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1. Proteasome inhibition enhances oncolytic reovirus therapy in multiple myeloma independently of its direct cytotoxic effects.

Author

Dona, Ada, Tandoh, Theophilus, Nigam, Lokesh, Singer, Mahmoud, Caserta, Enrico, Murtadha, Mariam, Zhu, Yinghui, Moloudizargari, Milad, Sharma, Preeti, Napolitano, Ottavio, Winchester, Janet, Chowdhury, Arnab, Pozhitkov, Alex, Sanchez, James, Vahed, Hawa, Marcucci, Guido, Coffey, Matt, Nuovo, Gerard, Sborov, Douglas, Pichiorri, Flavia, and Hofmeister, Craig

Subjects
Mass cytometry, Monocytes, Multiple myeloma, Oncolytic therapy, Proteasome inhibitors, Reovirus, Multiple Myeloma, Humans, Oncolytic Virotherapy, Proteasome Inhibitors, Animals, Mice, Oncolytic Viruses, Reoviridae, Cell Line, Tumor, Virus Replication, Combined Modality Therapy
Abstract

BACKGROUND: Reovirus (RV) is an oncolytic virus with natural tropism for cancer cells. We previously showed that RV administration in multiple myeloma (MM) patients was safe, but disease control associated with viral replication in the cancer cells was not observed. The combination with proteasome inhibitors (PIs) has shown to enhance RV therapeutic activity, but the mechanisms of action have not been fully elucidated. METHODS: Electron microscopy, q-RT-PCR, single-cell mass cytometry (CyTOF), flow cytometry, plaque assays, immunohistochemistry, and Western blot analysis were used to assess RV infection of both myeloma and immune cells. Immune fluorescence, flow cytometry, and luciferase reporter assays were used to assess NF-κB pathway activation upon RV treatments. Immune profiling changes, both ex vivo and in MM patients, were analyzed by flow cytometry and CyTOF analysis. T-cell receptor (TCR) sequencing was also conducted both in immune competent MM mice and in patients enrolled in a phase 1b trial per a standard 3 + 3 dose escalation schedule. RESULTS: Here we show ex vivo and in vivo that proteasome inhibitors (PIs) potentiate reovirus replication in circulating classical monocytes, increasing viral delivery to myeloma cells. We found that the anti-viral signals in monocytes primarily rely on NF-κB activation and that this effect is impaired by the addition of PIs. Conversely, the addition of PIs to RV therapy supports immune activation and killing of MM, independently of direct PI sensitivity. To validate the importance of PIs in enhancing oncolytic viral therapy independently of their killing activity on cancer cells, we then conducted a phase 1b trial of the reovirus Pelareorep together with the PI carfilzomib in 13 heavily pretreated PI-resistant MM patients. Objective responses, which were associated with active reovirus replication in MM cells, T cell activation, and monocytic expansion, were noted in 70% of patients. CONCLUSIONS: Although characterized as immunosuppressive drugs, PIs improved RV delivery to MM cells but also enhanced anti-MM efficacy through immune-mediated killing of myeloma cells, independently of their PI sensitivity. These results highlight a more generalizable use of PIs as therapeutic companions to support oncolytic-based therapies in cancers. TRIAL REGISTRATION: clinicaltrials.gov, NCT02101944.

Published
2025

2. Operational Definitions Related to Pediatric Ventilator Liberation

Author

Abu-Sultaneh, Samer, Iyer, Narayan Prabhu, Fernández, Analía, Gaies, Michael, González-Dambrauskas, Sebastián, Hotz, Justin Christian, Kneyber, Martin CJ, López-Fernández, Yolanda M, Rotta, Alexandre T, Werho, David K, Baranwal, Arun Kumar, Blackwood, Bronagh, Craven, Hannah J, Curley, Martha AQ, Essouri, Sandrine, Fioretto, Jose Roberto, Hartmann, Silvia MM, Jouvet, Philippe, Korang, Steven Kwasi, Rafferty, Gerrard F, Ramnarayan, Padmanabhan, Rose, Louise, Tume, Lyvonne N, Whipple, Elizabeth C, Wong, Judith Ju Ming, Emeriaud, Guillaume, Mastropietro, Christopher W, Napolitano, Natalie, Newth, Christopher JL, Khemani, Robinder G, and Network, Pediatric Acute Lung Injury and Sepsis Investigators

Subjects
Lung, Bioengineering, Pediatric, Assistive Technology, Patient Safety, Humans, Child, Respiration, Artificial, Ventilator Weaning, Ventilators, Mechanical, Research Design, Airway Extubation, airway extubation, extubation failure, high-flow nasal cannula, mechanical ventilation, noninvasive ventilation, pediatric ICU, ventilator weaning, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, Clinical Sciences, Respiratory System
Abstract

