Confirmatory validation analysis of the PROFFIT questionnaire to assess financial toxicity in cancer patients.

BACKGROUND: The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire was developed to measure financial toxicity (FT) and identify its determinants. The aim of the present study was to confirm its validity in a prospective cohort of patients receiving anticancer treatment. PATIENTS AND METHODS: From March 2021 to July 2022, 221 patients were enrolled at 10 Italian centres. Selected items of the EORTC-QLQ-C30 questionnaire represented the anchors, specifically, question 28 (Q-28) on financial difficulties, and questions 29-30 measuring global health status/quality of life (HR-QOL). The study had 80% power to detect a 0.20 correlation coefficient (r) between anchors and PROFFIT-score (items 1-7, range 0-100, 100 indicating maximum FT) with bilateral alpha 0.05 and 80% power. Confirmatory factor analysis was conducted. FT determinants (items 8-16) were described. RESULTS: Median age of patients was 65 years, 116 (52.5%) were females, 96 (43.4%) had low education level. Confirmatory factor analysis confirmed goodness of fit of the PROFFIT-score. Significant partial correlation of PROFFIT-score was found with Q-28 (r = 0.51) and HR-QOL (r = -0.23). Mean (SD) PROFFIT-score at baseline was 36.5 (24.9); it was statistically significantly higher for patients living in South Italy, those with lower education level, those who were freelancer/unemployed at diagnosis and those who reported significant economic impact from the COVID-19 pandemic. Mean (SD) scores of determinants ranged from 17.6 (27.1) for item 14 (support from medical staff) to 49.0 (36.3) for item 10 (expenses for medicines or supplements). PROFFIT-score significantly increased with worsening response to determinants. CONCLUSIONS: External validation of PROFFIT-score in an independent sample of patients was successful. The instrument is now being used in clinical studies.

Presence of the Eucalyptus snout beetle in Ecuador and potential invasion risk in South America.

Eucalyptus snout beetles are a complex of at least eight cryptic species (Curculionidae: Gonipterus scutellatus complex), native to mainland Australia and Tasmania, that defoliate Eucalyptus trees and are considered important pests. Since the 19th century, three species of the complex have been introduced to other continents. Here, we document the presence of Eucalyptus snout beetles in Ecuador. We used DNA data for species identification and unambiguously demonstrated that the Ecuadorian specimens belong to the species Gonipterus platensis, which has low genetic diversity compared with other species in the complex. We analyzed G. platensis' potential distribution in South America with ecological niche models and found several areas of high to intermediate climatic suitability, even in countries where the pest has not been registered, like Peru and Bolivia. Accurate identification of species in the G. scutellatus complex and understanding of their potential distribution are essential tools for improved management and prevention tactics.

Los gorgojos del eucalipto son un complejo de al menos ocho especies crípticas (Curculionidae: complejo Gonipterus scutellatus), nativos de Australia continental y Tasmania, que defolian árboles de eucalipto y son considerados como plagas de importancia. Desde el siglo 19, tres especies de este complejo se han introducido a otros continentes. En este trabajo reportamos la presencia de gorgojos del eucalipto en Ecuador. Usamos datos genéticos para la identificación específica y demostramos claramente que los especímenes ecuatorianos pertenecen a la especie Gonipterus platensis, la cual tiene baja diversidad genética comparada con otras especies en el complejo. Analizamos la distribución potencial de G. platensis en América del Sur con modelos de nicho ecológico y encontramos varias áreas con idoneidad ambiental alta a intermedia, incluso en países donde esta especie no ha sido registrada, como Perú y Bolivia. La correcta identificación de las especies del complejo Gonipterus scutellatus y una mejor comprensión de su distribución potencial constituyen herramientas fundamentales para optimizar medidas de manejo y prevención.

Socioeconomic inequalities in dental visits among high school students in Chile, years 2013 and 2017.

