Pre-Diagnosis Diet Predicts Response to Exclusive Enteral Nutrition and Correlates with Microbiome in Pediatric Crohn Disease.

Exclusive enteral nutrition (EEN) is effective in inducing remission in pediatric Crohn disease (CD). EEN alters the intestinal microbiome, but precise mechanisms are unknown. We hypothesized that pre-diagnosis diet establishes a baseline gut microbiome, which then mediates response to EEN. We analyzed prospectively recorded food frequency questionnaires (FFQs) for pre-diagnosis dietary patterns. Fecal microbiota were sequenced (16SrRNA) at baseline and through an 18-month follow-up period. Dietary patterns, Mediterranean diet adherence, and stool microbiota were associated with EEN treatment outcomes, disease flare, need for anti-tumor necrosis factor (TNF)-α therapy, and long-term clinical outcomes. Ninety-eight patients were included. Baseline disease severity and microbiota were associated with diet. Four dietary patterns were identified by FFQs; a "mature diet" high in fruits, vegetables, and fish was linked to increased baseline microbial diversity, which was associated with fewer disease flares (p < 0.05) and a trend towards a delayed need for anti-TNF therapy (p = 0.086). Baseline stool microbial taxa were increased (Blautia and Faecalibacterium) or decreased (Ruminococcus gnavus group) with the mature diet compared to other diets. Surprisingly, a "pre-packaged" dietary pattern (rich in processed foods) was associated with delayed flares in males (p < 0.05). Long-term pre-diagnosis diet was associated with outcomes of EEN therapy in pediatric CD; diet-microbiota and microbiota-outcome associations may mediate this relationship.

Person-Centered Models for Cardiovascular Care: A Review of the Evidence: A Scientific Statement From the American Heart Association.

Cardiovascular disease remains the leading cause of death and disability in the United States and globally. Disease burden continues to escalate despite technological advances associated with improved life expectancy and quality of life. As a result, longer life is associated with multiple chronic cardiovascular conditions. Clinical guidelines provide recommendations without considering prevalent scenarios of multimorbidity and health system complexities that affect practical adoption. The diversity of personal preferences, cultures, and lifestyles that make up one's social and environmental context is often overlooked in ongoing care planning for symptom management and health behavior support, hindering adoption and compromising patient outcomes, particularly in groups at high risk. The purpose of this scientific statement was to describe the characteristics and reported outcomes in existing person-centered care delivery models for selected cardiovascular conditions. We conducted a scoping review using Ovid MEDLINE, Embase.com, Web of Science, CINAHL Complete, Cochrane Central Register of Controlled Trials through Ovid, and ClinicalTrials.gov from 2010 to 2022. A range of study designs with a defined aim to systematically evaluate care delivery models for selected cardiovascular conditions were included. Models were selected on the basis of their stated use of evidence-based guidelines, clinical decision support tools, systematic evaluation processes, and inclusion of the patient's perspective in defining the plan of care. Findings reflected variation in methodological approach, outcome measures, and care processes used across models. Evidence to support optimal care delivery models remains limited by inconsistencies in approach, variation in reimbursement, and inability of health systems to meet the needs of patients with chronic, complex cardiovascular conditions.

Crohn's disease proteolytic microbiota enhances inflammation through PAR2 pathway in gnotobiotic mice.

