Prospective Monocentric Study Research Articles

Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases

Abstract Objectives To assess the variations and diagnostic performance of serum biomarkers of neurodegenerative diseases. Methods In this monocentric prospective study, neurofilament light (NFL), T-tau, p-tau181, p-tau217, Aβ40, and Aβ42 were measured in serum collected from orthopedic patients (control group, n=114) and patients in the neurology department (n=69) previously diagnosed with Alzheimer’s disease (AD, n=52), parkinsonian syndromes (n=10), and other etiologies of neurodegeneration (non-AD, n=7). Results In the control group, serum NFL, T-tau, p-tau181, p-tau217, and Aβ40 significantly increased with age, independently of sex. NFL (p=0.0078), p-tau217 (p<0.001) were significantly increased with neurodegeneration when compared to controls, with only p-tau217 significant in the multivariate analysis (p<0.001). Multivariate regression analysis accounting for age highlighted a significant increase of p-tau217 (p<0.001) in the AD subgroup. NFL was significantly increased in the non-AD patients (p<0.001), and in the parkinsonian syndromes subgroup (p=0.016) when compared to negative controls. Serum p-tau181 and p-tau217 were significantly correlated with CSF p-tau181 (Spearman’s coefficients of 0.43 and 0.48 respectively, n=40). Areas under the ROC curves for the identification of patients with neurodegenerative diseases were 0.62 (0.54–0.70) for NFL, 0.62 (0.54–0.71) for T-tau, 0.83 (0.76–0.89) for p-tau217, and 0.66 (0.58–0.74) for Aβ40. Conclusions Serum biomarkers can help identify patients with neurodegenerative disease and may be a valuable tool for care and orientation. Phosphorylated tau p-tau217 is a promising blood biomarker for AD and NFL for other etiologies.

Monocentric prospective study to valid multidisciplinary diagnostic and therapeutic approach for Nutcracker syndrome.

Background: Nutcracker syndrome (NCS) is defined as left renal vein (LRV) compression by the superior mesenteric artery. NCS diagnosis is rendered complex by confounding symptoms. The study objective was to perform a prospective observational analysis of the diagnostic and therapeutic criteria of the patients with suspected NCS. When NCS diagnosis was confirmed, transposition of the LRV was carried out by mini-invasive robotic surgery (MIRS). Method: All patients addressed to the vascular surgery department for suspicion of NCS between January 2022 and June 2023 were included in the study. Patients were subsequently assessed by means of a computed tomography scan, dynamic duplex ultrasound and phlebography associated with an occlusion test of the left gonadic vein (LGV). Diagnostic criteria included aorto-mesenteric angle, LGV diameter and reflux, velocity ratios and diameters and the reno-caval gradient. Result: Thirty two patients aged 37 ± 14years had suspicion of NCS. Twenty presented an aorto-mesenteric angle below 20°, twenty three had a LGV diameter greater than 5mm and twenty two of the latter patients also had LGV reflux. A significant reno-caval gradient greater than 5mmHg was found in ten cases, thereby consolidating NCS diagnosis. Overall, thirteen patients neither presented NCS or pelvic varicosities; eight had pelvic congestion syndrome without NCS and were successfully treated by embolization. Eleven patients with confirmed NCS underwent LRV transposition in the inferior vena cava (IVC). Eight of the latter patients received a complementary pelvic varicosity embolization 2days later. Two months post-operation 100% of transposed LRV were permeable as assessed by duplex ultrasound controls and all of these patients reported an improvement of symptoms. Conclusion: An innovative multidisciplinary decisional algorithm establishes certitude in NCS diagnosis which can subsequently be treated radically by MIRS.

Functional outcomes and quality of life after AcrySof IQ Vivity intraocular lens implantation in a real-world study

