Use of the socio-ecological model to explore trusted sources of COVID-19 information in Black and Latinx communities in Michigan.

BACKGROUND: Identifying trusted sources of health information and exploring what makes these sources trustworthy is an important aspect of public health. This exploration requires embracing the cultural differences in minoritized communities, which are often treated as homogeneous. This qualitative study identifies and analyze the sources of trusted COVID-19 information among Black and Latinx communities in Michigan and assesses the rationale underlying this trust. METHODS: Interviews were conducted with 24 Black and 16 Latinx participants (n = 40) in four Michigan counties significantly impacted by COVID-19. The socio-ecological model was applied as an analytical framework for understanding the entities considered trusted sources of information. Within each level of the model, the dimensions of trustworthiness most salient for participants were identified. RESULTS: We found that sources of information came from all levels of the model, including interpersonal (COVID-19 survivors, church representatives, friends, relatives), organizational (employers, healthcare providers, traditional news reports), social media (hybrid source), community (members and groups), and public policy (county health department, federal and state government). Furthermore, participants determined whether they could trust information about COVID-19 by cross-referencing multiple resources. We identified competence, confidence, communication, and system trust as the dimensions of trustworthiness most often reported by participants. CONCLUSIONS: Our research suggests public health communications should engage in cross-referencing practices, providing information from sources at all levels of interaction, cultural competency, and awareness of historical/structural inequities. These efforts would be further strengthened by attending to needs for both factual information as well as care and personal connection.

Progress and harmonization of gene editing to treat human diseases: Proceeding of COST Action CA21113 GenE-HumDi.

The European Cooperation in Science and Technology (COST) is an intergovernmental organization dedicated to funding and coordinating scientific and technological research in Europe, fostering collaboration among researchers and institutions across countries. Recently, COST Action funded the "Genome Editing to treat Human Diseases" (GenE-HumDi) network, uniting various stakeholders such as pharmaceutical companies, academic institutions, regulatory agencies, biotech firms, and patient advocacy groups. GenE-HumDi's primary objective is to expedite the application of genome editing for therapeutic purposes in treating human diseases. To achieve this goal, GenE-HumDi is organized in several working groups, each focusing on specific aspects. These groups aim to enhance genome editing technologies, assess delivery systems, address safety concerns, promote clinical translation, and develop regulatory guidelines. The network seeks to establish standard procedures and guidelines for these areas to standardize scientific practices and facilitate knowledge sharing. Furthermore, GenE-HumDi aims to communicate its findings to the public in accessible yet rigorous language, emphasizing genome editing's potential to revolutionize the treatment of many human diseases. The inaugural GenE-HumDi meeting, held in Granada, Spain, in March 2023, featured presentations from experts in the field, discussing recent breakthroughs in delivery methods, safety measures, clinical translation, and regulatory aspects related to gene editing.

Histological assessment of nanostructured fibrin-agarose skin substitutes grafted in burnt patients. A time-course study.

A previously developed fibrin-agarose skin model-UGRSKIN-showed promising clinical results in severely burnt patients. To determine the histological parameters associated to the biocompatibility and therapeutic effects of this model, we carried out a comprehensive structural and ultrastructural study of UGRSKIN grafted in severely burnt patients after 3 months of follow-up. The grafted epidermis was analogue to native human skin from day 30th onward, revealing well-structured strata with well-differentiated keratinocytes expressing CK5, CK8, CK10, claudin, plakoglobin, filaggrin, and involucrin in a similar way to controls, suggesting that the epidermis was able to mature and differentiate very early. Melanocytes and Langerhans cells were found from day 30th onward, together with a basement membrane, abundant hemidesmosomes and lack of rete ridges. At the dermal layer, we found an interface between the grafted skin and the host tissue at day 30th, which tended to disappear with time. The grafted superficial dermis showed a progressive increase in properly-oriented collagen fibers, elastic fibers and proteoglycans, including decorin, similarly to control dermis at day 60-90th of in vivo follow-up. Blood vessels determined by CD31 and SMA expression were more abundant in grafted skin than controls, whereas lymphatic vessels were more abundant at day 90th. These results contribute to shed light on the histological parameters associated to biocompatibility and therapeutic effect of the UGRSKIN model grafted in patients and demonstrate that the bioengineered skin grafted in patients is able to mature and differentiate very early at the epithelial level and after 60-90 days at the dermal level.

High Influenza Vaccine Effectiveness and Absence of Increased Influenza-like-Illness Epidemic Activity in the 2021-2022 Influenza Season in Catalonia (Spain) Based on Surveillance Data Collected by Sentinel Pharmacies.

