[Discussion on reference sample research of traditional Chinese medicine compound preparations developed from catalogued ancient classical prescriptions].

The concept of reference sample was put forward in the Guidance on CMC of Traditional Chinese Medicine Compound Preparations Developed from Catalogued Ancient Classical Prescriptions(Interim). The research on reference sample is a key link in the research and development of traditional Chinese medicine(TCM) compound prescriptions from catalogued ancient classical prescriptions(known as Category 3.1 TCM). This paper discusses the content of research on reference sample by analyzing the characteristics of Category 3.1 TCM and the purpose of research on reference sample. Furthermore, suggestions on the research of reference sample are proposed according to the development and evaluation practice of Category 3.1 TCM and research achievements of TCM regulatory science, aiming to provide reference for colleagues in this industry.

Promoting high-quality therapeutic research on nontuberculous mycobacteria pulmonary disease in China / 中华临床感染病杂志

The incidence of pulmonary disease caused by nontuberculous mycobacteria infection (NTM-PD) shows a growing trend. The treatment of NTM-PD is of low cure rate, high mortality and recurrence rate at present, it is necessary to promote the high-quality clinical therapeutic research. Based on the clinical guidelines, clinicians should carry out high-quality clinical research of NTM-PD treatment, focusing on the current urgent problems, especially the time of treatment initiation, optimization of treatment regimens, as well as prevention and rehabilitation strategies.

Research progress in quality research and evaluation of human mesenchymal stem cells / 国际生物医学工程杂志

As adult stem cells, human mesenchymal stem cells (hMSCs) have the potential for self-replication, renewal, and multidirection differentiation. Their unique biological function determines their wide clinical indications. Researchers can define the quality attributes of hMSCs according to clinical expectations. The quality study of hMSCs should consider microbiological safety, biological safety, cell biological properties, and biological effectiveness. Quality evaluation is a common physical, chemical, and biological evaluation method for hMSCs. Traditional product safety evaluation strategies cannot fully adapt to current technology and product usage characteristics. Researchers have developed new, effective evaluation methods based on current technology. In terms of product efficacy evaluation strategies, an efficacy evaluation system has been gradually established and standardized according to the intended clinical use and based on quality studies, which can enable researchers to evaluate hMSCs products more comprehensively at different stages and processes. In this paper, the progress of quality research and evaluation of human mesenchymal stem cells was reviewed to provide a reference for the utilization of stem cells in the field of regenerative medicine.

How a Malnutrition Quality Improvement Initiative Furthers Malnutrition Measurement and Care: Results From a Hospital Learning Collaborative.

BACKGROUND: Malnutrition in hospitalized patients can adversely affect health outcomes and increase the cost of care. Real-world strategies are needed for prompt identification and treatment of patients at risk of malnutrition. OBJECTIVES: The aim of this quality improvement (QI) study was to measure the impact of a nutrition-focused program on the malnutrition care processes of participating hospitals. Secondary objectives were to determine whether improvements in these nutrition-related processes reduced hospital readmissions and length of stay (LOS) in patients ≥65 years. METHODS: A group of 27 US hospitals ("The Collaborative") implemented the Malnutrition Quality Improvement Initiative (MQii), as guided by a Malnutrition QI Toolkit and 4 electronic clinical quality measures (eCQMs), including (1) nutrition screening; (2) nutrition assessment following detection of malnutrition risk; (3) nutrition care plan for patients identified as malnourished after completed nutrition assessment; and (4) documentation of malnutrition diagnoses. Multivariate analyses identified the variables best correlated with patient outcomes. RESULTS: Improvements were observed for all 4 eCQMs. The greatest improvements were achieved as a result of timely nutrition assessment (P = .06) and malnutrition diagnosis (P = .02). Patients ≥65 years with a malnutrition diagnosis and nutrition care plan had a 24% lower likelihood of 30-day readmission but a longer mean LOS than did those without a care plan. CONCLUSIONS: In this study, the implementation of MQii practices significantly improved the identification of malnutrition. The prompt identification and treatment of patients at malnutrition risk can improve patient care and health, as well as reduce costly readmissions.

