Abstract Background Data Research Articles

Motor and cognitive outcomes of neonates with low birth weight in Brazil: a systematic review and meta-analysis.

Data on the outcomes of preterm newborns in South American countries are scarce. Given the great effect of low birth weight (LBW) and/or prematurity on children's neurodevelopment, it is extremely necessary to conduct studies on these phenomena in greater depth in more heterogeneous populations such as those ones from countries with limited resources. We conducted a comprehensive literature search on databases including PubMed, the Cochrane Library, and Web of Science for articles published in Portuguese and English up to March 2021 involving children born and evaluated in Brazil. The analysis of the risk of bias was adapted from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and used to evaluate the methodology of the included studies. From the eligible trials, 25 articles were selected for qualitative synthesis, and 5 of those, for quantitative synthesis (meta-analysis). The meta-analyses showed that children born with LBW presented lower scores on motor development when compared with controls (standardized mean difference: -1.15; 95% confidence interval [95%CI]: -1.56--0.73]; I2: 80%) and also scored lower in terms of cognitive development (standardized mean difference: -0.71; 95% CI: -0.99--0.44; I2: 67%). The results of the present study reinforce that impaired motor and cognitive functions can be a significant long-term outcome of LBW. The lower the gestational age at delivery, the higher the risk of impairment in those domains. The study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database under number CRD42019112403.

Treatment and Epidemiology of Third-Generation Cephalosporin-Resistant Urinary Tract Infections.

Limited data are available on the contemporary epidemiology, clinical management, and health care utilization for pediatric urinary tract infection (UTI) due to third-generation cephalosporin-resistant Enterobacterales (G3CR) in the United States. The objective is to describe the epidemiology, antimicrobial treatment and response, and health care utilization associated with G3CR UTI. Multisite, matched cohort-control study including children with G3CR UTI versus non-G3CR UTI. UTI was defined as per American Academy of Pediatrics guidelines, and G3CR as resistance to ceftriaxone, cefotaxime, or ceftazidime. We collected data from the acute phase of illness to 6 months thereafter. Among 107 children with G3CR UTI and 206 non-G3CR UTI with documented assessment of response, the proportion with significant improvement on initial therapy was similar (52% vs 57%; odds ratio [OR], 0.81; 95% confidence interval [CI], 0.44-1.50). Patients with G3CR were more frequently hospitalized at presentation (38% vs 17%; OR, 3.03; 95% CI, 1.77-5.19). In the follow-up period, more patients with G3CR had urine cultures (75% vs 53%; OR, 2.61; 95% CI, 1.33-5.24), antimicrobial treatment of any indication (53% vs 29%; OR, 2.82; 95% CI, 1.47-5.39), and subspecialty consultation (23% vs 6%; OR, 4.52; 95% CI, 2.10-10.09). In multivariate analysis, previous systemic antimicrobial therapy remained a significant risk factor for G3CR UTI (adjusted OR, 1.91; 95% CI, 1.06-3.44). We did not observe a significant difference in response to therapy between G3CR and susceptible UTI, but subsequent health care utilization was significantly increased.

Comparison of 6-month outcomes of sepsis versus non-sepsis critically ill patients receiving mechanical ventilation

BackgroundData on long-term outcomes after sepsis-associated critical illness have mostly come from small cohort studies, with no information about the incidence of new disability. We investigated whether sepsis-associated critical illness was independently associated with new disability at 6 months after ICU admission compared with other types of critical illness.MethodsWe conducted a secondary analysis of a multicenter, prospective cohort study in six metropolitan intensive care units in Australia. Adult patients were eligible if they had been admitted to the ICU and received more than 24 h of mechanical ventilation. There was no intervention.ResultsThe primary outcome was new disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS) 12 level score compared between baseline and 6 months. Between enrollment and follow-up at 6 months, 222/888 (25%) patients died, 100 (35.5%) with sepsis and 122 (20.1%) without sepsis (P < 0.001). Among survivors, there was no difference for the incidence of new disability at 6 months with or without sepsis, 42/106 (39.6%) and 106/300 (35.3%) (RD, 0.00 (− 10.29 to 10.40), P = 0.995), respectively. In addition, there was no difference in the severity of disability, health-related quality of life, anxiety and depression, post-traumatic stress, return to work, financial distress or cognitive function.ConclusionsCompared to mechanically ventilated patients of similar acuity and length of stay without sepsis, patients with sepsis admitted to ICU have an increased risk of death, but survivors have a similar risk of new disability at 6 months.Trial registration NCT03226912, registered July 24, 2017.