The extended depth-of-focus AcrySof IQ Vivity intraocular lens technology offers promising features for presbyopia management, evaluated in this research in a 6 months real-world setting. Prospective interventional mono-centric study including 40 patients who underwent elective bilateral phacoemulsification. We performed one pre-operative visit (V0) and one evaluation six months post-operatively (V1), evaluating uncorrected and corrected visual acuity for near (UNVA/CNVA), intermediate (UIVA/CIVA) and far (UDVA/UCVA), slit-lamp evaluation, tomography with static pupillometry, endothelial cell count and contrast sensitivity chart. In order to assess post-operative Quality of Life, we administered the patients McAlinden’s Quality of Vision test and Morlock’s Patient-Reported Spectacle Independence Questionnaire. We divided eyes in with Toric-IOL and with non-Toric IOL. A total of 36 eyes received non-tonic IOL implantation, whereas 44 eyes received toric IOL implantation. There were no statistically significant disparities observed in visual outcome measures and contrast sensitivity between the toric group and the non-toric group. Furthermore, we assessed the predictive preoperative refractive astigmatism (PPRA) and residual refractive astigmatism (RRA) in both cohorts, and no statistical significance was found between the two cohorts (p = 0.08). Twenty-one (53%) patients reported total independence from their glasses at all distances. The mean difference between the predicted and measured refractive error, as calculated by spherical equivalent, was 0.09 D. AcrySof IQ Vivity is a well-tolerated and effective IOL with optimal refractive target for both distant and intermediate vision, needing slight spherical addition for the best near vision. Great questionnaire-based satisfaction was reported by the patients.

Body image and pelvic floor dysfunction in pregnancy and postpartum: A prospective one-year follow-up cohort study.

To determine the prevalence of pelvic floor dysfunction (PFD) among pregnant women, their clustering and their association with body image disturbance (BID) up to 1 year postpartum. Monocentric prospective cohort study. University Hospitals Leuven. Pregnant women attending for pregnancy care, first assessed prior to 14 weeks of gestation and agreeing to follow-up until 1 year postpartum. Standardised questionnaires reporting on PFD and BID at 12-14 and 28-32 weeks of gestation, and again at 6-8 weeks and 1 year postpartum. We calculated the prevalence of PFD, how the cases clustered and how the cases correlated with BID using a linear mixed-model analysis. A minimum of 174 women with complete follow-up were required. The questionnaires used were the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF), St. Mark's Incontinence Score (SMIS), Patient Assessment of Constipation Symptoms (PAC-SYM), Pelvic Organ Prolapse Distress Inventory (POPDI), Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA Revised (PISQ-IR) and the Body Image Disturbance Questionnaire (BIDQ). Out of 208 women, 92.8% reported one or multiple symptoms of PFD at 28-32 weeks of gestation, dropping to 73.6% by 1 year postpartum. The most common symptoms were constipation (65.3% at 28-32 weeks of gestation and 42.8% at 1 year postpartum) and urinary incontinence (56.8% at 28-32 weeks of gestation and 35.1% at 1 year postpartum). After correcting for body mass index, parity and mode of delivery, the severity of BID was associated with the ICIQ-UI SF score (β = 0.016, range 0.007-0.024), the PAC-SYM score (β = 0.006, range 0.002-0.011) and the POPDI score (β = 0.009, range 0.005-0.012), but not with the SMIS score (β = 0.015, range -0.001 to 0.031) or the PISQ-IR score, in sexually active women. Urinary incontinence, constipation and symptoms of prolapse have a measurable impact on BID.

Reliability of a 2D-Panoramic Ultrasound System for the Determination of Muscle Volume in Older Hospitalized Patients.

Reliability of muscle thickness assessed in B-mode ultrasound has been confirmed in adults but remains a less direct assessment of muscle mass than muscle volume (MV). The aim of this prospective monocentric study was to assess the interday reliability of MV determined by the 2D-panoramic ultrasound in older hospitalized patients.Ten participants hospitalized in geriatric ward (mean age = 84) underwent 2 sessions of panoramic ultrasound scanning 1 week apart for MV assessment and DXA for leg lean mass (LLM) assessment when it was possible. The interday reliability of MV assessed using the intraclass correlation coefficient (ICC) was excellent, whatever was the muscle analyzed: ICC = 0.99 for tibialis anterior; ICC = 0.99 for vastus lateralis; ICC = 1 for rectus femoris. The pilot analysis of its association with leg lean mass revealed a good association between the vastus lateralis MV and LLM, but this needs to be confirmed on a larger number of participants (Pearson correlation coefficient = 0.91, P = 0.03).The 2D-panoramic ultrasound system for the determination of MV was reliable in older hospitalized patients with measurements performed on the patient's bed. MV seemed to be more correlated to LLM than muscle thickness. Future research will need to reduce the data processing time maybe with automation of data measurement.

