Family Management of Hypertension in Brazil: A Cross-Sectional Study.

In Brazil, research indicates that primary family members are the main source of support for individuals with chronic conditions such as hypertension (HTN). The burden of caregiving not only hinders effective HTN management but can also cause stress and anxiety, potentially leading to HTN in caregivers. Despite this, few studies have explored the impact of caregiving on these family members. Aims of the study were to: (1) Describe the prevalence of blood pressure (BP) control in family members of individuals with HTN; (2) identify family member perspectives on facilitators and barriers to HTN management; and (3) identify influences that help or interfere with family member functioning (levels of stress, quality of life [QOL], and caregiver burden). This descriptive, cross-sectional study included 213 family members randomly selected from 3 Family Health Strategy units. Family members were largely female (n = 143; 67.1%); the mean age was 60.1 years (SD ± 17.02) and 42.6% (n = 96) had less than a high school education. The three most important facilitators and barriers were related to medication, medical visits, healthy eating, physical activity, and stress. The mean systolic BP was 132.7 (SD ± 21.9) mmHg and a diastolic BP of 85.9 (SD ± 18.1) mmHg with 120 (56.3%) of family members classified as having normal BP. In regard to family member contributions to the self-care of the individual with HTN, family members displayed low levels of self-care maintenance (n = 148; 69.4%) and management (n = 47; 71.2%) support, while a slight majority (n = 114; 53.5%) had adequate levels of self-care confidence in supporting the individual with HTN. Family members (n = 189; 88.8%) showed moderate-to-high levels of perceived stress, but good physical (n = 189; 88.7%) and mental QOL (n = 196; 92%) and low levels of caregiver burden (n = 113; 53.1%). A variety of contextual sociocultural influences were associated with the outcomes under study. Family-based interventions are urgently needed to address the inadequate management of HTN.

Validación de un instrumento para la aplicación de los principios bioéticos principialistas en los protocolos de investigación clínica

El artículo informa acerca de la validación de un instrumento sobre la aplicación de los principios bioéticos de la corriente principialista en cada uno de los elementos de los protocolos de investigación clínica. Para ello, se realizó la valoración de un instrumento de 173 ítems por medio del método Delphi, con la colaboración de 12 expertos latinoamericanos en bioética de la investigación. El instrumento tuvo dos rondas de revisión. Al final solo se tuvieron 171 ítems, en el que se aplicaron los principios bioéticos en 208 ocasiones, de los cuales 87 (41,82%) pertenecían a Beneficencia, 63 (30,29%) a No Maleficencia, 36 (17,31%) a Justicia y 22 (10,58%) a Autonomía. En cuanto a la congruencia de los principios en general respecto de las variables de los elementos del protocolo de investigación clínica, se encontró en 189 (90,87% IC 95% 86.10 a 94.41) ocasiones, K=0.98 (0.01), p=<0.0001. Se concluye que ell instrumento validado nos brinda la opción de aplicar los principios bioéticos de la corriente principialista a cada uno de los elementos de los protocolos de investigación clínica.

The aim of this article is to report on the validation of an instrument on the application of principialist bioethical principles in each of the elements of clinical research protocols. To this end, a 173-item instrument was evaluated using the Delphi method, with the collaboration of 12 Latin American experts in research bioethics. The instrument underwent two rounds of revision. In the end there were only 171 items, in which the bioethical principles were applied 208 times, of which 87 (41.82%) belonged to Beneficence, 63 (30.29%) to Non-Maleficence, 36 (17.31%) to Justice and 22 (10.58%) to Autonomy. Regarding the congruence of the principles in general with respect to the variables of the elements of the clinical research protocol, it was found on 189 (90.87% CI 95% 86.10 to 94.41) occasions, K=0.98 (0.01), p=<0.0001. It is concluded that the validated instrument gives us the option of applying the bioethical principles of the principialist current to each of the elements of the clinical research protocols.