[A modular model for quality assessment in medical and nutritional journalism]. / Ein modulares Modell zur Qualitätssicherung im Medizin- und Ernährungsjournalismus.

BACKGROUND AND OBJECTIVES: The quality of medical articles in journalism has a central role in informed decision-making by patients as well as by political, economic and social players, but also to general "health literacy". Therefore, quality standards that take into account basic scientific and journalistic principles, but are also scalable to specific health-related topics (such as medicine, nutrition and environment) are particularly relevant. MATERIALS AND METHODS: Starting from an internationally established catalogue in the framework of the "media doctor project", criteria for good medical journalism were analysed, reclassified and completed on the basis of theoretical concepts and practical applicability. In parallel, existing criteria from medical journalism were transferred to an adapted criteria catalogue for reporting on nutrition. RESULTS: A consensus was reached on a catalogue of criteria modularised into general journalistic, general science journalistic and specific medical journalistic aspects, which is published here for the first time in a scientific paper. With some rare exceptions, quality criteria for medical journalism could be well adapted to nutritional topics. Based on the two catalogues, further media contributions have been regularly evaluated. CONCLUSIONS: The advanced modularisation of the criteria catalogues facilitates their applicability and possibly their extension to other disciplines and for use by medical doctors as well as by laypersons. While medical journalism is strongly oriented towards the criteria of scientific evidence, the role of academic studies and experts versus anecdotal evidence should be further investigated for nutritional journalism.

Acute stroke care in a New York City comprehensive stroke center during the COVID-19 pandemic.

BACKGROUND AND PURPOSE: The coronavirus disease-2019 (COVID-19) pandemic caused unprecedented demand and burden on emergency health care services in New York City. We aim to describe our experience providing acute stroke care at a comprehensive stroke center (CSC) and the impact of the pandemic on the quality of care for patients presenting with acute ischemic stroke (AIS). METHODS: We retrospectively analyzed data from a quality improvement registry of consecutive AIS patients at New York University Langone Health's CSC between 06/01/2019-05/15/2020. During the early stages of the pandemic, the acute stroke process was modified to incorporate COVID-19 screening, testing, and other precautionary measures. We compared stroke quality metrics including treatment times and discharge outcomes of AIS patients during the pandemic (03/012020-05/152020) compared with a historical pre-pandemic group (6/1/2019-2/29/2020). RESULTS: A total of 754 patients (pandemic-120; pre-pandemic-634) were admitted with a principal diagnosis of AIS; 198 (26.3%) received alteplase and/or mechanical thrombectomy. Despite longer median door to head CT times (16 vs 12 minutes; p = 0.05) and a trend towards longer door to groin puncture times (79.5 vs. 71 min, p = 0.06), the time to alteplase administration (36 vs 35 min; p = 0.83), door to reperfusion times (103 vs 97 min, p = 0.18) and defect-free care (95.2% vs 94.7%; p = 0.84) were similar in the pandemic and pre-pandemic groups. Successful recanalization rates (TICI≥2b) were also similar (82.6% vs. 86.7%, p = 0.48). After adjusting for stroke severity, age and a prior history of transient ischemic attack/stroke, pandemic patients had increased discharge mortality (adjusted OR 2.90 95% CI 1.77 - 7.17, p = 0.021) CONCLUSION: Despite unprecedented demands on emergency healthcare services, early multidisciplinary efforts to adapt the acute stroke treatment process resulted in keeping the stroke quality time metrics close to pre-pandemic levels. Future studies will be needed with a larger cohort comparing discharge and long-term outcomes between pre-pandemic and pandemic AIS patients.

[A study on quality of Paridis Rhizoma and consideration on standards of Paridis Rhizoma in Chinese Pharmacopoeia].

