Pre-prandial plasma liver-expressed antimicrobial peptide 2 (LEAP2) concentration in humans is inversely associated with hunger sensation in a ghrelin independent manner.

PURPOSE: The liver-expressed antimicrobial peptide 2 (LEAP2) is a newly recognized peptide hormone that acts via the growth hormone secretagogue receptor (GHSR) blunting the effects of ghrelin and displaying ghrelin-independent actions. Since the implications of LEAP2 are beginning to be elucidated, we investigated if plasma LEAP2 concentration varies with feeding status or sex and whether it is associated with glucose metabolism and appetite sensations. METHODS: We performed a single test meal study, in which plasma concentrations of LEAP2, ghrelin, insulin and glucose as well as visual analogue scales for hunger, desire to eat, prospective food consumption, fullness were assessed before and 60 min after breakfast in 44 participants (n = 21 females) with normal weight (NW) or overweight/obesity (OW/OB). RESULTS: Pre-prandial plasma LEAP2 concentration was ~ 1.6-fold higher whereas ghrelin was ~ 2.0-fold lower in individuals with OW/OB (p < 0.001) independently of sex. After adjusting for body mass index (BMI) and sex, pre-prandial plasma LEAP2 concentration displayed a direct relationship with BMI (ß: 0.09; 95%CI: 0.05, 0.13; p < 0.001), fat mass (ß: 0.05; 95%CI: 0.01, 0.09; p = 0.010) and glycemia (ß: 0.24; 95%CI: 0.05, 0.43; p = 0.021), whereas plasma ghrelin concentration displayed an inverse relationship with BMI and fat mass but not with glycemia. Postprandial plasma LEAP2 concentration increased ~ 58% in females with OW/OB (p = 0.045) but not in females with NW or in males. Pre-prandial plasma LEAP2 concentration displayed an inverse relationship with hunger score (ß: - 11.16; 95% CI: - 18.52, - 3.79; p = 0.004), in a BMI-, sex- and ghrelin-independent manner. CONCLUSIONS: LEAP2 emerges as a key hormone implicated in the regulation of metabolism and appetite in humans. TRIAL REGISTRATION: The study was retrospectively registered in clinicaltrials.gov (April 2023). CLINICALTRIALS: gov Identifier: NCT05815641.

Incidence of acute otitis media from 2003 to 2019 in children ≤ 17 years in England.

BACKGROUND: The 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in 2006 and the 13-valent pneumococcal conjugate vaccine (PCV13) in 2010 in the UK. PCVs are active immunization for the prevention of invasive disease, pneumonia and acute otitis media (AOM) caused by Streptococcus pneumoniae in children. The aim of this observational study was to estimate incidence rates (IRs) of AOM in children ≤17 years from 2003 to 2019 in England, before and after the introduction of pneumococcal conjugate vaccines (PCVs). METHODS: AOM episodes were identified using Read diagnosis codes in children aged ≤17 years in the Clinical Practice Research Datalink (CPRD) Gold database from 2003 to 2019. Annual IRs with 95% confidence intervals (CI) by age group were calculated as the number of episodes/person-years (PY) at risk. Interrupted time series analyses were conducted to estimate incidence rate ratios (IRR) across post-PCV7 (2007-2009), early post-PCV13 (2011-2014) and late post-PCV13 (2015-2019) periods compared to the pre-PCV7 period (2003-2005) using generalized linear models. RESULTS: From 2003 to 2019, 274,008 all-cause AOM episodes were identified in 1,500,686 children. The overall AOM IR was 3690.9 (95% CI 3677.1-3704.8) per 100,000 PY. AOM IRs were highest in children aged < 5 years and decreased by age; < 2 years: 8286.7 (95% CI 8216.8-8357.1); 2-4 years: 7951.8 (95% CI 7902.5-8001.4); 5-17 years: 2184.4 (95% CI 2172.1-2196.8) (per 100,000 PY). Overall AOM IRs declined by 40.3% between the pre-PCV7 period and the late-PCV13 period from 4451.9 (95% CI 4418.1-4485.9) to 2658.5 (95% CI 2628.6-2688.7) per 100,000 PY, and across all age groups. IRRs indicated a significant decrease in AOM IRs in all the post-vaccination periods, compared to the pre-PCV7 period: post-PCV7 0.87 (95% CI 0.85-0.89), early post-PCV13 0.88 (95% CI 0.86-0.91), and late post-PCV13 0.75 (95% CI 0.73-0.78). CONCLUSIONS: The AOM IRs declined during the 2003-2019 period; however, the clinical burden of AOM remains substantial among children ≤17 years in England.