The feasibility of assessing perfusion of the bone using quantitative ICG fluorescence imaging

Background For successful reconstructive surgery, adequate tissue perfusion is necessary. Near infrared (NIRF) imaging, using indocyanine green (ICG) allows perfusion to be visualized of which objective perfusion parameters can be provided after additional measurements. Therefore, it has great potential in predicting adequate tissue perfusion. However, regarding bone tissue the evidence of the feasibility and usefulness of NIRF imaging using ICG is very limited. Methods A prospective monocentric pilot study was carried out at a tertiary hospital in the Netherlands. Patients undergoing autologous breast reconstruction from August 2021 to August 2022 were included. During surgery ICG (0.1 mg/kg) was injected intravenously and a fluorescent angiogram of four minutes was made directly after injection. Post hoc time-intensity curves were generated of the region of interest (ROI) of 5mm, which was positioned on the cross-sectional lateral surface of the rib. Results Nine patients and eleven ribs were included for further analyzation. Time intensity curves of the endosteal measurement was performed in ten ribs. Three of the curves show a steep and well-defined ingress and egress. In all other patients, the curves show a much more flattened ingress and egress. Periosteal measurement was performed in nine ribs. No adverse events related to ICG were observed intraoperatively. Conclusions This feasibility study suggests that quantitative NIRF imaging using ICG can provide objective parameters of endosteal rib perfusion. Larger prospective series are needed to investigate the value of NIRF imaging using ICG to assess bone perfusion intraoperatively and to establish cutoff values for adequate bone perfusion.

Chemotherapy induced alopecia in breast cancer patients: A monocentric prospective study.

Alopecia is one of the main adverse events of chemotherapy in breast cancer. However, its impact is often ignored and underestimated by clinicians. Our aim was to evaluate the quality of life of breast cancer patients with chemotherapy induced alopecia. We conducted a prospective study including 72 breast cancer patients who developed alopecia on or after stopping chemotherapy in the last 6 months. Clinical information and characteristics of alopecia were assessed using a self-prepared questionnaire. DLQI score was used to evaluate patients' quality of life. We interviewed a total of 72 women with a mean age of 53.5 ± 6 years. Alopecia appeared soon after the first course in 62.5%. All patients actively tried to hide induced hair fall (either by a hat in 6.9% or by a headscarf in 93.1%). Quality of life was impacted in 97.2% of patients with a median DLQI score of 6.5. Women who did not underwent mastectomy were significantly more bothered by hair loss than those who had radical surgery (78.1% vs 55%, p = 0.04). Working status was a significant predictor factor of a bad quality of life due to alopecia (100% in working women vs 58.3% in homemaker or retired patients, p = 0.006). Chemotherapy induced alopecia had a negative impact on quality of life of patients with breast cancer, especially in working women and those who did not have radical surgery. Prior wearing of headscarves did not impact significantly the DLQI score.

Cancer therapy-related cardiac dysfunction after radiation therapy for breast cancer: results from the BACCARAT cohort study

BackgroundRadiation therapy (RT) for breast cancer (BC) can result in subtle cardiac dysfunction that can occur early after treatment. In 2022, the European Society of Cardiology (ESC) published the first guidelines in cardio-oncology with a harmonized definition of cancer therapy-related cardiac dysfunction (CTRCD). The aim of this study was to evaluate CTRCD occurrence over 24 months of follow-up after RT in BC patients and to analyze the association with cardiac radiation exposure.MethodsThe prospective monocentric BACCARAT study included BC patients treated with RT without chemotherapy, aged 40–75 years, with conventional and 2D Speckle tracking echocardiography performed before RT, 6 and 24 months after RT. Based on ESC cardio-oncology guidelines, CTRCD and corresponding severity were defined with left ventricle ejection fraction and global longitudinal strain decrease, occurring at 6 or 24 months after RT. Dosimetry for whole heart, left ventricle (LV) and left coronary artery (left anterior descending and circumflex arteries (CX)) was considered to evaluate the association with CTRCD, based on logistic regressions (Odds Ratio – OR and 95% confidence interval – 95%CI). Youden index based on receiver operating characteristic curve analysis was used to identify the optimal threshold of dose-volume parameters for predicting CTRCD.ResultsThe study included 72 BC patients with a mean age of 58 ± 8.2 years. A total of 32 (44%) patients developed CTRCD during follow-up: 20 (28%) mild CTRCD, 7 (9%) moderate CTRCD, and 5 (7%) severe CTRCD. Cardiac radiation doses were generally higher among patients with CTRCD rather than non-CTRCD. Dose-response relationships were significant for mean CX dose (OR = 2.48, 95%CI (1.12–5.51), p = 0.02) and marginally significant for V2 of LV (OR = 1.03 95%CI (1.00-1.06), p = 0.05). V2 of LV ≥ 36% and mean CX dose ≥ 1.40 Gy thresholds were determined to be optimal for predicting CTRCD.ConclusionFor BC patients treated with RT without chemotherapy, CTRCD can be observed in an important proportion of the population over 24 months after treatment. Left ventricle and circumflex coronary artery exposure were found to be associated with CTRCD and could be used for the prediction of such cardiotoxicity. Further research remains needed to confirm these results.Trial RegistrationClinicalTrials.gov Identifier- NCT02605512.

