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J Assoc Physicians India ; 67(4): 14-17, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31299831


Background: White matter hyperintensities (WMH) on MRI brain in the periventricular and deep white matter regions are commonly seen in older persons with normal cognition and in patients with AD. Aims: To compare presence and severity of WMHs in patients with AD with that in a cognitively normal control group, and to evaluate effect of presence of Hypertension and Diabetes on WMHs in both groups. Material and Methods: Thirty four patients with AD were serially recruited from Neurology and Psychiatry OPDs. An age and gender matched cohort of 24 persons with MMSE over 27/30 from the community acted as controls. Vascular risk factors, MMSE and MRI brain were assessed in all. Fezeka's and Pasquier grading of WMH and atrophy were done. Periventricular WMHs (PVWMH) and Deep WMH (DWMH) were assessed separately. Results and Conclusions: Overall, Periventricular WMHs of grade 2 and over were seen in 19/34 patients, and in 7/24 controls (P value 0.044). Significantly higher grades of PVWMHs were seen in hypertensives as compared to nonhypertensives in the case group, and in women compared to men. In the control group, hypertension had no effect on severity of PVWMHs. Among both Diabetics and non-diabetics, no difference in PVWMHs was found between the case and control groups. DWMHs were, conversely, seen only in the control group. Overall, over a quarter of cognitively normal older persons had WM hyperintensities of grade 2 and over on MRI brain; 55% of AD patients had PVWMH of Gd 2 or over, and no DWMHs.

Doença de Alzheimer/patologia , Diabetes Mellitus/patologia , Hipertensão/patologia , Substância Branca , Idoso , Idoso de 80 Anos ou mais , Grupos Controle , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino
Invest. educ. enferm ; 37(2): [E05], 15-06-2019. Diag 1, Tab 1, Tab 2
Artigo em Inglês | LILACS, COLNAL | ID: biblio-1007512


Abstract Objective. This work sought to determine the effectiveness of an aerobic exercise program on the occupational stress of nurses. Methods. Prevention-type controlled clinical trial carried out with the participation of 60 nurses working in hospitals affiliated to Shahrekord University of Medical Sciences in Iran. Randomly, the nurses were assigned to the experimental group or to the control group. The intervention consisted in an aerobic exercise program lasting three months with three weekly sessions one hour each. The Health and Safety Executive (HSE) questionnaire measured occupational stress with 35 questions, each with five Likert-type response options, which can have a maximum score of 175 points; higher scores meant lower levels of occupational stress. The HSE was evaluated during three moments: upon registering, after finishing the exercise program (week 8), and two months after terminating the intervention (week 16). Results. The level of occupational stress was the same in the experimental and control groups during registration (86.2 vs. 86.3). Upon finishing the aerobic exercise program(week 8), the experimental group showed a higher score than the control group (119.7 vs. 86.2, p<0.01), with this score diminishing after two months of having ended the intervention (91.4 vs. 85.8, p=0.061). Conclusion. The aerobic exercise program was associated to decreased work stress of nurses in the experimental group compared to the control group at eight weeks, but this difference did not persist when the experimental group did not continue with the program.

Resumen Objetivo. Determinar la efectividad de un programa de ejercicio aeróbico en el estrés ocupacional de las enfermeras. Métodos. Ensayo clínico controlado de tipo preventivo que se llevó a cabo con la participación de 60 enfermeras que trabajaban en hospitales afiliados a Shahrekord University of Medical Sciences en Irán. Las enfermeras se asignaron aleatoriamente al grupo experimental o al grupo control. La intervención consistió en un programa de ejercicio aeróbico realizado durante dos meses con tres sesiones semanales de una hora de duración. El estrés ocupacional se midió con el cuestionario Health and Safety Executive (HSE) de 35 preguntas, con opciones de respuesta tipo Likert que van de 1 a 5; puede llegar a puntuar en 175 como máximo: a mayor puntaje, menor el nivel de estrés ocupacional. Se evaluó el HSE en tres momentos: en la inscripción, después de finalizar el programa de ejercicio (semana 8) y también dos meses después de terminada la intervención (semana 16). Resultados. Fue igual el nivel de estrés ocupacional en los grupos de intervención y de control en la inscripción (86.2 vs. 86.3), pero al finalizar el programa de ejercicios aeróbicos (semana 8) el grupo experimental mostró un puntaje mayor que el del grupo control (119.7 vs. 86.2, p<0.01), para luego disminuir este puntaje a los dos meses de haber finalizado la intervención, (91.4 vs. 85.8, p=0.061). Conclusión. El programa de ejercicio aeróbico se asoció a la disminución del estrés laboral de las enfermeras en el grupo de intervención en comparación con el grupo control a las ocho semanas, pero esta diferencia no se mantuvo cuando el grupo experimental no continuó con el programa.

Resumo Objetivo. Determinar a efetividade de um programa de exercício aeróbico sobre o estresse ocupacional das enfermeiras. Métodos. Ensaio clínico controlado de tipo preventivo que se levou a cabo com a participação de 60 enfermeiras que trabalhavam em hospitais afiliados a Shahrekord University of Medical Sciences no Irã. Em forma aleatorizada, as enfermeiras foram designadas ao grupo experimental ou ao grupo controle. A intervenção consistiu num programa de exercício aeróbico realizado durante dois meses com três sessões semanais de uma hora de duração. O estresse ocupacional se mediu com o questionário Health and Safety Executive (HSE) de 35 perguntas, que tem opções de resposta tipo Likert que vão de 1 a 5, pode chegar a pontuação de 175 como máximo; a maior pontuação, é menor o nível de estresse ocupacional. Se avaliou o HSE em três momentos: a inscrição, depois de finalizar o programa de exercício (semana 8) e também dois meses depois de terminada a intervenção (semana 16). Resultados. Foi igual o nível de estresse ocupacional nos grupos de intervenção e de controle na inscrição (86.2 vs. 86.3), mas ao finalizar o programa de exercícios aeróbicos (semana 8) o grupo experimental mostrou uma pontuação maior que o do grupo controle (119.7 vs. 86.2, p<0.01), para depois diminuir esta pontuação aos dois meses de haver finalizado a intervenção, (91.4 vs. 85.8, p=0.061). Conclusão. O programa de exercício aeróbico se associou à diminuição do estresse profissional das enfermeiras no grupo de intervenção em comparação com o grupo de controle às oito semanas, mas esta diferença não se manteve quando o grupo experimental não continuou com o programa.