Emerging evidence implicates microbial proteolytic activity in ulcerative colitis (UC), but whether it also plays a role in Crohn's disease (CD) remains unclear. We investigated the effects of colonizing adult and neonatal germ-free C57BL/6 mice with CD microbiota, selected based on high (CD-HPA) or low fecal proteolytic activity (CD-LPA), or microbiota from healthy controls with LPA (HC-LPA) or HPA (HC-HPA). We then investigated colitogenic mechanisms in gnotobiotic C57BL/6, and in mice with impaired Nucleotide-binding Oligomerization Domain-2 (NOD2) and Protease-Activated Receptor 2 (PAR2) cleavage resistant mice (Nod2-/-; R38E-PAR2 respectively). At sacrifice, total fecal proteolytic, elastolytic, and mucolytic activity were analyzed. Microbial community and predicted function were assessed by 16S rRNA gene sequencing and PICRUSt2. Immune function and colonic injury were investigated by inflammatory gene expression (NanoString) and histology. Colonization with HC-LPA or CD-LPA lowered baseline fecal proteolytic activity in germ-free mice, which was paralleled by lower acute inflammatory cell infiltrate. CD-HPA further increased proteolytic activity compared with germ-free mice. CD-HPA mice had lower alpha diversity, distinct microbial profiles and higher fecal proteolytic activity compared with CD-LPA. C57BL/6 and Nod2-/- mice, but not R38E-PAR2, colonized with CD-HPA had higher colitis severity than those colonized with CD-LPA. Our results indicate that CD proteolytic microbiota is proinflammatory, increasing colitis severity through a PAR2 pathway.

Serum neurofilament light chain levels are associated with all-cause mortality in the general US population.

INTRODUCTION: Serum neurofilament light chain (sNfL) levels are biomarkers of neuro-axonal injury in multiple neurological diseases. Little is known on their potential role as prognostic markers in people without known neurological conditions. OBJECTIVE: The aim of this study is to evaluate the association between sNfL levels and all-cause mortality in a general population setting. METHODS: sNfL levels were measured in 2071 people aged 25-75 years from the general US population that participated in the 2013-2014 cycles of the National Health and Nutrition Examination Survey (NHANES). Cognitive function was evaluated in a subset of participants aged 60-75 years using the Consortium to Establish a Registry for Alzheimer's Disease-Word Learning test, the Animal Fluency test and the Digit Symbol Substitution test. We applied Cox proportional hazard models adjusted for several potential confounders to evaluate the association between sNfL and all-cause mortality through December 2019 by linking NHANES data with data from the National Death Index. RESULTS: In a cross-sectional analysis, higher sNfL levels were associated with worse performance in all three cognitive function tests. Over a median follow-up of 6.1 years, 85 participants died. In a multivariable model adjusted for age, sex, race-ethnicity, diabetes, chronic kidney disease, harmful alcohol consumption, cigarette smoke and prevalent cardiovascular disease, higher sNfL levels were significantly and positively associated with all-cause mortality (HR per unit increase in log-transformed sNfL: 2.46, 95% CI 1.77-3.43, p < 0.001). Results were robust when analyses were stratified according to age, sex, body mass index and kidney function. CONCLUSION: We found a positive association between sNfL levels and mortality in the general US population. Further studies are needed to understand the biological mechanisms underlying this association.

Nursing knowledge captured in electronic health records.

PURPOSE: The purpose of this study was to describe the extent to which nursing assessment data was present in the electronic health record and linked to NANDA-I, NIC, and NOC. METHODS: This retrospective review used a descriptive approach to examine documentation in the electronic health records (EHR) of 10 hospitalized patients requiring cardiac surgery. A team of experts applied a Delphi consensus-building process to identify the supports and barriers for nursing documentation. FINDINGS: Collection of the health history was organized using Gordon's Functional Health Pattern (FHP) Framework. Seventy-five fields were noted for the entry of nursing assessment data of which 65 focused on health history data and 30 documented physical findings and observations. There were no references to the defining characteristics or etiologies with any of the diagnostic labels used. Care plans included the nursing diagnoses, goals of care, and interventions, although there was a lack of clear alignment between the assessment, NANDA-I, NIC, and NOC and the care plan. Progress note documentation addressed significant events in the patient's clinical course; however, these were not nursing problem or diagnosis focused. Four expert reviewers arrived at consensus regarding the supports and challenges impacting nurses' ability to document data depicting nursing's contribution to care using a FHP and standardized nursing language in the EHR. CONCLUSIONS: The EHR provides an opportunity to reflect nursing clinical judgment and make nursing care visible. These findings suggest there are challenges to capturing nurse focused data elements in the EHR. IMPLICATIONS FOR NURSING PRACTICE: This work has important implications for clinicians, educators, and administrators alike. EHR systems must accurately capture nurses' contribution to patient care to plan for resource allocation and quality care delivery. Ultimately, the development of standardized data sources reflecting the outcomes of nursing care will expand the opportunities to advance nursing knowledge.

