Co-creation of information materials within the assent process: From theory to practice.

INTRODUCTION: The informed consent process is key to safeguarding the autonomy of the participant in medical research. For this process to be valid, the information presented to the potential participant should meet their needs and be understood by them. The i-CONSENT project has developed 'Guidelines for adapting the informed consent process in clinical trials' which aim to improve informed consent so that they are easier to understand and better adapted to the needs and preferences of the target population. The best way to tailor information to the characteristics and preferences of the target population is to involve the community itself. METHODS: Following guidelines developed by i-CONSENT, assent materials were co-created for a mock clinical trial of the human papillomavirus vaccine in adolescents. During the process, two design thinking sessions were conducted involving a total of 10 children and 5 parents. The objectives of the sessions were to find out the children's opinion of the informed consent (assent in their case) process in clinical trials, identify the parts that were most difficult to understand and alternatives for their presentation and wording, identify the preferred formats for receiving the information and the main characteristics of these formats, design a video explaining the clinical trial and evaluate a tool for assessing comprehension. RESULTS: Assent materials were co-created in three formats: a web-based material following a layered approach; a video in story format; a pdf document with an innovative way of presenting information compared to traditional assent documents. In addition, the Comprehension of Assent Questionnaire was co-designed, based on the Quality of Informed Consent questionnaire. CONCLUSION: The design thinking methodology has proven to be an easy and useful tool for involving children in designing information tailored to their needs and preferences. PATIENT OR PUBLIC CONTRIBUTION: A sample of the target population participated in the design and piloting of the materials created using design thinking methodology. In addition, patient representatives participated in the design and evaluation of the guidelines developed by the i-CONSENT project that were followed for the development of the materials in this study.

Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.

Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants' homes and local surroundings. In this study, we conducted semi-structured interviews with 20 European regulators to identify regulatory challenges and opportunities for the implementation of DCTs in the European Union. The key opportunities for DCTs that were recognized by regulators include a reduced participation burden, which could facilitate the participation of underserved patients. In addition, regulators indicated that data collected in DCTs are expected to be more representative of the real world. Key challenges recognized by regulators for DCTs include concerns regarding investigator oversight and participants' safety when physical examinations and face-to-face contact are limited. To facilitate future learning, hybrid clinical trials with both on-site and decentralized elements are proposed by the respondents.

Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.

BACKGROUND: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders. METHODS: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting. RESULTS: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms. CONCLUSIONS: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.

Digital tools in the informed consent process: a systematic review.

BACKGROUND: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients' autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process. METHODS: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. RESULTS: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. CONCLUSIONS: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

Seguridad de las vacunas antigripales en grupos de riesgo: análisis de las sospechas de reacciones adversas notificadas en Comunidad Valenciana entre 2005 y 2011 / Safety of influenza vaccines in risk groups: analysis of adverse events following immunization reported in Valencian Community from 2005 to 2011

Objetivo. Evaluar las notificaciones de sospechas de reacciones adversas a las vacunas administradas frente a la gripe, por sexo, grupos de riesgo y por grupos de edad en la Comunidad Valenciana desde el año 2005 a 2011. Métodos. Se ha realizado un estudio farmacoepidemiológico de diseño observacional descriptivo y transversal, basado en las notificaciones de sospechas de reacciones adversas a las vacunas (NRAV) frente a la gripe, registradas a través del Sistema de Información Vacunal (SIV) de la Comunidad Valenciana, de 1 de enero de 2005 hasta 31 de diciembre de 2011. Resultados. Durante el periodo de estudio se registraron 5.107.790 dosis de vacuna frente a la gripe, con una tasa de notificación de NRAV de 1,94 por 100.000 (IC95% 1,59-2,36) y 228.094 dosis de vacuna de gripe A(H1N1)pdm09 (tasa 96,45 por 100.000; IC95% 84,52-110,06). El 70,71% (70) y el 64,55% (142), respectivamente, de las NRAV correspondieron a mujeres. El grupo de riesgo de trabajadores sociosanitarios presentó una mayor tasa de notificación para la gripe estacional (25,35 por 100.000; IC95%: 17,65-36,40) así como para gripe A(H1N1)pdm09 (864,13 por 100.000; IC95% 714,38-1044,93) durante el periodo de estudio. Conclusiones. Las vacunas frente a la gripe administradas durante el periodo de estudio muestran un elevado perfil de seguridad tanto en población con patología de riesgo como en otros grupos diana susceptibles de la vacunación. Las reacciones registradas durante el estudio coinciden en su mayoría con las descritas en las fichas técnicas de las vacunas (AU)

Objective. To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. Methods. A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. Results. During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. Conclusions. Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines (AU)

[Safety of influenza vaccines in risk groups: analysis of adverse events following immunization reported in Valencian Community from 2005 to 2011]. / Seguridad de las vacunas antigripales en grupos de riesgo: análisis de las sospechas de reacciones adversas notificadas en Comunidad Valenciana entre 2005 y 2011.

OBJECTIVE: To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. METHODS: A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. RESULTS: During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. CONCLUSIONS: Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines.

Crisis económica y condiciones de empleo: diferencias de género y respuesta de las políticas sociales de empleo. Informe SESPAS 2014 / Economic crisis and employment conditions: gender differences and the response of social and employment policies. SESPAS report 2014

La crisis económica ha tenido impacto en toda la Unión Europea, pero en España sus consecuencias han sido devastadoras en el mercado laboral, pasando a ser el país de la UE-15 con peores indicadores de empleo. La situación es peor en la población joven, de la cual en 2012 una de cada dos personas está en situación de desempleo, con una tasa algo superior en los hombres (54,4% frente a 51,8% en las mujeres). La reducción del gasto en políticas activas de empleo por punto de tasa de paro en 2012 con respecto a 2007 hará difícil la mejora de los indicadores de empleo. Además, la reducción del gasto en políticas pasivas de empleo producirá un empeoramiento de la salud de la población desempleada (AU)

The economic crisis has had an impact across the European Union (EU), but has had a devastating impact on the labor market in Spain, which has become the country within the EU-15 with the worst employment indicators. The situation is worse in younger people, half of whom were unemployed in 2012, with a slightly higher rate in men (54.4%) than in women (51.8%). This high unemployment rate will be even more difficult to redress because of the decrease in public spending on active employment per percentage point of unemployment in 2012 compared with 2007. Furthermore, the decrease in spending on passive employment policies will worsen the health of the unemployed population (AU)

[Economic crisis and employment conditions: gender differences and the response of social and employment policies. SESPAS report 2014]. / Crisis económica y condiciones de empleo: diferencias de género y respuesta de las políticas sociales de empleo. Informe SESPAS 2014.

The economic crisis has had an impact across the European Union (EU), but has had a devastating impact on the labor market in Spain, which has become the country within the EU-15 with the worst employment indicators. The situation is worse in younger people, half of whom were unemployed in 2012, with a slightly higher rate in men (54.4%) than in women (51.8%). This high unemployment rate will be even more difficult to redress because of the decrease in public spending on active employment per percentage point of unemployment in 2012 compared with 2007. Furthermore, the decrease in spending on passive employment policies will worsen the health of the unemployed population.

Guía de ayuda contra la violencia de género

Guía que pretende que el/la profesional farmacéutico adquiera conocimientos suficientes sobre la violencia de género para que sean capaces de informar y ayudar a sus víctimas.