Humanos , Grupos Controle , Esforço Físico , Estresse Ocupacional , Enfermeiros
Invest. educ. enferm ; 37(2): [E07], 15-06-2019. Fig 1, Tab 1, Tab 2
Artigo em Inglês | LILACS, COLNAL | ID: biblio-1007626


Abstract Objective. This work was conducted to determine the effectiveness of a nursing intervention, based on the motivational interview, to diminish preoperative anxiety in patients programmed for knee replacement surgery. Methods. Preventive type controlled and randomized clinical trial, on a sample of 56 patients programmed for knee replacement surgery in a clinic in Girardot (Colombia). Random assignment was made: an intervention group (n=28) and a control group (n=28). The six-question Amsterdam Preoperative Anxiety and Information Scale was applied before and after the intervention. The scale has a total score ranging from 5 to 30; the higher the score, the greater the preoperative anxiety. The nursing intervention was conducted in three sessions of motivational interview each lasting 40 min, during the six weeks prior to the surgical procedure; the control group received conventional management of education in the health institution. Results. The mean score of preoperative anxiety was equal in the pre-intervention evaluation in both groups (19.76 in the experimental versus 22.02 in the control =22.02; p<0.226), while during the post-intervention, the anxiety score was lower in the intervention group compared with the control group (15.56 and 20.30, respectively; p<0.013). Conclusion. Nursing intervention based on the motivational interview was effective in diminishing preoperative anxiety in patients programmed for knee replacement surgery.

Resumen Objetivo. Determinar la efectividad de una intervención de enfermería basada en la entrevista motivacional, para disminuir la ansiedad preoperatoria en pacientes programados para cirugía de reemplazo de rodilla. Métodos. Ensayo clínico controlado y aleatorizado tipo preventivo, en una muestra de 56 pacientes programados para cirugía de remplazo de rodilla en una clínica en Girardot (Colombia). Se asignaron en forma aleatoria: un grupo de intervención (n=28) y un grupo de control (n=28). Antes y después de la intervención, se aplicó la escala de seis preguntas, APAIS (The Amsterdam Preoperative Anxiety and Information Scale), la cual tiene un puntaje total que va de 5 a 30: a más puntaje, mayor la ansiedad preoperatoria. La intervención de enfermería se desarrolló en 3 sesiones de entrevista motivacional con una duración de 40 minutos, durante las 6 semanas anteriores a la realización del procedimiento quirúrgico. El grupo de control recibió el manejo convencional de educación en la institución de salud. Resultados. La media del puntaje de ansiedad preoperatoria fue igual en la evaluación preintervención en los dos grupos (19.76 en el experimental versus 22.02 en el control = 22.02; p<0.226), mientras que en la posintervención el puntaje de ansiedad fue menor en el grupo de intervención comparado con el grupo control (15.56 y 20.30, respectivamente; p<0.013). Conclusión. La intervención de enfermería basada en la entrevista motivacional fue efectiva en la disminución de la ansiedad preoperatoria en pacientes programados para cirugía de reemplazo de rodilla.

Resumo Objetivo. Determinar a efetividade de uma intervenção de enfermagem baseada na entrevista motivacional, para diminuir a ansiedade pré-operatória em pacientes programados para cirurgia de prótese de joelho. Métodos. Ensaio clínico controlado e aleatorizado tipo preventivo, numa amostra de 56 pacientes programados para cirurgia de prótese de joelho numa clínica em Girardot (Colômbia). Foram designados em forma aleatória: um grupo de intervenção (n=28) e um grupo de controle (n=28). Se aplicou antes e depois da intervenção, a escala de seis perguntas, APAIS (The Amsterdam Preoperative Anxiety and Information Scale), a qual tem uma pontuação total que vá de 5 a 30 a mais pontuação, é maior a ansiedade pré-operatório. A intervenção de enfermagem se desenvolvimento em 3 sessões de entrevista motivacional com uma duração de 40 minutos, durante as 6 semanas anteriores à realização do procedimento cirúrgico; o grupo de controle recebeu o manejo convencional de educação na instituição de saúde. Resultados. A média da pontuação de ansiedade pré-operatória foi igual na avaliação préintervenção nos dois grupos (19.76 no experimental versus 22.02 no controle = 22.02; p<0.226), enquanto que na pós-intervenção a pontuação de ansiedade foi menor no grupo de intervenção comparado com o grupo controle (15.56 e 20.30, respectivamente; p<0.013). Conclusão. A intervenção de enfermagem baseada na entrevista motivacional foi efetiva na diminuição da ansiedade pré-operatória em pacientes programados para cirurgia de prótese de joelho.

