the health and well-being of nursing students in clinical practice . what prevents it? what promotes it?

Introduction: The training of nursing students in the context of clinical practice, is characterized by educational experiences, subject to various emotional stress (stress, ambivalence, frustration, conflict), sometimes making it very vulnerable student.However not all students use the same strategies minimizing their meanings and negative effects on the level of your health and well-being Objetiv:To analyze the perception that nursing students have about the determinants of their health status and well-being in clinical practice Methods: Exploratory research Results:The results reveal the complexity of the teaching / learning process in clinical practice, identified determinants that limit and / or promote health and well-being of students, or not contributing to their motivation, self-confidence and learning. All students value the presence of the following dimensions: affective-emotional (humanization in learning experiences); relational dynamics (interactions developed with all stakeholders); methods used (professional competence of the clinical supervisor and teacher); school curriculum (adaptation of learning in theory); socialization to the profession (become nurse).Conclusions: The results indicate, that although all students evidencing the dimensions described as fundamental to learning in clinical practice, the study results are dichotomous and ambivalent. Students 2nd and 3ºanos refer a low perception in clinical practice, the indicated dimensions, and for these source of concern and uncertainty in learning, such as limiting their health condition and well-being. For students of the 4th year, these dimensions are percecionadas as gifts, and sources of motivation, learning and catalysts such as promoting their health and well-being.

Integrated molecular analysis of endometrial carcinoma: translation of biomarker profiles into the clinical practice

The Cancer Genome Atlas (TCGA) collaborative project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompassed POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP tumors present a wide variability in molecular alterations and biological aggressiveness. This study aims to investigate the impact of ARID1A and CTNNB1/β-catenin alterations by targeted Next-generation sequencing (NGS) and immunohistochemistry (IHC) in a consecutive series of 125 molecularly classified ECs. NGS and IHC were used to assign surrogate TCGA groups and to identify molecular alterations of multiple target genes including POLE, PTEN, ARID1A, CTNNB1, TP53. Associations with clinicopathologic parameters, molecular subtypes, and outcomes identified NSMP category as the most heterogeneous group in terms of clinicopathologic features and outcome. Integration of surrogate TCGA molecular classification with ARID1A and β-catenin analysis showed NSMP cases with ARID1A mutation characterized by the worst outcome with early recurrence, while NSMP tumors with ARID1A wild-type and β-catenin alteration had indolent clinicopathologic features and no recurrence. This study indicates how the identification of ARID1A and β-catenin alterations in EC represents a simple and effective way to characterize NSMP tumor aggressiveness and metastatic potential.

Omission of axillary clearance in patients with early breast cancer and positive sentinel node biopsy treated with conservative surgery: application of the ACOSOG Z011 trial in clinical practice

Background: Axillary lymph node dissection (ALND) in presence of sentinel lymph node (SLN) metastases has been the standard in breast cancer (BC) patients for many years. Today, after the publication of the ACOSOG Z0011 trial, ALND is a procedure restricted to a dwindling group of patients with a clearly metastatic axilla. Material and methods: This was a prospective observational trial involving two Italian Breast Units: Policlinico di Sant’Orsola and San Raffaele hospital. Objective was to evaluate that the omission of ALND in patients with cT1-2 cN0 BC undergoing breast conserving surgery (BCS) and histological finding of metastases in 1 or 2 SLN is not associated with a worse prognostic outcome. Primary endpoint was overall survival (OS). Secondary endpoints were disease free survival (DFS) and locoregional recurrence. All BC patients treated between the 1st of November 2020 and 31st of July 2023 with cT1-2 cN0 BC, preoperative negative axillary ultrasound and 1 or 2 metastatic SLN treated with sentinel node biopsy (SLNB) alone entered the study. Results: 795 cT1-2 cN0 BC patients underwent BCS and SLNB. Ninety patients were included. Median age was 60 (52-68) years. Seventy-five patients (83%) had T1 tumor and 15 (17%) T2. Median tumor size was 16 mm (11-19). The median SLN removed was 2 (1-3). Eighty-one patients had 1 positive SLN (90%), while 9 had 2 SLN metastasis (10%). 39 (43%) micrometastases were identified and 51 macrometastasis (57%). All patients underwent radiotherapy. Seventeen (19%) performed adjuvant chemotherapy. Two received immunotherapy with trastuzumab and pertuzumab. Endocrine therapy was given to 84 (93%). At a median follow-up of 19 months (IQR 13-23) OS and DFS were 100%. No loco-regional recurrence was seen. Conclusion: The preliminary results of our study confirm that omitting ALND in patients meeting Z011 criteria is oncologically safe and should be the standard of care.