BackgroundCommon, operational definitions are crucial to assess interventions and outcomes related to pediatric mechanical ventilation. These definitions can reduce unnecessary variability among research and quality improvement efforts, to ensure findings are generalizable, and can be pooled to establish best practices.Research questionCan we establish operational definitions for key elements related to pediatric ventilator liberation using a combination of detailed literature review and consensus-based approaches?Study design and methodsA panel of 26 international experts in pediatric ventilator liberation, two methodologists, and two librarians conducted systematic reviews on eight topic areas related to pediatric ventilator liberation. Through a series of virtual meetings, we established draft definitions that were voted upon using an anonymous web-based process. Definitions were revised by incorporating extracted data gathered during the systematic review and discussed in another consensus meeting. A second round of voting was conducted to confirm the final definitions.ResultsIn eight topic areas identified by the experts, 16 preliminary definitions were established. Based on initial discussion and the first round of voting, modifications were suggested for 11 of the 16 definitions. There was significant variability in how these items were defined in the literature reviewed. The final round of voting achieved ≥ 80% agreement for all 16 definitions in the following areas: what constitutes respiratory support (invasive mechanical ventilation and noninvasive respiratory support), liberation and failed attempts to liberate from invasive mechanical ventilation, liberation from respiratory support, duration of noninvasive respiratory support, total duration of invasive mechanical ventilation, spontaneous breathing trials, extubation readiness testing, 28 ventilator-free days, and planned vs rescue use of post-extubation noninvasive respiratory support.InterpretationWe propose that these consensus-based definitions for elements of pediatric ventilator liberation, informed by evidence, be used for future quality improvement initiatives and research studies to improve generalizability and facilitate comparison.

Published
2023

3. Executive Summary of the Second International Guidelines for the Diagnosis and Management of Pediatric Acute Respiratory Distress Syndrome (PALICC-2).

Author

Emeriaud, Guillaume, López-Fernández, Yolanda, Iyer, Narayan, Bembea, Melania, Agulnik, Asya, Barbaro, Ryan, Baudin, Florent, Bhalla, Anoopindar, Brunow de Carvalho, Werther, Carroll, Christopher, Cheifetz, Ira, Chisti, Mohammod, Cruces, Pablo, Curley, Martha, Dahmer, Mary, Dalton, Heidi, Erickson, Simon, Essouri, Sandrine, Fernández, Analía, Flori, Heidi, Grunwell, Jocelyn, Jouvet, Philippe, Killien, Elizabeth, Kneyber, Martin, Kudchadkar, Sapna, Korang, Steven, Lee, Jan, Macrae, Duncan, Maddux, Aline, Modesto I Alapont, Vicent, Morrow, Brenda, Nadkarni, Vinay, Napolitano, Natalie, Newth, Christopher, Pons-Odena, Martí, Quasney, Michael, Rajapreyar, Prakadeshwari, Rambaud, Jerome, Randolph, Adrienne, Rimensberger, Peter, Rowan, Courtney, Sanchez-Pinto, L, Sapru, Anil, Sauthier, Michael, Shein, Steve, Smith, Lincoln, Steffen, Katerine, Takeuchi, Muneyuki, Thomas, Neal, Tse, Sze, Valentine, Stacey, Ward, Shan, Watson, R, Yehya, Nadir, Zimmerman, Jerry, and Khemani, Robinder

Subjects
Child, Humans, Respiratory Distress Syndrome, Respiration, Artificial, Acute Lung Injury, Consensus
Abstract

OBJECTIVES: We sought to update our 2015 work in the Second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) guidelines for the diagnosis and management of pediatric acute respiratory distress syndrome (PARDS), considering new evidence and topic areas that were not previously addressed. DESIGN: International consensus conference series involving 52 multidisciplinary international content experts in PARDS and four methodology experts from 15 countries, using consensus conference methodology, and implementation science. SETTING: Not applicable. PATIENTS: Patients with or at risk for PARDS. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Eleven subgroups conducted systematic or scoping reviews addressing 11 topic areas: 1) definition, incidence, and epidemiology; 2) pathobiology, severity, and risk stratification; 3) ventilatory support; 4) pulmonary-specific ancillary treatment; 5) nonpulmonary treatment; 6) monitoring; 7) noninvasive respiratory support; 8) extracorporeal support; 9) morbidity and long-term outcomes; 10) clinical informatics and data science; and 11) resource-limited settings. The search included MEDLINE, EMBASE, and CINAHL Complete (EBSCOhost) and was updated in March 2022. Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to summarize evidence and develop the recommendations, which were discussed and voted on by all PALICC-2 experts. There were 146 recommendations and statements, including: 34 recommendations for clinical practice; 112 consensus-based statements with 18 on PARDS definition, 55 on good practice, seven on policy, and 32 on research. All recommendations and statements had agreement greater than 80%. CONCLUSIONS: PALICC-2 recommendations and consensus-based statements should facilitate the implementation and adherence to the best clinical practice in patients with PARDS. These results will also inform the development of future programs of research that are crucially needed to provide stronger evidence to guide the pediatric critical care teams managing these patients.