OBJECTIVE: To analyze prevalence changes in dental visits and socioeconomic inequalities among high school students in Chile, years 2013 and 2017. METHODS: Analysis of nationally representative data from 2013 and 2017 waves of the Chilean National Socioeconomic Characterization Survey (CASEN). In a sample of high school students aged 14 to 20 years old (n=12699 in 2013; n=11122 in 2017) we investigated prevalence of dental visits in the last 3 months, by urban-rural residence, sex, type of health insurance, type of school, income level and benefit of dental care at school. For inequality analysis we estimated prevalence ratio of dental visits in the last 3 months according to study variables. RESULTS: There was a significant increase in the prevalence of dental visits in the last 3 months and the receipt of dental care at school between years 2013 and 2017. The highest prevalence of dental visits in the last 3 months was found among students living in urban residence, women, with private insurance, in the highest income level, that attended private schools. Inequalities persist but the gap associated with type of residence, health insurance and between the lowest income quintiles decreased over the years. CONCLUSIONS: The Comprehensive Dental Care for senior year high school students, a public policy that began in 2015 in Chile, could have aided the gap reduction and the increase in visits to the dentist in the last 3 months in this group.

Cetuximab as third-line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild-type circulating tumor DNA: Individual patient data pooled analysis of CRICKET and CAVE trials.

The rechallenge strategy is based on the concept that a subset of patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC) could still benefit of epidermal growth factor receptor (EGFR) inhibition, after progression to an anti-EGFR based-therapy. We performed a pooled analysis of two-phase II prospective trials to determine the role of rechallenge in third-line mCRC patients with RAS/BRAF WT baseline circulating tumor DNA (ctDNA). Individual data of 33 and 13 patients from CAVE and CRICKET trials that received as third-line therapy cetuximab rechallenge were collected. Overall survival (OS), Progression-free survival (PFS), Overall response rate (ORR), Stable disease (SD) >6 months were calculated. Adverse events were reported. For the whole 46 patient population, median PFS (mPFS) was 3.9 months (95% Confidence Interval, CI 3.0-4.9) with median OS (mOS) of 16.9 months (95% CI 11.7-22.1). For CRICKET patients, mPFS was 3.9 months (95% CI 1.7-6.2); mOS was 13.1 months (95% CI 7.3-18.9) with OS rates at 12, 18, and 24 months of 62%, 23%, and 0%, respectively. For CAVE patients, mPFS was 4.1 months (95% CI 3.0-5.2); mOS was 18.6 months (95% CI 11.7-25.4) with OS rates at 12, 18, 24 months of 61%, 52%, 21%, respectively. Skin rash was more frequently reported in CAVE trial (87.9% vs. 30.8%; p = 0.001), whereas a increased incidence of hematological toxicities was observed in CRICKET trial (53.8%% vs. 12.1%; p = 0.003). Third-line cetuximab rechallenge in combination with either irinotecan or avelumab in RAS/BRAF WT ctDNA mCRC patients represents a promising therapy.

Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey.

BACKGROUND: Information about the adherence to scientific societies guidelines in the 'real-world' therapeutic management of oncological patients are lacking. This multicenter, prospective survey was aimed to improve the knowledge relative to 2017-2018 recommendations of the Italian Association of Medical Oncology (AIOM). PATIENTS AND METHODS: Treatment-naive adult patients with pancreatic adenocarcinoma were enrolled. Group A received adjuvant therapy, group B received primary chemotherapy, and group C had metastatic disease. The results on patients accrued until 31 October 2019 with a mature follow-up were presented. RESULTS: Since July 2017, 833 eligible patients of 923 (90%) were enrolled in 44 Italian centers. The median age was 69 years (range 36-89 years; 24% >75 years); 48% were female; 93% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; group A: 16%, group B: 30%; group C: 54%; 72% Nord, 13% Center, 15% South. In group A, guidelines adherence was 68% [95% confidence interval (CI) 59% to 76%]; 53% of patients received gemcitabine and 15% gemcitabine + capecitabine; median CA19.9 was 29 (range 0-7300; not reported 15%); median survival was 36.4 months (95% CI 27.5-47.3 months). In group B, guidelines adherence was 96% (95% CI 92% to 98%); 55% of patients received nab-paclitaxel + gemcitabine, 27% FOLFIRINOX, 12% gemcitabine, and 3% clinical trial; median CA19.9 was 337 (range 0-20220; not reported 9%); median survival was 18.1 months (95% CI 15.6-19.9 months). In group C, guidelines adherence was 96% (95% CI 94% to 98%); 71% of patients received nab-paclitaxel + gemcitabine, 16% gemcitabine, 8% FOLFIRINOX, and 4% clinical trial; liver and lung metastases were reported in 76% and 23% of patients, respectively; median CA19.9 value was 760 (range 0-1374500; not reported 9%); median survival was 10.0 months (95% CI 9.1-11.1 months). CONCLUSIONS: The GARIBALDI survey shows a very high rate of adherence to guidelines and survival outcome in line with the literature. CA19.9 testing should be enhanced; nutritional and psychological counseling represent an unmet need. Enrollment to assess adherence to updated AIOM guidelines is ongoing.

