What is the Opinion of the Health Care Personnel Regarding the Use of Different Assistive Tools to Improve the Quality of Neonatal Resuscitation?

OBJECTIVE: It is important to determine whether the use of different quality improvement tools in neonatal resuscitation is well-received by health care teams and improves coordination and perceived quality of the stabilization of the newborn at birth. This study aimed to explore the satisfaction of personnel involved in resuscitation for infants under 32 weeks of gestational age (<32 wGA) at birth with the use of an assistance toolkit: Random Real-time Safety Audits (RRSA) of neonatal stabilization stations, the use of pre-resuscitation checklists, and the implementation of briefings and debriefings. STUDY DESIGN: A quasi-experimental, prospective, multicenter intervention study was conducted in five level III-A neonatal intensive care units in Madrid (Spain). The intervention involved conducting weekly RRSA of neonatal resuscitation stations and the systematic use of checklists, briefings, and debriefings during stabilization at birth for infants <32 wGA. The satisfaction with their use was analyzed through surveys conducted with the personnel responsible for resuscitating these newborns. These surveys were conducted both before and after the intervention phase (each lasting 1 year) and used a Likert scale response model to assess various aspects of the utility of the introduced assistance tools, team coordination, and perceived quality of the resuscitation. RESULTS: Comparison of data from 200 preintervention surveys and 155 postintervention surveys revealed statistically significant differences (p < 0.001) between the two phases. The postintervention phase scored higher in all aspects related to the effective utilization of these tools. Improvements were observed in team coordination and the perceived quality of neonatal resuscitation. These improved scores were consistent across personnel roles and years of experience. CONCLUSION: Personnel attending to infants <32 wGA in the delivery room are satisfied with the application of RRSA, checklists, briefings, and debriefings in the neonatal resuscitation and perceive a higher level of quality in the stabilization of these newborns following the introduction of these tools. KEY POINTS: · RRSA, checklists, briefings, and debriefings improve the quality of neonatal resuscitation at birth.. · These tools, when used together, are well-received and enhance perceived resuscitation quality.. · Perception of utility and quality improvement is consistent across roles and experience..

Reverse TAR may be added when necessary in open preperitoneal repair of lateral incisional hernias: a retrospective multicentric cohort study.

BACKGROUND: The best approach for lateral incisional hernia is not known. Posterior component separation (reverse TAR) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane. The aim of our multicenter study was to compare the operative and patient-reported outcomes measures (PROMs) using two open surgical techniques from the lateral approach: a totally preperitoneal vs a reverse TAR. METHODS: A retrospective cohort study was performed since 2012 to 2020. Patients with lateral incisional hernia treated through a lateral approach were identified from a prospectively maintained multicenter database. Reverse TAR was added when the preperitoneal plane could not be safely dissected. The results obtained using these two lateral approaches were compared, including short- and long-term complications, as well as PROMs, using the specific tool EuraHSQoL. RESULTS: A total of 61 patients were identified. Reverse TAR was performed in 33 patients and lateral retromuscular preperitoneal approach in 28 patients. Both groups were comparable in terms of sociodemographic and comorbidities variables. Surgical site occurrences occurred in 13 cases (21.3%), with 8 patients (13.1%) requiring procedural intervention. During a median follow-up of 34 months, no incisional hernia recurrence was registered. There was a case (1.6%) of symptomatic bulging that required reoperation. Also 12 patients (19.7%) presented an asymptomatic bulging. No statistically significant difference was identified in the complications and PROMs between the two procedures. CONCLUSION: The open lateral retromuscular reconstruction using very large meshes that reach the midline has excellent long-term results with acceptable postoperative complications, including PROMs. A reverse TAR may be added, when necessary, without increasing complications and obtaining similar long-term results.

A prospective study among neonates born to mothers with active or past Graves disease.