Published
2023

4. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study

Author

Villar, Jose, Conti, Constanza P Soto, Gunier, Robert B, Ariff, Shabina, Craik, Rachel, Cavoretto, Paolo I, Rauch, Stephen, Gandino, Serena, Nieto, Ricardo, Winsey, Adele, Menis, Camilla, Rodriguez, Gabriel B, Savasi, Valeria, Tug, Niyazi, Deantoni, Sonia, Fabre, Marta, de Tejada, Begoña Martinez, Rodriguez-Sibaja, Maria Jose, Livio, Stefania, Napolitano, Raffaele, Maiz, Nerea, Sobrero, Helena, Peterson, Ashley, Deruelle, Philippe, Giudice, Carolina, Teji, Jagjit S, Casale, Roberto A, Salomon, Laurent J, Prefumo, Federico, Ismail, Leila Cheikh, Gravett, Michael G, Vale, Marynéa, Hernández, Valeria, Sentilhes, Loïc, Easter, Sarah R, Capelli, Carola, Marler, Emily, Cáceres, Daniela M, Crespo, Guadalupe Albornoz, Ernawati, Ernawati, Lipschuetz, Michal, Takahashi, Ken, Vecchiarelli, Carmen, Hubka, Teresa, Ikenoue, Satoru, Tavchioska, Gabriela, Bako, Babagana, Ayede, Adejumoke I, Eskenazi, Brenda, Thornton, Jim G, Bhutta, Zulfiqar A, Kennedy, Stephen H, Papageorghiou, Aris T, and Consortium, INTERCOVID-2022 International

Subjects
Prevention, Pediatric, Lung, Clinical Research, Immunization, Clinical Trials and Supportive Activities, Vaccine Related, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Good Health and Well Being, Pregnancy, Infant, Newborn, Humans, Female, Male, Pregnancy Outcome, Vaccine Efficacy, COVID-19, SARS-CoV-2, COVID-19 Testing, Prospective Studies, Mothers, INTERCOVID-2022 International Consortium, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundIn 2021, we showed an increased risk associated with COVID-19 in pregnancy. Since then, the SARS-CoV-2 virus has undergone genetic mutations. We aimed to examine the effects on maternal and perinatal outcomes of COVID-19 during pregnancy, and evaluate vaccine effectiveness, when omicron (B.1.1.529) was the variant of concern.MethodsINTERCOVID-2022 is a large, prospective, observational study, involving 41 hospitals across 18 countries. Each woman with real-time PCR or rapid test, laboratory-confirmed COVID-19 in pregnancy was compared with two unmatched women without a COVID-19 diagnosis who were recruited concomitantly and consecutively in pregnancy or at delivery. Mother and neonate dyads were followed until hospital discharge. Primary outcomes were maternal morbidity and mortality index (MMMI), severe neonatal morbidity index (SNMI), and severe perinatal morbidity and mortality index (SPMMI). Vaccine effectiveness was estimated, adjusted by maternal risk profile.FindingsWe enrolled 4618 pregnant women from Nov 27, 2021 (the day after WHO declared omicron a variant of concern), to June 30, 2022: 1545 (33%) women had a COVID-19 diagnosis (median gestation 36·7 weeks [IQR 29·0-38·9]) and 3073 (67%) women, with similar demographic characteristics, did not have a COVID-19 diagnosis. Overall, women with a diagnosis had an increased risk for MMMI (relative risk [RR] 1·16 [95% CI 1·03-1·31]) and SPMMI (RR 1·21 [95% CI 1·00-1·46]). Women with a diagnosis, compared with those without a diagnosis, also had increased risks of SNMI (RR 1·23 [95% CI 0·88-1·71]), although the lower bounds of the 95% CI crossed unity. Unvaccinated women with a COVID-19 diagnosis had a greater risk of MMMI (RR 1·36 [95% CI 1·12-1·65]). Severe COVID-19 symptoms in the total sample increased the risk of severe maternal complications (RR 2·51 [95% CI 1·84-3·43]), perinatal complications (RR 1·84 [95% CI 1·02-3·34]), and referral, intensive care unit (ICU) admission, or death (RR 11·83 [95% CI 6·67-20·97]). Severe COVID-19 symptoms in unvaccinated women increased the risk of MMMI (RR 2·88 [95% CI 2·02-4·12]) and referral, ICU admission, or death (RR 20·82 [95% CI 10·44-41·54]). 2886 (63%) of 4618 total participants had at least a single dose of any vaccine, and 2476 (54%) of 4618 had either complete or booster doses. Vaccine effectiveness (all vaccines combined) for severe complications of COVID-19 for all women with a complete regimen was 48% (95% CI 22-65) and 76% (47-89) after a booster dose. For women with a COVID-19 diagnosis, vaccine effectiveness of all vaccines combined for women with a complete regimen was 74% (95% CI 48-87) and 91% (65-98) after a booster dose.InterpretationCOVID-19 in pregnancy, during the first 6 months of omicron as the variant of concern, was associated with increased risk of severe maternal morbidity and mortality, especially among symptomatic and unvaccinated women. Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. Vaccination coverage among pregnant women remains a priority.FundingNone.

