Competências do enfermeiro no cuidado a pacientes com acidente vascular cerebral elegíveis à terapia trombolítica / Competencias de enfermería en el cuidado de personas con accidente cerebrovascular elegibles para terapia trombolítica / Nursing competencies in the care of patients with stroke who are eligible for thrombolytic therapy

Resumo Introdução: O acidente vascular cerebral isquêmico tem como tratamento a terapia trombolítica, aplicada ainda na fase aguda, promovendo melhora importante nas sequelas acarretadas por este agravo. Considerando a complexidade da terapia trombolítica, torna-se necessário que os enfermeiros compreendam suas competências para auxiliar no cuidado. Objetivo: Identificar evidências científicas acerca das competências do enfermeiro no cuidado a pacientes com acidente vascular cerebral elegíveis à terapia trombolítica. Metodologia: Revisão integrativa composta por seis etapas em seis etapas (elaboração da questão, busca na literatura, coleta de dados, análise, discussão e apresentação da revisão), realizada nas bases de dados MEDLINE, LILACS, BDENF, IBECS, PubMed, Scopus, Web of Science, Embase e CINAHL. A busca foi realizada entre agosto e setembro de 2022 adotando como critérios de inclusão estudos primários; gratuitos, disponíveis eletronicamente na íntegra; nos idiomas inglês, português e espanhol. Foram obtidos inicialmente 2.830 estudos, os quais passaram por uma seleção, onde foram incluídos aqueles que atendiam os critérios previamente estabelecidos. Resultados: Com base nos doze estudos incluídos nesta revisão identificaram-se competências voltadas à três atividades do cuidado: gestão do cuidado como trabalho em equipe, códigos, fluxos e protocolos, assistência ao paciente antes, durante e após a utilização da terapia trombolítica e educação em saúde para equipe, pacientes e familiares. Conclusão: Os achados desta revisão puderam evidenciar as competências do enfermeiro no cuidado aos pacientes elegíveis a terapia trombolítica, as quais perpassam diferentes áreas de atuação do enfermeiro. Para este estudo prevaleceram as competências assistências, seguida por competências gerenciais.

Resumen Introducción: El accidente cerebrovascular isquémico se trata con terapia trombolítica, aplicada incluso en la fase aguda, que promueve una mejoría significativa de las secuelas provocadas por este padecimiento. Considerando la complejidad de la terapia trombolítica, es necesario que las personas profesionales de enfermería comprendan sus competencias para ayudar en el cuidado. Objetivo: Identificar evidencias científicas sobre las competencias del personal de enfermería en el cuidado de pacientes con accidente cerebrovascular elegibles para terapia trombolítica. Metodología: Revisión integradora que consta de seis etapas (elaboración de la pregunta, búsqueda bibliográfica, recolección de datos, análisis, discusión y presentación de la revisión), realizada en las bases de dados MEDLINE, LILACS, BDENF, IBECS, PubMed, Scopus, Web of Science, Embase y CINAHL. La búsqueda se realizó entre agosto y septiembre de 2022. Los criterio de inclusión fueron: estudios primarios, gratuito, disponible electrónicamente en su totalidad, en inglés, portugués y español. Inicialmente se obtuvieron 2830 estudios, los cuales fueron sometidos a un proceso de selección, que incluyó aquellos que cumplían con los criterios previamente establecidos. Resultados: A partir de los doce estudios incluidos en esta revisión, se identificaron competencias centradas en tres actividades asistenciales: gestión del cuidado como trabajo en equipo, códigos, flujos y protocolos, atención a pacientes antes, durante y después del uso de la terapia trombolítica y educación en salud para personal, pacientes y familias. Conclusión: Los hallazgos de esta revisión pudieron resaltar las competencias de las personas profesionales en enfermería en el cuidado de personas elegibles para terapia trombolítica, que abarcan diferentes áreas de actuación del personal de enfermería. Para este estudio, prevalecieron las habilidades asistenciales, seguidas de las competencias gerenciales.

