Visión de la innovación en un centro cubano de la biotecnología aplicada a la salud / Vision of innovation in a Cuban center of biotechnology applied to health

Introducción: La evaluación de los factores claves de éxito de la innovación en la industria biotecnológica aplicada a la salud constituye un problema de investigación. Objetivo: Evaluar la innovación en un centro cubano de la biotecnología aplicada a la salud. Métodos: Se aplicó en dos momentos la encuesta de innovación en el Centro de Inmunología Molecular. Los resultados se procesaron con el diagrama de caja, la estadística básica y el análisis de la correlación. Se analizaron artículos científicos que muestran los resultados de la innovación en el centro. Resultados: La encuesta se aplicó en el 2015 y 2018 a 33 miembros del consejo de dirección y a especialistas, identificándose como estrategias genéricas las de innovación, calidad y liderazgo y como objetivos de innovación los de calidad y el mercado. Las fuentes de innovación más importantes se refieren a las actividades de investigación y desarrollo, la producción, la alta dirección y los centros de investigaciones. Los factores que limitan están relacionados con el período largo de rentabilidad de la innovación, el financiamiento y la adquisición de los insumos. Conclusiones: La evaluación de la innovación en el centro de biotecnología corroboró la significación que tiene para la empresa la estrategia de innovación como factor clave, que lo ubica en una posición de excelencia en la industria biofarmacéutica cubana e internacional(AU)

Introduction: The assessment of the key success factors of innovation in the biotechnology industry applied to health constitutes a research problem. Objective: To assess innovation process in a Cuban center of biotechnology applied to health. Methods: It was applied in two moments the survey of innovation in the Molecular Immunology Center. The results were processed by the box plot, basic statistics and analysis of the correlation. Scientific articles that show the results of innovation in the Center were analyzed. Results: The survey was applied in 2015 and 2018 to 33 members of the board of directors and to specialists, and being identified innovation, quality and leadership as generic strategies, and quality and the market as objectives of innovation. The most important sources of innovation referred to the research and development activities, production, top management and research centers. The limiting factors are related to the long term return of innovation, financing, and the acquisition of supplies. Conclusions: The assessment of innovation in the Biotechnology Center corroborated the significance of the innovation strategy for the company as a key factor, which places it in a position of excellence in the Cuban and international biopharmaceutical industry(AU)

Nursing work in assisted human reproduction: between technology and humanization / El trabajo del enfermero en reproducción humana asistida: entre la tecnología y la humanización / Trabalho do enfermeiro em reprodução humana assistida: entre tecnologia e humanização

ABSTRACT Objectives: To analyze the social representations of nurses who work with assisted human reproduction about the operation with reproductive biotechnologies. Methods: Qualitative approach, supported by the Theory of Social Representations, with sixteen participants. Individual, semi-structured interviews, analyzed through the Alceste software. Results: Pragmatic elements related to nurses' performance from a professional, institutional, and public policy perspective in reproductive biotechnologies emerged, demonstrating the practical dimension of these representations. The characteristics of the professional to act in this area were addressed, showing the lack of information and search for scientificity; precarious perception of the organizational structure of health services; and attributions of nursing care arising from the health care practice in assisted human reproduction. Final considerations: Social representation is anchored in the link between technology/medicalization and humanization/reception regarding reproductive biotechnologies. Working in assisted human reproduction involves a new and challenging nursing care, requiring specific and ethical knowledge.

RESUMEN Objetivos: Analizar las representaciones sociales del enfermero que trabaja con reproducción humana asistida acerca del trabajo con biotecnologías reproductivas. Métodos: Estudio de tipo cualitativo basándose en la Teoría de las Representaciones Sociales, realizado con 16 participantes. Las entrevistas individuales, semiestructuradas, se analizaron por medio del software Alceste. Resultados: Se desvelaron los elementos pragmáticos relacionados al desempeño del enfermero desde la perspectiva profesional, institucional y de conformación de las políticas públicas en biotecnologías reproductivas, demostrando la dimensión práctica de esas representaciones. Se abordaron las características del profesional para actuar en este campo, demostrando carencia de información y búsqueda del valor científico; la percepción precaria de la estructura organizativa de los servicios de salud; y las funciones del cuidado del enfermero provenientes de la práctica asistencial en reproducción humana asistida. Consideraciones finales: La representación social se fundamenta en el enlace entre la tecnología/medicalización y la humanización/acogida con relación a las biotecnologías reproductivas. El trabajo en reproducción humana asistida implica un nuevo y desafiante cuidado de la enfermería y le exige un conocimiento específico y de la ética.

