Feasibility of Goal-Directed Fluid Therapy in Patients with Transcatheter Aortic Valve Replacement - An Ambispective Analysis.

INTRODUCTION: Goal-directed fluid therapy (GDFT) has been shown to reduce postoperative complications. The feasibility of GDFT in transcatheter aortic valve replacement (TAVR) patients under general anesthesia has not yet been demonstrated. We examined whether GDFT could be applied in patients undergoing TAVR in general anesthesia and its impact on outcomes. METHODS: Forty consecutive TAVR patients in the prospective intervention group with GDFT were compared to 40 retrospective TAVR patients without GDFT. Inclusion criteria were age ≥ 18 years, elective TAVR in general anesthesia, no participation in another interventional study. Exclusion criteria were lack of ability to consent study participation, pregnant or nursing patients, emergency procedures, preinterventional decubitus, tissue and/or extremity ischemia, peripheral arterial occlusive disease grade IV, atrial fibrillation or other severe heart rhythm disorder, necessity of usage of intra-aortic balloon pump. Stroke volume and stroke volume variation were determined with uncalibrated pulse contour analysis and optimized according to a predefined algorithm using 250 ml of hydroxyethyl starch. RESULTS: Stroke volume could be increased by applying GDFT. The intervention group received more colloids and fewer crystalloids than control group. Total volume replacement did not differ. The incidence of overall complications as well as intensive care unit and hospital length of stay were comparable between both groups. GDFT was associated with a reduced incidence of delirium. Duration of anesthesia was shorter in the intervention group. Duration of the interventional procedure did not differ. CONCLUSION: GDFT in the intervention group was associated with a reduced incidence of postinterventional delirium.

Replacing concurrent controls with virtual control groups in rat toxicity studies.

Virtual control groups (VCGs) in nonclinical toxicity represent the concept of using appropriate historical control data for replacing concurrent control group animals. Historical control data collected from standardized studies can serve as base for constructing VCGs and legacy study reports can be used as a benchmark to evaluate the VCG performance. Replacing concurrent controls of legacy studies with VCGs should ideally reproduce the results of these studies. Based on three four-week rat oral toxicity legacy studies with varying degrees of toxicity findings we developed a concept to evaluate VCG performance on different levels: the ability of VCGs to (i) reproduce statistically significant deviations from the concurrent control, (ii) reproduce test substance-related effects, and (iii) reproduce the conclusion of the toxicity study in terms of threshold dose, target organs, toxicological biomarkers (clinical pathology) and reversibility. Although VCGs have shown a low to moderate ability to reproduce statistical results, the general study conclusions remained unchanged. Our results provide a first indication that carefully selected historical control data can be used to replace concurrent control without impairing the general study conclusion. Additionally, the developed procedures and workflows lay the foundation for the future validation of virtual controls for a use in regulatory toxicology.

Feasibility of Goal-Directed Fluid Therapy in Patients with Transcatheter Aortic Valve Replacement - An Ambispective Analysis

ABSTRACT Introduction: Goal-directed fluid therapy (GDFT) has been shown to reduce postoperative complications. The feasibility of GDFT in transcatheter aortic valve replacement (TAVR) patients under general anesthesia has not yet been demonstrated. We examined whether GDFT could be applied in patients undergoing TAVR in general anesthesia and its impact on outcomes. Methods: Forty consecutive TAVR patients in the prospective intervention group with GDFT were compared to 40 retrospective TAVR patients without GDFT. Inclusion criteria were age ≥ 18 years, elective TAVR in general anesthesia, no participation in another interventional study. Exclusion criteria were lack of ability to consent study participation, pregnant or nursing patients, emergency procedures, preinterventional decubitus, tissue and/or extremity ischemia, peripheral arterial occlusive disease grade IV, atrial fibrillation or other severe heart rhythm disorder, necessity of usage of intra-aortic balloon pump. Stroke volume and stroke volume variation were determined with uncalibrated pulse contour analysis and optimized according to a predefined algorithm using 250 ml of hydroxyethyl starch. Results: Stroke volume could be increased by applying GDFT. The intervention group received more colloids and fewer crystalloids than control group. Total volume replacement did not differ. The incidence of overall complications as well as intensive care unit and hospital length of stay were comparable between both groups. GDFT was associated with a reduced incidence of delirium. Duration of anesthesia was shorter in the intervention group. Duration of the interventional procedure did not differ. Conclusion: GDFT in the intervention group was associated with a reduced incidence of postinterventional delirium.

