Single-center Pilot Research Articles

Single-center pilot study of remote therapeutic monitoring in patients with operative spinal pathologies

ObjectivesSpine pathology affects a significant portion of the population, leading to neck and back pain, impacting quality of life, and potentially requiring surgical intervention. Current pre- and postoperative monitoring methods rely on patient reported outcome (PRO) measures and lack continuous objective data on patients' recoveries. Remote therapeutic monitoring (RTM) using wearable devices offers a promising solution to bridge this gap, providing real-time physical function data. This study aims to assess the feasibility and correlation between changes in physical function and daily activity levels using RTM for individuals with operative spinal pathologies. MethodsA single-center pilot study involving 21 participants with operative spinal pathologies was conducted at an academic hospital. Participants were provided Bluetooth-enabled Fitbit Inspire 2 activity trackers and asked to wear them daily for 100 days. The Healthcare Recovery Solutions (HRS) mobile application facilitated remote administration of the PROMIS - Physical Function Short Form 6b PROs questionnaire at days 1, 30, and 90. Linear regression, Students' paired T tests, and one-way ANOVA were used to analyze collected data. ResultsAverage compliance with RTM was found to be 82.4% compared to only 48% for PROMs. Changes in daily steps were moderately positively correlated with changes in PROs at both 30 and 90 days. Participant satisfaction with RTM was high, and responses indicated greater satisfaction with RTM compared to PROMs. ConclusionsRTM offers continuous and objective data collection, presenting a potential solution to the limitations of intermittent clinical assessments and self-reported outcomes. The study demonstrated a moderate correlation between changes in activity levels and changes in PROs, suggesting that RTM data could serve as a surrogate for PROs. Participants' high compliance and satisfaction with RTM underscore its feasibility and potential clinical utility. This study lays the groundwork for larger future investigations into the clinical benefits and broader application of RTM in spine care.

68Ga]Ga-FAPI-46 PET/CT for penile cancer - a feasibility study.

Penile cancer is a rare entity and has a good prognosis in localized stage. Delayed surgical treatment of lymphatic disease is associated with poor overall survival but conventional imaging cannot detect occult lymph node metastasis sufficiently. Imaging cancer related fibroblasts has shown promising results as non-invasive staging tool in various tumor entities but has not yet been evaluated in penile cancer. In this single-center pilot study, patients planned for surgical treatment for penile cancer underwent preoperatively [68Ga]Ga-FAPI-46 PET/CT. Post-operative histopathology was compared to [68Ga]Ga-FAPI-46 PET/CT results. From January 2022 to June 2022, a total number 11 patients with histopathologically proven penile cancer underwent surgery and received [68Ga]Ga-FAPI-46 PET/CT prior therapy. 8 primary tumor sites and 4 lymph node regions were analyzed. FAPI uptake was increased on primary tumor site (SUVmax 16.2 (9.1 - 25.8)). Histopathological proven lymph node regions showed highly increased FAPI uptakes (SUVmax 17.9 (16.4 - 23.5) on [68Ga]Ga-FAPI-46 PET/CT. In this first pilot cohort, there were no false-positive FAPI uptake which might allow the detection of occult lymph node metastasis by [68Ga]Ga-FAPI-46 PET/CT and might consequently lead to omitting lymph node regions during surgery that had no increased FAPI uptake pre-operatively.

Outcomes in pediatric recipients of single kidney transplantation from pediatric donors with acute kidney injury: A single-center pilot study.

Outcomes in pediatric recipients of single kidney transplantation from pediatric donors with acute kidney injury: A single-center pilot study.

Hemadsorption to Contain Postoperative Cell-Free Hemoglobin and Haptoglobin Preservation for Extended Cardiopulmonary Bypass Time in Cardiac Surgery for Acute Kidney Injuries Prevention.

