Active production of music as distraction for venipuncture in children and adolescents: a randomized clinical trial.

More than 50% of children report considerable pain during venipuncture or intravenous cannulation. Despite the tools and techniques may be employed to reduce pain and distress in everyday clinical practice, the care offered is frequently insufficient. Music's potential effect in healthcare settings has received increasing attention. This study aimed to verify if the active production of music with a Leap Motion Controller could help decreasing pain and distress during venipuncture in children and adolescents. We conducted an open-label randomized controlled clinical trial with parallel arms. Children aged 8 to 17 were enrolled at the blood-drawing center of the Institute for Maternal and Child Health IRCCS Burlo Garofolo of Trieste, Italy. We hypothesized that in order to demonstrate an adequate improvement in the pain score in the intervention group, at least 200 children, 100 in each group, were needed, with alpha 5% and 1-beta 80%. Differences between the groups were evaluated with the nonparametric Mann-Whitney U-test. The subjects were randomly assigned either to the active production of music group or to the standard of care group. The primary outcome was the median self-reported procedural pain score between experimental and standard of care group. Secondary outcomes were: the median pain and distress scores according to parental judgment and operators' judgment between the experimental and control group. Three hundred subjects entered the study and were randomized, 150 in the active production of music group and 150 in the standard of care group. Median self-reported pain scores were 1 (0-2) in the active production of music group and 2 (1-2) in the standard of care group and this difference was statistically significant (p = 0.0016). Median procedural distress was 1 (0-3) in the active production of music group and 3 (1-6) in the standard of care group, according to parental judgment, and this difference was statistically significant (p = 0.0000016). CONCLUSION: This research showed that the active production of music is a valuable distraction technique to decrease venipuncture related pain and distress in children and adolescents. TRIAL REGISTRATION: The study protocol was registered with ClinicalTrial.gov (June 28[th] 2022, NCT05441241) before the start of the subjects' enrolment. WHAT IS KNOWN: • The benefits of music on pain and anxiety are well known and have been tested during different painful procedures. • The effect of active production of music has never been tested in children during venipuncture. WHAT IS NEW: • In our study median self-reported pain scores and median procedural distress, according to parental judgment, were lower in the active production of music group than in the standard of care group and these differences were statistically significant.

Histopathology of oral lichen planus and oral lichenoid lesions: An exploratory cross-sectional study.

OBJECTIVE: To better characterize the histopathology of oral lichen planus and oral lichenoid lesions and to highlight the differences between them in order to support the clinician in the diagnostic and therapeutic management of such conditions. SUBJECTS AND METHODS: Fifty-five patients, clinically diagnosed with oral lichen planus (n = 25) or oral lichenoid lesions (n = 30), were consecutively enrolled in the present study. Subsequently, one blind pathologist reviewed all the biopsy specimens of enrolled subjects following a specific protocol to provide a detailed histopathological description. Demographic, anamnestic, and clinical data were also recorded from all the participants. Patients' data were analysed and compared using the chi-squared test, to provide distinguishing features between the studied conditions. RESULTS: We found a higher and statistically significant number of eosinophils in the oral lichenoid lesions compared with the oral lichen planus group (p < 0.01), an equally promising result was seen regarding plasma cells, which were more represented (p = 0.05) in the oral lichenoid lesions than in the oral lichen planus cases. No statistically significant differences were detected in demographic, anamnestic and clinical data. CONCLUSION: A mixed lichenoid inflammatory infiltrate, consisting of eosinophils and plasma cells, could be used as reliable histological features for the diagnosis of oral lichenoid lesions, as long as compared with findings obtained from the patients' history and clinical examination.

Bone quality in relation to skeletal maturation in palatal miniscrews insertion sites.

