A study protocol of a comparative mixed study of the T-Control catheter.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach. The general purpose of this study is to determine the effectiveness, comfort, and experience of the patient catheterized with T-Control® compared with patients with a conventional Foley catheter. Study Design: This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups. Endpoints: The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization's healthcare resources; and level of satisfaction and workload of health professionals. Patients and Methods: Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.

Effectiveness of the T-Control catheter: A study protocol.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the Foley-type catheter in patients with Acute Urine Retention (AUR). Study design: This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T-Control catheter or a conventional Foley-type catheter in patients with AUR. Endpoints: The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life-related to self-perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T-Control device as well as the patient experience. Patients and methods: Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in-depth interview.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study.

OBJECTIVES: This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain. DESIGN: Prospective, multicentre pre-post study. SETTING: Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. PARTICIPANTS: 156 patients were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention's total cost was estimated by multiplying health resource usage with unit costs. RESULTS: In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (-0.46%; 95% CI -0.69% to -0.23%), 6 months (-0.49%; 95% CI -0.73% to -0.25%) and 12 months (-0.43%; 95% CI -0.68% to -0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (-0.37; 95% CI -0.62 to -0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss. CONCLUSIONS: The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

Persistent Respiratory Failure and Re-Admission in Patients with Chronic Obstructive Pulmonary Disease Following Hospitalization for COVID-19.

Background: Chronic obstructive pulmonary disease (COPD) has been associated with worse clinical evolution/survival during a hospitalization for SARS-CoV2 (COVID-19). The objective of this study was to learn the situation of these patients at discharge as well as the risk of re-admission/mortality in the following 12 months. Methods: We carried out a subanalysis of the RECOVID registry. A multicenter, observational study that retrospectively collected data on severe acute COVID-19 episodes and follow-up visits for up to a year in survivors. The data collection protocol includes general demographic data, smoking, comorbidities, pharmacological treatment, infection severity, complications during hospitalization and required treatment. At discharge, resting oxygen saturation (SpO2), dyspnea according to the mMRC (modified Medical Research Council) scale and long-term oxygen therapy prescription were recorded. The follow-up database included the clinical management visits at 6 and 12 months, where re-admission and mortality were recorded. Results: A total of 2047 patients were included (5.6% had a COPD diagnosis). At discharge, patients with COPD had greater dyspnea and a greater need for prescription home oxygen. After adjusting for age, sex and Charlson comorbidity index, patients with COPD had a greater risk of hospital re-admission due to respiratory causes (HR 2.57 [1.35-4.89], p = 0.004), with no significant differences in survival. Conclusion: Patients with COPD who overcome a serious SARS-CoV2 infection show a worse clinical situation at discharge and a greater risk of re-admission for respiratory causes.

Expression of angiogenic and lymphangiogenic genes in primary cutaneous melanoma: relationship with angiolymphatic invasion and disease-free survival.

Melanoma is one of the most common cancers in the world. The main routes of tumor progression are related to angiogenesis and lymphangiogenesis. These routes can occur by local invasion, which is called angiolymphatic invasion (ALI). In this study, we assess gene expression of relevant biomarkers of angiogenesis and lymphangiogenesis in 80 FFPE melanoma samples to determine a molecular profile that correlates with ALI, tumor progression, and disease-free survival. The results were enhanced by a posttranscriptional analysis by an immunofluorescence assay. Three SNPs in the VEGFR-2 gene were genotyped in 237 malignant melanoma (MM) blood DNA samples by qPCR. A significant correlation was found for LYVE -1 and ALI, qualitative ( P  = 0.017) and quantitative ( P  = 0.005). An increased expression of protein LIVE-1 in ALI samples supported these results ( P  = 0.032). VEGFR2 was lower in patients who showed disease progression ( P  = 0.005) and protein VEGFR2 posttranscriptional expression decreased ( P  = 0.016). DFS curves showed differences ( P  = 0.023) for VEGFR2 expression detected versus the absence of VEGFR2 expression. No significant influence on DFS was detected for the remaining analyzed genes. Cox regression analysis suggested that VEGFR2 expression has a protective role (HR = 0.728; 95% CI = 0.552-0.962; P  = 0.025) on disease progression. No significant association was found between any of the studied SNPs of VEGFR2 and DFS or progression rate. Our main results suggest that LYVE-1 gene expression is closely related to ALI; the relationship with the development of metastases in MM deserves further studies. Low expression of VEGFR2 was associated with disease progression and the expression of VEGFR2 correlates with an increased DFS.