Thin layer chromatography, high performance liquid chromatography and multivariate statistical analysis were integrated in current study to provide a basis for the quality evaluation and the standard improvement of Paridis Rhizoma(Chinese name: Chong-lou). The results demonstrated that the primary saponins in the two authorized sources of Paridis Rhizoma were polyphyllinsⅠ, Ⅱ and Ⅶ, while the rhizome of Trillium tschonoskii an adulterant of Paridis Rhizoma was rich of polyphyllin Ⅵ. Therefore, the apparent content of polyphyllin Ⅵ plays a determinant role towards the source authentication of raw materials and decoction slices of Paridis Rhizoma, whose adulterants frequently occur in the market. Moreover, the contents of polyphyllin Ⅵ in the two authorized sources could meet the requirements of Chinese Pharmacopoeia. Therefore, we suggested that polyphyllin Ⅵ should not be omitted from the quality standard of Paridis Rhizoma in the Chinese Pharmacopoeia, and on the other side, polyphyllinsⅠ, Ⅱ and Ⅶ should be the eligible quality indicators. The study aims to sound information and evidences for the quality evaluation of Paridis Rhizoma, and also to provide a theoretical basis for the standard revision of Paridis Rhizoma in the future Chinese Pharmacopoeia.

Learning from a Feasibility Trial of a Simple Intervention: Is Research a Barrier to Service Delivery, or is Service Delivery a Barrier to Research?

(1) Background: Applied health services research (AHSR) relies upon coordination across multiple organizational boundaries. Our aim was to understand how competing organizational and professional goals enhance or impede the conduct of high quality AHSR. (2) Methods: A qualitative study was conducted in two local health care systems in the UK, linked to a feasibility trial of a clinic-based intervention in secondary care. Data collection involved 24 semi-structured interviews with research managers, clinical research staff, health professionals, and patients. (3) Results: This study required a dynamic network of interactions between heterogeneous health and social care stakeholders, each characterized by differing ways of organizing activities which constitute their core functions; cultures of collaboration and interaction and understanding of what research involves and how it contributes to patient care. These interrelated factors compounded the occupational and organizational boundaries that hindered communication and coordination. (4) Conclusions: Despite the strategic development of multiple organizations to foster inter-professional collaboration, the competing goals of research and clinical practice can impede the conduct of high quality AHSR. To remedy this requires the alignment and streamlining of organizational goals, so that all agencies involved in AHSR develop a shared understanding and mutual respect for the progress of evidence-based medicine and the complex and often nuanced environments in which it is created and practiced.

Towards the enhancement of quality publication practices in clinical psychological science.

Addressing the 'replication crisis' and questionable research practices are at the forefront of international research agendas in clinical psychological science. The aim of this paper is to consider how the quality of research practices can be improved by a specific focus on publication practices. Currently, the responsibility for documenting quality research practices is primarily placed on authors. However, barriers to improved quality publication practices cut across all levels of the research community and require a broader approach that shares the burden for ensuring the production of high quality publications. We describe a framework that is intended to be ambitious and aspirational and encourage discussion and adoption of strategies to improve quality publication practices (QPPs). The framework cuts across multiple stakeholders and is designed to enhance (a) the quality of reporting; (b) adherence to protocols and guidelines; (c) timely accessibility of study materials and data. We discuss how QPPs might be improved by (a) funding bodies considering formally supporting QPPs; (b) research institutions encouraging a research culture that espouses quality research practices, and internally supporting QPP review processes and professional development in QPPs; (c) journals expanding editorial teams to include reviewers with design and statistical expertise, considering strategies to enhance QPP adherence during the peer review process, and committing to ongoing assessment and development of QPP training for peer reviewers; and (d) authors and peer reviewers integrating QPPs during the manuscript preparation/peer review process, engaging in ongoing QPP training, and committing to openness and transparency initiatives. We discuss the current state and potential next steps within each stage of the framework and provide information and resources to enhance QPPs. We hope that the suggestions offered here inspire research institutions, leaders and faculty to discuss, reflect on, and take action towards, integrating these, or other, QPPs into their research practice and workplace.