Influenza surveillance and influenza vaccination are the key activities for preventing and controlling influenza epidemics. The study assessed the influenza surveillance and influenza vaccination data obtained from sentinel pharmacies of Catalonia, Spain, in the 2021-2022 influenza season. The sentinel pharmacies were selected from all community pharmacies to report all influenza-like illness (ILI) cases detected during the 2021-2022 influenza season and collect influenza surveillance and influenza vaccination data. The ILI cases were identified based on European Centre for Disease Control (ECDC) criteria. The moving epidemic method (MEM) was used to assess the ILI epidemic activity. The screening method was used to assess influenza vaccination effectiveness in patients aged 65-or-more years old. The sentinel pharmacies reported 212 ILI cases with a negative COVID-19 test and a total number of 412 ILI cases. An absence of increased ILI epidemic activity was observed in the 2021-2022 influenza season based on two criteria: (1) Number of ILI cases reported per week in the 2021-2022 influenza season significantly lower than the MEM-based epidemic threshold. (2) Mean number of ILI cases reported per week in the 2021-2022 influenza season significantly lower than during the ILI/influenza epidemic periods detected from 2017 to 2020 using the same methodology. Influenza vaccination was effective in preventing ILI among patients aged 65-or-more-years old. The absence of the influenza epidemic during the 2021-2022 influenza season could be explained by influenza vaccination and COVID-19 prevention measures (wearing face masks, social distancing). The sentinel pharmacies provided influenza surveillance data not provided by traditional influenza surveillance systems.

Estimation of the incidence of invasive meningococcal disease using a capture-recapture model based on two independent surveillance systems in Catalonia, Spain.

OBJECTIVES: Invasive meningococcal disease (IMD) is an urgent notifiable disease and its early notification is essential to prevent cases. The objective of the study was to assess the sensitivity of two independent surveillance systems and to estimate the incidence of IMD. DESIGN: We used capture-recapture model based on two independent surveillance systems, the statutory disease reporting (SDR) system and the microbiological reporting system (MRS) of the Public Health Agency of Catalonia, between 2011 and 2015. The capture-recapture analysis and 95% CIs were calculated using the Chapman formula. Multivariate vector generalised linear model was performed for adjusted estimation. MEASURES: The variables collected were age, sex, year of report, size of municipality (<10 000 and ≥10 000), clinical form, death, serogroup, country of birth and type of reporting centre (private and public). RESULTS: The sensitivity of the two combined surveillance systems was 88.5% (85.0-92.0). SDR had greater sensitivity than the MRS (67.9%; 62.7-73.1 vs 64.7%; 59.4-70.0). In 2014-2015, the sensitivity of both systems was higher (80.6%; 73.2-87.9 vs 73.4%; 65.2-81.6) than in 2011-2013 (59.3%; 52.6-66.0 vs 58.3%; 51.6-65.1). In private centres, the sensitivity was higher for SDR than for MRS (100%; 100-100 vs 4.8%; -4.4-13.9). The adjusted estimate of IMD cases was lower than that obtained using the Chapman formula (279; 266-296 vs 313; 295-330). The estimated adjusted incidence of IMD was 0.7/100 000 persons-year. CONCLUSIONS: The sensitivity of enhanced surveillance through the combination of two complementary sources was higher than for the sources individually. Factors associated with under-reporting in different systems should be analysed to improve IMD surveillance.

Effectiveness of maternal pertussis vaccination in protecting newborn: A matched case-control study.

INTRODUCTION: The objective was to estimate the effectiveness of maternal pertussis vaccination in protecting infants aged < 2 months. METHODS: We performed a case-control study. Laboratory-confirmed cases aged <8 weeks at disease onset were identified and 2-4 matched-controls born within ± 15 days of the case were included. Information was obtained from healthcare providers and maternal interviews. Odds ratios (OR) were calculated using multivariable conditional logistic regression. Vaccine effectiveness (VE) was estimated as (1 - OR) × 100%. RESULTS: 47 cases and 124 controls were studied. The mean age (in days) (39.8 ± 12.7 vs. 40.8 ± 13.2), weeks of gestation (38.8 vs. 39.1, p = 0.43) and mean birth weight (3.309 vs. 3.253 kg, p = 0.55) were comparable between cases and controls. Mothers of cases were less frequently vaccinated in the third trimester (59.6% vs. 83.9%, p <0.001). The VE of maternal vaccination in pregnancy was 88.0% (95%CI 53.8% -96.5%), and was slightly higher in those vaccinated before the 32nd week of gestation (88.5% vs 87.8%). CONCLUSION: Pertussis vaccination in pregnancy is very effective in reducing pertussis in children aged < 2 months. Vaccination before and after the 32nd week of pregnancy are equally effective in reducing the risk of pertussis.

