Satisfaction analysis of overground gait exoskeletons in people with neurological pathology. a systematic review.

BACKGROUND: People diagnosed with neurological pathology may experience gait disorders that affect their quality of life. In recent years, research has been carried out on a variety of exoskeletons in this population. However, the satisfaction perceived by the users of these devices is not known. Therefore, the objective of the present study is to evaluate the satisfaction perceived by users with neurological pathology (patients and professionals) after the use of overground exoskeletons. METHODS: A systematic search of five electronic databases was conducted. In order to be included in this review for further analysis, the studies had to meet the following criteria: [1] the study population was people diagnosed with neurological pathology; [2] the exoskeletons had to be overground and attachable to the lower limbs; and [3]: the studies were to include measures assessing either patient or therapist satisfaction with the exoskeletons. RESULTS: Twenty-three articles were selected, of which nineteen were considered clinical trials. Participants diagnosed with stroke (n = 165), spinal cord injury (SCI) (n = 102) and multiple sclerosis (MS) (n = 68). Fourteen different overground exoskeleton models were analysed. Fourteen different methods of assessing patient satisfaction with the devices were found, and three ways to evaluate it in therapists. CONCLUSION: Users' satisfaction with gait overground exoskeletons in stroke, SCI and MS seems to show positive results in safety, efficacy and comfort of the devices. However, the worst rated aspects and therefore those that should be optimized from the users' point of view are ease of adjustment, size and weight, and ease of use.

Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series.

BACKGROUND: Children with spinal muscular atrophy (SMA) present muscle weakness and atrophy that results in a number of complications affecting their mobility, hindering their independence and the development of activities of daily living. Walking has well-recognized physiological and functional benefits. The ATLAS 2030 exoskeleton is a paediatric device that allows gait rehabilitation in children with either neurological or neuromuscular pathologies with gait disorders. The purpose is to assess the effects in range of motion (ROM) and maximal isometric strength in hips, knees and ankles of children with SMA type II after the use of ATLAS 2030 exoskeleton. METHODS: Three children (mean age 5.7 ± 0.6) received nine sessions bi-weekly of 60 min with ATLAS 2030. ROM was assessed by goniometry and strength by hand-held dynamometer. All modes of use of the exoskeleton were tested: stand up and sit down, forward and backward walking, and gait in automatic and active-assisted modes. In addition, different activities were performed during the gait session. A descriptive analysis of all variables was carried out. RESULTS: The average time of use was 53.5 ± 12.0 min in all sessions, and all participants were able to carry out all the proposed activities as well as to complete the study. Regarding isometric strength, all the measurements increased compared to the initial state, obtaining the greatest improvements for the hip flexors (60.2%) and extensors muscles (48.0%). The ROM increased 12.6% in hip and 34.1% in the ankle after the study, while knee ROM remained stable after the study. CONCLUSION: Improvements were showed in ROM and maximal isometric strength in hips, knees and ankles after using ATLAS 2030 paediatric gait exoskeleton in all three children. This research could serve as a preliminary support for future clinical integration of ATLAS 2030 as a part of a long-term rehabilitation of children with SMA. TRIAL REGISTRATION: The approval was obtained (reference 47/370329.9/19) by Comunidad de Madrid Regional Research Ethics Committee with Medical Products and the clinical trial has been registered on Clinical Trials.gov: NCT04837157.

A new lower limb portable exoskeleton for gait assistance in neurological patients: a proof of concept study.

BACKGROUND: Few portable exoskeletons following the assist-as-needed concept have been developed for patients with neurological disorders. Thus, the main objectives of this proof-of-concept study were 1) to explore the safety and feasibility of an exoskeleton for gait rehabilitation in stroke and multiple sclerosis patients, 2) to test different algorithms for gait assistance and measure the resulting gait changes and 3) to evaluate the user's perception of the device. METHODS: A cross-sectional study was conducted. Five patients were recruited (4 patients with stroke and 1 with multiple sclerosis). A robotic, one-degree-of-freedom, portable lower limb exoskeleton known as the Marsi Active Knee (MAK) was designed. Three control modes (the Zero Force Control mode, Mode 1 and Mode 3) were implemented. Spatiotemporal gait parameters were measured by the 10-m walking test (10MWT), the Gait Assessment and Intervention Tool (G.A.I.T.) and Tinetti Performance Oriented Mobility Assessment (gait subscale) before and after the trials. A modified QUEST 2.0 questionnaire was administered to determine each participant's opinion about the exoskeleton. The data acquired by the MAK sensors were normalized to a gait cycle, and adverse effects were recorded. RESULTS: The MAK exoskeleton was used successfully without any adverse effects. Better outcomes were obtained in the 10MWT and G.A.I.T. when Mode 3 was applied compared with not wearing the device at all. In 2 participants, Mode 3 worsened the results. Additionally, Mode 3 seemed to improve the 10MWT and G.A.I.T. outcomes to a greater extent than Mode 1. The overall score for the user perception of the device was 2.8 ± 0.4 95% CI. CONCLUSIONS: The MAK exoskeleton seems to afford positive preliminary results regarding safety, feasibility, and user acceptance. The efficacy of the MAK should be studied in future studies, and more advanced improvements in safety must be implemented.