ABSTRACT Introduction: Ischemic stroke is treated with thrombolytic therapy, applied even in the acute phase, promoting a significant improvement in the after-effects caused by this condition. Considering the complexity of thrombolytic therapy, it is necessary for nurses to understand the skills required to assist in care. Objective: To identify scientific evidence about the competencies of nurses in the care of patients with stroke who are eligible for thrombolytic therapy. Methodology: An integrative review consisting of six stages (elaboration of the question, literature review, data collection, analysis, discussion, and presentation), conducted in MEDLINE, LILACS, BDENF, IBECS, PubMed, Scopus, Web of Science, Embase, and CINAHL databases. The search was carried out between August and September 2022 using primary studies as the inclusion criteria: free of charge, fully available electronically, published in English, Portuguese, or Spanish. Initially, 2.830 studies were obtained, which underwent a selection process that included only those studies that met the previously established criteria. Results: Based on the twelve studies included in this review, competencies focused on three care activities were identified: care management such as teamwork; codes; flows and protocols; patient care before, during, and after the use of thrombolytic therapy; and education health education for staff, patients, and families. Conclusion: The findings of this review highlighted the nurses' competencies in the care of patients eligible for thrombolytic therapy, which encompass different areas of the nurse's work. For this study, assistance competencies prevailed, followed by management competencies.

Renal osteodystrophy and clinical outcomes: a prospective cohort study / Osteodistrofia renal e desfechos clínicos: um estudo de coorte prospectivo

Abstract Introduction: Renal osteodystrophy (ROD) refers to a group of bone morphological patterns that derive from distinct pathophysiological mechanisms. Whether the ROD subtypes influence long-term outcomes is unknown. Our objective was to explore the relationship between ROD and clinical outcomes. Methods: This study is a subanalysis of the Brazilian Registry of Bone Biopsies (REBRABO). Samples from individual patients were classified as having osteitis fibrosa (OF), mixed uremic osteodystrophy (MUO), adynamic bone disease (ABD), osteomalacia (OM), normal/minor alterations, and according to turnover/mineralization/volume (TMV) system. Patients were followed for 3.4 yrs. Clinical outcomes were: bone fractures, hospitalization, major adverse cardiovascular events (MACE), and death. Results: We enrolled 275 participants, of which 248 (90%) were on dialysis. At follow-up, 28 bone fractures, 97 hospitalizations, 44 MACE, and 70 deaths were recorded. ROD subtypes were not related to outcomes. Conclusion: The incidence of clinical outcomes did not differ between the types of ROD.

Resumo Introdução: Osteodistrofia renal (OR) refere-se a um grupo de padrões morfológicos ósseos que decorrem de mecanismos fisiopatológicos distintos. É desconhecido se os subtipos de OR influenciam desfechos em longo prazo. Nosso objetivo foi explorar as relações entre OR e desfechos. Métodos: Este estudo é uma subanálise do Registro Brasileiro de Biópsias Ósseas (REBRABO). As amostras de cada paciente foram classificadas em osteíte fibrosa (OF), osteodistrofia urêmica mista (MUO), doença óssea adinâmica (ABD), osteomalácia (OM), alterações normais/menores, e pelo sistema Remodelação / Mineralização / Volume (RMV). Os pacientes foram acompanhados por 3,4 anos. Os eventos clínicos foram: fraturas ósseas, hospitalizações, eventos cardiovasculares adversos maiores (MACE), e óbito. Resultados: Analisamos 275 indivíduos, 248 (90%) deles estavam em diálise. No acompanhamento, 28 fraturas ósseas, 97 hospitalizações, 44 MACE e 70 óbitos foram registrados. Os subtipos de OR não foram relacionados aos desfechos clínicos. Conclusão: A incidência de desfechos clínicos não diferiu entre os tipos de OR.

Tumor analysis of MMR genes in Lynch-like syndrome: Challenges associated with results interpretation.

BACKGROUND: Up to 70% of suspected Lynch syndrome patients harboring MMR deficient tumors lack identifiable germline pathogenic variants in MMR genes, being referred to as Lynch-like syndrome (LLS). Previous studies have reported biallelic somatic MMR inactivation in a variable range of LLS-associated tumors. Moreover, translating tumor testing results into patient management remains controversial. Our aim is to assess the challenges associated with the implementation of tumoral MMR gene testing in routine workflows. METHODS: Here, we present the clinical characterization of 229 LLS patients. MMR gene testing was performed in 39 available tumors, and results were analyzed using two variant allele frequency (VAF) thresholds (≥5% and ≥10%). RESULTS AND DISCUSSION: More biallelic somatic events were identified at VAF ≥ 5% than ≥10% (35.9% vs. 25.6%), although the rate of nonconcordant results regarding immunohistochemical pattern increased (30.8% vs. 20.5%). Interpretation difficulties question the current utility of the identification of MMR somatic hits in the diagnostic algorithm of suspected LS cases.

A Qualitative Study of Biomedical Engineering Student Critical Reflection During Clinical Immersion Experiences.