Published
2023

5. Executive Summary: International Clinical Practice Guidelines for Pediatric Ventilator Liberation, A Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network Document.

Author

Abu-Sultaneh, Samer, Iyer, Narayan, Fernández, Analía, Gaies, Michael, González-Dambrauskas, Sebastián, Hotz, Justin, Kneyber, Martin, López-Fernández, Yolanda, Rotta, Alexandre, Werho, David, Baranwal, Arun, Blackwood, Bronagh, Craven, Hannah, Curley, Martha, Essouri, Sandrine, Fioretto, Jose, Hartmann, Silvia, Jouvet, Philippe, Korang, Steven, Rafferty, Gerrard, Ramnarayan, Padmanabhan, Rose, Louise, Tume, Lyvonne, Whipple, Elizabeth, Wong, Judith, Emeriaud, Guillaume, Mastropietro, Christopher, Napolitano, Natalie, Newth, Christopher, and Khemani, Robinder

Subjects
airway extubation, clinical protocols, mechanical ventilators, pediatric intensive care units, ventilator weaning, Humans, Child, Respiration, Artificial, Ventilator Weaning, Ventilators, Mechanical, Airway Extubation, Sepsis
Abstract

Rationale: Pediatric-specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients readiness for extubation. Methods: Twenty-six international experts comprised a multiprofessional panel to establish pediatrics-specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. A systematic review was conducted for questions that did not meet an a priori threshold of ⩾80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence and drafted and voted on the recommendations. Measurements and Main Results: Three questions related to systematic screening using an extubation readiness testing bundle and a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ⩾80% agreement. For the remaining eight questions, five systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials, measures of respiratory muscle strength, assessment of risk of postextubation upper airway obstruction and its prevention, use of postextubation noninvasive respiratory support, and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. Conclusions: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.

Published
2023

6. Effects of prenatal exposure to maternal COVID-19 and perinatal care on neonatal outcome: results from the INTERCOVID Multinational Cohort Study.

Author

Giuliani, Francesca, Oros, Daniel, Gunier, Robert B, Deantoni, Sonia, Rauch, Stephen, Casale, Roberto, Nieto, Ricardo, Bertino, Enrico, Rego, Albertina, Menis, Camilla, Gravett, Michael G, Candiani, Massimo, Deruelle, Philippe, García-May, Perla K, Mhatre, Mohak, Usman, Mustapha Ado, Abd-Elsalam, Sherief, Etuk, Saturday, Napolitano, Raffaele, Liu, Becky, Prefumo, Federico, Savasi, Valeria, Do Vale, Marynéa Silva, Baafi, Eric, Ariff, Shabina, Maiz, Nerea, Aminu, Muhammad Baffah, Cardona-Perez, Jorge Arturo, Craik, Rachel, Tavchioska, Gabriela, Bako, Babagana, Benski, Caroline, Hassan-Hanga, Fatimah, Savorani, Mónica, Sentilhes, Loïc, Carola Capelli, Maria, Takahashi, Ken, Vecchiarelli, Carmen, Ikenoue, Satoru, Thiruvengadam, Ramachandran, Soto Conti, Constanza P, Cetin, Irene, Nachinab, Vincent Bizor, Ernawati, Ernawati, Duro, Eduardo A, Kholin, Alexey, Teji, Jagjit Singh, Easter, Sarah Rae, Salomon, Laurent J, Ayede, Adejumoke Idowu, Cerbo, Rosa Maria, Agyeman-Duah, Josephine, Roggero, Paola, Eskenazi, Brenda, Langer, Ana, Bhutta, Zulfiqar A, Kennedy, Stephen H, Papageorghiou, Aris T, and Villar, Jose