Humanos , Ortopedia , Enfermagem Perioperatória , Grupos Controle , Artroplastia do Joelho , Entrevista Motivacional
Invest. educ. enferm ; 37(1): [E04], Febrero 2019.
Artigo em Inglês | LILACS, COLNAL | ID: biblio-981722


Objective. To evaluate the effect of the "Caring for Caregivers" program in the caring ability and burden in family caregivers of patients with chronic diseases at health care institutions. Methods. A randomized controlled clinical trial was conducted in 34 relatives of patients with chronic diseases that had cared for them for more than 3 months. Zarit scale was used to measure caregiver burden and the CAI (Caring Ability Inventory) was also used to measure caring ability. An educational intervention was applied based on the "Caring for Caregivers" strategy of the Universidad Nacional de Colombia. Results. Although both groups improved their percentage of unburdened caregivers from the first to the second assessment, the difference between the two assessments was 41.2% in the intervention group whereas it was 11.8% in the control group, being only statistically significant the difference for the intervention group. Regarding the caring ability, no significant changes were identified in both groups. Conclusion. On family caregivers, it was observed that the "Caring for Caregivers" intervention had a positive impact on decreasing burden, but not on improving the caring ability.

Objetivo. Evaluar el efecto del programa "Cuidando a Cuidadores" en la habilidad del cuidado y la carga de los cuidadores familiares de personas con enfermedad crónica que asisten a una institución de salud. Métodos. Ensayo clínico controlado randomizado, realizado en 34 familiares de personas con enfermedad crónica que los hubieran cuidado por más de 3 meses. Se utilizaron las escalas de ZARIT para medir la sobrecarga del cuidador y el CAI (Caring Ability Inventory) para medir la habilidad del cuidado. Se aplicó una intervención educativa basada en la estrategia "cuidando a cuidadores" de la Universidad Nacional de Colombia. Resultados. Aunque ambos grupos mejoraron en el porcentaje de cuidadores sin sobrecarga de la primera a la segunda evaluación, en el grupo de intervención la diferencia entre los dos momentos de evaluación fue de 41.2%, mientras que en el grupo control fue de 11.8%, estadísticamente significante la diferencia para el grupo de intervención. En la habilidad del cuidado no se identificaron cambios significativos en los dos grupos. Conclusión. En los cuidadores familiares se apreció que la intervención "cuidando a los cuidadores" presentó impacto positivo en disminución de la sobrecarga, pero no en la mejora de la habilidad de cuidado.

Objetivo. Avaliar o efeito do programa "Cuidando a Cuidadores" na habilidade do cuidado e a carga dos cuidadores familiares de pessoas com doenças crônica que frequentam a uma instituição de saúde. Métodos. Ensaio controlado randomizado, realizado em 34 familiares de pessoas com doenças crônica que os tiveram cuidado por mais de 3 meses. Se utilizaram as escalas de ZARIT para medir a sobrecarga do cuidador e o CAI (Caring Ability Inventory) para medir a habilidade do cuidado. Se aplicou uma intervenção educativa baseada na estratégia "cuidando a cuidadores" da Universidade Nacional de Colômbia. Resultados. Embora ambos grupos melhoraram na porcentagem de cuidadores sem sobrecarga da primeira à segunda avaliação, no grupo de intervenção a diferença entre os dois momentos de avaliação é de 41.2%, enquanto que no grupo controle é de 11.8%, sendo unicamente estatisticamente significante esta diferença para o grupo de intervenção. Na habilidade do cuidado não se identificaram câmbios significativos nos dos grupos. Conclusão. Nos cuidadores familiares se apreciou que a intervenção "cuidando aos cuidadores" apresentou impacto positivo em diminuição da sobrecarga, mas não na melhora da habilidade de cuidado.

Humanos , Doença Crônica , Grupos Controle , Ensaio Clínico , Cuidadores , Doenças não Transmissíveis
Invest. educ. enferm ; 37(1): [E09], Febrero 2019.
Artigo em Inglês | LILACS, COLNAL | ID: biblio-987576


Objective. To investigate how group reflection about spiritual care affects nursing students' spiritual wellbeing and attitude toward spirituality and spiritual care. Methods. This was a randomized controlled trial conducted on 63 second-year nursing students who were studying at Nursing and Midwifery Colleges in Shiraz and Jahrom, both located in south of Iran. The students were randomly divided into an intervention (n=30) and a control (n=33) group. The study data were collected using the Spiritual Well-Being Scale and Spirituality and Spiritual Care Rating Scale before and after the intervention. The intervention consisted in four sessions of group reflection based on the scenarios related to spiritual care. The control group was given a related lecture in one session. Results. A significant difference was found between the two groups' means in spiritual well-being scores after the interventioncompared to before that. Likewise, a significant difference was observed in the intervention group students' total scores of attitude before and after the intervention. Conclusion. Group reflection improved the nursing students' spiritual well-being and their attitude toward spirituality and spiritual care compared with control group.

Objetivo. Investigar cómo la reflexión grupal sobre el cuidado espiritual afecta el bienestar espiritual y la actitud de los estudiantes de enfermería hacia la espiritualidad y el cuidado espiritual. Métodos. Este fue un ensayo controlado aleatorio realizado en 63 estudiantes de segundo año de dos escuelas de enfermería y partería en Irán. Los estudiantes se dividieron aleatoriamente en los grupos de intervención (n=30) y de control (n=33). Los datos del estudio se recopilaron utilizando la Escala de Bienestar Espiritual y la Escala de Calificación de Espiritualidad y Cuidado Espiritual antes y después de la intervención. La intervención consistió en cuatro sesiones de reflexión grupal basadas en escenarios relacionados con el cuidado espiritual. El grupo de control recibió solamente una conferencia relacionada con el tema. Resultados. Se encontró una diferencia significativa entre las medias de los dos grupos en cuanto a las puntuaciones de bienestar espiritual después de la intervención en comparación con la de la preintervención. Asimismo, se observó una diferencia significativa en las puntuaciones totales de actitud de los estudiantes del grupo de intervención antes y después de la intervención. Conclusión. La reflexión grupal mejoró el bienestar espiritual de los estudiantes de enfermería y su actitud hacia la espiritualidad y el cuidado espiritual en comparación con el grupo de control.