Évaluation de la faisabilité du dispositif d’auto-administration des médicaments par le patient dans un centre hospitalier universitaire : audits de pratique et recommandations pour une mise en œuvre sûre

The French Health Authority recently published guidelines about patient self-administration of medications for voluntary hospitalized patients under medical supervision. This study aimed to assess medication management practices in our hospital and provide recommendations for self-administration medication.A prospective monocentric study was performed from January to June 2023, involving patient and nurse surveys based on the guidelines from the French Health Authority.A total of 207 patients participated in the survey, with a mean age of 59.6 years. Among them, 56% were inclined to self-manage treatments initiated during hospitalization. Among patients with regular treatments, 62% were inclined to self-manage them in the hospital. In weekday hospitalization units, 92% of patients were inclined to self-manage their regular treatments, and 75% of those initiated during hospitalization. Among the 26 surveyed nurses, 71% reported patient autonomy for taking drugs in narrative transmissions, and 88% verified medication intake through self-administration, while 96% digitally traced it.The concept of self-administration of medication appears promising, especially within weekday hospitalization units, particularly for patients with a good understanding of their treatment. Nurses currently assess patient autonomy without specific monitoring tools. Collaborative efforts among healthcare professionals, with pharmacists playing a central role, are essential for the success of this innovative approach.

Percutaneous Deep Venous Arterialization Using an IVUS-Guided Technique in no-Option Patients with Chronic Limb-Threatening Ischemia: 24-Month Results.

In some patients, revascularization is not possible or is not effective. For these, percutaneous deep vein arterialization (p-DVA) could be considered an alternative treatment. The aim of this study is to evaluate the long-term results of an intravascular ultrasound (IVUS)-guided technique that has only one percutaneous access. This is a prospective monocentric study on 18 no-option CLTI limbs treated with an IVUS-guided p-DVA. The primary outcome measures are: the freedom from major adverse events (MAEs) and survival at 30 days; limb salvage and amputation free survival (AFS) at 30 days, 6 months, 12months and 24 months. The secondary outcome measures are: procedural success, survival, patency and wound healing. We treated 14 patients with no-option CLTI, carrying out 18 p-DVA. Median age was 74,4years (60-87). All these patients had a previous failed angioplasty of the tibial and foot arteries. Procedural success rate, defined as the establishment of arterial flow into the venous system of the foot, was 100%. No deaths and MAEs recorded at 30 days. Survival was 100%, 83.4% and 77.8%; limb salvage was 88.9%, 77.8% and 77.8%; AFS was 88.9%, 61.1% and 55.6% at 6, 12 and 24 months. Complete wound healing was 18.7% at 6 months, 80.0% at 12 months and 100% at 24 months. Based on these results, the IVUS-guided p-DVA seems to be safe and effective for no-option CLTI patients, with no mortality related to the intervention, an acceptable limb salvage rate and amputation free survival.

Increased risk of respiratory events during endobronchial ultrasound examination in patients with reduced forced expiratory volume: a prospective observational study.

