Impact of telenurse-led intervention in clinical trials on health literacy, empowerment, and health outcomes in patients with solid tumours: a pilot quasi-experimental study.

BACKGROUND: During the COVID-19 pandemic, decentralised clinical trials incorporated self-monitoring, self-reporting, and telenursing tools to address health literacy and health empowerment of patients enrolled in clinical trials. We aimed to determine the impact of an educational intervention using telenursing consultations on health literacy, health empowerment, and health-related quality of life in cancer patients enrolled in clinical trials by measuring the level of satisfaction with the care received and assessing the views of healthcare professionals concerning the advanced practice nurse (APN) role in oncology clinical trials. METHODS: In this pilot analytical, descriptive, longitudinal, quasi-experimental, and pre-post test study, an educational intervention was conducted by 5 visits with an APN using synchronous teleconsultation in patients starting cancer treatment for the first time in a clinical trial (n = 60), and health professionals working with the APN (n = 31). A descriptive analysis of the samples and questionnaires were utilised along with statistical comparisons. RESULTS: After the intervention, patients' health literacy (31.7%), health empowerment (18.3%), and health-related quality of life (33.3%) increased (p < 0.05), with a decrease and trend towards resolution of care needs (p < 0.05). Satisfaction with the quality and care received in terms of perceived convenience, transition, and continuity of care showed positive results in 64.9 ± 20.7, 77.6 ± 19.5, and 72.1 ± 20.4 of respondents, respectively. On the overall assessment of the APN role, healthcare professionals expressed a high level of agreement with the statements related to their work performance. CONCLUSIONS: The data indicates that a clinical trial APN-led telenursing educational intervention results in an overall increase in health literacy, an improvement in health empowerment and health-related quality of life, and a decrease in care needs of oncology clinical trials patients. Patients stated that they received a high quality of care and health professionals indicated high levels of acceptance with APNs. Based on these results, we suggest that the APN role should gain more recognition in the Spanish healthcare system and their professional competencies should be aligned with those of other countries.

The importance of CXCR4 expression in tumor stroma as a potential biomarker in pancreatic cancer.

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is one of the main causes of cancer mortality in the world. A characteristic feature of this cancer is that a large part of the tumor volume is composed of a stroma with different cells and factors. Among these, we can highlight the cytokines, which perform their function through binding to their receptors. Given the impact of the CXCR4 receptor in the interactions between tumor cells and their microenvironment and its involvement in important signaling pathways in cancer, it is proposed as a very promising prognostic biomarker and as a goal for new targeted therapies. Numerous studies analyze the expression of CXCR4 but we suggest focusing on the expression of CXCR4 in the stroma. METHODS: Expression of CXCR4 in specimens from 33 patients with PDAC was evaluated by immunohistochemistry techniques and matched with clinicopathological parameters, overall and disease-free survival rates. RESULTS: The percentage of stroma was lower in non-tumor tissue (32.4 ± 5.2) than in tumor pancreatic tissue (67.4 ± 4.8), P-value = 0.001. The level of CXCR4 expression in stromal cells was diminished in non-tumor tissue (8.7 ± 4.6) and higher in tumor pancreatic tissue (23.5 ± 6.1), P-value = 0.022. No significant differences were identified in total cell count and inflammatory cells between non-tumor tissue and pancreatic tumor tissue. No association was observed between CXCR4 expression and any of the clinical or pathological data, overall and disease-free survival rates. Analyzing exclusively the stroma of tumor samples, the CXCR4 expression was associated with tumor differentiation, P-value = 0.05. CONCLUSIONS: In this study, we reflect the importance of CXCR4 expression in the stroma of patients diagnosed with PDAC. Our results revealed a high CXCR4 expression in the tumor stroma, which is related to a poor tumor differentiation. On the contrary, we could not find an association between CXCR4 expression and survival and the rest of the clinicopathological variables. Focusing the study on the CXCR4 expression in the tumor stroma could generate more robust results. Therefore, we consider it key to develop more studies to enlighten the role of this receptor in PDAC and its implication as a possible biomarker.

Aprotinin treatment against SARS-CoV-2: A randomized phase III study to evaluate the safety and efficacy of a pan-protease inhibitor for moderate COVID-19.