OBJECTIVE: The aim of this prospective study was to describe demographic and clinical characteristics of neonates born to mothers with active or past Graves disease and to assess compliance since implementation of a new protocol in our center. METHODS: We prospectively followed up neonates born to mothers with active or past Graves disease in a tertiary hospital in Spain between August 2019 and September 2021 according to our protocol. We reviewed maternal and neonatal history of these neonates, and we followed up newborns at risk of neonatal hyperthyroidism. RESULTS: Among 5808 births, 33 neonates were born to mothers with active or past Graves disease (0.57%). Six mothers (18.2%) had positive levels of thyroid-stimulating hormone receptor antibodies during pregnancy and five mothers (15.1%) between weeks 20 and 24 of pregnancy. Two of them had received definitive therapy for Graves disease before pregnancy. Two neonates (7.1%) were at high risk of neonatal hyperthyroidism and were followed-up until two months, without hyperthyroidism signs or abnormal thyroid hormone levels. Compliance of protocol during pregnancy was 84.9% and 75.8% at birth. CONCLUSIONS: Prevalence of Graves disease among pregnant women was 0.57%, with no cases of neonatal hyperthyroidism. Compliance of protocol was adequate during pregnancy (84.9%) and acceptable at birth (75.8%).

Real-Time Safety Audits of Neonatal Delivery Room Resuscitation Areas: Are We Sufficiently Prepared?

OBJECTIVE: This study aimed to use real-time safety audits to establish whether preparation of the equipment required for the stabilization and resuscitation of newborns in the delivery room areas is adequate. STUDY DESIGN: This was a descriptive, multicenter study performed at five-level III-A neonatal units in Madrid, Spain. For 1 year, one researcher from each center performed random real-time safety audits (RRTSAs), on different days and during different shifts, of at least three neonatal stabilization areas, either in the delivery room or in the operating room used for caesarean sections. Three factors in each area were reviewed: the set-up of the radiant warmer, the materials, and medication available. The global audit was considered without defect when no errors were detected in any of the audited factors. Possible differences in the results were analyzed as a function of the study month, day of the week, or shift during which the audit had been performed. RESULTS: A total of 852 audits were performed. No defects were detected in any of the three factors analyzed in the 534 (62.7%, 95% confidence interval [CI]: 59.3-65.9) cases. Slight defects were detected in 98 (11.5%, 95% CI: 9.4-13.8) cases and serious defects capable of producing adverse events in the newborn during resuscitation were found in 220 (25.8%, 95% CI: 22.9-28.9) cases. No statistically significant differences in the results were found according to the day of the week or time during which the audits were performed. However, the percentage of RRTSAs without defect increased as the study period progressed (first quarter 38.1% vs. the last quarter 84.2%; p < 0.001). CONCLUSION: The percentage of adequately prepared resuscitation areas was low. RRTSAs made it possible to detect errors in the correct availability of the neonatal stabilization areas and improved their preparation by preventing errors from being perpetuated over time. KEY POINTS: · RRTSAs are a tool for improving clinical safety.. · The use of RRTSAs in perinatal care is very uncommon.. · RRTSAs improve the preparation of newborn CPR areas..

Medical Versus Surgical Approach to Initial Treatment in Septic Arthritis: A Single Spanish Center's 8-Year Experience.

OBJECTIVE: The aim of this study was to compare the functional results of 2 different procedure types, medical or surgical used in treating native joint septic arthritis. METHODS: In this cohort study, we reviewed the clinical registries of patients admitted to a single third-level hospital with the diagnosis of septic arthritis during the period of January 1, 2008, to January 31, 2016. RESULTS: A total of 63 cases of septic arthritis were identified in which the initial approach for 49 patients was medical (arthrocentesis), whereas the initial approach for 14 patients was surgical (arthroscopy or arthrotomy). Of the 49 patients who received initial medical treatment (IMT), 15 patients (30%) later required surgical treatment because of poor progress. The median age of the patients was 60 (SD, 18) years. The group who received IMT were older than those who received initial surgical treatment (median, 64 years [interquartile range {IQR}, 54-76 years], vs. 48 years [IQR, 30-60 years]). There was a larger percentage of male patients in the surgical group (78% vs. 42% [p = 0.018]). Thirty percent of the medical group had been receiving corticosteroid treatment (p = 0.018). Results of complete recovery of joint functionality showed no significant differences after 1 year (68% with MT vs. 67% with ST, p = 0.91). Both groups had similar symptom duration until diagnosis, duration of antibiotic therapy (median, 30 days [IQR, 28-49 days], vs. 29.5 days [IQR, 27-49] days), and mortality rate (3 in the medical group). CONCLUSIONS: The results of the study show that initial surgical treatment in patients with native joint septic arthritis is not superior to IMT. However, half of the patients with shoulder and hip infections treated with IMT eventually required surgical intervention, suggesting that perhaps this should be the preferred initial approach in these cases.