Incidence and severity of pertussis hospitalisations in infants aged less than 1 year in 37 hospitals of six EU/EEA countries, results of PERTINENT sentinel pilot surveillance system, December 2015 to December 2018.

IntroductionPERTINENT is a pilot active surveillance system of infants hospitalised with pertussis in six European Union/European Economic Area countries (37 hospitals, seven sites).AimThis observational study aimed to estimate annual pertussis incidence per site from 2016 to 2018 and respective trends between 2017 and 2018. Pertussis cases were described, including their severity.MethodsWe developed a generic protocol and laboratory guidelines to harmonise practices across sites. Cases were hospitalised infants testing positive for Bordetella pertussis by PCR or culture. Sites collected demographic, clinical, laboratory data, vaccination status, and risk/protective factors. We estimated sites' annual incidences by dividing case numbers by the catchment populations.ResultsFrom December 2015 to December 2018, we identified 469 cases (247 males; 53%). The median age, birthweight and gestational age were 2.5 months (range: 0-11.6; interquartile range (IQR): 2.5), 3,280 g (range: 700-4,925; IQR: 720) and 39 weeks (range: 25-42; IQR: 2), respectively. Thirty cases (6%) had atypical presentation either with cough or cyanosis only or with absence of pertussis-like symptoms. Of 330 cases with information, 83 (25%) were admitted to intensive care units including five deceased infants too young to be vaccinated. Incidence rate ratios between 2018 and 2017 were 1.43 in Czech Republic (p = 0.468), 0.25 in Catalonia (p = 0.002), 0.71 in France (p = 0.034), 0.14 in Ireland (p = 0.002), 0.63 in Italy (p = 0.053), 0.21 in Navarra (p = 0.148) and zero in Norway.ConclusionsIncidence appeared to decrease between 2017 and 2018 in all but one site. Enhanced surveillance of hospitalised pertussis in Europe is essential to monitor pertussis epidemiology and disease burden.

Azithromycin to Prevent Pertussis in Household Contacts, Catalonia and Navarre, Spain, 2012-2013.

We retrospectively assessed the effectiveness of azithromycin in preventing transmission of pertussis to a patient's household contacts. We also considered the duration between symptom onset in the primary patient and azithromycin administration. We categorized contacts into 4 groups: those treated within <7 days, 8-14 days, 15-21 days, and >21 days after illness onset in the primary patient. We studied 476 primary index patients and their 1,975 household contacts, of whom 4.5% were later identified as having pertussis. When contacts started chemoprophylaxis within <21 days after the primary patient's symptom onset, the treatment was 43.9% effective. Chemoprophylaxis started >14 days after primary patient's symptom onset was less effective. We recommend that contacts of persons with pertussis begin chemoprophylaxis within <14 days after primary patient's symptom onset.

Intervenciones farmacológicas para el tratamiento de la Enfermedad por Coronavirus (COVID-19) / Pharmacological interventions for the treatment of Coronavirus Disease (COVID-19)

RESUMEN Varios fármacos han sido propuestos como alternativas terapéuticas para COVID-19. Se efectuó una búsqueda sistematica en MEDLINE (vía PubMed) hasta el 20 de marzo de 2020, con el fin de identificar la evidencia disponible sobre intervenciones farmacológicas para tratamiento específico de COVID-19. 947 publicaciones fueron identificadas y 15 estudios seleccionados: 3 ensayos clínicos, 5 series de casos y 7 reportes de casos. La calidad de la evidencia procedente de ensayos clínicos fue evaluada según la metodología GRADE. La evidencia existente para hidroxicloroquina, favipiravir y lopinavir/ritonavir procede de ensayos clínicos que reportan resultados favorables para los dos primeros fármacos en tanto que no se observó ningún beneficio al adicionar lopinavir/ritonavir al tratamiento estándar. Sin embargo, debido a las limitaciones metodológicas, la evidencia es de muy baja certeza para hidroxicloroquina y de baja certeza para favipiravir y lopinavir/ritonavir. Respecto al uso de arbidol interferón, o el uso combinado de estos con lopinavir/ritonavir, la evidencia es limitada ya que deriva de serie de casos o reporte de casos con resultados no determinantes. No se identificaron estudios que permitan determinar la eficacia y seguridad de intervenciones farmacológicas frente a COVID-19.