Celiac disease in Chilean adults.

INTRODUCTION AND AIM: To characterize a university hospital population of Chilean adult patients with celiac disease. PATIENTS AND METHOD: We retrospectively reviewed the records of patients under control that were diagnosed with celiac disease through clinical characteristics, serology, and histology. RESULTS: A total of 149 patients were included, 119 (79.9%) of whom were women. Mean patient age was 42 years at diagnosis and 13.4% of patients had a family history of celiac disease. Mean body mass index was 24.3kg/m2, 55.3% presented with normal weight, 37.9% with overweight and obesity, and 6.8% with underweight. The main reasons for consultation were diarrhea (47%), weight loss (31%), dyspepsia (43%), and fatigue (26.1%). Anemia (26.1%), elevated transaminases (17.4%), low ferritin (11.4%), and hypovitaminosis D (9.3%) stood out, among others, in the initial laboratory work-up. The more frequent associated diseases were hypothyroidism (15.4%) and depressive disorder (11.4%). Small intestinal bacterial overgrowth was found in 10.1% and lactose malabsorption in 15.4%. The primary histologic diagnosis was celiac disease, with Marsh stage 3a villous atrophy (34.9%). CONCLUSION: Our results were similar to those of other case series on adults, finding that celiac disease was more frequent in women, disease began in the fourth decade of life, extraintestinal symptoms predominated, and there was an association with other autoimmune diseases. An important percentage of patients were also overweight and obese.

Breast cancer patient-reported outcomes on level 1 and level 2 oncoplastic procedures using BREAST-Q®.

PURPOSE: In breast cancer management not only mortality and surgical morbidity measurements are important but also patient satisfaction indexes. The authors evaluated the satisfaction and health-related quality of life (HRQOL) using the breast-conserving therapy (BCT) and breast reduction (BR) modules of BREAST-Q®. METHODS: This is a cross-sectional study that analyzed breast cancer patients consecutively submitted to breast surgery between January 2011 and April 2018 using two modules of BREAST-Q®. 968 patients were contacted and 232 answers were gathered: 171 patients submitted to oncoplastic level 1 surgery answered the BCT module and 61 submitted to oncoplastic level 2 surgery answered the BR module. Clinical data were retrieved from patients' medical records. RESULTS: Among the 232 questionnaires received, the median scores for psychosocial well-being, sexual well-being and (postoperative) satisfaction with breasts for BCT and BR modules were, respectively, 77.0 and 73.5 (p = 0.17); 62.0 and 53.0 (p = 0.14); 72.0 and 66.0 (p = 0.66). The median of adverse effects of radiation in the BCT module was 87.0. The median satisfaction with outcome in the BR module was 86.0. Both groups of patients revealed high scores of satisfaction with care. For the BCT patients, satisfaction with breasts strongly correlated with sexual well-being and was moderately correlated with psychosocial and physical well-being. For the BR patients, the satisfaction with outcome strongly correlated with satisfaction with medical team and moderately correlated with the remaining scales. CONCLUSION: Both oncoplastic surgery levels yielded similar satisfaction outcomes when assessed using BCT and BR modules of BREAST-Q®.

Evaluation of the Antimicrobial Effect on Enterococcus Faecalis of Bioceramic Cements with and without Silver Nanoparticles.

OBJECTIVE: To compare the antimicrobial effect of bioceramic endodontic cements with and without silver nanoparticles on Enterococcus faecalis. MATERIALS AND METHODS: Six groups were evaluated (n=8), and divided according to the materials: MTA Flow + AgNP ; MTA Flow Group; Bio C Repair + AgNP; Bio C Repair; PBS Cimmo + AgNP; PBS Cimmo. The groups were maintained for 72 h in the suspension of Enterococcus faecalis in Simulated Body Fluid (SBF). Samples of 100 µL were removed from the suspension at 0, 24, 48 and 72 h and seeded in triplicate in a Petri dish. Colony forming units (CFU) were counted using a colony counter. All procedures described were performed in a laminar flow chamber. Two-way ANOVA followed by Tukey's post hoc test and paired t-test were used for statistical analyses (α = 0.05). RESULTS: The addition of silver nanoparticles resulted in a statistically significant difference for MTA and CIMMO PBS cements (p⟨0.05), with the lowest bacterial growth being shown by the MTA group. For all groups, only the times of 48 and 72 h presented results without differences. CONCLUSION: The addition of silver nanoparticles to bioceramic cements was efficient to promote an acceleration of bacterial death.