RESUMO Objetivos: Analisar as representações sociais do enfermeiro que trabalha com reprodução humana assistida acerca da atuação com biotecnologias reprodutivas. Métodos: Abordagem qualitativa sustentada pela Teoria das Representações Sociais com dezesseis participantes. Entrevista individual, semiestruturada, analisada pelo software Alceste. Resultados: Emergiram elementos pragmáticos relacionados à atuação do enfermeiro na perspectiva profissional, institucional e de conformação das políticas públicas em biotecnologias reprodutivas, demonstrando a dimensão prática dessas representações. Abordaram-se as características do profissional para atuar nesta área, demonstrando carência de informação e busca pela cientificidade; percepção precária da estrutura organizacional dos serviços de saúde; e atribuições do cuidado do enfermeiro que advêm da prática assistencial em reprodução humana assistida. Considerações finais: A representação social ancora-se no elo entre a tecnologia/medicalização e a humanização/acolhimento em relação às biotecnologias reprodutivas. O trabalho em reprodução humana assistida envolve um novo e desafiador cuidado de enfermagem e exige conhecimento específico e ético.

Uso de digitalizador e impressora doméstica em 3 dimensões em rinoplastia / Domestic three-dimensional scanner and printer in patients undergoing rhinoplasty

Os princípios para uma rinoplastia bem-sucedida incluem consulta e planejamento pré-operatório e uma análise clínica abrangente que defina as metas da cirurgia. Mais recentemente, a digitalização e a impressão doméstica em 3 dimensões tornaram-se disponíveis. O objetivo deste estudo é descrever um método de digitalização em 3 dimensões e de impressão doméstica da anatomia real do paciente para ser usada como ajuda intraoperatória. Nós apresentamos uma forma de uso desta tecnologia no transoperatório, auxiliando o cirurgião a comparar os resultados obtidos após suas manobras, verificar a sua adesão ao plano cirúrgico previamente estabelecido e melhorar a sua tomada de decisão durante a cirurgia. Em conclusão, a aplicação da impressão doméstica em 3 dimensões demonstra um efeito positivo sobre o tratamento de alterações estéticas do nariz.

The principles for a successful rhinoplasty include preoperative consultation and planning, as well as a comprehensive clinical analysis and defining rhinoplasty goals. Three-dimensional domestic scanning and printing have recently become available. We sought to objectively describe this method as an intraoperative aid in patients' anatomy. This method can be used trans-operatively to help surgeons compare the results of his or her technique, check adherence to the surgical plan, and improve his or her surgical decision-making. We found that the application of 3-dimensional printing had a positive effect on the treatment of patients with aesthetic nose disorders.

Enhancing surgical innovation through a specialized medical school pathway of excellence in innovation and entrepreneurship: Lessons learned and opportunities for the future.

The mission of an academic medical center and academic departments of surgery focuses on teaching, scholarship/research, and expertise of clinical care. The standard 4-year medical school curriculum and general surgery residency training are well balanced to expose trainees to these missions in varying degrees, yet the advancement of medicine as a field is predicated on the creation, development, and successful implementation of medical innovations. Surgeons, by virtue of their clinical training, are immersed in medical technology and are continually required to use this technology effectively in combination with their own technical skills and judgment to provide optimal patient care. As such, they routinely face the challenges of current technology and the need for innovation and improvement, leading many to become natural inventors. Having a good idea or innovation to improve patient care, however, is just the starting point of the complex process of implementing that idea in the clinic. Unfortunately, the vast majority of surgeons and medical students have no formal educational training on the innovation process regarding how good ideas can be developed successfully for clinical and commercial implementation. Added to this lack of formal education are the limited resources and time constraints that surgeons, residents, and medical students face in acquiring the educational skill set to adeptly navigate this innovation and entrepreneurial landscape. To address these challenges, the University of Michigan recently created the first pathway of excellence for medical students to focus their passions and interests in medical innovation and entrepreneurship. This program has been transformative for building a new culture of young, motivated medical innovators, many of whom have dedicated their talents already to addressing several key problems in surgical patient care.