The effect of interventional program underpinned by health belief model on awareness, attitude, and performance of nurses in preventing nosocomial infections: A randomized controlled trial study / Efecto de un programa de intervención basado en el modelo de creencias en salud sobre el conocimiento, la actitud y el desempeño del personal de enfermería en la prevención de las infecciones intrahospitalarias. Ensayo controlado aleatorizado / Efeito de um programa de intervenção baseado no modelo de crenças em saúde no conhecimento, atitude e atuação da equipe de enfermagem na prevenção de infecções hospitalares. Teste controlado e aleatório

Objective. The present study examined the effect of an interventional program underpinned by the Health Belief Model (HBM) on nurses' awareness, attitude, and performance in preventing nosocomialinfections.Methods. This randomized controlled trial study was performed on 60 clinical nurses in lar, Iran. Nurses were selected using the simple random sampling method and assigned to two experimental (n=30) and control (n=30) groups. Data collection tool included the valid and reliable questionnaire was developed by Soleimani et al. The research intervention consisted of five 90-min sessions based on the health belief model in preventing hospital infection for experimental group. Before the intervention, immediately and two months after the intervention, the two groups completed the questionnaire. The control group received no intervention. Results. Data analysis showed that the differences between the two groups was statistically significant immediately and two months after the intervention (p<0.05). In experimental group the changes in the mean score of knowledge, attitude and performance of nurses before, immediately and two months after the intervention were significant (p<0.05), but in the control group, only the changes in the mean score of performance were significant (p<0.05). Conclusion. The results showed that the HBM-based intervention is effective in promoting nurses' knowledge, attitude, and performance in preventing nosocomialinfections. hence, periodical and in-service HBM-based training programs on preventing nosocomialinfections are recommended to be held for nurses.

Objetivo. El presente estudio examinó el efecto de un programa de intervención basado en el modelo de creencias en salud (Health Belief Model -HBM-, en inglés sobre el conocimiento, la actitud y el desempeño de las enfermeras en la prevención de las infecciones intrahospitalarias. Métodos. Este ensayo controlado aleatorizado se realizó en 60 enfermeras clínicas de lar, Irán. Las enfermeras fueron seleccionadas mediante el método de muestreo aleatorio simple y asignadas a dos grupos experimental (n=30) y de control (n=30). La herramienta para la recogida de datos incluyó el cuestionario válido y fiable desarrollado por Soleimani et al.La intervención consistió en cinco sesiones de 90 minutos basadas en el modelo de creencias de salud para prevenir la infección intrahospitalaria en el grupo experimental. Antes de la intervención, inmediatamente y dos meses después de la intervención, los dos grupos completaron el cuestionario. El grupo de control no recibió ninguna intervención. Resultados. El análisis de los datos mostró diferencias estadísticamente significativas entre los dos grupos en los momentos inmediatamente y dos meses después de la intervención (p<0.05). En el grupo experimental, los cambios en la puntuación media de conocimientos, actitudes y rendimiento de las enfermeras se observaron en los momentos de antes, inmediatamente y dos meses después de la intervención (p<0.05); mientras que en el grupo de control solamente los cambios en la puntuación media de desempeño fueron significativos (p<0.05). Conclusión. Los resultados mostraron que la intervención basada en HBM fue eficaz para promover el conocimiento, la actitud y el rendimiento de las enfermeras en la prevención de las infecciones intrahospitalaria, por lo que se recomienda impartir a las enfermeras programas de formación periódicos y en servicio basados en HBM sobre la prevención de las infecciones intrahospitalarias.