ABSTRACT Several drugs have been proposed as therapeutic alternatives for COVID-19. An electronic systematic search of MEDLINE (via PubMed) was carried out until March 20th 2020, in order to identify the available evidence on pharmacological interventions for specific treatment of COVID-19. The quality of the evidence from clinical trials was evaluated according to the GRADE methodology. 947 publications were identified and 15 studies were selected: 3 clinical trials, 5 case series and 7 case reports. The existing evidence for hydroxychloroquine, favipiravir and lopinavir/ritonavir comes from clinical trials reporting favorable results for the first two drugs, while no benefit was observed when lopinavir/ritonavir was added to standard treatment. However, due to methodological issues, the evidence for hydroxychloroquine is very low. For favipiravir and lopinavir/ritonavir the evidence is low. Regarding the use of arbidol interferon, or the combined use of these with lopinavir/ritonavir, the evidence is limited since it derives from case series or case report with non-determining results. No studies were identified that reliably demonstrate the efficacy and safety of any pharmacological intervention against COVID-19.

Transplant of Tissue-Engineered Artificial Autologous Human Skin in Andalusia: An Example of Coordination and Institutional Collaboration.

A new model of tissue-engineered artificial autologous human skin developed in Andalusia is currently being transplanted into patients suffering from large burns within the Andalusian Public Healthcare System. This product is considered an advanced therapy medicinal product (ATMP) in Europe, and its clinical use implies meeting transplant and medicinal product legal requirements, being the Guidelines of Good Manufacturing Practice for ATMPs of particular importance. The preclinical research and clinical translation of the product have represented a technical, regulatory, and organizational challenge, which has taken 10 years since the first preclinical experiments were designed. Twelve patients with large burns, including 3 pediatric patients, have hitherto received artificial autologous skin grafts with an overall survival rate of 75% and positive clinical, homeostatic, and histologic results. Achieving such a milestone within our Healthcare System was possible through a multidisciplinary approach and the joint efforts of multiple publicly funded institutions and units under the coordination of the Andalusian Initiative for Advanced Therapies. In this article, we present the organizational model set up to facilitate collaboration and logistics among the professionals involved, totaling more than 80 people. The similarities between the tissue-engineered artificial autologous human skin transplant and other organ and tissue transplants, in terms of logistic requirements, reveal how regional and hospital transplant coordination have played a crucial role.

Successful development and clinical translation of a novel anterior lamellar artificial cornea.

Blindness due to corneal diseases is a common pathology affecting up to 23 million individuals worldwide. The tissue-engineered anterior human cornea, which is currently being tested in a Phase I/II clinical trial to treat severe corneal trophic ulcers with preliminary good feasibility and safety results. This bioartificial cornea is based on a nanostructured fibrin-agarose biomaterial containing human allogeneic stromal keratocytes and cornea epithelial cells, mimicking the human native anterior cornea in terms of optical, mechanical, and biological behavior. This product is manufactured as a clinical-grade tissue engineering product, fulfilling European requirements and regulations. The clinical translation process included several phases: an initial in vitro and in vivo preclinical research plan, including preclinical advice from the Spanish Medicines Agency followed by additional preclinical development, the adaptation of the biofabrication protocols to a good manufacturing practice manufacturing process, including all quality controls required, and the design of an advanced therapy clinical trial. The experimental development and successful translation of advanced therapy medicinal products for clinical application has to overcome many obstacles, especially when undertaken by academia or SMEs. We expect that our experience and research strategy may help future researchers to efficiently transfer their preclinical results into the clinical settings.

Effectiveness and impact of the hepatitis B vaccination program in preadolescents in Catalonia 21 years after its introduction.

Hepatitis B is a viral disease of global importance. In Catalonia in the 1980s, the seroepidemiological pattern of HBV infection was low-intermediate. In 1990, the Expert Committee on Vaccinations of the Department of Health of the Generalitat of Catalonia evaluated the systematic introduction of hepatitis B vaccination in preadolescents, maintaining the vaccination of risk groups. The objective of this study was to estimate the effectiveness and impact of the systematic hepatitis B vaccination programme in preadolescents in Catalonia 21 years after its introduction. A retrospective cohort study was conducted, comparing the disease incidence in vaccinated and unvaccinated cohorts. Cases of hepatitis B were defined as those reported by the General Subdirectorate of Surveillance and Response to Public Health Emergencies between 2000 and 2014. The incidence rate was 2.5 per 100,000 persons in 1991 and 1.2 per 100,000 persons in 2014, a reduction of 52%. During the study period, 388 cases of hepatitis B infection were notified, of which three were classified as vaccine failures. Vaccine effectiveness was 99.30% (95% CI: 97.83-99.78) and the population prevented fraction in the cohorts of preadolescents studied was 64.56% (95% CI: 60.45-68.66). The effectiveness and impact of the hepatitis B vaccination program in preadolescents in Catalonia is high, with the consequent benefits for the population.