Treatment of Trochanteric Hip Fractures with Cephalomedullary Nails: Single Head Screw vs. Dual Integrated Compression Screw Systems.

Extracapsular hip fractures are very common in the elderly. They are mainly treated surgically with an intramedullary nail. Nowadays, both endomedullary hip nails with single cephalic screw systems and interlocking double screw systems are available on the market. The latter are supposed to increase rotational stability and therefore decrease the risk of collapse and cut-out. A retrospective cohort study was carried out, in which 387 patients with extracapsular hip fracture undergoing internal fixation with an intramedullary nail were included to study the occurrence of complications and reoperations. Of the 387 patients, 69% received a single head screw nail and 31% received a dual integrated compression screw nail. The median follow-up was 1.1 years, and in that time, a total of 17 reoperations were performed (4.2%; 2.1% for single head screw nails vs. 8.7% for double head screws). According to the multivariate logistic regression model adjusted for age, sex and basicervical fracture, the adjusted hazard risk of reoperation required was 3.6 times greater when using double interlocking screw systems (p = 0.017). A propensity scores analysis confirmed this finding. In conclusion, despite the potential benefits of using two interlocking head screw systems and the increased risk of reoperation in our single center, we encourage to other researchers to explore this question in a wider multicenter study.

Ecografía cervical para la evaluación de las cuerdas vocales: estudio piloto en una unidad de cirugía endocrina / Cervical ultrasound for the evaluation of the vocal cords: A pilot study in an endocrine surgery unit

Introducción: La ecografía cervical (EC) ha surgido como una herramienta prometedora en los últimos años para la evaluación de las cuerdas vocales (CV) en pacientes sometidos a cirugía de tiroides. Nuestro objetivo es valorar la fiabilidad de la EC una vez implementada en una unidad de cirugía endocrina y realizada por los propios cirujanos. Método: Se incluyeron 86 participantes sin antecedentes de enfermedad laríngea ni cirugía cervical a los que se les realizó una EC por parte de 3 cirujanos endocrinos independientes. Se analizaron las estructuras laríngeas y específicamente las CV. Para considerar la exploración como diagnóstica debían visualizarse las CV de manera estática y durante la fonación. También se analizó el tiempo de realización de la técnica y la variabilidad interobservador. Resultados: De los 86 participantes el 51,2% fueron varones y la edad media fue de 43 años. El rango de exploraciones diagnósticas entre los cirujanos fue de 60-68%, con una concordancia sustancial entre los 3 exploradores (valor K de Fleiss's=0,714). El sexo masculino y la edad avanzada fueron factores asociados a la no evaluabilidad de la técnica. El tiempo medio del procedimiento fue de 72segundos. Conclusión: La EC es una herramienta rápida, no invasiva, viable a pie de cama y útil para la evaluar las CV antes de la cirugía tiroidea, principalmente en mujeres jóvenes. (AU)

Introduction: Cervical ultrasound (CE) has emerged as a promising tool in recent years for vocal cord (VC) assessment in patients undergoing thyroid surgery. Our aim is to assess the reliability of CE once implemented in an endocrine surgery unit and performed by the surgeons themselves. Method: 86 participants with no history of laryngeal pathology or cervical surgery underwent CE by three independent endocrine surgeons. Laryngeal structures and specifically the VCs were analysed. To consider the examination as diagnostic, the VCs had to be visualised statically and during phonation. The time taken to perform the technique and the interobserver variability were also analysed.Results: Of the 86 participants, 51.2% were male with a mean age of 43 years. The range of diagnostic examinations between surgeons was 60-68%, with substantial agreement between the 3 explorers (Fleiss's K-value=.714). Male sex and advanced age were factors associated with non-assessability of the technique. The mean procedure time was 72s. Conclusion: CE is a fast, non-invasive, feasible bedside tool useful for the assessment of VCs prior to thyroid surgery, mainly in young women. (AU)

Cervical ultrasound for the evaluation of the vocal cords: A pilot study in an endocrine surgery unit.