Objetivo. Examinar o efeito de um programa de intervenção baseado no Modelo de Crenças em Saúde (MBH) no conhecimento, atitude e desempenho dos enfermeiros na prevenção de infecções hospitalares. Métodos. Este ensaio clínico randomizado foi conduzido em 60 enfermeiras clínicas de lar, Irã. Os enfermeiros foram selecionados pelo método de amostragem aleatória simples e distribuídos em dois grupos experimental (n=30) e controle (n=30). O instrumento de coleta de dados incluiu o questionário válido e confiável desenvolvido por Soleimani et al. A intervenção consistiu em cinco sessões de 90 minutos baseadas no modelo de crenças em saúde para prevenir infecção hospitalar no grupo experimental. Antes, imediatamente e dois meses após a intervenção, ambos os grupos responderam ao questionário. O grupo controle não recebeu nenhuma intervenção. Resultados.A análise dos dados mostrou diferenças estatisticamente significativas entre os dois grupos imediatamente e dois meses após a intervenção (p<0.05). No grupo experimental foram observadas alterações na pontuação média de conhecimentos, atitudes e desempenho dos enfermeiros antes, imediatamente e dois meses após a intervenção (p<0.05); enquanto no grupo controle apenas as alterações na pontuação média de desempenho foram significativas (p<0.05). Conclusão.Os resultados demonstraram que a intervenção baseada no HBM foi eficaz na promoção do conhecimento, atitude e desempenho dos enfermeiros na prevenção de infecções hospitalares, pelo que se recomenda proporcionar aos enfermeiros este tipo de programas de formação em serviço baseados no HBM.

Can Historical Control Group Data Be Used to Replace Concurrent Controls in Animal Studies?

The availability of large amounts of high-quality control data from tightly controlled regulated animal safety data has created the idea to re-use these data beyond its classical applications of quality control, identification of treatment-related effects and assessing effect-size relevance for building virtual control groups (VCGs). While the ethical and cost-saving aspects of such a concept are immediately evident, the potential challenges need to be carefully considered to avoid any effect which could lower the sensitivity of an animal study to detect adverse events, safety thresholds, target organs, or biomarkers. In our brief communication, we summarize the current discussion regarding VCGs and propose a path forward how the replacement of concurrent control with VCGs resulting from historical data could be systematically assessed and to come to conclusions regarding the scientific value of the concept.

Temporal lobe tumors modify local venous drainage.

OBJECTIVE: Superficial Middle Cerebral Vein (SMCV) is an anastomotic vein frequently exposed during surgery. Changes in the pattern of cerebral venous outflow can occur in many pathological settings. We explored the hypothesis that the growth of an intracranial tumor could determine alterations in the venous outflow. We analyzed SMCV anatomical variants in patients undergoing surgery for intracranial tumors; we furthermore focused on association with histology. METHODS: We retrospectively collected data of 120 patients undergoing surgery, 60 presenting intracranial tumor and 60 presenting cerebral aneurysms (control group). Tumor series was divided into "Low Growth-Rate tumors" (WHO grade I and II) and "High Growth-Rate tumors" (WHO grade III and IV). Anatomical variants of SMCV were analyzed on intraoperative videos and then classified as Type 1 (normotrophic), 2 A (hypotrophic) and Type 2B (absent/atrophic). We furthermore defined as Type 2 any alteration of the SMCV (2 A+2B) encountered. Relationships among SMCV types and both populations were analyzed using the chi-squared test; values of p < 0.05 were considered statistically significant. RESULTS: We found a positive correlation between the presence of a primary brain tumor and Type 2B SMCV (PC.004, p < 0.05) and Type 2 SMCV (PC.000, p < 0.05). Specifically, we found a strong correlation between the absence of SMCV (Type 2B) and both tumors subgroups. Thus, the growth of a primary brain tumor seems to affect the cerebral local outflow. CONCLUSIONS: Primary brain tumors seem to alter local venous network of SMCV. Clinical and oncological implications remain subject of further investigation.

Hurdles and signposts on the road to virtual control groups-A case study illustrating the influence of anesthesia protocols on electrolyte levels in rats.