INTRODUCTION: This study aimed to investigate the relationship between bone density and quantity at the insertion sites of palatal miniscrews and skeletal maturation-evaluated with the middle phalanx maturation method-in growing patients. METHODS: Sixty patients were analyzed as having a staged third finger middle phalanx radiograph and a cone-beam computed tomography of the maxilla. On the cone-beam computed tomography, a grid was designed to parallel the midpalatal suture (MPS) and posterior to the nasopalatine foramen, both on the palatal and lower nasal cortical bones. Bone density and thickness were measured at the intersections, and medullary bone density was also calculated. RESULTS: Of patients in MPS stages 1-3, 67.6% showed a mean palatal cortical thickness of <1 mm, whereas in 78.3% of the patients in stages 4 and 5, it was >1 mm. The nasal cortical thickness showed a similar trend (MPS stages 1-3: 62.16% <1 mm; MPS stages 4 and 5: 65.2% >1 mm). There was a significant difference in the density of the palatal cortical bone between MPS stages 1-3 (1272.05 ± 191.13) and stages 4 and 5 (1572.33 ± 274.89) and in nasal cortical density between MPS stages 1-3 (1428.09 ± 198.97) and stages 4 and 5 (1597.97 ± 267.75) (P <0.001). CONCLUSIONS: This study revealed a correlation between skeletal maturity and maxillary bone quality. MPS stages 1-3 have lower palatal cortical bone density and thickness but high nasal cortical bone density values. MPS stage 4 and, even more, stage 5 show increasing palatal cortical bone thickness and palatal and nasal cortical bone density values.

Pediatric males receiving hematopoietic stem cell transplant lose their male disadvantage in disease risk after the procedure: A retrospective observational study.

Sex differences play a relevant role in cancer susceptibility, incidence and survival. Exploring such differences is difficult because of the close interplay of genetic, epigenetic and hormonal factors. However, a better understanding of the role of such disparities in cancer mechanisms could improve its prevention and therapy. Our study explores how sex differences in pediatric outcomes vary after undergoing first and advanced-line therapy for hematological malignancies. The primary goal was to evaluate if sex differences in pediatric outcomes after first-line therapy persist after allogeneic hematopoietic stem cell transplantation (HSCT). The secondary goal was to analyze sex differences in disease risk at onset and pediatric outcomes after first-line therapy to compare our results with the literature's reported results. Among a total of 485 patients (280 males, 205 females) admitted for hematological malignancies, disease risk at the onset was significantly higher in males (P < .05). One hundred and seventy-four patients (111 males and 63 females) had a high-risk disease requiring HSCT. Before HSCT, all patients underwent myeloablative conditioning, which substantially impaired gonadal function. Although the number of boys undergoing HSCT was almost double that of girls, there were no sex-related differences in overall survival, cancer relapse and complications after HSCT exposure (P > .05). These findings suggest that the existing sex differences in cancer risk ab initio can be somehow flattened by a conditioning regimen, shedding new light on the role of hormonal factors in cancer mechanism and management.

Long-term resveratrol treatment improves the capillarization in the skeletal muscles of ageing C57BL/6J mice.

We recently showed that the treatment with Resveratrol (RES) contrasts the effects of ageing on the skeletal muscle (SKM), reduces the appearance of tubular aggregates (TAs), and improves the fatigue resistance. Since fatigue resistance depends on the SKM capillary network, and RES has been described to improve vascularisation, we analysed the SKM capillarization in naturally ageing C57BL/6J male mice, fed with 0.04% RES in the diet for 6 months, which showed a better fatigue resistance in a previous work. Our data show an inverse correlation between the number of capillaries per fibre (CAF) and TAs in both control and treated type IIB fibres, and an increase of CAF in ageing SKM upon RES-treatment. The present work suggests that capillarization is one of the determinants of the development of TAs and fatigue resistance, and that RES can be considered a good candidate to counteract capillary rarefaction in the SKM tissue.

Use of low field nuclear magnetic resonance to monitor lung inflammation and the amount of pathological components in the sputum of cystic fibrosis patients.