Método manométrico alternativo de calibración de transductores de presión para la monitorización hemodinámica invasiva / Alternative manometric method of calibration of pressure transducers for invasive hemodynamic monitoring

Introducción: La calibración de los transductores tiene gran importancia para la medición precisa de las presiones, durante la monitorización hemodinámica invasiva de los pacientes que requieren observación estrecha en las unidades de atención al grave y en el quirófano. Objetivo: Desarrollar y validar un método de calibración para transductores de presión, sencillo, eficaz y de bajo costo. Métodos: Se desarrolló un método manométrico alternativo, basado en la ley de Pascal, para la calibración de los transductores de presión durante la monitorización hemodinámica invasiva que se realiza en la Unidad de Cuidados Intensivos de Cirugía Cardiovascular del Hospital Clínico-Quirúrgico Hermanos Ameijeiras. Este método fue validado mediante la comparación con el estándar recomendado en un total de 215 pacientes que requirieron monitorización hemodinámica invasiva entre los meses de enero y junio del 2015. Resultados: Con el método manométrico alternativo creado se obtiene el mismo resultado que con el método hidráulico recomendado por la literatura. Conclusiones: El método alternativo creado es preciso, eficaz y costo-efectivo(AU)

Introduction: Transducer calibration is very important for the accurate measurement of pressures during invasive hemodynamic monitoring of patients requiring close observation in the primary care units and in the operating room. Objective: To develop and validate a method of calibration of pressure transducers, which is simple, efficient and low-cost. Methods: An alternative manometric method, based on Pascal's law, was developed for the calibration of pressure transducers during invasive hemodynamic monitoring performed at the intensive care unit of the cardiovascular surgery department at Hermanos Ameijeiras Clinical-Surgical Hospital. This method was validated by its comparison with the recommended standard in a total of 215 patients who required invasive hemodynamic monitoring between January and June 2015. Results: With the alternative manometric method created, the same result was obtained as with the hydraulic method recommended by the literature. Conclusions: The alternative method created is accurate, efficient and cost-effective(AU)

[ISO 9001 certification of innovation and clinical research departments: Extending the scope of health assessment]. / Certification ISO 9001 des Directions de la recherche clinique et de l'innovation : vers une extension du périmètre aux évaluations économiques.

BACKGROUND: The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies. METHOD: All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs. RESULTS: In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed. CONCLUSION: By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making.

A guide to the anti-innovation "pharmaphobia" narrative for the aspiring innovator.

Thomas P. Stossel is an American Cancer Society Professor of Medicine Emeritus at Harvard Medical School, Honorary Physician in the Hematology Division of Brigham & Women's Hospital, founding scientist of BioAegis Therapeutics, Visiting Scholar of The American Enterprise Institute and cofounder of Options for Children in Zambia.

An in-house real-time polymerase chain reaction: standardisation and comparison with the Cobas Amplicor HBV monitor and Cobas AmpliPrep/Cobas TaqMan HBV tests for the quantification of hepatitis B virus DNA

This study aimed to standardise an in-house real-time polymerase chain reaction (rtPCR) to allow quantification of hepatitis B virus (HBV) DNA in serum or plasma samples, and to compare this method with two commercial assays, the Cobas Amplicor HBV monitor and the Cobas AmpliPrep/Cobas TaqMan HBV test. Samples from 397 patients from the state of São Paulo were analysed by all three methods. Fifty-two samples were from patients who were human immunodeficiency virus and hepatitis C virus positive, but HBV negative. Genotypes were characterised, and the viral load was measure in each sample. The in-house rtPCR showed an excellent success rate compared with commercial tests; inter-assay and intra-assay coefficients correlated with commercial tests (r = 0.96 and r = 0.913, p < 0.001) and the in-house test showed no genotype-dependent differences in detection and quantification rates. The in-house assay tested in this study could be used for screening and quantifying HBV DNA in order to monitor patients during therapy.