Real world safety of methoxyflurane analgesia in the emergency setting: a comparative hybrid prospective-retrospective post-authorisation safety study.

BACKGROUND: Low-dose analgesic methoxyflurane (Penthrox®) was approved in Europe for emergency relief of moderate to severe pain in conscious adults with trauma in 2015. A comparative post-authorisation safety study (PASS) was conducted to assess the risk of hepatotoxicity and nephrotoxicity with methoxyflurane during routine clinical practice. METHODS: This was a comparative hybrid prospective-retrospective cohort study. The comparative cohorts consisted of adults who were given methoxyflurane (methoxyflurane cohort) or another analgesic (concurrent cohort) routinely used for moderate to severe trauma and associated pain in the emergency setting (ambulance and Emergency Department) in the UK between December 2016 and November 2018. Hepatic and renal events were captured in the ensuing 12 weeks. A blinded clinical adjudication committee assessed events. A historical comparator cohort (non-concurrent cohort) was identified from patients with fractures in the English Hospital Episode Statistics (HES) accident and emergency database from November 2013 and November 2015 (before commercial launch of methoxyflurane). Hepatic and renal events were captured in the ensuing 12 weeks via linkage with the Clinical Practice Research Datalink (CPRD) and HES hospital admissions databases. RESULTS: Overall, 1,236, 1,101 and 45,112 patients were analysed in the methoxyflurane, concurrent and non-concurrent comparator cohorts respectively. There was no significant difference in hepatic events between the methoxyflurane and concurrent cohorts (1.9% vs. 3.0%, P = 0.079) or between the methoxyflurane and non-concurrent cohorts (1.9% vs. 2.5%, P = 0.192). Renal events were significantly less common in the methoxyflurane cohort than in the concurrent cohort (2.3% vs. 5.6%, P < 0.001). For methoxyflurane versus non-concurrent cohort the lower occurrence of renal events (2.3% vs. 3.2%, P = 0.070) was not statistically significant. Multivariable adjustment did not change these associations. CONCLUSIONS: Methoxyflurane administration was not associated with an increased risk of hepatotoxicity or nephrotoxicity compared with other routinely administered analgesics and was associated with a reduced risk of nephrotoxicity compared with other routinely administered analgesics. TRIAL REGISTRATION: Study registered in the EU PAS Register (ENCEPP/SDPP/13040).

Primary Cardiac Triple-Hit Lymphoma.

Cardiac double-hit and triple-hit lymphomas (DHLs, THLs) are rare; in fact, studies examining both DHL and THL remain scarce. THL with cardiac involvement constitutes a rare disease with few cases reported so far. Thus, in this study, we report the case of a 67-year-old woman who presented with initial symptoms of pulmonary embolism. Upon further evaluation, a right atrial mass was detected incidentally, and this was surgically removed under the assumption of a cardiac myxoma. Later, immunohistochemistry analysis of the mass revealed a THL. Aggressive treatment with chemotherapy was necessary; however, the patient refused treatment and had a poor prognosis.

[IGG4-related disease. Report of 52 patients]. / Enfermedad relacionada a IgG4. Serie clínica de pacientes chilenos.

BACKGROUND: IgG4-related disease (IgG4 RD) is an immune-mediated fibro-inflammatory disorder, with tissue infiltration of IgG4+ plasma cells. It causes pseudotumors, tumors, and a wide spectrum of clinical manifestations. AIM: To report the clinical, laboratory, histopathological and treatment characteristics of a group of Chilean patients with IgG4 RD. MATERIAL AND METHODS: Review of medical records of 52 patients aged 18 to 76 years with IgG4 RD seen at six medical centers. RESULTS: Elevated IgG4 serum levels (> 135 mg/dl) were found in 18 of 44 (41%) patients. There was histological confirmation of the disease in 46 patients. The most common sites of involvement were lungs, eyes and kidneys. Eighteen (35%) patients had only one organ involved, 34 (65%) patients had two organs and 13 (25%) patients had three or more organs. The involvement of two organs was significantly more common in men (p < 0.05). In patients with only one organ involvement, the most frequent location was orbital and meningeal. All patients with kidney or lung disease had multiorgan involvement. All patients received corticosteroid therapy, 67% synthetic immunosuppressants, and 16% rituximab. CONCLUSIONS: ER-IgG4 can affect any tissue. Multiorgan involvement was more common in this series, with preference for lungs, eyes and kidneys. An excellent response to steroids is characteristic of the disease, but with a high relapse rate that requires additional immunosuppression.