Objetivo. Investigar como a reflexão grupal sobre o cuidado espiritual afeta o bemestar espiritual e a atitude dos estudantes de enfermagem para a espiritualidade e o cuidado espiritual. Métodos. Este foi um ensaio controlado aleatório realizado em 63 estudantes de segundo ano de duas escolas de enfermagem e de parteiras no Irã. Os estudantes se dividiram aleatoriamente nos grupos de intervenção (n=30) e de controle (n=33). Os dados do estudo se recopilaram utilizando a Escala de Bemestar Espiritual e a Escala de Qualificação de Espiritualidade e Cuidado Espiritual antes e depois da intervenção. A intervenção consistiu em quatro sessões de reflexão grupal baseadas em cenários relacionados com o cuidado espiritual. O grupo de controle recebeu somente uma conferência relacionada com o assunto. Resultados. Se encontrou uma diferença significativa entre as médias dos dois grupos em quanto às pontuações de bem-estar espiritual depois da intervenção em comparação com a da pré-intervenção. Assim mesmo, se observou uma diferença significativa nas pontuações totais de atitude dos estudantes do grupo de intervenção antes e depois da intervenção. Conclusão. A reflexão grupal melhorou o bem-estar espiritual dos estudantes de enfermagem e sua atitude à espiritualidade e o cuidado espiritual em comparação com o grupo de controle.

Humanos , Estudantes de Enfermagem , Atitude , Grupos Controle , Espiritualidade , Cuidados de Enfermagem
Arch. Soc. Esp. Oftalmol ; 94(2): 75-80, feb. 2019. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-180368


Antecedentes: El marcado descenso en los niveles de C-LDL producidos por los inhibidores de la proproteína convertasa plasmática subtilisina kexina tipo 9 (iPCSK9) podría asociarse con un mayor riesgo de cataratas. Métodos: Realizamos un metaanálisis que incluyó ensayos clínicos aleatorizados y controlados con iPCSK9, solos o combinados con otros fármacos hipolipidemiantes, que reportaron nuevos casos de cataratas, buscando en PubMed/Medline, bases de datos de EMBASE y Cochrane Clinical Trials. Se utilizó un modelo de efectos fijos y se realizó una metarregresión evaluando la relación entre el C-LDL intratratamiento y el riesgo de desarrollar cataratas. Resultados: Se tomaron en cuenta 5 estudios elegibles con iPCSK9 que incluyeron 83.492 pacientes para el análisis, refiriendo 531 nuevos casos de cataratas en el grupo con iPCSK9 frente a 532 en el grupo placebo. La terapia con iPCSK9 no se asoció con un mayor riesgo de presentar cataratas (OR: 0,96; IC 95%: 0,85-1,08; p = 0,86, I2: 0%]. Asimismo, no se encontró una asociación significativa entre la diferencia de C-LDL intratratamiento entre las ramas de los estudios y el riesgo de cataratas. Conclusión. En nuestro análisis, la utilización de iPCSK9 no se asoció con un mayor riesgo de cataratas

Background: The marked decrease in LDL-C levels produced by the inhibitors of the plasma proprotein convertase subtilisin/kexin type 9 (iPCSK9) could be associated with an increased risk of cataracts. Methods: A meta-analysis was performed that included randomised clinical trials controlled with iPCSK9, alone, or in combination with other lipid-lowering drugs, which reported new cases of cataracts, by searching PubMed/Medline, databases of EMBASE and Cochrane Clinical Trials. A fixed-effect model was used, and a meta-regression was carried out evaluating the relationship between intra-treatment LDL-C and the risk of developing cataracts. Results: Five eligible studies of iPCSK9 including 83,492 patients were taken into account for the analysis, and 531 new cases of cataracts in iPCSK9 group vs. 532 in placebo group were diagnosed. The iPCSK9 therapy was not associated with an increased risk of cataracts [OR: 0.96, 95% CI: 0.85-1.08; P = .86, I2: 0%]. Likewise, no significant association was found between on-treatment LDL-C levels, differences between study arms, and new cases of cataracts. Conclusion: In this analysis, the use of iPCSK9 was not associated with an increased risk of cataracts

Humanos , Oftalmopatias/classificação , Inibidores de Proteases/classificação , Lipoproteínas LDL/classificação , Preparações Farmacêuticas/classificação , Cardiopatias/classificação , Placebos/classificação , Colesterol/classificação , Grupos Controle
Trials ; 20(1): 128, 2019 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-30760299


BACKGROUND: Binge-eating disorder (BED) is characterized by recurrent episodes of loss of control over eating and is related to a higher prevalence of other mental disorders and somatic consequences associated with overweight and obesity. In community-based samples, 2-4% of women and 1-3% men are diagnosed with BED. Psychotherapeutic interventions focusing on maintenance factors of disturbed eating behavior have proven to be effective. However, treatment access is limited for a considerable number of patients with BED. A lack of specialized institutions and treatment resources, but also long distances to treatment facilities for people living in remote or rural areas are often causes of insufficient care. Internet-based guided self-help (GSH) programs have the potential to fill this gap. METHODS: This project aims to develop and evaluate an Internet-based treatment for BED derived from an evidence-based manualized cognitive behavioral therapy (CBT). The primary goal is to test feasibility and suitability of the Internet-based program and to evaluate the treatment outcome in comparison to a pure and a placebo-inspired waitlist control group (i.e. reduction of binge-eating episodes and eating disorder pathology as primary outcome variables). In total, 60 women and men aged 18-70 years with a BED diagnosis will be recruited. The Internet-based GSH treatment comprises eight sessions followed by three booster sessions. The placebo-inspired waitlist control group receives weekly messages containing information increasing positive expectations regarding the treatment effects during the four-week waiting period. The pure waitlist control group receives weekly messages simply asking patients to fill in a short questionnaire. DISCUSSION: The access to evidence-based treatments for BED might be made easier using an Internet-based GSH approach. The present study protocol presents a randomized controlled trial. As well as evaluating the suitability and efficacy of the Internet-based GSH treatment, there will also be a prelimarily investigation on the influence of positive expectations (placebo) for a therapeutic intervention on core symptoms. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00012355 . Registered on 14 September 2017.