Evaluation of a recombinant rhoptry protein 2 enzyme-linked immunoassay for the diagnosis of toxoplasmosis acquired during pregnancy

The aim of this study was to evaluate an enzyme-linked immunoassay with recombinant rhoptry protein 2 (ELISA-rROP2) for its ability to detectToxoplasma gondii ROP2-specific IgG in samples from pregnant women. The study included 236 samples that were divided into groups according to serological screening profiles for toxoplasmosis: unexposed (n = 65), probable acute infection (n = 48), possible acute infection (n = 58) and exposed to the parasite (n = 65). When an indirect immunofluorescence assay forT. gondii-specific IgG was considered as a reference test, the ELISA-rROP2 had a sensitivity of 61.8%, specificity of 62.8%, predictive positive value of 76.6% and predictive negative value of 45.4% (p = 0.0002). The ELISA-rROP2 reacted with 62.5% of the samples from pregnant women with probable acute infection and 40% of the samples from pregnant women with previous exposure (p = 0.0180). Seropositivity was observed in 50/57 (87.7%) pregnant women with possible infection. The results underscored that T. gondii rROP2 is recognised by specific IgG antibodies in both the acute and chronic phases of toxoplasmosis acquired during pregnancy. However, the sensitivity of the ELISA-rROP2 was higher in the pregnant women with probable and possible acute infections and IgM reactivity.

[Typical problems in pediatric emergencies: Possible solutions]. / Typische Probleme bei Kindernotfällen: Mögliche Lösungsstrategien.

BACKGROUND: Pediatric emergencies are rare and challenging for health care providers, parents, and patients. The purpose of this article is to highlight typical difficulties in the treatment of pediatric patients and to discuss potential solutions. MATERIALS AND METHODS: This article is based on a selective literature search using PubMed and the experience of the authors in the field of simulation and pediatric emergencies. RESULTS: Inexperience with pediatric emergencies, uncertainty in technical skills, in the usage of pediatric equipment and in medication dosage as well as parental presence foster the perception of stress and potentially compromise the success of patient care. Beside implementation of simplified technical skill devices (e.g., intraosseous vascular access system, supraglottic airway devices, and alternative approaches for drug administration), there have been many efforts in recent years to improve patient safety. Tools for estimating body weight and precalculated drug-dosing charts have been implemented as well as standardized courses for guidelines, technical skills, and team-related skills have been established. CONCLUSION: To improve patient safety, regular training and implementation of a sustainable safety culture are mandatory.

Biodesign process and culture to enable pediatric medical technology innovation.

Innovation is the process through which new scientific discoveries are developed and promoted from bench to bedside. In an effort to encourage young entrepreneurs in this area, Stanford Biodesign developed a medical device innovation training program focused on need-based innovation. The program focuses on teaching systematic evaluation of healthcare needs, invention, and concept development. This process can be applied to any field of medicine, including Pediatric Surgery. Similar training programs have gained traction throughout the United States and beyond. Equally important to process in the success of these programs is an institutional culture that supports transformative thinking. Key components of this culture include risk tolerance, patience, encouragement of creativity, management of conflict, and networking effects.

Surgical innovation and quality assurance: Can we have both?

Innovation is the major force for progress in pediatric surgery. Most of the progress in surgery has evolved secondary to novel approaches developed by surgeons confronted with difficult pathologic conditions. Up to the present time, most surgical innovation has been practiced with few rules for guidance. Innovation to make surgical procedures more effective and less morbid is highly desirable. However, the absence of oversight has the potential to lead to unbridled human experimentation. The quality improvement movement in medicine is attempting to improve outcomes using evidence-based clinical pathways. Quality improvement aims to decrease the variation in therapeutic approaches by scientifically defining best practices. There is a significant potential for autonomous surgical innovators to clash with well-meaning proponents of quality improvement. A suggested remedy to encourage surgical innovators while protecting patients from unintended harm is for institutions to develop Surgical Innovation Committees to evaluate and give oversight to the early application of new techniques and devices. Scientific evaluation under the auspices of an IRB should follow when feasible.