Financial toxicity in allogeneic haematopoietic stem cell transplant patients from a social determinants of health perspective.

PURPOSE: Financial toxicity (FT) refers to the subjective perception of financial distress resulting from objective economic strain due to illness, exerting a detrimental influence on health outcomes. This study aimed to describe FT among allogeneic haematopoietic stem cell transplant (allo-HSCT) recipients within a public health framework, employing a social determinants of health approach. METHODS: A multi-centre cross-sectional study involving adult allo-HSCT patients was conducted across three public hospitals in Madrid. FT was assessed using a validated COST scale (range 0-44; lower scores indicating higher FT). Patient-administered paper/online questionnaires were utilized to collect data on sociodemographic, socioeconomic, clinical, and healthcare access variables. Descriptive, non-parametric univariate statistical analysis and multiple linear regression models were performed. RESULTS: Sixty-six patients, with a mean age: 52.5 years (SD: 11.5), 50% women, 28.7% displaced to Madrid for HSCT, and 71.4% lacking financial support were included. The median FT score was 20 points (IQR 12-27.25). Independent factors associated with higher FT included being females (Coef = -3.26; p = 0.079), perceived income loss after HSCT (Coef = -6.81; p < 0.001) and a monthly household income of ≤1000 € compared to 1001-2500€ (Coef = 8.29; p = 0.005) or >2500 € (Coef = 15.75; p < 0.001). CONCLUSIONS: Despite the limited sample size, our findings underscore the presence of financial toxicity among allo-HSCT patients, shaped by social determinants of health. Recognizing and addressing FT within the HSCT process is essential to mitigate social inequalities in health.

Donor Lung Preservation at 10°C: Clinical and Logistical Impact.

INTRODUCTION: Cold static donor lung preservation at 10°C appears to be a promising method to safely extend the cold ischemic time (CIT) and improve lung transplant (LTx) logistics. METHODS: LTx from November 2021 to February 2023 were included in this single institution, prospective, non-randomized study comparing prolonged preservation at 10°C versus standard preservation on ice. The inclusion criteria for 10°C preservation were suitable grafts for LTx without any donor retrieval concerns. PRIMARY ENDPOINT: primary graft dysfunction (PGD) grade-3 at 72-h. Secondary endpoints: clinical outcomes, cytokine profile and logistical impact. RESULTS: Thirty-three out of fifty-seven cases were preserved at 10°C. Donor and recipient characteristics were similar across the groups. Total preservation times (h:min) were longer (p<0.001) in the 10°C group [1st lung: median 12:09 (IQR 9:23-13:29); 2nd: 14:24 (12:00-16:20)] vs. standard group [1st lung: median 5:47 (IQR 5:18-6:40); 2nd: 7:15 (6:33-7:40)]. PGD grade-3 at 72-h was 9.4% in 10°C group vs. 12.5% in standard group (p=0.440). Length of mechanical ventilation (MV), ICU and hospital stays were similar in both groups. Thirty and ninety-day mortality rates were 0% in 10°C group (vs. 4.2% in standard group). IL-8 concentration was significantly higher 6-h post-LTx in the standard group (p=0.025) and IL-10 concentration was increased 72-h post-LTx in the 10°C group (p=0.045). CONCLUSIONS: Preservation at 10°C may represent a safe and feasible strategy to intentionally prolong the CIT. In our center, extending the CIT at 10°C may allow for semi-elective LTx and improve logistics with similar outcomes compared to the current standard preservation on ice.

Outcomes after lung transplantation from selected donors older than 70 years in a single centre: time to close the debate?