Transcorneal Electrical Stimulation for Patients with Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Exploratory Study

PURPOSE. To assess the safety of transcorneal electrical stimulation (TES) and explore its efficacy in various subjective and objective parameters of visual function in patients with retinitis pigmentosa (RP). METHODS. Twenty-four patients in this prospective, randomized, partially blinded, good-clinical-practice study underwent TES (5-ms biphasic pulses; 20 Hz; DTL electrodes) 30 minutes per week for 6 consecutive weeks. The patients were randomly assigned to one of three groups: sham, 66%, or 150% of individual electrical phosphene threshold (EPT). Visual acuity (VA), visual field (VF; kinetic, static), electroretinography (Ganzfeld, multifocal), dark-adaptation (DA), color discrimination, and EPTs were assessed at all visits or four times, according to the study plan. RESULTS. TES using DTL electrodes was tolerated well; all patients finished the study. Two adverse (foreign body sensation), but no serious adverse events were encountered. There was a tendency for most functional parameters to improve (8/18) or to remain constant (8/18) in the 150% group. VF area and scotopic b-wave amplitude reached statistical significance (P < 0.027 and P < 0.001, respectively). Only desaturated color discrimination and VF mean sensitivity decreased. There was no obvious trend in the 66% group. CONCLUSIONS. TES was found to be safe in RP patients. Positive trends were discovered, but due to the small sample size of this exploratory study, statistical significance was reached only for VF area and scotopic b-wave amplitude. Further studies with larger sample sizes and longer duration are needed to confirm the findings and to define optimal stimulation parameters. (ClinicalTrials.gov number, NCT00804102.) (Invest Ophthalmol Vis Sci. 2011;52:4485-4496) DOI:10.1167/iovs.10-6932

EAACI Position Paper: prevention of work-related respiratory allergies among pre-apprentices or apprentices and young workers.

ABSTRACT: Apprenticeship is a period of increased risk of developing work-related respiratory allergic diseases. There is a need for documents to provide appropriate professional advice to young adults aiming to reduce unsuitable job choices and prevent impairment from their careers. The present document is the result of a consensus reached by a panel of experts from European and non-European countries addressed to allergologists, pneumologists, occupational physicians, primary care physicians, and other specialists interested in this field, which aims to reduce work-related respiratory allergies (rhinoconjunctivitis and asthma) among allergic or nonallergic apprentices and other young adults entering the workforce. The main objective of the document is to issue consensus suggestions for good clinical practice based on existing scientific evidence and the expertise of a panel of physicians.

Diabetes in pregnancy: are we providing the best care?

This third and final report of the CEMACH national diabetes programme comes at an important time in the national drive to improve services for women with diabetes in pregnancy. The National Service Framework (NSF) for Diabetes requires the NHS to develop, implement and monitor policies that seek to empower and support women with diabetes to optimise the outcomes of their pregnancy. The CEMACH report shows that, whilst progress has been made in improving services for women with diabetes and their babies, there is much still to be done to meet the standards recommended by the NSF. Too many women continue to be poorly prepared for pregnancy in the critical areas of glycaemic control and folic acid supplementation. The report underlines the need for an increased focus on diabetes preconception care services and the development of strategies to educate women with diabetes of childbearing age. The growing proportion of women with type 2 diabetes during pregnancy, many of whom are from minority ethnic groups, presents an additional challenge for health services in developing responsive and accessible services.This CEMACH report has identifi ed several areas of good clinical practice during pregnancy in women with pre-existing diabetes. However, there continue to be areas where there is room for improvement, including antenatal fetal surveillance, glycaemic control during labour and delivery and postnatal diabetes care. The National Institute for Health and Clinical Excellence (NICE) is currently in the fi nal stages of development of its new guideline for the management of diabetes in pregnancy. This guideline, when taken together with the CEMACH report, will provide local health services with an unprecedented wealth of material on which to base their development of improved services for women with diabetes in pregnancy.��

Transcatheter renal denervation for the treatment of resistant arterial hypertension: the Swiss expert consensus.

Transcatheter (or percutaneous) renal denervation is a novel technique developed for the treatment of resistant hypertension. So far, only one randomised controlled trial has been published, which has shown a reduction of office blood pressure. The Swiss Society of Hypertension, the Swiss Society of Cardiology, The Swiss Society of Angiology and the Swiss Society of Interventional Radiology decided to establish recommendations to practicing physicians and specialists for good clinical practice. The eligibility of patients for transcatheter renal denervation needs (1.) confirmation of truly resistant hypertension, (2.) exclusion of secondary forms of hypertension, (3.) a multidisciplinary decision confirming the eligibility, (4.) facilities that guarantee procedural safety and (5.) a long-term follow-up of the patients, if possible in cooperation with a hypertension specialist. These steps are essential until long-term data on safety and efficacy are available.

Building legitimacy by criticising the pharmaceutical industry: a qualitative study among prescribers and local opinion leaders.

PRINCIPLES: The literature has described opinion leaders not only as marketing tools of the pharmaceutical industry, but also as educators promoting good clinical practice. This qualitative study addresses the distinction between the opinion-leader-as-marketing-tool and the opinion-leader-as-educator, as it is revealed in the discourses of physicians and experts, focusing on the prescription of antidepressants. We explore the relational dynamic between physicians, opinion leaders and the pharmaceutical industry in an area of French-speaking Switzerland. METHODS: Qualitative content analysis of 24 semistructured interviews with physicians and local experts in psychopharmacology, complemented by direct observation of educational events led by the experts, which were all sponsored by various pharmaceutical companies. RESULTS: Both physicians and experts were critical of the pharmaceutical industry and its use of opinion leaders. Local experts, in contrast, were perceived by the physicians as critical of the industry and, therefore, as a legitimate source of information. Local experts did not consider themselves opinion leaders and argued that they remained intellectually independent from the industry. Field observations confirmed that local experts criticised the industry at continuing medical education events. CONCLUSIONS: Local experts were vocal critics of the industry, which nevertheless sponsor their continuing education. This critical attitude enhanced their credibility in the eyes of the prescribing physicians. We discuss how the experts, despite their critical attitude, might still be beneficial to the industry's interests.

International comparison of the German evidence-based S3-guidelines on the diagnosis and multimodal treatment of early and locally advanced gastric cancer, including adenocarcinoma of the lower esophagus.

BACKGROUND: Clinical guidelines are essential in implementing and maintaining nationwide stage-specific diagnostic and therapeutic standards. In 2011, the first German expert consensus guideline defined the evidence for diagnosis and treatment of early and locally advanced esophagogastric cancers. Here, we compare this guideline with other national guidelines as well as current literature. METHODS: The German S3-guideline used an approved development process with de novo literature research, international guideline adaptation, or good clinical practice. Other recent evidence-based national guidelines and current references were compared with German recommendations. RESULTS: In the German S3 and other Western guidelines, adenocarcinomas of the esophagogastric junction (AEG) are classified according to formerly defined AEG I-III subgroups due to the high surgical impact. To stage local disease, computed tomography of the chest and abdomen and endosonography are reinforced. In contrast, laparoscopy is optional for staging. Mucosal cancers (T1a) should be endoscopically resected "en-bloc" to allow complete histological evaluation of lateral and basal margins. For locally advanced cancers of the stomach or esophagogastric junction (≥T3N+), preferred treatment is preoperative and postoperative chemotherapy. Preoperative radiochemotherapy is an evidence-based alternative for large AEG type I-II tumors (≥T3N+). Additionally, some experts recommend treating T2 tumors with a similar approach, mainly because pretherapeutic staging is often considered to be unreliable. CONCLUSIONS: The German S3 guideline represents an up-to-date European position with regard to diagnosis, staging, and treatment recommendations for patients with locally advanced esophagogastric cancer. Effects of perioperative chemotherapy versus chemoradiotherapy are still to be investigated for adenocarcinoma of the cardia and the lower esophagus.