Reduction of Direct Health Costs Associated with Pertussis Vaccination with Acellular Vaccines in Children Aged 0-9 Years with Pertussis in Catalonia (Spain).

OBJECTIVES: The aim of this study was to assess direct health costs in children with pertussis aged 0-9 years who were vaccinated, partially vaccinated, and unvaccinated during childhood, and to assess the association between pertussis costs and pertussis vaccination in Catalonia (Spain) in 2012-2013. METHODS: Direct healthcare costs included pertussis treatment, pertussis detection, and preventive chemotherapy of contacts. Pertussis patients were considered vaccinated when they had received 4-5 doses, and unvaccinated or partially vaccinated when they had received 0-3 doses of vaccine. The Chi square test and the odds ratios were used to compare percentages and the t test was used to compare mean pertussis costs in different groups, considering a p < 0.05 as statistically significant. The correlation between pertussis costs and study variables was assessed using the Spearman's ρ, with a p < 0.05 as statistically significant. Multiple linear regression analysis (IBM-SPSS program) was used to quantify the association of pertussis vaccination and other study variables with pertussis costs. RESULTS: Vaccinated children with pertussis aged 0-9 years had significantly lower odds ratios of hospitalizations (OR 0.02, p < 0.001), laboratory confirmation (OR 0.21, p < 0.001), and severe disease (OR 0.02, p < 0.001) than unvaccinated or partially vaccinated children with pertussis of the same age. Mean direct healthcare costs were significantly lower (p < 0.001) in vaccinated patients (€190.6) than in unvaccinated patients (€3550.8), partially vaccinated patients (€1116.9), and unvaccinated/partially vaccinated patients (€2330). Multivariable linear regression analysis showed that pertussis vaccination with 4-5 doses was associated with a non-significant reduction of pertussis costs of €107.9 per case after taking into account the effect of other study variables, and €200 per case after taking into account pertussis severity. CONCLUSIONS: Direct healthcare costs were lower in children with pertussis aged 0-9 years vaccinated with 4-5 doses of acellular vaccines than in unvaccinated or partially vaccinated children with pertussis of the same age.

Hepatitis A surveillance: sensitivity of two information sources.

BACKGROUND: The frequency of mild forms of hepatitis A, especially in children, could lead to underreporting. The objective of the study was to investigate the sensitivity of two surveillance systems, mandatory Statutory Disease Reports and the Microbiological Reporting System of Catalonia, using capture-recapture techniques. METHODS: The study was conducted in Catalonia between 2011 and 2015. Hepatitis A cases reported to two independent surveillance systems were included: Statutory Disease Reports (SDR) and Microbiological Reporting System of Catalonia (MRS). The variables collected were: age, sex, year of declaration, size of municipality (< 10,000 and ≥ 10,000), country of birth (Spain or abroad), reporting centre (primary care/hospital) and notification method (electronic or paper). The capture-recapture analysis and the estimate of 95% confidence intervals were made using the Chapman formula for comparison of two sources, both for the estimate of the total number of cases and the stratification according to variables. Multinomial logistic regression was performed to obtain an adjusted estimate. RESULTS: The SDR had a greater overall sensitivity than the MRS (48.8%; 43.5-55.6 vs. 19.3%; 17.2-21.9). In cases aged < 15 years the sensitivity of both systems was higher (76.6%; 72.7-81 vs. 25.2%; 20.9-29.5) than in cases aged > 15 years (25.5%; 22.8-28.3 vs. 12.1%; 10-14.2). For those born in Spain, the sensitivity was 57.2% (49.6-67.4) in the SDR and 27.1% (23.5-31.9) in the MRS, lower than that for foreign-born patients (58%; 51.2-66.8 vs. 49.1%; 43.4-56.6). In electronically-reported cases, the sensitivity was much higher in the SDR than in the MRS (47.2%; 42.3-52.1 vs. 9.4%; 6.5-12.3). No differences were observed according to sex, size of municipality, and year of declaration or reporting centre. The estimated total number of cases using the Chapman formula was very similar to the adjusted estimate (1121; 985-1258 vs. 1120; 876-1525), indicating the robustness of the results. CONCLUSIONS: The sensitivity of the SDR was greater than that of MRS, especially in patients aged < 15 years, although for patients born abroad the difference in sensitivity was lower. Reinforced surveillance combining the SDR and MRS improves the efficiency in the detection of cases.

