Characteristics and outcomes of multisystem inflammatory syndrome in children: A multicenter, retrospective, observational cohort study in Mexico.

Introduction: Multisystem inflammatory syndrome in children associated with coronavirus disease 2019 (MIS-C), a novel hyperinflammatory condition secondary to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is associated with severe outcomes such as coronary artery aneurysm and death. Methods: This multicenter, retrospective, observational cohort study including eight centers in Mexico, aimed to describe the clinical characteristics and outcomes of patients with MIS-C. Patient data were evaluated using latent class analysis (LCA) to categorize patients into three phenotypes: toxic shock syndrome-like (TSSL)-MIS-C, Kawasaki disease-like (KDL)-MIS-C, and nonspecific MIS-C (NS-MIS-C). Risk factors for adverse outcomes were estimated using multilevel mixed-effects logistic regression. Results: The study included 239 patients with MIS-C, including 61 (26%), 70 (29%), and 108 (45%) patients in the TSSL-MIS-C, KDL-MIS-C, and NS-MIS-C groups, respectively. Fifty-four percent of the patients were admitted to the intensive care unit, and 42%, 78%, and 41% received intravenous immunoglobulin, systemic glucocorticoids, and anticoagulants, respectively. Coronary artery dilatation and aneurysms were found in 5.7% and 13.2% of the patients in whom coronary artery diameter was measured, respectively. Any cause in-hospital mortality was 5.4%. Hospitalization after ten days of symptoms was associated with coronary artery abnormalities (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.2-2.0). Age ≥10 years (OR: 5.6, 95% CI: 1.4-2.04), severe underlying condition (OR: 9.3, 95% CI: 2.8-31.0), platelet count <150,000 /mm3 (OR: 4.2, 95% CI: 1.2-14.7), international normalized ratio >1.2 (OR: 3.8, 95% CI: 1.05-13.9), and serum ferritin concentration >1,500 mg/dl at admission (OR: 52, 95% CI: 5.9-463) were risk factors for death. Discussion: Mortality in patients with MIS-C was higher than reported in other series, probably because of a high rate of cases with serious underlying diseases.

Risk factors for healthcare-associated infections in newborns after surgery in a neonatal intensive care unit.

BACKGROUND: Health care-associated infections (HAIs) are a common cause of morbidity and mortality. There is little information on the risk factors associated with HAI in surgical newborns. OBJECTIVE: To identify the risk factors associated with healthcare-associated infections in surgical newborns. METHODS: Nested case-control study carried out during 2016-2017. Cases were newborns with healthcare-associated infections and controls were newborns without infection. Perinatal characteristics, use of antimicrobial prophylaxis, use of central venous catheter (CVC), mechanical ventilation, parenteral nutrition, age, and weight at the time of surgery, type of surgery, surgical wound classification, duration of surgery, number of surgical procedures, postsurgical HAIs and type of infection were registered. Univariate and multivariate analyses were performed. RESULTS: Seventy-one cases and 142 controls were included. The most frequent HAI was bloodstream infection (36.6%); the main microorganisms isolated in blood cultures were gram-positive cocci. Independent risk factors associated with HAIs in the multivariate analysis were CVC duration > 8 days (aOR = 17.2, 95% CI = 3.8-49.1), ≥ 2 surgeries (aOR = 16.5, 95% CI 5.8 -42.1) and abdominal surgery (aOR = 2.6, 95% CI = 1.2-6.6). CONCLUSION: Newborns undergoing surgery, mainly those with risk factors, require close monitoring during the postoperative period. CVC should be withdrawn as soon as possible.

ANTECEDENTES: Las infecciones asociadas a la atención de la salud (IAAS) son causa frecuente de morbilidad y mortalidad. OBJETIVO: Identificar los factores de riesgo para el desarrollo de IAAS en recién nacidos (RN) sometidos a cirugía. MATERIAL Y MÉTODOS: Estudio de casos y controles anidado en una cohorte. Los casos fueron RN sometidos a cirugía, con IAAS y los controles, RN sometidos a cirugía sin IAAS. Se registraron datos perinatales, uso de profilaxis antimicrobiana, de catéter venoso central (CVC), ventilación mecánica, nutrición parenteral y sondas; edad y peso al momento de la cirugía, tipo de cirugía, clasificación de la herida quirúrgica, duración de la cirugía, número de procedimientos quirúrgicos y tipo de infección. Se realizó análisis univariado y multivariado. RESULTADOS: Se incluyeron 71 casos y 142 controles. Las IAAS más frecuentes fueron las infecciones sanguíneas (36.6 %); los principales microorganismos aislados en hemocultivos fueron cocos grampositivos. Los factores de riesgo asociados a IAAS en el análisis multivariado fueron duración del CVC > 8 días (RMa = 17.2), ≥ 2 intervenciones quirúrgicas (RMa = 16.5) y cirugía abdominal (RMa = 2.6). CONCLUSIONES: Los RN sometidos a cirugía, principalmente aquellos con factores de riesgo, requieren vigilancia estrecha durante el posoperatorio. El CVC debe ser retirado tan pronto sea posible.