Prevalence of and factors associated with limited health literacy in spine patients.

BACKGROUND: Limited health literacy exacerbates health inequity and has serious implications for patient care. It hinders successful communication and comprehension of relevant health information, which can lead to suboptimal care. Despite the evidence regarding the significance of health literacy, the topic has received little consideration in orthopedic spine patients. PURPOSE: To investigate the prevalence of and factors associated with limited health literacy among outpatients presenting to a tertiary urban academic hospital-based orthopedic spine center. STUDY DESIGN: Cross-sectionals. PATIENT SAMPLE: Patients 18 years of age or older seen at a tertiary urban academic hospital-based multi-surgeon outpatient spine center. OUTCOME MEASURES: The Newest Vital Sign (NVS) health literacy assessment. METHODS: Between December 2021 and March 2022, 447 consecutive English-speaking patients over the age of 18 years and new to the outpatient spine clinic were approached for participation in a cross-sectional survey study, of which 405 agreed to participate. Patients completed the Newest Vital Sign (NVS) health literacy assessment tool, the Rapid Estimation of Adult Literacy in Medicine Short Form (REALM-SF), and a sociodemographic survey (including race/ethnicity, level of education, employment status, income, and marital status). The NVS scores were divided into limited (0-3) and adequate (4-6) health literacy. REALM-SF scores were classified into reading levels below ninth grade (0-6) or at least ninth grade (7). Additional demographic data was extracted from patient records. Online mapping tools were used to collect the Social Vulnerability Index (SVI) and the Area Deprivation Index (ADI) for each patient. Subsequently, multivariable regression modeling was performed to identify independent factors associated with limited health literacy. RESULTS: The prevalence of limited health literacy in patients presenting to an urban academic outpatient spine center was 33% (135/405). Unadjusted analysis found that patients who were socioeconomically disadvantaged (eg, unemployed, lower household income, publicly insured and higher SVI) and had more unfavorable social determinant of health features (eg, housing concerns, higher ADI, less years of education, below ninth grade reading level, unmarried) had high rates of limited health literacy. Adjusted regression analysis demonstrated that limited health literacy was independently associated with higher ADI state decile, living less than 10 years at current address, having housing concerns, not being employed, non-native English speaking, having less years of education and below ninth grade reading level. CONCLUSIONS: This study found that a substantial portion of the patients presenting to an outpatient spine center have limited health literacy, more so if they are socially disadvantaged. Future efforts should investigate the impact of limited health literacy on access to care, treatment outcomes and health care utilization in orthopedic patients. Neighborhood social vulnerability measures may be a feasible way to identify patients at risk of limited health literacy in clinical practice and offer opportunities for tailored patient care. This may contribute to prioritizing the mitigation of disparities and aid in the development of meaningful interventions to improve health equity in orthopedics.

Diagnosis of Organizing Pneumonia with an Ultrathin Bronchoscope and Cone-Beam CT: A Case Report.

Organizing pneumonia (OP) is a pulmonary disease histopathologically characterized by plugs of loose connective tissue in distal airways. The clinical and radiological presentations are not specific and they usually require a biopsy confirmation. This paper presents the case of a patient with a pulmonary opacity sampled with a combined technique of ultrathin bronchoscopy and cone-beam CT. A 64-year-old female, a former smoker, was admitted to the hospital of Reggio Emilia (Italy) for exertional dyspnea and a dry cough without a fever. The history of the patient included primary Sjögren Syndrome interstitial lung disease (pSS-ILD) characterized by a non-specific interstitial pneumonia (NSIP) radiological pattern; this condition was successfully treated up to 18 months before the new admission. The CT scan showed the appearance of a right lower lobe pulmonary opacity of an uncertain origin that required a histological exam for the diagnosis. The lung lesion was difficult to reach with traditional bronchoscopy and a percutaneous approach was excluded. Thus, cone-beam CT, augmented fluoroscopy and ultrathin bronchoscopy were chosen to collect a tissue sample. The histopathological exam was suggestive of OP, a condition occurring in 4-11% of primary Sjögren Syndrome cases. This case showed that, in the correct clinical and radiological context, even biopsies taken with small forceps can lead to a diagnosis of OP. Moreover, it underlined that the combination of multiple advanced technologies in the same procedure can help to reach difficult target lesions, providing proper samples for a histological diagnosis.