Prevention of acute kidney injury during cardiopulmonary bypass (CPB) is still a challenge and has been the object of numerous studies. The incidence of acute kidney injury in the context of CPB is related to a multifactorial etiology. The role of hemadsorption in relation to cell-free hemoglobin and haptoglobin preservation is not well defined in the literature on CPB during cardiac surgery procedures. This is a single-center pilot randomized report including 20 patients undergoing elective CPB procedures with an expected time > 120 minutes for each extracorporeal procedure. Patients were randomly allocated to either standard of care (n=10) or Jafron HA380 (n=10) during CPB. The primary outcome measured was the incidence of postoperative acute kidney injuries. The Jafron study group vs. control group reported postoperative values for cell-free hemoglobin at 10 minutes after CPB (mg/L) (11.6 ± 0.6 vs. 29.9 ± 0.3) (P-value 0.021), haptoglobin 10 minutes after CPB (mg/dl) (129.16 ± 1.22 vs. 59.17 ± 1.49) (P-value 0.017), creatinine peak after CPB (mg/dL) (0.92 ± 0.17 vs. 1.32 ± 0.9) (P-value 0.030), and acute kidney injury after 48 hours (number of patients) (one vs. four) (P-value 0.027). This pilot study suggested that the use of Hemoperfusion Cartridge HA380 Jafron for extended CPB time for complex cardiac surgery procedures was safe and effective and is associated with a better postoperative preservation of haptoglobin with a reduction of cell-free hemoglobin values and less incidence of acute kidney injury, though larger studies are warranted to confirm our result.

Systemic Capillary Responses to Acute Exercise in Hypertensive Seniors: Insights from a Single-Center Pilot Study.

This study was a single- center pilot trial. The study took place in the Faculty of Health, Tsukuba University of Technology, Japan. Hypertensive community-dwelling elderly people took part in the study. Microcirculation was observed before and 1 min after an arm-curl exercise by means of capillary microscopy of the non-exercised limb. Additionally, we examined other health-related indicators. Methods: We measured the acute effects of reperfusion on nailfold density, flow, and diameters. Secondary outcomes included the correlations between microvascular parameters and other health-related indicators. We hypothesized that brief exercise could enhance microcirculation reperfusion and correlate with other health-related parameters. Results: There were 20 participants with a mean (SD) age of 67.1 (5.8) years. The capillary flow rate changed from 2.3 ± 6.7 to 2.7 ± 0.2 log µm/s (p < 0.01), and the capillary density changed from 0.8 ± 0.2 to 0.9 ± 0.1 log/mm (p < 0.01), which included a significant increase in the non-exercising limb. Significant correlations were observed between the nailfold capillary diameter and body fat mass, the capillary diameter and physical activity, and the capillary density and bone mineral density. Conclusions: The acute effects of exercise on high-risk elderly individuals can be safe, and even 1 of min exercise can potentially improve their nailfold capillary function, despite the brief time, compared to no exercise. The results indicate that capillaries have an impact on the function of the whole body. Thus, they may be a useful diagnostic tool for assessing nailfold capillaries.

Investigating the risk of reintubation by cough force assessment using cough peak expiratory flow: a single-center observational pilot study

BackgroundNo objective indicator exists for evaluating cough strength during extubation of tracheally intubated patients. This study aimed to determine whether cough peak expiratory flow (CPEF) can predict the risk of reintubation due to decreased cough strength.MethodsThis was a retrospective cohort study of patients who were admitted to our Emergency Intensive Care Unit between September 1, 2020 and August 31, 2021 and were under artificial ventilation management for ≥ 24 h. The patients were divided into two groups: successful extubation and reintubation groups, and the relationship between CPEF immediately before extubation and reintubation was investigated.ResultsSeventy-six patients were analyzed. In the univariate analysis, CPEF was significantly different between the successful extubation (90.7 ± 25.9 L/min) and reintubation (57.2 ± 6.4 L/min) groups (p < 0.001). In the multivariate analysis with age and duration of artificial ventilation as covariates, CPEF was significantly lower in the reintubation group (p < 0.01). The cutoff value of CPEF for reintubation according to the receiver operating characteristic curve was 60 L/min (area under the curve, 0.897; sensitivity, 78.5%; specificity, 90.9%; p < 0.01).ConclusionCPEF in tracheally intubated patients may be a useful indicator for predicting the risk of reintubation associated with decreased cough strength. The cutoff CPEF value for reintubation due to decreased cough strength was 60 L/min.

Bone health and skeletal fragility in second- and third-line medical therapies for acromegaly: preliminary results from a pilot single center experience.