Innovation in surgical technology and techniques: Challenges and ethical issues.

The pace of medical innovation continues to increase. The deployment of new technologies in surgery creates many ethical challenges including how to determine safety of the technology, what is the timing and process for deployment of a new technology, how are patients informed before undergoing a new technology or technique, how are the outcomes of a new technology evaluated and how are the responsibilities of individual patients and society at large balanced. Ethical considerations relevant to the implementation of ECMO and robotic surgery are explored to further discussion of how we can optimize the delicate balance between innovation and regulation.

Innovating for quality and value: Utilizing national quality improvement programs to identify opportunities for responsible surgical innovation.

Innovation in surgical techniques, technology, and care processes are essential for improving the care and outcomes of surgical patients, including children. The time and cost associated with surgical innovation can be significant, and unless it leads to improvements in outcome at equivalent or lower costs, it adds little or no value from the perspective of the patients, and decreases the overall resources available to our already financially constrained healthcare system. The emergence of a safety and quality mandate in surgery, and the development of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) allow needs-based surgical care innovation which leads to value-based improvement in care. In addition to general and procedure-specific clinical outcomes, surgeons should consider the measurement of quality from the patients' perspective. To this end, the integration of validated Patient Reported Outcome Measures (PROMs) into actionable, benchmarked institutional outcomes reporting has the potential to facilitate quality improvement in process, treatment and technology that optimizes value for our patients and health system.

Patients as partners in innovation.

As the culture of medical practice has evolved, so has the relationship between the physician and patient. This is decidedly true with regards to the introduction of innovative therapies, especially in the surgical arena. A critical challenge is identifying and defining innovative therapy. Is the proposed treatment an incremental change, a research proposal, or more commonly someplace in between? This gray area creates a transition zone commonly referred to as innovative therapy. Given the complexities of the current landscape of innovation, innovation therapy committees may provide a mechanism to help to guide both physicians and patients through such difficult topics as the process of informed consent, managing conflicts of interest, and how to evaluate the outcomes of innovative therapies. As surgical innovation remains critical to the advancement of care, it must occur in a transparent partnership with patients, under the eye of guiding entities, aimed at ultimately improving outcomes and care.

Getting Clearer About Surgical Innovation: A New Definition and a New Tool to Support Responsible Practice.

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new." CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations.

Systematic review of surgical innovation reporting in laparoendoscopic colonic polyp resection.

BACKGROUND: The IDEAL framework (Idea, Development, Exploration, Assessment, Long-term study) proposes a staged assessment of surgical innovation, but whether it can be used in practice is uncertain. This study aimed to review the reporting of a surgical innovation according to the IDEAL framework. METHODS: Systematic literature searches identified articles reporting laparoendoscopic excision for benign colonic polyps. Using the IDEAL stage recommendations, data were collected on: patient selection, surgeon and unit expertise, description of the intervention and modifications, outcome reporting, and research governance. Studies were categorized by IDEAL stages: 0/1, simple technical preclinical/clinical reports; 2a, technique modifications with rationale and safety data; 2b, expanded patient selection and reporting of both innovation and standard care outcomes; 3, formal randomized controlled trials; and 4, long-term audit and registry studies. Each stage has specific requirements for reporting of surgeon expertise, governance details and outcome reporting. RESULTS: Of 615 abstracts screened, 16 papers reporting outcomes of 550 patients were included. Only two studies could be put into IDEAL categories. One animal study was classified as stage 0 and one clinical study as stage 2a through prospective ethical approval, protocol registration and data collection. Studies could not be classified according to IDEAL for insufficient reporting details of patient selection, relevant surgeon expertise, and how and why the technique was modified or adapted. CONCLUSION: The reporting of innovation in the context of laparoendoscopic colonic polyp excision would benefit from standardized methods.