A study on quality of Paridis Rhizoma and consideration on standards of Paridis Rhizoma in Chinese Pharmacopoeia / 中国中药杂志

Thin layer chromatography, high performance liquid chromatography and multivariate statistical analysis were integrated in current study to provide a basis for the quality evaluation and the standard improvement of Paridis Rhizoma(Chinese name: Chong-lou). The results demonstrated that the primary saponins in the two authorized sources of Paridis Rhizoma were polyphyllinsⅠ, Ⅱ and Ⅶ, while the rhizome of Trillium tschonoskii an adulterant of Paridis Rhizoma was rich of polyphyllin Ⅵ. Therefore, the apparent content of polyphyllin Ⅵ plays a determinant role towards the source authentication of raw materials and decoction slices of Paridis Rhizoma, whose adulterants frequently occur in the market. Moreover, the contents of polyphyllin Ⅵ in the two authorized sources could meet the requirements of Chinese Pharmacopoeia. Therefore, we suggested that polyphyllin Ⅵ should not be omitted from the quality standard of Paridis Rhizoma in the Chinese Pharmacopoeia, and on the other side, polyphyllinsⅠ, Ⅱ and Ⅶ should be the eligible quality indicators. The study aims to sound information and evidences for the quality evaluation of Paridis Rhizoma, and also to provide a theoretical basis for the standard revision of Paridis Rhizoma in the future Chinese Pharmacopoeia.

Review of Surgical Education Research Trends in North America.

OBJECTIVE: The purpose of this study was to synthesize surgical education research literature over the last decade and to address the following questions: (1) What are the most common subjects studied? (2) What research designs and data-gathering strategies are commonly employed? (3) Where are these papers being published? (4) What subject and research design trends have emerged in the last decade? DESIGN: A literature review was conducted on surgical education publications from January 2008 to July 2018, using the search terms, "Graduate Medical Education," and "General Surgery." Inclusion criteria included articles published in the United States and Canada specific to general surgery and graduate medical education. RESULTS: A total of 1043 articles met inclusion criteria and were categorized according to year published, journal type, journal of publication, subject of research, research design, and data collection method. The following observations were noted: (1) curriculum/teaching remains the most common subject of surgical education research, with growing emphasis on program evaluation, well-being, duty hours, and case exposure. (2) Descriptive research is the most common, although qualitative and mixed methods research is becoming more common. (3) Online surveys are the most common data collection method as they are the quickest way to gather data but there is an increasing use of interviews as support for qualitative research grows. and (4) Surgical education papers are largely published in journals specifically designed for education, and have slowly grown in popularity in generalized surgical journals. CONCLUSIONS: As surgical education continues to develop as a field, we anticipate further acceptance of qualitative research in major peer-reviewed surgical journals, increased emphasis on resident well-being, and more effective use of interviews and mixed methods including online resources for data collection.

Nem herói, nem vilão: elementos da prática médica na atenção básica em saúde / Neither a hero nor a villain: elements of medical practice in primary care

Resumo O artigo sistematiza e discute elementos presentes na prática médica que contribuam para uma melhor compreensão da sua reconhecida baixa adesão às diretrizes da Política Nacional de Atenção Básica (PNAB). Para tanto, fez uso de material empírico produzido em duas investigações de caráter qualitativo conduzidas pelo mesmo grupo de pesquisa. Na primeira, entrevistas feitas com dirigentes gestores e controle social de dois municípios paulistas, os médicos são apontados como explicação importante para as dificuldades de se construir uma atenção básica qualificada e resolutiva: um "médico vilão". Na segunda, utilizou-se observação direta do cotidiano em sete unidades básicas de saúde em três municípios paulistas, com registros de cenas do médico em ação e/ou quando reflete sobre seu trabalho ou quando observado pela equipe. Emerge assim um médico mais complexo, fragilizado, com instrumental reduzido para atuar perante o "social" que invade seu consultório, ameaçado em sua autonomia profissional, com dificuldade de integrar-se ao trabalho em equipe, expropriado das funções regulatórias e nem sempre com clareza do lugar reservado para a clínica na atenção básica: um médico humano, demasiado humano, nem herói, nem vilão.

Abstract This article describes the elements present in medical practice that contribute to understand its acknowledged low adhesion to the guidelines set forth by the Brazilian Primary Health Care (PHC) Policy. The empirical material produced by the two investigations of a qualitative nature led by the research team were put into use. In the first, in interviews involving managers and social control in cities the State of São Paulo, Brazil, physicians (acknowledged as central professionals for the construction of the Brazilian Unified Health System - SUS), are referred to as important assets to explain the difficulties to form a qualified primary health care service: the so-called "villain physicians." In the latter, ethnographic/cartographic research carried out in seven PHC Units in cities of São Paulo, with the use of scenes showing the doctors in action and/or thinking about their jobs, and the health team observing their work, more complex physicians emerge: fragile professionals with a reduced set of instruments to act before the "social factor" that invade their practices, threatened in their autonomy, finding it hard to engage in teamwork, dispossessed of their regulatory functions, and unaware of the space reserved for primary practices: decidedly human physicians - neither heroes nor villains.