Skeletal fragility is a clinically relevant and not-reversible complication of acromegaly, involving around 30-40% of patients since the disease diagnosis. Few studies have investigated the effects on skeletal health of medical therapies for acromegaly. In this retrospective longitudinal monocentre study, we investigated the outcome of skeletal fragility in patients treated with Pasireotide Lar in combination with Pegvisomant (Pasi-Lar + Peg-V), also comparing those observed in patients treated with conventional therapies. We included 6 patients treated with Pasi-Lar + Peg-V, 5 patients treated with Peg-V in monotherapy (m-Peg-V), 16 patients treated with Peg-V plus first-generation somatostatin receptor ligands (fg-SRLs + Peg-V), 9 patients treated with Pasi-Lar. None of the patients treated with Pasi-Lar + Peg-V experienced worsening of spine and femoral bone mineral density (BMD) and incident vertebral fractures (i-VFs). Eight patients experienced i-VFs. The frequency of i-VFs was significantly lower in patients treated with the Pasi-Lar + Peg-V (0/8; 0%), as compared to those observed in m-Peg-V treated patients (4/8; 50%, p = 0.02). The frequency of i-VFs was slightly but not significantly higher in Pasi-Lar treated patients (1/8; 12.5% p = 0.6) and in fg-SRLs + Peg-V treated patients (3/8; 37.5% p = 0.364), concerning those treated with Pasi-Lar + Peg-V (0/8; 0%). I-VFs occurred more frequently in patients with higher GH levels at acromegaly diagnosis (p < 0.001), and in patients who experienced a BMD worsening (p = 0.005). Our preliminary data suggested that in conventional and multi-drug resistant acromegaly, the combination therapy Pasi-Lar + Peg-V may prevent the worsening of BMD and the occurrence of i-VFs. Prospective and translational studies should further validate these results and ascertain underlying physiopathology mechanisms.

Indirect calorimetry directed feeding and cycling in the older ICU population: a pilot randomised controlled trial

BackgroundOlder critically ill patients experience rapid muscle loss during stay in an intensive care unit (ICU) due to physiological stress and increased catabolism. This may lead to increased ICU length of stay, delayed weaning from ventilation and persistent functional limitations. We hypothesized that with optimal nutrition and early physical therapy acting in synergism, we can reduce muscle mass loss and improve functional outcomes.MethodsThis was a prospective, single blinded randomized, controlled single-center pilot study to compare the lean muscle mass (measured at bilateral quadriceps femoris using ultrasound) of older ICU patients at 4 time points over 14 days between the control and intervention groups. The control group received standard weight-based empiric feeding and standard ICU physiotherapy. The intervention group received indirect calorimetry directed feeding adjusted daily and 60 min per day of cycle ergometry. 21 patients were recruited and randomized with 11 patients in the control arm and 10 patients in the intervention arm. Secondary outcome measures included ICU and hospital mortality, length of stay, functional assessments of mobility and assessment of strength.ResultsMedian age was 64 in the control group and 66 in the intervention group. Median calories achieved was 24.5 kcal/kg per day in the control group and 23.3 kcal/kg per day in the intervention group. Cycle ergometry was applied to patients in the intervention group for a median of 60 min a day and a patient had a median of 8.5 sessions in 14 days. Muscle mass decreased by a median of 4.7cm2 in the right quadriceps femoris in the control group and 1.8cm2 in the intervention group (p = 0.19), while the left quadriceps femoris decreased by 1.9cm2 in the control group and 0.1cm2 in the intervention group (p = 0.51).ConclusionIn this pilot study, we found a trend towards decrease muscle loss in bilateral quadriceps femoris with our combined interventions. However, it did not reach statistical significance likely due to small number of patients recruited in the study. However, we conclude that the intervention is feasible and potentially beneficial and may warrant a larger scale study to achieve statistical significance.Trial RegistrationThis study was registered on Clinicaltrials.gov on 30th May 2018 with identifier NCT03540732.

Phenotype variability in intron2 splice variant of CYP21A2 gene - a single-centre pilot study on children and adolescents

Phenotype variability in intron2 splice variant of CYP21A2 gene - a single-centre pilot study on children and adolescents

Understanding vision outcomes in children with history of prenatal opioid exposure: a single-center pilot study.

Understanding vision outcomes in children with history of prenatal opioid exposure: a single-center pilot study.

A Multimodal Ayurveda and Mind-Body Therapeutic Intervention for Chronic Symptoms Attributed to a Postinfectious Syndrome: A Pilot Study.