The incidence of adverse events during endobronchial ultrasound is low. Nevertheless, it is unclear, whether patients with impaired pulmonary function have an increased risk of respiratory events during the intervention. A monocentric prospective observational study was performed at the Department of Respiratory Medicine, University Hospital Frankfurt/Main, Germany. Adult patients undergoing an endobronchial ultrasound examination with propofol-sedation were included. Pre-interventional screening included pulmonary function testing, laboratory tests and electrocardiogram. The occurrence of hypercapnia >55 mmHg or reduced oxygen saturation <85% was defined as a respiratory event was recorded and compared between patients with normal and impaired pulmonary function tests. In total, 126 patients were included. Pulmonary function testing revealed a median FEV1 of 2.2 l (range 0.4-6.04l) and a predicted FEV1 of 79.5% (range 20-127.8%) respectively. The median FVC was 3.0 l (range 0.87-7.28l), the median predicted FVC was 82% (range 31.4-128.4%). In 72 examinations (60%) pCO2 levels >55 mmHg were measured. Transient oxygen desaturation <85% occurred in 31 cases (25.8%). The Mann Whitney U-test showed a significantly lower FEV1 (% predicted value) in patients with respiratory events (p = 0.007). ROC analysis identified a predicted FEV1 of 78.5% as the optimal cut-off with a sensitivity of 58% and a specificity of 71%. Using Z-score instead of predicted values, there was no significant association between a lower Z- score of FEV or FVC and hypercapnic or hypoxic events. However, both a lower absolute value of FEV1/FVC and a lower Z-score of the FEV1/FVC index were associated with the occurrence of respiratory events. In binary logistic regression analysis, we could not demonstrate any association with other relevant parameters (age, BMI, sedation dosage, sedation duration, or ASA-score). An impaired forced expiratory volume is associated with the frequency of respiratory events during endobronchial ultrasound examination under propofol-sedation.

Nasal High-Flow Oxygen Therapy in Chronic Respiratory Failure for Homecare Applications-A Feasibility Study.

Background: While high-flow nasal cannulas (HFNCs) represent the standard of care in the intensive care unit for patients with severe hypoxemia, its use in homecare settings is uncommon despite its potential. The potential benefits and challenges of the high-flow nasal cannula (HFNC) in homecare settings compared to standard long-term oxygen via nasal low-flow therapy are unclear. Methods: We conducted a prospective monocentric feasibility study at the Department of Respiratory Medicine, University Hospital, Goethe University Frankfurt, Germany. Patients with interstitial lung disease or severe bronchiectasis (including cystic fibrosis) were enrolled into the study. The HFNC was introduced during hospitalization. The patients' compliance with home use advice and arterial blood gas results were evaluated at a 4-6-week follow-up. Results: A total of 12 patients were analyzed. HFNC initiation did not result in a significant improvement of the pO2/fiO2 (p/f) ratio. Only 8 out of 12 (66.6%) patients used the HFNC at home after the initial in-hospital initiation. Only 7 of the total 12 patients were using the therapy at a follow-up 3-6 weeks after HFNC onset. Two patients died during the observation, resulting in a surveillance mortality rate of 16.7%. Conclusions: The feasibility data showed low adherence to the HFNC at home. The lack of any positive effect on the p/f ratio may be due to low airflow rates and overall mild hypoxemia compared to patients with severe respiratory failure in the ICU.

Cranial nerve injuries post carotid endarterectomy: a 15-year prospective study with routine otolaryngologist and neurological evaluation

ObjectiveThe aim of this prospective monocentric cohort study was to analyze the risk of otolaryngologist-assessed cranial nerve injuries (CNIs) following carotid endarterectomy (CEA) in our academic center during a 15-year period, and to identify possible risk factors for CNI development. MethodsFrom January 2007 to December 2022, 3749 consecutive CEAs were performed and their data prospectively recorded in a dedicated database. CNIs were assessed and defined according to a standardized protocol. Instrumental ear, nose, and throat (ENT) evaluations were conducted within 30 days before intervention and before discharge. Preoperative neurological assessments were carried out in all patients with symptomatic carotid stenosis, whereas postoperative neurological evaluations were performed in all patients. Patients with newly onset CNIs underwent follow-up assessments at 30 days and, if necessary, at 6, 12, and 24 months. Perioperative results, including mortality, major central neurological events, and postoperative CNIs, were analyzed. Regression or persistence of lesions during follow-up visits was assessed, and multivariate analysis (binary logistic regression) was conducted to evaluate clinical, anatomical, and surgical technique factors influencing the occurrence of CNIs. ResultsCEAs were performed more frequently in male patients (2453 interventions; 65.5%) than in females (1296 interventions; 34.5%). The interventions were performed in asymptomatic patients in 3078 cases (82%). In 66 cases, the interventions followed a previous ipsilateral CEA. At preoperative ENT evaluation, no cases of ipsilateral pre-existent CNI were recorded. The 30-day stroke and death rate was 1%. In 113 patients (3%), a postoperative neck bleeding requiring surgical revision and drainage was noted. Pre-discharge ENT evaluations identified 259 motor CNIs, accounting for 6.9% of the entire study group. Eighteen patients had lesions in more than one cranial nerve. ENT and neurological evaluations at 30 days showed the complete resolution of 161 lesions, whereas in 98 cases (2.6%), the CNI persisted. At 1 year, the rate of persistent CNI was 0.4% (10 patients), whereas at 2 years, it was 0.25% (6 cases), in all but one asymptomatic. At multivariate analysis, urgent intervention in unstable patients, secondary intervention, a clamping time >40 minutes, a hematoma requiring revision, and a postoperative stroke were independent predictors of CNIs. ConclusionsData from this prospective monocentric cohort study showed that the occurrence of CNI following CEA was low, even when an independent multi-specialist evaluation was performed. The percentage of persistent lesions at 2 years was negligible and, in most cases, asymptomatic.