Purpose: Clinical immersion experiences provide engineering students with opportunities to identify unmet user needs and to interact with clinical professionals. These experiences have become common features of undergraduate biomedical engineering curricula, with many published examples in the literature. There are, however, few or no published studies that describe rigorous qualitative analysis of biomedical engineering student reflections from immersion programs. Methods: Fifteen reflection prompts that align with program learning goals were developed and structured based on the DEAL model for critical reflection. Undergraduate participants in a summer immersion program responded to these prompts throughout five weeks of clinical rotations. Data from two summer cohorts of participants (n = 20) were collected, and thematic analysis was performed to characterize student responses. Results: Students reported learning about key healthcare topics, such as medical insurance, access to healthcare (and lack thereof), stakeholder perspectives, and key medical terminology and knowledge. Most reflections also noted that students could apply newly gained medical knowledge to biomedical engineering design. Further, clinical immersion provided students with a realistic view of the biomedical engineering profession and potential areas for future professional growth, with many reflections identifying the ability to communicate with a variety of professionals as key to student training. Some students reflected on conversations with patients, noting that these interactions reinvigorated their passion for the biomedical engineering field. Finally, 63% of student reflections identified instances in which patients of low socioeconomic status were disadvantaged in health care settings. Conclusions: Clinical immersion programs can help close the gap between academic learning and the practical experience demands of the field, as design skills and product development experience are becoming increasingly necessary for biomedical engineers. Our work initiates efforts toward more rigorous analysis of students' reactions and experiences, particularly around socioeconomic and demographic factors, which may provide guidance for continuous improvement and development of clinical experiences for biomedical engineers.

Assessing the Accuracy and Reliability of Cone-Beam Computed Tomography (CBCT) in Diagnosing Grade II and III Furcation Involvement Compared to Traditional Clinical Examination Methods.

Introduction Chronic periodontal diseases can lead to bone defects and tooth loss, making accurate diagnosis essential for treatment. Various methods are used for diagnosing furcation involvement, with clinical examination and cone-beam computed tomography (CBCT) being the most effective. CBCT produces reliable images with submillimeter resolution, revealing marginal bone contours and furcation defects. Limited studies show that CBCT is more precise than clinical detection for diagnosing furcation involvement. Therefore, CBCT technology can be considered as an adjunct method for furcation involvement detection. This study tests the accuracy and efficiency of CBCT and clinical examination in detecting furcation involvement. Material and methods The study included 25 patients (68 molars) with generalized periodontitis of stage II to IV, Grade B and C. Inclusion criteria required at least two intrabony defects with probing depth > 6mm in both jaws and criteria of periodontitis in at least 30% of the teeth present. Results The study compared clinical examination and CBCT readings for measuring maxillary and mandibular teeth furcation involvement. The results show significant differences between clinical and CBCT measurements of maxillary teeth furcation involvement, particularly in specific areas and types of furcation involvement. In contrast, there were significant differences between clinical and CBCT readings for only a few measurements of mandibular teeth furcation involvement. Therefore, the study suggests that CBCT imaging may be beneficial for accurate diagnosis and treatment planning in cases of furcation involvement in maxillary teeth. Conclusion CBCT imaging is a reliable adjunct method for detecting furcation involvement in maxillary teeth, while clinical examination alone may not be sufficient. Therefore, the use of CBCT technology should be considered in cases where accurate detection of furcation involvement is necessary for successful treatment outcomes. However, further studies with larger sample sizes are needed to confirm these findings.

Rapidly Growing and Aggressive Squamous Cell Carcinoma of the Forearm: A Report of Successful Treatment With Mohs Surgery and Complex Reconstruction With Rhombic Triple Z-Plasty.

Reconstruction of complex post-surgical wounds requires functional and aesthetic considerations. We present a case of a complex radial-dorsal forearm defect in a patient who underwent Mohs surgery for an aggressive and rapidly growing squamous cell carcinoma. Following complete tumor excision, we utilized a modified rhombic flap for complete wound coverage with long-term conservation of extensor function. The rhombic flap modification included three Z-plasties at the flap base to add rotational components to the flap transposition. Long-term follow-up showed acceptable cosmesis, preserved extensor tendon function, and no evidence of tumor recurrence.

Fibroepithelial Polyp of the Vagina With Torsion: A Difficult Diagnosis Based on Clinical and Morphological Findings of the Vaginal Lesion.