Safety and usability of the MAK exoskeleton in patients with stroke.

BACKGROUND AND PURPOSE: Stroke is one of the leading causes of disability in adults worldwide, and one of the main objectives in the rehabilitation of these patients is to recover the gait. New technologies have emerged to cope with this issue, complementing conventional therapy with the use of devices such as exoskeletons. The Marsi Active Knee (MAK) exoskeleton (Marsi Bionics SL, Madrid, Spain) has already been tested, but an updated version was improved to allow the patients to perform functional exercises. The aim of this study was to assess the safety and usability of the MAK in the stroke population as well as its potential clinical effects. METHODS: A single-group open label intervention trial was conducted. The device was used twice a week for 5 weeks during 1 h per visit. During the visits, sit-to-stand transitions, walking, stair climbing, trunk rotations, and weight-transfer exercises were performed using the device. Adverse events were collected from participants and therapists to assess safety. The Quebec User Evaluation of the Satisfaction with assistive Technology (QUEST 2.0) was used by both therapists and participants to assess usability. To evaluate its clinical effects, active range of motion (ROM) and muscle strength were assessed in the lower limb. RESULTS: Six participants with stroke were recruited. The device was shown to be safe since no serious adverse events were reported neither by patients nor by therapists. Every proposed exercise was performed. Regarding clinical effects, overall muscle strength showed an increase after the treatment, although ROM measurements did not show any difference. DISCUSSION: Our results suggest that the MAK device is safe for stroke patients. Nevertheless, further changes to enhance usability are recommended, such as an improvement of the attachment system and an adaptation for the drop foot. Beneficial effects regarding increases in muscle strength were obtained. Further trials with a larger sample size, longer intervention periods, and a control group are needed to verify these results. Also, future research should focus on the usability of the MAK as an assistive technology.

Women's leadership in clinical research: A retrospective observational study over two decades in Spain.

BACKGROUND AND OBJECTIVE: Available data support differences by gender in the leadership of clinical investigations (CI). This study analyzes to what extent women lead these investigations. MATERIALS AND METHODS: Observational-retrospective study in a tertiary university hospital associated with one of the most important health research institutes in Spain. We analyzed the principal investigators (PI) by gender from 2001 to 2020. MAIN OUTCOME: proportion of CI led by female doctors (FD) during the study period. SECONDARY OUTCOMES: differences in PI by gender according to the type of study: clinical trials (CT) or non-interventional-researches (NIR) and according to type of funding. DATA SOURCES: Research Ethics Committee (REC) and Human Resources Department registries. RESULTS: During the study, the REC approved 8466 protocols, 52% (4408/8466) were EC, the rest were NIR. Women led 39.7% (3360/8466) of the total. The gender gap was observed mainly in EC: FD were IP of 31.5% of them (1391/4408) and 48.5% (1969/4058) of NIR. This despite the increasing trend in the number of FD staff. By type of funding, when the studies were supported by private sector there was a wider gap markedly unfavorable for women. CONCLUSIONS: Our results show that there is underrepresentation of women in research leadership, mainly those with private financing. This study reinforces the idea that there is still a long way to go in this field. More studies are necessary to identify the existing differences that allow the implementation of actions at the institutional and cultural level that promote gender equality in the field of clinical research.

Construction and validation of nursing diagnoses for premature newborns.

OBJECTIVE: To build and validate nursing diagnoses based on the International Classification of Nursing Practice (ICNP®) for premature newborns admitted to the Neonatal Intensive Care Unit. METHOD: Methodological study based on the Brazilian method for developing subsets: use of specialized nursing language terms, construction of diagnostic statements and content validation of the statements by 40 specialist nurses. Those with a Content Validity Index (CVI) ≥ 0.80, organized according to Wanda Horta's basic human needs theory, were considered valid. RESULTS: 146 nursing diagnosis statements were constructed and 145 (93.3%) diagnoses were validated, with a predominance of the human need for cutaneous-mucosal integrity. CONCLUSION: The specificity of neonatal care is evident when these diagnoses are presented and validated in order to support nurses in their clinical reasoning and decision-making.

ICNP® terminological subset for people with diabetic foot ulcer in primary health care.