INTRODUCTION: Cervical ultrasound (CE) has emerged as a promising tool in recent years for vocal cord (VC) assessment in patients undergoing thyroid surgery. Our aim is to assess the reliability of CE once implemented in an endocrine surgery unit and performed by the surgeons themselves. MATERIAL AND METHOD: 86 participants with no history of laryngeal pathology or cervical surgery underwent CE by three independent endocrine surgeons. Laryngeal structures and specifically the VCs were analysed. To consider the examination as diagnostic, the VCs had to be visualised statically and during phonation. The time taken to perform the technique and the interobserver variability were also analysed. RESULTS: Of the 86 participants, 51.2% were male with a mean age of 43 years. The range of diagnostic examinations between surgeons was 60-68%, with substantial agreement between the 3 explorers (Fleiss's K-value = .714). Male sex and advanced age were factors associated with non-assessability of the technique. The mean procedure time was 72 s. CONCLUSIONS: CE is a fast, non-invasive, feasible bedside tool useful for the assessment of VCs prior to thyroid surgery, mainly in young women.

Evaluation of the multimorbidity network and its relationship with clinical phenotypes in chronic obstructive pulmonary disease: The GALAXIA study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a complex and heterogeneous condition, in which taking into consideration clinical phenotypes and multimorbidity is relevant to disease management. Network analysis, a procedure designed to study complex systems, allows to represent connections between the distinct features found in COPD. METHODS: Network analysis was applied to a cohort of patients with COPD in order to explore the degree of connectivity between different diseases, taking into account the presence of two phenotypic traits commonly used to categorize patients in clinical practice: chronic bronchitis (CB+ /CB- ) and the history of previous severe exacerbations (Ex+ /Ex- ). The strength of association between diseases was quantified using the correlation coefficient Phi (ɸ). RESULTS: A total of 1726 patients were included, and 91 possible links between 14 diseases were established. Although the four phenotypically defined groups presented a similar underlying comorbidity pattern, with special relevance for cardiovascular diseases and/or risk factors, classifying patients according to the presence or absence of CB implied differences between groups in network density (mean ɸ: 0.098 in the CB- group and 0.050 in the CB+ group). In contrast, between-group differences in network density were small and of questionable significance when classifying patients according to prior exacerbation history (mean ɸ: 0.082 among Ex- subjects and 0.072 in the Ex+ group). The degree of connectivity of any given disease with the rest of the network also varied depending on the selected phenotypic trait. The classification of patients according to the CB- /CB+ groups revealed significant differences between groups in the degree of conectivity between comorbidities. On the other side, grouping the patients according to the Ex- /Ex+ trait did not disclose differences in connectivity between network nodes (diseases). CONCLUSIONS: The multimorbidity network of a patient with COPD differs according to the underlying clinical characteristics, suggesting that the connections linking comorbidities between them vary for different phenotypes and that the clinical heterogeneity of COPD could influence the expression of latent multimorbidity. Network analysis has the potential to delve into the interactions between COPD clinical traits and comorbidities and is a promising tool to investigate possible specific biological pathways that modulate multimorbidity patterns.

Cost-effectiveness of multicomponent interventions in type 2 diabetes mellitus in a cluster randomised controlled trial: the INDICA study.

OBJECTIVE: To analyse the cost-effectiveness of multicomponent interventions designed to improve outcomes in type 2 diabetes mellitus (T2DM) in primary care in the Canary Islands, Spain, within the INDICA randomised clinical trial, from the public health system perspective. DESIGN: An economic evaluation was conducted for the within-trial period (2 years) comparing the four arms of the INDICA study. SETTING: Primary care in the Canary Islands, Spain. PARTICIPANTS: 2334 patients with T2DM without complications were included. INTERVENTIONS: Interventions for patients (PTI), for primary care professionals (PFI), for both (combined intervention arm for patients and professionals, CBI) and usual care (UC) as a control group. OUTCOMES: The main outcome was the incremental cost per quality-adjusted life-years (QALY). Only the intervention and the healthcare costs were included. ANALYSIS: Multilevel models were used to estimate results, and to measure the size and significance of incremental changes. Missed values were treated by means of multiple imputations procedure. RESULTS: There were no differences between arms in terms of costs (p=0.093), while some differences were observed in terms of QALYs after 2 years of follow-up (p=0.028). PFI and CBI arms were dominated by the other two arms, PTI and UC. The differences between the PTI and the UC arms were very small in terms of QALYs, but significant in terms of healthcare costs (p=0.045). The total cost of the PTI arm (€2571, 95% CI €2317 to €2826) was lower than the cost in the UC arm (€2750, 95% CI €2506 to €2995), but this difference did not reach statistical significance. Base case estimates of the incremental cost per QALY indicate that the PTI strategy was the cost-effective option. CONCLUSIONS: The INDICA intervention designed for patients with T2DM and families is likely to be cost-effective from the public healthcare perspective. A cost-effectiveness model should explore this in the long term. TRIAL REGISTRATION NUMBER: NCT01657227.