Observation of Rayleigh-Lamb waves generated by the 2022 Hunga-Tonga volcanic eruption with the POLA detectors at Ny-Ålesund.

The eruption of the Hunga-Tonga volcano in the South Pacific Ocean on January 15, 2022, at about 4:15 UTC, generated a violent explosion, which created atmospheric pressure disturbances in the form of Rayleigh-Lamb waves detected all over the globe. Here we discuss the observation of the Hunga-Tonga shock-wave performed at the Ny-Ålesund Research Station on the Spitsbergen island, by the detectors of the PolarquEEEst experiment and their ancillary sensors. Online pressure data as well as the results of dedicated offline analysis are presented and discussed in details. Results include wave arrival times, wave amplitude measurements and wave velocity calculation. We observed five passages of the shock wave with a significance larger than 3 [Formula: see text] and an amplitude up to 1 hPa. The average propagation velocity resulted to be (308 ± 0.6) m/s. Possible effects of the atmospheric pressure variation associated with the shock-wave multiple passages on the cosmic-ray rate at ground level are also investigated. We did not find any significant evidence of this effect.

Clinical efficacy of sequential treatments in KRASG12C-mutant metastatic colorectal cancer: findings from a real-life multicenter Italian study (CRC-KR GOIM).

BACKGROUND: The presence of KRASG12C mutation in metastatic colorectal cancer (mCRC) correlates with poor outcome. Although different selective inhibitors are under clinical development, the optimal treatment remains uncertain. Thus, we conducted a retrospective analysis in a large cohort of patients with KRASG12C mCRC treated in 12 Italian oncology units. PATIENTS AND METHODS: Patients with unresectable mCRC harboring KRASG12C mutation receiving a first-line chemotherapy doublet or triplet between 2011 and 2021 were included in the study. Evaluation of overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) analysis was carried out. RESULTS: A total of 256/6952 (3.7%) patients with mCRC displayed KRASG12C mutation; of these, 111 met the inclusion criteria. The ORR of first-line therapy was 38.7% (43/111). Median PFS (mPFS) was 9 months [95% confidence interval (CI) 7.5-10.5 months]. After progression, only 62% and 36% of the patients are fit to receive second or third lines of treatment, with limited clinical benefit. Median OS (mOS) was 21 months (95% CI 17.4-24.6 months). In patients receiving first-line triplet chemotherapy, ORR was 56.3% (9/16), mPFS was 13 months (95% CI 10.3-15.7 months) and mOS was 32 months (95% CI 7.7-56.3 months). For irinotecan-based doublets, ORR was 34.5 (10/29), mPFS was 9 months (95% CI 6.4-11.6 months) and mOS was 22 months (95% CI 16.0-28.0 months). With oxaliplatin-based doublets ORR was 36.4% (24/62), mPFS was 7 months (95% CI 4.6-9.4 months) and mOS was 18 months (95% CI, 13.6-22.4 months). CONCLUSION: Patients with KRASG12C-mutant mCRC had a disappointing response to standard treatments. Within the limitations of a retrospective study, these results suggest that first-line chemotherapy intensification with FOLFOXIRI is a valid option in fit patients.

Maternofetal outcomes in early-onset gestational diabetes: does weight gain matter?