OBJECTIVES: to elaborate an ICNP® terminological subset for people with diabetic foot ulcers in Primary Health Care. METHODS: this is a methodological study that followed five steps: 1) Identification of relevant terms for the patients through an integrative literature review and official documents in the area; 2) Mapping of terms identified with ICNP® terms; 3) Construction of statements of nursing diagnoses, outcomes and interventions; 4) Structuring of a terminological subset with the Self-Care Deficit Theory; and 5) Content validity of statements constructed with nurses from a programmatic area in Rio de Janeiro. RESULTS: the subset developed is composed of 81 diagnoses/outcomes and 583 nursing interventions, organized into universal, change and development requirements. CONCLUSIONS: the subset on screen was predominantly composed of statements inserted in self-care requirements related to health changes, reinforcing the importance of quality of life and recovery.

Construction and validation of nursing diagnoses for people with diabetic foot ulcers.

OBJECTIVE: To construct and validate nursing diagnoses statements of the International Classification for Nursing Practice (ICNP®) for the person with diabetic foot ulcer being followed up in primary health care. METHOD: This is a methodological study structured in four stages: identification of terms; cross-mapping of identified terms with ICNP terms®, version 2019/2020; construction of nursing diagnoses statements and organization with Orem's Theory of Self-care; and content validation by expert nurses working in primary care, with those with Content Validity Index (CVI) ≥ 0.80 being considered valid. RESULTS: Eighty-one diagnostic statements were constructed, five of which were positive, 67 negative, and nine risky. Of these, 58 were included in ICNP® and 23 were not, 51% of which were categorized as self-care requirements related to health changes. CONCLUSION: ICNP® subsidized the construction of a technical product, which can be consulted and used by nurses and will allow the strengthening of the standardization of a specific language in the context of care for people with diabetic foot ulcers in primary health care.

Weakening of nurses practice delivering same day-access in primary care.

OBJECTIVE: To identify and analyze the weaknesses of the nurse's practice in meeting spontaneous demands in primary care units in the city of Rio de Janeiro. METHOD: Qualitative study carried out in Rio de Janeiro, in 2016, with 20 nurses recruited unintentionally. The focus group and simple observation were applied, and data were subjected to thematic content analysis. RESULTS: The spontaneous demand service causes tensions and work overload. Nurses and community health agents are primarily responsible for organizing access. FINAL CONSIDERATIONS: There was a lack of understanding of the practice of spontaneous demand as part of care management, in addition to a polysemy related to the term. While for some, welcoming practices means greater autonomy, incorporating a larger scope of actions related to care and expanding their clinical practice; for others, they represent a stage that precedes medical consultation and a disorganizing element of care.

[Tuberculous peritonitis in peritoneal dialysis]. / Peritonitis tuberculosa en diálisis peritoneal.

We report a patient in Automatic Peritoneal Dialysis (APD) with tuberculous peritonitis by possible peritoneal infection due to the proximity between fallopian tube and the left ovary, a peritoneal liquid culture was constantly negative. The patient presented a bad clinic evolution. Her only medical history was hypercalcemia six months before developing a peritonitis and occasionally nausea and vomits To confirm the diagnosis it was needed a peritoneal biopsy by means of a laparoscopy with a removal of the peritoneal catheter and left anexectomy. Now, the patient is asintomatic in daily home hemodialysis.

Terminologia especializada de enfermagem para pacientes renais crônicos em hemodiálise / Terminología de enfermería especializada para pacientes renales crónicos en hemodiálisis / Specialized nursing terminology for chronic kidney patients on hemodialysis

Resumo Objetivos identificar os termos que representam as necessidades humanas afetadas no paciente renal crônico em hemodiálise; e realizar o mapeamento cruzado destes termos com os já existentes na Classificação Internacional para a Prática de Enfermagem. Método estudo descritivo com abordagem quantitativa, realizado entre os meses de fevereiro a dezembro de 2021, período no qual foi elaborada uma revisão integrativa da literatura para levantamento dos termos que representam as necessidades humanas afetadas no paciente renal crônico em hemodiálise; em seguida, procedeu-se ao mapeamento cruzado destes termos identificados com os termos da CIPE® versão 2019/2020. Resultados foram identificados 1.946 termos extraídos dos artigos que fizeram parte da revisão integrativa. Depois do processo de normalização e uniformização, foram excluídos 689 termos, resultando na subsequente composição de 1.257 termos, os quais foram mapeados com os termos da Classificação Internacional para a Prática de Enfermagem versão 2019/2020. Ao final, o banco de termos ficou constituído por 626 termos constantes e 631 termos não constantes. Conclusão e implicação para a prática foram identificados os termos relevantes para a prática de enfermagem na assistência aos pacientes renais crônicos em hemodiálise. Os termos serão subsídios para auxiliar o enfermeiro na promoção de uma assistência sistematizada, utilizando-se de uma prática baseada em evidências.