Factors associated with the health-related quality of life among people with Duchenne muscular dystrophy: a study using the Health Utilities Index (HUI)

BackgroundData on health state utility in Duchenne muscular dystrophy (DMD) are few. This study estimated mean utility values by age, ambulatory status and over time, and investigated which aspects of health-related quality-of-life (HRQoL) are most strongly associated with utility in DMD.MethodsData from placebo-treated ambulant boys with DMD with exon 51 skip amenable mutations, (NCT01254019), were included. Ambulatory function assessments were conducted at baseline and every 12 weeks for the trial duration. Family member proxies completed the Health Utility Index (HUI) at baseline, 24 and 48 weeks; and HUI3 and HUI2 utility values were summarized. Changes in HUI attribute level over time, and predictors of changes in utility, were explored.ResultsSixty-one boys (mean [range] age of 8.0 [5–16] years) were included in the analysis. Mean baseline utilities were 0.82 (HUI3) and 0.87 (HUI2); and utilities were 0.35 (HUI3) and 0.55 (HUI2) after loss of ambulation (LOA, where applicable). Over the follow-up period mean utility declined more among the older versus younger boys. Pain accounted for the highest proportion of variability (42%) in change in HUI3 utility from baseline to week 48, while for HUI2, self-care (39%) did. After LOA, change in ambulation levels explained 88% of the decline in mean HUI3 utility and change in mobility levels explained 66% of the decline in mean HUI2 utility.ConclusionsUtility values among this sample were higher than previously published estimates. In younger boys utility remained relatively stable, but older boys and those losing ambulation experienced important declines over follow-up.

Passive Sensor Data for Characterizing States of Increased Risk for Eating Disorder Behaviors in the Digital Phenotyping Arm of the Binge Eating Genetics Initiative: Protocol for an Observational Study

BackgroundData that can be easily, efficiently, and safely collected via cell phones and other digital devices have great potential for clinical application. Here, we focus on how these data could be used to refine and augment intervention strategies for binge eating disorder (BED) and bulimia nervosa (BN), conditions that lack highly efficacious, enduring, and accessible treatments. These data are easy to collect digitally but are highly complex and present unique methodological challenges that invite innovative solutions.ObjectiveWe describe the digital phenotyping component of the Binge Eating Genetics Initiative, which uses personal digital device data to capture dynamic patterns of risk for binge and purge episodes. Characteristic data signatures will ultimately be used to develop personalized models of eating disorder pathologies and just-in-time interventions to reduce risk for related behaviors. Here, we focus on the methods used to prepare the data for analysis and discuss how these approaches can be generalized beyond the current application.MethodsThe University of North Carolina Biomedical Institutional Review Board approved all study procedures. Participants who met diagnostic criteria for BED or BN provided real time assessments of eating behaviors and feelings through the Recovery Record app delivered on iPhones and the Apple Watches. Continuous passive measures of physiological activation (heart rate) and physical activity (step count) were collected from Apple Watches over 30 days. Data were cleaned to account for user and device recording errors, including duplicate entries and unreliable heart rate and step values. Across participants, the proportion of data points removed during cleaning ranged from <0.1% to 2.4%, depending on the data source. To prepare the data for multivariate time series analysis, we used a novel data handling approach to address variable measurement frequency across data sources and devices. This involved mapping heart rate, step count, feeling ratings, and eating disorder behaviors onto simultaneous minute-level time series that will enable the characterization of individual- and group-level regulatory dynamics preceding and following binge and purge episodes.ResultsData collection and cleaning are complete. Between August 2017 and May 2021, 1019 participants provided an average of 25 days of data yielding 3,419,937 heart rate values, 1,635,993 step counts, 8274 binge or purge events, and 85,200 feeling observations. Analysis will begin in spring 2022.ConclusionsWe provide a detailed description of the methods used to collect, clean, and prepare personal digital device data from one component of a large, longitudinal eating disorder study. The results will identify digital signatures of increased risk for binge and purge events, which may ultimately be used to create digital interventions for BED and BN. Our goal is to contribute to increased transparency in the handling and analysis of personal digital device data.Trial RegistrationClinicalTrials.gov NCT04162574; https://clinicaltrials.gov/ct2/show/NCT04162574International Registered Report Identifier (IRRID)DERR1-10.2196/38294

Real-world evidence on perioperative chemotherapy in localized soft tissue sarcoma of the extremities and trunk wall; a population-based study