High Rates of Nosocomial Infections and Antimicrobial Resistance in a Moroccan PICU: A Cause for Alarm

IntroductionThis study aimed to determine the epidemiology of nosocomial infections (NI), in a pediatric intensive care unit (PICU) and to define the risk factors associated with NI. MethodsWe performed a prospective descriptive and analytical monocentric study on the incidence of NI in PICU, between July 2021 and May 2022. Children with NI (cases) were compared with a matched controls without NI. Results: We analyzed 396 patients; 102 had NI. The global incidence of nosocomial infection is 44.7 % (incidence density of 10.6 per 1000 days of hospitalization). The incidence densities of Blood Stream infection, Pneumonia associated with mechanical ventilation, and urinary tract infection were 10/ 1000 days of CVC, 7,2/ 1000 of mechanical ventilation, and 11,1/ 1000 days urinary catheter. The overall microbiological profile of nosocomial infections is dominated by Gram negative bacilli in 78 % followed by Gram positive Cocci in 13 %. The most common agents in sepsis were Klebsiella pneumoniae. In pneumonias Acinetobacter Baumanii was the most common cause, and in UTI the most frequent agents were BGN especially Escherichia Coli (33.3%). The presence of NI was associated with a long period of hospitalization, use of invasive devices (central venous catheter, mechanical ventilation, bladder catheters), and use of antibiotics. ConclusionsThe incidence of NI acquired in this unit was high and was associated with extrinsic and intrinsic factors.

An Automated Real-Time PCR Assay versus Next-Generation Sequencing in the Detection of BRAF V600 Mutations in Melanoma Tissue Samples.

Next-generation sequencing (NGS) is the most commonly used method for determining BRAF mutational status in patients with advanced melanoma. Automated PCR-based methods, such as the IdyllaTM system, are increasingly used for mutation diagnostics, but it is unclear what impact the choice of diagnostic method has on the management of melanoma. To compare the concordance rate of BRAF V600 mutational analysis using IdyllaTM and NGS and to analyze the technical and clinical turnaround time. The clinical relevance is compared by analyzing the impact on the treatment decision. In this monocentric prospective cohort study, the BRAF mutation status of 51 patients was determined using both methods in parallel. BRAF V600 mutation was detected in 23/51 cases (45%). IdyllaTM showed a 100% concordant result with a faster turnaround time (0.2 days) compared to NGS (12.2 days). In general, less tumor material was required for IdyllaTM than for NGS. Most patients received immunotherapy as a first-line therapy regardless of the BRAF V600 status. IdyllaTM testing proved to be a reliable and rapid alternative to NGS in the determination of BRAF V600 mutation. Although BRAF. status was available earlier, this had no influence on the treatment decision in most cases.

Elevated uric acid is associated with a low bone mineral density in pre- but not post-menopausal women with rheumatoid arthritis: a pilot study.

The role of uric acid (UA) on bone metabolism is controversially discussed. Higher UA levels have been associated with higher T-scores and a reduced incidence of fractures in postmenopausal women. However, in the context of rheumatoid arthritis (RA), the role of UA remains unclear. This pilot study aimed to investigate the association of UA levels with bone mineral density in RA female and male patients. This pilot study analyzed patients with RA to explore preliminary associations. We utilized data from the Rh-GIOP cohort, a prospective monocentric observational study focusing on bone health in chronic rheumatic diseases. To assess the association between UA levels and the lowest T-scores measured at the lumbar spine, hip, or femur, we used linear regression with adjustment for various confounders. An interaction term was included to evaluate differential associations in pre- and postmenopausal women. Data on dual X-ray absorptiometry (DXA) measurements and serum UA levels were analyzed in a total of 206 patients. Among the 167 women 16 were premenopausal (age 40 ± 8 years) and 149 postmenopausal (age 65 ± 10 years). As expected, postmenopausal had lower T-scores than premenopausal patients (-1.53 ± 1.01 versus - 0.41 ± 1.29, respectively). No association of UA levels with T-scores was found when analyzing the whole cohort (Slope β: -0.04; p = 0.45). However, a significant negative correlation of UA with T-scores in premenopausal (Slope β: -0.98; p = 0.014), but not postmenopausal (Slope β: -0.04; p > 0.05) women was found. Uric acid appears to be negatively associated with bone mineral density in premenopausal but not in postmenopausal women with RA. Thus, the impact of UA on bone health seems to depend on the hormonal status of women. Further investigations are required to validate these results in a larger cohort of patients and to investigate the underlying mechanisms.