Introduction: Virtual Control Groups (VCGs) represent the concept of using historical control data from legacy animal studies to replace concurrent control group (CCG) animals. Based on the data curation and sharing activities of the Innovative Medicine Initiatives project eTRANSAFE (enhancing TRANSlational SAFEty Assessment through Integrative Knowledge Management) the ViCoG working group was established with the objectives of i) collecting suitable historical control data sets from preclinical toxicity studies, ii) evaluating statistical methodologies for building adequate and regulatory acceptable VCGs from historical control data, and iii) sharing those control-group data across multiple pharmaceutical companies. During the qualification process of VCGs a particular focus was put on the identification of hidden confounders in the data sets, which might impair the adequate matching of VCGs with the CCG. Methods: During our analyses we identified such a hidden confounder, namely, the choice of the anesthetic procedure used in animal experiments before blood withdrawal. Anesthesia using CO2 may elevate the levels of some electrolytes such as calcium in blood, while the use of isoflurane is known to lower these values. Identification of such hidden confounders is particularly important if the underlying experimental information (e.g., on the anesthetic procedure) is not routinely recorded in the standard raw data files, such as SEND (Standard for Exchange of Non-clinical Data). We therefore analyzed how the replacement of CCGs with VCGs would affect the reproducibility of treatment-related findings regarding electrolyte values (potassium, calcium, sodium, and phosphate). The analyses were performed using a legacy rat systemic toxicity study consisting of a control and three treatment groups conducted according to pertinent OECD guidelines. In the report of this study treatment-related hypercalcemia was reported. The rats in this study were anesthetized with isoflurane. Results: Replacing the CCGs with VCGs derived from studies comprising both anesthetics resulted in a shift of control electrolyte parameters. Instead of the originally reported hypercalcemia the use of VCG led to fallacious conclusions of no observed effect or hypocalcemia. Discussion: Our study highlights the importance of a rigorous statistical analysis including the detection and elimination of hidden confounders prior to the implementation of the VCG concept.

Simulation-based training program on patient safety management: A quasi-experimental study among new intensive care unit nurses.

BACKGROUND: Patient safety is an essential responsibility of nurses. However, newly graduated nurses experience patient safety incidents due to a lack of patient safety competency. In particular, intensive care unit nurses provide care to critical patients, making it difficult for new nurses to maintain patient safety. Therefore, it is necessary to improve the patient safety competency of newly graduated nurses working in the intensive care unit. OBJECTIVES: To analyze the effects of a simulation-based training program on patient safety management on the patient safety competency, patient safety management activity, communication self-efficacy, and teamwork of newly graduated nurses working in an intensive care unit. DESIGN: A quasi-experimental study. SETTINGS: The study was conducted at a university in Korea. PARTICIPANTS: A total of 44 newly graduated nurses working in the intensive care unit of a university hospital. METHODS: A simulation-based training program on patient safety management was applied to the experimental group (n = 22), while only the usual hospital training program was used for the control group (n = 22). A structured questionnaire survey comprising Patient Safety Competency Self-Evaluation, Patient Safety Management Activities, the Korean version of the self-efficacy questionnaire, and K-self assessment of teamwork was conducted at baseline test (T1), post test (T2), and follow-up test (T3). Data were analyzed using a repeated measures ANOVA. RESULTS: The experimental group showed significantly higher patient safety competency, patient safety knowledge, and patient safety skills, along with higher communication self-efficacy scores than the control group (p < .05) after the intervention and at four weeks after the intervention. CONCLUSIONS: The simulation-based training program on patient safety management effectively improved the patient safety competency, patient safety knowledge, and patient safety skills as well as communication self-efficacy of newly graduated nurses working in an intensive care unit.

Time-Dependent Changes in Depressive Symptoms Among Control Participants in Digital-Based Psychological Intervention Studies: Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Digital-based psychological interventions (DPIs) have been shown to be efficacious in many randomized controlled trials (RCTs) in dealing with depression in adults. However, the effects of control comparators in these DPI studies have been largely overlooked, and they may vary in their effects on depression management. OBJECTIVE: This meta-analytical study aimed to provide a quantitative estimate of the within-subject effects of control groups across different time intervals and explore the moderating effects of control types and symptom severity at baseline. METHODS: A systematic literature search was conducted in late September 2021 on selected electronic databases: PubMed; ProQuest; Web of Science; and the Ovid system with MEDLINE, PsycINFO, and Embase. The control conditions in 107 RCTs with a total of 11,803 adults with depressive symptoms were included in the meta-analysis, and effect sizes (Hedges g) were calculated using the standardized mean difference approach. Study quality was assessed using the Cochrane risk-of-bias tool for randomized trials version 2. RESULTS: The control conditions collectively yielded small to moderate effects in reducing depressive symptoms within 8 weeks since the baseline assessment (g=-0.358, 95% CI -0.434 to -0.281). The effects grew to moderate within 9 to 24 weeks (g=-0.549, 95% CI -0.638 to -0.460) and peaked at g=-0.810 (95% CI -0.950 to -0.670) between 25 and 48 weeks. The effects were maintained at moderate to large ranges (g=-0.769, 95% CI -1.041 to -0.498) beyond 48 weeks. The magnitude of the reduction differed across the types of control and severity of symptoms. Care as usual was the most powerful condition of all and produced a large effect (g=-0.950, 95% CI -1.161 to -0.739) in the medium term. The findings showed that waitlist controls also produced a significant symptomatic reduction in the short term (g=-0.291, 95% CI -0.478 to -0.104), refuting the previous suspicion of a nocebo effect. In addition, a large effect on depressive symptom reduction in the long term (g=-1.091, 95% CI -1.210 to -0.972) was noted among participants with severe levels of depressive symptoms at baseline. CONCLUSIONS: This study provided evidence that depressive symptoms generally reduced over time among control conditions in research trials of DPIs. Given that different control conditions produce variable and significant levels of symptomatic reduction, future intervention trials must adopt an RCT design and should consider the contents of control treatments when investigating the efficacy of DPIs. The results of waitlist controls confirmed previous findings of spontaneous recovery among people with mild to moderate depressive symptoms in face-to-face studies. Researchers may adopt watchful waiting as participants wait for the availability of digital-based psychological services.