O objetivo deste artigo é informar acerca da validação de um instrumento sobre a aplicação dos princípios bioéticos da corrente principialista em cada um dos elementos dos protocolos de investigação clínica. Para isso, realizou-se a valoração de um instrumento de 173 itens por meio do método Delphi, com a colaboração de 12 especialistas latino-americanos em bioética da investigação. O instrumento teve duas rodadas de revisão. Ao final, analisou-se 171 itens, aos quais se aplicaram os princípios bioéticos em 208 ocasiões, dos quais 87 (41,82%) pertenciam a Beneficência, 63 (30,29%) a Não Maleficência, 36 (17,31%) a Justiça e 22 (10,58%) a Autonomia. Quanto à congruência dos princípios em geral, a respeito das variáveis dos elementos do protocolo de investigação clínica, encontrou-se em 189 (90,87% IC 95% 86.10 a 94.41) ocasiões, K=0.98 (0.01), p=<0.0001. Concluiu-se que o instrumento validado nos dá a opção de aplicar os princípios bioéticos da corrente principialista a cada um dos elementos dos protocolos de investigação clínica.

ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.

INTRODUCTION: ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation. METHODS: The platform's database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted. RESULTS: ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months. DISCUSSION: ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.

Consideraciones Éticas y Académicas sobre el Uso de Inteligencia Artificial en Cursos de Metodología de la Investigación en Rehabilitación / Ethical and Academic Reflections on the Integration of Artificial Intelligence in Research Methodology Courses in Rehabilitation Science

En el cruce entre la revolución tecnológica y la educación en ciencias de la rehabilitación y del movimiento humano, la inteligencia artificial (IA) emerge como herramienta transformadora en los cursos de metodología de investigación. Este artículo destaca su potencial para optimizar la experiencia de aprendizaje y personalizar la instrucción, pero enfatiza la necesidad crucial de abordar desafíos éticos y pedagógicos. Propone orientaciones para equilibrar la innovación educativa y la responsabilidad académica, resaltando la importancia de la implementación consciente y planificada de la IA en los equipos de investigación en ciencias de la rehabilitación y del movimiento humano, garantizando así la integridad científica y ética en este campo en constante evolución.

In the intersection between technological advancements and education in rehabilitation science, artificial intelligence (AI) emerges as a transformative tool in research methodology. This article navigates the ethical and academic considerations tied to the incorporation of AI in rehabilitation and movement science courses. While acknowledging its potential to enhance learning experiences, it critically addresses the imperative to tackle ethical and pedagogical challenges. The paper offers guidance to strike a balance between educational innovation and academic responsibility. It emphasizes the need for a conscientious and planned implementation of AI, ensuring both scientific integrity and ethical adherence in this dynamically evolving field.

External urology consultation quality at a third-level public hospital in Mexico.

INTRODUCTION: Patient satisfaction is the degree of conformity with the healthcare they receive. It is real evidence and one of the most important factors in determining the effectiveness and quality of healthcare systems. OBJECTIVE: To identify the quality of care in the Urology outpatient department of a third-level hospital. MATERIALS AND METHODS: The NHS (National Health Service) 2018 quality of care questionnaire with 11 sections, 133 items, and duration of approximately 25min was randomly administered to 250 patients attending Urology outpatients at a third-level public hospital in Mexico. RESULTS: According to responses, 92% (n=230) knew the reason for the consultation. 64.8% (n=162) had a consultation with the same physician by whom they were initially seen. The longest reported hospital wait time before being seen was more than 2h in 29.6% (n=74). As for consultation time, 212 patients responded and the duration was 11-20min in 52.8% (n=112). Finally, 33.2% (n=83) considered the quality of service to be good. CONCLUSIONS: The use of the NHS 2018 survey in the Urology service at a third-level public hospital in Mexico is feasible, since we managed to obtain a significant and continuous improvement in all its indicators which is satisfactory for all.