Sustained Improvement in Quality of Patient Handoffs After Orthopaedic Surgery I-PASS Intervention.

PURPOSE: The I-PASS tool has been shown to decrease medical errors in patient handoffs in nonorthopaedic surgery fields. We prospectively studied the implementation of a version of this handoff tool modified for orthopaedic surgery patients in an academic practice at two level I trauma centers. METHODS: This was a prospective study of a multicenter handoff improvement program. Handoffs were evaluated preintervention and at 1, 6, 9, and 18 months postintervention for key data elements defined by I-PASS. Rates of adverse clinical outcomes were compared before and after the handoff intervention. RESULTS: Seven hundred five electronic patient handoffs were analyzed. From preintervention to the 18-month time point, notable improvement was observed in 8 of 9 targeted quality elements. In Poisson regression analysis, adherence to the standardized handoff format was sustained at markedly improved levels throughout all postintervention time points. No statistically significant differences were observed between rates of 30-day readmission, 90-day readmission, urinary tract infection, pulmonary embolism/deep vein thrombosis, surgical site infection, or delirium before and after the intervention. CONCLUSION: Introduction of an orthopaedic-specific I-PASS tool produced sustained adherence from a group of over 50 orthopaedic providers. Objective quality of handoffs improved markedly as defined by the I-PASS standard, and 86% of the providers supported the ongoing use of the tool. Despite the improvement in handoff quality, we were unable to demonstrate a notable change in measured clinical outcomes. Methods for the development and implementation of the orthopaedic-specific I-PASS tool are described. Orthopaedic residency programs should consider using a version of I-PASS to standardize care.

Diagnosis and Pattern Identification of Intrathoracic Malignant Melanoma Metastasis: A Retrospective Single Center Analysis.

The lung is a frequent site of secondary malignancies. Melanoma is a malignant tumor originating from melanocytes, that accounts for the majority of death related to skin cancers. In advanced stages, it can also present with intrathoracic metastasis, particularly in the lungs, but infrequent intrathoracic manifestations are possible. A retrospective analysis of the cases referred to the pulmonary endoscopy unit of the hospital of Reggio Emilia in the last 10 years (since December 2012) was carried out, discovering 17 cases of melanoma metastasis with thoracic localizations, either with or without a diagnosis of primary melanoma. Four repetitive patterns of clinical-radiological presentation have been identified and described through the same number of paradigmatic clinical cases: nodal involvement (35%), lung mass(es) (41%), diffuse pulmonary involvement (12%), and pleural involvement (12%). These different presentations imply the use of different diagnostic techniques, with an overall high diagnostic yield (87.5%). Finally, a brief analysis of survival based on the pattern of presentation has been performed, finding no statistically significant differences between the four groups at metastasis diagnosis (p-value = 0.06, median survival of respectively 54, 8, 9, and 26 months from metastasis diagnosis), while there is a significant difference considering patients with lung involvement versus nodal/pleural involvement (p = 0.01).

Lifestyle Changes Related to Eating Habits, Physical Activity, and Weight Status During COVID-19 Quarantine in Italy and Some European Countries.