Factores de riesgo para infecciones asociadas al cuidado de la salud en recién nacidos sometidos a cirugía en una unidad de cuidados intensivos neonatales / Risk factors for healthcare-associated infections in newborns after surgery in a neonatal intensive care unit

Resumen Antecedentes: Las infecciones asociadas a la atención de la salud (IAAS) son causa frecuente de morbilidad y mortalidad. Objetivo: Identificar los factores de riesgo para el desarrollo de IAAS en recién nacidos (RN) sometidos a cirugía. Material y métodos: Estudio de casos y controles anidado en una cohorte. Los casos fueron RN sometidos a cirugía, con IAAS y los controles, RN sometidos a cirugía sin IAAS. Se registraron datos perinatales, uso de profilaxis antimicrobiana, de catéter venoso central (CVC), ventilación mecánica, nutrición parenteral y sondas; edad y peso al momento de la cirugía, tipo de cirugía, clasificación de la herida quirúrgica, duración de la cirugía, número de procedimientos quirúrgicos y tipo de infección. Se realizó análisis univariado y multivariado. Resultados: Se incluyeron 71 casos y 142 controles. Las IAAS más frecuentes fueron las infecciones sanguíneas (36.6 %); los principales microorganismos aislados en hemocultivos fueron cocos grampositivos. Los factores de riesgo asociados a IAAS en el análisis multivariado fueron duración del CVC > 8 días (RMa = 17.2), ≥ 2 intervenciones quirúrgicas (RMa = 16.5) y cirugía abdominal (RMa = 2.6). Conclusiones: Los RN sometidos a cirugía, principalmente aquellos con factores de riesgo, requieren vigilancia estrecha durante el posoperatorio. El CVC debe ser retirado tan pronto sea posible.

Abstract Background: Healthcare-associated infections (HAIs) are a common cause of morbidity and mortality. Objective: To identify the risk factors for the development of HAIs in newborns (NBs) undergoing surgery. Material and methods: Nested case-control study. Cases were NBs undergoing surgery with HAIs, while controls were NBs undergoing surgery with no HAIs. Perinatal data, use of antimicrobial prophylaxis, use of central venous catheter (CVC), mechanical ventilation, parenteral nutrition, and other medical devices were recorded, as well as age and weight at the time of surgery, type of surgery, surgical wound classification, duration of surgery, number of surgical procedures, and type of infection. Univariate and multivariate analyses were performed. Results: Seventy-one cases and 142 controls were included. The most frequent HAI was bloodstream infection (36.6%); the main microorganisms isolated in blood cultures were gram-positive cocci. The risk factors associated with HAIs in the multivariate analysis were CVC duration > 8 days (aOR = 17.2), ≥ 2 surgical interventions (aOR = 16.5) and abdominal surgery (aOR = 2.6). Conclusions: NBs undergoing surgery, mainly those with risk factors, require close monitoring during the postoperative period. CVC should be withdrawn as soon as possible.

Limited Therapeutic Options in Mexico for the Treatment of Urinary Tract Infections.

The rise in antimicrobial resistance (AMR) has complicated the management of urinary tract infections (UTIs). The objective of this study was to evaluate the antimicrobial susceptibility patterns of Escherichia coli and Klebsiella pneumoniae. Design: prospective observational study. Bacteria were classified as susceptible or resistant to ampicillin-sulbactam, amikacin, gentamicin, ciprofloxacin, norfloxacin, nitrofurantoin, trimethoprim-sulfamethoxazole (TMP/SMZ), ertapenem, meropenem, and fosfomycin. The sensitivity to fosfomycin and chloramphenicol was evaluated by the disk diffusion method. Statistical analysis: the chi-square test and Fisher's exact test were used to compare differences between categories. A p value < 0.05 was considered statistically significant. Isolates were collected from January 2019 to November 2020 from 21 hospitals and laboratories. A total of 238 isolates were received: a total of 156 E. coli isolates and 82 K. pneumoniae isolates. The majority were community-acquired infections (64.1%). Resistance was >20% for beta-lactams, aminoglycosides, fluoroquinolones, and TMP/SMZ. For E. coli isolates, resistance was <20% for amikacin, fosfomycin, and nitrofurantoin; for K. pneumoniae, amikacin, fosfomycin, chloramphenicol, and norfloxacin. All were susceptible to carbapenems. K. pneumoniae isolates registered a higher proportion of extensively drug-resistant bacteria in comparison with E. coli (p = 0.0004). In total, multidrug-resistant bacteria represented 61% of all isolates. Isolates demonstrated high resistance to beta-lactams, fluoro-quinolones, and TMP/SMZ.