OBJECTIVES: The aim of this study was to compare the outcomes of lung transplantations using grafts from donors aged over 70 years against those performed using younger donors. METHODS: This retrospective single-centre analysis includes lung transplants conducted at our institution from January 2014 to June 2022. Lung recipients were classified into 2 groups based on donor age (group A <70 years; group B ≥70 years). Variables regarding demographics, peri and postoperative outcomes and survival were included. The statistical analysis approach included univariable analysis, propensity score matching to address imbalances in donor variables (smoking status), recipient characteristics (sex, age, diagnosis and lung allocation score) and calendar period and survival analysis. RESULTS: A total of 353 lung transplants were performed in this period, 47 (13.3%) using grafts from donors aged over 70 years. Donors in group B were more frequently women (70.2% vs 51.6%, P = 0.017), with less smoking history (22% vs 43%, P = 0.002) and longer mechanical ventilation time (3 vs 2 days, P = 0.025). Recipients in group B had a higher lung allocation score (37.5 vs 35, P = 0.035). Postoperative variables were comparable between both groups, except for pulmonary function tests. Group B demonstrated lower forced expiratory volume 1 s levels (2070 vs 2580 ml, P = 0.001). The propensity score matching showed a lower chance of chronic lung allograft dysfunction by 12% for group B. One-, three- and five-year survival was equal between the groups. CONCLUSIONS: The use of selected expanded-criteria donors aged over 70 years did not result in increased postoperative morbidity, early mortality or survival in this study.

Clinical and Demographic Characteristics of Centenarians versus Other Age Groups Over 75 Years with Hip Fractures.

Objective: The primary objective was to describe the clinical characteristics, management, and outcomes of centenarians with fragility hip fracture and compare them to other age groups. The secondary objective was to determine the variables associated with length of stay, in-hospital mortality and 30-day mortality. Materials and Methods: This is a secondary analysis of the Spanish National Hip Fracture Registry. We included patients ≥75 years admitted for fragility hip fractures in 86 Spanish hospitals between 2017 and 2019, dividing the sample into four age groups. The variables studied were baseline characteristics, type of fracture, management, length of stay, in-hospital mortality and 30-day mortality. Results: We included 25,938 patients (2888 were 75-79 years old; 14,762 octogenarians; 8,035 nonagenarians and 253 centenarians). Of the centenarians, 83% were women, 33% had severe dementia, 9% had severe dependency and 36% lived in residential care homes. Six out of ten had intertrochanteric fracture. Length of hospital stay was 8.6 days; in-hospital mortality was 10.3% and 30-day mortality 20.9%. Older age groups had more women, severe functional dependency, severe dementia, intertrochanteric fracture, living in care facilities and being discharged to nursing care. They had less frequent early mobilization, osteoporosis treatment and discharge to rehabilitation units. In-hospital and 30-day mortality were higher with increasing age. In centenarians, time to surgery >48 hours was independently associated with length of stay (correlation coefficient 3.99 [95% CI: 2.35-5.64; p<0.001]) and anaesthetic risk, based on an ASA score of V, was related to 30-day mortality (ASA score II [OR 0.25, 95% CI: 0.09-0.70; p=0.009] and ASA score III [OR 0.43, 95% CI: 0.19-0.96; p=0.039]). Conclusion: Centenarians had different clinical characteristics, management and outcomes. Although centenarians had worse outcomes, nearly 4 out of 5 centenarians were alive one month after surgery.

Association of the presence of a COVID-19 infection at the time of birth and the rates of exclusive breastfeeding upon discharge in BFHI hospitals: a multicenter, prospective cohort study.

BACKGROUND: Very few studies have assessed the association between COVID-19 infection and the rates of exclusive breastfeeding (EBF) upon discharge following the first waves of the pandemic and after initiation of vaccination. The primary objective of this study is to compare the rates of EBF since birth upon discharge in mothers diagnosed with COVID-19 infection at the time of the delivery versus a group of non-infected mothers in maternity hospitals with Baby Friendly Hospital Initiative (BFHI) accreditation. The secondary objectives include determining the rates of any breastfeeding at three and six months of life in both groups, as well as determining the possible factors associated with EBF rates observed upon discharge. METHODS: An observational, Spanish multi-center hospital, prospective cohort study conducted from 1 to 2021 to 31 March 2022 and with follow-up during the first six months of life. Follow-up was performed via telephone contact with calls performed at three and six months. A multivariate logistic regression analysis model was used to identify the factors related to a lower probability of EBF upon discharge. RESULTS: 308 mother-infant pairs participated in the study, 111 in the cohort of women with COVID infection and 197 in the comparison group. EBF upon discharge was 62.7% in the COVID group vs. 81.2% in the comparison group (p = 0.002); at three months; 52.4% vs. 57.0% (p = 0.33) were performing EBF, with the rates of EBF at six months being 43.0% vs. 39.3% (p = 0.45), respectively. Exposure to COVID-19 at delivery (AOR 5.28; 95% CI 2.01, 13.86), not practicing BF previously (AOR 36.3; 95% CI 7.02, 187.74), birth via Cesarean section (AOR 5.06; 95% CI 1.62, 15.79) and low birth weight of the newborn (AOR 1.01; 95% CI 1.01, 1.01) were associated with a greater risk of not performing EBF upon discharge. CONCLUSIONS: Mothers with a mild or asymptomatic COVID-19 infection at the time of the delivery were less likely to have exclusively breastfed during their hospital stay than other mothers in these BFHI-accredited hospitals. However, there were no differences in breastfeeding rates between the groups at three and six months postpartum.