Vaginal fibroepithelial polyps are rare benign tumors of the mucosa of the anterior vaginal wall. In extremely rare cases, they may originate from the posterior vaginal wall or be complicated by torsion. Our case concerns a 63-year-old patient who presented to the gynecology outpatient clinic of the General Hospital of Trikala with minor vaginal bleeding. On vaginal examination, a large pedunculated painless hemorrhagic polypoid mass was noticed, originating from the posterior vaginal wall. A torsion of the pedunculated vaginal tumor was suspected, leading to its surgical excision with clear resection margins. Due to extensive tissue necrosis, accurate histological identification of the vaginal neoplasm was not possible. Histological examination excluded vaginal malignancy. Based predominantly on the clinical and morphological features of the vaginal lesion, a diagnosis of vaginal fibroepithelial polyp with torsion was made, acknowledging its limitations. The patient was discharged from the clinic the same afternoon following the surgery. Three months later, no recurrence of the lesion in the vaginal wall was noted. Following the case presentation, this paper provides a brief literature review of this rare entity, focusing on the diagnostic and therapeutic approaches.

A Survey Exploring Inflammatory Back Pain in Patients With Inflammatory Bowel Disease.

Background Diagnostic delay of axial spondyloarthritis (axSpA) is a widely recognized issue worldwide, providing a great burden for patients with this disease. AxSpA is present in a significant proportion of patients with inflammatory bowel disease (IBD). This UK study primarily aims to identify the presence of inflammatory back pain (IBP) in patients attending IBD clinic. Further aims of this study include investigating if participants had received further referrals and diagnoses for their IBP and considering factors contributing to diagnostic delay. Methods Patients were recruited from a Royal Free London NHS Trust hospital's IBD clinic. Each participant completed a 23-question survey. The Berlin criteria were applied to the questions to investigate the presence of IBP. Further questions were asked about their IBD diagnosis and treatment, the healthcare professionals they had seen for their back pain, and other extra-articular features associated with axSpA. Results Seventy-five patients completed the online survey sent out via email. Forty percent (n = 30) of participants were female and 60% (n = 45) were male. Sixty-one percent (n = 36) of participants from the colitis clinic reported they had back pain, and 41% of the participants reported back pain for over three months. Of these, 39% (12) of participants fulfilled the Berlin criteria for IBP. Of patients experiencing back pain for over three months, we found that 10% (3) fulfilled the Berlin criteria but had not received a diagnosis for their IBP. All patients who had fulfilled the Berlin criteria but had not received a diagnosis for their IBP had seen their general practitioner (GP) and an allied healthcare professional, but not a rheumatologist. Conclusions This study highlights the presence of possibly undiagnosed axSpA in patients with IBD. The reasons for the diagnostic delay of axSpA are multifactorial. We consider specific patient characteristics, lack of awareness and education of the condition, and issues in the referral process. There is a need to improve education and awareness of axSpA, reconsider referral processes, and consider new initiatives such as joint specialty clinics to identify and treat axSpA on time.

COVID-19-Associated Cognitive Biases on Pneumonia Differential Diagnosis.

The coronavirus disease 2019 (COVID-19) pandemic favors cognitive biases such as anchoring and availability biases. The first refers to overvaluing some of the initial information and establishing a diagnosis too early, with resistance to future adjustments. The latter happens when diagnoses more frequently considered are regarded as more common in reality. This case, in which the correct diagnosis was delayed due to these biases, highlights the need to remain aware of them as a means toward timely diagnosis and therapeutic success of pneumonia cases. An 84-year-old woman presented with a mild non-productive cough for two months and fever. She had a history of breast carcinoma treated with radiotherapy in the previous year. Computerized tomography (CT) showed extensive bilateral consolidation foci with ground-glass-opacification areas and bilateral pleural effusion, CO-RADS 3. COVID-19 with bacterial superinfection was suspected and levofloxacin was initiated. Nasopharyngeal swab polymerase chain reaction (PCR) was carried out three times, always negative for SARS-CoV-2. As the patient remained with fever and cough, the antibiotic was escalated to piperacillin/tazobactam and then to meropenem/vancomycin. She underwent bronchofibroscopy and alveolar lavage, with negative SARS-CoV-2 PCR. The re-evaluation CT scan maintained bilateral consolidations, with an aerial bronchogram. The biopsy of pulmonary consolidation allowed the diagnosis of radiation-induced organizing pneumonia. Prednisolone was initiated and achieved clinical remission and radiological improvement. This case highlights the need to remain aware of cognitive biases both when COVID-19 is suspected or ruled out and to consider other diagnoses when there is a lack of therapeutic response.