Knowledge, attitudes, perceptions, and COVID-19 hesitancy in a large public university in Mexico city during the early vaccination rollout.

BACKGROUND: Vaccination against COVID-19 is a primary tool for controlling the pandemic. However, the spread of vaccine hesitancy constitutes a significant threat to reverse progress in preventing the disease. Studies conducted in Mexico have revealed that vaccination intention in Mexico among the general population ranges from 62 to 82%. OBJECTIVE: To know the prevalence of COVID-19 vaccine hesitancy and associated factors among academics, students, and administrative personnel of a public university in Mexico City. METHODS: We administered an online survey investigating sociodemographic aspects, knowledge, attitudes, practices, and acceptance/hesitancy regarding the COVID-19 vaccine. Using generalized linear Poisson models, we analyzed factors associated with vaccine hesitancy, defined as not intending to be vaccinated within the following six months or refusing vaccination. RESULTS: During May and June 2021, we studied 840 people, prevalence of vaccine hesitancy was 6%. Hesitancy was significantly associated with fear of adverse effects, distrust of physician's recommendations, lack of knowledge regarding handwashing, age younger than 40 years, refusal to use face masks, and not having received influenza vaccination during the two previous seasons. CONCLUSIONS: Vaccine hesitancy in this population is low. Furthermore, our results allowed us the identification of characteristics that can improve vaccine promotion.

Clinical presentation of pediatric patients with symptomatic SARS-CoV-2 infection during the first months of the COVID-19 pandemic in a single center in Mexico City.

Background: The clinical spectrum of COVID-19 is broad, from asymptomatic to severe cases and death. The objective of this study is to analyze the clinical course of patients attended during the first months of the SARS-CoV-2 pandemic in a third-level pediatric hospital. Methods: Design: prospective cohort study. Patients with viral respiratory disease or suspected cases of COVID-19 were evaluated at the Pediatric Hospital, National Medical Center XXI Century, Mexico City, from 21 March 2020 to 13 January 2021. Statistical analysis: Chi-square test and Fisher's exact test were used for comparisons; a logistic regression model was constructed to identify clinical or laboratory characteristics associated with critical disease. A p-value < 0.05 was considered statistically significant. Results: A total of 697 patients met the operational definition of viral respiratory disease or suspected cases of COVID-19 and underwent real-time reverse transcription polymerase chain reaction (rRT-PCR) SARS-CoV-2 testing. Patients with a positive result were included. Of the 181 patients (26%), 121 (66.8%) had mild disease and were treated as outpatients and 60 (33.1%) were hospitalized. A total of six patients met the criteria for multisystem inflammatory syndrome in children (MIS-C). Of the 60 inpatients, 65% were males, and 82% had one or more comorbidities. The main comorbidities were cancer (42%) and overweight (15%). The median hospital stay was 9 days. The inpatients had a higher frequency of fever, general malaise, dyspnea, chills, polypnea, and cyanosis than the outpatients (p < 0.05). Only 21.4% of the outpatients had one or more comorbidities, which were lower than in the hospitalized patients (p < 0.001). Laboratory data at admission were similar between critically ill and those with moderate and severe disease. The patients who developed pneumonia were at higher risk of critical disease, while older age was associated with a better prognosis. A total of 13 of the 60 inpatients died (mortality 7.1%). All but one had one or more comorbidities: four had cancer, four congenital heart disease, one chronic kidney disease and epilepsy, one Epstein-Barr virus-induced hemophagocytic lymphohistiocytosis, one obesity, and one diabetes mellitus. Conclusion: Hospital mortality is high, especially in children with comorbidities. Despite 2 years having passed since the beginning of the COVID-19 pandemic, the epidemiological and clinical data on children are still helpful to improve their prognosis.

Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial.