Factors associated with family function in school children: Case-control study.

Background: Family functionality is that which promotes the integral development of its members, as well as a favorable state of health in them; fulfilling the basic parameters of adaptation, participation, growth, affection, and resources. Family dysfunction is understood as the failure to comply with any of these functions due to an alteration in one or more of the subsystems. Objective: There is little research on variables related to family functioning with a case-control design, for this reason, we present the family functioning of school students, identify variables found to be related to family functioning, and describe a model of variables related to family dysfunction. Materials and methods: Analytical study of cases and controls. The sample was made up of 290 students. The APGAR scale was used to identify family dysfunction. The statistical processing was done in Epi-Info 7.0 and STATA 14. The variables that were considered were: Municipality, area, age, sex, school grade, mother's age, disability, and displacement. Results: The factors associated with adequate family function were: displacement, (OR = 0.17, CI: 0.03-0.99). You are followed, your parents pay attention and listen to you (OR = 0.25, CI: 0.08-0.74), you talk to your mother every day (OR = 0.35 CI: 0.16-0.74), you spend free time with your parents (OR = 0.41, CI: 0.20-0.86), play sports at least once a week (OR = 0.42, CI = 0.20-0.91), and finally, attend religious services (OR = 0.51, CI: 0.29-0.90). While the factors associated with family dysfunction were: your parents punish you by forbidding you things (OR = 2.98, CI: 1.32-6.71) and you have friends close to where you live followed by an (OR = 2.60, CI: 1.13-5.96). Conclusions: Dysfunctionality was evident in the four municipalities of the Valley. Among the main factors associated with dysfunctionality was punishment by parents for forbidding things and having friends near the schoolchild's home.

The effect of interventional program underpinned by health belief model on awareness, attitude, and performance of nurses in preventing nosocomial infections: A randomized controlled trial study.

Objective: The present study examined the effect of an interventional program underpinned by the Health Belief Model (HBM) on nurses' awareness, attitude, and performance in preventing nosocomial infections. Methods: This randomized controlled trial study was performed on 60 clinical nurses in lar, Iran. Nurses were selected using the simple random sampling method and assigned to two experimental (n=30) and control (n=30) groups. Data collection tool included the valid and reliable questionnaire was developed by Soleimani et al. The research intervention consisted of five 90-min sessions based on the health belief model in preventing hospital infection for experimental group. Before the intervention, immediately and two months after the intervention, the two groups completed the questionnaire. The control group received no intervention. Results: Data analysis showed that the differences between the two groups was statistically significant immediately and two months after the intervention (p<0.05). In experimental group the changes in the mean score of knowledge, attitude and performance of nurses before, immediately and two months after the intervention were significant (p<0.05), but in the control group, only the changes in the mean score of performance were significant (p<0.05). Conclusion: The results showed that the HBM-based intervention is effective in promoting nurses' knowledge, attitude, and performance in preventing nosocomial infections. hence, periodical and in-service HBM-based training programs on preventing nosocomial infections are recommended to be held for nurses.