La formulation du critère de la faute médicale à l’ère de la médecine fondée sur les faits

La comparaison de certaines institutions fondamentales de la responsabilité  professionnelle avec les outils développés par la « médecine fondée sur les faits », paradigme émergent en matière de pratique clinique, permet de mettre en lumière l’unité conceptuelle variable de certaines notions partagées par la médecine et le droit. Ces observations prennent une acuité particulière alors que la faute, telle que généralement conçue par le champ de la responsabilité médicale, pourrait se révéler perméable aux conceptions de la « bonne pratique clinique » sous-tendues par  la médecine fondée sur les faits. Cette perspective pourrait se révéler utile à l’analyse de ce que l’auteur Daniel Jutras a qualifié de « crise conceptuelle » de la responsabilité médicale.

L’analyse d’indicateurs de la qualité des soins infirmiers aux personnes ayant subi un AVC en Catalogne

Résumé L’Accident Vasculaire Cérébral (AVC) constitue une des principales causes de décès et de handicap au monde. La guérison après l’AVC ainsi que l’atténuation du handicap dépendent entre autres de la rapidité du diagnostic ainsi que de la mise en place de traitements et des soins très spécialisés. Afin de guider la pratique clinique et de fonder cette pratique sur des résultats probants, des guides de pratique clinique (GPC) ont été publiés et disséminés en Catalogne en 2005. De plus, trois audits explorant les soins hospitaliers aigus ont été réalisées en 2005, 2007 et 2010 afin d’évaluer et améliorer le suivi des recommandations proposées dans les GPC. Le suivi de ces recommandations, dont certaines font référence aux soins infirmiers, a été mesuré à l’aide d’un nombre limité d’indicateurs. L’analyse de ces indicateurs, qui a été réalisée de façon globale, n’a toutefois pas permis d’identifier les facteurs influençant le suivi des recommandations en soins infirmiers ni l’impact de ce suivi sur les résultats concernant la santé des patients. Ainsi, le but général de cette étude est d’analyser les indicateurs de la qualité des soins infirmiers aux personnes ayant subi un AVC en Catalogne. Plus spécifiquement, il vise à : 1) décrire le suivi des recommandations en soins infirmiers aux personnes ayant subi un AVC en 2010 en Catalogne, mesuré à l’aide de six indicateurs spécifiques aux soins infirmiers; 2) analyser l’évolution de ce suivi entre 2005, 2007 et 2010; 3) identifier des facteurs susceptibles d’avoir influencé ce suivi en 2010; et 4) analyser la relation entre le suivi de ces recommandations et les résultats concernant la santé des patients. Une analyse secondaire des données a été faite à partir des données de l’audit de 2010. Cet audit a été réalisé dans 46 des 49 hôpitaux publics en Catalogne et comprend un échantillon de 2 190 cas représentant une population de 10 842 cas. Les résultats indiquent que le suivi des recommandations portant sur l’ECG basal, la glycémie basale et la mobilisation précoce est élevé. Le suivi de la recommandation portant sur la dysphagie s’est amélioré à travers les trois audits, mais il demeure sous-optimal. Et le suivi des recommandations portant sur l’évaluation de l’humeur et l’éducation à la personne famille est très faible. En ce qui concerne les facteurs qui semblent influencer le suivi de ces recommandations, les résultats ajustés pour les caractéristiques et la sévérité des patients montrent un suivi majeur de la recommandation en lien avec le dépistage de la dysphagie chez les personnes admises en neurologie et dans les centres de plus de 300 admissions pour AVC /année ainsi que chez les patients présentant une dysphagie. De plus, la durée du séjour hospitalier a été plus longue chez les patients dont l’évaluation de l’humeur a été faite et plus courte chez les patients mobilisés de façon précoce. Bien que, le suivi de certaines recommandations demeure très bas, ces résultats indiquent une amélioration progressive du suivi des recommandations en soins infirmiers, et donc de la qualité des soins, et soulignent l’utilité de l’audit pour surveiller et améliorer la qualité des soins de l’AVC.