El estatuto epistemológico de la psicologia moderna según Abelardo Pithod / O estatuto epistemológico da psicologia moderna segundo Abelardo Pithod / The epistemological status of modern psychology according to Abelardo Pithod / Le retour de l'inatteignable objet du désir. Une lecture de la nouvelle "L'Autel de los Muertosde morts" d'e Henry James

El objetivo de este estúdio es rescatar el valor y alcance epistemológico que tiene la investigación psicoclínica en la obra de Abelardo Pithod. Este filósofo argentino participó activamente en el debate acerca del estatuto epistemológico de las ciencias sociales y humanas. Este estudio presenta la comprensión de este autor sobre la psicología moderna, es decir, de este campo del saber que se configura como disciplina autónoma a partir de su independización y desarrollo desde finales del siglo XIX. Pithod se preocupó por destacar, dentro de una comprensión aristotélica de la práctica científica, el valor epistémico del conocimiento empírico y probabilístico que proporcionan los estudios psicoclínicos. Su contribución podría significar un aporte en el escenario argentino y del mundo en general, consagrado a legitimar el ejercicio y la investigación psicoclínica.

Des auteurs comme Freud et Lacan ont souvent eu recours à la fiction pour illustrer des structures psychopathologiques. Partant d'une perspective psychanalytique, cet article se concentre sur le personnage principal de la nouvelle "L'autel des morts" d'Henry James. Nous soutenons que les différentes strategies dont il fait preuve au cours de sa vie, telles que décrites par l'auteur, servent à éviter la confrontation à l'objet du désir et suggèrent une structure obsessionnelle. Pour le sujet obsessionnel, il s'agit d'assurer la subsistance de l'objet tout en le rendant intouchable. Le désir est donc conçu comme impossible, une façon d'assurer l'existence de l'objet qui le produit. L'idéalisation de la mort, l'inhibition de l'amour sensuel et la ritualisation de son existence sont les symptômes d'une lutte personnelle, un conflit qui s'avérera insoluble.

Resumos The objective of this study is to rescue the value and epistemological scope of psycho-clinical research according to Abelardo Pithod. This Argentinean philosopher actively participated in the debate about on the epistemological status of the social and human sciences. We will limit ourselves to presenting his understanding of modern psychology, that is, of theis field of knowledge that is has been configured as an autonomous discipline from since its independence and development since in the end of the 19th century. PithodOur author was concerned to highlight, within an Aristotelian understanding of scientific practice, the epistemic value of empirical and probabilistic knowledge provided by psycho-clinical studies. His understanding of the issue could mean be a contribution in the Argentinean scenario, and in the world in general, devoted to legitimizingas it aims to legitimize psycho-clinical exercise practice and research.

O objetivo deste estudo é resgatar o valor e o alcance epistemológico da pesquisa psico-clínica na obra de Abelardo Pithod. Este filósofo argentino participou ativamente do debate sobre a situação epistemológica das ciências sociais e humanas. Limitar-nos-emos a apresentar a sua compreensão da psicologia moderna, ou seja, deste campo do conhecimento que se configura como disciplina autónoma desde a sua independência e desenvolvimento desde o final do século XIX. Nosso autor preocupou-se em destacar, dentro de uma compreensão aristotélica da prática científica, o valor epistêmico do conhecimento empírico e probabilístico proporcionado pelos estudos psico-clínicos. Sua contribuição pode significar uma contribuição para a cena argentina e para o mundo em geral, dedicada a legitimar o exercício e a pesquisa psico-clínica.

Corrigendum: Assessment of the accuracy of 11 different diagnostic tests for the detection of Schistosomiasis mansoni in individuals from a Brazilian area of low endemicity using latent class analysis.

[This corrects the article DOI: 10.3389/fmicb.2022.1048457.].

Breaking the unvirtuous cycle: barriers and opportunities for research and development in Paraguay. A case study.