PURPOSE: To develop a novel approach to monitor lung ventilation/inflammation in cystic fibrosis (CF) patients. Lung assessment in CF patients is relevant given that most patients succumb to respiratory failure. Respiratory functional tests (forced expiratory volume in the first second; FEV1 ) and inflammatory markers are used to test pulmonary ventilation/inflammation, respectively. However, FEV1 is effort dependent and might be uncomfortable for CF patients. Furthermore, inflammatory marker detection is costly and not rapid. To overcome these limitations, we propose the measurement, by means of low field nuclear magnetic resonance, of the spin-spin relaxation time (T2m ) of water hydrogens present in CF patient sputum. In CF sputum, different biological components are pathologically increased and inversely related to lung functionality. Moreover, we showed that these components alter in a dose-dependent manner the T2m in synthetic CF sputum. METHODS: Sputum samples were obtained from 42 CF subjects by voluntary expectoration; FEV1 , C-reactive protein (CRP), blood neutrophil counts together with cytokine (tumor necrosis factor alpha [TNFα], interleukin [IL]-1ß, IL-4, and vascular endothelial growth factor) quantifications were then evaluated. RESULTS: In sputum samples, we observe that T2m directly correlates (rFEV1 = 0.44; P < 10-4 ; 169 samples) with FEV1 . Moreover, T2m inversely correlates with the circulating inflammation markers CRP/neutrophil number (rCRP = -0.44, P < 10-4 ; rNC = -0.37, P < 2 * 10-4 ; 103 and 86 samples, respectively) and with the sputum inflammatory cytokines TNFα/IL-ß1 (rTNFα = -0.72, P < 10-4 ; rIL-1ß = -0.685, P < 10-4 ; 27 samples). T2m variations also correspond to FEV1 values over time in defined patients. CONCLUSION: These findings, together with the fast, reliable, and simple determination of T2m , make our approach a novel tool potentially usable in the real world of CF patients.

Age Dependent Modification of the Metabolic Profile of the Tibialis Anterior Muscle Fibers in C57BL/6J Mice.

Skeletal muscle aging is accompanied by mass reduction and functional decline, as a result of multiple factors, such as protein expression, morphology of organelles, metabolic equilibria, and neural communication. Skeletal muscles are formed by multiple fibers that express different Myosin Heavy Chains (MyHCs) and have different metabolic properties and different blood supply, with the purpose to adapt their contraction to the functional need. The fine interplay between the different fibers composing a muscle and its architectural organization determine its functional properties. Immunohistochemical and histochemical analyses of the skeletal muscle tissue, besides evidencing morphological characteristics, allow for the precise determination of protein expression and metabolic properties, providing essential information at the single-fiber level. Aiming to gain further knowledge on the influence of aging on skeletal muscles, we investigated the expression of the MyHCs, the Succinate Dehydrogenase (SDH) activity, and the presence of capillaries and Tubular Aggregates (TAs) in the tibialis anterior muscles of physiologically aging C57BL/6J mice aged 8 (adult), 18 (middle aged), and 24 months (old). We observed an increase of type-IIB fast-contracting fibers, an increase of the oxidative capacity of type-IIX and -IIA fibers, a general decrease of the capillarization, and the onset of TAs in type-IIB fibers. These data suggest that aging entails a selective modification of the muscle fiber profiles.

Primary Stability of Short Implants Inserted Using Piezoelectric or Drilling Systems: An In Vitro Comparison.

The primary objective of the present in vitro study was to evaluate the influence of implant site preparation technique (drills vs ultrasonic instrumentation) on the primary stability of short dental implants with two different designs inserted in simulated low-quality cancellous bone. Eighty implant sites were prepared in custom-made solid rigid polyurethane blocks with two different low cancellous bone densities (5 or 15 pounds per cubic foot [PCF]), equally distributed between piezoelectric (Surgysonic Moto, Esacrom, Italy) and conventional drilling techniques. Two short implant systems (Prama and Syra, Sweden & Martina) were tested by inserting 40 fixtures of each system (both 6.0 mm length and 5.0 mm diameter), divided in the four subgroups (drills/5 PCF density; drills/15 PCF density; piezo/5 PCF density; piezo/15 PCF density). Insertion torque (Ncm), implant stability quotient values, removal torque (Ncm), and surgical time were recorded. Data were analyzed by 3-way ANOVA and Scheffé's test (α = 0.05). With slight variations among the considered dependent variables, overall high primary implant stability was observed across all subgroups. Piezoelectric instrumentation allowed for comparable or slightly superior primary stability in comparison with the drilling procedures in both implant systems. The Prama implants group showed the highest mean reverse torque and Syra implants the highest implant stability quotient values. Piezoelectric implant site preparation took prolonged operative time compared to conventional preparation with drills; among the drilling procedures, Syra system required fewer surgical steps and shorter operative time.