Linking process indicators and clinical/safety outcomes to assess the effectiveness of abatacept (ORENCIA) patient alert cards in patients with rheumatoid arthritis.

PURPOSE: Patient alert cards (PACs) for abatacept (ORENCIA) inform patients and healthcare professionals (HCPs) about the risk of infections and allergic reactions. The study evaluates the effectiveness of the PACs in rheumatoid arthritis patients and HCPs, using process indicators (awareness, receipt, utility, knowledge, behaviour) and outcomes. METHODS: Surveys of patients and HCPs in five European countries. A retrospective chart review permitted linking clinical and safety outcomes with survey responses. RESULTS: Data on 190 patients and 79 HCPs (50 physicians and 29 nurses) were analysed. Sixty percent of patients were aware of the PAC, of whom 95% had received it. Knowledge of risk of infection was higher among patients who had received the PAC vs those who had not (64% vs 46%; P = .013). Infections leading to hospitalisation increased with decreasing patient survey global scores: scores of ≥67%, 34%-67% and ≤ 33% were associated with hospitalisation rates of 2.5%, 5.2% and 8.4%, respectively (P = .4). Among HCPs 90% were aware and 68% had accessed the PAC. More nurses than physicians were aware (93% vs 88%), had accessed (78% vs 74%), read (90% vs 59%), distributed (81% vs 66%) and explained the content (94% vs 43%) of the PAC. Knowledge of risk of infection was higher among HCPs who had (91%) vs those who had not (73%) accessed the PAC (P = .053). CONCLUSIONS: PACs were effective in improving knowledge of key safety messages in patients and HCPs. This novel study design bridges the gap of linking process indicators with outcomes in the same patients, thereby strengthening the clinical relevance of patient surveys.

Pre/post effectiveness evaluation of updated additional risk minimisation measures for an orphan disease: Myozyme (alglucosidase alfa) Safety Information Packet.

BACKGROUND: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs. METHODS: A two-wave pre-post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP. Changes between the waves were analysed. RESULTS: Forty-six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P = .024) with a tendency for increases in the appropriate performance of all types of testing in W2. CONCLUSIONS: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes.

[Lymphadenopathies in patients with rheumatic diseases. Review of 19 cases]. / Poliadenopatías de origen reumatológico y las claves del diagnóstico diferencial: Análisis de 19 casos.

BACKGROUND: The presence of multiple lymphadenopathies can be a diagnostic challenge. AIM: To describe the clinical, laboratory and imaging characteristics of 19 patients with lymphadenopathies of rheumatologic origin. MATERIAL AND METHODS: Review of medical records of 19 patients aged 16 to 72 years (68%) with lymphadenopathies presumably secondary to a rheumatic disease. RESULTS: Six patients had systemic lupus erythematosus, six had Sjogren's disease, three had sarcoidosis, two had rheumatoid arthritis, one had IgG4 related disease and one had mixed connective tissue disease. A lymph node biopsy was performed in 11 patients and in eight a lymphoid follicular hyperplasia was found. Systemic symptoms were reported by 68% of patients. Blood lactate dehydrogenase was elevated only in cases associated with hemolytic anemia. There was no specific or predictable localization of the lymphadenopathies in imaging studies, except in the cases of sarcoidosis. The average size of the lymphadenopathies was 13.5 mm in diameter in short axis and there was no presence of necrosis, calcification, or conglomerate formation. Only one case presented splenomegaly. All patients responded favorably to corticosteroids. CONCLUSIONS: Lymphadenopathies associated with rheumatologic diseases can occur in a wide variety of diseases, especially systemic lupus erythematosus and Sjögren's disease. The absence of LDH elevation and splenomegaly and the absence of imaging findings such as conglomerates can orient to a rheumatologic origin.

[Cost-effectiveness assessment through theoretical cost-minimization analysis of the use of two gastro-resistant modified-release mesalazine formulations in the management of ulcerative colitis in Spain]. / Evaluación de coste-efectividad mediante análisis teórico de minimización de costes del uso de dos mesalazinas gastrorresistentes de liberación prolongada en el manejo de la colitis ulcerosa en España.