Efficacy and Safety of Oral and IV Levonadifloxacin Therapy in Management of Bacterial Infections: Findings of a Prospective, Observational, Multi-center, Post-marketing Surveillance Study.

Background Antimicrobial resistance by bacteria poses a substantial threat to morbidity and mortality worldwide, and treatment of resistant infections is a challenge for the treating clinician. Levonadifloxacin is a novel broad-spectrum agent belonging to the benzoquinolizine subclass of quinolone, which can be used by both oral and intravenous administration for the treatment of infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data from 1266 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of various bacterial infections. The duration of the study was 18 months. Study outcomes were clinical success and microbial success at the end of therapy. Global assessments were done for safety and efficacy at the end of therapy using a 5-point Likert scale (excellent, very good, good, satisfactory, and poor). Results The mean (median) duration of therapy was 7.2 (7.0) days, with a median time to clinical improvement of four days. Oral therapy was administered to 224 patients; 940 received IV, and 102 received IV followed by oral therapy. Patients were prescribed levonadifloxacin for gram-positive infections, skin and soft tissue infections, diabetic foot infections, septicemia, catheter-related blood-stream infections, bone and joint infections, febrile neutropenia, and respiratory infections, including COVID-19 pneumonia. The clinical cure on the eighth day was 95.7%, whereas the microbial success on the eighth day was 93.3% (n=60). For different types of infections, the clinical success rates ranged from 85.2% to 100%. There were only 30 treatment-emergent adverse events reported in 29 patients. Overall, about 95.6% of patients rated the efficacy as good to excellent, whereas only 3.8% of patients rated it satisfactory; for safety, 95.7% of patients rated it as good to excellent, with only 3.9% of patients rated it as satisfactory. Conclusions The excellent safety and efficacy profile of levonadifloxacin, when administered as an oral or intravenous therapy, makes it a desirable treatment modality for the management of various bacterial infections, including those caused by resistant pathogens such as MRSA and quinolone-resistant Staphylococcus aureus (QRSA). Features of levonadifloxacin, such as availability in both IV and oral form, minimal drug-drug interactions, lack of the need to adjust dosages in renal and hepatically impaired patients along with a broad spectrum of coverage, make it a suitable agent that meets several unmet clinical needs of physicians.

Novel and potential future therapeutic options in systemic autoimmune diseases.

Autoimmune inflammation is caused by the loss of tolerance to specific self-antigens and can result in organ-specific or systemic disorders. Systemic autoimmune diseases affect a significant portion of the population with an increasing rate of incidence, which means that is essential to have effective therapies to control these chronic disorders. Unfortunately, several patients with systemic autoimmune diseases do not respond at all or just partially respond to available conventional synthetic disease-modifying antirheumatic drugs and targeted therapies. However, during the past few years, some new medications have been approved and can be used in real-life clinical settings. Meanwhile, several new candidates appeared and can offer promising novel treatment options in the future. Here, we summarize the newly available medications and the most encouraging drug candidates in the treatment of systemic lupus erythematosus, rheumatoid arthritis, Sjögren's disease, systemic sclerosis, systemic vasculitis, and autoimmune myositis.

Rapid duplex flap probe-based isothermal assay to identify the Cryptococcus neoformans and Cryptococcus gattii.

Cryptococcosis is a life-threatening invasive fungal infection with significantly increasing mortality worldwide, which is mainly caused by Cryptococcus neoformans and Cryptococcus gattii. These two species complexes have different epidemiological and clinical characteristics, indicating the importance of accurate differential diagnosis. However, the clinically used culture method and cryptococcal capsular antigen detection couldn't achieve the above goals. Herein, we established a novel duplex flap probe-based isothermal assay to identify the Cryptococcus neoformans and Cryptococcus gattii within 1 hour. This assay combined the highly sensitive nucleic acid isothermal amplification and highly specific fluorescence probe method, which could effectively distinguish the sequence differences of the two species complexes using two different fluorescence flap probes in a single reaction system. This novel method showed excellent detection performance with sensitivity (10 copies/µL each) and specificity (100%) compared to traditional culture and sequencing methods. Furthermore, we applied this method to spiked clinical samples, 30 cerebrospinal fluids and 30 bronchoalveolar lavage fluids, which kept good detection performance. This novel rapid duplex flap probe-based isothermal assay is a promising and robust tool for applications in differential diagnosis of the Cryptococcus neoformans and Cryptococcus gattii in clinical settings, especially when clinical suspicion for cryptococcal disease is high and epidemiological studies.