Primary stability of short implants inserted using piezoelectric or drilling systems: an in vitro comparison.

The primary objective of the present in vitro study was to evaluate the influence of implant site preparation technique (drills vs. ultrasonic instrumentation) on the primary stability of short dental implants with two different designs inserted in simulated low quality cancellous bone. Eighty implant sites were prepared in custom-made solid rigid polyurethane blocks with two different low cancellous bone densities (5 or 15 pounds per cubic foot, PCF), equally distributed between piezoelectric (Surgysonic Moto, Esacrom, Italy) and conventional drilling techniques. Two short implant systems (Prama and Syra, Sweden & Martina) were tested by inserting 40 fixtures of each system (both 6.0 mm length and 5.0 mm diameter), divided in the four subgroups (drills/5 PCF density; drills/15 PCF density; piezo/5 PCF density; piezo/15 PCF density). Insertion torque (Ncm), implant stability quotient values, removal torque (Ncm) and surgical time were recorded. Data were analyzed by three-way ANOVA and Scheffé's test (α=0.05). With slight variations among the considered dependent variables, overall high primary implant stability was observed across all subgroups. Piezoelectric instrumentation allowed for comparable or slightly superior primary stability in comparison with the drilling procedures in both implant systems. Prama implants group showed the highest mean reverse torque, Syra implants the highest implant stability quotient values. Piezoelectric implant site preparation took prolonged operative time compared to conventional preparation with drills; among the drilling procedures, Syra system requires fewer surgical steps and shorter operative time.

Early Recovery of Aphasia through Thrombolysis: The Significance of Spontaneous Speech.

BACKGROUND: Aphasia is one of the most devastating stroke-related consequences for social interaction and daily activities. Aphasia recovery in acute stroke depends on the degree of reperfusion after thrombolysis or thrombectomy. As aphasia assessment tests are often time-consuming for patients with acute stroke, physicians have been developing rapid and simple tests. The aim of our study is to evaluate the improvement of language functions in the earliest stage in patients treated with thrombolysis and in nontreated patients using our rapid screening test. MATERIALS AND METHODS: Our study is a single-center prospective observational study conducted at the Stroke Unit of the University Medical Hospital of Trieste (January-December 2016). Patients treated with thrombolysis and nontreated patients underwent 3 aphasia assessments through our rapid screening test (at baseline, 24 hours, and 72 hours). The screening test assesses spontaneous speech, oral comprehension of words, reading aloud and comprehension of written words, oral comprehension of sentences, naming, repetition of words and a sentence, and writing words. RESULTS: The study included 40 patients: 18 patients treated with thrombolysis and 22 nontreated patients. Both groups improved over time. Among all language parameters, spontaneous speech was statistically significant between 24 and 72 hours (P value = .012), and between baseline and 72 hours (P value = .017). CONCLUSIONS: Our study demonstrates that patients treated with thrombolysis experience greater improvement in language than the nontreated patients. The difference between the 2 groups is increasingly evident over time. Moreover, spontaneous speech is the parameter marked by the greatest improvement.

Correlation between antibiotic consumption and resistance of bloodstream bacteria in a University Hospital in North Eastern Italy, 2008-2014.