Efectividad del tratamiento inmunomodulador con leucocitos alogénicos, en aborto involuntario recurrente. Revisión sistemática y metaanálisis

Dentro del marco del aborto involuntario recurrente (AIR), se han propuesto causas autoinmunes y alogénicas, e implementación de terapias como la inmunización activa con leucocitos alogénicos de la pareja o de donantes. La evidencia disponible en cuanto a la efectividad de estos tratamientos es contradictoria, por lo que se desea realizar una revisión sistemática para evaluar la efectividad de la inmunización activa con leucocitos alogénicos de la pareja o de donantes para esta condición. Se realizó un estudio tipo revisión sistemática de la literatura, usando las siguientes bases de datos: Medline, Embase, Cochrane Library y Scielo. Se realizó una búsqueda a través del registro de ensayos clínicos del Instituto Nacional de Salud de los Estados Unidos (www.clinicaltrials.gov) y, una búsqueda manual a través de las referencias de los estudios seleccionados siguiendo la estrategia de bola de nieve. Se seleccionaron ensayos clínicos y estudios de cohorte analítica, en idioma inglés y español. Se realizó un análisis cuantitativo de la información por medio de un metaanálisis. El tratamiento inmunomodulador con linfocitos puede considerarse como una terapia efectiva para mantener la gestación y lograr recién nacido vivo según resultados estadísticos; sin embargo la calidad de los estudios incluidos es baja, por lo que no se aconseja para la práctica rutinaria. Se sugiere la realización de estudios con metodologías robustas y que apoyen los resultados presentados en esta investigación.

Avaliacao da necessidade da dosagem rotineira de hematocrito, hemoglobina, ureia e creatinina sericos durante a avaliacao pre-anestesica

Background and Objectives - There are many questions and opinions about the value of routine preoperative tests as an integral part of the preanesthetic evaluation. Current trends suggest that such tests should be based on detailed clinical and physical evaluation. Since such tests are still routinely performed and questions about their real value still persist, the aim of this study was to assess the value of routine hematocrit (Ht), hemoglobin concentration (Hb), blood urea nitrogen (BUN) and serum creatinine results in patients undergoing elective surgery, to establish when they are needed and aiming at answering such questions. Methods - 1065 patients aged 12 years and above, physical status ASA I, II and III, scheduled for elective surgery were studied. Patients were divided into 7 different age groups with randomized distribution of gender. Ht, Hb, BUN and serum creatinine results, routinely asked by our surgical departments, were observed and analyzed. Variance Analysis was used for each variable, and the Bonferroni Multiple Comparison Test was used to compare group to group. Differences were considered significant when p < 0.05 (5%). Results - For all patients, 4025 laboratory tests were obtained. The number of tests was the same for each group. There were no differences in Ht and Hb values which remained within normal ranges. Considering BUN and serum creatinine, there was a difference between younger and older patients, but the results were normal in all groups. Conclusions - We concluded that mean Ht, Hb, BUN and serum creatinine values in all age groups were all acceptable for surgical patients in general. However, they are barely useful if performed regardless of clinical evaluation. Thus, such preoperative routine tests should be abandoned and the good clinical practice with common sense should prevail in indicating them.

Como desenhar e escrever um protocolo de pesquisa clínica em Cosmiatria

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. © 2013 by Anais Brasileiros de Dermatologia.

Avaliação crítica da pesquisa clínica no Brasil

Pós-graduação em Patologia - FMB