Resumen Objetivo identificar los términos que representan las necesidades humanas afectadas en pacientes con insuficiencia renal crónica en hemodiálisis; y cruzar estos términos con los ya existentes en la Clasificación Internacional para la Práctica de Enfermería. Método estudio descriptivo con enfoque cuantitativo, realizado entre febrero y diciembre de 2021, período en el que se realizó una revisión bibliográfica integradora para relevar los términos que representan las necesidades humanas afectadas en el paciente renal crónico en hemodiálisis; luego se procedió al mapeo cruzado de estos términos identificados con los términos de la CIPE® versión 2019/2020. Resultados se identificaron 1.946 términos extraídos de los artículos que formaban parte de la revisión integradora. Tras el proceso de normalización y estandarización, se excluyeron 689 términos, resultando en la posterior composición de 1.257 términos, que fueron mapeados con los términos de la Clasificación Internacional para la Práctica de Enfermería versión 2019/2020. Al final, el banco de términos estaba compuesto por 626 términos constantes y 631 términos no constantes. Conclusión e implicación para la práctica se identificaron los términos relevantes para la práctica enfermera en el cuidado de los pacientes con insuficiencia renal crónica en hemodiálisis. Los términos se subsiguen para ayudar al enfermero a promover una asistencia sistematizada, utilizando una práctica basada en la evidencia.

Abstract Objectives to identify the terms that represent the human needs affected in chronic renal failure patients on hemodialysis; and to cross-map these terms with those already existing in the International Classification for Nursing Practice. Method a descriptive study with a quantitative approach, conducted between February and December 2021, a period in which an integrative literature review was prepared to survey the terms that represent the human needs affected in chronic renal failure patients on hemodialysis; then, we proceeded to the cross-mapping of these terms identified with the ICNP® terms 2019/2020 version. Results 1,946 terms were identified extracted from the articles that were part of the integrative review. After the normalization and standardization process, 689 terms were excluded, resulting in the subsequent composition of 1,257 terms, which were mapped with the terms of the International Classification for Nursing Practice 2019/2020 version. In the end, the term bank consisted of 626 constant terms and 631 non-constant terms. Conclusion and implications for practice relevant terms were identified for nursing practice in the care of chronic kidney disease patients on hemodialysis. The terms will help nurses to promote a systematized care, using an evidence-based practice.

Construction and validation of nursing diagnoses for premature newborns / Construcción y validación de diagnósticos de enfermería para recién nacidos prematuros / Construção e validação de diagnósticos de enfermagem para recém-nascidos prematuros

ABSTRACT Objective: To build and validate nursing diagnoses based on the International Classification of Nursing Practice (ICNP®) for premature newborns admitted to the Neonatal Intensive Care Unit. Method: Methodological study based on the Brazilian method for developing subsets: use of specialized nursing language terms, construction of diagnostic statements and content validation of the statements by 40 specialist nurses. Those with a Content Validity Index (CVI) ≥ 0.80, organized according to Wanda Horta's basic human needs theory, were considered valid. Results: 146 nursing diagnosis statements were constructed and 145 (93.3%) diagnoses were validated, with a predominance of the human need for cutaneous-mucosal integrity. Conclusion: The specificity of neonatal care is evident when these diagnoses are presented and validated in order to support nurses in their clinical reasoning and decision-making.

RESUMEN Objetivo: Construir y validar diagnósticos de enfermería basados en la Clasificación Internacional de la Práctica de Enfermería (CIPE®) para recién nacidos prematuros ingresados en la Unidad de Cuidados Intensivos Neonatales. Método: Estudio metodológico basado en el método brasileño de elaboración de subconjuntos: utilización de términos del lenguaje enfermero especializado, construcción de enunciados diagnósticos y validación de contenido de los enunciados por 40 enfermeros especialistas. Se consideraron válidos aquellos con Índice de Validez de Contenido (IVC) ≥ 0,80, organizados según las necesidades humanas básicas de Wanda Horta. Resultados: Se construyeron 146 enunciados de diagnóstico de enfermería y se validaron 145 (93,3%) diagnósticos, con predominio de la necesidad humana de integridad cutáneo-mucosa. Conclusión: La especificidad de los cuidados neonatales es evidente desde el momento en que estos diagnósticos son presentados y validados con el objetivo de subsidiar a las enfermeras en su razonamiento clínico y toma de decisiones.

RESUMO Objetivo: Construir e validar diagnósticos de enfermagem fundamentados na Classificação Internacional da Prática de Enfermagem (CIPE®) para recém-nascidos prematuros internados em Unidade de Terapia Intensiva Neonatal. Método: Estudo metodológico sustentado pelo método brasileiro para desenvolvimento de subconjuntos: utilização de termos da linguagem especializada de enfermagem, construção dos enunciados de diagnósticos e validação de conteúdo dos enunciados por 40 enfermeiros especialistas. Foram considerados válidos aqueles com Índice de Validade de Conteúdo (IVC) ≥ 0.80, organizados conforme à teoria das necessidades humanas básicas de Wanda Horta. Resultados: Foram construídos 146 enunciados de diagnósticos de enfermagem, e ao final foram validados 145 (93,3%) diagnósticos, com predominância na necessidade humana de integridade cutâneo-mucosa. Conclusão: A especificidade do cuidado neonatal fica evidente a partir do momento em que se apresentam tais diagnósticos, e que são validados com o objetivo de subsidiar o enfermeiro no raciocínio clínico e na tomada de decisão.