Background Data from the real-world setting on perioperative chemotherapy in high-risk, localized soft tissue sarcoma (STS) is limited. Real-world data (RWD) includes data derived from patients treated outside clinical trials and often captures long-term follow-up not recorded in clinical trials. The aim of this study was to provide population-based, real-world evidence on perioperative chemotherapy in localized STS. Material and methods Adult patients with localized STS in the extremities or trunk wall treated at Oslo University Hospital, Oslo, Norway from 1998 to 2017 were included in the study. Data were extracted from a prospectively maintained database, supplemented by retrospective review of medical records. Results The total study cohort included 806 patients, of whom 154 (19%) received perioperative chemotherapy. A regimen with anthracycline and ifosfamide was given in 141 of 154 cases (92%). During long-term follow-up two patients developed secondary malignancies, cardiac toxicity was registered in 11 patients (7%) and renal toxicity in 12 patients (8%). Seventy-one of 154 patients (46%) were treated outside of clinical trials and constituted the RWD cohort. The median age at surgery was slightly lower and there were more synovial sarcomas and fewer myxofibrosarcomas in the RWD cohort. No difference in chemotherapy dose intensity was observed. The estimated 5-year metastasis-free survival (MFS) in all patients receiving perioperative chemotherapy was 58%. In the RWD cohort 5-year MFS was 53% and in the clinical study cohort 61% (HR 1.24; 95% CI 0.77–2.00). Conclusion Long-term outcome after perioperative chemotherapy was comparable for patients treated in routine clinical practice to those in clinical trials. Secondary malignancy and cardiac toxicity were observed. The risk of serious late side effects should be included in the decision process on perioperative chemotherapy.

Continued effectiveness of COVID-19 vaccination among urban healthcare workers during delta variant predominance

BackgroundData on COVID-19 vaccine effectiveness (VE) among healthcare workers (HCWs) during periods of delta variant predominance are limited.MethodsWe followed a population of urban Massachusetts HCWs (45% non-White) subject to epidemiologic surveillance. We accounted for covariates such as demographics and community background infection incidence, as well as information bias regarding COVID-19 diagnosis and vaccination status.ResultsDuring the study period (December 16, 2020 to September 30, 2021), 4615 HCWs contributed to a total of 1,152,486 person-days at risk (excluding 309 HCWs with prior infection) and had a COVID-19 incidence rate of 5.2/10,000 (114 infections out of 219,842 person-days) for unvaccinated person-days and 0.6/10,000 (49 infections out of 830,084 person-days) for fully vaccinated person-days, resulting in an adjusted VE of 82.3% (95% CI 75.1–87.4%). For the secondary analysis limited to the period of delta variant predominance in Massachusetts (i.e., July 1 to September 30, 2021), we observed an adjusted VE of 76.5% (95% CI 40.9–90.6%). Independently, we found no re-infection among those with prior COVID-19, contributing to 74,557 re-infection-free person-days, adding to the evidence base for the robustness of naturally acquired immunity.ConclusionsWe found a VE of 76.5% against the delta variant. Our work also provides further evidence of naturally acquired immunity.

MO1025: Periostin as a Potential Biomarker of Renal and Arterial Damage in Children with Tuberous Sclerosis Complex

Abstract BACKGROUND AND AIMS Experimental data suggest that periostin is involved in the formation of renal cysts. Tuberous sclerosis complex (TSC) is a multisystem genetic disease characterized by the formation of lesions in virtually all organs, including the kidney—most commonly angiomyolipomas (AML) and cysts. There are no reliable markers of progression of renal lesions in patients with TSC. The study aimed to evaluate serum periostin levels in children with TSC and to assess the usefulness of periostin as a marker of renal lesion severity and arterial damage in this group of patients. METHOD In a group of 35 children with TSC (mean age 8.46 ± 5.64 years, 17 boys, 18 girls), serum periostin levels (ng/mL), anthropometric parameters, renal changes (by ultrasound and magnetic resonance imaging), blood pressure and biochemical parameters were evaluated. The control group consisted of 25 healthy children (mean age 8.72 ± 4.73 years, 14 boys, 11 girls). In addition, central pressure and parameters of arterial structure and function (cIMT, PWV, AIx75HR) were assessed in 20 children with TSC and 17 healthy children (age ≥ 4 years). RESULTS Arterial hypertension was found in two (5.7%) patients; AML was present in 20 (57.1%) children, including 9 (27.3%) atypical AML and 22 (62.8%) had cysts in the kidneys. Children with TSC did not differ in periostin levels compared with healthy children [67.46 ± 35.61 versus 68.14 ± 24.07 (ng/mL), P = .499]. In children with TSC, periostin concentration was negatively correlated with age (r = −0.614, P &amp;lt; .001), height (r = −0.634, P &amp;lt; .001), body weight (r = −0.658, P &amp;lt; .001), maximum cyst size (r = −0.481, P = .004) and office and ABPM systolic and diastolic blood pressure (r = −0.396 to −0.621, P &amp;lt; .050). There was no relationship between periostin levels and AML size or arterial damage parameters. In multivariate analysis, the only determinant of serum periostin levels in children with TSC was age [beta = −0.547, 95% confidence interval (95% CI) (−0.831 to −0.262)]. CONCLUSION The usefulness of serum periostin determination as a marker of renal cystic lesions in children with tuberous sclerosis requires further study.