A comparison of target volumes drawn on arterial and venous phase scans during radiation therapy planning for patients with pancreatic cancer: the PANCRINJ study

BackgroundThe planification of radiation therapy (RT) for pancreatic cancer (PC) requires a dosimetric computed tomography (CT) scan to define the gross tumor volume (GTV). The main objective of this study was to compare the inter-observer variability in RT planning between the arterial and the venous phases following intravenous contrast.MethodsPANCRINJ was a prospective monocentric study that included twenty patients with non-metastatic PC. Patients underwent a pre-therapeutic CT scan at the arterial and venous phases. The delineation of the GTV was performed by one radiologist (gold standard) and two senior radiation oncologists (operators). The primary objective was to compare the Jaccard conformity index (JCI) for the GTVs computed between the GS (gold standard) and the operators between the arterial and the venous phases with a Wilcoxon signed rank test for paired samples. The secondary endpoints were the geographical miss index (GMI), the kappa index, the intra-operator variability, and the dose-volume histograms between the arterial and venous phases.ResultsThe median JCI for the arterial and venous phases were 0.50 (range, 0.17–0.64) and 0.41 (range, 0.23–0.61) (p = 0.10) respectively. The median GS-GTV was statistically significantly smaller compared to the operators at the arterial (p < 0.0001) and venous phases (p < 0.001), respectively. The GMI were low with few tumors missed for all patients with a median GMI of 0.07 (range, 0-0.79) and 0.05 (range, 0-0.39) at the arterial and venous phases, respectively (p = 0.15). There was a moderate agreement between the radiation oncologists with a median kappa index of 0.52 (range 0.38–0.57) on the arterial phase, and 0.52 (range 0.36–0.57) on the venous phase (p = 0.08). The intra-observer variability for GTV delineation was lower at the venous phase than at the arterial phase for the two operators. There was no significant difference between the arterial and the venous phases regarding the dose-volume histogram for the operators.ConclusionsOur results showed inter- and intra-observer variability in delineating GTV for PC without significant differences between the arterial and the venous phases. The use of both phases should be encouraged. Our findings suggest the need to provide training for radiation oncologists in pancreatic imaging and to collaborate within a multidisciplinary team.

“Mid-P strategy” versus “internal target volume strategy in locally advanced non small cell lung cancer: Clinical results from the randomized non-comparative phase II study Mid-P

BackgroundLocally advanced non-small cell lung cancer (LA-NSCLC) reported poor 5-year survival rates with frequent local or regional recurrences. Personalized RT may contribute to improve control and clinical outcome. We investigated efficacy and tolerance of “Mid-position” (Mid-P) strategy versus the conventional Internal Target Volume (ITV) strategy in LA-NSCLC patients treated by definitive conformal radiotherapy. MethodsThis prospective non-comparative randomized monocentric phase II trial included adult patients with non-resected, non-metastatic, non-previously irradiated proven LA-NSCLC treated with definitive normo-fractionated conformal radiotherapy (+/- chemotherapy). Allocated patients (randomisation 2:1) were treated using Mid-P or ITV strategy. A Fleming single-stage design (1-sided α = 0.1, 80 % power, P0 = 30 %, P1 = 50 %) planned enrolment of 36 patients in the Mid-P group. The ITV group ensured the absence of selection bias. The primary outcome was 1-year progression-free- survival (1y-PFS) rate. ResultsAmong 54 eligible patients included from September 2012 to May 2018, 51 patients were analyzed (Mid-P: N = 34; ITV: 17). The 1y-PFS was 38 % (1-sided 95 %CI 25 %-not reached) with Mid-P strategy, and 47 % (95 %CI [27 %-not reached[) with ITV. Loco-regional failure as first event mainly occurred within radiation-field regardless the strategy. Acute and middle-term radiation toxicities were observed with both strategies. ConclusionLocal control and survival remain poor using the Mid-P strategy in this prospective randomized non-comparative monocentric study investigating Mid-P strategy versus ITV strategy in LA-NSCLC. Since the Mid-P strategy is not integrated into routine software, and perceived as a time-consuming method, Mid-P strategy cannot be recommended in LA-NSCLCC treated by definitive normo-fractionated conformal radiotherapy outside clinical trials.