Peripheral blood eosinophilia as a marker of acute cellular rejection in lung transplant recipients.

Previous studies in solid organ transplantation have shown a relationship between circulating eosinophil (EOS) counts and the presence of acute cellular rejection (ACR). However, the relationship between this potential biomarker and ACR in lung transplant (LTx) patients remains unclear. OBJECTIVE: To assess the association between EOS and the presence of acute cellular rejection in lung transplant recipients. MATERIALS AND METHODS: Retrospective study of 583 transbronchial biopsies (TBB) performed in 256 lung transplant patients between 2012 and 2018. We analyzed age, sex, underlying pathology, date of transplant, indications for TBB, presence and degree of ACR, and the simultaneous absolute and relative EOS. RESULTS: ACR were observed in 170 of 583 TBB (29.2%). EOS in patients with ACR were higher than in patients without ACR (203.6 ± 248/mm3 vs 103.1 ± 153/mm3; p < 0.001). High levels of both absolute and relative EOS were associated with the presence of ACR regardless of the underlying disease (odds ratio [OR] 1.003; 95% confidence interval [CI], 1.002-1.004; OR 1.226; 95% CI, 1.120-1.342) and time after transplant (OR 1.003; 95% CI, 1.002-1.004 and OR 1.239; 95% CI, 1.132-1.356). Moreover, both absolute and relative EOS were strongly associated with moderate and severe grades of ACR (OR 3.55; 95% CI, 3.00-4.10 and OR 3.56; 95% CI, 3.00-4.12). CONCLUSIONS: EOS are elevated in ACR, especially in moderate or severe ACR. Increased vigilance for ACR is therefore advisable in lung transplant recipients with elevated EOS.

Combined application of various quality assessment tools in neonatal resuscitation.

INTRODUCTION: In neonatal resuscitation, it is important to know whether the use of a combination of quality assessment tools has an impact on the preparation of the resuscitation bed and equipment, the correct performance of the procedure and the clinical outcomes of the most vulnerable neonates. MATERIAL AND METHODS: Multicentre, prospective, quasi-experimental interventional study in five level III-A neonatal units. In the pre- and post-intervention phases, both of which lasted 1 year, there were weekly random audits of the stabilization beds in the delivery room to assess their preparation. In the post-intervention phase, checklists, briefings and debriefings were used in the resuscitation of neonates delivered before 32 weeks. We compared the performance of the procedure and early post-resuscitation outcomes in the 2 periods. RESULTS: Total of 852 audits were carried out in the pre-intervention period and 877 in the post-intervention period. There was a greater percentage of audits that did not identify defects in the second phase (63% vs 81%; P < .001). The first phase included 75 resuscitations and the second 48, out of which all the quality assessment tools had been used in 36 (75%). We did not find any differences in the main clinical variables during stabilization, although we observed a trend towards fewer technical problems during the procedure in the second period. CONCLUSIONS: The use of random audits, checklists, briefings and debriefings in the resuscitation of newborns delivered before 32 weeks is feasible but has no impact on short-term clinical outcomes or correct performance of the procedure. Audits of neonatal resuscitation beds significantly improved their preparation.

Interrupted versus continuous suture for bronchial anastomosis in lung transplantation: does it matter?