Introduction: Medical research and development (R&D) is an undoubtedly relevant activity to drive innovation, improve healthcare policies and bring patients treatment opportunities for common and rare diseases. Equity and inclusion are matters of concern in research. High-income countries' research teams are more likely to have more impactful publications, grant funding, and clinical trials than middle or low-income countries. Low budget allocations to R&D and existing gaps in regulatory frameworks are some obstacles to growth. This unvirtuous cycle results in scarce advances in common endemic diseases and the underrepresentation of specific populations in innovative therapeutics research. Materials and methods: We conducted a policy review and qualitative research to determine the principal characteristics of basic and clinical medical research in Paraguay, as well as barriers and facilitators to improve innovative R&D strategies in this country. To this aim, we examined published articles from 2005 to 2020, the organizational structure of national research agencies, the current regulation framework, and the composition and experience of local research groups and ethical review boards (ERBs). In addition, we performed semi-structured interviews to evaluate perceptions and expectations from different stakeholders, including investigators, ERBs members, sponsor associates, and Regulatory Agency executive staff. Results: In 2018, Paraguay ranked 10th out of 12 South American countries in total number of publications and cumulative h-index score. Total Gross Domestic Product (GDP) allocation for R&D was 0.15%, ranking eighth out of 12 in the region. In 2021, the number of trials registered on ClinicalTrials.gov was 52, with only 16 ongoing recruiting studies at that time.Some of the main barriers identified included low incentives for academic careers and lack of experience in pharmaceutical research. An emergent necessity to develop a straight- forward normative framework was detected. Main facilitators included the development of two research initiative programs (PRONII and PROCIENCIA) from CONACYT (National Council of Science and Technology) which were associated with higher budget allocation and total number of publications in the 2011 to 2017 period. A total of six stakeholders participated in the semi-structured surveys. Interviewees highlighted the necessity of a centralized policy to promote R&D, which incorporates investigators and ERBs training, the development of standardized procedures, and the dissemination of research activities. Sponsor associates underlined that real-world evidence may represent a distinctive opportunity to enhance local research. Conclusion: Coordinated efforts are needed to break the unvirtuous cycle. There is an increasing interest in enhancing health research in Paraguay, materialized in the creation of specific programs that encourage the collaborative work of healthcare providers, basic scientists, and private investors. Nonetheless, a comprehensive approach is needed also to strengthen regulatory agencies and attract external sponsorship. While modern and currently popular topics, including artificial intelligence, real-world data, and translational research may represent key opportunities to seek investment, special policies should be adopted to prioritize research on the determinants of health in the Paraguayan population.

Clinical Research With Large Language Models Generated Writing-Clinical Research with AI-assisted Writing (CRAW) Study.

IMPORTANCE: The scientific community debates Generative Pre-trained Transformer (GPT)-3.5's article quality, authorship merit, originality, and ethical use in scientific writing. OBJECTIVES: Assess GPT-3.5's ability to craft the background section of critical care clinical research questions compared to medical researchers with H-indices of 22 and 13. DESIGN: Observational cross-sectional study. SETTING: Researchers from 20 countries from six continents evaluated the backgrounds. PARTICIPANTS: Researchers with a Scopus index greater than 1 were included. MAIN OUTCOMES AND MEASURES: In this study, we generated a background section of a critical care clinical research question on "acute kidney injury in sepsis" using three different methods: researcher with H-index greater than 20, researcher with H-index greater than 10, and GPT-3.5. The three background sections were presented in a blinded survey to researchers with an H-index range between 1 and 96. First, the researchers evaluated the main components of the background using a 5-point Likert scale. Second, they were asked to identify which background was written by humans only or with large language model-generated tools. RESULTS: A total of 80 researchers completed the survey. The median H-index was 3 (interquartile range, 1-7.25) and most (36%) researchers were from the Critical Care specialty. When compared with researchers with an H-index of 22 and 13, GPT-3.5 was marked high on the Likert scale ranking on main background components (median 4.5 vs. 3.82 vs. 3.6 vs. 4.5, respectively; p < 0.001). The sensitivity and specificity to detect researchers writing versus GPT-3.5 writing were poor, 22.4% and 57.6%, respectively. CONCLUSIONS AND RELEVANCE: GPT-3.5 could create background research content indistinguishable from the writing of a medical researcher. It was marked higher compared with medical researchers with an H-index of 22 and 13 in writing the background section of a critical care clinical research question.