Evaluation of Adverse Effects in Nursing Mothers and Their Infants After COVID-19 mRNA Vaccination.

Background and Objectives: Breastfeeding women are generally excluded from clinical trials with new vaccines. The objective of the study was to explore whether the BNT162b2 mRNA and mRNA-1273 COVID-19 vaccines are safe for breastfeeding mothers and their breastfed infants. Methods: A convenience sample prospective cohort single institution study was performed on breastfeeding health care professionals, who were exposed to second dose of SARS-CoV2 vaccine at the beginning of the study period. They and their breastfed children's symptoms were followed up through online questionnaires for 14 days. Results: Of the 95 finally included participants, only 1 was lost to follow-up on day 7. Mean age of the mothers was 35.9 ± 3.9 years and that of their infants was 14.6 ± 12.1 months. At least one adverse event was reported by 85% (95% confidence interval [CI]: 76-91.5%) of the mothers. The most frequent was injection site pain in 81% of cases. Moreover, 31% (95% CI: 22-41%) observed some event in their breastfed children. Most frequently, 19% (95% CI: 13-30%) of the children were irritable. During the 14 days of follow-up, 36% of the children (95% CI: 27-46%) were diagnosed with respiratory infection. Conclusions: Most mothers' reactions were mild and transitory, generally limited to the first 3 days after vaccination. Many children's events were associated with concomitant infectious processes and we did not detect a notable peak on any particular day of follow-up. Neither mothers nor their infants developed serious adverse events nor were they diagnosed with COVID-19 within the study period.

Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial.

OBJECTIVE: This study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term. Design: open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions. PARTICIPANTS: A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres. SETTING: Primary Care Centers in Canary Islands (Spain). INTERVENTION: The intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI). OUTCOME MEASURE: Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables. RESULTS: Compared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group). CONCLUSIONS: Assessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227.

Mal control de la diabetes tipo 2 en un centro de salud de atención primaria: factores modificables y población diana / Uncontrolled type 2 diabetes in primary care health center: Modifiable factors and target population

Objetivos: Detectar factores modificables y poblaciones diana asociados al mal control de la diabetes tipo 2 (DM2) en atención primaria. Diseño: Estudio descriptivo transversal restrospectivo. Emplazamiento: Centro de salud de Barranco Grande, Tenerife. Participantes: selección aleatoria de pacientes con DM2 atendidos por 12 médicos de familia y 12 enfermeras. Mediciones principales: Además del control de la DM2, se obtuvieron datos sociodemográficos, clínicos, hábitos de vida y seguimiento de medidas preventivas y terapéuticas. Tras análisis bivariado, se ajustó un modelo multivariado multinivel tomando el cupo médico-enfermero como efecto mixto de segundo nivel y el resto como variables de primer nivel. Resultados: Fueron reclutados 587 pacientes (46,5% mujeres), tratados con 1,9±1,1 fármacos antidiabéticos, con 4,1% de incumplimiento terapéutico, y padeciendo un 13,8% inercia terapéutica. El 23,7% mostraba mal control de DM2, siendo peor (p<0,05) en sexo masculino, edad <65 años, evolución DM2 ≥5 años, dieta inadecuada, síndrome metabólico, ratio triglicéridos/HDL≥3, complicaciones de la DM2, índice Charlson<5, visitas a enfermera<3/año, sin ECG en el último año y mayor número de fármacos prescritos para DM2. El cupo médico-enfermero se asoció al mal control con un coeficiente intraclase de 0,01. Conclusiones: Los hombres menores de 65 años con larga evolución de DM2 son población diana para intensificar intervenciones. El incumplimiento terapéutico, dieta inadecuada, falta de adhesión a los protocolos de seguimiento y ratio triglicéridos/HDL>3 son factores sobre los que intervenir. La asociación del cupo médico-enfermero con el control de la DM2 es débil, probablemente por adecuado seguimiento de los programas preventivos.(AU)