Evaluación de los comparadores empleados en los estudios pivotales de nuevos medicamentos e indicaciones / Assessment of comparators used in pivotal studies of new medicines and indications

Objetivo: En algunos casos, los estudios pivotales para aprobar nuevos medicamentos no emplean el comparador más adecuado. El objetivo es cuantificar este problema analizando los Informes de Posicionamiento Terapéutico (IPT) publicados por el Ministerio de Sanidad español.Métodos: El comparador se clasificó en seis categorías según la adecuación del tratamiento, es decir, si coincidía con el estándar de tratamiento al ser autorizado: A-“inicialmente adecuado”, B-“sin comparador por causa ética”, C-“sin comparador excluyendo los clasificados en B”, D-“inadecuado” y E-“parcialmente subóptimo” (cuando era estándar solo para parte de los pacientes).La variable principal fue la proporción de nuevos fármacos/indicaciones con comparación suficiente (categorías A, B y C) o deficiente (el resto). La información sobre comparadores y tratamiento estándar se extrajo del IPT. Resultados: Se analizaron aleatoriamente 186 IPT con nuevos medicamentos/indicaciones, publicados entre 2013 y 2022. La comparación se consideró suficiente en un 73,7% (IC95 66,9-79,5) de los casos. El 26,3% restante (IC95 20,5-33,1) presentaba comparaciones deficientes en el ensayo pivotal, ya fuera por comparador inadecuado (11,3%), parcialmente subóptimo (5,4%) o ausencia de un estudio comparativo (9,7%). No hubo diferencias en relación con el año de aprobación.Conclusiones: Aproximadamente uno de cada cuatro nuevos medicamentos o indicaciones carece de una comparación suficiente en el momento de empezar a ser utilizado en la práctica clínica. La proporción no mejora a lo largo de los últimos 10 años. Las agencias reguladoras deben ser más exigentes en la selección del comparador para los ensayos clínicos pivotales, por cuestiones éticas y sanitarias. (AU)

Objective: Pivotal studies to approve new medicines often do not use the most appropriate comparator. The objective is to quantify this problem by analysing the Therapeutic Positioning Reports (IPT for its acronym in Spanish) published by the Spanish Health Ministry.Methods: The comparator was classified into six categories, based on the appropriateness of the treatment, i.e. whether it matched the standard of treatment when authorised: A-«initially adequate» (at the start of the study), B-«no comparator for ethical reasons», C-«no comparator -excluding B-«, D-«inadequate» and E-«partially suboptimal» (when it was standard for part of the included patients but not for all of them).The primary endpoint was the proportion of new drugs/indications with sufficient (categories A, B and C) or poor comparator (the rest). Information on comparators and standard treatment was extracted from the IPT. Results: We randomly analysed 186 IPTs with new drugs or indications, published between 2013 and March 2022. Comparability was assessed as sufficient in 73.7% (95%CI 66.9-79.5) of cases. The remaining 26.3% (95%CI 20.5-33.1) had poor comparisons in the pivotal trial, either due to inadequate comparator (11.3%), partially suboptimal (5.4%) or absence of a comparative study excluding ethical justification (9.7%). Conclusions: Approximately one in four new medicines or indications lacks sufficient comparability at the time of entry into clinical practice. The proportion has not improved over the last 10 years. Regulatory agencies need to be more stringent in comparator selection for pivotal clinical trials, for ethical and health reasons. (AU)

Comparison of test-negative and syndrome-negative controls in SARS-CoV-2 vaccine effectiveness evaluations for preventing COVID-19 hospitalizations in the United States.

BACKGROUND: Test-negative design (TND) studies have produced validated estimates of vaccine effectiveness (VE) for influenza vaccine studies. However, syndrome-negative controls have been proposed for differentiating bias and true estimates in VE evaluations for COVID-19. To understand the use of alternative control groups, we compared characteristics and VE estimates of syndrome-negative and test-negative VE controls. METHODS: Adults hospitalized at 21 medical centers in 18 states March 11-August 31, 2021 were eligible for analysis. Case patients had symptomatic acute respiratory infection (ARI) and tested positive for SARS-CoV-2. Control groups were test-negative patients with ARI but negative SARS-CoV-2 testing, and syndrome-negative controls were without ARI and negative SARS-CoV-2 testing. Chi square and Wilcoxon rank sum tests were used to detect differences in baseline characteristics. VE against COVID-19 hospitalization was calculated using logistic regression comparing adjusted odds of prior mRNA vaccination between cases hospitalized with COVID-19 and each control group. RESULTS: 5811 adults (2726 cases, 1696 test-negative controls, and 1389 syndrome-negative controls) were included. Control groups differed across characteristics including age, race/ethnicity, employment, previous hospitalizations, medical conditions, and immunosuppression. However, control-group-specific VE estimates were very similar. Among immunocompetent patients aged 18-64 years, VE was 93 % (95 % CI: 90-94) using syndrome-negative controls and 91 % (95 % CI: 88-93) using test-negative controls. CONCLUSIONS: Despite demographic and clinical differences between control groups, the use of either control group produced similar VE estimates across age groups and immunosuppression status. These findings support the use of test-negative controls and increase confidence in COVID-19 VE estimates produced by test-negative design studies.