Contextualización del inicio sexual y barreras individuales del uso de anticonceptivos en adolescentes de Lima, Huamanga e Iquitos / Contextualization of sexual initiation and individual barriers to the use of contraceptives by adolescents of Lima, Huamanga, and Iquitos

RESUMEN Objetivos . Contextualizar el inicio sexual y las barreras individuales hacia el uso de anticonceptivos en adolescentes, con conocimiento adecuados sobre anticoncepción y enfermedades de transmisión sexual. Materiales y métodos. Se desarrolló un estudio cuanticualitativo en adolescentes procedentes de ciudades con altas tasas de embarazo: Iquitos, Huamanga y Lima. La convocatoria se realizó a través de Facebook, luego se aplicaron encuestas para seleccionar a los adolescentes que cumplían los criterios de inclusión y, finalmente, se realizaron entrevistas para abordar el tema en profundidad. Resultados . Participaron 33 mujeres y 23 varones adolescentes urbanos, con edades entre 18 y 19 años. La edad de inicio sexual osciló entre los 14 y 16 años; las principales razones de inicio sexual en los varones fue el deseo sexual; en las mujeres fue la presión de la pareja; la persona con la que se iniciaron fue, principalmente, una pareja ocasional en los varones, y en las mujeres fue "su enamorado". Se identificaron barreras individuales en relación al uso de anticonceptivos como la estabilidad de la pareja, la responsabilidad de la mujer al usar anticonceptivos, la limitada capacidad de negociación y temor al abandono del varón por exigir su uso, además de la reducción de la sensibilidad sexual generada por el uso del condón. Conclusiones. Estas barreras limitan el uso de anticonceptivos, sugiriendo la necesidad de desarrollar estrategias específicas para fortalecer las habilidades interpersonales del adolescente que se extienden más allá de ofrecer información acerca de los riesgos del sexo sin protección.

ABSTRACT Objectives. To contextualize sexual initiation and barriers to the use of contraceptives by adolescents as well as the acquisition of adequate knowledge regarding contraception and sexually transmitted diseases. Materials and methods. This quantitative and qualitative study evaluated adolescents living in three cities with high pregnancy rates in Peru: Iquitos, Huamanga, and Lima. Subjects were invited to participate in the study via Facebook. Questionnaires were then used to select adolescents who met the inclusion criteria, and interviews were conducted to obtain detailed data regarding the study topic. Results. A total of 33 women and 23 men aged 18 to 19 years participated in the study. The age of onset of sexual activity ranged from 14 to 16 years; the main reasons for sexual initiation were sexual desire among men and pressure from the partner among women; in most cases, the sexual partner was an occasional companion for men and a boyfriend for women. The barriers related to the use of contraceptives were the financial stability of the partner, responsibility of the female partner when using contraceptives, limited capacity to negotiate choices, fear of abandonment by the male partner for demanding the use of contraceptives, and the reduction of sexual sensitivity with the use of condoms. Conclusions. The barriers identified in this study limit the use of contraceptives and indicate the need to develop specific strategies to strengthen the interpersonal skills of adolescents and provide accurate information about the risks of unprotected sex.

Utilidad de los diálogos deliberativos para la formulación de recomendaciones de guías de práctica clínica / Use of Deliberative Dialogues for the Formulation of Recommendations for Clinical Practice Guidelines

RESUMEN En el presente artículo se reporta la experiencia obtenida por el Instituto Nacional de Salud de Perú, en la utilidad del desarrollo de diálogos deliberativos para la formulación de recomendaciones, como uno de los componentes del proceso de adaptación de Guías de Práctica Clínica basadas en evidencia, utilizando el sistema GRADE (por sus siglas en ingles: Grading of Recommendations, Assessment, Development and Evaluations). Describe los temas de salud pública que fueron deliberados y la participación de los actores implicados con un enfoque multidisciplinario. Presenta los aspectos que fueron tomados en cuenta de forma previa y durante los diálogos. Finalmente, propone los desafíos que serán abordados en las siguientes experiencias a fin de optimizar estos procesos y colaborar en la interacción entre las evidencias científicas y el valor agregado que otorgan los actores implicados a través de su experiencias, perspectivas y conocimientos para el desarrollo de recomendaciones en salud.

ABSTRACT This study reports the experience obtained by the National Institute of Health of Peru in the use of deliberative dialogues for the formulation of recommendations as one of the stages of the process of adaptation of evidence-based clinical practice guidelines using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system. Using a multidisciplinary approach, this study describes: 1. the public health problems addressed in the dialogues; 2. the role of the involved parties; 3. the parameters that were considered before and during the discussions; 4. the challenges for optimizing these dialogues and stimulating the interaction between scientific evidence and the added value provided by the involved parties through their experiences, perspectives, and knowledge for the development of recommendations in health.