The Research Cycle: Improving Care and Outcomes for Newborn Infants.

Ensuring that policies and practice in perinatal care are informed by evidence from high-quality research is fundamental to improving outcomes for newborn infants and their families. Effective interventions in the perinatal period can have a life-long impact disproportionate to their costs. Many of the major advances in care that have transformed outcomes for preterm and sick newborn infants have been informed by empirical and applied health research. Conversely, there are examples of life-long adverse consequences for infants and families that are a legacy of practices based on poor-quality evidence. The challenge in the 21st century is to maintain the trajectory of improvements in care and outcomes. This will most likely be achieved via marginal gains from new or improved care practices underpinned by a range of research approaches, from preclinical and laboratory-based empirical studies that uncover pathogenic pathways or therapeutic mechanisms, to large-scale, applied research such as multicentre, randomised controlled trials. This will involve the coordination and collaboration of research efforts globally. Strategies to develop and prioritise research questions need to involve parents and families. Given the context in which much perinatal research is conducted, particularly in emergency situations around the time of birth, robust and transparent ethics and governance frameworks are essential to maintain the trust and engagement of communities. An ethical imperative exists to ensure that research output is disseminated effectively, and that effective and cost-effective interventions are implemented and integrated within a cycle that audits and benchmarks good practice and outcomes, and informs research evidence-based continuous quality improvement. This is the first in a series of articles on research methodology in neonatal medicine to be published in Neonatology, in response to a request from trainee researchers. We introduce the series by describing the research cycle, in particular how it is applied in neonatal medicine. Subsequent articles will cover translational research, clinical trials, diagnostic tests, global challenges, and the ethical issues relating to neonatal/perinatal research.

Toward sustainable environmental quality: Identifying priority research questions for Latin America.

The Global Horizon Scanning Project (GHSP) is an innovative initiative that aims to identify important global environmental quality research needs. Here we report 20 key research questions from Latin America (LA). Members of the Society of Environmental Toxicology and Chemistry (SETAC) LA and other scientists from LA were asked to submit research questions that would represent priority needs to address in the region. One hundred questions were received, then partitioned among categories, examined, and some rearranged during a workshop in Buenos Aires, Argentina. Twenty priority research questions were subsequently identified. These research questions included developing, improving, and harmonizing across LA countries methods for 1) identifying contaminants and degradation products in complex matrices (including biota); 2) advancing prediction of contaminant risks and effects in ecosystems, addressing lab-to-field extrapolation challenges, and understanding complexities of multiple stressors (including chemicals and climate change); and 3) improving management and regulatory tools toward achieving sustainable development. Whereas environmental contaminants frequently identified in these key questions were pesticides, pharmaceuticals, endocrine disruptors or modulators, plastics, and nanomaterials, commonly identified environmental challenges were related to agriculture, urban effluents, solid wastes, pulp and paper mills, and natural extraction activities. Several interesting research topics included assessing and preventing pollution impacts on conservation protected areas, integrating environment and health assessments, and developing strategies for identification, substitution, and design of less hazardous chemicals (e.g., green chemistry). Finally, a recurrent research need included developing an understanding of differential sensitivity of regional species and ecosystems to environmental contaminants and other stressors. Addressing these critical questions will support development of long-term strategic research efforts to advance more sustainable environmental quality and protect public health and the environment in LA. Integr Environ Assess Manag 2018;14:344-357. © 2018 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Research Progress in Medicinal Ingredients of Ananas Comosus L. Leaves / 中国药师

Ananas comosus L. leaves,the leaves of pineapple,have a variety of medicinal values. Therefore,they can be used to prevent and treat many diseases. Pineapple leaves are actually safe that few studies have shown the side effects. The chemical composi-tion,medicinal value,toxicity and safety of pineapple leaves were summarized in the article, and the quality research was described simply as well.