Enhanced survival and accelerated perfusion of skin flap to recipient site following administration of human amniotic membrane in rat models.

The human amniotic membrane contains the cellular parts obligatory for cell integration and tissue remodeling and has high tensile strength and persistence. We theorized that such material could function as a scaffold to improve the survival of ischemic tissue in random skin flaps. Male Albino Wistar rats (n = 30) were randomly assigned to three groups, each receiving a different model of AM on dorsal paravertebral areas: saline, amniotic membrane sheet, and micronized amniotic membrane. Digital photographs were taken, and the survival area was examined after one week. Histological analysis of skin flap tissue was performed, and the expression rate of vascular endothelial growth factor and apoptotic protein was examined. The survival percentage increased over time in all groups; however, one week after the implanted AM was increased survival in both experimental groups, with significantly greater than in the group control. In the experimental groups, there was a more regular arrangement of collagen and improved epithelialization in the flap tissue, also an increased number of inflammatory cells was observed in the control group. Additionally, VEGF and apoptotic protein expression, respectively, were significantly lower and greater in the control group than in the experimental groups. These results show that micronized membrane is an excellent scaffold for promoting flap survival.

Effect of Benson's relaxation technique on caregiver burden in caregivers of hemodialysis patients. A Randomized Controlled Trial / Efecto de la técnica de relajación de Benson en la carga del cuidador de pacientes en hemodiálisis. Un entudio controlado aleatorizado / Efeito da técnica de relaxamento de Benson na sobrecarga do cuidador em pacientes em hemodiálise. Um estudo controlado randomizado

Methods. This is a randomized controlled trial study on 52 caregivers of hemodialysis patients referred an universitary hospital at Jahrom. The caregivers were randomly divided into intervention and control groups. In the intervention group, Benson's relaxation was performed twice a day for 15 minutes each time, and continued for one month. Data collection tools included demographic information questionnaire and standard Zarit Burden Interview questionnaire which was completed by all participants before the intervention and one month after it. Results. After the intervention, the mean caregiver burden of hemodialysis patients in the intervention group decreased significantly compared to the control group (p<0.001). The results of paired t-test showed that in the intervention group, the mean scores of caregiver burden after the intervention (14.46± 10.91) was significantly lower than before the intervention (38.33±16.94) (p=0.001). Conclusion. Benson's relaxation method can reduce caregiver burden in caregivers of hemodialysis patients.

Objetivo. Investigar el efecto de la técnica de relajación de Benson sobre la carga de los cuidadores de pacientes en hemodiálisis. Métodos. Estudio de intervención realizado con la participación de 52 cuidadores de pacientes en hemodiálisis remitidos a un hospital universitario de Jahrom (Iran). Los cuidadores fueron divididos aleatoriamente en los grupos de intervención y de control. En el grupo de intervención, se realizó la técnica de relajación de Benson dos veces al día durante 15 minutos cada vez, y se continuó durante un mes. Las herramientas de recogida de datos incluían un cuestionario de información demográfica y la entrevista de percepción de carga del cuidador "Zarit Burden Interview" que fue completado por todas participantes antes de la intervención y un mes después de terminada la misma. Resultados. Después de la intervención, la carga media de los cuidadores de pacientes en hemodiálisis en el grupo de intervención disminuyó significativamente en comparación con el grupo de control (p<0.001). Los resultados de la prueba t pareada mostraron que en el grupo de intervención, las puntuaciones medias de la carga del cuidador después de la intervención (14.46±10.91) fueron significativamente menores que antes de la intervención (38.33±16.94) (p=0.001). Conclusión. El método de relajación de Benson puede reducir la carga de los cuidadores de pacientes en hemodiálisis.