INTRODUCTION: The prevalence of ulcerative colitis (UC) and its associated economic burden is increasing in Spain. Oral mesalazines, which are the recommended first-line treatment for mild-moderate UC, show considerable variability in their formulations and prices. OBJECTIVE: To carry out a cost-effectiveness assessment of the use of the two formulations of oral gastro-resistant modified-release mesalazine formulations marketed in Spain (Salofalk(®) and Mezavant(®)) for the phases of induction of remission and its maintenance. METHODS: We adapted internationally validated economic models for the management of UC to the Spanish setting. The adaptation focused on the use of oral gastro-resistant modified-release mesalazines. We conducted cost minimization analyses of remission induction (decision tree) and remission maintenance (Markov model). RESULTS: For the remission induction, Salofalk(®) 3 g/day was superior to (same effectiveness at lower costs) Mezavant(®) 3.6 g/day and 4.8 g/day in any treatment strategy that included oral gastro-resistant modified-release mesalazines. When compared with Mezavant(®) 2.4 g/day, Salofalk(®) was the most cost-effective option. For remission maintenance, all treatment strategies using Salofalk(®) were the most cost-effective option in all the scenarios considered. CONCLUSION: Because of the lower cost per gram of Salofalk(®), any treatment strategy based on this drug is more cost-effective than Mezavant(®) for the treatment of mild-moderate UC, whether for the induction of remission or for its maintenance.

Vegetation patches improve the establishment of Salvia mexicana seedlings by modifying microclimatic conditions.

Human disturbance has disrupted the dynamics of plant communities. To restore these dynamics, we could take advantage of the microclimatic conditions generated by remaining patches of vegetation and plastic mulch. These microclimatic conditions might have great importance in restoring disturbed lava fields located south of Mexico City, where the rock is exposed and the soil is shallow. We evaluated the effects of both the shade projected by vegetation patches and plastic mulch on the mean monthly soil surface temperature (Tss) and photosynthetic photon flux density (PPFD) and on the survival and growth of Salvia mexicana throughout the year. This species was used as a phytometer of microsite quality. Shade reduced the T ss to a greater extent than mulch did. Both survival and growth were enhanced by shade and mulch, and the PPFD was related with seedling growth. During the dry season, plant biomass was lost, and there was a negative effect of PPFD on plant growth. At micro-meteorological scales, the use of shade projected by patches of vegetation and mulch significantly reduced the mortality of S. mexicana and enhanced its growth. Survival and growth of this plant depended on the environmental quality of microsites on a small scale, which was determined by the environmental heterogeneity of the patches and the landscape. For plant restoration, microsite quality must be evaluated on small scales, but on a large scale it may be enough to take advantage of landscape shade dynamics and the use of mulch to increase plant survival and growth.

Exploring factors associated with obesity in Argentinian children using structural equation modeling.

Habits and behaviors related to obesity risk are strongly associated with the family environment and are affected by socioeconomic factors. Structural equation modeling (SEM) allows us to hypothesize on how the relationships between these factors occur and measure their impact. This study aimed to explore the relationship between family socioeconomic indicators and childhood obesity, mediated by habits linked to energy balance, applying a SEM. A cross sectional study was performed on 861 Argentinian schoolchildren aged 6-12 years, from 2015 to 2016. The model included three latent variables: socioeconomic status, healthy habits, and obesity. Socioeconomic status indicators and healthy habits were surveyed by self-administered parental questionnaires, whereas obesity indicators were evaluated with anthropometry. The applied model showed an acceptable fit (NFI = 0.966; CFI = 0.979; RMSEA = 0.048). Socioeconomic status positively influenced parental education, health insurance, and car possession, while negatively influenced crowding (p < 0.001). Healthy habits significantly influenced physical activity, meals frequency, and sleep hours, while negatively influenced sedentary hours and mother's nutritional status (p < 0.001). Obesity factor positively influenced body mass index, body fat, and waist-to-height ratio (p < 0.001). Finally, socioeconomic status positively influenced health habits, which in turn negatively influenced obesity factor. Healthy habits (especially physical activity and mother's nutritional status) mediated the relationship between socioeconomic status and child obesity. Further research should include other indicators related to diet, eating habits, and physical activity like neighborhood characteristics.