A study protocol for a multicentre randomised clinical trial evaluating the safety and feasibility of a bioengineered human allogeneic nanostructured anterior cornea in patients with advanced corneal trophic ulcers refractory to conventional treatment.

INTRODUCTION: There is a need to find alternatives to the use of human donor corneas in transplants because of the limited availability of donor organs, the incidence of graft complications, as well as the inability to successfully perform corneal transplant in patients presenting limbal deficiency, neo-vascularized or thin corneas, etc. We have designed a clinical trial to test a nanostructured fibrin-agarose corneal substitute combining allogeneic cells that mimics the anterior human native cornea in terms of optical, mechanical and biological behaviour. METHODS AND ANALYSIS: This is a phase I-II, randomised, controlled, open-label clinical trial, currently ongoing in ten Spanish hospitals, to evaluate the safety and feasibility, as well as clinical efficacy evidence, of this bioengineered human corneal substitute in adults with severe trophic corneal ulcers refractory to conventional treatment, or with sequelae of previous ulcers. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 45 days, receiving the bioengineered corneal graft. In the second phase of the trial (currently ongoing), subjects are block randomised (2:1) to receive either the corneal graft (n=10), or amniotic membrane (n=5), as the control treatment. Adverse events, implant status, infection signs and induced neovascularization are evaluated as determinants of safety and feasibility of the bioengineered graft (main outcomes). Study endpoints are measured along a follow-up period of 24 months, including 27 post-implant assessment visits according to a decreasing frequency. Intention to treat, and per protocol, and safety analysis will be performed. ETHICS AND DISSEMINATION: The trial protocol received written approval by the corresponding Ethics Committee and the Spanish Regulatory Authority and is currently recruiting subjects. On completion of the trial, manuscripts with the results of phases I and II of the study will be published in a peer-reviewed journal. TRIAL REGISTRATION: CT.gov identifier: NCT01765244 (Jan2013). EudraCT number: 2010-024290-40 (Dec2012).

Resultados y retos en salud pública ante la alerta por Ébola: una perspectiva desde Cataluña / Ebola alert: results and challenges in public health. A view from Catalonia (Spain)

El brote de enfermedad por virus Ébola iniciado en Guinea Conakry y notificado a la Organización Mundial de la Salud en marzo de 2014ha sido el mayor documentado hasta la fecha. Su extensión a países limítrofes y el riesgo de expansión fuera del continente africano hicieron que, en agosto de 2014, fuese declarado emergencia de salud pública internacional. En el marco de lo establecido por el Centro de Coordinación de Alertas y Emergencias Sanitarias, la Agencia de Salud Pública de Cataluña inició las actuaciones de salud pública en marzo de 2014 y elaboró un único protocolo para todo el territorio, consejos para viajeros y cooperantes procedentes de países afectados, y una nota informativa semanal. Asimismo, en Cataluña, se crearon el Comité de Análisis y Seguimiento de Ébola y el Comité Científico Asesor de Ébola. Se realizaron sesiones informativas y formativas a más de 9600 profesionales de la salud de diferentes ámbitos. Desde agosto de 2014, a través del Sistema de Urgencias de Vigilancia Epidemiológica de Cataluña se notificaron 117 sospechas de Ébola. En tres casos se activó el protocolo con derivación al centro hospitalario de referencia, siendo los resultados descartados microbiológicamente. Se realizó la vigilancia de 95 cooperantes, un 52% mujeres y un 74% procedentes de Sierra Leona. En la gestión de alertas fueron esenciales la preparación y la planificación previas, el trabajo sinérgico entre la red epidemiológica, la asistencial y el conjunto de agentes implicados, así como la comunicación de riesgo precisa, veraz y proporcionada. Fue clave el circuito de cribado previo establecido ante la sospecha de casos por parte de los servicios de vigilancia epidemiológica. Así, solo se activó el protocolo de inmediato en aquellos casos que cumplían estrictamente los criterios. Este es un aspecto esencial a reforzar y mantener de cara a futuras alertas de salud pública internacional (AU)