Transtorno da Compulsão Alimentar/terapia , Terapia Cognitivo-Comportamental , Internet , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Idoso , Grupos Controle , Estudos de Viabilidade , Humanos , Pessoa de Meia-Idade , Placebos , Resultado do Tratamento , Listas de Espera
Artigo em Inglês | MEDLINE | ID: mdl-30595210


A database of the micronuclei counts was built up for historical negative control data from human lymphocyte in vitro micronuclei tests (MnVit) carried out in 8 laboratories with experience of the method. The mean incidence of micronucleated cells (mnt)/1000 cells ranged from 2.2/1000 to 15.9/1000. There were no large differences in incidence between the presence or absence of S9 mix or between different treatment lengths. There was also little evidence that different solvents affected the numbers of micronuclei appreciably. A number of laboratories did show significant inter-experiment variability, indicating that there remained unidentified factors affecting frequencies. Donor variance may be one such factor. Inter-individual variability may explain some of these differences. The approximate 7.5-fold difference in mnt/1000 scores in a relatively small group of experienced laboratories illustrates the potential complications that can arise if a metric like a fold increase was considered the only biologically important finding. Although there is inherent variability between experiments, it was evident that within a laboratory the overall laboratory mean remains constant over time. It is believed that these findings will provide help to laboratories conducting studies using human lymphocytes in the MnVit and to those involved in the assessment of MnVit results.

Núcleo Celular/fisiologia , Grupos Controle , Linfócitos/metabolismo , Testes para Micronúcleos/métodos , Solventes/farmacologia , Adolescente , Adulto , Divisão Celular , Feminino , Humanos , Masculino , Inquéritos e Questionários , Adulto Jovem
Toxicol Pathol ; 47(1): 53-72, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30563426


We assessed the variability of spleen and mesenteric lymph node (MLN) microscopic observations and the correlations of these observations with other study data from 478 control cynomolgus monkeys from 53 routine nonclinical safety studies. Spleen weight parameters (absolute and relative to body or brain weights) were highly variable both within a control group on an individual study (up to 5.11-fold) and among animals with the same light microscopic observation. Grades for microscopic observations were also highly variable. The most frequent microscopic observations for spleen were changes in the size and number of germinal centers (58%), acidophilic (hyaline) material in lymphoid follicles (52%), and compound lymphoid follicles (20%). The most frequent microscopic observations in the MLN were eosinophil infiltrates (90%), changes in size and number of germinal centers (42%), and brown pigment (21%). The only meaningful relationships ( r2 > 0.3) were positive correlations between reticuloendothelial hyperplasia and malarial pigment in the spleen and between each of these observations and spleen weight parameters. We conclude that determination of test article-related effects on the immune system in routine monkey toxicology studies requires careful consideration and a weight-of-evidence approach due to the low numbers of animals/group, the inherent variability in spleen and MLN parameters, and the infrequent correlation among immune system-related end points.

Linfonodos/anatomia & histologia , Macaca fascicularis/imunologia , Baço/anatomia & histologia , Testes de Toxicidade/normas , Envelhecimento , Animais , Grupos Controle , Centro Germinativo , Linfonodos/crescimento & desenvolvimento , Linfonodos/imunologia , Macaca fascicularis/anatomia & histologia , Macaca fascicularis/crescimento & desenvolvimento , Tamanho do Órgão , Baço/crescimento & desenvolvimento , Baço/imunologia
Regul Toxicol Pharmacol ; 102: 13-22, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30572081


Recent updates of the OECD Guidelines for the Testing of Chemicals (Section 4: Health Effects) on genotoxicity testing emphasize the use of appropriate statistical methods for data analysis and proficiency proof. Updates also concern the mammalian erythrocyte micronucleus test (OECD 474), as the currently most often performed regulatory in vivo test. As the updated guideline gives high importance to adequate statistical assessment of historical negative control data to estimate validity of experiments and judge results, the present study evaluated statistical methodologies for handling of historical negative control data sets, and comes forward with respective proposals and reference data. Therefore, the working group "Statistics" within the German-speaking "Gesellschaft für Umwelt-Mutationsforschung e.V." (GUM) compiled a data set of 891 negative control rats from valid OECD 474-studies of four laboratories. Based on these data, Analysis-of-Variance (ANOVA) identified "laboratory" and "strain", but not "gender" as relevant stratification parameters, and argued for approximately normally distributed micronucleus frequencies in polychromatic erythrocytes per animal. This assumption provided the basis for further specifying one-sided parametric tolerance intervals for determination of corresponding upper historical negative control limits. Finally, the stability of such limits was investigated as a function of the number of experiments performed, using a simulation-based statistical strategy.

Grupos Controle , Testes para Micronúcleos/estatística & dados numéricos , Animais , Medula Óssea , Feminino , Masculino , Ratos Wistar , Valores de Referência
Nurse Res ; 26(2): 37-40, 2019 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-30226337


BACKGROUND: Quantitative research designs are broadly classified as either experimental or quasi-experimental. The main distinguishing feature of the quasi-experiment is the manipulation of the independent variable without randomisation. When randomisation or use of a control group is unfeasible, a researcher can choose from a range of quasi-experimental designs. AIM: To present the features of the quasi-experimental 'non-equivalent control group post-test-only' design, which aims to demonstrate causality between an intervention and an outcome. DISCUSSION: This paper provides an overview of the non-equivalent control group post-test-only design in terms of its design features, applications and statistical analysis, as well as its advantages and disadvantages. CONCLUSION: The non-equivalent control group post-test-only design can be used in natural settings, where randomisation cannot be conducted for ethical or practical reasons. Although the design is less complex than some other designs, with low error propagation, it is vulnerable to threats to internal validity.