ICNP® terminological subset for people with diabetic foot ulcer in primary health care / Subconjunto terminológico CIPE® para personas con úlcera de pie diabético en atención primaria de salud / Subconjunto terminológico CIPE® para pessoas com úlcera do pé diabético na atenção primária à saúde

ABSTRACT Objectives: to elaborate an ICNP® terminological subset for people with diabetic foot ulcers in Primary Health Care. Methods: this is a methodological study that followed five steps: 1) Identification of relevant terms for the patients through an integrative literature review and official documents in the area; 2) Mapping of terms identified with ICNP® terms; 3) Construction of statements of nursing diagnoses, outcomes and interventions; 4) Structuring of a terminological subset with the Self-Care Deficit Theory; and 5) Content validity of statements constructed with nurses from a programmatic area in Rio de Janeiro. Results: the subset developed is composed of 81 diagnoses/outcomes and 583 nursing interventions, organized into universal, change and development requirements. Conclusions: the subset on screen was predominantly composed of statements inserted in self-care requirements related to health changes, reinforcing the importance of quality of life and recovery.

RESUMEN Objetivos: desarrollar un subconjunto terminológico de la CIPE® para personas con úlceras del pie diabético en la Atención Primaria de Salud. Métodos: estudio metodológico, que siguió cinco etapas: 1) identificación de términos relevantes para la clientela a través de una revisión integradora de literatura y documentos oficiales en el área; 2) mapeo de términos identificados con los términos CIPE®; 3) construcción de diagnósticos, resultados e intervenciones de enfermería; 4) estructuración del subconjunto terminológico con la Teoría del Déficit de Autocuidado; y 5) validación de contenido de enunciados construidos con enfermeros de un área programática de Rio de Janeiro. Resultados: el subconjunto desarrollado está compuesto por 81 diagnósticos/resultados y 583 intervenciones de enfermería, organizados en requisitos universales, de cambio y de desarrollo. Conclusiones: el subconjunto en pantalla estuvo compuesto predominantemente por declaraciones insertadas en los requisitos de autocuidado relacionados con cambios en la salud, lo que refuerza la importancia de la calidad de vida y la recuperación.

RESUMO Objetivos: elaborar um subconjunto terminológico CIPE® para a pessoa com úlcera do pé diabético na Atenção Primária à Saúde. Métodos: estudo metodológico, que seguiu cinco etapas: 1) identificação de termos revelantes para a clientela por uma revisão integrativa de literatura e em documentos oficiais da área; 2) mapeamento dos termos identificados com os termos da CIPE®; 3) construção dos enunciados de diagnósticos, resultados e intervenções de enfermagem; 4) estruturação do subconjunto terminológico com a Teoria do Déficit do Autocuidado; e 5) validação de conteúdo dos enunciados construídos com enfermeiros de uma área programática do Rio de Janeiro. Resultados: o subconjunto desenvolvido é composto por 81 diagnósticos/resultados e 583 intervenções de enfermagem, organizados em requisitos universais, de alterações e desenvolvimento. Conclusões: o subconjunto em tela foi composto predominantemente por enunciados inseridos nos requisitos de autocuidado relativos às alterações de saúde, reforçando a importância da qualidade de vida e recuperação.

[Prototheca Wickerhami peritonitis in patients on peritoneal dialysis]. / Peritonitis por Prototheca Wickerhamii en paciente en diálisis peritoneal.

Prototheca spp exits throughout nature but only infrequently cause infection in humans. Most of the cases of human infection have involved the skin or subcutaneous tissues, but there have been reports of rare cases of protothecosis of the urinary tract, and disseminated disease. The species most commonly isolated is Prototheca wickerhamii. Few cases of peritonitis due to P. wickerhamii in peritoneal dialysis had been reported. We report a successful treatment of Prototheca peritonitis complicating peritoneal dialysis with amphotericin, itraconazole and removal of the catheter.