[Integrated mother-child care. Effects on adherence and knowledge of contraceptive methods]. / Atención integrada madre-niño. Efectos sobre adherencia y conocimientos de métodos anticonceptivos.

INTRODUCTION: Scientific evidence suggests that mother-child joint care strategies would facilitate knowledge of contraceptive methods (MAC) and their access. The objective was to evaluate the effect of the Integrated Mother and Child Care Model on adherence and knowledge of CAM in women during the first postpartum semester. METHODS: An intervention study was carried out, 2 groups were formed, GI: intervention group (3 controls up to 6 months postpartum) and GC: control group (one control at 6 months postpartum). The intervention consisted of face-to-face counseling about MAC combined with informative brochures and WhatsApp⌖ messages. Sociodemographic data, gynecological and obstetric history, use and knowledge of contraceptive methods were collected. Adherence to the use and knowledge of MAC were compared in both groups at 6 months postpartum. The analysis was performed using R software version 4.0.3. RESULTS: Thirty-nine women were incorporated into each group. A difference was found in the use of MAC between groups at 6 months (92.3% vs. 64.1%), its use being higher in GI. Significant differences were found in the knowledge of some MAC at 6 months. A higher percentage of women in GI knew about birth control pills (p = 0.009), tubal ligation (p = 0.04) and vasectomy (p = 0.010), compared to GC. DISCUSSION: Early postpartum intervention with various communication and information strategies can be useful to choose the MAC that is considered most appropriate for each woman and its correct use.

Introducción: La evidencia científica sugiere que estrategias de atención conjunta madre-hijo facilitarían el conocimiento de métodos anticonceptivos (MAC) y su acceso. El objetivo fue evaluar el efecto del Modelo de atención integrada de la madre y el niño sobre la adherencia y conocimientos de MAC en mujeres durante el primer semestre postparto. Métodos: Se realizó un estudio de intervención, se conformaron 2 grupos, GI: grupo de intervención (3 controles hasta los 6 meses postparto) y GC: grupo control (un control a los 6 meses postparto). La intervención consistió en asesoramiento presencial acerca de MAC combinada con folletería informativa y mensajes de WhatsApp⌖. Se recabaron datos sociodemográficos, antecedentes gineco-obstétricos, uso y conocimientos de MAC. Se comparó la adherencia al uso y el conocimiento de MAC en ambos grupos a los 6 meses post parto. El análisis se realizó mediante el software R versión 4.0.3. Resultados: Se incorporaron 39 mujeres en cada grupo. Se halló una diferencia en el uso de MAC entre grupos a los 6 meses (92.3% vs. 64.1%), siendo más elevado su uso en el GI. Se hallaron diferencias significativas en el conocimiento de algunos MAC a los 6 meses. Un mayor porcentaje de mujeres del GI conocía las pastillas anticonceptivas (p = 0.009), ligadura de trompas (p = 0.04) y la vasectomía (p = 0.010), en comparación con el GC. Discusión: La intervención en el postparto temprano con diversas estrategias de comunicación e información pueden ser útiles para elegir el MAC que se considere más adecuado para cada mujer y su utilización correcta.

Leptin receptor expression in blood mononuclear cells of lactating women is associated with infant body weight: Potential role as a molecular biomarker.

BACKGROUND: Molecular biomarkers of maternal leptin resistance associated with infant weight are needed. OBJECTIVES: To evaluate gene expression of leptin receptor (LEPR), suppressor of cytokine signalling 3 (SOCS3) and insulin receptor in peripheral blood mononuclear cells (PBMCs) of lactating women and their relationship with infant body weight and adiposity. METHODS: At day 10 postpartum, maternal gene expression in PBMCs as well as leptin and insulin concentrations in plasma and milk were assessed (n = 68). Infant weight and BMI z-scores, skinfolds and arm circumference were obtained at 10 days and/or at 3 months old. RESULTS: In mothers with pre-pregnancy overweight or obesity (OW/OB), LEPR expression was reduced (p = 0.013) whereas plasma and milk leptin and milk insulin concentrations were elevated. LEPR expression was positively related with infant weight z-score (Beta (95% CI): 0.40 (0.17, 0.63), p = 0.001) but not with leptin concentrations. SOCS3 expression was positively related with infant weight z-score (Beta (95% CI): 0.28 (0.04, 0.51), p = 0.024) and arm circumference (Beta (95% CI): 0.57 (0.32, 0.82), p < 0.001). Relationships remained significant after adjusting for maternal and infant confounders. CONCLUSIONS: LEPR and SOCS3 gene expression in PBMCs are novel maternal molecular biomarkers that reflect leptin resistance and are associated with infant body weight and adiposity.