BACKGROUND: SARS-CoV-2 virus requires host proteases to cleave its spike protein to bind to its ACE2 target through a two-step furin-mediated entry mechanism. Aprotinin is a broad-spectrum protease inhibitor that has been employed as antiviral drug for other human respiratory viruses. Also, it has important anti-inflammatory properties for inhibiting the innate immunity contact system. METHODS: This was a multicentre, double-blind, randomized trial performed in four Spanish hospitals comparing standard treatment versus standard treatment + aprotinin for patients with COVID-19 between 20 May 2020 and 20 October 2021. The primary efficacy outcomes were length of hospital stay and ICU admission. The secondary endpoints were each of the primary efficacy outcomes and a composite of oxygen therapy, analytical parameters and death. Safety outcomes included adverse reactions to treatment during a 30-day follow-up period. Treatment was given for 11 days or till discharge. RESULTS: With almost identical analytical profiles, significant differences were observed in treatment time, which was 2 days lower in the aprotinin group (p = .002), and length of hospital admission, which was 5 days shorter in the aprotinin group (p = .003). The incidence of discharge was 2.19 times higher (HR: 2.188 [1.182-4.047]) in the aprotinin group than in the placebo group (p = .013). In addition, the aprotinin-treated group required less oxygen therapy and had no adverse reactions or side effects. CONCLUSION: Inhaled aprotinin may improve standard treatment and clinical outcomes in hospitalized patients with COVID-19, resulting in a shorter treatment time and hospitalization compared with the placebo group. The administration of aprotinin was safe.

Short and long-term outcomes of underwater EMR compared to the traditional procedure in the real clinical practice.

BACKGROUND AND AIMS: underwater endoscopic mucosal resection (U-EMR) has been recently described as an alternative to endoscopic mucosal resection (EMR) for flat colorectal polyps. However, the real applications remain unclear due to the lack of comparative studies. METHODS: a multi-centric prospective study was performed from November 2016 to December 2017. All lesions larger than 15 mm that were resected with both techniques were included in the study. The samples were matched using the size, morphology, site and access (SMSA) score as a reference. The efficacy, efficiency and adverse events rates were compared. RESULTS: a total of 162 resections were collected (112 EMR and 50 U-EMR) with an average size of 25 mm. U-EMR achieved better results for the en bloc resection rate (49 vs 62%; p = 0.08) and there were no cases of an incomplete resection (10.7 vs 0%; p = 0.01). U-EMR was faster than EMR and there were no differences in the adverse events rate. Furthermore, U-EMR tended to achieve better results in terms of recurrence. Performing the resection in emersion appeared to prevent the cautery artefact, especially in sessile serrated adenomas. CONCLUSION: in the real clinical practice, U-EMR and EMR are equivalent in terms of efficacy and safety. Furthermore, U-EMR may be a feasible approach to prevent cautery artefact, allowing an accurate pathologic assessment.

Prevention of Surgical Site Infection: Analysis and Narrative Review of Clinical Practice Guidelines. / Prevención de la infección de sitio quirúrgico: análisis y revisión narrativa de las guías de práctica clínica.

Surgical site infection is one of the most prevalent healthcare-associated infections and presents a considerable morbidity. The aim of this comprehensive narrative review is to describe the evidence and grade of recommendation of the preventive measures developed in the three phases of the surgical process (preoperative, perioperative and postoperative phases), as well as coincidences and divergences between selected Clinical Practice Guidelines (CPG). Four preventive measures were recommended with similar high grade evidence in all CPG: Hair removal, antibiotic prophylaxis, surgical site preparation and normothermia. However, critical points, new preventive measures and bundle implementations by surgical process are under discussion. These results represent a significant progress toward improving programs to prevent surgical site infection and they should be taken into account for improved future interventions in this area.

Spanish version of the short European Health Literacy Survey Questionnaire HLS-Q12: Transcultural adaptation and psychometric properties.