PURPOSE: The spread of multidrug-resistant bacteria is a worrisome problem worldwide. This study investigated the correlation between antibiotic consumption and antimicrobial resistance trends of the most important bacteria causing bacteremia at the University hospital of Trieste, Italy, from 2008 to 2014. METHODS: Antibiotic consumption (Defined Daily Dose-DDD-per 100 patient/days) and antibiotic resistance (percentage of antibiotic intermediate o resistant isolates) were analyzed independently with linear correlation by year. Potential correlations between antibiotic consumption and bacteria resistance rates were investigated through the Pearson's correlation. RESULTS: The overall consumption of antibiotic grew from 80 to 97 DDD 100 patient/days (p = 0.005) during the study period. The increased consumption of amoxicillin/clavulanate and piperacillin/tazobactam was associated with the reduction of MRSA rate from 48.5 to 25.9% (p = 0.007 and p = 0.04, respectively). The increased consumption of piperacillin/tazobactam was associated with the reduction of ESBL-positive Enterobacteriaceae rate from 28.9 to 20.9% (p = 0.01). The increased consumption of carbapenems was associated with the increased rate of carbapenem-resistant Acinetobacter baumannii from 0 to 96.4% (p = 0.03). No carbapenem-resistant Enterobacteriaceae isolates were reported. The consumption of vancomycin grew significantly (p = 0.005). A dramatic spread of vancomycin-resistant Enterococcus faecium occurred in 2014. The consumption of fluoroquinolones and extended-spectrum cephalosporins remained stable. CONCLUSIONS: An antibiotic stewardship program targeted to limit the consumption of extended-spectrum cephalosporins and fluoroquinolones in favor of amoxicillin/clavulanate and piperacillin/tazobactam correlates with a decreasing rate of MRSA and ESBL-positive Enterobacteriaceae. The analysis of correlations between antibiotic consumption and bacterial resistance rates is a useful tool to orient antimicrobial stewardship policies at local level.

NBI utility in the pre-operative and intra-operative assessment of oral cavity and oropharyngeal carcinoma.

PURPOSE: Despite advances in the surgical management of head and neck squamous cell carcinoma, the identification of synchronous lesions, precancerous lesions around the main tumor, or the unknown primary in the case of neck metastasis remains a problem, as these lesions may be invisible to the naked eye or with standard white light (WL) endoscopy. However, the advent of tools such as narrow-band imaging (NBI) could help the clinician. The purpose of this study was to assess the impact of NBI during the pre-operative and intra-operative stages of management of oral and oropharyngeal cancers. MATERIALS AND METHODS: NBI was used pre-operatively in 47 patients with oral or oropharyngeal squamous cell carcinoma to identify the involvement of adjacent subsites, multifocality, synchronous lesions or an unknown primary. NBI was used intra-operatively in 30 patients to better define the tumor limits and guide the resection. The advantage of NBI versus WL endoscopy was analyzed by calculating the true and false positive rate pre-operatively, and the need for resection enlargements, histology of the enlargement, and the rate of clear margins at definitive histology, intra-operatively. RESULTS: Pre-operatively, the diagnostic gain of NBI was 8.5%, allowing identification of three synchronous tumors and one unknown primary. Intra-operatively, NBI improved the definition of tumor limits in 67.7% of cases, with resection enlargements showing dysplasia and carcinoma in 8 and 12 patients, respectively; we obtained 74.2% negative margins at histology. CONCLUSIONS: NBI could represent an added value in the pre-operative and intra-operative assessment of oral cavity and oropharyngeal carcinoma.

Influence of Maxillary Sinus Width on New Bone Formation After Transcrestal Sinus Floor Elevation: A Proof-of-Concept Prospective Cohort Study.

PURPOSE: Graft maturation in the maxillary sinus requires adequate angiogenesis and osteoprogenitor cells migration from the surrounding bony walls: the aim of this study was to analyze the correlation between sinus cavity dimensions and new bone formation after transcrestal sinus floor elevation (tSFE). METHODS: Patients needing maxillary sinus augmentation (residual crest height ≤ 4 mm) were treated with tSFE using xenogeneic granules. Six months later, bone-core biopsies were retrieved for histological analysis in the implant insertion sites. Buccopalatal sinus width (SW) was evaluated on cone beam computed tomography, and correlations between histomorphometric and anatomical parameters were quantified by means of linear regression analysis. RESULTS: Eight consecutive patients underwent tSFE procedures: at 6 months, average percentage of newly formed bone resulted 24.2% ± 7.9%. Statistical analysis showed a strong inverse correlation between SW and new bone formation (R = 0.88), and a strong direct correlation between the number of exposed bone walls and new bone formation (R = 0.82). CONCLUSION: Within the limitations of this proof-of-concept study, in which a restricted number of patients were analyzed, tSFE showed more predictable results in narrow than in large sinuses, in terms of new bone formation.