Subjects
Humans, Pregnancy Complications, Infectious, Pregnancy Complications, Premature Birth, Prenatal Exposure Delayed Effects, Pregnancy Outcome, Perinatal Care, Cohort Studies, Pregnancy, Child, Infant, Newborn, Female, Infectious Disease Transmission, Vertical, COVID-19, COVID-19 Testing, SARS-CoV-2, SARS-CoV-2 exposure, birthweight, breastfeeding, cesarean delivery, cohort, feeding problems, hospital stay, infections, intrauterine growth restriction, morbidity, mortality, multicenter study, neonatal intensive care unit admission, neonatal outcomes, neonate, neurologic outcome, newborn, perinatal practices, preeclampsia, pregnancy, preterm birth, respiratory support, respiratory symptoms, risk ratio, rooming-in, skin-to-skin, small for gestational age, Pediatric, Prevention, Clinical Research, Pediatric Research Initiative, Perinatal Period - Conditions Originating in Perinatal Period, Preterm, Low Birth Weight and Health of the Newborn, Conditions Affecting the Embryonic and Fetal Periods, Infant Mortality, Contraception/Reproduction, Reproductive health and childbirth, Good Health and Well Being, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Abstract

BackgroundThe effect of COVID-19 in pregnancy on maternal outcomes and its association with preeclampsia and gestational diabetes mellitus have been reported; however, a detailed understanding of the effects of maternal positivity, delivery mode, and perinatal practices on fetal and neonatal outcomes is urgently needed.ObjectiveTo evaluate the impact of COVID-19 on fetal and neonatal outcomes and the role of mode of delivery, breastfeeding, and early neonatal care practices on the risk of mother-to-child transmission.Study designIn this cohort study that took place from March 2020 to March 2021, involving 43 institutions in 18 countries, 2 unmatched, consecutive, unexposed women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge. COVID-19 in pregnancy was determined by laboratory confirmation and/or radiological pulmonary findings or ≥2 predefined COVID-19 symptoms. The outcome measures were indices of neonatal and perinatal morbidity and mortality, neonatal positivity and its correlation with mode of delivery, breastfeeding, and hospital neonatal care practices.ResultsA total of 586 neonates born to women with COVID-19 diagnosis and 1535 neonates born to women without COVID-19 diagnosis were enrolled. Women with COVID-19 diagnosis had a higher rate of cesarean delivery (52.8% vs 38.5% for those without COVID-19 diagnosis, P14 days). Among neonates born to mothers with COVID-19 diagnosis, birth via cesarean delivery was a risk factor for testing positive for COVID-19 (odds ratio, 2.4; 95% confidence interval, 1.2-4.7), even when severity of maternal conditions was considered and after multivariable logistic analysis. In the subgroup of neonates born to women with COVID-19 diagnosis, the outcomes worsened when the neonate also tested positive, with higher rates of neonatal intensive care unit admission, fever, gastrointestinal and respiratory symptoms, and death, even after adjusting for prematurity. Breastfeeding by mothers with COVID-19 diagnosis and hospital neonatal care practices, including immediate skin-to-skin contact and rooming-in, were not associated with an increased risk of newborn positivity.ConclusionIn this multinational cohort study, COVID-19 in pregnancy was associated with increased maternal and neonatal complications. Cesarean delivery was significantly associated with newborn COVID-19 diagnosis. Vaginal delivery should be considered the safest mode of delivery if obstetrical and health conditions allow it. Mother-to-child skin-to-skin contact, rooming-in, and direct breastfeeding were not risk factors for newborn COVID-19 diagnosis, thus well-established best practices can be continued among women with COVID-19 diagnosis.

Published
2022

7. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial

Author

Gounder, Mrinal M, Razak, Albiruni Abdul, Somaiah, Neeta, Chawla, Sant, Martin-Broto, Javier, Grignani, Giovanni, Schuetze, Scott M, Vincenzi, Bruno, Wagner, Andrew J, Chmielowski, Bartosz, Jones, Robin L, Riedel, Richard F, Stacchiotti, Silvia, Loggers, Elizabeth T, Ganjoo, Kristen N, Le Cesne, Axel, Italiano, Antoine, del Muro, Xavier Garcia, Burgess, Melissa, Piperno-Neumann, Sophie, Ryan, Christopher, Mulcahy, Mary F, Forscher, Charles, Penel, Nicolas, Okuno, Scott, Elias, Anthony, Hartner, Lee, Philip, Tony, Alcindor, Thierry, Kasper, Bernd, Reichardt, Peter, Lapeire, Lore, Blay, Jean-Yves, Chevreau, Christine, Morales, Claudia Maria Valverde, Schwartz, Gary K, Chen, James L, Deshpande, Hari, Davis, Elizabeth J, Nicholas, Garth, Gröschel, Stefan, Hatcher, Helen, Duffaud, Florence, Herráez, Antonio Casado, Beveridge, Roberto Diaz, Badalamenti, Giuseppe, Eriksson, Mikael, Meyer, Christian, von Mehren, Margaret, Van Tine, Brian A, Götze, Katharina, Mazzeo, Filomena, Yakobson, Alexander, Zick, Aviad, Lee, Alexander, Gonzalez, Anna Estival, Napolitano, Andrea, Dickson, Mark A, Michel, Dayana, Meng, Changting, Li, Lingling, Liu, Jianjun, Ben-Shahar, Osnat, Van Domelen, Dane R, Walker, Christopher J, Chang, Hua, Landesman, Yosef, Shah, Jatin J, Shacham, Sharon, Kauffman, Michael G, and Attia, Steven