Novel human coronavirus disease (COVID-19), an infectious respiratory disease, has affected more than 50 million people around the world up to November 2020, thereby becoming the fifth documented pandemic since the Spanish flu in 1918. SARS-CoV-2 virus originated in China and evolved for 4 months within the country before becoming a global threat. There is currently no drug approved by the Food and Drug Administration (FDA) for which efficacy on the virus has been proved. Therefore, the only strategy against this virus is to apply measures that are capable of reducing its spread, such as isolation and quarantine, social distancing, community-wide containment, and strict enforcement of hygiene. Quarantine has proved to be effective in combating the spread of the virus; however, it has inevitably led to a radical change in the lives of people. Studies have been conducted in Italy and some European countries to highlight the role that quarantine has played in determining the lifestyle changes both in eating habits and physical activity and their possible correlation with increase in weight. The selection criteria involved answering a questionnaire that included information on the weight status and at least one of the other two aspects: changes in eating habits and/or physical activity during the quarantine period. The results obtained indicate, in general, that the negative effect of quarantine was on eating habits and physical activity. This was based on the observation that there has been an increase in food consumption and a reduction in physical activity with a consequent increase in weight.

Infección por SARS-CoV-2 en niños: características clínicas y dinámica de la transmisión de SARS-CoV-2 en un centro de salud privado: Uruguay / SARS-CoV-2 infection in children: clinical characteristics and dynamics of SARS-CoV-2 transmission in a private health center: Uruguay

INTRODUCCIÓN: Hasta la fecha, la prevalencia y gravedad de la enfermedad COVID- 19 en niños es menor que en adultos. Existen controversias en relación a la dinámica de la transmisión y al rol que juegan en la diseminación de la enfermedad. OBJETIVO: Describir las características clínicas y la dinámica de transmisión de los pacientes bajo 15 años de edad notificados por sospecha y/o contacto para COVID-19 en el período 13 marzo - 20 noviembre 2020, en un prestador integral privado de salud (Médica Uruguaya Corporación de Asistencia Médica, MUCAM). METODOLOGÍA: Estudio descriptivo, retrospectivo, en el que se describen manifestaciones clínicas, noción epidemiológica, casos secundarios, gravedad y evolución. Se estimó el riesgo y la tasa de ataque secundaria intradomiciliaria. RESULTADOS: Cumplieron los criterios de inclusión 539 pacientes. El diagnóstico se confirmó en 29 (5,3%): 13 (7,0%) de los 351 niños sintomáticos y 16 (4,5%) de los 188 asintomáticos. Tuvieron noción de contacto el 100% de los casos confirmados y 85% de los no confirmados (p < 0.05). El OR para la infección a partir de un contacto intradomiciliario fue 26,5 (9,8- 71,7) y la tasa de ataque secundaria intradomiciliaria 23% ± 4,1. CONCLUSIONES: En esta serie, en los pacientes bajo 15 años de edad predominaron las formas leves y asintomáticas. Uno de cada cinco expuestos intradomiciliarios contrajo la enfermedad siendo esta noción de contacto decisiva para indicar estudios confirmatorios. La mayoría de los niños no continuó la cadena de transmisión.

BACKGROUND: To date, the prevalence and severity of the COVID-19 disease in children is lower than in adults. There are controversies regarding the dynamics of transmission and the role they play in the spread of the disease. AIM: To describe the clinical characteristics and transmission dynamics of patients under 15 years of age reported for suspicion and/or contact for COVID-19 in the period March 13 - November 20, 2020, in a private comprehensive health provider (Médica Uruguaya Medical Assistance Corporation, MUCAM). METHODS: Descriptive, retrospective study, in which clinical manifestations, epidemiological notion, secondary cases, severity and evolution are described. The risk and rate of secondary intradomiciliary attack were estimated. RESULTS: 539 patients met the inclusion criteria. The diagnosis was confirmed in 29 (5.3%): 13 (7.0%) of the 351 symptomatic children and 16 (4.5%) of the 188 asymptomatic. 100% of the confirmed cases and 85% of the unconfirmed cases had the notion of contact (p < 0.05). The OR for infection from an indoor contact was 26.5 (9.8-71.7) and the rate of secondary indoor attack 23% ± 4.1. CONCLUSIONS: In this series, mild and asymptomatic forms predominated in patients under 15 years of age. One in five exposed indoors contracted the disease, this notion of contact being decisive to indicate confirmatory studies. Most of the children did not continue the chain of transmission.