MO310: Clinical Characteristics and Outcomes of Acute Kidney Injury in Hospitalized Patients With COVID-19: Experience at a Major Tertiary Care Center in Pakistan

BACKGROUND AND AIMSLimited data exists on acute kidney injury (AKI) in patients hospitalized with COVID-19, its risk factors and associated outcomes from low-middle income countries. We aimed to determine the epidemiology of AKI and its impact on outcomes at a tertiary-care center in Karachi, Pakistan.METHODA retrospective observational study was conducted at Aga Khan University Hospital from October to December 2020. Data on demographics, presenting clinical symptoms, laboratory results and patient outcomes were collected from medical records. AKI was defined according to KDIGO criteria.RESULTSOf 301 patients admitted with COVID-19, AKI developed in 188 (62.5%). The peak stages of AKI were stage 1 in 57%, stage 2 in 14.9% and stage 3 in 27.7%. Of these, 15 (8%) required KRT. Patients requiring ICU admission (63.8% versus 34.5%), vasopressors (31.9% versus 5.3%) or mechanical ventilation (25% versus 2.7%) had a higher risk of AKI. Independent predictors of AKI were elevated blood urea nitrogen and creatinine at the time of presentation, need for mechanical ventilation and use of anticoagulants. AKI, presence of proteinuria, elevated SCr at presentation, use of vasopressors and need for KRT were all significantly associated with in-hospital death, and the likelihood of mortality increased with the advancing stage of AKI.CONCLUSIONCompared with other countries, AKI occurred more frequently among hospitalized patients with COVID-19 in a Pakistani cohort and was associated with a 7.7-fold increase in odds of in-hospital death. Patients with severe AKI had a greater likelihood of fatal outcomes compared with earlier stages or non-AKI patient groups.

MO579: The Long-Term Efficacy and Safety of Low-Protein Diets in Non-Diabetic Patients with Advanced CKD: Focus on Elderly

Abstract BACKGROUND AND AIMS Current data suggest the benefits of protein restriction in the management of advanced chronic kidney disease (CKD), improving metabolic abnormalities, optimizing blood pressure control and allowing to postpone kidney replacement therapy (KRT). However, feasibility, safety and even the long-term benefits of low protein diets (LPDs) are questioned, especially in elderly. This study aimed to compare the long-term efficacy and safety of two types of LPDs in elderly non-diabetic patients with advanced CKD. METHOD Long-term follow-up (FU) data from a prospective randomized controlled single-center trial (RCT) on 207 CKD stage 4 + non-diabetic patients are presented. The RCT compared the effects of vegetarian very low protein diet supplemented with keoanalogues of essential amino acids (sVLPD, vegetable proteins 0.3 g/kg-day plus, Ketosteril®, Bad Homburg, Germany, 1 tb/5 kg bw-day) with conventional LPD (mixed proteins 0.6g/kg-day) for 15 months (Garneata L et al. JASN. 2016; doi:10.1681/ASN.2 015 040 369). The composite endpoint was the need of KRT or the patients’ death. The census point was either the occurrence of primary endpoint or 31 July 2018. We are presenting a sub-analysis focusing on elderly patients (&amp;gt;65 years old). Safety was assessed throughout the study by anthropometric measures, Subjective Global Assessment (SGA), serum levels of albumin (SAlb) and C-reactive protein (CRP). Davies Comorbidity score was also registered during the follow-up. RESULTS Two hundred patients who ended the RCT were enrolled in the FU. All of them voluntarily continued the prescribed intervention. Data analysis showed sVLPD to be superior to LPD on long-term with respect to the primary endpoint, preserving the nutritional status (published data). Of the 200 subjects, 36 (18%) were elderly, 15 on LPD and 21 on sVLPD. At 31 July 2018, more than 10 years after the end of RCT, 70% of the elderly patients were alive with no statistically significant difference between groups (81 versus 43.3%, P = 0.08 in sVLPD and LPD, respectively). The median follow-up was significantly higher in the sVLPD group: 116 (106–123) versus 97 (49–115) months. The need for KRT during FU was significantly lower in patients on sVLPD: 43 versus 100%. The time until KRT was similar between groups: 32 (7–54) versus 35 (6–131) months, sVLPD and LPD, respectively. There were no significant differences between sVLPD and LPD at the end of FU (EOFU) in the nutritional status assessed by SGA and SAlb [4.41 (4.14–4.56) versus 4.31 (3.90–4.35) g/dL]. At the EOFU, CRP was significantly lower in the sVLPD group: 7 (4–9) versus 10.5 (7–16) mg/L. Davies Comorbidity Score increased during the FU in both groups, with no difference: 3 (1–3) versus 3 (3–5), sVLPD and LPD, respectively. Kaplan–Meier analysis showed better survival rates in the sVLPD group, both for the patient (10-year survival 78 versus 53% in sVLPD and LPD, respectively) and for kidney (10-year survival 82 versus 20% in sVLPD and LPD, respectively). Cox regression analysis of data showed SGA A and the sVLPD to be associated with better patients’ survival, while only sVLPD was associated with better kidneys’ survival. CONCLUSION Both types of protein-restricted diets proved feasible and safe on long-term in elderly. Vegetarian very low protein diet supplemented with ketoanalogues was associated with better patients and kidneys survival as compared with low protein diet in elderly non-diabetic patients.