Background: Some studies suggested that adequate levels of vitamin D (VD) decrease the risk of severe COVID-19. Information about the effectiveness of VD supplementation in children is scarce. Objective: To assess the efficacy and safety of VD supplementation compared to the standard of care in hospitalized children with COVID-19. Patients and methods: An open-label randomized controlled single-blind clinical trial was carried out. We included patients from 1 month to 17 years, with moderate COVID-19, who required hospitalization and supplemental oxygen. They were randomized into two groups: the VD group, which received doses of 1,000 (children < 1 year) or 2,000 IU/day (from 1 to 17 years) and the group without VD (control). The outcome variables were the progression of oxygen requirement, the development of complications, and death. Statistical analysis: For comparison between groups, we used the chi-squared test or Fisher's exact test and the Mann-Whitney U test. Absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated. p ≤ 0.05 was considered statistically significant. Results: From 24 March 2020 to 31 March 2021, 87 patients were eligible to participate in the trial; 45 patients were randomized: 20 to the VD group and 25 to the control group. There was no difference in general characteristics at baseline, including serum VD levels (median 13.8 ng/ml in the VD group and 11.4 ng/ml in the control group). Outcomes: 2/20 (10%) in the VD group vs. 9/25 (36%) in the control group progressed to a superior ventilation modality (p = 0.10); one patient in the VD group died (5%) compared to 6 (24%) patients in the control group (p = 0.23). ARR was 26% (95% CI 8.8 to 60.2%) and NNT was 3 (2 to 11) for progression and ARR was 19% (95% CI -3.9 to 42.8%) and NNT was 6 (2 to 26) for death. None of the patients receiving VD had adverse effects. The trial was stopped for ethical reasons; since after receiving the results of the basal VD values, none of the patients had normal levels. Conclusion: In this trial, VD supplementation in pediatric patients seems to decrease the risk of COVID-19 progression and death. More studies are needed to confirm these findings. Clinical Trial Registration: This protocol was registered on ClinicalTrials.gov with the registration number NCT04502667.

Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial.

BACKGROUND: Associations between vitamin D (VD) deficiency and the risk of SARS-CoV-2 infection have been documented in cross-sectional population studies. Intervention studies in patients with moderate to severe COVID-19 have failed to consistently document a beneficial effect. OBJECTIVE: To determine the efficacy and safety of VD-supplementation in the prevention of SARS-CoV-2 infection in highly exposed individuals. METHODS: A double-blind, parallel, randomized trial was conducted. Frontline healthcare workers from four hospitals in Mexico City, who tested negative for SARS-CoV-2 infection, were enrolled between July 15 and December 30, 2020. Participants were randomly assigned to receive 4,000 IU VD (VDG) or placebo (PG) daily for 30 d. RT-PCR tests were taken at baseline and repeated if COVID-19 manifestations appeared during follow-up. Serum 25-hydroxyvitamin D3 and antibody tests were measured at baseline and at day 45. Per-protocol and intention-to-treat analysis were conducted. RESULTS: Of 321 recruited subjects, 94 VDG and 98 PG completed follow-up. SARS-CoV-2 infection rate was lower in VDG than in PG (6.4 vs. 24.5%, p <0.001). The risk of acquiring SARS-CoV-2 infection was lower in the VDG than in the PG (RR: 0.23; 95% CI: 0.09-0.55) and was associated with an increment in serum levels of 25-hydroxyvitamin D3 (RR: 0.87; 95% CI: 0.82-0.93), independently of VD deficiency. No significant adverse events were identified. CONCLUSIONS: Our results suggest that VD-supplementation in highly exposed individuals prevents SARS-CoV-2 infection without serious AEs and regardless of VD status.

COVID-19 in Neonates with Positive RT-PCR Test. Systematic Review.

BACKGROUND: COVID-19 is an infectious disease of variable severity caused by a new coronavirus. Clinical presentation ranges from asymptomatic cases to severe illness. Most cases in newborns appear to be asymptomatic or mild. OBJECTIVE: To conduct a systematic review of the literature on published studies of COVID-19 in newborns with a positive RT-PCR test. METHODS: The PubMed and EMBASE databases were searched for infection data in newborns from 1 December 2019-21 May 2021. The mesh terms included "SARS-CoV-2", "COVID-19", "novel coronavirus", "newborns" and "neonates". The selection criteria were as follows: original studies reporting clinical, radiological, laboratory, and outcome data in newborns with a positive RT-PCR test for SARS-CoV-2. Two independent investigators reviewed the studies. RESULTS: Seventy-two studies that involved 236 newborns were included. The main clinical manifestations were fever (43.2%), respiratory (46.6%), and gastrointestinal (35.2%) symptoms; 60.1% had mild/moderate disease. A total of 52.5% had a chest X-ray; 43.5% were normal, and 24.1% reported consolidation/infiltration images. The most frequent laboratory abnormalities were elevated C reactive protein and elevated procalcitonin and lymphopenia. Mortality was 1.7%. CONCLUSION: Symptoms of SARS-CoV-2 infection were mild to moderate in most of the newborns. The prognosis was good, and mortality was mainly associated with other comorbidities.