Terminologia especializada de enfermagem para a pessoa com úlcera do pé diabético / Terminología especializada en enfermería para personas con úlcera de pie diabético / Specialized nursing terminology for people with diabetic foot ulcers

Resumo Objetivo Construir uma terminologia especializada de enfermagem para a pessoa com úlcera do pé diabético na Atenção Primária à Saúde. Métodos Pesquisa metodológica, abordagem quantitativa, orientada pelas diretrizes de elaboração de subconjuntos terminológicos da Classificação Internacional para a Prática de Enfermagem. A terminologia foi elaborada a partir dos termos coletados em 62 artigos científicos e cinco documentos oficiais, por meio de ferramenta computacional, normalizados e mapeados com a classificação internacional proposta. Resultados Após a coleta de 12.696 termos, 308 foram considerados relevantes para a pessoa com úlcera do pé diabético. Destes, 182 eram constantes e 126 não constantes na classificação utilizada. Os termos constantes apresentaram prevalência no eixo Foco (46%), seguido pelos eixos Ação (19%), Localização (12%), Meio (11%), Julgamento (5%), Tempo (5%) e Cliente (2%). Dentre os termos não constantes, 48% foram classificados como mais restritos, 46% considerados mais abrangentes e 6% não apresentaram concordância com nenhum termo primitivo da Classificação Internacional para a Prática de Enfermagem versão 2019/2020. Conclusão Os termos especializados de enfermagem constituídos neste estudo contribuirão na construção do subconjunto terminológico da Classificação Internacional para a Prática de Enfermagem para a pessoa com úlcera do pé diabético na atenção primária à saúde. O alcance do objetivo proporciona o avanço no conhecimento sobre a classificação, com potencial para fomentar sistemas de informação na Atenção Primária à Saúde com vistas à qualificação do cuidado a pessoas com a prioridade eleita.

Resumen Objetivo Construir una terminología especializada en enfermería para personas con úlcera de pie diabético. Métodos Investigación metodológica, enfoque cuantitativo, orientada por las directivas de elaboración de subconjuntos terminológicos de la Clasificación Internacional para la Práctica de Enfermería. La terminología se ha elaborado a partir de los términos recopilados en 62 artículos científicos y en cinco documentos oficiales, por medio de herramienta informática, normalizados y mapeados con la clasificación internacional propuesta. Resultados Después de la recopilación de 12.696 términos, 308 fueron considerados relevantes para personas con úlcera de pie diabético. De ellos, 182 eran constantes y 126 no constantes en la clasificación utilizada. Los términos constantes presentaron prevalencia en el eje Enfoque (46 %), seguido por los ejes Acción (19 %), Ubicación (12 %), Medio (11 %), Juicio (5 %), Tiempo (5 %) y Cliente (2 %). Entre los términos no constantes, el 48 % fue clasificado como más restringido, el 46 % considerado más abarcador y el 6 % no presentó concordancia con ningún término primitivo de la Clasificación Internacional para la Práctica de Enfermería versión 2019/2020. Conclusión Los términos especializados en enfermería constituidos en este estudio contribuirán para la construcción del subconjunto terminológico de la Clasificación Internacional para la Práctica de Enfermería para personas con úlcera de pie diabético en la atención primaria de salud. El alcance del objetivo proporciona el avance para el conocimiento sobre la clasificación, con potencial para fomentar sistemas de información en la Atención Primaria de la Salud con el objetivo de cualificar el cuidado de las personas con la prioridad seleccionada.

Abstract Objective To build a specialized nursing terminology for people with diabetic foot ulcers in Primary Health Care. Methods This is methodological research with quantitative approach, guided by guidelines for elaborating the International Classification for Nursing Practice terminology subsets. A terminology was elaborated from the terms collected in 62 scientific articles and five official documents, by means of a computational tool, normalized and mapped with the proposed international classification. Results After collecting 12,696 terms, 308 were considered relevant for people with diabetic foot ulcers. Of these, 182 were listed and 126 were unlisted in the classification used. The terms listed showed prevalence in axis Focus (46%), followed by Action (19%), Location (12%), Means (11%), Judgment (5%), Time (5%) and Client (2%). Among the unlisted terms, 48% were classified as more restricted, 46% were considered more comprehensive and 6% did not agree with any primitive term of the International Classification for Nursing Practice 2019/2020. Conclusion Specialized nursing terms constituted in this study will contribute to building the International Classification for Nursing Practice terminology subsets for people with diabetic foot ulcers in Primary Health Care. Achieving the objective provides an advance in knowledge about classification, with the potential to foster information systems in Primary Health Care with a view to qualifying care for people with the chosen priority.

Construction and validation of nursing diagnoses for people with diabetic foot ulcers / Construcción y validez de diagnósticos de enfermería para el paciente con úlcera del pie diabético / Construção e validação de diagnósticos de enfermagem para a pessoa com úlcera do pé diabético

ABSTRACT Objective: To construct and validate nursing diagnoses statements of the International Classification for Nursing Practice (ICNP®) for the person with diabetic foot ulcer being followed up in primary health care. Method: This is a methodological study structured in four stages: identification of terms; cross-mapping of identified terms with ICNP terms®, version 2019/2020; construction of nursing diagnoses statements and organization with Orem's Theory of Self-care; and content validation by expert nurses working in primary care, with those with Content Validity Index (CVI) ≥ 0.80 being considered valid. Results: Eighty-one diagnostic statements were constructed, five of which were positive, 67 negative, and nine risky. Of these, 58 were included in ICNP® and 23 were not, 51% of which were categorized as self-care requirements related to health changes. Conclusion: ICNP® subsidized the construction of a technical product, which can be consulted and used by nurses and will allow the strengthening of the standardization of a specific language in the context of care for people with diabetic foot ulcers in primary health care.