Dietary Patterns in the Argentinian Population and Their Association With Sociodemographic Characteristics: Results From the ELANS Study (2014-2015).

Aim: To describe dietary patterns in the Argentinian population and their association with sociodemographic characteristics. Methods: Cross-sectional analysis of Argentina's food consumption and sociodemographic data of 1,266 men and women between 15 and 65 years from the Latin American Study of Nutrition and Health carried out between March 2014 and December 2015. Dietary patterns were identified by using factor analysis and median factor scores were calculated for gender, age, region, body mass index (BMI), socioeconomic, education, and physical activity categories. Results: Five dietary patterns were identified. Western, Local Western, and Rural were generally characterized by high consumptions of animal fats, sugar-sweetened beverages, meats or processed meats, pizza and empanadas, sweets, pastries, and low consumption of fruits and vegetables. Traditional pattern was mainly characterized by consumption of oils, starchy vegetables, and red meat and Sweet Prudent by milk and yogurt, vegetables, fruit, artificially sweetened beverages, sweets, and cookies. Higher adherence to the Sweet Prudent pattern was observed in women, in people who meet physical activity guidelines and higher socioeconomic and educational levels. Higher adherence to traditional pattern was only observed for men. Higher adherence to the rest of the patterns was observed mostly by men, young, leaner, lower socioeconomic, and educational levels, not meeting physical activity guidelines, from the metropolitan area of Buenos Aires or northern regions. Conclusion: Food consumption in Argentina is expressed in a diversity of dietary patterns. Men, younger, and sedentary individuals, with lower socioeconomic and educational level, from the metropolitan area of Buenos Aires and northern regions, seem to have higher adherence to least healthy dietary patterns.

Localised neuropathic pain in the primary care setting: a cross-sectional study of prevalence, clinical characteristics, treatment patterns, quality of life and sleep performance.

BACKGROUND: Localised Neuropathic Pain (LNP) is challenging to diagnose and manage in primary care. OBJECTIVE: To describe clinical characteristics, treatment patterns, quality of life and sleep performance of patients with LNP and estimate its prevalence in primary care. METHODS: Cross-sectional study in 4 European countries. Patients were identified using a screening tool for LNP. Patients completed the EQ-5D VAS score and Chronic Pain Sleep Inventory (CPSI). RESULTS: There were 1030 LNP patients for analysis. They presented a median pain intensity of 6.0 (IQR 4.0-7.0) with a median duration of 30.9 months (IQR 12.0-75.3), despite 97% receiving pain treatment. Main sites affected were the limbs (62% upper/58% lower) and spine (41%). Main aetiologies were neuropathic low back pain (47%), post-surgical neuropathic pain (17%), and diabetic poly-neuropathy (12%). Thirty percent received a single analgesic (2% topical), while combinations comprised 43% systemic-systemic, 24% topical-systemic, 1% topical-topical. Medications included NSAIDs (45%), anticonvulsants (38%), WHO step 2 opioids (35%), and topical analgesics (27%). In the previous 6 months, 40% had switched treatment. The mean (SD) EQ-5D VAS score was 58 (22.3) and the mean (SD) EQ-5D summary score (UK tariff) was 0.62 (0.25). Patients had a CPSI mean index of 41/100, and sleeping pills were used by 33% of patients. The standardized prevalence of LNP by age and sex was 2.01% in the general population and 43.3% among chronic pain patients. CONCLUSIONS: Many LNP patients reported pain intensities of six on a ten-point scale in average for durations longer than 2.5 years, with quality of life and sleep performance affected, with frequent treatment combinations and switches, suggesting suboptimal pain management.

Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union.