Effect of physical activity on the development and the resolution of nonalcoholic fatty liver in relation to body mass index

BackgroundData on whether physical activity (PA) levels are related to nonalcoholic fatty liver disease (NAFLD) when considering body mass index (BMI) are scarce. We assessed whether PA affects the development or resolution of NAFLD in conjunction with BMI changes.MethodsOverall, 130,144 participants who underwent health screening during 2011–2016 were enrolled. According to the PA level in the Korean version of the validated International PA Questionnaire Short Form, participants were classified into the inactive, active, and health-enhancing PA (HEPA) groups.ResultsIn participants with increased BMI, the hazard ratio (HR) and 95% confidence interval after multivariable Cox hazard model for incident NAFLD was 0.97 (0.94–1.01) in the active group and 0.94 (0.89–0.99) in the HEPA group, whereas that for NAFLD resolution was 1.03 (0.92–1.16) and 1.04 (0.88–1.23) (reference: inactive group). With increased BMI, high PA affected only new incident NAFLD. PA enhancement or maintenance of sufficient PA prevented new incident NAFLD. In participants with decreased BMI, the HRs were 0.98 (0.90–1.07) and 0.88 (0.78–0.99) for incident NAFLD and 1.07 (0.98–1.17) and 1.33 (1.18–1.49) for NAFLD resolution in the active and HEPA groups, respectively. With decreased BMI, high PA reduced incident NAFLD and increased NAFLD resolution. Maintenance of sufficient PA led to a considerable resolution of NAFLD.ConclusionIn this large longitudinal study, PA prevented incident NAFLD regardless of BMI changes. For NAFLD resolution, sufficient PA was essential along with BMI decrease. Maintaining sufficient PA or increasing the PA level is crucial for NAFLD prevention or resolution.

KMSubtraction: reconstruction of unreported subgroup survival data utilizing published Kaplan-Meier survival curves

BackgroundData from certain subgroups of clinical interest may not be presented in primary manuscripts or conference abstract presentations. In an effort to enable secondary data analyses, we propose a workflow to retrieve unreported subgroup survival data from published Kaplan-Meier (KM) plots.MethodsWe developed KMSubtraction, an R-package that retrieves patients from unreported subgroups by matching participants on KM plots of the overall cohort to participants on KM plots of a known subgroup with follow-up time. By excluding matched patients, the opposing unreported subgroup may be retrieved. Reproducibility and limits of error of the KMSubtraction workflow were assessed by comparing unmatched patients against the original survival data of subgroups from published datasets and simulations. Monte Carlo simulations were utilized to evaluate the limits of error of KMSubtraction.ResultsThe validation exercise found no material systematic error and demonstrates the robustness of KMSubtraction in deriving unreported subgroup survival data. Limits of error were small and negligible on marginal Cox proportional hazard models comparing reconstructed and original survival data of unreported subgroups. Extensive Monte Carlo simulations demonstrate that datasets with high reported subgroup proportion (r = 0.467, p < 0.001), small dataset size (r = − 0.374, p < 0.001) and high proportion of missing data in the unreported subgroup (r = 0.553, p < 0.001) were associated with uncertainty are likely to yield high limits of error with KMSubtraction.ConclusionKMSubtraction demonstrates robustness in deriving survival data from unreported subgroups. The limits of error of KMSubtraction derived from converged Monte Carlo simulations may guide the interpretation of reconstructed survival data of unreported subgroups.