RESUMEN Objetivo: Construir y validar enunciados de diagnósticos de enfermería de la Clasificación Internacional para la Práctica de Enfermería (CIPE®) para el paciente con úlcera del pie diabético en acompañamiento en la atención primaria a la salud. Método: Estudio metodológico, estructurado en cuatro etapas: identificación de términos; mapeo cruzado de los términos identificados con los términos de la CIPE®, versión 2019/2020; construcción de los enunciados de diagnósticos de enfermería y organización con la Teoría del Autocuidado de Orem; y validez de contenido por enfermeros expertos actuantes en la atención primaria, siendo considerado validos aquellos con Índice de Validez de Contenido (IVC) ≥ 0.80. Resultados: Fueron construidos 81 enunciados de diagnósticos, siendo cinco positivos, 67 negativos y nueve de riesgo. De esos, 58 eran constantes en la CIPE® y 23 no constantes, siendo un 51% categorizados como requisitos de autocuidado relativos a las alteraciones de salud. Conclusión: La CIPE® subvencionó la construcción de un producto técnico, que se puede consultar y utilizar entre los profesionales de enfermería, el cual permitirá el fortalecimiento de la estandarización de un lenguaje propio en el contexto del cuidado al paciente con úlcera del pie diabético en la atención primaria a la salud.

RESUMO Objetivo: Construir e validar enunciados de diagnósticos de enfermagem da Classificação Internacional para a Prática de Enfermagem (CIPE®) para a pessoa com úlcera de pé diabético em acompanhamento na atenção primária à saúde. Método: Estudo metodológico, estruturado em quatro etapas: identificação de termos; mapeamento cruzado dos termos identificados com os termos da CIPE®, versão 2019/2020; construção dos enunciados de diagnósticos de enfermagem e organização com a Teoria do Autocuidado de Orem; e validação de conteúdo por enfermeiros peritos atuantes na atenção primária, sendo considerados válidos aqueles com Índice de Validade de Conteúdo (IVC) ≥ 0.80. Resultados: Foram construídos 81 enunciados de diagnósticos, sendo cinco positivos, 67 negativos e nove de risco. Desses, 58 eram constantes na CIPE® e 23 não constantes, sendo 51% categorizados como requisitos de autocuidado relativos às alterações de saúde. Conclusão: A CIPE® subsidiou a construção de um produto técnico, passível de consulta e utilização pelos enfermeiros, o qual permitirá o fortalecimento da padronização de uma linguagem própria no contexto do cuidado à pessoa com úlcera do pé diabético na atenção primária à saúde.

Native plant growth promoting bacteria Bacillus thuringiensis and mixed or individual mycorrhizal species improved drought tolerance and oxidative metabolism in Lavandula dentata plants.

This study evaluates the responses of Lavandula dentata under drought conditions to the inoculation with single autochthonous arbuscular mycorrhizal (AM) fungus (five fungal strains) or with their mixture and the effects of these inocula with a native Bacillus thuringiensis (endophytic bacteria). These microorganisms were drought tolerant and in general, increased plant growth and nutrition. Particularly, the AM fungal mixture and B. thuringiensis maximized plant biomass and compensated drought stress as values of antioxidant activities [superoxide dismutase (SOD), catalase (CAT) and ascorbate peroxidase APX)] shown. The AMF-bacteria interactions highly reduced the plant oxidative damage of lipids [malondialdehyde (MDA)] and increased the mycorrhizal development (mainly arbuscular formation representative of symbiotic functionality). These microbial interactions explain the highest potential of dually inoculated plants to tolerate drought stress. B. thuringiensis "in vitro" under osmotic stress does not reduce its PGPB (plant growth promoting bacteria) abilities as indole acetic acid (IAA) and ACC deaminase production and phosphate solubilization indicating its capacity to improve plant growth under stress conditions. Each one of the autochthonous fungal strains maintained their particular interaction with B. thuringiensis reflecting the diversity, intrinsic abilities and inherent compatibility of these microorganisms. In general, autochthonous AM fungal species and particularly their mixture with B. thuringiensis demonstrated their potential for protecting plants against drought and helping plants to thrive in semiarid ecosystems.

[The patents game. Generic and biosimilar drugs]. / Juego de patentes. Sobre medicamentos genéricos y biosimilares.

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use.

