household consumption. CONCLUSIONS: the introduction of the Law 42/2010 has had no impact on the levels of household consumption expenses on hospitality venues. Changes in consumption expenses could be explained by sociodemographic characteristics (such as the number of children per household) and the impact of the economic crisis (unemployment and a decrease in household income).