Enhancing medical ethics education for medical students in clinical research: considerations and strategy analysis / Mejorando la educación ética médica para los estudiantes de medicina en la investigación clínica: consideraciones y análisis de estrategias / Melhorando a educação de ética médica para estudantes de medicina em pesquisa clínica: pensamentos e análise de estratégia

In recent years, the vigorous development of clinical researches carried out by medical schools is inseparable from the effective participation of medical students. However, as the number and categories of clinical research projects that medical students participate in increase, medical ethics related issues gradually occur. This article sorts out the ethical issues that arose in clinical researches, in which medical students participated, analyzes the underlying causes, and proposes solutions for the above-mentioned ethical issues, aiming to provide reference for medical ethics education and research project management for medical schools.

La participación efectiva de los estudiantes de medicina ha contribuido en gran medida al desarrollo exitoso de la investigación clínica en las escuelas de medicina de China en los últimos años. Sin embargo, con el creciente número y tipos de proyectos de investigación clínica en los que participan estudiantes de medicina, las cuestiones éticas se exponen gradualmente. Este trabajo enumera las cuestiones éticas que han surgido en la participación de los estudiantes de medicina en la investigación clínica en los últimos años, analiza las causas subyacentes y propone soluciones a las cuestiones éticas mencionadas anteriormente, con el objetivo de proporcionar referencia para la enseñanza de la ética médica y la gestión de proyectos de investigación para las escuelas de medicina.

A participação efetiva dos estudantes de medicina tem contribuído muito para o próspero desenvolvimento da pesquisa clínica nas escolas médicas da China nos últimos anos. No entanto, com o aumento do número e tipos de projetos de pesquisa clínica dos quais os estudantes de medicina participam, questões relacionadas à ética e à alfabetização são gradualmente expostas. Este artigo lista as questões éticas que surgiram na participação de estudantes de medicina em pesquisas clínicas nos últimos anos, analisa as causas subjacentes e propõe soluções para as questões éticas acima mencionadas, com o objetivo de fornecer referência para o ensino de ética médica e gestão de projetos de pesquisa para escolas médicas.

Implant survival/success and peri-implant outcomes of titanium-zirconium mini implants for mandibular overdentures: Results from a 1-year randomized clinical trial.

OBJECTIVE: To report the 1-year implant survival/success and peri-implant outcomes of mandibular overdentures retained by four titanium-zirconium mini implants (Straumann® Mini Implant System), and to assess how surgery and loading protocols influence these outcomes. MATERIALS AND METHODS: A 2 × 2 factorial randomized clinical trial (RCT) tested the combined effects of two loading protocols (immediate or delayed) and two surgical approaches (flapless or flapped) on the success/survival of the mini implants, and peri-implant parameters (plaque, bleeding, sulcus depth, gingival position, and marginal bone loss). Outcomes were assessed up to 1-year after loading, and generalized estimating equations (GEEs) were used to analyze longitudinal and within-patient clustered data. RESULTS: Two hundred and ninety-six implants were placed in 74 patients. The implant survival/success rates after 1 year were 100%, and no major biological complications were observed. After 1-year, descriptive data suggest no noticeable changes in plaque scores, whilst a reduction in bleeding scores at the 6-month and 1-year follow-ups compared to baseline. Good longitudinal stability was observed for the probing depth and gingival margin height measures. Overall mean marginal bone loss was 0.68 (±0.68) mm after 3 months and 0.89 (±0.75) mm after 1-year. The flapless protocol showed better results on soft tissue stability and health but a slightly higher risk for marginal bone loss. CONCLUSION: The results of this RCT suggest that mandibular overdentures retained by this novel mini implant system represent a safe and predictable treatment option as confirmed by implant survival/success and peri-implant outcomes, even when flapless surgery and immediate loading protocols are adopted.

Introduction: Historical Development and Progression of Clinical Research on Ageing.

Research on ageing has developed since Greek times. It had a very slow advance during the Middle Ages and a big increase in the Renaissance. Darwin contributed somehow to the understanding of the ageing process and initiated a cumulus of ageing explications under the name of Evolutionary Theories. Subsequently, science discovered a great number of genes, molecules, and cell processes that intervened in ageing. This led to the beginning of trials in animals to retard or avoid the ageing process. Alongside this, improvements, geriatric clinical investigations (with the evidence-based medicine tools) started to consolidate as a discipline and commenced to show the challenges and deficiencies of actual clinical trials in ageing; the COVID-19 outbreak revealed some of them. The history of clinical research in ageing has already begun and is essential to affront the challenges that the world will face with the increasing ageing population.