OBJECTIVES: Bronchial anastomotic complications remain a major concern in lung transplantation. We aim to compare 2 different techniques, continuous suture (CS) versus interrupted suture (IS) by analysing airway complications requiring intervention. METHODS: Lung transplantations between January 2015 and December 2020 were included. Airway complications requiring intervention were classified following the 2018 International Society for Heart and Lung Transplantation consensus and analysed comparing 3 groups of patients according to surgical technique: group A, both anastomosis performed with CS; group B, both with interrupted; and group C, IS for 1 side and CS for the contralateral side. RESULTS: A total of 461 anastomoses were performed in 245 patients. The incidence of airway complications requiring intervention was 5.7% [95% confidence interval (CI): 2.8-8.6] per patient (14/245) and 3.7% (95% CI: 2.0-5.4) per anastomosis (17/461). Complications that required intervention were present in 5 out of 164 (3.1%) anastomosis with interrupted technique, and in 12/240 (5%) with CS. No significant differences were found between techniques (P = 0.184). No statistical differences were found among group A, B or C in terms of incidence of anastomotic complications, demographics, transplant outcomes or overall survival (log-rank P = 0.513). In a multivariable analysis, right laterality was significantly associated to complications requiring intervention (OR 3.7 [95% CI: 1.1-12.3], P = 0.030). Endoscopic treatment was successful in 12 patients (85.7%). Retransplantation was necessary in 2 patients. CONCLUSIONS: In summary, although it seems that anastomotic complications requiring intervention occur more frequently with CS, there are no statistical differences compared to IS. Endoscopic treatment offers good outcomes in most of the airway complications after lung transplantation.

Assessment of exposure-response relationship for cetuximab in patients with metastatic colorectal cancer and head and neck cancer.

OBJECTIVE: There is limited scientific evidence on the cetuximab exposure-response relationship and no concentration threshold has been associated with optimal disease control. The aims were to assess, in a real-life setting, the  relationship between steady state cetuximab concentrations (Ctrough, SS) and  disease control. METHOD: A prospective observational study in patients with metastatic colorectal cancer or head and neck cancer treated with cetuximab.  Steady state trough concentrations were compared with the results of  radiological assessment of response (progression or clinical benefit).  Generalized estimating equations analysis was performed. To test the  association between steady state concentrations and overall survival and  progression-free survival, Cox proportional hazard models were developed. An  optimal cut-off point was searched using the area under the receiver operating  characteristic curve. RESULTS: A total of 30 steady state cetuximab concentrations from 16 patients  were analysed. Median Ctrough, SS was 26.86 mg/L and there was marked  inter- and intraindividual variability (standard deviation 32.4 mg/L and 16.9 mg/L, respectively). A positive association was found between cetuximab  Ctrough, SS and clinical benefit (odds ratio 1.24, 95% confidence interval:  0.95-1.63, p = 0.113), although without reaching statistical significance. The  area under the receiver operating characteristic curve (n = 30) had moderate  discrimination power (0.71; 95% confidence interval 0.49­0.93), and the  empirical optimal cutoff point was 19.12 mg/L. However, no association was  observed between cetuximab Ctrough, SS and survival in metastatic colorectal  cancer or neck cancer patients. CONCLUSIONS: We cannot confirm a relationship between cetuximab Ctrough,  SS and disease control despite a positive association. This study was  conducted with a small sample, which reduces the power analysis. Further  controlled randomised studies with a sufficient number of patients are needed.