Objetivo. Investigar o efeito do relaxamento de Benson na sobrecarga do cuidador em cuidadores de pacientes em hemodiálise na cidade de Jahrom. Métodos. Este é um estudo controlado randomizado envolvendo 52 cuidadores de pacientes em hemodiálise encaminhados a um hospital afiliado à Jahrom University of Medical Sciences. Os cuidadores foram divididos aleatoriamente em grupos intervenção (n=24) e controle (n=24). No grupo intervenção, os cuidadores realizaram o relaxamento de Benson duas vezes ao dia por 15 minutos cada, e foi continuado por um mês. A coleta de informações incluiu um questionário de informações demográficas e o questionário padrão Zarit que foi preenchido por todos os participantes antes da intervenção e um mês após o seu preenchimento. Resultado S. A maioria dos cuidadores nos grupos intervenção (79.2%) e controle (64.3%) eram mulheres. Após a intervenção, a sobrecarga média dos cuidadores de pacientes em hemodiálise no grupo intervenção diminuiu significativamente em relação ao grupo controle (p<0.001). Os resultados do teste t pareado mostraram que, apenas no grupo intervenção, os escores médios de sobrecarga do cuidador após a intervenção (14.46 ±10.1) foram significativamente menores do que antes da intervenção (38.33) ±16.94) com p <0.001. Conclusão. O método de relaxamento de Benson demonstrou ser eficaz na redução da sobrecarga dos cuidadores de pacientes em hemodiálise.

Housekeeping Proteins Exhibit a High Level of Expression Variability Within Control Group and Between Ischemic Human Heart Biopsies.

Background Human cardiac biopsies are widely used in clinical and fundamental research to decipher molecular events that characterize cardiac physiological and pathophysiological states. One of the main approaches relies on the analysis of semiquantitative immunoblots that reveals alterations in protein expression levels occurring in diseased hearts. To maintain semiquantitative results, expression level of target proteins must be standardized. The expression of HKP (housekeeping proteins) is commonly used to this purpose. Methods and Results We evaluated the stability of HKP expression (actin, ß-tubulin, GAPDH, vinculin, and calsequestrin) and total protein staining within control (coefficient of variation) and comparatively with ischemic human heart biopsies (P value). All HKP exhibited a high level of intragroup (ie, actin, ß-tubulin, and GAPDH) and/or intergroup variability (ie, GAPDH, vinculin, and calsequestrin). Among all, we found total protein staining to exhibit the highest degree of stability within and between groups, which makes this reference the best to study protein expression level in human biopsies from ischemic hearts and age-matched controls. In addition, we illustrated that using an inappropriate reference protein marker misleads interpretation on SERCA2 (sarco/endoplasmic reticulum Ca2+ ATPase) and cMyBPC (cardiac myosin binding protein-C) expression level after myocardial infarction. Conclusions These reemphasize the need to standardize the level of protein expression with total protein staining in comparative immunoblot studies on human samples from control and diseased hearts.

A Longitudinal Effectiveness Study of a Child Obesity Electronic Health Record Tool.

BACKGROUND: Primary-care providers, clinic staff, and nurses play an important role in reducing child obesity; yet time restraints and clinical demands compete with effective pediatric weight management and prevention. METHODS: To investigate the potential impact of an electronic health record (EHR) enabled tool to assist primary care teams in addressing child obesity, we conducted a controlled effectiveness study of FitTastic compared with usual care on the BMI pattern of 291 children (2 to 17 years) up to 4 years later. RESULTS: Per χ2 analysis, a greater proportion of children with baseline overweight/obesity in the EHR tool group than the control group had a favorable BMI pattern (32% vs 13%, P = .03). In logistic regression, FitTastic children were more likely than control children to have a favorable BMI pattern at follow-up (OR 3.8, 95% CI 1.1 to 13.2), adjusted for age, gender, race, and parental education. CONCLUSION: Study findings suggest that EHR-enabled tools to assist primary care teams in managing child obesity may be useful for helping to address the weight in children with overweight/obesity, especially in younger children (2 to 5 years). Digital and EHR-enabled technologies may prove useful for partnering health care teams and families in the important tasks of setting positive, family-centered healthy lifestyle behavioral goals and managing child overweight and obesity.