BACKGROUND: A Guide for Healthcare Professionals (HCP Guide) and patient alert card (PAC) for atezolizumab as additional risk minimization measures for physicians were distributed to raise awareness and help in the detection and management of immune-related adverse drug reactions. OBJECTIVES: The main objective of this study was to assess the receipt, knowledge, and behaviors of physicians regarding the atezolizumab HCP Guide and PAC. METHODS: A multi-country, one-wave, observational, cross-sectional, web-based, self-reported physician survey was conducted to assess the level of knowledge of key messages related to immune-related adverse drug reactions summarized in the atezolizumab HCP Guide and PAC among physicians (oncologists, pulmonologists, and urologists) prescribing atezolizumab in six European countries (Denmark, Germany, Italy, Spain, Sweden, and the UK). Responses regarding the receipt, understanding and use of the materials, and knowledge and behavior related to the HCP Guide and PAC are presented as percentages and continuous scores scaled out of 100 points, with corresponding 95% confidence intervals (CIs). RESULTS: Among 313 physicians (255 oncologists, 30 pulmonologists, and 28 urologists), 77.4% received the HCP Guide and 74.2% the PAC. The HCP Guide was read by 71.3% of the 267 physicians who received the materials, and the mean usage score was 69.5 (95% CI 66.0-72.9), and 57.1% of physicians had scores ≥ 70. The HCP Guide was completely understood by 85.4% of physicians who had read it. Mean knowledge scores were 63.9 (95% CI 62.1-65.7) and 39.4% of physicians had correct knowledge scores ≥ 70. Mean knowledge scores were 66.8 (95% CI 64.9-68.7) for receipt of both the HCP Guide and PAC, 59.4 (95% CI 55.5-63.4) for one of the materials, and 60.8 (95% CI 55.4-66.2) for having received none of the materials. Mean behavior scores were 78.9 (95% CI 76.8-81.0), and 74.8% of physicians had behavior scores ≥ 70. The mean behavior score was 79.0 (95% CI 76.5-81.5) for those who received both the HCP Guide and PAC, 76.9 (95% CI 72.2-81.5) for receipt of one of the materials, and 81.5 (95% CI 75.0-88.0) for those who received none of the materials. CONCLUSIONS: The study assessed the effectiveness of the atezolizumab additional risk minimization educational materials among physicians in six European countries, using process indicators. The educational materials reached over 70% of target physicians, 57.1% of whom reported using them. Knowledge and behavior related to immune-related adverse drug reactions for atezolizumab were no better in those who received the additional risk minimization educational materials. The results support the safe use of atezolizumab by these physician groups and contributed to the European Medicines Agency permitting removal of the HCP Guide.

Effect of subcutaneous lidocaine infiltration on blood loss secondary to corporal lipoaspiration: a prospective, randomized, double-masked clinical trial.

BACKGROUND: Lipoaspiration is one of the most frequently performed aesthetic surgical procedures worldwide. The use of tumescent solution containing lidocaine to infiltrate subcutaneous fat before surgery has been accepted as the standard of care for these procedures. Its objective is to diminish postoperative analgesic necessities and secondary blood loss, but its role in hematocrit reduction is not clear at this time. This study aimed to measure the effect of subcutaneous lidocaine infiltration on blood loss secondary to corporal liposuction. METHODS: A prospective, randomized, double-masked clinical trial was performed. Between November 2005 and July 2007, 70 consecutive female patients submitted to corporal liposuction as a single surgery were included in the study. All the patients were randomly assigned to two groups. The study group received tumescent solution containing lidocaine and epinephrine, whereas the control group received tumescent solution containing only epinephrine. Hematocrit was measured preoperatively, then 2 to 4, 12, and 24 h postoperatively. RESULTS: The comparison between the two groups did not show significant statistical differences with respect to age, body mass index, infiltrated volume, aspirated fat volume, surgical time, hospital stay, preoperative hematocrit, or comparison of the areas lipoaspirated. The mean hematocrit reduction in the study group was 10.8% +/- 2.9% compared with 8.8% +/- 2.6% in the control group (P = 0.004). CONCLUSION: The use of lidocaine in the tumescent solution for subcutaneous fat infiltration significantly increases postoperative anemia compared with the results obtained when epinephrine infiltration alone is used.

Association between Eating Speed and Classical Cardiovascular Risk Factors: A Cross-Sectional Study.