BACKGROUND: Health literacy has a direct impact on the health of populations. It is related to education, capacity for self-care, and management of health resources. The Health Literacy Survey Questionnaire HLS-Q12 is one of the reference instruments but has not yet been adapted to Spanish. The aims of the study were to cross-culturally adapt and evaluate the psychometric properties of the Spanish version of the HLS-Q12. METHODS: Data was collected from June 2020 to March 2022. The sample consisted of 60 patients who initiated cancer treatment for the first time within a clinical trial. Double direct translation, back-translation, cognitive debriefing with a 10-patient sample, and an expert committee were used for cross-cultural adaptation. For validation of the HLS-Q12, a psychometric analysis was performed to assess feasibility, reliability, sensitivity to change and construct validity with other measures such as health-related quality of life, empowerment, and health needs. RESULTS: The HLS-Q12 is equivalent at the semantic, conceptual, and content level to the original version and its psychometric properties demonstrated good internal consistency with a Cronbach's alpha of 0.88 and a McDonald´s omega of 0.91, a high degree of fit for the confirmatory factor analysis, and a statistically significant sensitivity to change (p = 0.025). CONCLUSIONS: Based on robust psychometric values, the Spanish version of HLS-Q12 was found to be a good cross-culturally adapted tool for collecting correct information on health literacy in cancer patients regardless of tumour type or stage. Although more studies are needed, this version of HLS-Q12 could be used in research for collecting data on the health literacy needs of Spanish-speaking patients.

Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients.

AIM: To evaluate the effect of faster aspart over glycaemic variability in type 1 diabetes (T1D) patients treated with sensor-augmented pump (SAP) in a real-world scenario. METHODS: Observational study with SAP-treated adult T1D patients treated with faster aspart for three months. The primary endpoint was the mean amplitude of glucose excursions (MAGE). RESULTS: Fifty patients were treated with faster aspart. Eleven patients (23%) withdrew during the follow-up mainly due to worsening of diabetes control (9 patients). Mean age was 41.2 yrs. (range 21-59) and T1D duration 22.4±10.0 yrs. Mean SAP treatment duration was 3.6±3.1 yrs. We detected a reduction of -7.0 (95% CI -1.1, -12.9; p=0.021) in MAGE at the end of the study. Other glycemic variability indices were also improved: standard deviation of mean interstitial glucose (-3mg/dl; 95% CI, -1, -5; p=0.01), CONGA4 (-2.2; 95% CI -0.3, -4.2; p=0.029), CONGA6 (-2.6; 95% CI -0.6, -4.6; p=0.011), GRADE (-0.5; 95% CI -0.1, -0.9; p=0.022), HBGI (-0.7; 95% CI -0.2, -1.3; p=0.013), J-index (-2.9; 95% CI -0.7, -5.0; p=0.011) and MODD (-5.7; 95% CI -1.7, -9.7; p=0.006). A slight reduction in mean glucose management indicator was also detected (-0.14%; 95% CI, -0.02, -0.27; -1.4mmol/mol; 95% CI -0.1, -3.3; p=0.03). CONCLUSIONS: In SAP-treated T1D patients, faster aspart insulin was associated with reduced glycaemic variability, but also a high percentage of dropouts due to worsened glycaemic control. NCT04233203.

Clinical features and mortality of COVID-19 patients admitted to ICU according to SOFA score.

The Sequential Organ Failure Assessment (SOFA) could function as an effective risk stratification tool in the admission of critically ill patients with COVID-19 and would allow stratification based on a risk assessment. We aimed to examine whether the SOFA score is useful to define 2 severity profiles in COVID-19 patients admitted to ICU: mild with SOFA < 5, and severe with SOFA ≥ 5. A retrospective cohort, multicenter study was conducted from February 11 to May 11, 2020. We analyzed patients admitted to all ICUs of the 14 public hospitals of the Castilla-La Mancha Health Service at the beginning of the pandemic and with SARS-CoV-2 infection. Patients were divided in 2 groups according to the level of severity by SOFA at admission to the ICU. Cox regression was used to evaluate factors associated with survival and Kaplan-Meier test to examine survival probability. In total, 405 patients with a complete SOFA panel were recruited in the 14 participating ICUs. SOFA <5 group showed that age above 60 years and D-dimer above 1000 ng/mL were risk factors associated with lower survival. In SOFA ≥ 5 it was found that high blood pressure was a risk factor associated with shorter survival. Kaplan-Meier showed lower survival in SOFA ≥ 5 in combination with high blood pressure, time since viral symptom onset to admission in ICU < 7 days, D-dimer ≥1000 ng/mL and respiratory pathology. However, SOFA < 5 showed only higher age (≥60 years) associated with lower survival. Age over 60 years and D-dimer over 1000 ng/mL were risk factors reflecting lower survival in patients with SOFA < 5. Moreover, SOFA ≥ 5 patients within a week after COVID-19 onset and comorbidities such as high blood pressure and previous respiratory pathology showed lower survival.