AIM: Women with early-onset gestational diabetes mellitus (GDM) have overall lower gestational weight gain (GWG) compared to those with later-onset GDM, albeit with usually worse maternofetal outcomes. We intent to investigate the association between inadequate GWG and maternofetal outcomes in pregnant women with early-onset GDM. METHODS: We performed a retrospective study of women with early-onset GDM based on the National Registry of GDM. Three study groups were defined according to the recommendations of the Institute of Medicine for GWG: excessive GWG (eGWG), adequate (aGWG) or insufficient (iGWG). RESULTS: A total of 8040 pregnant women were included: 27% (n = 2170) eGWG, 31% (n = 2492) aGWG and 42% (n = 3378) iGWG. Preeclampsia (4.3 vs 3 vs 1.6%, p < 0.001), polyhydramnios (3.1 vs 2.3 vs 1.8%, p = 0.008) and cesarean section (37.4 vs 34.1 vs 29.5%, p < 0.001) were significantly more frequent among women with eGWG. Additionally, there was a higher frequency of macrosomia (8.1 vs 3.6 vs 2.4%, p < 0.001), large-for-gestational-age (8.2 vs 3.7 vs 2.6%, p < 0.001) and birth trauma (2.6 vs 1.5 vs 1.1%, p < 0.001) in this group. On the other hand, fetal death (0.2 vs 0.2 vs 0.5%, p = 0.04), small-for-gestational-age (9 vs 10.3 vs 14.9, p < 0.001) and preterm delivery (5.6 vs 7.1 vs 7.5%, p = 0.03) were more frequent in iGWG group. CONCLUSIONS: Over two-thirds of pregnant women with early-onset GDM had inappropriate GWG, which was significantly associated with adverse maternofetal outcomes. Weight management must be a focus of special attention in women with early-onset GDM, beyond glycemic control, to achieve healthy pregnancy outcomes.

Role of molecular genetics in the clinical management of cholangiocarcinoma.

The incidence of cholangiocarcinoma (CCA) has steadily increased during the past 20 years, and mortality is increasing. The majority of patients with CCA have advanced or metastatic disease at diagnosis, and treatment options for unresectable disease are limited, resulting in poor prognosis. However, recent identification of targetable genomic alterations has expanded treatment options for eligible patients. Given the importance of early and accurate diagnosis in optimizing patient outcomes, this review discusses best practices in CCA diagnosis, with a focus on categorizing molecular genetics and available targeted therapies. Imaging and staging of CCAs are discussed, as well as recommended biopsy collection techniques, and molecular and genomic profiling methodologies, which have become increasingly important as molecular biomarker data accumulate. Approved agents targeting actionable genomic alterations specifically in patients with CCA include ivosidenib for tumors harboring IDH1 mutations, and infigratinib and pemigatinib for those with FGFR2 fusions. Other agents currently under development in this indication have shown promising results, which are presented here.

Covid-19 vaccine dissemination: A public health ethical evaluation of Pennsylvania's plan during Phase 1A.

Background: The novel COVID-19 pandemic afforded public health leaders an opportunity to expedite vaccine development and dissemination. The United States found itself faced with the arduous task of ensuring swift and equitable distribution of limited resources, in the midst of often-competing priorities, including public health ethics, medical ethics, economic demands, and societal strains. Methodology: Using the American Public Health Association's (APHA) newly revised public health code of ethics, which provides a decision-making framework and guidance for ethical analysis, we analyzed how Pennsylvania's COVID-19 vaccine dissemination plan aligned with the four core functions of public health ethics inquiry. Results/Discussion: Upon investigation, the state's plan evidenced use of public health ethics in goal setting and design. However, the core public health value given the highest priority, promoting health and safety, competed with the other core public health values of inclusivity and engagement, health justice and equity, and professionalism and trust. Despite known social disparities and risk factors, the state plan for COVID-19 vaccine dissemination aligned closely with federal guidance and prioritized all healthcare personnel and long-term care facility populations over high-risk individuals residing in the community. Conclusion/Perspectives: Should another pandemic necessitate allocation of scarce resources, especially preventative measures such as vaccines, decision-making agencies must consider disparate populations in planning and dissemination of material to the public. Any anticipated limitations in the ability to fulfill public health ethical principles should be clearly communicated to the public prior to implementation, thereby increasing trust.

Unlocking Andean sigmodontine diversity: five new species of Chilomys (Rodentia: Cricetidae) from the montane forests of Ecuador.