Grupos Controle , Coleta de Dados , Pesquisa em Enfermagem , Projetos de Pesquisa
J. vasc. bras ; 18: e20180073, 2019. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1002487


Background Elevated arterial stiffness is associated with increased cardiovascular mortality. The relationship between arterial stiffness and critical limb ischemia (CLI) is not well established. Objectives The objective of this study is to analyze the relationship between arterial stiffness indices and the degree of limb ischemia measured by the ankle-brachial index (ABI). Methods A cross-sectional study comparing patients with CLI and controls. Arterial stiffness was measured using brachial artery oscillometry. The arterial stiffness indices pulse wave velocity (PWV) and augmentation index normalized to 75 beats/min (AIx@75) were determined. Multiple linear regression was applied to identify predictors of arterial stiffness indices. Results Patients in the CLI group had higher PWV (12.1±1.9 m/s vs. 10.1±1.9 m/s, p < 0.01) and AIx@75 (31.8±7.8% vs. 17.5±10.8%, p < 0.01) than controls. Central systolic pressure was higher in the CLI group (129.2±18.4 mmHg vs. 115.2±13.1 mmHg, p < 0.01). There was an inverse relationship between AIx@75 and ABI (Pearson coefficient = 0.24, p = 0.048), but there was no relationship between ABI and PWV (Pearson coefficient = 0.19, p = 0.12). In multiple regression analysis, reduced ABI was a predictor of elevated levels of AIx@75 (β = -25.02, p < 0.01). Conclusions Patients with CLI have high arterial stiffness measured by brachial artery oscillometry. The degree of limb ischemia, as measured by the ABI, is a predictor of increased AIx@75. The increased AIx@75 observed in CLI may have implications for the prognosis of this group of patients with advanced atherosclerosis

A rigidez arterial aumentada está associada ao aumento da mortalidade cardiovascular. A relação entre rigidez arterial e isquemia crítica do membro (IC) não está bem estabelecida. Objetivos O objetivo deste estudo é analisar a relação entre índices de rigidez arterial e o grau de isquemia de membro medido pelo índice tornozelo-braço (ITB). Métodos Foi feito um estudo transversal em pacientes com IC e controles. A rigidez arterial foi medida usando a oscilometria da artéria braquial. Os índices de rigidez arterial mensurados foram a velocidade de onda de pulso (VOP) e o índice de aumentação corrigido para a frequência cardíaca de 75 batimentos/min (AIx@75). Regressão linear múltipla foi aplicada para identificar preditores dos índices de rigidez arterial. Resultados Pacientes do grupo IC tiveram VOP (12,1±1,9 m/s vs. 10,1±1,9 m/s, p < 0,01) e AIx@75 (31,8±7,8% vs. 17,5±10,8%, p < 0,01) maiores que controles. Pressão sistólica central foi maior no grupo IC (129,2±18,4 mmHg vs. 115,2±13,1 mmHg, p < 0,01). Houve uma relação inversa entre o AIx@75 e o ITB (coeficiente de Pearson = 0,19, p = 0,12). A análise de regressão múltipla mostrou que o ITB reduzido foi um preditor de elevação do AIx@75 (β = -25,02, p < 0,01). Conclusões Pacientes com IC têm elevada rigidez arterial medida por oscilometria da artéria braquial. O grau de isquemia do membro, medido pelo ITB, é um preditor do AIx@75 elevado. O aumento do AIx@75 na IC pode ter implicações de prognóstico no grupo de pacientes com aterosclerose avançada

Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Artéria Braquial , Índice Tornozelo-Braço , Rigidez Vascular , Isquemia/diagnóstico , Oscilometria/métodos , Pressão Sanguínea , Doenças Cardiovasculares/mortalidade , Grupos Controle , Estudos Transversais , Análise Estatística , Extremidade Inferior , Diabetes Mellitus , Aterosclerose/complicações , Doença Arterial Periférica , Hipertensão
Toxicol In Vitro ; 54: 189-193, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30290203


Positive controls are an important feature in experimental studies as they show the responsiveness of the model under investigation. An often applied reagent for a pro-inflammatory stimulus is the endotoxin lipopolysaccharide (LPS), which has been shown to induce a cytokine release by various cell cultures. The effect of LPS in monocultures of 16HBE14o-, a bronchial cell line, and of A549, an alveolar cell line, were compared in submerged and air-liquid interface cultures, as well as in co-cultures of the two epithelial cells with monocyte-derived macrophages and dendritic cells. The protein and mRNA levels of the two most relevant pro-inflammatory mediators, Tumor necrosis factor alpha (TNF) and Interleukin 8 (CXCL8), were measured after 4 h and 24 h exposure. 16HBE14o- cells alone as well as in co-cultures are non-responsive to an LPS stimulus, but an already increased basal expression of both pro-inflammatory mediators after prolonged time in culture was observed. In contrary, A549 in monocultures showed increased CXCL8 production at the gene and protein level after LPS exposure, while TNF-levels were below detection limit. In A549 co-cultured with immune cells both mediators were upregulated. This study shows the importance of a careful evaluation of the culture system used, including the application of positive controls. In addition, the use of co-cultures with immune cells more adequately reflects the inflammatory response upon exposure to toxicants.