Characteristics and Risk Factors Associated With Mortality in a Multicenter Spanish Cohort of Patients With COVID-19 Pneumonia.

INTRODUCTION: Spain is one of the countries with the highest number of COVID-19 patients. Unfortunately, few data for regions are available. OBJECTIVES: This study aimed to describe the characteristics and independent risk factors associated with COVID-19 mortality in Castilla-La Mancha, Spain. METHODS: Cohort and multicenter study in all 14 public hospitals of the Castilla-La Mancha Health Service. Baseline characteristics, preexisting comorbidities, symptoms, clinical features and treatments were included. Multivariable logistic regression was used to evaluate factors associated with death and Kaplan-Meier test to examine survival probability. Statistical significance was considered with p < 0.05 (95% CI). SPSS (version 24.0 for Windows) and R 4.0.2 (R Statistics) software were used. RESULTS: The cohort comprised 12,126 patients sequentially attended between February 11 and May 11, 2020. The mean age of patients was 66.4 years; 5667 (46.7%) were women. Six protective factors against exitus were defined: female sex, anosmia, cough, chloroquine and azithromycin. The risk factors were: age over 50, obesity, cardiac pathology, fever, dyspnea, lung infiltrates, lymphopenia, D-dimer above 1000 ng/mL, and mechanical ventilation requirement. Survival analysis showed higher survival rate in women (75.7%) than men (72.1%). Cumulative survival was 87.5% for non-hospitalized patients, 70.2% for patients admitted to hospital and 61.2% in ICU patients. Additionally, survival probability decreased with increasing age range. CONCLUSION: Determination of protective or death-promoting factors could be useful to stratify patients by severity criteria and to improve COVID-19 care management.

INTRODUCCIÓN: España es uno de los países con mayor número de pacientes con COVID-19. Desafortunadamente, se dispone de pocos datos por regiones. OBJETIVOS: Describir las características y los factores de riesgo independientes asociados a mortalidad por COVID-19 en Castilla-La Mancha, España. MÉTODOS: Estudio de cohorte, multicéntrico de los 14 hospitales públicos de Castilla-La Mancha. Se evaluaron las características clínicas, comorbilidades preexistentes, síntomas y tratamientos. Se utilizó una regresión logística multivariable para evaluar los factores asociados a muerte y Kaplan-Meier para medir supervivencia. Se consideró significación estadística con p < 0,05 (IC 95%). Se utilizaron los programas SPSS (versión 24.0 para Windows) y R 4.0.2 (R Statistics). RESULTADOS: Se estudiaron 12.126 pacientes atendidos secuencialmente entre el 11 de febrero y el 11 de mayo de 2020. La edad media fue de 66,4 años; 5.667 (46,7%) fueron mujeres. Se definieron seis factores protectores contra el exitus: sexo femenino, anosmia, tos, cloroquina y azitromicina. Los factores de riesgo fueron: edad superior a 50, obesidad, patología cardíaca, fiebre, disnea, infiltrados pulmonares, linfopenia, dímero-D > 1.000 ng/mL y necesidad de ventilación mecánica. Se observó mayor tasa de supervivencia en mujeres (75,7%) que en hombres (72,1%). La supervivencia acumulada fue del 87,5% para pacientes no hospitalizados, 70,2% para admitidos en planta hospitalaria y 61,2% en la Unidad de Cuidados Intensivos (UCI). Además, la probabilidad de supervivencia disminuyó con el aumento del rango de edad. CONCLUSIÓN: La determinación de los factores protectores o favorecedores de muerte podría ser útil para estratificar pacientes por criterios de gravedad y mejorar la atención frente a la COVID-19.

Long-term effects of continuous subcutaneous insulin infusion in adults with type 1 diabetes mellitus patients: Results of a public healthcare system.