OBJETIVO: Evaluar, en condiciones de vida real, la relación entre las concentraciones valle en estado estacionario de cetuximab y el control de  la enfermedad, así como buscar la relación entre estas concentraciones y la supervivencia. Además, estudiar si existe una concentración límite que se  pueda asociar con la probabilidad de beneficio clínico.Método: Estudio observacional prospectivo llevado a cabo en pacientes con  cáncer colorrectal metastásico o cáncer de cabeza y cuello en tratamiento con  cetuximab. Se realizó un análisis de regresión de ecuaciones de estimación  generalizadas para evaluar la asociación entre la concentración valle en estado  estacionario de cetuximab y la respuesta al tratamiento (progresión o beneficio  clínico). Mediante modelos de riesgos proporcionales de Cox, se  evaluó la asociación entre la mediana de concentraciones valle en estado  estacionario de cetuximab en cada paciente o la última medida con la  supervivencia global y la supervivencia libre de progresión, en cada una de las  patologías. Asimismo, se buscó un punto de corte óptimo a través del área  bajo la curva de características operativas del receptor. RESULTADOS: Se analizaron 30 muestras de 16 pacientes. La concentración valle en estado estacionario mediana fue 26,86 mg/l y se  encontró una gran variabilidad inter e intraindividual (desviación estándar de  32,4 y 16,9 mg/l, respectivamente). Se observó una asociación positiva entre  la concentración valle en estado estacionario y el beneficio clínico (odds ratio  1,24; intervalo de confianza del 95%: 0,95-1,63; p = 0,113), aunque no alcanzó significación estadística debido a la baja potencia. El área bajo la  curva de características operativas del receptor de las concentraciones (n =  30) tuvo una moderada capacidad discriminatoria (área bajo la curva de  características operativas del receptor 0,710; intervalo de confianza del 95%:  0,49-0,93) y el punto de corte estimado fue de 19,12 mg/l. Sin embargo, no  se observó relación entre la supervivencia y las concentraciones valle en  estado estacionario en ninguna de las patologías. CONCLUSIONES: No se ha podido confirmar una relación entre exposición a  cetuximab y eficacia, a pesar de encontrar una tendencia positiva en el control  de la enfermedad con el aumento de la concentración valle en estado  estacionario. El nivel de evidencia se vio reducido por la pequeña muestra de  pacientes en cada grupo, por lo que se necesitan estudios aleatorizados y  controlados, con un número suficiente de pacientes, para evaluar  adecuadamente esta relación.

Impact of Recommended Maternal Vaccination Programs on the Clinical Presentation of SARS-CoV-2 Infection: A Prospective Observational Study.

The COVID-19 pandemic has raised questions about the possible cross immunity resulting from common vaccination programs and SARS-CoV-2 infection. Therefore, the Spanish Obstetric Emergency group performed a multicenter prospective study on the vaccination status of Influenza and Tdap (diphtheria, tetanus and pertussis vaccine boost administered in adulthood) in consecutive cases of SARS-CoV-2 infection in a pregnancy cohort, in order to assess its possible association with the clinical presentation and severity of symptoms of SARS-CoV-2 infection, as well as to determine the factors that may affect vaccination adherence. A total of 1150 SARS-CoV-2 positive pregnant women from 78 Spanish hospitals were analyzed: 183 had not received either vaccine, 23 had been vaccinated for Influenza only, 529 for Tdap only and 415 received both vaccines. No association was observed between the vaccination status and the clinical presentation of SARS-CoV-2 infection and/or the severity of symptoms. However, a lower adherence to the administration of both vaccines was observed in the Latin-American subgroup. Based on the results above, we reinforce the importance of maternal vaccination programs in the actual pandemic. Health education campaigns should be specially targeted to groups less likely to participate in these programs, as well as for a future SARS-CoV-2 vaccination campaign.

Assessment of exposure-response relationship for bevacizumab in patients with metastatic colorectal cancer.

Limited literature is available for bevacizumab exposure-response relationship and there is not a concentration threshold associated with an optimal disease control. This prospective observational study in patients with metastatic colorectal cancer (mCRC) aims to evaluate, in a real-life setting, the relationship between bevacizumab through concentrations at steady state (Ctrough, SS) and disease control. Ctrough, SS were drawn, coinciding with the radiological evaluation of the response (progression or clinical benefit). Generalized estimating equations (GEE) analysis was performed. To test the association between Ctrough, SS in each patient with overall survival (OS) or progression-free survival (PFS), Cox proportional hazard models were developed. Data included 50 bevacizumab Ctrough, SS from 27 patients. The GEE model did not suggest any positive association between bevacizumab Ctrough, SS and clinical benefit (OR 0.99, 95% CI: 0.98-1.02, p = 0.863). The Cox regression showed association between higher median Ctrough, SS with better OS (HR 0.86, 95% CI: 0.73-1.01, p = 0.060), but not with PFS. We cannot confirm a relationship between bevacizumab Ctrough, SS and clinical benefit but this is the first real-world study trying to show a relationship between bevacizumab Ctrough, SS and disease control in mCRC. It was conducted in a small sample size which reduces the level of evidence. Further controlled randomized studies with a sufficient number of patients are required.

Baby Friendly Hospital Initiative Breastfeeding Outcomes in Mothers with COVID-19 Infection During the First Weeks of the Pandemic in Spain.