Objective: Evaluate feasibility and impact of a multimodal integrative therapeutic intervention in patients presenting with chronic symptoms attributed to a postinfectious syndrome. Design: This was a prospective longitudinal single-center pilot study conducted from January 2019 to December 2020. Setting/Location: University of Maryland Lyme Program, Baltimore Maryland. Subjects: Persons presenting for Lyme evaluation for symptoms attributed to Lyme disease. Interventions: Participants attended two 1-h individual instructional sessions consisting of Ayurveda-based dietary intervention and breath-coordinated mind-body practice to be used for home practice. Outcome measures: Standard measures of impact were obtained at baseline, 1, 3, 6, and 12 months using the following validated survey instruments: Perceived Stress Scale (PSS), PROMIS Global Health v1.2 (GH), and PROMIS 29 v2.0 survey. Results: From 216 patients presenting for Lyme evaluation, 19 participants enrolled with 84% completing the study (N = 16). Baseline PROMIS GH scores consisting of general Physical Health (GPH) and general Mental Health (GMH) scores were lower in the study population than in the general U.S. population. PROMIS 29 scores were higher for fatigue, anxiety, and pain than those in the general U.S. population. Over 12-month period, improvement in both the GPH and GMH was 6.09 (confidence interval [95% CI] = 2.71-9.46; p < 0.001) and 4.65 (95% CI = 1.50-7.80; p = 0.004), respectively. PROMIS 29 scores showed the greatest improvement in fatigue at -7.91 (95% CI = -12.34 to -3.48; p < 0.001), pain interference -5.08 (95% CI = -9.20 to -0.96; p = 0.016), and ability to participate in social roles and activities 7.48 (95% CI = 3.21-11.75; p = 0.001) and least with depression -1.82 (95% CI = -4.74 to 1.10; p = 0.223). Employment status had significant effects on almost all outcome scores. Postinfectious state was associated with improvement in anxiety and PSS scores. Conclusions: A multimodal Ayurvedic and breath-coordinated mind-body therapeutic intervention is feasible and a potential nonpharmacologic therapeutic option for persons presenting with pain, stress, fatigue, physical dysfunction, and sleep disturbance attributed to a postinfectious syndrome. Further research is needed to determine efficacy in this population and in other groups with similar symptom complexes due to postinfectious syndromes.

Multiparameter immunoprofiling for the diagnosis and differentiation of progressive versus nonprogressive nontuberculous mycobacterial lung disease-A pilot study.

Clinical prediction of nontuberculous mycobacteria lung disease (NTM-LD) progression remains challenging. We aimed to evaluate antigen-specific immunoprofiling utilizing flow cytometry (FC) of activation-induced markers (AIM) and IFN-γ enzyme-linked immune absorbent spot assay (ELISpot) accurately identifies patients with NTM-LD, and differentiate those with progressive from nonprogressive NTM-LD. A Prospective, single-center, and laboratory technician-blinded pilot study was conducted to evaluate the FC and ELISpot based immunoprofiling in patients with NTM-LD (n = 18) and controls (n = 22). Among 18 NTM-LD patients, 10 NTM-LD patients were classified into nonprogressive, and 8 as progressive NTM-LD based on clinical and radiological features. Peripheral blood mononuclear cells were collected from patients with NTM-LD and control subjects with negative QuantiFERON results. After stimulation with purified protein derivative (PPD), mycobacteria-specific peptide pools (MTB300, RD1-peptides), and control antigens, we performed IFN-γ ELISpot and FC AIM assays to access their diagnostic accuracies by receiver operating curve (ROC) analysis across study groups. Patients with NTM-LD had significantly higher percentage of CD4+/CD8+ T-cells co-expressing CD25+CD134+ in response to PPD stimulation, differentiating between NTM-LD and controls. Among patients with NTM-LD, there was a significant difference in CD25+CD134+ co-expression in MTB300-stimulated CD8+ T-cells (p <0.05; AUC-ROC = 0.831; Sensitivity = 75% [95% CI: 34.9-96.8]; Specificity = 90% [95% CI: 55.5-99.7]) between progressors and nonprogressors. Significant differences in the ratios of antigen-specific IFN-γ ELISpot responses were also seen for RD1-nil/PPD-nil and RD1-nil/anti-CD3-nil between patients with nonprogressive vs. progressive NTM-LD. Our results suggest that multiparameter immunoprofiling can accurately identify patients with NTM-LD and may identify patients at risk of disease progression. A larger longitudinal study is needed to further evaluate this novel immunoprofiling approach.