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Genetics, Patient Safety, Clinical Research, 6.1 Pharmaceuticals, Cancer, Child, Double-Blind Method, Humans, Hydrazines, Liposarcoma, Triazoles, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeAntitumor activity in preclinical models and a phase I study of patients with dedifferentiated liposarcoma (DD-LPS) was observed with selinexor. We evaluated the clinical benefit of selinexor in patients with previously treated DD-LPS whose sarcoma progressed on approved agents.MethodsSEAL was a phase II-III, multicenter, randomized, double-blind, placebo-controlled study. Patients age 12 years or older with advanced DD-LPS who had received two-five lines of therapy were randomly assigned (2:1) to selinexor (60 mg) or placebo twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS). Patients who received at least one dose of study treatment were included for safety analysis (ClinicalTrials.gov identifier: NCT02606461).ResultsTwo hundred eighty-five patients were enrolled (selinexor, n = 188; placebo, n = 97). PFS was significantly longer with selinexor versus placebo: hazard ratio (HR) 0.70 (95% CI, 0.52 to 0.95; one-sided P = .011; medians 2.8 v 2.1 months), as was time to next treatment: HR 0.50 (95% CI, 0.37 to 0.66; one-sided P < .0001; medians 5.8 v 3.2 months). With crossover, no difference was observed in overall survival. The most common treatment-emergent adverse events of any grade versus grade 3 or 4 with selinexor were nausea (151 [80.7%] v 11 [5.9]), decreased appetite (113 [60.4%] v 14 [7.5%]), and fatigue (96 [51.3%] v 12 [6.4%]). Four (2.1%) and three (3.1%) patients died in the selinexor and placebo arms, respectively. Exploratory RNA sequencing analysis identified that the absence of CALB1 expression was associated with longer PFS with selinexor compared with placebo (median 6.9 v 2.2 months; HR, 0.19; P = .001).ConclusionPatients with advanced, refractory DD-LPS showed improved PFS and time to next treatment with selinexor compared with placebo. Supportive care and dose reductions mitigated side effects of selinexor. Prospective validation of CALB1 expression as a predictive biomarker for selinexor in DD-LPS is warranted.

Published
2022

8. Diabetes mellitus, maternal adiposity, and insulin-dependent gestational diabetes are associated with COVID-19 in pregnancy: the INTERCOVID study

Author

Eskenazi, Brenda, Rauch, Stephen, Iurlaro, Enrico, Gunier, Robert B, Rego, Albertina, Gravett, Michael G, Cavoretto, Paolo Ivo, Deruelle, Philippe, García-May, Perla K, Mhatre, Mohak, Usman, Mustapha Ado, Elbahnasawy, Mohamed, Etuk, Saturday, Napolitano, Raffaele, Deantoni, Sonia, Liu, Becky, Prefumo, Federico, Savasi, Valeria, Marques, Patrícia F, Baafi, Eric, Zainab, Ghulam, Nieto, Ricardo, Serrano, Berta, Aminu, Muhammad Baffah, Cardona-Perez, Jorge Arturo, Craik, Rachel, Winsey, Adele, Tavchioska, Gabriela, Bako, Babagana, Oros, Daniel, Benski, Caroline, Galadanci, Hadiza, Savorani, Mónica, Oberto, Manuela, Sentilhes, Loïc, Risso, Milagros, Takahashi, Ken, Vecciarelli, Carmen, Ikenoue, Satoru, Pandey, Anil K, Soto Conti, Constanza P, Cetin, Irene, Nachinab, Vincent Bizor, Ernawati, Ernawati, Duro, Eduardo A, Kholin, Alexey, Firlit, Michelle L, Easter, Sarah Rae, Sichitiu, Joanna, John-Akinola, Yetunde, Casale, Roberto, Cena, Hellas, Agyeman-Duah, Josephine, Roggero, Paola, Langer, Ana, Bhutta, Zulfiqar A, Kennedy, Stephen H, Villar, Jose, and Papageorghiou, Aris T