Grupos Controle , Inflamação/induzido quimicamente , Lipopolissacarídeos/farmacologia , Testes de Toxicidade/métodos , Linhagem Celular , Técnicas de Cocultura , Humanos , Inflamação/genética , Inflamação/metabolismo , Interleucina-8/genética , Interleucina-8/metabolismo , Pulmão/citologia , Fator de Necrose Tumoral alfa/genética , Fator de Necrose Tumoral alfa/metabolismo
Invest. educ. enferm ; 36(3): [e09], Diciembre 15 de 2018. Tab 1, Tab 2, Tab 3, Fig 1
Artigo em Inglês | LILACS, COLNAL | ID: biblio-967236


Objective. To establish the effect of tele-nursing in the improving of the ultrasound findings in patients with non-alcoholic fatty liver disease. Methods. In this clinical trial, 60 patients with non-alcoholic fatty liver referring to specialized gastroenterology clinics affiliated to Shiraz University of Medical Sciences (Iran) were selected were randomly assigned to control or intervention group. All patients received necessary trainings on diet and physical activity. The subjects in the intervention group were followed up via phone by nurses for 12 weeks (twice a week during the first month and once a week during the following two months). The control group participants did not receive any interventions and were only followed up as usual by a specialist. Before and after the intervention, the liver size and histological status of their liver were examined using ultrasound in all the participants. Results. After 12 weeks of start of the study, the mean of liver size decreased in the group followed up via phone by a nurse (13.15±1.22 cm to 12.90±1.16 cm, p=0.013), but this did not change significantly in the control group (12.55±1.56 cm to 12.56±1.57 cm, p=0.326). The greater difference in the mean liver size between the evaluations was in the intervention group with 0.26±0.53 cm versus -0.003±0.018 cm in the control group (p=0.012). Additionally, the fatty infiltration status of the liver tissue improves in the 66.6% of the intervention group versus 6.6% in the control group (p<0.001). Conclusion. The results of this study showed that tele-nursing led to improvement in liver size and liver histology in patients with Non-alcoholic fatty liver.(AU)

Objetivo. Establecer el efecto de la tele-enfermería en la mejoría de los hallazgos ecográficos en pacientes con hígado graso no alcohólico. Métodos. En este ensayo clínico, 60 pacientes con hígado graso no alcohólico referidos a servicios de Gastroenterología especializada afiliadas a la Universidad de Ciencias médicas de Shiraz (Irán) se dividieron aleatoriamente en los grupos de control y de intervención. Todos los pacientes recibieron capacitaciones sobre aspectos de la dieta y la actividad física. Los pacientes del grupo de intervención tuvieron seguimiento telefónico por enfermera (dos veces a la semana en el primer mes y una vez por semana los otros dos meses), y los del grupo control no recibieron atenciones diferentes a las consultas usuales al especialista. Tanto al ingreso al estudio como a las 12 semanas, a todos los participantes se les evaluó con ultrasonografía el tamaño y el estado histológico del hígado. Resultados. Después de 12 semanas de inicio del estudio decreció el tamaño del hígado en el grupo con seguimiento telefónico por enfermera (13.15±1.22 cm a 12.90±1.16 cm, p=0.013), mientras que no se observó diferencia significante en el grupo control (12.55 1.56 cm a 12.56±1.57 cm, p=0.326). La más grande diferencia entre las dos evaluaciones fue en el grupo de intervención con 0.26±0.53 cm versus -0.003±0.018 cm en el grupo control (p=0.012). Adicionalmente, el estado de infiltración grasa del tejido hepático mejoró en el 66.6% del grupo de intervención versus 6.6% en el grupo de control (p<0.001). Conclusión. Los resultados de este estudio mostraron que la tele-enfermería condujo a la mejoría del tamaño de hígado y la histología hepática en pacientes con hígado graso no alcohólico.(AU)

Objetivo. Estabelecer o efeito da tele-enfermagem na melhora das descobertas ecográficos em pacientes com fígado grasso não alcoólico. Métodos. Neste ensaio clínico, 60 pacientes com fígado grasso não alcoólico referidos a serviços de Gastrenterologia especializada afiliadas à Universidade de Ciências médicas de Shiraz (Irão) foram divididos aleatoriamente nos grupos de controle e de intervenção. Todos os pacientes receberam capacitações sobre aspectos da dieta e a atividade física. Os pacientes do grupo de intervenção tiveram seguimento telefónico por enfermeira (duas vezes por semana no primeiro mês e uma vez por semana os outros dois meses), e os do grupo controle não receberam atenções diferentes às consultas usuais ao especialista. A todos os participantes ao ingresso ao estudo e às 12 semanas se lhes avaliou com ultrassonografia o tamanho e o estado histológico do fígado. Resultados. Depois de 12 semanas de início do estudo diminuiu o tamanho do fígado no grupo com seguimento telefónico por enfermeira (13.15±1.22 cm a 12.90±1.16 cm, p=0.013), enquanto que não se observou diferença significante no grupo controle (12.55 1.56 cm a 12.56±1.57 cm, p=0.326). A maior diferença entre as duas avaliações foi no grupo de intervenção com 0.26±0.53 cm versus -0.003±0.018 cm no grupo controle (p=0.012). Adicionalmente, o estado de infiltração grassa do tecido hepático melhorou em 66.6% do grupo de intervenção versus 6.6% no grupo de controle (p<0.001). Conclusão. Os resultados deste estudo mostraram que a tele-enfermagem conduz à melhora do tamanho de fígado e a histologia hepática em pacientes com fígado grasso não alcoólico.(AU)

Humanos , Grupos Controle , Ultrassonografia , Ensaio Clínico Controlado Aleatório , Telenfermagem , Hepatopatia Gordurosa não Alcoólica
Med. intensiva (Madr., Ed. impr.) ; 42(8): 490-499, nov. 2018. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-180521