Childhood disability in rural Niger: a population-based assessment using the Key Informant Method

BackgroundData on childhood disability is essential for planning health, education and other services. However, information is lacking in many low- and middle-income countries, including Niger. This study uses the Key Informant Method, an innovative and cost-effective strategy for generating population-based estimates of childhood disability, to estimate the prevalence and causes of moderate/severe impairments and disabling health conditions in children of school-going age (7–16 years) in the Kollo department of western Niger.MethodsCommunity-based key informants were trained to identify children who were suspected of having the impairment types/health conditions included in this study. Children identified by key informants were visited by paediatricians and underwent an assessment for moderate/severe vision, hearing, physical and intellectual impairments, as well as epilepsy, albinism and emotional distress.ResultsTwo thousand, five hundred sixty-one children were identified by key informants, of whom 2191 were visited by paediatricians (response rate = 85.6%). Overall, 597 children were determined to have an impairment/health condition, giving a prevalence of disability of 11.4 per 1000 children (10.6- 12.2). Intellectual impairment was most common (6.5 per 1000), followed by physical (4.9 per 1000) and hearing impairments (4.7 per 1000). Many children had never sought medical attention for their impairment/health condition, with health seeking ranging from 40.0% of children with visual impairment to 67.2% for children with physical impairments.ConclusionThe Key Informant Method enabled the identification of a large number of children with disabling impairments and health conditions in rural Niger, many of whom have unmet needs for health and other services.

Long-term follow-up of patients after acute kidney injury in the neonatal period: abnormal ambulatory blood pressure findings

BackgroundData on the long-term effects of neonatal acute kidney injury (AKI) are limited.MethodsWe invited 302 children who had neonatal AKI and survived to hospital discharge; out of 95 patients who agreed to participate in the study, 23 cases were excluded due to primary kidney, cardiac, or metabolic diseases. KDIGO definition was used to define AKI. When a newborn had no previous serum creatinine, AKI was defined as serum creatinine above the mean plus two standard deviations (SD) (or above 97.5th percentile) according to gestational age, weight, and postnatal age. Clinical and laboratory features in the neonatal AKI period were recorded for 72 cases; at long-term evaluation (2–12 years), kidney function tests with glomerular filtration rate (eGFR) by the Schwartz formula, microalbuminuria, office and 24-h ambulatory blood pressure monitoring (ABPM), and kidney ultrasonography were performed.ResultsForty-two patients (58%) had stage I AKI during the neonatal period. Mean age at long-term evaluation was 6.8 ± 2.9 years (range: 2.3–12.0); mean eGFR was 152.3 ± 26.5 ml/min/1.73 m2. Office hypertension (systolic and/or diastolic BP ≥ 95th percentile), microalbuminuria (> 30 mg/g creatinine), and hyperfiltration (> 187 ml/min/1.73 m2) were present in 13.0%, 12.7%, and 9.7% of patients, respectively. ABPM was performed on 27 patients, 18.5% had hypertension, and 40.7% were non-dippers; 48.1% had abnormal findings. Female sex was associated with microalbuminuria; low birth weight (< 1,500 g) and low gestational age (< 32 weeks) were associated with hypertension by ABPM. Twenty-three patients (33.8%) had at least one sign of microalbuminuria, office hypertension, or hyperfiltration. Among 27 patients who had ABPM, 16 (59.3%) had at least one sign of microalbuminuria, abnormal ABPM (hypertension and/or non-dipping), or hyperfiltration.ConclusionEven children who experienced stage 1 and 2 neonatal AKI are at risk for subclinical kidney dysfunction. Non-dipping is seen in four out of 10 children. Long-term follow-up of these patients is necessary.