The Andean cloud forests of Ecuador are home to several endemic mammals. Members of the Thomasomyini rodents are well represented in the Andes, with Thomasomys being the largest genus (47 species) of the subfamily Sigmodontinae. Within this tribe, however, there are genera that have escaped a taxonomic revision, and Chilomys Thomas, 1897, constitutes a paradigmatic example of these "forgotten" Andean cricetids. Described more than a century ago, current knowledge of this externally unmistakable montane rodent is very limited, and doubts persist as to whether or not it is monotypic. After several years of field efforts in Ecuador, a considerable quantity of specimens of Chilomys were collected from various localities representing both Andean chains. Based on an extensive genetic survey of the obtained material, we can demonstrate that what is currently treated as C. instans in Ecuador is a complex comprising at least five new species which are described in this paper. In addition, based on these noteworthy new evidence, we amend the generic diagnosis in detail, adding several key craniodental traits such as incisor procumbency and microdonty. These results indicate that Chilomys probably has a hidden additional diversity in large parts of the Colombian and Peruvian territories, inviting a necessary revision of the entire genus.

Initial experience with targeted axillary dissection after neoadjuvant therapy in breast cancer patients.

BACKGROUND: Targeted axillary dissection (TAD) combines sentinel node biopsy (SNB) with the removal of the previously marked metastatic node. TAD is a promising concept for axillary restaging in node-positive breast cancer patients with pathological complete response (pCR) to neoadjuvant therapy (NAT). We aimed to evaluate TAD feasibility in this context. METHODS: A prospective observational study was conducted in biopsy-confirmed cN1 patients. The removal of the clipped node (CN) was guided by intraoperative ultrasound. SNB used indocyanine green and patent blue V dye. If the CN or sentinel lymph nodes (SLN) had any metastatic foci, or the TAD procedure was unsuccessful, the patient underwent axillary lymph node dissection (ALND). RESULTS: Thirty-seven patients were included. TAD and SNB identification rates were 97.3%. Every retrieved CN was also a SLN. At the individual level, SNB identification rate was 89.2% with indocyanine green and 85.5% with patent blue V dye. The CN identification rate was 81.1%, being higher when the CN was localized on the intraoperative ultrasound (84.4% vs 60.0%). Nodal pCR was achieved by 54.1% of our patients and was more frequent in HER2-positive and triple-negative tumors (p = 0.039). Nineteen patients were spared from ALND. CONCLUSION: TAD with intraoperative ultrasound-guided excision of the CN and SNB with indocyanine green and patent blue V dye is a feasible concept to identify patients without axillary residual disease after NAT, that can be spared from ALND, although the need for marking the biopsied node should be further investigated.

Cow's Milk in Human Nutrition and the Emergence of Plant-Based Milk Alternatives.

Cow's milk is considered a complete food, providing high-quality protein and essential micronutrients, including vitamins and minerals. For medical reasons or as a lifestyle choice, consumers are replacing cow's milk with plant-based milk alternatives (PBMA); some perceive them as healthier alternatives to cow's milk due to their low saturated fatty acid content and no cholesterol content. However, the nutritional composition of PBMA is quite variable between different types and even within, which makes a comparison with cow's milk a complex issue. Furthermore, the consumption of PBMA has been associated with the development of some diseases in infants and children. Meanwhile, the consumption of cow's milk in human health is a controversial issue since it has been associated with a favorable effect in some diseases (such as obesity, type 2 diabetes, and Alzheimer's) and a negative effect in others (such as prostate cancer risk and Parkinson's disease); while in some diseases, there is no consensus in the cow's milk consumption effect. The aim of this review is to make a nutritional comparison of cow's milk with PBMA and to clarify the potential health issues related to their consumption.

Moving Beyond the Status Quo of Integrated Inpatient Medical and Psychiatric Care Units: The Path to Real-World Evaluation.

Integrated inpatient medical and psychiatric care units (IMPUs) are hospital wards that care for inpatients with both acute general medical and psychiatric disorders. IMPU development has stalled, and wide variation in IMPU designs may reflect the fact that IMPUs are still in an early evolutionary stage. High-quality evidence concerning the costs and effectiveness of IMPUs is sparse, because IMPUs do not lend themselves well to traditional evidence-based medicine methods. As a result, most studies of IMPUs have been only observational. Therefore, it is time for a different approach, in which goals for IMPUs are explicitly formulated and IMPU research is incorporated into evidence-based practice (EBP) instead of evidence-based medicine. EBP can be viewed as integrating best available evidence into organizational practices by using four pillars of evidence: organizational, experiential, stakeholder, and scientific. Such types of evidence require an investment in describing the field more precisely. When pragmatic reasoning, where clinical expertise and organizational needs determine IMPU designs, is replaced with EBP, researchers can more effectively perform studies that may convince health care policy makers that IMPUs represent a cost-effective way to improve patients' health and that they increase the well-being of both patients and hospital staff.