TRIF-IFN-I pathway in Helicobacter-induced gastric cancer in an accelerated murine disease model and patient biopsies.

Helicobacter pylori (H. pylori) infection is a known cause of many digestive diseases, including gastritis, peptic ulcers, and gastric cancer. However, the underlying mechanisms by which H. pylori infection triggers these disorders are still not clearly understood. Gastric cancer is a slow progressing disease, which makes it difficult to study. We have developed an accelerated disease progression mouse model, which leverages mice deficient in the myeloid differentiation primary response 88 gene (Myd88-/-) infected with Helicobacter felis (H. felis). Using this model and gastric biopsy samples from patients, we report that activation of the Toll/interleukin-1 receptor (TIR)-domain-containing adaptor inducing interferon-ß (TRIF)-type I interferon (IFN-I) signaling pathway promotes Helicobacter-induced disease progression toward severe gastric pathology and gastric cancer development. Further, results implicated downstream targets of this pathway in disease pathogenesis. These findings may facilitate stratification of Helicobacter-infected patients and thus enable treatment prioritization of patients.

Enhancing Uterine Fibroid Care: Clinician Perspectives on Diagnosis, Disparities, and Strategies for Improving Health Care.

Objective: To explore clinicians' perspectives on diagnosing, treating, and managing uterine fibroids, identifying gaps and challenges in health care delivery, and offering recommendations for improving care. Materials and Methods: A qualitative design was used to conduct 14 semistructured interviews with clinicians who treat fibroid patients in central Indiana. Interviews were audio recorded, transcribed verbatim, and analyzed using thematic analysis techniques. Constant comparative analysis was used to identify emergent themes. Results: Four themes emerged. (1) Lack of patient fibroid awareness: Patients lacked fibroid awareness, leading to challenges in explaining diagnoses and treatment. Misconceptions and emotional distress highlighted the need for better education. (2) Inequities in care and access: Health care disparities affected Black women and rural patients, with transportation, scheduling delays, and financial constraints hindering access. (3) Continuum of care: Clinicians prioritized patient-centered care and shared decision-making, tailoring treatment based on factors like severity, location, size, cost, fertility goals, and recovery time. (4) Coronavirus disease 2019 (COVID-19) impact: The pandemic posed challenges and opportunities, prompting telehealth adoption and consideration of nonsurgical options. Conclusions: Clinician perspectives noted patient challenges with fibroids, prompting calls for enhanced education, interdisciplinary collaboration, and accessible care to address crucial aspects of fibroid management and improve women's well-being. Practice Implications: Clinicians identified a lack of patient awareness and unequal access to fibroid care, highlighting the need for improved education and addressing disparities. Findings also emphasized the importance of considering multidimensional aspects of fibroid care and adapting to challenges posed by the COVID-19 pandemic, recommending broader education, affordability, interdisciplinary collaboration, and research for better fibroid health care.

Animal models of Klebsiella pneumoniae mucosal infections.

Klebsiella pneumoniae is among the most relevant pathogens worldwide, causing high morbidity and mortality, which is worsened by the increasing rates of antibiotic resistance. It is a constituent of the host microbiota of different mucosa, that can invade and cause infections in many different sites. The development of new treatments and prophylaxis against this pathogen rely on animal models to identify potential targets and evaluate the efficacy and possible side effects of therapeutic agents or vaccines. However, the validity of data generated is highly dependable on choosing models that can adequately reproduce the hallmarks of human diseases. The present review summarizes the current knowledge on animal models used to investigate K. pneumoniae infections, with a focus on mucosal sites. The advantages and limitations of each model are discussed and compared; the applications, extrapolations to human subjects and future modifications that can improve the current techniques are also presented. While mice are the most widely used species in K. pneumoniae animal studies, they present limitations such as the natural resistance to the pathogen and difficulties in reproducing the main steps of human mucosal infections. Other models, such as Drosophila melanogaster (fruit fly), Caenorhabditis elegans, Galleria mellonella and Danio rerio (zebrafish), contribute to understanding specific aspects of the infection process, such as bacterial lethality and colonization and innate immune system response, however, they but do not present the immunological complexity of mammals. In conclusion, the choice of the animal model of K. pneumoniae infection will depend mainly on the questions being addressed by the study, while a better understanding of the interplay between bacterial virulence factors and animal host responses will provide a deeper comprehension of the disease process and aid in the development of effective preventive/therapeutic strategies.

Digital technologies used in clinical trial recruitment and enrollment including application to trial diversity and inclusion: A systematic review.