Eating Habits during the COVID-19 Lockdown in Italy: The Nutritional and Lifestyle Side Effects of the Pandemic.

To limit the spread of coronavirus SARS-CoV-2, a nationwide lockdown started in Italy in March 2020. In this unpredictable situation, a cross-sectional study using an online questionnaire was carried out by the Observatory on Food Surplus, Recovery and Waste of CREA Food and Nutrition Centre. The aim of this work was to evaluate how Italian habits changed during this period, the determinants of changes, and the effect on food waste prevention. In a sample of 2678 respondents, 62% showed low Adherence to the Mediterranean Diet (AMD). During lockdown many of participants improved the quality of their diet, increasing their consumption of fruit (24.4%), vegetables (28.5%), legumes (22.1%), nuts (12%), and fish or shellfish (14%). Unfavorable changes were observed with the excessive consumption of sweets or pastries (36.9%) and comfort foods (22.7%), and a lack of physical activity (37.2%). The main novelty of this study was the examination of dietary changes identified by a cluster analysis. Respondents with generally high AMD improved their eating habits, while the habits of the respondents with generally low AMD remained unchanged. In addition, nearly 80% of respondents were sensitive to food waste. The study provides a useful contribution to the debate on nutritional recommendations in case of further lockdown.

Azithromycin and the microbiota of cystic fibrosis sputum.

BACKGROUND: Azithromycin is commonly prescribed drug for individuals with cystic fibrosis (CF), with demonstrated benefits in reducing lung function decline, exacerbation occurrence and improving nutrition. As azithromycin has antimicrobial activity against components of the uncultured microbiome and increasingly the CF microbiome is implicated in disease pathogenesis - we postulated azithromycin may act through its manipulation. Herein we sought to determine if the CF microbiome changed following azithromycin use and if clinical benefit observed during azithromycin use associated with baseline community structure. RESULTS: Drawing from a prospectively collected biobank we identified patients with sputum samples prior to, during and after initiating azithromycin and determined the composition of the CF microbial community by sequencing the V3-V4 region of the 16S rRNA gene. We categorized patients as responders if their rate of lung function decline improved after azithromycin initiation. Thirty-eight adults comprised our cohort, nine who had not utilized azithromycin in at least 3 years, and 29 who were completely naïve. We did not observe a major impact in the microbial community structure of CF sputum in the 2 years following azithromycin usage in either alpha or beta-diversity metrics. Seventeen patients (45%) were classified as Responders - demonstrating reduced lung function decline after azithromycin. Responders who were naïve to azithromycin had a modest clustering effect distinguishing them from those who were non-Responders, and had communities enriched with several organisms including Stenotrophomonas, but not Pseudomonas. CONCLUSIONS: Azithromycin treatment did not associate with subsequent large changes in the CF microbiome structure. However, we found that baseline community structure associated with subsequent azithromycin response in CF adults.

Sputum microbiota in adults with CF associates with response to inhaled tobramycin.

BACKGROUND: Inhaled tobramycin powder/solution (TIP/S) use has resulted in improved clinical outcomes in patients with cystic fibrosis (CF) with chronic Pseudomonas aeruginosa. However, TIP/S effect on the CF sputum microbiome has not been explored. We hypothesised that TIP/S has additional 'off-target' effects beyond merely P. aeruginosa and that baseline microbiome prior to initiation of therapy is associated with subsequent patient response. METHODS: We drew sputum samples from a prospectively collected biobank. Patients were included if they had one sputum sample in the 18 months before and after TIP/S. Bacterial 16S rRNA gene profiling was used to characterise the sputum microbiome. RESULTS: Forty-one patients met our inclusion criteria and 151 sputum samples were assessed. At baseline, median age was 30.4 years (IQR 24.2-35.2) and forced expiratory volume in 1 (FEV1) second was 57% predicted (IQR 44-74). Nineteen patients were defined a priori as responders having no net decrease in FEV1 in the year following TIP/S. No significant changes were observed in key microbiome metrics of alpha (within-sample) or beta (between-sample) diversity for samples collected before and after TIP/S. However, significant beta-diversity (Bray-Curtis) differences were noted at baseline between patients based on response status. Notably, responders were observed to have a higher abundance of Staphylococcus in pretherapy baseline samples. CONCLUSIONS: Our longitudinal study demonstrates that the sputum microbiome of patients with CF is relatively stable following inhaled tobramycin over many months. Intriguingly, our findings suggest that baseline microbiome may associate with patient response to TIP/S-suggesting the sputum microbiome could be used to personalise therapy.