Nitroprusside Combined with Leg Raise at the Time of Right Heart Catheterization to Differentiate Precapillary from Other Hemodynamic Forms of Pulmonary Hypertension: A Single-Center Pilot Study.

Pulmonary hypertension (PH) can arise from several distinct disease processes, with a percentage presenting with combined pre- and postcapillary pulmonary hypertension (cpcPH). Patients with cpcPH are unsuitable candidates for PH-directed therapies due to elevated pulmonary capillary wedge pressures (PCWPs); however, the PCWP is dynamic and is affected by both preload and afterload. Many patients that are diagnosed with cpcPH are hypertensive at the time of right heart catheterization which has the potential to increase the PCWP and, therefore, mimic a more postcapillary-predominant phenotype. In this small pilot study, we examine the effect of nitroprusside combined with dynamic preload augmentation with a passive leg raise maneuver in hypertensive cpcPH patients at the time of right heart catheterization to identify a more precapillary-dominant PH phenotype. Patients that met the criteria of PCWP ≤ 15 mmHg with nitroprusside infusion and PCWP ≤ 18 mmHg with nitroprusside infusion and simultaneous leg raise were started on pulmonary vascular-targeted therapy. Long-term PH therapy was well tolerated, with increased six-minute walk distance, improved WHO functional class, decreased NT-proBNP, and improved REVEAL 2.0 Lite Risk Score in this precapillary-dominant PH phenotype. This small study highlights the importance of characterizing patient physiology beyond resting conditions at the time of right heart catheterization.

Chemical angioplasty vs. balloon plus chemical angioplasty for delayed cerebral ischemia: a pilot study of PbtO2 outcomes

BackgroundDelayed cerebral ischaemia (DCI) is a major cause of morbidity and mortality after aneurysmal subarachnoid haemorrhage (aSAH). Chemical angioplasty (CA) and transluminal balloon angioplasty (TBA) are used to treat patients with refractory vasospasm causing DCI. Multi-modal monitoring including brain tissue oxygenation (PbtO2) is routinely used at this centre for early detection and management of DCI following aSAH. In this single-centre pilot study, we are comparing these two treatment modalities and their effects on PbtO2.MethodsRetrospective case series of patients with DCI who had PbtO2 monitoring as part of their multimodality monitoring and underwent either CA or TBA combined with CA. PbtO2 values were recorded from intra-parenchymal Raumedic NEUROVENT-PTO® probes. Data were continuously collected and downloaded as second-by-second data. Comparisons were made between pre-angioplasty PbtO2 and post-angioplasty PbtO2 median values (4 h before angioplasty, 4 h after and 12 h after).ResultsThere were immediate significant improvements in PbtO2 at the start of intervention in both groups. PbtO2 then increased by 13 mmHg in the CA group and 15 mmHg in the TBA plus CA group in the first 4 h post-intervention. This improvement in PbtO2 was sustained for the TBA plus CA group but not the CA group.ConclusionCombined balloon plus chemical angioplasty results in more sustained improvement in brain tissue oxygenation compared with chemical angioplasty alone. Our findings suggest that PbtO2 is a useful tool for monitoring the response to angioplasty in vasospasm.

Effectiveness of psychotherapeutic nursing intervention on infertility stress, uncertainty, anxiety and implantation rate among women undergoing in-vitro fertilization treatment: A single centre pilot randomized controlled trial.