Assays of genotoxic damage in peripheral blood lymphocytes of individuals occupationally exposed to different x-ray systems in hospital radiology departments.

We obtained peripheral blood lymphocyte samples from individuals occupationally exposed to X-rays in hospital radiology departments that use different radiology systems: analog film (AF), computerized radiology (CR), or digital radiology (DR). The micronucleus test (MNT) and comet assay were performed on the samples. Micronucleus cell counts (means vs. controls, i.e., individuals not occupationally exposed to ionizing radiation) were as follows: AF, 1.96 ± 0.21 vs 1.2 ± 0.25; CR, 1.89 ± 0.15 vs 1.31 ± 0.36; and DR, 1.75 ± 0.11 vs 1.59 ± 0.32. For the comet assay, damage scores were as follows; AF, 0.84 ± 0.22 vs 0.47 ± 0.04; CR, 0.64 ± 0.26 vs 0.43 ± 0.04; and DR, 0.56 ± 0.19 vs 0.49 ± 0035. These findings were consistent with cytogenetic damage due to radiation exposure.

The molecular profiling of solid tumors by liquid biopsy: a position paper of the AIOM-SIAPEC-IAP-SIBioC-SIC-SIF Italian Scientific Societies.

The term liquid biopsy (LB) refers to the use of various biological fluids as a surrogate for neoplastic tissue to achieve information for diagnostic, prognostic and predictive purposes. In the current clinical practice, LB is used for the identification of driver mutations in circulating tumor DNA derived from both tumor tissue and circulating neoplastic cells. As suggested by a growing body of evidence, however, there are several clinical settings where biological samples other than tissue could be used in the routine practice to identify potentially predictive biomarkers of either response or resistance to targeted treatments. New applications are emerging as useful clinical tools, and other blood derivatives, such as circulating tumor cells, circulating tumor RNA, microRNAs, platelets, extracellular vesicles, as well as other biofluids such as urine and cerebrospinal fluid, may be adopted in the near future. Despite the evident advantages compared with tissue biopsy, LB still presents some limitations due to both biological and technological issues. In this context, the absence of harmonized procedures corresponds to an unmet clinical need, ultimately affecting the rapid implementation of LB in clinical practice. In this position paper, based on experts' opinions, the AIOM-SIAPEC-IAP-SIBIOC-SIF Italian Scientific Societies critically discuss the most relevant technical issues of LB, the current and emerging evidences, with the aim to optimizing the applications of LB in the clinical setting.

Mild periconceptional hyperglycemia: predictor of adverse fetomaternal outcomes in gestational diabetes?

AIM: To clarify whether mild first trimester hyperglycaemia (characteristic of early-onset GDM) is associated with higher incidence of congenital malformations and other adverse fetomaternal outcomes compared to women with second trimester hyperglycaemia (later-onset GDM). DESIGN AND METHODS: We analyzed the Portuguese National GDM database, containing data collected between 2011 and 2017. Two study groups were defined: Group 1-Women with GDM diagnosed during the first trimester (with fasting glycemia ≥ 92 and < 126 mg/dL); Group 2-Women with GDM diagnosed after the first 12 weeks of gestation, with either fasting glycemia or oral glucose tolerance test, according to the International Association of Pregnancy and Diabetes Study Group criteria. The fetomaternal characteristics of each group were compared. RESULTS: A total of 18.518 pregnant women diagnosed with GDM were included which 34.4% of them belonged to Group 1. Pregnant women from this group were significantly younger and had a higher median BMI than the women from the other group. Overall, there was no significant differences in maternal morbidity parameters between groups. Non-evolutive pregnancies were significantly more frequent along the present gestation in the group 1 (1.1% vs. 0.1%, p < 0.001), as was fetal death (0.6% vs. 0.2%, p < 0.001). Congenital malformations did not differ significantly between groups (3.2% vs. 2.8%, p = 0.155). CONCLUSIONS: The mild near conceptional hyperglycaemic state characteristic of an early-onset GDM seems to be associated with an increased prevalence of non-evolutive pregnancies and foetal deaths when compared to later-onset GDM.