Cardiovascular disease (CVD) is one of the main causes of morbidity and mortality around the world. Lifestyle is recognized as a key factor in the development of metabolic disorders and CVD. Recently, eating speed has been of particular interest since some studies have associated it with the development of obesity and other cardiometabolic disorders. We aimed to assess the association between eating speed and various cardiovascular risk factors. We conducted a cross-sectional analysis within the framework of the PREDIMED (Prevención con Dieta Mediterránea) study with 792 participants from the Reus-Tarragona center. Eating speed was self-reported according to participant perception and categorized as slow, medium, or fast. The association between eating speed and cardiovascular risk factors was assessed using Cox regression models with constant time of follow-up for all individuals. Compared to participants in the slow eating speed category, those in the faster eating speed category were 59% more likely to have the hypertriglyceridemia component of the metabolic syndrome (MetS) (Hazard Ratio, (HR) 1.59; 95% Confidence Interval (CI) 1.16⁻2.17), even after adjustment for potential confounders (HR 1.47; 95% CI 1.08⁻2.02). No other significant differences were observed. Eating speed was positively associated with the prevalence of the hypertriglyceridemia component of the MetS in a senior population at high cardiovascular risk.

Auditory brainstem responses as a clinical evaluation tool in children after perinatal encephalopathy.

UNLABELLED: Auditory brainstem responses (ABR) reveals the neurophysiological status of the neural axis. In this study we compared the ABR of healthy children, under 1-year-old, with children who suffered from perinatal encephalopathy (PE). OBJECTIVE: The purpose of this study was to characterize the ABR differences between children with PE and healthy children in order to identify groups with specific neurophysiological profiles, associated with their neurological condition. METHODS: Thirty-six children with perinatal encephalopathy (PE) and 36 healthy children, ages 1-12 months, were studied. The variables considered were: latencies of waves I, II, N1, III, V, and N2; interpeak latency interval (IPL) of waves I-III, III-V, and I-V; as well as amplitudes of waves I, III, and V. The results were analyzed using ANOVA, as well as Ji(2), and Ward's cluster analysis. RESULTS: The absolute latencies of the ABR showed an inverse correlation with the children's age. Latencies of waves I, II, N1, V, and N2, IPL III-V, and amplitude of waves III and V show significant differences (p<0.05) between healthy and PE children. Children with PE showed greater absolute latencies and larger wave amplitudes than the control group. Ward's cluster analysis, used to define the groups with similar functional characteristics, revealed three groups: fast, intermediate, and slow-responders, depending on their wave latencies and IPL wave amplitudes. These groups were gender- (p<0.03), age- (p<0.0001), and neurological damage- (p<0.01) related. CONCLUSIONS: Our data clearly show that the ABR obtained from PE children differ from ABR obtained from healthy children. PE infants showed larger wave latencies, intervals amplitudes than the control group. Three functional profiles resulted from the groups established using the Ward's method, and these indicate their neurological functional condition.

Desarrollo y validación de un índice de calidad de dieta basado en recomendaciones de las guías alimentarias para la población Argentina / Development and validation of a diet quality index based on recommendations of the Dietary Guidelines for the Argentine Population

INTRODUCCIÓN: Los índices de calidad de dieta son herramientas útiles para evaluar patrones alimentarios y adherencia a guías alimentarias. El objetivo fue desarrollar y validar un índice basado en las Guías Alimentarias para la Población Argentina (GAPA). MÉTODOS: Se desarrolló un índice basado en las guías locales, se analizó la validez de contenido por expertos y la validez de constructo y confiabilidad mediante un estudio de corte transversal. Se incluyó a voluntarios adultos sanos y se relevó información general y de consumo de alimentos. Se analizó la capacidad de otorgar puntajes variados y hallar diferencias entre grupos. Se evaluó la correlación entre el puntaje total y cada componente, y con la ingesta energética y de nutrientes. Se exploraron dimensiones subyacentes con análisis de componentes principales. Se analizó la consistencia interna mediante alfa de Cronbach. RESULTADOS: Se desarrolló un Índice de Calidad de Dieta Argentino (ICDAr) que refleja ocho mensajes principales de las guías y se halló buena aceptación por expertos (V de Aiken ≥0,8; p<0,05). El ICDAr demostró amplitud de rango (37,36-86,39) y diferencia entre fumadores y no fumadores (p=0,002). Se halló correlación positiva entre el puntaje total y cada componente y una mejor ingesta de nutrientes, pero no con ingesta energética. Se hallaron múltiples dimensiones subyacentes. El alfa de Cronbach fue 0,49. DISCUSIÓN: El ICDAr es válido para evaluar la calidad de dieta según la adherencia a las GAPA.