Weakening of nurses practice delivering same day-access in primary care / Fragilización de práctica de la enfermería a consulta a demanda espontánea en atención primaria / Fragilização da prática do enfermeiro no atendimento à demanda espontânea na atenção primária

ABSTRACT Objective To identify and analyze the weaknesses of the nurse's practice in meeting spontaneous demands in primary care units in the city of Rio de Janeiro. Method Qualitative study carried out in Rio de Janeiro, in 2016, with 20 nurses recruited unintentionally. The focus group and simple observation were applied, and data were subjected to thematic content analysis. Results The spontaneous demand service causes tensions and work overload. Nurses and community health agents are primarily responsible for organizing access. Final considerations There was a lack of understanding of the practice of spontaneous demand as part of care management, in addition to a polysemy related to the term. While for some, welcoming practices means greater autonomy, incorporating a larger scope of actions related to care and expanding their clinical practice; for others, they represent a stage that precedes medical consultation and a disorganizing element of care.

RESUMEN Objetivo Identificar y analizar las debilidades de la práctica de la enfermera para atender la demanda espontánea en las unidades de atención primaria de la ciudad de Rio de Janeiro. Método Estudio cualitativo realizado en Rio de Janeiro, en 2016, con 20 enfermeras reclutadas de manera no intencional. Se aplicó el grupo focal y la observación simple, y los datos fueron sometidos a análisis de contenido temático. Resultados El servicio de demanda espontánea genera tensiones y sobrecarga de trabajo. La enfermera y el agente de salud de la comunidad son los principales responsables de organizar el acceso. Consideraciones finales Existía una falta de comprensión de la práctica de la demanda espontánea como parte de la gestión del cuidado, además de una polisemia relacionada con el término. Mientras que para algunos las prácticas de acogida significan una mayor autonomía, incorporando un mayor abanico de acciones relacionadas con el cuidado y ampliando su práctica clínica; para otros, representan una etapa que precede a la consulta médica y un elemento desorganizador de la atención.

RESUMO Objetivo Analisar as fragilidades da prática do enfermeiro no atendimento à demanda espontânea nas unidades de atenção primária do município do Rio de Janeiro. Método Estudo qualitativo realizado no Rio de Janeiro, em 2016, com 20 enfermeiros recrutados não intencionalmente. Aplicou-se o grupo focal e a observação simples, e os dados foram submetidos à análise temática de conteúdo. Resultados O atendimento por demanda espontânea provoca tensões e sobrecarga no trabalho. O enfermeiro e o agente comunitário de saúde são os principais responsáveis pela organização do acesso. Considerações finais Constatou-se a incompreensão da prática da demanda espontânea como integrante da gestão do cuidado, além da polissemia relacionada ao termo. Enquanto para alguns as práticas de acolhimento significam maior autonomia, incorporando um escopo maior de ações referentes ao atendimento e ampliando a sua prática clínica; para outros, representam uma etapa que antecede a consulta médica e um elemento desorganizador da assistência.

[Monitoring protocol of native vascular accesses for haemodialysis]. / Programa de monitorización de accesos vasculares nativos para hemodiálisis.

Vascular access failure is an important cause of morbidity and mortality for patients on haemodialysis. We have prospectively studied, with a 5 years follow up, a monitoring protocol of native vascular accesses, using the available methods in every haemodialysis unit. All the native vascular accesses, created from 1- 1998 to XII-2001, with a posterior follow up until XII-2002, were monitored. Monitoring was based on physical examination, dificulty for blood flow greater than 300 ml/min, and in a monthly basis: dynamic venous pressure, urea recirculation and urea kinetic model. Abnormalities suggestive of fistulogram were a priori defined. During the recruitment period, a total of 164 accesses were created in 144 patients. Of these only 3 were grafts, 28 native vascular accesses were never functioning (primary failure rate 17. 1%), and 127 native accesses created in 113 patients (age 63.3 +/- 12.4 years; 18 % diabetics), were monitored (83% cephalic vein). Monitoring findings indicated realization of fistulogram in 35% and percutaneus angioplasty in 25% of the accesses. In order to maintain patency, the surgical intervention rate was 0.03 procedures/patient/year, the radiological 0.10 and the total 0.13. During the 5 years of the study occurred 41 thrombosis episodes in 40 accesses (0.07 thrombosis/patient/year), with percutaneus repermeabilization in 30%. Primary (unassisted) survival was 30.3 months (Confidence Interval 95% 25.6, 35.0) and secondary (assisted) survival 42.8 months (Confidence Interval 95%: 38.7, 46.9). Logistic regression analysis showed that presence of a central catheter at the time of creating the vascular access posses a greater risk for thrombosis (Relative Risk 5.6 if in subclavian vein), whereas age, diabetes, time to canulation, number of previous accesses and anatomic type do not increase that risk. In conclusion, in an old haemodialysis population, with an important diabetes prevalence, it is possible to create functioning native vascular accesses in most of them. The monitoring protocol allowed the detection and posterior correction of stenosis in a great number of accesses. The main risk of thrombosis is the presence of a central catheter at the time of creating a vascular access.