Aims: To detect modifiable factors and target populations associated with uncontrolled type 2 diabetes in primary care. Design: Retrospective cross-sectional descriptive study. Location: Health center of Barranco Grande, Tenerife. Participants: Random selection of patients with DM2 attended by 12 family doctors and 12 nurses. Main Measurements: In addition to the control of DM2, sociodemographic, clinical data, lifestyle and follow-up of preventive and therapeutic measures were obtained. After bivariate analysis, a multilevel multivariate model was adjusted by taking the quota of patients assisted by each physician as a second-level mixed-effect variable and the rest as first-level variables. Results: 587 patients were recruited (46.5% female), treated with 1.9-1.1 antidiabetic drugs, with 4.1% therapeutic non-compliance, and suffering 13.8% therapeutic inertia. 23.7% showed poor DM2 control, being significantly worse (p<0.05) in male sex, age <65 years, evolution DM2 -5 years, work-active, upper-middle studies, inadequate diet, metabolic syndrome, ratio TG/HDL-3, complications of DM2, Charlson index<5, nursing visits <3/year, without ECG in the last year, and more drugs prescribed for DM2. The doctor-nurse quota was associated with poor control with an intraclass coefficient of 0.01. Conclusions: Men under 65 years of age with DM2 evolution longer than 5 years are a target population to intensify interventions. Therapeutic non-compliance, inadequate diet, lack of adherence protocols and ratio TG/HDL>3 are the main modifiable factors on which to intervene. The association of the doctor-nurse quota with the control of DM2 is weak, probably due to adequate follow-up of preventive programs.(AU)

Efficacy of Human Papillomavirus Vaccination 4 Years After Conization for High-Grade Cervical Neoplasia.

OBJECTIVE: The aim of the study was to estimate human papillomavirus (HPV) vaccination efficacy in reducing recurrence risk within 4 years after conization for high-grade cervical neoplasia. MATERIALS AND METHODS: From January 2012 to June 2015, we performed a longitudinal, observational study (case-series study) on patients diagnosed with cervical intraepithelial neoplasia 2-3 neoplasia. Efficacy was estimated by a 95% CI of the relative risk, relative risk reduction, attributable risk, and number needed to treat. Parametric and nonparametric tests were used as appropriate to compare 160 vaccinated with 171 nonvaccinated patients. To estimate the hazard ratio of the vaccinated status, patients were subjected to multivariable analyses based on the Cox proportional hazard model. To compare recurrence-free survival, a Kaplan-Meier model and a log-rank test were applied. RESULTS: The overall recurrence was 9.4% in the nonvaccinated and 2.5% in the vaccinated group (p = .009). Vaccination was associated with a significant decrease in the relative risk (73.5%, 95% CI = 21.8%-90.9%) with a mean number needed to treat of 14 patients per relapse prevented. Although positive conization margins were related to the highest recurrence risk, not being vaccinated independently increased this risk 3.5-fold in a 4-year follow-up (p = .025). Cumulative recurrence-free rates differed significantly between both groups (log-rank test: p = .009). CONCLUSIONS: Our study corroborates the benefits of HPV vaccination, recommends a closer and longer follow-up in nonvaccinated women, and offers a 4-year prognosis for patients undergoing conization for high-grade cervical lesions.

SARS-CoV-2 Antibodies in Breast Milk After Vaccination.

BACKGROUND AND OBJECTIVES: Passive and active immunity transfer through human milk (HM) constitutes a key element in the infant's developing immunity. Certain infectious diseases and vaccines have been described to induce changes in the immune components of HM. METHODS: We conducted a prospective cohort single-institution study from February 2 to April 4, 2021. Women who reported to be breastfeeding at the time of their coronavirus disease 2019 (COVID-19) vaccination were invited to participate. Blood and milk samples were collected on day 14 after their second dose of the vaccine. Immunoglobulin G (IgG) antibodies against nucleocapsid protein as well as IgG, immunoglobulin M and immunoglobulin A (IgA) antibodies against the spike 1 protein receptor-binding domain against severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2 RBD-S1) were analyzed in both serum and HM samples. RESULTS: Most of the participants (ie, 94%) received the BNT162b2 messenger RNA COVID-19 vaccine. The mean serum concentration of anti-SARS-CoV-2 RBD-S-IgG antibodies in vaccinated individuals was 3379.6 ± 1639.5 binding antibody units per mL. All vaccinated study participants had anti-SARS-CoV-2 RBD-S1-IgG, and 89% of them had anti-SARS-CoV-2 RBD-S-IgA in their milk. The antibody concentrations in the milk of mothers who were breastfeeding 24 months were significantly higher than in mothers with breastfeeding periods <24 months (P < .001). CONCLUSIONS: We found a clear association between COVID-19 vaccination and specific immunoglobulin concentrations in HM. This effect was more pronounced when lactation periods exceeded 23 months. The influence of the lactation period on immunoglobulins was specific and independent of other variables.