Expanded vs. dense polytetrafluoroethylene membranes in vertical ridge augmentation around dental implants: a prospective randomized controlled clinical trial.

OBJECTIVE: This prospective randomized controlled trial was designed to test the performance of titanium-reinforced dense polytetrafluoroethylene (d-PTFE) membrane vs. titanium-reinforced expanded polytetrafluoroethylene (e-PTFE) membrane in achieving vertical bone regeneration, both associated with a composite grafting material. MATERIAL AND METHODS: The study enrolled 23 patients requiring bone augmentation with guided bone regeneration (GBR) procedures for placing implants in atrophic posterior mandibles (available bone height <7 mm). Implants were inserted and left to protrude from the bone level to achieve the programmed amount of vertical regeneration. Defects were filled with a composite bone graft (50% autologous bone and 50% mineralized bone allograft) and randomly covered with either an e-PTFE membrane (control) or a d-PTFE membrane (test). Membrane removal was performed after 6 months, and changes in bone height were recorded. RESULTS: Seventy-eight implants were inserted in 26 mandibular sites contextually to vertical ridge augmentation procedures. The healing period was uneventful in all sites, and the vertical defects were satisfactorily filled with a newly formed hard tissue. Mean defect fill after 6 months was 5.49 mm (SD ± 1.58) at test sites and 4.91 mm (SD ± 1.78) at control sites. The normalized data (percentage changes against baseline) did not show any statistically significant difference between test and control groups (P = NS). CONCLUSIONS: Based on the data from this study, both d-PTFE and e-PTFE membranes showed identical clinical results in the treatment of vertical bone defects around implants, using the GBR technique. The membrane removal procedure was easier to perform in the d-PTFE group than in the e-PTFE group.

Regulation of the spatial code for BDNF mRNA isoforms in the rat hippocampus following pilocarpine-treatment: a systematic analysis using laser microdissection and quantitative real-time PCR.

Brain-derived neurotrophic factor (BDNF) is essential for neuronal survival, differentiation, and plasticity and is one of those genes that generate multiple mRNAs with different alternatively spliced 5'UTRs. The functional significance of many BDNF transcripts, each producing the same protein, is emerging. On the basis of the analysis of the four most abundant brain BDNF transcripts, we recently proposed the "spatial code hypothesis of BDNF splice variants" according to which the BDNF transcripts, through their differential subcellular localization in soma or dendrites, represent a mechanism to synthesize the protein at distinct locations and produce local effects. In this study, using laser microdissection of hippocampal laminae and reverse transcription-quantitative real-time PCR (RT-qPCR), we analyzed all known BDNF mRNA variants at resting conditions or following 3 h pilocarpine-induced status epilepticus. In untreated rats, we found dendritic enrichment of BDNF transcripts encoding exons 6 and 7 in CA1; exons 1, 6, and 9a in CA3; and exons 5, 6, 7, and 8 in DG. Considering the low abundance of the other transcripts, exon 6 was the main transcript in dendrites under resting conditions. Pilocarpine treatment induced an increase of BDNF transcripts encoding exons 4 and 6 in all dendritic laminae and, additionally, of exon 2 in CA1 stratum radiatum and exons 2, 3, 9a in DG molecular layer while the other transcripts were decreased in dendrites, suggesting restriction to the soma. These results support the hypothesis of a spatial code to differentially regulate BDNF in the somatic or dendritic compartment under conditions of pilocarpine-induced status epilepticus and, furthermore, highlight the existence of subfield-specific differences.

Knowledge and awareness of oral cancer: A cross-sectional survey in Trieste, Italy.