Outpatient treatment for people with cancer who develop a low-risk febrile neutropaenic event.

BACKGROUND: People with febrile neutropaenia are usually treated in a hospital setting. Recently, treatment with oral antibiotics has been proven to be as effective as intravenous therapy. However, the efficacy and safety of outpatient treatment have not been fully evaluated. OBJECTIVES: To compare the efficacy (treatment failure and mortality) and safety (adverse events of antimicrobials) of outpatient treatment compared with inpatient treatment in people with cancer who have low-risk febrile neutropaenia. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 11) in the Cochrane Library, MEDLINE via Ovid (from 1948 to November week 4, 2018), Embase via Ovid (from 1980 to 2018, week 48) and trial registries (National Cancer Institute, MetaRegister of Controlled Trials, Medical Research Council Clinical Trial Directory). We handsearched all references of included studies and major reviews. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing outpatient with inpatient treatment for people with cancer who develop febrile neutropaenia. The outpatient group included those who started treatment as an inpatient and completed the antibiotic course at home (sequential) as well as those who started treatment at home. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility, methodological quality, and extracted data. Primary outcome measures were: treatment failure and mortality; secondary outcome measures considered were: duration of fever, adverse drug reactions to antimicrobial treatment, duration of neutropaenia, duration of hospitalisation, duration of antimicrobial treatment, and quality of life (QoL). We estimated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous data; we calculated weighted mean differences for continuous data. Random-effects meta-analyses and sensitivity analyses were conducted. MAIN RESULTS: We included ten RCTs, six in adults (628 participants) and four in children (366 participants). We found no clear evidence of a difference in treatment failure between the outpatient and inpatient groups, either in adults (RR 1.23, 95% CI 0.82 to 1.85, I2 0%; six studies; moderate-certainty evidence) or children (RR 1.04, 95% CI 0.55 to 1.99, I2 0%; four studies; moderate-certainty evidence). For mortality, we also found no clear evidence of a difference either in studies in adults (RR 1.04, 95% CI 0.29 to 3.71; six studies; 628 participants; moderate-certainty evidence) or in children (RR 0.63, 95% CI 0.15 to 2.70; three studies; 329 participants; moderate-certainty evidence).According to the type of intervention (early discharge or exclusively outpatient), meta-analysis of treatment failure in four RCTs in adults with early discharge (RR 1.48, 95% CI 0.74 to 2.95; P = 0.26, I2 0%; 364 participants; moderate-certainty evidence) was similar to the results of the exclusively outpatient meta-analysis (RR 1.15, 95% CI 0.62 to 2.13; P = 0.65, I2 19%; two studies; 264 participants; moderate-certainty evidence).Regarding the secondary outcome measures, we found no clear evidence of a difference between outpatient and inpatient groups in duration of fever (adults: mean difference (MD) 0.2, 95% CI -0.36 to 0.76, 1 study, 169 participants; low-certainty evidence) (children: MD -0.6, 95% CI -0.84 to 0.71, 3 studies, 305 participants; low-certainty evidence) and in duration of neutropaenia (adults: MD 0.1, 95% CI -0.59 to 0.79, 1 study, 169 participants; low-certainty evidence) (children: MD -0.65, 95% CI -0.1.86 to 0.55, 2 studies, 268 participants; moderate-certainty evidence). With regard to adverse drug reactions, although there was greater frequency in the outpatient group, we found no clear evidence of a difference when compared to the inpatient group, either in adult participants (RR 8.39, 95% CI 0.38 to 187.15; three studies; 375 participants; low-certainty evidence) or children (RR 1.90, 95% CI 0.61 to 5.98; two studies; 156 participants; low-certainty evidence).Four studies compared the hospitalisation time and found that the mean number of days of hospital stay was lower in the outpatient treated group by 1.64 days in adults (MD -1.64, 95% CI -2.22 to -1.06; 3 studies, 251 participants; low-certainty evidence) and by 3.9 days in children (MD -3.90, 95% CI -5.37 to -2.43; 1 study, 119 participants; low-certainty evidence). In the 3 RCTs of children in which days of antimicrobial treatment were analysed, we found no difference between outpatient and inpatient groups (MD -0.07, 95% CI -1.26 to 1.12; 305 participants; low-certainty evidence).We identified two studies that measured QoL: one in adults and one in children. QoL was slightly better in the outpatient group than in the inpatient group in both studies, but there was no consistency in the domains included. AUTHORS' CONCLUSIONS: Outpatient treatment for low-risk febrile neutropaenia in people with cancer probably makes little or no difference to treatment failure and mortality compared with the standard hospital (inpatient) treatment and may reduce time that patients need to be treated in hospital.