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Research, Nutrition, Diabetes, Prevention, Obesity, Reproductive health and childbirth, Metabolic and endocrine, Good Health and Well Being, Adiposity, Adolescent, Adult, Body Mass Index, COVID-19, COVID-19 Testing, Diabetes Mellitus, Type 1, Diabetes, Gestational, Female, Humans, Insulin, Obesity, Maternal, Overweight, Pregnancy, Pregnancy Outcome, body mass index, diabetes mellitus, gestational diabetes mellitus, obesity, overweight, pregnancy, SARS-CoV-2, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

BackgroundAmong nonpregnant individuals, diabetes mellitus and high body mass index increase the risk of COVID-19 and its severity.ObjectiveThis study aimed to determine whether diabetes mellitus and high body mass index are risk factors for COVID-19 in pregnancy and whether gestational diabetes mellitus is associated with COVID-19 diagnosis.Study designINTERCOVID was a multinational study conducted between March 2020 and February 2021 in 43 institutions from 18 countries, enrolling 2184 pregnant women aged ≥18 years; a total of 2071 women were included in the analyses. For each woman diagnosed with COVID-19, 2 nondiagnosed women delivering or initiating antenatal care at the same institution were also enrolled. The main exposures were preexisting diabetes mellitus, high body mass index (overweight or obesity was defined as a body mass index ≥25 kg/m2), and gestational diabetes mellitus in pregnancy. The main outcome was a confirmed diagnosis of COVID-19 based on a real-time polymerase chain reaction test, antigen test, antibody test, radiological pulmonary findings, or ≥2 predefined COVID-19 symptoms at any time during pregnancy or delivery. Relationships of exposures and COVID-19 diagnosis were assessed using generalized linear models with a Poisson distribution and log link function, with robust standard errors to account for model misspecification. Furthermore, we conducted sensitivity analyses: (1) restricted to those with a real-time polymerase chain reaction test or an antigen test in the last week of pregnancy, (2) restricted to those with a real-time polymerase chain reaction test or an antigen test during the entire pregnancy, (3) generating values for missing data using multiple imputation, and (4) analyses controlling for month of enrollment. In addition, among women who were diagnosed with COVID-19, we examined whether having gestational diabetes mellitus, diabetes mellitus, or high body mass index increased the risk of having symptomatic vs asymptomatic COVID-19.ResultsCOVID-19 was associated with preexisting diabetes mellitus (risk ratio, 1.94; 95% confidence interval, 1.55-2.42), overweight or obesity (risk ratio, 1.20; 95% confidence interval, 1.06-1.37), and gestational diabetes mellitus (risk ratio, 1.21; 95% confidence interval, 0.99-1.46). The gestational diabetes mellitus association was specifically among women requiring insulin, whether they were of normal weight (risk ratio, 1.79; 95% confidence interval, 1.06-3.01) or overweight or obese (risk ratio, 1.77; 95% confidence interval, 1.28-2.45). A somewhat stronger association with COVID-19 diagnosis was observed among women with preexisting diabetes mellitus, whether they were of normal weight (risk ratio, 1.93; 95% confidence interval, 1.18-3.17) or overweight or obese (risk ratio, 2.32; 95% confidence interval, 1.82-2.97). When the sample was restricted to those with a real-time polymerase chain reaction test or an antigen test in the week before delivery or during the entire pregnancy, including missing variables using imputation or controlling for month of enrollment, the observed associations were comparable.ConclusionDiabetes mellitus and overweight or obesity were risk factors for COVID-19 diagnosis in pregnancy, and insulin-dependent gestational diabetes mellitus was associated with the disease. Therefore, it is essential that women with these comorbidities are vaccinated.

Published
2022

9. A transient, closed-loop network of wireless, body-integrated devices for autonomous electrotherapy.

Author

Choi, Yeon, Yin, Rose, Avila, Raudel, Pfenniger, Anna, Yoo, Jaeyoung, Lee, Jong, Tzavelis, Andreas, Lee, Young, Chen, Sheena, Knight, Helen, Kim, Seungyeob, Ahn, Hak-Young, Wickerson, Grace, Vázquez-Guardado, Abraham, Higbee-Dempsey, Elizabeth, Russo, Bender, Napolitano, Michael, Holleran, Timothy, Razzak, Leen, Miniovich, Alana, Lee, Geumbee, Geist, Beth, Kim, Brandon, Han, Shuling, Brennan, Jaclyn, Aras, Kedar, Kwak, Sung, Kim, Joohee, Waters, Emily, Yang, Xiangxing, Burrell, Amy, San Chun, Keum, Liu, Claire, Wu, Changsheng, Rwei, Alina, Spann, Alisha, Banks, Anthony, Johnson, David, Zhang, Zheng, Haney, Chad, Jin, Sung, Sahakian, Alan, Huang, Yonggang, Trachiotis, Gregory, Knight, Bradley, Arora, Rishi, Efimov, Igor, Rogers, John, and Jeong, Hyoyoung