A busca pela Cirurgia Bariátrica: itinerário terapêutico vivido no Serviço Público de Saúde / The Search for Bariatric Surgery: therapeutic itinerary experienced in the Public Health Service

Introdução: A obesidade é um problema de saúde pública, por isso requer que o sistema se organize para atender as pessoas que vivenciam esta situação. Ao buscar pela Cirurgia Bariátrica no Serviço Público de Saúde, a pessoa se depara com diversas escolhas que constituem a malha de itinerações do vivido. Objetivo: Compreender o itinerário terapêutico vivido no Serviço Público de Saúde pela pessoa com obesidade em busca da Cirurgia Bariátrica. Método: Pesquisa qualitativa de abordagem fenomenológica, realizada em um Hospital Público de São Paulo. Participaram deste estudo 17 pessoas com obesidade que buscaram pela Cirurgia Bariátrica no Sistema Único de Saúde, internados na clínica médico-cirúrgica, com data agendada para o procedimento. A condução das entrevistas deu-se pelas questões norteadoras: Como foi a sua procura em busca da Cirurgia Bariátrica? Quais caminhos percorreu? Como foi vivenciar esses caminhos? Durante o tempo em busca do tratamento, como foi o atendimento recebido? Como espera continuar sendo atendido? Qual é a sua expectativa para depois da cirurgia? Resultados: O típico da ação vivida no itinerário terapêutico percorrido pela pessoa com obesidade, em busca da Cirurgia Bariátrica, mostrou-se como aquela que procurou e trilhou diversos caminhos nos serviços públicos de saúde; vivenciou a morosidade do tempo de espera na fila aguardando pela cirurgia, o que contribuiu tanto para o amadurecimento e reflexão sobre a situação vivida quanto para a manutenção e/ou aumento de peso, desencadeando problemas biopsicossociais e limitações no seu cotidiano; conviveu com a ansiedade, a dor, a incerteza do futuro e até mesmo com o medo da morte; sentiu-se descuidada durante o itinerário percorrido devido à lacuna existente entre o atendimento recebido e o preconizado pelas políticas, programas e diretrizes; considerou a ajuda dos profissionais de saúde imprescindível para que conseguisse percorrer o caminho e chegar até a aprovação para a Cirurgia Bariátrica; espera melhor estrutura nas redes de atendimento, práticas de cuidado realizadas por equipe multidisciplinar capacitada e diminuição da lacuna entre o atendimento ofertado pelo Serviço Público e a situação vivida no itinerário terapêutico. Para além da Cirurgia Bariátrica almeja a possibilidade de retomar a realização de atividades simples e rotineiras, ser inserida na sociedade e poder empreender na carreira profissional. Conclusão: Ao percorrer o caminho em busca da Cirurgia Bariátrica, a pessoa com obesidade experimenta dificuldades e barreiras, que a leva a buscar e utilizar recursos que nem sempre estão disponíveis no Sistema de Saúde, mas fazem parte do itinerário percorrido. O acesso e o acolhimento das necessidades e expectativas de cuidado das pessoas com obesidade podem favorecer o aprimoramento e o incremento da qualidade dos Serviços de Saúde oferecidos. Salienta-se a necessidade de a equipe multidisciplinar compreender as especificidades da pessoa com obesidade, de modo a estabelecer e compartilhar um plano de cuidados fundamentado nos aspectos sociais e individuais e da comunidade, valorizando as circunstâncias e contextos que possam interferir no itinerário terapêutico. Capacitar a pessoa para lidar com esta doença crônica de modo responsável exige que as intervenções sejam direcionadas para a compreensão da subjetividade, com propostas voltadas para os aspectos biopsicossociais.