Background: Within the realm of mental distress experienced by women who are unable to conceive, tension, uncertainty, and anxiety are prevalent concerns. The multitude of unpredictable elements that occur during IVF treatment process can cause anxiety and stress. This unpleasant feeling has an impact on the psycho-neurological pathways of women who are unable to conceive. As a consequence, fertilisation and implantation are inhibited, leading to adverse effects on pregnancy. The individual's experience will vary depending on the extent of social support, the coping mechanisms employed, the quality of the marital connection, and the level of stress caused by infertility. Material and method: The study was carried out on 20 women undergoing IVF treatment. Participants were selected by simple random sampling technique. (COMPI) Fertility Problem Stress Scale, Uncertainty Scale for Infertile Women and Short Version of the Spielberger State—trait Anxiety Inventory were used to assess the level of stress, uncertainty and anxiety. Results: The findings of the current study indicate that 80% of women undergoing IVF in the experimental group experienced a moderate degree of stress prior to the intervention. However, this percentage decreased to 60% after receiving intervention. In case of uncertainty maximum of women had mild level of uncertainty and it remain unchanged in experimental group after intervention However, there was a significant decrease in anxiety levels (both STAIS and STAIT) in the experimental group following the intervention. Participants that received psychotherapeutic nursing intervention showed a higher rate of implantation. Conclusion: Psychotherapeutic nursing intervention can decrease the anxiety among women undergoing in vitro fertilisation treatment and also enhance the implantation rate.

ВЛИЯНИЕ АНТРОПОМЕТРИЧЕСКИХ ПОКАЗАТЕЛЕЙ И СОСТАВА ТЕЛА НА ВСТРЕЧАЕМОСТЬ ДИСАНАПСИСА У ПОДРОСТКОВ С БРОНХИАЛЬНОЙ АСТМОЙ

Increase in the dysanapsis incidence in patients with bronchial asthma (BA) has been reported as the patients' body weight (BW) increases, but the relationship between the body composition, namely its fat component, and the incidence of dysanapsis has not yet been studied. The purpose of this research was to study the anthropometric indicators and body composition impact on the incidence of dysanapsis in adolescents with AD. Materials and methods used: a single-center observational cross-sectional pilot study of 101 adolescents (71.3% boys) aged 12 to 17 y/o (15.0 [13.0; 16.0] y/o median) with AD was conducted in the Nizhny Novgorod City Children’s Clinical Hospital No. 1 (Nizhny Novgorod, Russia) in 2017-2023. All participants underwent measurement of anthropometric and spirometric indicators, determination of body composition and diagnosis for dysanapsis. Dysanapsis is diagnosed when three conditions are met simultaneously: 1) high or high-normal z of forced vital capacity (FVC) (over 0.674); 2) normal z forced expiratory volume in 1 s (FEV1) (over -1.645); and 3) low FEV1/FVC index (below 80%). Results: fat ratio differed statistically significantly (p&lt;0.001) depending on the selected groups according to the body mass index (BMI). The body fat content among patients with normal body weight was increased in 12.1% (7/58) of patients, and decreased in 34.5% (20/58); among patients with excess BW, 8.3% (3/36) had decreased weight, 41.7% (15/36) had normal weight; in all 7 obese patients it was increased. In the group of patients with normal BW, the incidence of dysanapsis was 19.0% (11/58), among patients with overweight and obesity - 46.5% (20/43, p=0.003). Among patients with different body fat content, the incidence of dysanapsis was: with a reduced fat content - 17.4% (4/23), with a normal fat content - 26.1% (12/46), with an increased fat content - 46.9 % (15/32, p=0.042). Conclusion: the incidence of dysanapsis in children and adolescents with AD increases both as BMI increases and as the fat content in the patients’ body increases. An increase in body weight and body fat content may contribute to the formation and maintenance of an obstructive external respiration pattern in children and adolescents with BA.