The aim of the study was to verify the knowledge on oral cancer and to assess possible differences in awareness and information basing on different demographic and subject-related factors. An anonymous survey was provided to 750 random subjects using online-based questionnaires. Statistical analysis was performed in order to evaluate the influence of demographic variables (gender, age, education) on knowledge of oral cancer and its risk factors. 68.4% of individuals knew about the existence of oral cancer, mostly from media and family/friends. Awareness was significantly influenced by gender and higher education, but not by age. Most participants recognized smoking as a risk factor, but alcohol abuse and sunlight exposure are less known, especially among less educated subjects. On the contrary, our study shows a diffusion of false information: more than 30% of the participants indicated the possible role of amalgam fillings in oral cancer onset, independently of gender, age or education. The results of our study suggest the need for oral cancer awareness campaigns, where school and healthcare professionals should be actively involved in promoting, organizing and finding methods to monitor the medium and long-term efficacy with proper methodological quality.

Serological and cellular response to mRNA-SARS-CoV2 vaccine in patients with hematological lymphoid malignancies: Results of the study "Cervax".

messenger RNA (mRNA)-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccines such as BNT162b2 became available in late 2020, but hematological malignancy patients (HM pts) were not evaluated in initial registration trials. We hereby report the results of a prospective, unicentric, observational study Response to COVID-19 Vaccination in hEmatological malignancies (CERVAX) developed to assess the postvaccine serological and T-cell-mediated response in a cohort of SARS-CoV2-negative HM pts vaccinated with BNT162b2. Patients with lymphomas [non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL)], chronic lymphocytic leukemia (CLL), and multiple myeloma (MM); off-therapy for at least 3 months; in a watch-and-wait program; or in treatment with ibrutinib, venetoclax, and lenalidomide were included. Different time points were considered to assess the serological response to the vaccine: before the second dose (T1), at 3-6-12 months after the first dose (T2-3-4, respectively). Since March 2021, 39 pts have been enrolled: 15 (38%) NHL, 12 (31%) CLL, and 12 (31%) MM. There were 13 of the 39 pts (33%) seroconverted at T1; an increase of the serological response was registered after the second dose (T2) (22/39 pts, 56%) and maintained after 6 months (22/39 pts, 56%) and 12 months (24/39 pts, 61%) from the first dose (T3-T4, respectively). Non-serological responders at T4 were 7/39 (18%): 0/15 NHL, 1/12 MM (8%), and 6/12 CLL (50%). All of them were on therapy (one lenalidomide, three ibrutinib, and three venetoclax). SARS-CoV2-reactive T-cell analysis (interferon gamma release assays) was available since June 2022 and was evaluated at 12 months (T4) from the first dose of vaccine in 31/39 pts (79%). T-cell-mediated-responders were 17/31 (55%): most of them were NHL and MM (47%, 41% and 12% for NHL, MM, and CLL, respectively). Both serological and T-cell non-responders were represented by pts on active therapy (venetoclax/ibrutinib). During the period of observation, eight (20.5%) pts developed mild SARS-CoV2 infection; no coronavirus disease 19 (COVID-19)-related deaths or hospitalizations were registered. In conclusion, in our cohort of lymphoproliferative pts receiving BNT162b2, CLL diagnosis and venetoclax/ibrutinib seem to be related with a lower humoral or T-mediated response. Nevertheless, the efficacy of mRNA vaccine in HM pts and the importance to continue the vaccine program even in non-responders after the first dose are supported in our study by demonstrating that a humoral and T-cell-mediated seroconversion should be observed even in the subsets of heavily immunocompromised pts.

Evaluation of a breast cancer nomogram for predicting the likelihood of additional nodal metastases in patients with a positive sentinel node biopsy.