Human papillomavirus prevalence and genotype distribution landscapes in Shannan City, Tibet Tibetan Autonomous Region, China

BackgroundData regarding human papillomavirus (HPV) prevalence and genotype distribution are limited in Shannan City, Tibet Tibetan Autonomous Region, China. The purpose of this study is to provide reliable data for guiding women in Shannan City in cervical cancer screening and HPV vaccine innoculation.MethodsHPV testing was performed on women aged 16–109 years (mean age 44.03 ± 9.25 years) from Shannan City in 2019 and 2020, which was implemented technically by gynecological examination, vaginal discharge smear microscopy, cytology, and HPV detection. The overall prevalence, age-specific prevalence, and genotype distribution were analyzed.ResultsA total of 48,126 women received HPV testing, of which 3929 were detected human papillomavirus. The HPV-positive rate was 8.16% (3929/48,126), and the highest prevalence was in the ≤ 25-year-old age group (12.68%). After the age of 25, the prevalence rate decreased rapidly, and then slowly increased from 7.49% in the 46–55 age group to 9.82% in the ≥ 66 age group, showing a “U-shaped” pattern. The positive prevalence of HPV 16 or 18-only was 1.43%, that of other HPV genotypes except HPV 16 or 18 was 6.39%, and mixed HPV infections including HPV 16 or 18 was 0.34%.ConclusionsThe HPV infection rate in Shannan city is rather low, and the age-specific prevalence of HPV infection presents a “U” curve, suggesting the importance of screening among younger women and the necessity of detection among older women.

Longitudinal changes in forced expiratory volume in 1\xa0s in patients with eosinophilic chronic obstructive pulmonary disease

BackgroundData on changes in lung function in eosinophilic chronic obstructive pulmonary disease (COPD) are limited. We investigated the longitudinal changes in forced expiratory volume in 1 s (FEV1) and effects of inhaled corticosteroid (ICS) in Korean COPD patients.MethodsStable COPD patients in the Korean COPD subgroup study (KOCOSS) cohort, aged 40 years or older, were included and classified as eosinophilic and non-eosinophilic COPD based on blood counts of eosinophils (greater or lesser than 300 cells/μL). FEV1 changes were analyzed over a 3-year follow-up period.ResultsOf 627 patients who underwent spirometry at least twice during the follow up, 150 and 477 patients were classified as eosinophilic and non-eosinophilic, respectively. ICS-containing inhalers were prescribed to 40% of the patients in each group. Exacerbations were more frequent in the eosinophilic group (adjusted odds ratio: 1.49; 95% confidence interval: 1.10–2.03). An accelerated FEV1 decline was observed in the non-eosinophilic group (adjusted annual rate of FEV1 change: − 12.2 mL/y and − 19.4 mL/y for eosinophilic and non-eosinophilic groups, respectively). In eosinophilic COPD, the adjusted rate of annual FEV1 decline was not significant regardless of ICS therapy, but the decline rate was greater in ICS users (− 19.2 mL/y and − 4.5 mL/y, with and without ICS therapy, respectively).ConclusionsThe annual rate of decline in FEV1 was favorable in eosinophilic COPD compared to non-eosinophilic COPD, and ICS therapy had no beneficial effects on changes in FEV1.

Potential for the lung recruitment and the risk of lung overdistension during 21\xa0days of mechanical ventilation in patients with\xa0 COVID-19 after noninvasive ventilation failure: the COVID-VENT observational trial

BackgroundData on the lung respiratory mechanics and gas exchange in the time course of COVID-19-associated respiratory failure is limited. This study aimed to explore respiratory mechanics and gas exchange, the lung recruitability and risk of overdistension during the time course of mechanical ventilation.MethodsThis was a prospective observational study in critically ill mechanically ventilated patients (n = 116) with COVID-19 admitted into Intensive Care Units of Sechenov University. The primary endpoints were: «optimum» positive end-expiratory pressure (PEEP) level balanced between the lowest driving pressure and the highest SpO2 and number of patients with recruitable lung on Days 1 and 7 of mechanical ventilation. We measured driving pressure at different levels of PEEP (14, 12, 10 and 8 cmH2O) with preset tidal volume, and with the increase of tidal volume by 100 ml and 200 ml at preset PEEP level, and calculated static respiratory system compliance (CRS), PaO2/FiO2, alveolar dead space and ventilatory ratio on Days 1, 3, 5, 7, 10, 14 and 21.ResultsThe «optimum» PEEP levels on Day 1 were 11.0 (10.0–12.8) cmH2O and 10.0 (9.0–12.0) cmH2O on Day 7. Positive response to recruitment was observed on Day 1 in 27.6% and on Day 7 in 9.2% of patients. PEEP increase from 10 to 14 cmH2O and VT increase by 100 and 200 ml led to a significant decrease in CRS from Day 1 to Day 14 (p < 0.05). Ventilatory ratio was 2.2 (1.7–2,7) in non-survivors and in 1.9 (1.6–2.6) survivors on Day 1 and decreased on Day 7 in survivors only (p < 0.01). PaO2/FiO2 was 105.5 (76.2–141.7) mmHg in non-survivors on Day 1 and 136.6 (106.7–160.8) in survivors (p = 0.002). In survivors, PaO2/FiO2 rose on Day 3 (p = 0.008) and then between Days 7 and 10 (p = 0.046).ConclusionLung recruitability was low in COVID-19 and decreased during the course of the disease, but lung overdistension occurred at «intermediate» PEEP and VT levels. In survivors gas exchange improvements after Day 7 mismatched CRS.Trial registrationClinicalTrials.gov, NCT04445961. Registered 24 June 2020—Retrospectively registered.