ВЛИЯНИЕ ВОЗРАСТА И ПОЛА НА СИНОНАЗАЛЬНЫЕ СИМПТОМЫ У ДЕТЕЙ И ПОДРОСТКОВ С БРОНХИАЛЬНОЙ АСТМОЙ

There is a lack of information about the relationship between the age and gender and the nasal and sinonasal symptoms in patients with combined bronchial asthma (BA) and allergic rhinosinusitis (ARS) in childhood and adolescence in current bibliographical data. The purpose of this research was to study the influence of age and gender factors on nasal and sinonasal symptoms in children and adolescents with combined asthma, allergic rhinitis (AR) and/or ARS. Materials and methods used: a single-center observational cross-sectional pilot study of patients with atopic asthma aged 5 to 17 y/o was performed, median age 12.0 [9.0; 15.0] years, 73.1% (201/275) boys, in the Nizhny Novgorod City Children’s Clinical Hospital No. 1 (Nizhny Novgorod, Russia) in 2017-2023. All children underwent spirometric studies and assessment of nasal and sinonasal symptoms using the TNSS (Total Symptom Nasal Score) and SNOT-22 (SynoNasal Outcome Test-22) questionnaires. The patients were divided into 3 age groups: G1 of 90 aged 5 to 9 y/o, G2 of 111 aged 10 to 14 y/o, and G3 of 74 aged 15 to 17 y/o. Results: the severity of nasal symptoms (TNSS) in patients with asthma increased statistically significantly as their age increased, both in common sample and in the samples of boys and girls (p=0.005, p=0.020, p=0.037, respectively). Sinonasal symptoms (assessed with SNOT-22) increased statistically significantly as patients grew older in the sample of girls (p=0.002) and did not have statistically significant differences at different age groups in boys (p=0.414). Conclusion: understanding the role that gender factors play in the formation and course of AR and ARS in patients with asthma in childhood and adolescence can contribute to the development of new directions for personalized management of these patients taking into account their gender and age.

ВЛИЯНИЕ НИЗКОЙ МАССЫ ТЕЛА НА ПАРАМЕТРЫ ВНЕШНЕГО ДЫХАНИЯ И УРОВЕНЬ ЭОЗИНОФИЛОВ ПЕРИФЕРИЧЕСКОЙ КРОВИ У ДЕТЕЙ И ПОДРОСТКОВ С БРОНХИАЛЬНОЙ АСТМОЙ

Current data on the relationship between the body mass index (BMI) and low body weight (BW) and the lung function and peripheral blood eosinophils count in children and adolescents with bronchial asthma (BA) are contradictory. The purpose of this research was to study the relationship between BMI, spirometry parameters and the level of peripheral blood eosinophils in children and adolescents with BA. Materials and methods used: a single-center observational cross-sectional pilot study of 240 children and adolescents with BA of median age 12.0 [9.0; 15.0] y/o, of which 165 (68.8%) were boys, who were divided into two groups based on anthropometric measurements performed to calculate BMI and zBMI: G1 of those with normal BW (BMI -1Z to +1Z) and G2 with LBW (BMI below -1Z). The following spirometry parameters were analyzed: forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and FEV1/FVC ratio (absolute values and Z-scores). Results: absolute values of FVC and FEV1 in LBW patients were slightly lower than in patients with normal BW, the differences were trendy (p=0.055 and p=0.108, respectively). At the same time, zFVC and zFEV1 in low BW patients were statistically significantly lower than in patients with normal BW, amounting to 0.440±1.210 and 1.06±1.130 (p&lt;0.001) for zFVC, respectively, and for zFEV1 -0.241 [-0.974; 0.576] and 0.304 [-0.397; 1.00] (p=0.002). The values of both FEV1/FVC and zFEV1/FVC between these BMI groups did not have statistically significant differences (p=0.462 and p=0.300). Analysis of the relationships between zBMI and z-values of spirometric parameters revealed a significant direct relationship between zBMI and zFVC (R=0.308, p&lt;0.001), as well as a direct, significant, but less pronounced relationship between zBMI and zFEV1 (R=0.20, p=0.002). The relationship between zBMI and zFEV1/FVC was negative (R=-0.11) and did not have statistical significance (p=0.097). The absolute content of eosinophils in peripheral blood was significantly higher in patients with low BW (p=0.006) and had a significant negative relationship with zBMI (R=-0.217, p=0.023). Conclusion: zFVC and zFEV1 values are lower in children and adolescents with BA and low BW and the absolute count of eosinophils in peripheral blood is higher than in patients with normal BW. Therefore, maintaining nutritional status may be an important component of the formation of the respiratory system and an adequate immune response in children and adolescents with BA.

Improvements of complex post-traumatic stress disorder symptoms during a multimodal psychodynamic inpatient rehabilitation treatment – results of an observational single-centre pilot study