[Uncontrolled type 2 diabetes in primary care health center: Modifiable factors and target population]. / Mal control de la diabetes tipo 2 en un centro de salud de atención primaria: factores modificables y población diana.

AIMS: To detect modifiable factors and target populations associated with uncontrolled type 2 diabetes in primary care. DESIGN: Retrospective cross-sectional descriptive study. LOCATION: Health center of Barranco Grande, Tenerife. PARTICIPANTS: Random selection of patients with DM2 attended by 12 family doctors and 12 nurses. MAIN MEASUREMENTS: In addition to the control of DM2, sociodemographic, clinical data, lifestyle and follow-up of preventive and therapeutic measures were obtained. After bivariate analysis, a multilevel multivariate model was adjusted by taking the quota of patients assisted by each physician as a second-level mixed-effect variable and the rest as first-level variables. RESULTS: 587 patients were recruited (46.5% female), treated with 1.9-1.1 antidiabetic drugs, with 4.1% therapeutic non-compliance, and suffering 13.8% therapeutic inertia. 23.7% showed poor DM2 control, being significantly worse (p<0.05) in male sex, age <65 years, evolution DM2 -5 years, work-active, upper-middle studies, inadequate diet, metabolic syndrome, ratio TG/HDL-3, complications of DM2, Charlson index<5, nursing visits <3/year, without ECG in the last year, and more drugs prescribed for DM2. The doctor-nurse quota was associated with poor control with an intraclass coefficient of 0.01. CONCLUSIONS: Men under 65 years of age with DM2 evolution longer than 5 years are a target population to intensify interventions. Therapeutic non-compliance, inadequate diet, lack of adherence protocols and ratio TG/HDL>3 are the main modifiable factors on which to intervene. The association of the doctor-nurse quota with the control of DM2 is weak, probably due to adequate follow-up of preventive programs.

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals. OBJECTIVE: This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care. METHODS: The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both. In the intervention for patients, participants received an educational group program and were monitored and supported by logs, a web-based platform, and automated SMS. Those in the intervention for professionals also received an educational program, a decision support tool embedded in the electronic clinical record, and periodic feedback about patients' results. A total of 2334 people with T2DM, regardless of glycated hemoglobin (HbA1c) levels and without diabetes-related complications, were included. The primary end point was change in HbA1c level. The main analysis was performed using multilevel mixed models. RESULTS: For the overall sample, the intervention for patients attained a significant mean reduction in HbA1c levels of ‒0.27 (95% CI ‒0.45 to ‒0.10) at month 3 and ‒0.26 (95% CI ‒0.44 to ‒0.08) at month 6 compared with usual care, which remained marginally significant at month 12. A clinically relevant reduction in HbA1c level was observed in 35.6% (191/537) of patients in the intervention for patients and 26.0% (152/586) of those in usual care at month 12 (P=.006). In the combined intervention, HbA1c reduction was significant until month 18 (181/557, 32.6% vs 140/586, 23.9%; P=.009). Considering the subgroup of patients uncontrolled at baseline, all interventions produced significant reductions in HbA1c levels across the entire study period: ‒0.49 (95% CI ‒0.70 to ‒0.27) for the intervention for patients, ‒0.35 (95% CI ‒0.59 to ‒0.14) for the intervention for professionals, and ‒0.35 (95% CI ‒0.57 to ‒0.13) for the combined intervention. Differences in HbA1c for the area under the curve considering the entire period were significant for the intervention for patients and the combined intervention compared with usual care (P=.03 for both). Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure. CONCLUSIONS: In uncontrolled patients, the intervention for patients at baseline provided clinically relevant and significant longer-term reductions of HbA1c levels. The intervention for professionals and combined intervention also improved the cardiovascular risk profile of patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227.