Risk Factors for Central Line-Associated Bloodstream Infection in Critically Ill Neonates.

OBJECTIVE: To identify independent risk factors to develop a central line- associated bloodstream infection (CLABSI) in critically ill neonates with major underlying diseases. METHODS: A nested case-control study was conducted in a neonatal intensive care unit (NICU). Patients with a central venous catheter (CVC) were included. Cases were neonates who developed a CLABSI and controls were patients without CLABSI. Variables included: perinatal history, characteristics of the catheter, installation and catheter use, surgical interventions, and hospital stay. Odds ratio (OR) and 95% confidence intervals (CI) were calculated. X2, Fisher exact, and Mann-Whitney U tests were used when appropriate. Variables with a p value ≤0.10 in the univariate analysis were introduced in a non-conditional logistic regression model. RESULTS: Seventy four cases and 105 controls were analyzed. Univariate risk factors were: any surgery, abdominal surgery, length of hospitalization (≥14 d), double-lumen CVC, surgical cut-down technique, complications, CVC placement in internal jugular vein, dressing type, blood transfusions, parenteral nutrition, and number of CVC manipulations (>200). In the logistic regression analysis, independent risk factors with a p value <0.05 were: double-lumen catheter (OR 5.8, 95% CI 1.2-30), length of hospitalization ≥14 d (OR 4.6, 95% CI 1.8-11.4), abdominal surgery (OR 2.7, 95% CI 1.2-6.2) and blood transfusions (OR 2.5, 95% CI 1.2-5.3). CONCLUSIONS: One risk factor was related to the catheter itself. Management of underlying diseases in specialized NICU contributes to a greater extent to the development of a central line-associated bloodstream infection.

Early discharge of pediatric patients with cancer, fever, and neutropenia with low-risk of systemic infection / Egreso temprano en pacientes pediátricos con cáncer, fiebre y neutropenia con bajo riesgo de infección sistémica

Abstract: Background: Ambulatory therapy in low-risk patients with cancer, fever, and neutropenia seems to be a secure and effective alternative. This study aimed to compare the effectiveness and safety of the antimicrobial treatment in early discharge vs. in-hospital treatment in children with cancer and febrile neutropenia (FN) with low risk of invasive bacterial infection (IBI). Methods: Quasi-experimental design with a historical cohort control group. Children with cancer during an episode of FN and low risk of IBI were included. The control group were inpatient children that received intravenous piperacillin/tazobactam. The experimental group was early discharge patients, who received 48 h of IV treatment and were switched to oral treatment. Outcomes: fever resolution, readmissions, and mortality. Results: Eighty low-risk FN episodes were included; the median age was 6 years old (2.6-11 years), and 43 (54%) were female. Main diagnoses were solid tumors (52 patients) and leukemia or lymphoma (28 patients). Forty-three patients received in-hospital treatment, and 37 were selected for early discharge (31 patients received ciprofloxacin and six received amoxicillin/clavulanate). Two patients were readmitted, one due to a relapse of fever with tumor progression and the other due to epistaxis. Adverse effects occurred in 21.6% of the early discharge group and 12% of the inpatient treatment group (p = 0.04). Conclusions: Early discharge in pediatric patients with cancer, fever, and neutropenia is an acceptable and safe alternative for low-risk patients.