Assessment of Inter-Laboratory Variation in the Characterization and Analysis of the Mucosal Microbiota in Crohn's Disease and Ulcerative Colitis.

BACKGROUND: In studies evaluating the microbiome, numerous factors can contribute to technical variability. These factors include DNA extraction methodology, sequencing protocols, and data analysis strategies. We sought to evaluate the impact these factors have on the results obtained when the sequence data are independently generated and analyzed by different laboratories. METHODS: To evaluate the effect of technical variability, we used human intestinal biopsy samples resected from individuals diagnosed with an inflammatory bowel disease (IBD), including Crohn's disease (n = 12) and ulcerative colitis (n = 10), and those without IBD (n = 10). Matched samples from each participant were sent to three laboratories and studied using independent protocols for DNA extraction, library preparation, targeted-amplicon sequencing of a 16S rRNA gene hypervariable region, and processing of sequence data. We looked at two measures of interest - Bray-Curtis PERMANOVA R 2 values and log2 fold-change estimates of the 25 most-abundant taxa - to assess variation in the results produced by each laboratory, as well the relative contribution to variation from the different extraction, sequencing, and analysis steps used to generate these measures. RESULTS: The R 2 values and estimated differential abundance associated with diagnosis were consistent across datasets that used different DNA extraction and sequencing protocols, and within datasets that pooled samples from multiple protocols; however, variability in bioinformatic processing of sequence data led to changes in R 2 values and inconsistencies in taxonomic assignment and abundance estimates. CONCLUSION: Although the contribution of DNA extraction and sequencing methods to variability were observable, we find that results can be robust to the various extraction and sequencing approaches used in our study. Differences in data processing methods have a larger impact on results, making comparison among studies less reliable and the combined analysis of bioinformatically processed samples nearly impossible. Our results highlight the importance of making raw sequence data available to facilitate combined and comparative analyses of published studies using common data processing protocols. Study methodologies should provide detailed data processing methods for validation, interpretability, reproducibility, and comparability.

Continuous-infusion and outpatient setting: A chance for patients, a challenge for hospital pharmacists.

The use of continuous-infusion in outpatient setting could be widely used in oncology and haematology care. Many times the lack of data stability about single drug or admixture of drugs, together with patient education and safety, make difficult the transition from inpatient to outpatient setting. Nowadays, this is a big challenge for hospital pharmacists, who must take into consideration the critical issues related to chemical and physical stability, besides microbiological one, in order to ensure high quality preparations and guarantee the safety and quality of care, to protect patients and their health. The aim of this article is to highlight the critical issues concerning the transition from inpatient to outpatient setting, with particular interest regarding chemotherapy protocols, which require preparation with long-term continuous-infusion.

Correction to: Management of early ankle osteoarthritis through anterior joint-preserving surgery: a retrospective evaluation at mid- to long-term follow-up.

The original version of this article unfortunately contained a mistake. The spelling of the 'Francesco Ceccarelli' name was incorrect.

Management of early ankle osteoarthritis through anterior joint-preserving surgery: a retrospective evaluation at mid- to long-term follow-up.