Impact of diabetes mellitus on the risk of severe exacerbation in patients with chronic obstructive pulmonary disease.

INTRODUCTION: Suffering type 2 diabetes mellitus (T2DM) appears to promote the occurrence of respiratory infections. However, studies to evaluate the risk of hospital admission due to exacerbations in patients with chronic obstructive pulmonary disease (COPD) and concomitant T2DM are scarce. MATERIALS AND METHODS: Prospective, observational study with a maximum follow-up of 18 months. Information on lung function, body mass index, degree of dyspnea, number of exacerbations, comorbidities and pneumococcal vaccination was obtained. Patients were classified into the categories COPD with (COPD/+T2DM) and without T2DM (COPD/-T2DM). RESULTS: A total of 121 patients with COPD were enrolled. Forty-seven (38%) of the study participants were diabetic. The presence of T2DM increased the risk of hospital admission due to COPD exacerbation (OR 2.66; P = 0.031), but no significant difference in the total number of exacerbations was detected. CONCLUSIONS: The risk of hospital admission in the course of exacerbation seems to be higher in COPD/+T2DM patients than in COPD/-T2DM subjects.

Cost-effectiveness of the hospital nutrition screening tool CIPA.

INTRODUCTION: Hospital malnutrition is very common and worsens the clinical course of patients while increasing costs. Lacking clinical-economic studies on the implementation of nutrition screening encouraged the evaluation of the CIPA (Control of Food Intake, Protein, Anthropometry) tool. MATERIAL AND METHODS: An open, non-randomized, controlled clinical trial was conducted on patients admitted to internal medicine and general and digestive surgery wards, who were either assigned to a control (standard hospital clinical care) or to an intervention, CIPA-performing ward (412 and 411, respectively; n = 823). Length of stay, mortality, readmission, in-hospital complications, and quality of life were evaluated. Cost-effectiveness was analysed in terms of cost per quality-adjusted life years (QALYs). RESULTS: The mean length of stay was higher in the CIPA group, though not significantly (+ 0.95 days; p = 0.230). On the surgical ward, more patients from the control group moved to critical care units (p = 0.014); the other clinical variables did not vary. Quality of life at discharge was similar (p = 0.53), although slightly higher in the CIPA group at 3 months (p = 0.089). Patients under CIPA screening had a higher mean cost of € 691.6 and a mean QALY gain over a 3-month period of 0.0042. While the cost per QALY for the internal medicine patients was € 642 282, the results for surgical patients suggest that the screening tool is both less costly and more effective. CONCLUSIONS: The CIPA nutrition screening tool is likely to be cost-effective in surgical but not in internal medicine patients.

Prognostic ability of the distance-saturation product in the 6-minute walk test in patients with chronic obstructive pulmonary disease.

INTRODUCTION: The product (DSP) of the distance walked (meters) and minimum oxygen saturation obtained during the 6-minute walk test (6MWT) has been proposed as a predictor of mortality in idiopathic pulmonary fibrosis and in bronchiectasis not related to cystic fibrosis. OBJECTIVE: The aim of this study was to determine the DSP's ability to predict mortality in patients with chronic obstructive pulmonary disease (COPD) at the outpatient level and compare it to the BODE index and meters walked in the 6MWT. MATERIAL AND METHODS: Descriptive observational study in a cohort of patients with COPD being treated at outpatient pulmonology clinics. Each of the patients completed the 6MWT following ATS/ERS protocols and their BODE index and DSP were calculated. RESULTS: About 103 patients were included. The average length of follow-up was 36 months. Patients who died showed a lower number of meters walked in the 6MWT (P < 0.001), as well as a lower DSP (P < 0.001). A 6MWT < 334 m, a DSP < 290 and a BODE ≥ 4 showed good prognostic ability at 3 years (AUC 71%, 69% and 70.4%, respectively). The 6MWT was superior to the BODE index in predicting mortality during the first year of follow-up (P = 0.023). We did not find any differences between DSP and meters walked in the 6MWT. CONCLUSIONS: The DSP is a good predictor of mortality, although it does not offer a better prognostic ability than that of meters walked in the 6MWT.