AIM: Completion axillary lymph node dissection (CALND) performed as a standard procedure after a positive sentinel node biopsy (SLNB) in breast cancer patients results, in almost 40-70% of cases, in no additional positive nodes. A nomogram has been developed at Memorial Sloan Kettering Cancer Center (MSKCC) to predict the likelihood of nonsentinel node metastases (NSLNM) after a positive SLNB. Aim of study was to assess the accuracy of MSKCC nomogram in our community breast cancer population. MATERIAL OF STUDY: From a retrospective database of 276 breast cancer patients we evaluated 62 consecutive cases who underwent CALND after a positive SLNB. Patient and tumor characteristics were collected and the nomogram was used to calculate the probability of NSLNM. The accuracy of MSKCC nomogram was tested by the Receiver Operating Characteristic (ROC) curve. The Area Under the Curve (AUC), sensitivity and specificity were calculated for a 10% cut-off value. RESULTS: Presence of macrometastases (p=0.03) and its extranodal extension (p=0.013) in sentinel node were associated with NSLNM, while other tumor and patient characteristics were not. The accuracy of MSKCC nomogram as measured by AUC was 0.67. The nomogram showed 95% sensitivity and 14% specificity. We revised the nomogram by incorporating the presence of extranodal extension and we obtained a new test with improved specificity (84%). DISCUSSION: The modified predictive model is a useful tool in predicting the likelihood of NSLNM in our cohort of patients and may help decision regarding the need of completion axillary lymph node dissection.

Accuracy of the digital workflow for guided insertion of orthodontic palatal TADs: a step-by-step 3D analysis.

BACKGROUND: The introduction in the orthodontic field of the digital workflow for guided insertion of palatal TADs and the development of the 1-visit protocol led to the reduction of chair time and the possibility of complete customization of designs and materials. Conversely, the reduction of operative steps implicates a lower tolerance of deviations between the planned and the actual position of the miniscrews, particularly when the orthodontic device is fixed on 4 palatal TADs or has a rigid structure. This study aims to analyze the influence of each step of the digital workflow on the deviation of the miniscrews' axis of insertion in a bicortical sample. The null hypothesis is that there are no significant differences in the deviations among the operative steps. METHODS: 33 subjects were selected for insertion of bicortical palatal miniscrews with a 1-visit protocol. Digital files were collected at the three stages of the workflow (i.e., digital planning, laboratory prototype, post-insertion impression). A 3D software analysis was performed on a total of 64 miniscrews. After automatic shape recognition of the guiding holes of the digital plan and the scanbodies of the laboratory prototype and post-insertion impression as geometric cylinders, their three-dimensional longitudinal axis was traced and the deviation among them was calculated. Friedman test with Bonferroni correction was performed to assess the significance of the deviations among the three steps, with significance set at p < 0.05. RESULTS: The laboratory step has a significantly lower degree of deviations (2.12° ± 1.62) than both the clinical step (6.23° ± 3.75) and the total deviations (5.70° ± 3.42). No significant differences were found between miniscrews inserted on the left or the right side. CONCLUSIONS: This study suggests that laboratory procedures such as surgical guide production or rapid prototyping don't play a significant role in the degree of deviations between the planned and the positioned palatal TADs. Conversely, the clinical steps have a bigger influence and need to be carefully evaluated. Despite this difference, there is a cumulative effect of deviations that can lead to the failure of the 1-visit protocol.

How to Cope with the Ponseti Method for Clubfoot: The Families' Standpoint.

(1) Background: The Ponseti Method is the gold standard for the treatment of congenital clubfoot. It is a low-cost treatment consisting in a series of plaster casts, a percutaneous Achilles' tenotomy and a Mitchell Ponseti brace to wear with a definite protocol. This treatment allows children to be with their families instead of being hospitalized. This advantage is also a challenge for the families that have to follow the protocol at home. This paper aims to analyze the perception, the difficulties and the overcomes of the families during the treatment. (2) Methods: We used a 41 questions questionnaire by Nogueira and Morquende. Questions were answered by families who had already finished the treatment or were still following it. (3) Results: We interviewed 92 families. The worst handling phase appeared to be the cast phase, while the brace seemed more bearable. In total, 57 families overrated tenotomy; (4) Conclusions: Families perceived the Ponseti Method as a quality treatment. The anxiety about the diagnosis played a strong role, but none of the difficulties encountered decreased the treatment outcomes or affected families' adherence to the protocol. The open-ended answers highlighted that the positive relationship with doctors played a key role in the everyday compliance and the achievement of good results.