Background: Many clinical trials fail because of poor recruitment and enrollment which can directly impact the success of biomedical and clinical research outcomes. Options to leverage digital technology for improving clinical trial management are expansive, with potential benefits for improving access to clinical trials, encouraging trial diversity and inclusion, and potential cost-savings through enhanced efficiency. Objectives: This systematic review has two key aims: (1) identify and describe the digital technologies applied in clinical trial recruitment and enrollment and (2) evaluate evidence of these technologies addressing the recruitment and enrollment of racial and ethnic minority groups. Methods: We conducted a cross-disciplinary review of articles from PubMed, IEEE Xplore, and ACM Digital Library, published in English between January 2012 and July 2022, using MeSH terms and keywords for digital health, clinical trials, and recruitment and enrollment. Articles unrelated to technology in the recruitment/enrollment process or those discussing recruitment/enrollment without technology aspects were excluded. Results: The review returned 614 results, with 21 articles (four reviews and 17 original research articles) deemed suitable for inclusion after screening and full-text review. To address the first objective, various digital technologies were identified and characterized, which included articles with more than one technology subcategory including (a) multimedia presentations (19%, n = 4); (b) mobile applications (14%, n = 3); (c) social media platforms (29%, n = 6); (d) machine learning and computer algorithms (19%, n = 4); (e) e-consenting (24%, n = 5); (f) blockchain (5%, n = 1); (g) web-based programs (24%, n = 5); and (h) virtual messaging (24%, n = 5). Additionally, subthemes, including specific diseases or conditions addressed, privacy and regulatory concerns, cost/benefit analyses, and ethnic and minority recruitment considerations, were identified and discussed. Limited research was found to support a particular technology's effectiveness in racial and ethnic minority recruitment and enrollment. Conclusion: Results from this review illustrate that several types of technology are currently being explored and utilized in clinical trial recruitment and enrollment stages. However, evidence supporting the use of digital technologies is varied and requires further research and evaluation to identify the most valuable opportunities for encouraging diversity in clinical trial recruitment and enrollment practices.

Open notes in psychotherapy: An exploratory mixed methods survey of psychotherapy students in Switzerland.

Background: In a growing number of countries, patients are offered access to their full online clinical records, including the narrative reports written by clinicians (the latter, referred to as "open notes"). Even in countries with mature patient online record access, access to psychotherapy notes is not mandatory. To date, no research has explored the views of psychotherapy trainees about open notes. Objective: This study aimed to explore the opinions of psychotherapy trainees in Switzerland about patients' access to psychotherapists' free-text summaries. Methods: We administered a web-based mixed methods survey to 201 psychotherapy trainees to explore their familiarity with and opinions about the impact on patients and psychotherapy practice of offering patients online access to their psychotherapy notes. Descriptive statistics were used to analyze the 42-item survey, and qualitative descriptive analysis was employed to examine written responses to four open-ended questions. Results: Seventy-two (35.8%) trainees completed the survey. Quantitative results revealed mixed views about open notes. 75% agreed that, in general open notes were a good idea, and 94.1% agreed that education about open notes should be part of psychotherapy training. When considering impact on patients and psychotherapy, four themes emerged: (a) negative impact on therapy; (b) positive impact on therapy; (c) impact on patients; and (d) documentation. Students identified concerns related to increase in workload, harm to the psychotherapeutic relationship, and compromised quality of records. They also identified many potential benefits including better patient communication and informed consent processes. In describing impact on different therapy types, students believed that open notes might have differential impact depending on the psychotherapy approaches. Conclusions: Sharing psychotherapy notes is not routine but is likely to expand. This mixed methods study provides timely insights into the views of psychotherapy trainees regarding the impact of open notes on patient care and psychotherapy practice.

Adjudication of a primary trial outcome: Results of a calibration exercise and protocol for a large international trial.