Resumen: Introducción: El tratamiento ambulatorio en pacientes con cáncer, fiebre y neutropenia de bajo riesgo parece ser una alternativa segura y efectiva. El objetivo de este trabajo fue comparar la efectividad y la seguridad del tratamiento antimicrobiano en la modalidad de egreso temprano vs. el tratamiento intrahospitalario en niños con cáncer y neutropenia febril (NF), con bajo riesgo de infección bacteriana invasiva (IBI). Métodos: Diseño cuasi-experimental con un grupo control histórico. Se incluyeron niños con cáncer durante un episodio de NF con bajo riesgo de IBI. El grupo control fue constituido por pacientes que recibieron tratamiento hospitalario con piperacilina-tazobactam intravenosa. Los pacientes en el grupo de egreso temprano recibieron 48 horas de tratamiento intravenoso y egresaron con antimicrobianos por vía oral. Desenlaces: resolución de la fiebre, reingreso al hospital y muerte. Resultados: Se incluyeron 80 pacientes con NF de bajo riesgo; la mediana de edad fue de 6 años; 43 pacientes (54%) eran de sexo femenino. Los diagnósticos principales fueron tumores sólidos (52) y leucemia o linfoma (28). Cuarenta y tres pacientes recibieron tratamiento hospitalario y 37 fueron seleccionados para egreso temprano. En el grupo de egreso temprano, 31 pacientes recibieron ciprofloxacino y 6 recibieron amoxicilina-clavulanato. Dos pacientes reingresaron, uno por fiebre secundaria a progresión tumoral y otro por epistaxis. Los efectos adversos se presentaron en el 21.6% de los pacientes en el grupo de egreso temprano y en el 12% del grupo de tratamiento hospitalario (p = 0.04). Conclusiones: El egreso temprano para niños con cáncer y NF de bajo riesgo es una alternativa aceptable y segura.

Early discharge of pediatric patients with cancer, fever, and neutropenia with low-risk of systemic infection.

Background: Ambulatory therapy in low-risk patients with cancer, fever, and neutropenia seems to be a secure and effective alternative. This study aimed to compare the effectiveness and safety of the antimicrobial treatment in early discharge vs. in-hospital treatment in children with cancer and febrile neutropenia (FN) with low risk of invasive bacterial infection (IBI). Methods: Quasi-experimental design with a historical cohort control group. Children with cancer during an episode of FN and low risk of IBI were included. The control group were inpatient children that received intravenous piperacillin/tazobactam. The experimental group was early discharge patients, who received 48 h of IV treatment and were switched to oral treatment. Outcomes: fever resolution, readmissions, and mortality. Results: Eighty low-risk FN episodes were included; the median age was 6 years old (2.6-11 years), and 43 (54%) were female. Main diagnoses were solid tumors (52 patients) and leukemia or lymphoma (28 patients). Forty-three patients received in-hospital treatment, and 37 were selected for early discharge (31 patients received ciprofloxacin and six received amoxicillin/clavulanate). Two patients were readmitted, one due to a relapse of fever with tumor progression and the other due to epistaxis. Adverse effects occurred in 21.6% of the early discharge group and 12% of the inpatient treatment group (p = 0.04). Conclusions: Early discharge in pediatric patients with cancer, fever, and neutropenia is an acceptable and safe alternative for low-risk patients.

Introducción: El tratamiento ambulatorio en pacientes con cáncer, fiebre y neutropenia de bajo riesgo parece ser una alternativa segura y efectiva. El objetivo de este trabajo fue comparar la efectividad y la seguridad del tratamiento antimicrobiano en la modalidad de egreso temprano vs. el tratamiento intrahospitalario en niños con cáncer y neutropenia febril (NF), con bajo riesgo de infección bacteriana invasiva (IBI). Métodos: Diseño cuasi-experimental con un grupo control histórico. Se incluyeron niños con cáncer durante un episodio de NF con bajo riesgo de IBI. El grupo control fue constituido por pacientes que recibieron tratamiento hospitalario con piperacilina-tazobactam intravenosa. Los pacientes en el grupo de egreso temprano recibieron 48 horas de tratamiento intravenoso y egresaron con antimicrobianos por vía oral. Desenlaces: resolución de la fiebre, reingreso al hospital y muerte. Resultados: Se incluyeron 80 pacientes con NF de bajo riesgo; la mediana de edad fue de 6 años; 43 pacientes (54%) eran de sexo femenino. Los diagnósticos principales fueron tumores sólidos (52) y leucemia o linfoma (28). Cuarenta y tres pacientes recibieron tratamiento hospitalario y 37 fueron seleccionados para egreso temprano. En el grupo de egreso temprano, 31 pacientes recibieron ciprofloxacino y 6 recibieron amoxicilina-clavulanato. Dos pacientes reingresaron, uno por fiebre secundaria a progresión tumoral y otro por epistaxis. Los efectos adversos se presentaron en el 21.6% de los pacientes en el grupo de egreso temprano y en el 12% del grupo de tratamiento hospitalario (p = 0.04). Conclusiones: El egreso temprano para niños con cáncer y NF de bajo riesgo es una alternativa aceptable y segura.

[Experimental studies: research designs for the evaluation of interventions in clinical settings]. / Estudios experimentales: diseños de investigación para la evaluación de intervenciones en la clínica.