Hubungan Pengetahuan dan Budaya dengan Terapi Uap Panas (Peusale) Pada Ibu Nifas di Kecamatan Lhoknga Kabupaten Aceh Besar Tahun 2021

Back ground data obtained from the lhoknga publik helth center in 2018 AKI 0f 453 people and IMR of 4 people, in 2019 AKI of 8 people in 2020 AKI of 11 people in IMR of 2 people a total of 480 pospartum care is on effort mode by midwives, pospartum mothers and famillies with the aim that the nutritional needs of postpartum mothers are fulfillid, personal hygiene is maintained. Research objectives to dermine the relationship between knaowledge and the influence of cultur with hot steam therapy (peusale) on postpartum mothers in lhoknga district, aceh besar regency 2021. This research method used the method the analytikal cross sectional approach wich was carried out on september 14-19-2021 was carried out in the lhoknga sub-district. The population in this study was all 31 postpartum mothers. Sampling using total sampling data analysis using univariatee and bivariate analysis with the chi-squer test method showed a p-value of 0.000 0.05 research results. The results of statistical resets wit chi-squer test showed a p-value of 0.000&lt;0.05, meaning that there was an influence of knowledge with peusale steam therapy culture. Besed on the chi-squer thes table shows a p-value of 0.001&lt;0.05, there is an influence between culture and steam therapy for postpartum mothers in lhoknga district, aceh besar district

Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial

BackgroundData on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline.MethodsBASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m2. The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years.ResultsA total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67–1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76–1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07–0.92; p = 0.037) and not influenced by presence of CKD.ConclusionsThe long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT 01574534).Graphical Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial

ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study

BackgroundData from phase 3 trials have demonstrated the efficacy and safety of benralizumab in patients with severe eosinophilic asthma (SEA). We conducted a real-world study examining the baseline characteristics of a large SEA population treated with benralizumab in clinical practice and assessed therapy effectiveness.MethodsANANKE is an Italian multi-center, retrospective cohort study including consecutive SEA patients who had started benralizumab therapy ≥ 3 months before enrolment (between December 2019 and July 2020), in a real-world setting. Data collection covered (1) key patient features at baseline, including blood eosinophil count (BEC), number and severity of exacerbations and oral corticosteroid (OCS) use; (2) clinical outcomes during benralizumab therapy. We also conducted two post-hoc analyses in patients grouped by body mass index and allergic status. Analyses were descriptive only.ResultsOf 218 patients with SEA enrolled in 21 Centers, 205 were evaluable (mean age, 55.8 ± 13.3 years, 61.5% females). At treatment start, the median BEC was 580 cells/mm3 (interquartile range [IQR]: 400–850); all patients were on high-dose inhaled controller therapy and 25.9% were on chronic OCS (median dose: 10 mg/die prednisone-equivalent [IQR: 5–25]); 92.9% experienced ≥ 1 exacerbation within the past 12 months (annualized exacerbation rate [AER] 4.03) and 40.3% reported ≥ 1 severe exacerbation (AER 1.10). During treatment (median duration: 9.8 months [IQR 6.1–13.9]; ≥ 12 months for 34.2% of patients), complete eosinophil depletion was observed; exacerbation-free patients increased to 81% and only 24.3% reported ≥ 1 severe event. AER decreased markedly to 0.27 for exacerbations of any severity (− 93.3%) and to 0.06 for severe exacerbations (− 94.5%). OCS therapy was interrupted in 43.2% of cases and the dose reduced by 56% (median: 4.4 mg/die prednisone-equivalent [IQR: 0.0–10.0]). Lung function and asthma control also improved. The effectiveness of benralizumab was independent of allergic status and body mass index.ConclusionsWe described the set of characteristics of a large cohort of patients with uncontrolled SEA receiving benralizumab in clinical practice, with a dramatic reduction in exacerbations and significant sparing of OCS. These findings support benralizumab as a key phenotype-specific therapeutic strategy that could help physicians in decision-making when prescribing biologics in patients with SEA.Trial registration ClinicalTrials.gov Identifier: NCT04272463