En los estudios de casos y controles anidados, el muestreo de los controles se hace habitualmente por densidad de incidencia y mediante emparejamiento. Con respecto a los casos control clásicos, son más eficientes, permiten el cálculo de la incidencia de la enfermedad y cuentan con más validez interna por la menor presencia de sesgo. Las técnicas de riesgos competitivos pueden usarse si se estudian diferentes tipos de eventos y nos centramos en el tiempo y el tipo del primer evento. El particionamiento recursivo es un tipo de análisis multivariante cuyo propósito es la construcción de algoritmos de clasificación, especialmente útiles cuando hay un gran número de variables predictoras con relaciones complejas con el evento objeto de estudio

In nested case-control studies, sampling of controls is usually done by density of incidence and pairing. With regard to the classic control cases studies, nested ones are more efficient, allow the calculation of the incidence of the disease and they have more internal validity due to the lower presence of bias. Competitive risks techniques can be used if we study different types of events and focus on the time and type of the first event. Recursive partitioning is a type of multivariate analysis whose purpose is the construction of classification algorithms, and it is especially useful when there are a large number of predictive variables with complex relationships with the event

Humanos , Estudos de Casos e Controles , Ensaios Clínicos como Assunto/ética , Cuidados Críticos/estatística & dados numéricos , Estudos Epidemiológicos , Pesquisa/estatística & dados numéricos , Algoritmos , Causalidade , Ensaios Clínicos como Assunto/estatística & dados numéricos , Grupos Controle , Projetos de Pesquisa Epidemiológica , Ética em Pesquisa , Estudos Observacionais como Assunto/ética , Estudos Observacionais como Assunto/estatística & dados numéricos
BMC Infect Dis ; 18(1): 466, 2018 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-30223772


BACKGROUND: To prevent cross infection the surgical team perform preoperative hand disinfection before dressed in surgical gowns and gloves. Preoperative hand disinfection does not make hands sterile and the surgical glove cuff end has been regarded as a weak link, since it is not a liquid-proof interface. The aims were to investigate if there were differences in bacterial growth and recolonization of hands between operating room nurses and non-health care workers as well as to investigate if bacterial growth existed at the surgical glove cuff end during surgery. METHODS: This pilot project was conducted as an exploratory comparative clinical trial. Bacterial cultures were taken from the glove and gown interface and at three sites of the hands of 12 operating room nurses and 13 non-health care workers controls directly after preoperative hand disinfection and again after wearing surgical gloves and gowns. Colony forming units were analysed with Mann-Whitney U test and Wilcoxon Sign Ranks test comparing repeated measurements. Categorical variables were evaluated with chi-square test or Fisher's exact test. RESULTS: Operating room nurses compared to non-health care workers had significant higher bacterial growth at two of three culture sites after surgical hand disinfection. Both groups had higher recolonization at one of the three culture sites after wearing surgical gloves. There were no differences between the groups in total colony forming units, that is, all sampling sites. Five out of 12 of the operating room nurses had bacterial growth at the glove cuff end and of those, four had the same bacteria at the glove cuff end as found in the cultures from the hands. Bacteria isolated from the glove cuff were P. acnes, S. warneri, S. epidermidis and Micrococcus species, the CFU/mL ranged from 10 to 40. CONCLUSIONS: There were differences in bacterial growth and re-colonization between the groups but this was inconclusive. However, bacterial growth exists at the glove cuff and gown interface, further investigation in larger study is needed, to build on these promising, but preliminary, findings. TRIAL REGISTRATION: Trial registration was performed prospectively at Research web (FOU in Sweden, 117,971) 14/01/2013, and retrospectively at ( NCT02359708 ). 01/27/2015.

Bactérias/crescimento & desenvolvimento , Desinfecção das Mãos , Mãos/microbiologia , Enfermeiras e Enfermeiros , Salas Cirúrgicas , Adulto , Bactérias/citologia , Contagem de Colônia Microbiana , Grupos Controle , Infecção Hospitalar/microbiologia , Infecção Hospitalar/prevenção & controle , Feminino , Luvas Protetoras/microbiologia , Luvas Cirúrgicas/microbiologia , Desinfecção das Mãos/normas , Voluntários Saudáveis , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Período Pré-Operatório , Infecção da Ferida Cirúrgica/microbiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Suécia , Recursos Humanos
J Toxicol Sci ; 43(9): 557-563, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30185696


There is sometimes controversy over whether or not statistically significant responses produced in carcinogenicity studies have biologically significance. Ambiguous results from our previous two-year oral carcinogenicity study on acotiamide hydrochloride hydrate (acotiamide-HH), a prokinetic drug for functional dyspepsia, in rats made it unclear whether the drug may exhibit uterine carcinogenicity. To check this finding, we performed a second long-term carcinogenicity study using two identical control groups to more accurately evaluate uterine carcinogenesis by considering the incidence of spontaneous neoplasms. Female Fischer 344 rats were divided into three groups: the two control groups (control 1 and 2) were administered vehicle (0.5% w/v methylcellulose) and the acotiamide-HH-treated group was administered 2,000 mg/kg/day of acotiamide-HH by oral gavage for two years. Among all groups, the incidence of endometrial adenocarcinoma (EmA) was highest in the control 2 group, followed by the acotiamide-HH-treated group and the control 1 group. Moreover, acotiamide-HH did not affect the incidence of precursor lesions of EmA. In cases where an ambiguous difference is observed, the use of two control groups allows for a more informed interpretation of the findings in the drug-treated groups. The outcomes in this study strongly support the hypothesis that the increase in EmA in rats treated with acotiamide-HH in our previous study is unrelated to administration of the drug.

Adenocarcinoma/induzido quimicamente , Benzamidas/toxicidade , Testes de Carcinogenicidade/métodos , Grupos Controle , Neoplasias do Endométrio/induzido quimicamente , Tiazóis/toxicidade , Administração Oral , Animais , Benzamidas/administração & dosagem , Reações Falso-Positivas , Feminino , Ratos Endogâmicos F344 , Tiazóis/administração & dosagem , Fatores de Tempo