AIM: To evaluate the long-term clinical effect of continuous subcutaneous insulin infusion (CSII) in adult type 1 diabetes mellitus (T1DM) patients in a regional public healthcare system real-world scenario. METHODS: All adult T1DM patients on CSII for ≥10 years subjected to follow-up in the regional Castilla-La Mancha Public Health Service were included. The primary efficacy outcome was the variation in HbA1c during follow-up. Direct patient data were compiled through the web-based Spanish national registry on CSII therapy. RESULTS: A total of 69 T1DM adult patients were treated with insulin pumps for ≥10 years in our region. The mean age was 45.0±10.5 years, with a T1DM duration of 13.9±8.5 years. The mean duration of CSII therapy was 11.4±2.1 years. The main indications for treatment were high glucose variability (39%), problematic hypoglycemia (26%), and HbA1c >53mmol/mol (7%) on multiple daily injections (20%). Sensor-augmented pump therapy was used by 31% of the patients. Glycosylated hemoglobin did not change during follow-up (58±11mmol/mol vs. 58±11mmol/mol; 7.5±1.0 vs. 7.5±1.0; p=0.66). However, the percentage of patients with at least one episode of severe hypoglycemia during the last year and unnoticed hypoglycemia decreased from 36% to 7% (p=0.006) and from 38% to 32% (p<0.001), respectively. The proportion of subjects with ≥1 episode of diabetic ketoacidosis in the last year decreased from 30% to 6% (p=0.045). CONCLUSIONS: The reduction of severe hypoglycemia without deterioration of glycemic control can be sustained over long-term CSII therapy.

Influence of biomedical education on health and eating habits of university students in Spain.

OBJECTIVE: The aim of this study was to explore the influence of an enrolled degree course on health and eating habits in a population of Spanish university students (17-26 y of age). METHODS: A cross-sectional observational study was carried out with 648 students. Volunteers were stratified into biomedical (medicine and nursing, 48%) and non-biomedical students (other fields of study, 52%). Data were collected using previously self-reported questionnaires focused on anthropometric and sociodemographic profile, lifestyle practices, body image perception, health consciousness, eating habits, physical activity, and food addiction. Mann-Whitney U tests and Pearson's χ2 tests were applied to identify associations between the two groups. RESULTS: Self-reported body mass index was higher for the non-biomedical group (22.1 ± 3.1 versus 23 ± 5 kg/m2; P < 0.05), which also reported less regularity in taking meals (91 versus 95%; P < 0.05), eating fewer colored vegetables and fruits (65 versus 77%; P < 0.001) and a higher alcohol intake (27 versus 20%; P < 0.001). In contrast, the proportion of students that showed more interest in the diet-health duality (92 versus 85%; P < 0.001) and a desire to adopt healthier habits (80 versus 78%; P < 0.05) was larger in the biomedical group. Dietary habits, obtained by means of a food frequency questionnaire, suggested that biomedical students make healthier food choices. Additionally, the group of biomedical students took more walks per week (5.8 ± 1.8 versus 5.5 ± 1.9; P < 0.05). CONCLUSIONS: Healthier lifestyle factors cluster into the biomedical group in various components of the study, except food addiction where no differences were observed. The data presented here suggest the necessity to develop health promotion strategies targeting university students.

Streptococcus gallolyticus infection in colorectal cancer and association with biological and clinical factors.

There is an unambiguous association of Streptococcus gallolyticus infection with colorectal cancer, although there is limited information about epidemiology or interaction between molecular and environmental factors. We performed an original quantitative analysis of S. gallolyticus in unselected colorectal cancer patients (n = 190) and their association with clinical, pathological tumor molecular profiles (microsatellite instability, hypermethylator phenotype and chromosomal instability pathways), and other biological factors in colorectal tumor and normal tissues (cytomegalovirus and Epstein-Barr virus infection). We developed a new quantitative method to assess bacterial load. Analytical validation was reached with a very high sensitivity and specificity. Our results showed a 3.2% prevalence of S. gallolyticus infection in our unselected cohort of colorectal cancer cases (6/190). The average S. gallolyticus copy number was 7,018 (range 44-34,585). No previous reports relating to S. gallolyticus infection have been published for unselected cohorts of patients. Finally, and despite a low prevalence of S. gallolyticus in this study, we were able to define a specific association with tumor tissue (p = 0.03) and with coinfection with Epstein-Barr virus (p = 0.042; OR: 9.49; 95% IC: 1.1-82.9). The prevalence data provided will be very useful in the design of future studies, and will make it possible to estimate the sample size needed to assess precise objectives. In conclusion, our results show a low prevalence of S. gallolyticus infection in unselected colorectal cancer patients and an association of positive S. gallolyticus infection with tumor tissue and Epstein-Barr virus coinfection. Further studies will be needed to definitively assess the prevalence of S. gallolyticus in colorectal cancer and the associated clinicopathological and molecular profiles.