Background: Ascertainment of the severity of the primary outcome of upper gastrointestinal (GI) bleeding is integral to stress ulcer prophylaxis trials. This protocol outlines the adjudication process for GI bleeding events in an international trial comparing pantoprazole to placebo in critically ill patients (REVISE: Re-Evaluating the Inhibition of Stress Erosions). The primary objective of the adjudication process is to assess episodes submitted by participating sites to determine which fulfil the definition of the primary efficacy outcome of clinically important upper GI bleeding. Secondary objectives are to categorize the bleeding severity if deemed not clinically important, and adjudicate the bleeding site, timing, investigations, and treatments. Methods: Research coordinators follow patients daily for any suspected clinically important upper GI bleeding, and submit case report forms, doctors' and nurses' notes, laboratory, imaging, and procedural reports to the methods center. An international central adjudication committee reflecting diverse specialty backgrounds conducted an initial calibration exercise to delineate the scope of the adjudication process, review components of the definition, and agree on how each criterion will be considered fulfilled. Henceforth, bleeding events will be stratified by study drug, and randomly assigned to adjudicator pairs (blinded to treatment allocation, and study center). Results: Crude agreement, chance-corrected agreement, or chance-independent agreement if data have a skewed distribution will be calculated. Conclusions: Focusing on consistency and accuracy, central independent blinded duplicate adjudication of suspected clinically important upper GI bleeding events will determine which events fulfil the definition of the primary efficacy outcome for this stress ulcer prophylaxis trial. Registration: NCT03374800 (REVISE: Re-Evaluating the Inhibition of Stress Erosions).

Comparative Evaluation of the Effectiveness of Innovative Periorbital Eye Massager and Virtual Reality Eyeglasses for Reducing Dental Anxiety during Dental Restorative Procedures in Children.

Background: Many behavior management techniques are employed to reduce the anxiety associated with dental procedures in children. One of the most commonly used methods comprises audiovisual distraction using virtual reality (VR) eyeglasses. In this study, an innovative device, a periorbital eye massager (PEM), is compared with VR to evaluate dental anxiety in children. Materials and methods: in this study, 22 children were divided into two groups, that is, group I consisting of PEM and group II consisting of VR. The participants were instructed to wear the device and then subjected to dental restorative procedures. After completion of the procedure, anxiety was measured using a validated questionnaire by the children and by using the modified behavior pain scale by the second investigator. Also, physiological parameters like heart rate and oxygen saturation were evaluated before and after a dental procedure. Results: The results were statistically insignificant for group I and group II when a validated questionnaire and modified behavior pain scale were used to measure the dental anxiety of children. Also, the data also shows no significant difference in heart rate and oxygen saturation between the two groups. Conclusion: The innovative PEM can also be used as an effective behavior management tool in managing dental anxiety in children, as there was no statistically significant difference between PEM and VR. Clinical significance: As a pediatric dentist, the methods for administering a patient present a novel challenge because behavior management varies from patient to patient. As a result, the prospects for augmenting various techniques of behavior therapy for pediatric patients are limitless. How to cite this article: Gala UP, Kalaskar R. Comparative Evaluation of the Effectiveness of Innovative Periorbital Eye Massager and Virtual Reality Eyeglasses for Reducing Dental Anxiety during Dental Restorative Procedures in Children. Int J Clin Pediatr Dent 2024;17(1):48-53.

Contralateral acupuncture for migraine without aura: a randomized trial protocol with multimodal MRI.

Introduction: Migraine is a common clinical disorder, ranks as the second most disabling disease worldwide, and often manifests with unilateral onset. Contralateral acupuncture (CAT), as a classical acupuncture method, has been proven to be effective in the treatment of migraine without aura (MWoA). However, its neural mechanisms have not been investigated using multimodal magnetic resonance imaging (MRI). Methods and analysis: In this multimodal neuroimaging randomized trial, a total of 96 female MWoA participants and 30 female healthy controls (HCs) will be recruited. The 96 female MWoA participants will be randomized into three groups: Group A (CAT group), Group B [ipsilateral acupuncture (IAT) group], and Group C (sham CAT group) in a 1:1:1 allocation ratio. Each group will receive 30 min of treatment every other day, three times a week, for 8 weeks, followed by an 8-week follow-up period. The primary outcome is the intensity of the migraine attack. Data will be collected at baseline (week 0), at the end of the 8-week treatment period (weeks 1-8), and during the 8-week follow-up (weeks 9-16). Adverse events will be recorded. Multimodal MRI scans will be conducted at baseline and after 8-week treatment. Discussion: This study hypothesized that CAT may treat MWoA by restoring pathological alterations in brain neural activity, particularly by restoring cross-integrated functional connectivity with periaqueductal gray (PAG) as the core pathological brain region. The findings will provide scientific evidence for CAT in the treatment of MWoA. Ethics and dissemination: The Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine has given study approval (approval no. 2022-006). This trial has been registered with the Chinese Clinical Trials Registry (registration no. ChiCTR2300069456). Peer-reviewed papers will be used to publicize the trial's findings. Clinical trial registration: https://clinicaltrials.gov/, identifier ChiCTR2300069456.