Experimental studies are used to assess the efficacy and effectiveness of therapeutic (pharmacological or surgical), preventive (such as vaccination or lifestyle changes) or educational interventions (e.g., workshops to improve quality and healthcare). There are different experimental studies but, currently, randomized controlled trial (RCT) is recognized as the type of study that provides the highest level of evidence. When this type of research cannot be carried out, there are quasi-experimental studies, where there may be no randomization or a control group; however, this type of studies has a lower degree of validity. This article describes the way different types of RCT and quasi-experimental studies are performed; their advantages and disadvantages are also explained.

Los estudios experimentales se utilizan para evaluar la eficacia y efectividad de una intervención terapéutica (farmacológica o quirúrgica), preventiva (como la vacunación o los cambios estilo de vida) o educativa (por ejemplo, taller para mejorar la calidad y la atención a la salud). Existen diferentes estudios experimentales, pero en la actualidad se reconoce que el ensayo clínico controlado y aleatorizado es el que brinda el mayor grado de evidencia. Cuando no se puede llevar a cabo este tipo de investigación se tienen disponibles los estudios cuasiexperimentales, en los cuales puede ser que no se realice aleatorización o no exista un grupo control, sin embargo, tienen un menor grado de validez. En este artículo se describe la forma de realizar los diferentes tipos de ensayo clínico controlado y aleatorizado y estudios cuasiexperimentales; también se exponen sus ventajas y desventajas.

[The importance of clinical case reports in research]. / La importancia de los reportes de casos clínicos en la investigación.

Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse) of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

Los reportes de casos clínicos corresponden a artículos que tienen la más baja evidencia entre los diferentes estudios de investigación. Sin embargo, no solo son comunes y significativos en el ámbito médico, sino que en muchas ocasiones han sido la base para la generación de investigación. El propósito de la publicación puede ser científico o educacional. En términos generales, en estos documentos se narran, entre otras cosas, el descubrimiento de nuevas enfermedades, la presentación de enfermedades raras, formas inusuales de enfermedades comunes, las complicaciones de un tratamiento común, o bien, el efecto (benéfico o adverso) de un tratamiento. Los reportes de casos clínicos siguen siendo una de las fuentes más importantes de conocimiento. El advenimiento de una guía estandarizada para la creación de reportes de este tipo permite homogeneizar la forma y el contenido de los casos que en un futuro próximo se pretendan describir; así mismo, permitirá a los autores contar con una referencia al momento de elaborar este tipo de publicaciones. Los reportes de caso son recursos valiosos de información nueva e inusual que pueden incentivar y servir en el futuro para realizar estudios de investigación con mayor nivel de evidencia.

[Research protocol VII. Validity and reliability of the measurements]. / El protocolo de investigación VII. Validez y confiabilidad de las mediciones.

The concept of validity in research refers to what is true or what is close to the truth. It is considered that the results of an investigation will be valid when the study is free of errors. The errors or biases appear in the development of research, are due to methodological problems and, in general, can be grouped into three: selection bias, measurement bias and confusion bias. In this article, measurement biases will be addressed; this type of error has three axes: 1) the research subject, 2) the instrument for the measurement of the variable (s), and 3) those who make the evaluation of the measurement (s). To improve the obtaining of data and to prevent errors, some strategies can be followed: in every study protocol, it is necessary to include the operational definition of the variables; the subjects that will carry out the measurements or surveys must be trained. If measuring instruments are used, their proper functioning must be verified; when questionnaires are included, they must be validated in the language in which they will be applied, they have had a process of adaptation to the language of the participants in the study, and self-applicable ones are preferred. It is necessary to quantify the variability of the measurements from the statistical point of view to increase the validity of a study.

El concepto de validez en investigación se refiere a lo que es verdadero o se acerca a la verdad. Se considera que los resultados de una investigación son válidos cuando el estudio está libre de errores. Los errores o sesgos que se presentan en el desarrollo de una investigación se deben a problemas metodológicos y pueden agruparse en tres categorías: sesgos de selección, sesgo en la medición y sesgo de confusión. En este artículo se abordan los sesgos de medición, tipo de error que tienen tres ejes: el sujeto de investigación, el instrumento para la medición de las variables y el evaluador de las mediciones. Para mejorar la obtención de los datos y prevenir los errores se pueden seguir algunas estrategias: incluir la definición operacional de las variables, la capacitación de los sujetos que van a realizar las mediciones o encuestas, la verificación del adecuado funcionamiento de los instrumentos de medición, la validación de los cuestionarios en el idioma en el que se van a aplicar, su adecuación al idioma de los participantes en el estudio y que de preferencia sean autoaplicables. Es necesario cuantificar la variabilidad de las mediciones desde el punto de vista estadístico, para aumentar la validez de un estudio.