The Ebola outbreak in Guinea Conakry was notified to the World Health Organization (WHO) in March 2014. It is the most complex Ebola outbreak to date, affecting Guinea Conakry as well as the surrounding countries and with a risk of the disease spreading outside Africa. For this reason, the World Health Organization declared this Ebola outbreak an international public health emergency in August 2014. The Public Health Agency of Catalonia, through the Spanish Alert and Emergencies Coordination Network, initiated public health actions in March 2014, developing a single protocol of action to be applied by all the health care providers in the whole Catalan territory, advice for travellers and voluntary workers arriving from affected countries and a weekly newsletter addressed to health professionals. At the same time, the Ebola Analysis and Monitoring Committee and the Ebola Scientific and Advisory Committee were established. More than 9600 professional health workers attended training sessions and informative sessions. From August 2014, the Catalan Epidemiological Surveillance Emergency Service (SUVEC) reported 117 suspected Ebola cases, of which only 3 met the epidemiological and clinical criteria leading to the activation of the action protocol. All 3 cases proved negative for Ebola. Also, 95 voluntary workers were monitored, 52% of whom were female and 74% had returned from Sierra Leone. Dealing with the suspected Ebola cases required a detailed advance preparation and planning, with a coordinated effort between the epidemiological and health-care network, and all the agents involved, as well as precise, realistic and appropriate risk communication. The prior screening of suspected Ebola cases by the SUVEC meant the immediate protocol was activated only in the cases that met the epidemiological and clinical criteria. This is a key point to be reinforced in any future international public health alerts (AU)

[Ebola alert: results and challenges in public health. A view from Catalonia (Spain)]. / Resultados y retos en salud pública ante la alerta por Ébola: una perspectiva desde Cataluña.

The Ebola outbreak in Guinea Conakry was notified to the World Health Organization (WHO) in March 2014. It is the most complex Ebola outbreak to date, affecting Guinea Conakry as well as the surrounding countries and with a risk of the disease spreading outside Africa. For this reason, the World Health Organization declared this Ebola outbreak an international public health emergency in August 2014. The Public Health Agency of Catalonia, through the Spanish Alert and Emergencies Coordination Network, initiated public health actions in March 2014, developing a single protocol of action to be applied by all the health care providers in the whole Catalan territory, advice for travellers and voluntary workers arriving from affected countries and a weekly newsletter addressed to health professionals. At the same time, the Ebola Analysis and Monitoring Committee and the Ebola Scientific and Advisory Committee were established. More than 9600 professional health workers attended training sessions and informative sessions. From August 2014, the Catalan Epidemiological Surveillance Emergency Service (SUVEC) reported 117 suspected Ebola cases, of which only 3 met the epidemiological and clinical criteria leading to the activation of the action protocol. All 3 cases proved negative for Ebola. Also, 95 voluntary workers were monitored, 52% of whom were female and 74% had returned from Sierra Leone. Dealing with the suspected Ebola cases required a detailed advance preparation and planning, with a coordinated effort between the epidemiological and health-care network, and all the agents involved, as well as precise, realistic and appropriate risk communication. The prior screening of suspected Ebola cases by the SUVEC meant the immediate protocol was activated only in the cases that met the epidemiological and clinical criteria. This is a key point to be reinforced in any future international public health alerts.

[Use of Deliberative Dialogues for the Formulation of Recommendations for Clinical Practice Guidelines]. / Utilidad de los diálogos deliberativos para la formulación de recomendaciones de guías de práctica clínica.

This study reports the experience obtained by the National Institute of Health of Peru in the use of deliberative dialogues for the formulation of recommendations as one of the stages of the process of adaptation of evidence-based clinical practice guidelines using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system. Using a multidisciplinary approach, this study describes: 1. the public health problems addressed in the dialogues; 2. the role of the involved parties; 3. the parameters that were considered before and during the discussions; 4. the challenges for optimizing these dialogues and stimulating the interaction between scientific evidence and the added value provided by the involved parties through their experiences, perspectives, and knowledge for the development of recommendations in health.

En el presente artículo se reporta la experiencia obtenida por el Instituto Nacional de Salud de Perú, en la utilidad del desarrollo de diálogos deliberativos para la formulación de recomendaciones, como uno de los componentes del proceso de adaptación de Guías de Práctica Clínica basadas en evidencia, utilizando el sistema GRADE (por sus siglas en ingles: Grading of Recommendations, Assessment, Development and Evaluations). Describe los temas de salud pública que fueron deliberados y la participación de los actores implicados con un enfoque multidisciplinario. Presenta los aspectos que fueron tomados en cuenta de forma previa y durante los diálogos. Finalmente, propone los desafíos que serán abordados en las siguientes experiencias a fin de optimizar estos procesos y colaborar en la interacción entre las evidencias científicas y el valor agregado que otorgan los actores implicados a través de su experiencias, perspectivas y conocimientos para el desarrollo de recomendaciones en salud.