Innovative mechanisms of pre-marketing authorization access for rare diseases in Brazil: a case study of pabinafusp-alfa for mucopolysaccharidosis type II / Mecanismos inovadores de acesso pré-comercialização a tecnologias para doenças raras no Brasil: um estudo de caso de alfapabinafuspe para mucopolissacaridose tipo II

Patients with rare diseases frequently face unmet medical needs due to the high costs, lengthy development times, and slow approval processes for new treatments. This case study discusses innovative access alternatives for rare diseases in Brazil, focusing on early access to pabinafusp-alfa for mucopolysaccharidosis type II (MPS-II), a rare genetic lysosomal storage disease characterized by a deficiency of the enzyme iduronate-2-sulfatase. From September 2018 to March 2023, 20 Brazilian MPS-II patients received pabinafusp-alfa through a clinical research protocol. This enzyme replacement therapy (ERT) crosses the blood-brain barrier to address central nervous system manifestations unmet by existing treatments. Patients' participation in the clinical study resulted in an estimated BRL 65 million in cost savings for the public healthcare system compared to conventional ERT with idursulfase-alfa and potentially better clinical outcomes. The case study underscores the importance of innovative mechanisms in addressing patients' medical needs. Early access alternatives include: a) clinical study access, with execution/development aligned with healthcare managers and linked to future access strategies; b) regulatory-level risk-sharing, considering effectiveness uncertainties and the possibility of market withdrawal and/or reimbursement in case of negative results; and c) drug pre-delivery, with payment contingent on positive phase III clinical study outcomes. Although public-private partnerships in clinical research are underused, they could benefit all stakeholders by accelerating drug development, facilitating early patient access to innovative medicines, and generating healthcare system savings, particularly for rare diseases.

Pacientes com doenças raras frequentemente enfrentam necessidades médicas não atendidas devido aos altos custos, longos tempos de desenvolvimento e processos de aprovação lentos para novos tratamentos. Este estudo de caso discute alternativas inovadoras de acesso para doenças raras no Brasil, com foco no acesso precoce ao alfapabinafuspe para mucopolissacaridose tipo II (MPS-II), uma doença lisossômica de armazenamento genético rara, caracterizada por uma deficiência da enzima iduronato-2-sulfatase. De setembro de 2018 a março de 2023, 20 pacientes brasileiros com MPS-II receberam alfapabinafuspe por meio de pesquisa clínica. Essa terapia de reposição enzimática (TRE) atravessa a barreira hematoencefálica para tratar manifestações do sistema nervoso central não atendidas pelos tratamentos existentes. A participação dos pacientes no estudo clínico resultou em uma economia estimada de 65 milhões de reais para o sistema público de saúde, em comparação com a TRE convencional com idursulfase alfa, além de potencialmente melhores resultados clínicos. O estudo de caso destaca a importância de mecanismos inovadores no atendimento das necessidades médicas dos pacientes. As alternativas de acesso precoce incluem: a) acesso por meio de estudos clínicos, com execução/desenvolvimento alinhada aos gestores de saúde e vinculada a estratégias futuras de acesso; b) compartilhamento de risco em nível regulatório, considerando as incertezas de eficácia e a possibilidade de retirada do mercado e reembolso em caso de resultados negativos; e c) pré-entrega do medicamento, com pagamento condicionado aos resultados positivos do estudo clínico de fase III. Embora as parcerias público-privadas em pesquisa clínica sejam subutilizadas, elas poderiam beneficiar todas as partes interessadas ao acelerar o desenvolvimento de medicamentos, facilitar o acesso precoce dos pacientes a medicamentos inovadores e gerar economias para o sistema de saúde, especialmente para doenças raras.

Anne Haffajee: An inspirational role model.