PURPOSE: Chronic anterior ankle pain is a recognized and straightforward characteristic of anterior impingement syndrome. This retrospective study aims to evaluate outcomes, clinical and radiological results in patients affected by anterior ankle impingement, in a context of early osteoarthritis, and treated with mini-open anterior ankle arthrolysis, in the perspective to delay or avoid other demolitive surgical options, such as total ankle replacement and joint fusion. METHODS: In total, 49 patients (50 feet, mean age 45 years) undergone mini-open anterior ankle arthrolysis for anterior impingement, fulfilled inclusion criteria and gave their consent and have been enlisted in the study. Patients were retrospectively reviewed with AOFAS ankle-hindfoot score and SF-36 score at a minimum follow-up of 36 months. Statistical analysis was performed. RESULTS: A marked improvement was noticed in terms of preoperative clinical score (mean AOFAS score 47.32 ± 17.89) compared to follow-up clinical score (mean AOFAS score 70.66 ± 16.62; p < 0.005), and all of 8 SF-36 domains showed statistically improved (p < 0.05) from preoperative to follow-up. Statistical significance has been shown. CONCLUSIONS: It is possible to consider the mini-open anterior arthrolysis, thanks to the reduction of the painful symptomatology, a valid tool for procrastinating more invasive interventions such as arthrodesis or prosthetic replacement in patients with grade 1 or 2 of ankle osteoarthritis.

A Preliminary Study on the Mechanical Reliability and Regeneration Capability of Artificial Bone Grafts in Oncologic Cases, With and Without Osteosynthesis.

Several bone grafts are available for clinical use, each with their own peculiar biological and mechanical properties. A new bone graft was obtained by combining mineral structures from natural bovine bones with bioresorbable polymers and cellular nutrients. The study aims to evaluate the clinical, biological and structural properties of this bone graft and its reliability in orthopedic oncology. 23 adult patients (age range 18-85 years) were treated between October 2016 and December 2018; the oncologicdiagnoses were heterogeneous. After surgical curettage and bone grafting, a clinical-radiological follow up was conducted. Radiographs were used to evaluate graft integration according to the usual bone healing and oncologic follow up. Local complications (infection, local recurrence, wound dehiscence, fracture or early reabsorption) were evaluated. The mean followup was of 18.34 ± 4.83 months. No fracture or infection occurred. One case of patellar Giant Cell Tumor (GCT) and one of proximal tibia low-grade chondrosarcoma recurred after about one year. Two wound dehiscences occurred (one required a local flap). Follow-up X-rays showed good to excellent graft integration in most patients (20 out of 21). The investigated graft has a mechanical and structural function that can allow early weight-bearing and avoid a preventive bone fixation (only needed in four patients in this series). The graft blocks are different for shapes and dimensions, but they can be customized by the producer or sawcut by the surgeon in the operating theatre to fit the residual bone cavity. The complication rate was low, and a rapid integration was observed with no inflammatory reaction in the surrounding tissues. Further studies are mandatory to confirm these promising results.

Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors.

BACKGROUND AND OBJECTIVES: Limb salvage surgery remains the standard treatment in bone and soft tissue tumors. Toronto Extremity Salvage Score (TESS) is the most used quality of life measure. Our objective was to perform cross-cultural adaptation and validation in Italian, testing test-retest reliability, construct validity, and responsiveness. METHODS: We interviewed patients already treated for content validity. A total of 124 patients completed TESS and other questionnaires presurgery, at 3 months, 3 months + 2 weeks, and 6 months follow-up. We calculated intraclass correlation coefficients (ICCs) for reliability, associations with Pearson's r, and change over time with paired T tests. RESULTS: A new item regarding touch-screen devices was added to the upper extremity (UE) questionnaire. ICC resulted of 0.99 for lower extremity (LE) and 0.98 for UE patients, Pearson's r between TESS and Musculoskeletal Tumor Society was .66 and .64, EuroQol-5D-5L r was .62 and .61, and r between TESS and short form-36 physical function subscale was .76 and .71 for LE and UE groups, respectively. Paired T test results were statistically significant to detect change over time (0.03, 0.04, and 0.04 for LE groups and 0.03, 0.01, and 0.04 for UE groups). CONCLUSION: The Italian version of TESS can be used for the bone and soft tissue sarcoma population in clinical trials in Italy and with Italian speaking patients abroad to ensure patients' perspectives for efficacy and efficiency of treatments.