Introduction: Obesity is a public health problem that requires the system to organize itself so as to assist people experiencing this situation. When reaching out for bariatric surgery through the public health system, people come to face several choices that make up the set of paths taken. Objective: To understand the therapeutic itinerary taken in the Public Health Service by the person with obesity in search of Bariatric Surgery. Method: This qualitative study, using a phenomenological approach, was conducted in a public hospital in São Paulo. Study participants were 17 obese people who were candidates for a bariatric surgery through the Brazilian unified health system, and who were hospitalized in the medical-surgical clinic of the studied hospital, with a date scheduled for the procedure. Interviews were conducted following the guiding questions: How was your search for Bariatric Surgery? Which paths did you take? What was it like to experience these paths? During the time you searched for treatment, what was the service you received like? How do you expect to be served from now on? What are your expectations after the surgery? Results: The usual experience lived in the therapeutic path taken by obese people who search for a bariatric surgery was that of a person who searched and took several paths in public health services; experienced a slow waiting list for the surgery, which contributed significantly for them to become more mature and reflect on the situation experienced as regards the weight maintenance and/or gain, triggering biopsychosocial problems and limitations in their daily living; experienced anxiety, pain, uncertainty regarding the future and even fear of death; felt neglected during the path taken due to the gaps existing between the service received and that recommended in policies, programs, and guidelines; considered the help of health professionals essential to be able to take the necessary path to get to the approval of a bariatric surgery; hopes for a better structure in service networks, care practices performed by a qualified multiprofessional team and the reduction of gaps between the service offered by the public system and the situation experienced in the therapeutic path. After the bariatric surgery, these individuals expect the possibility to resume performing simple and routine activities, be inserted in society and be able to undertake in a professional career. Conclusion: When walking the path in search of Bariatric Surgery, the person with obesity experience difficulties and barriers, which lead them to search and use resources that are not always available in the Health System, but which are part of the path taken. Access and embracement of the care needs and expectations of obese people can favor an improvement and an increase in the quality of the Health Services offered. It is worth noting the need for the multiprofessional team to understand the specificities the person with obesity, so as to establish and share a care plan grounded on community, social and individual aspects, valuing the circumstances and contexts that may interfere in the therapeutic path. Interventions must be directed towards the understanding of subjectivity, with proposals considering biopsychosocial aspects, in order to qualify people to deal with this chronic disease with responsibility.

Biosimilarity Study Regarding Product Quality of Candidate Recombinant Monoclonal Antibodies as Biosimilars / 中国药学杂志

OBJECTIVE: Nowadays, recombinant monoclonal antibodies developed as biosimilar domains in application category for Investigational New Drug in domestic. The quality similarity should be prequalified for candidate drug to be developed as biosimilar. Here, the concept of quality biosimilarity was proposed and discussed from reviewer as well as developer. METHODS: The challenge of developing and evaluating biosimilar antibodies was emphasized. Then, the domestic sponsor's common problems were sorted out and critical quality attributes of some originator antibodies were summarized. Lastly, the reasons of holding letter or case rejected were exemplified and analyzed. RESULTS: AND CONCLUSION: The sponsor are encouraged to conduct comparing exercise by state-of-art analytical technologies to conform the quality similarity between a proposed biosimilar antibody and the originator product, the reviewers should also be very cautious to assess quality differences. Joint efforts and effective communication from researcher and reviewer are critical for promoting development of domestic biosimilar and addressing the unmet medicine need.

[Quality analyses of the development of preterm infants: results of the Lower-Saxonian preterm infant follow-up project and a comparison group of term infants]. / Qualitätsanalysen zur Entwicklung Frühgeborener: Ergebnisse des Niedersächsischen Frühgeborenen-Nachuntersuchungsprojekts und eines Vergleichskollektivs reif geborener Kinder.

Based on perinatal and neonatal quality assurance programmes, a follow-up project for the high-risk group of extremely preterm infants, unparalleled in Germany, was initiated in the federal state of Lower Saxony in 2004. Here we describe the new approach of examining a comparison group of term infants, which, for the first time, allows a valid interpretation of the collection of area-wide long-term outcome data on preterm children. The prospective long-term outcome project investigates the medical care situation for children born at less than 28 weeks of gestation up to school age. Based on the information obtained about the children's development the quality of health care will be optimised. A standardised examining concept with established development tests at defined follow-up intervals (at the age of 6 months, 2, 5 and 10 years) is used. At the age of five years 75 % of the examined premature children exhibited impairments. In order to better assess remarkable results, a comparison group of term infants (n=305) selected by a matched-pairs method was examined at the age of five using an analogous concept in kindergartens in Lower Saxony. The results were compared with the first two age cohorts of the follow-up-project (n=226) and quality analyses performed. As expected, significant differences have been found in the children's motor, cognitive and linguistic development between the preterm and term infants examined. This fact draws attention to the importance of early support for the majority of extremely premature infants. Feedback on the results given to the medical staff involved allows for the implementation of best practices and quality improvements. Identifying potential for improvement in everyday health care will help to develop specific optimisation measures.