This article honors Dr. Anne Haffajee's career, her highest research standards, scholarly integrity, and inspirational mentorship. Anne-as she liked to be called-was one of the most productive clinical scientists of her time. Gifted with the unique combination of knowledge in the fields of clinical research, oral ecology, data analysis, and computer programing, her work triggered unprecedented advances in the diagnosis, progression, and treatment of periodontitis. Anne's pivotal clinical trials elucidated the effects of non-surgical and surgical periodontal therapies. In addition to her scholarly achievements, Anne played an important role in mentoring young scientists, many of whom have developed independent leadership careers in periodontal research. She always found time to help her mentees, and ultimately became a warm-hearted friend to many of them, including myself. Anne was consistently devoted to contributing to the future of clinical investigation, and more specifically concerned about the lack of interest by (1) funding agencies in supporting such studies and by (2) the new generation of investigators in pursuing a career in the area. She passed away prematurely, in 2013, at the age of 65. Undoubtedly, her work and legacy assured the continuity of high-standard clinical studies in periodontics and the survival of a whole generation of clinical researchers.

Barriers to and Outcomes of Initiating Clinical Research at Two Trauma Centers in Mexico.

INTRODUCTION: Despite efforts to advance clinical research through collaboration between Latin and North American partners, there remains persistent barriers to performing investigative work. To overcome these obstacles, a team of over 100 surgeon-leaders from 18 Latin American countries founded the Asociación de Cirujanos Traumatólogos de las Américas (ACTUAR). One of ACTUAR's first major collaborative projects, initiated in 2018, was a prospective, observational, multicenter study evaluating quality of life after open tibia fracture management. The current study identified common barriers experienced during the initiation of this study, as exemplified through two sites in Mexico. The study aims to identify obstacles to proactively overcome these in future collaborative work. METHODS: Two research assistants from University of California, San Francisco and two research coordinators from Mexico were recruited to share their experiences, identify common barriers experienced during site enrollment and on-boarding for the ACTUAR open tibia study, and discuss possible solutions. RESULTS: Barriers were organized into three categories: structural, logistical, and intrapersonal. Structural barriers included differences in patient populations and resources between private and public hospitals. Logistical barriers included ambiguous ethical review processes, internet availability, and low patient follow-up. Primary enrollment as a resident responsibility led to some intrapersonal barriers. Potential solutions were identified for each barrier and agreed upon by all collaborators. CONCLUSIONS: Multiple barriers were identified by research personnel who initiated a prospective surgical clinical research study in Mexico. Through collaborative approaches, many potential solutions may help overcome these barriers and build locally led research capacity in Latin America.

Call for Inclusive and Diverse Suicide Prevention Strategies Among Cuban Americans: A Brief Report.

Suicide is a leading cause of death in Hispanics globally and nationally. Intentional death rates were higher in Cuba than Mexico in 2016. In the United States (US), suicide mortality rates were greater among Hispanics in rural than urban areas from 2001 to 2015. Although the US lacks suicide research in undocumented Hispanics, few studies have reported increased risk in immigrants. Limited research also indicates higher intentional death rates in Cuban Americans compared with other Hispanic American subgroups. However, suicide prevention strategies for at-risk Cuban Americans are lacking due to a scarcity of research among diverse Hispanics. Researchers could collaborate with health care providers to develop effective suicide prevention methods for Cuban Americans with suicidal problems. This report provides an overview of suicidal behavior in Hispanic Americans with a focus on Cuban Americans. Gaps related to the research topic, as well as recommendations for practice, research, and health policy, are provided in this report.

Current scenario and future perspectives of clinical research in Brazil: a national survey.