BACKGROUND: Adherence to the Ten Steps of the Baby-Friendly Hospital Initiative has been shown to have a protective role for the initiation and maintenance of breastfeeding. RESEARCH AIMS: (1) To determine the breastfeeding rate during the first 6 months of life in children of mothers diagnosed with COVID-19 infection at the time of birth; and (2) to assess the possible influence of being born in a center with Baby-Friendly Hospital Initiative accreditation. METHODS: This was a two-group comparative longitudinal observational study of infants born to mothers with COVID-19 at the time of birth, between March 13-May 31, 2020 (the first wave of the pandemic) in Spain. Fourteen Spanish hospitals participated, five (35.7%) were Baby-Friendly Hospital Initiative accredited. Type of feeding was assessed prospectively at discharge, 1, 3, and 6 months of age. A total of 248 newborns were included in the study. RESULTS: A total of 117 (47.3%) newborns were born in Baby-Friendly Hospital Initiative (BFHI) accredited centers. These centers applied skin-to-skin contact with greater probability (OR = 1.9; 95% CI [1.18, 3.29]) and separated the newborns from their mothers less frequently (OR = 0.46; 95% CI [0.26, 0.81]) than non-accredited centers. No differences were observed in relation to the presence of a companion at the time of birth. At discharge, 49.1% (n = 57) of newborns born in BFHI-accredited centers received exclusive breastfeeding versus 35.3% (n = 46) in non-accredited centers (p = .03). No differences were observed in breastfeeding rates throughout follow-up. CONCLUSIONS: The exclusive breastfeeding rate at discharge in children of mothers with COVID-19 infection at birth was higher in Baby-Friendly Hospital Initiative accredited centers, which most frequently applied skin-to-skin contact at birth as well as rooming-in.

A survey of procedural pain assessment and non-pharmacologic analgesic interventions in neonates in Spanish public maternity units.

OBJECTIVE: To qualify and quantify clinical practices related to pain assessment and non-pharmacologic analgesia (NPA) in newborns in Spanish public maternity hospitals STUDY DESIGN: We surveyed providers online regarding their use of pain assessment scales, NPA interventions in neonates undergoing procedures, as well parents' presence or absence during interventions. RESULTS: The number of painful procedures and the subjective grading of pain from the responding physicians were similar in all hospitals. Only 12.5% of hospitals used pain scales. No NPA was employed in 37.7% of procedures, with less NPA used in the lower complexity hospitals for venous extraction (p < 0.001) and gastric lavage (p = 0.001). Respondents reported parents' absence during 56.1% of procedures. CONCLUSIONS: Available pain assessment scales and NPA interventions to mitigate pain are being underused. The presence of the parents during painful interventions is low despite the evidence that this may help to reduce newborns' perception of pain.

Cessation of breastfeeding in association with oxytocin administration and type of birth. A prospective cohort study.

BACKGROUND: Some studies have suggested an association between synthetic oxytocin administration and type of birth with the initiation and consolidation of breastfeeding. AIM: This study aimed to test whether oxytocin administration and type of birth are associated with cessation of exclusive breastfeeding at different periods. A second objective was to investigate whether the administered oxytocin dose is associated with cessation of exclusive breastfeeding. METHODS: We conducted a prospective cohort study (n=529) in a tertiary hospital. Only full-term singleton pregnancies were included. Four groups were established based on the type of birth (vaginal or cesarean) and the intrapartum administration of oxytocin. Follow-up was performed to evaluate the consolidation of exclusive breastfeeding at 1, 3 and 6months. FINDINGS: During follow-up, the proportion of exclusive breastfeeding decreased in all groups. After adjusting for confounding variables, the group with cesarean birth without oxytocin (planned cesarean birth) had the highest risk of cessation of exclusive breastfeeding (odds ratio [95% confidence interval], 2.51 [1.53-4.12]). No association was found between the oxytocin dose administered during birth and puerperium period and the cessation of exclusive breastfeeding. CONCLUSION: Planned cesarean birth without oxytocin is associated with the cessation of exclusive breastfeeding at 1, 3 and 6months of life. It would be desirable to limit elective cesarean births to essentials as well as to give maximum support to encourage breastfeeding in this group of women. The dose of oxytocin given during birth and puerperium period is not associated with cessation of exclusive breastfeeding.