General considerations of quality study for biosimilar products containing recombinant monoclonal antibodies / 中国药学杂志

OBJECTIVE: Different from new drug application, research on biosimilar products mainly focuses on similarity in quality as well as equivalence or non-inferiority in clinical application compared to reference products. Quality research on biosimilar products is one of the most important research fields, for not only it is the main work to secure the safety, efficacy and quality of the products, but also it is the key point that would determine whether the products could follow the requirements for development of biosimilar products.

Novas possibilidades metodológicas: a quebra dos paradigmas qualitativo e quantitativo em psicologia / Nuevas posibilidades metodológicas: la ruptura de los paradigmas cualitativos y cuantitativos en psicología / New methodological possibilities: rupture of qualitative and quantitative paradigms in psychology

O presente relato propõe uma metodologia materialista dialética de análise de dados que rompe com os paradigmas qualitativos e quantitativos, numa perspectiva transdisciplinar e complexa, tomando como categorias analíticas historicidade, identidade, narcisismo, efemeridade e transitoriedade. Relata-se o caso "O Climatério na Contemporaneidade", que utilizou discursos e escalas padronizadas. Nos resultados, construiu-se uma articulação entre os vários tipos de dados, a partir de uma análise estatística fatorial e de cluster para revelar tanto as semelhanças, quanto as diferenças entre as mulheres pesquisadas, além da formação de grupos qualitativos, de forma não arbitrária ou tendenciosa, baseada nas impressões dos pesquisadores. Demonstra-se criatividade metodológica que contempla a complexidade do objeto, ao construir um caminho metodológico original, baseado no pensamento dialético, que abarca tanto a diversidade quanto a totalidade do fenômeno, demonstrando que qualidade e quantidade, objetividade e subjetividade são duas faces de uma mesma moeda...

Se propone un método materialista dialéctico de análisis de datos que rompe con los paradigmas cualitativos y cuantitativos, en una perspectiva transdisciplinaria y compleja, teniendo como categorías analíticas historicidad, identidad, narcisismo, efimeridad y transitoriedad. Presentamos el caso "El climaterio en la contemporaneidad", que utiliza discursos y escalas estandarizadas. En los resultados, hemos construido un vínculo entre los distintos tipos de datos, a partir de un análisis factorial y cluster para revelar similitudes y diferencias entre las mujeres encuestadas, además, la formación de grupos cualitativos, de forma no arbitraria o sesgada, basada en las impresiones de los investigadores. Se muestra creatividad metodológica, que incluye la complejidad del objeto, para construir un enfoque metodológico único, basado en el pensamiento dialéctico, que tanto abraza la diversidad como el fenómeno en su totalidad, lo que demuestra que la calidad y la cantidad, la objetividad y la subjetividad son dos caras de la misma moneda...

This report proposes a dialectic method of data analysis that breaks with the qualitative and quantitative paradigms in a complexity and transdisciplinary perspective taking as analytic categories historicity, gender relations, identity, narcissism, ephemerality and transitority. To illustrate this construction it is reported the case, "The Climacteric in Contemporary," which used standardized scales and speeches. In the analysis we constructed a linkage between the various types of results from a factor analysis and cluster to reveal both similarities and differences between the women surveyed, besides the formation of groups qualitative without being arbitrary or biased based the impressions of researchers. It is shown that creativity involves the methodological complexity of the object studied by building a unique methodological approach, based on dialectical thinking, which includes both the diversity as the totality of the phenomenon, showing that the quantity and quality and objectivity and subjectivity are two sides of a same phenomenon...