Background: Epidemiological and clinical cancer research is essential to understanding tumour behaviour and developing new therapies in oncology. However, several countries including Brazil as well as many other regions of the world have limited participation in cancer research. Despite 625,000 new cancer cases recorded in Brazil in 2022, only 2.2% of ongoing cancer clinical trials are available in the country. We conducted an online survey to describe physician engagement with research and to identify the main barriers precluding participation in and conduct of clinical cancer research in the country. Methods: An anonymous online survey of 23 objective questions was sent by e-mail to Brazilian members of the Latin American Cooperative Oncology Group and the Brazilian Society of Clinical Oncology. The first 13 questions addressed demographic information, medical training and previous research participation. In the second part, the main barriers to engagement and participation in clinical trials in Brazil were addressed. Continuous variables were measured by median and range. Analyses were performed using SAS statistical software (version 9.4; SAS Institute, Inc. Cary, NC). Results: 109 physicians answered the survey. Most participants were oncologists (N = 98, 89.9%), living in capital cities (N = 84, 77.1%), were from the Southeast region of Brazil (N = 63, 57.8%) and worked at institutions providing exclusively private healthcare (N = 59, 54.1%). Of the 109 respondents, 83 (76.1%) reported working in research centres (as investigators or sub-investigators). Surprisingly, 31.2% of physicians recognised they invite less than 1% of their patients to participate in clinical trials, even though 98 (89.9%) considered the participation of patients in clinical trials extremely relevant. The main barriers compromising the conduct of research in the country were the low number of available trials (48.2%) and the lack of qualified human resources to staff research sites (22.9%). Other reported barriers were the lengthy regulatory approval process (42.2%), followed by a lack of awareness of clinical research by patients resulting in low recruitment rates (24.1%). Of the 26 (23.8%) respondents not working with research, 25 (96.1%) reported interest in being involved, 31.8% have tried participating in research and 62.4% reported limited knowledge of trial procedures. Conclusion: These results suggest a clear need to further engage physicians in clinical research activities in Brazil. Patient education strategies should improve the low recruitment rates and secondarily increase the number of proposed trials in the country.

Perfil dos protocolos de ensaios clínicos sobre Covid-19 com participação da Fiocruz / Profile of clinical trial protocols for Covid-19 with the participation of Fiocruz

Resumo Objetivo Identificar a atuação da Fiocruz em estudos clínicos relacionados à Covid-19. Analisar as diferentes terminologias utilizadas para se referir à participação da Fiocruz. Mapear a região desses estudos. Mensurar a quantidade dos estudos aprovados nas plataformas de registro de estudos clínicos e bases ético-regulatórias. Dentre estes, analisar as características metodológicas e de boas práticas dos protocolos dos estudos intervencionais. Métodos Foram revisadas as bases de dados da Agência Nacional de Vigilância Sanitária (ANVISA), Comissão Nacional de Ética em Pesquisa (Conep), Registro Brasileiro de Ensaios Clínicos (ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) e Instituto Nacional de Propriedade Industrial (INPI). Resultados Foram encontrados 53 estudos clínicos sobre Covid-19 com a participação da Fiocruz em 39 destes como instituição proponente. Dentre os 53 estudos, 19 estão em plataformas de registro. Sobre os estudos intervencionais registrados, cinco são de prevenção e nove de tratamento. A intervenção mais analisada nestes estudos foi cloroquina/hidroxicloroquina. Observou-se ainda maior concentração dos estudos clínicos na Região Sudeste, com o total de 37. Conclusão Foram analisadas algumas limitações no delineamento metodológico que podem afetar o alcance dos estudos. Espera-se que os dados obtidos sejam utilizados para orientação futura de estudos clínicos sobre Covid-19 com participação da Fiocruz.

Abstract Objective To identify Fiocruz's performance in clinical studies related to Covid-19. Analyze the different terminologies used to refer to Fiocruz participation. Map the region of these studies. Measure the number of studies approved on clinical study registration platforms and regulatory ethical bases. Analyze the methodological characteristics and good practices of the interventional study protocols. Methods We reviewed databases of Brazilian National Research Ethics Committee, databases of Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) and Brazilian National Institute of Industrial Property (Instituto Nacional de Propriedade Industrial-INPI). Results 53 clinical studies on Covid-19 were found with the participation of Fiocruz in 39 of them as a proponent institution. Among the 53 studies, 19 are on registration platforms. Of the registered interventional studies, 5 are for prevention and 9 for treatment. The intervention most frequently evaluated in these studies was chloroquine / hydroxychloroquine. There was also a greater concentration of clinical studies in the southeastern region, with a total of 37 studies. Conclusion Some limitations in the methodological design were analyzed, which may affect the scope of the studies. It is expected that the data obtained will be used to guide future clinical studies on Covid-19 with Fiocruz participation.