Évaluation du dispositif Medpack® en médecine d’urgence préhospitalière

Introduction: The MEDPACK® workstation, which won the Lépine competition in 2018, was created with the aim of improving nursing practices in terms of hygiene and ergonomics in pre-hospital emergency care. With an adapted nomenclature, it aims to provide the majority of care by itself, thus lightening the intervention bag.Method: We carried out a monocentric observational prospective study from 23/06/2018 to 01/03/2019 in the 6 resuscitation ambulances of the Paris Fire Brigade. A self-administered data collection notebook was filled in by the nurses after each intervention. It included an assessment of the hygiene and ergonomics of care with MEDPACK®, as well as a list of the medical devices and medicines used in the intervention bag, in addition to those used in MEDPACK®.Results: Seventy-two percent of the nurses felt that their care was more in line with good hygiene practices, with 76% perceiving an ergonomic gain when using MEDPACK®. The MEDPACK® was used in 69% of Vascular Access Placement (VAPP) procedures, while the intervention bag was useless in 75% of procedures. When the bag was used, it was used in 34% of cases for intubation equipment and in 15% of cases for onboard biology equipment. Forty-eight percent of the materials in the intervention bag were used in less than 1% of the interventions.Discussion: The MEDPACK® enables pre-hospital emergency paramedical care to be carried out in a way that is more in line with hygiene requirements, with ergonomics more suited to this context. An adjusted nomenclature of MEDPACK® makes it possible to carry out a large proportion of interventions and to rethink the materials making up the intervention bag. A period of adaptation to its use is necessary to modify nursing practices in order to allow its acceptance and appropriation. Moreover, its nomenclature is modular, which is why it could be adapted to fields other than pre-hospital emergency care, such as private practice or disaster medicine.:The MEDPACK® enables pre-hospital emergency paramedical care to be carried out in a way that is more in line with hygiene requirements, with ergonomics more suited to this context. An adjusted nomenclature of MEDPACK® makes it possible to carry out a large proportion of interventions and to rethink the materials making up the intervention bag. A period of adaptation to its use is necessary to modify nursing practices in order to allow its acceptance and appropriation. Moreover, its nomenclature is modular, which is why it could be adapted to fields other than pre-hospital emergency care, such as private practice or disaster medicine.

Insights into Digital MedicRehApp Maintenance Model for Pulmonary Telerehabilitation: Observational Study.

Maintenance strategies after center-based pulmonary rehabilitation (CBPR) are currently needed. This study aimed to evaluate the feasibility and effect on the quality of life of a home-based pulmonary rehabilitation (HBPR) program delivered by a digital app. As secondary objectives, the patients' adherence, symptoms, effort tolerance changes, and safety were evaluated. This was a single-arm prospective observational monocentric study on 30 patients referred for chronic respiratory diseases. The prescription and evaluations of the HBPR programs performed at the pulmonary facility and delivery of structured exercise and counselling by the digital health tool were achieved under the supervision of a respiratory therapist. Digital capabilities included aerobic, strength, and respiratory exercises, which were monitored with a fitness tracker. The engagement rate of the HBPR after the CBPR was 1:10. The EuroQoL VAS score increased from 66.2 ± 16.28 to 75.60 ± 16.07 (p < 0.001), mainly in younger subjects. No patient was lost during the HBPR program. The global adherence session rate was 94%. The Medical Research Council dyspnea scale (MRC), COPD Assessment Test (CAT) score, and six-minute walking test (6MWT) improved from admission into the pulmonary unit to the end of the HBPR program. Between the beginning and end of the CBPR, the CAT score decreased from 14.4 ± 6.39 to 8.50 ± 5.39 (p < 0.001), the MRC decreased from 1.87 ± 0.9 to 1.17 ± 0.83 (p < 0.001), and the 6MWT increased from 451 ± 93 to 473 ± 115 m (p < 0.05). The average Technology Acceptance Model score for usability was high (145 ± 12.1) and no adverse events occurred during the HBPR program. This HBPR model seemed to be feasible and well-accepted by patients, leading to improvements in quality of life, symptoms, and functional capacity.