ABSTRACT Background: Complex post-traumatic stress disorder (CPTSD) describes chronic disturbances in self-organization (i.e. affect dysregulation; negative self-concept; severe difficulties in relationships) which are frequently observed in survivors of prolonged, repeated or multiple traumatic stressors. So far, evidence of psychodynamic treatment approaches for CPTSD is scarce. Methods: In this single-centre observational pilot study, symptom change during a 6-week psychodynamic inpatient treatment in a multimodal psychosomatic rehabilitation centre was evaluated using repeated measures analyses of variance (ANOVAs). Patients completed questionnaires on PTSD and CPTSD symptoms (ITQ), anxiety, depression and somatization (BSI-18), functional impairment (WHODAS) and epistemic trust, mistrust and credulity (ETMCQ) before (T1) and at the end of treatment (T2). A hierarchical linear regression analysis was calculated to identify factors associated with improved CPTSD symptoms. Results: A total of n = 50 patients with CPTSD were included in the study, of whom n = 40 (80%) completed treatment. Patients reported a significant reduction of CPTSD symptoms during treatment with a large effect size (−3.9 points; p < .001; η 2 = .36), as well as a significant reduction of psychological distress (p < .001; η 2 = .55) and functional impairment (p < .001; η 2 = .59). At the end of treatment, 41.0% of patients no longer fulfilled the diagnostic criteria for CPTSD. Changes in epistemic stance included improved epistemic trust (β = –.34, p = .026) and decreased epistemic credulity (β = .37, p = .017), which together with lower age (β = .43, p = .012) and lower depression levels at baseline (β = .35, p = .054) were significantly associated with baseline adjusted mean change of CPTSD symptoms during therapy and explained 48% of its variance. Discussion: In our study, patients reported a significant reduction of CPTSD symptoms and comorbid symptoms during a multimodal psychodynamic inpatient rehabilitation treatment. Improved epistemic trust may facilitate the establishment of a trusting therapeutic relationship, thus fostering an environment of openness for knowledge transfer (i.e. social learning) and the exploration of diverse viewpoints and perspectives in the therapeutic process.

Detecting High-Dose Methotrexate-Induced Brain Changes in Pediatric and Young Adult Cancer Survivors Using [18F]FDG PET/MRI: A Pilot Study.

Significant improvements in treatments for children with cancer have resulted in a growing population of childhood cancer survivors who may face long-term adverse outcomes. Here, we aimed to diagnose high-dose methotrexate-induced brain injury on [18F]FDG PET/MRI and correlate the results with cognitive impairment identified by neurocognitive testing in pediatric cancer survivors. Methods: In this prospective, single-center pilot study, 10 children and young adults with sarcoma (n = 5), lymphoma (n = 4), or leukemia (n = 1) underwent dedicated brain [18F]FDG PET/MRI and a 2-h expert neuropsychologic evaluation on the same day, including the Wechsler Abbreviated Scale of Intelligence, second edition, for intellectual functioning; Delis-Kaplan Executive Function System (DKEFS) for executive functioning; and Wide Range Assessment of Memory and Learning, second edition (WRAML), for verbal and visual memory. Using PMOD software, we measured the SUVmean, cortical thickness, mean cerebral blood flow (CBFmean), and mean apparent diffusion coefficient of 3 different cortical regions (prefrontal cortex, cingulate gyrus, and hippocampus) that are routinely involved during the above-specified neurocognitive testing. Standardized scores of different measures were converted to z scores. Pairs of multivariable regression models (one for z scores < 0 and one for z scores > 0) were fitted for each brain region, imaging measure, and test score. Heteroscedasticity regression models were used to account for heterogeneity in variances between brain regions and to adjust for clustering within patients. Results: The regression analysis showed a significant correlation between the SUVmean of the prefrontal cortex and cingulum and DKEFS-sequential tracking (DKEFS-TM4) z scores (P = 0.003 and P = 0.012, respectively). The SUVmean of the hippocampus did not correlate with DKEFS-TM4 z scores (P = 0.111). The SUVmean for any evaluated brain regions did not correlate significantly with WRAML-visual memory (WRAML-VIS) z scores. CBFmean showed a positive correlation with SUVmean (r = 0.56, P = 0.01). The CBFmean of the cingulum, hippocampus, and prefrontal cortex correlated significantly with DKEFS-TM4 (all P < 0.001). In addition, the hippocampal CBFmean correlated significantly with negative WRAML-VIS z scores (P = 0.003). Conclusion: High-dose methotrexate-induced brain injury can manifest as a reduction in glucose metabolism and blood flow in specific brain areas, which can be detected with [18F]FDG PET/MRI. The SUVmean and CBFmean of the prefrontal cortex and cingulum can serve as quantitative measures for detecting executive functioning problems. Hippocampal CBFmean could also be useful for monitoring memory problems.