Subjects
Absorbable Implants, Animals, Cardiac Pacing, Artificial, Dogs, Heart Rate, Humans, Pacemaker, Artificial, Postoperative Care, Rats, Wireless Technology
Abstract

Temporary postoperative cardiac pacing requires devices with percutaneous leads and external wired power and control systems. This hardware introduces risks for infection, limitations on patient mobility, and requirements for surgical extraction procedures. Bioresorbable pacemakers mitigate some of these disadvantages, but they demand pairing with external, wired systems and secondary mechanisms for control. We present a transient closed-loop system that combines a time-synchronized, wireless network of skin-integrated devices with an advanced bioresorbable pacemaker to control cardiac rhythms, track cardiopulmonary status, provide multihaptic feedback, and enable transient operation with minimal patient burden. The result provides a range of autonomous, rate-adaptive cardiac pacing capabilities, as demonstrated in rat, canine, and human heart studies. This work establishes an engineering framework for closed-loop temporary electrotherapy using wirelessly linked, body-integrated bioelectronic devices.

Published
2022

10. Examining the impact of social distancing and methamphetamine use on sexual risk and intimate partner violence in sexual and gender minority young adults during the COVID-19 pandemic

Author

Xavier Hall, Casey D, Javanbakht, Marjan, Iyer, Chitra, Costales, Cocoa, Napolitano, Julia C, Johnson, Tony, Castro, Christian Felix, Newcomb, Michael E, Kipke, Michele D, Shoptaw, Steven, Gorbach, Pamina M, and Mustanski, Brian

Subjects
Biochemistry and Cell Biology, Biomedical and Clinical Sciences, Biological Sciences, Epidemiology, Health Sciences, Pharmacology and Pharmaceutical Sciences, Infectious Diseases, Sexual and Gender Minorities (SGM/LGBT*), Basic Behavioral and Social Science, HIV/AIDS, Drug Abuse (NIDA only), Sexually Transmitted Infections, Behavioral and Social Science, Violence Against Women, Women's Health, Pediatric, Mental Health, Social Determinants of Health, Coronaviruses Disparities and At-Risk Populations, Emerging Infectious Diseases, Clinical Research, Coronaviruses, Prevention, Health Disparities, Substance Misuse, Methamphetamine, Violence Research, Infection, Good Health and Well Being, Peace, Justice and Strong Institutions, Adult, Humans, Male, Young Adult, COVID-19, Intimate Partner Violence, Pandemics, Physical Distancing, SARS-CoV-2, Sexual and Gender Minorities, Female, Stimulants, HIV, Violence, Sexual and gender minorities, Medical and Health Sciences, Psychology and Cognitive Sciences, Substance Abuse, Biochemistry and cell biology, Pharmacology and pharmaceutical sciences
Abstract

BackgroundDuring the COVID-19 pandemic in 2020, concerns were raised about the potential impact of pandemic-related social distancing measures on existing health disparities among sexual and gender minority (SGM) young adults, including HIV transmission risk and intimate partner violence (IPV). Another concern was the potential for increased methamphetamine use during the pandemic, which is a known risk factor for HIV transmission and IPV.MethodsThe present analysis examines the impact of COVID-19 social distancing (social distancing and quarantining) and methamphetamine use on HIV risk and IPV in a combined dataset from 3 cohort studies of SGM young adults (two in Los Angeles and one in Chicago) from May 2020 to April 2021 (n = 1142). Bivariate analyses and multivariable logistic regressions were estimated.ResultsThe median age was 26. All participants were assigned male at birth and most participants were men (93.8%). The largest racial groups were Hispanic/Latinx (44.6%) and Black (29.0%). In adjusted models methamphetamine use was consistently associated with having a new sex partner, higher numbers of sex partners, and experience of IPV, during the pandemic. Reporting no social distancing and reporting one social distancing behavior, were associated with experience of IPV relative to reporting 2 social distancing behaviors. Social distancing was not associated with sexual risk behavior or Pre-exposure Prophylaxis use.ConclusionsSGM young adults live at the intersection of multiple vulnerabilities during the COVID-19 pandemic. Addiction services, HIV prevention services, and violence support services should be prepared to support young adult SGM needs, particularly those who use methamphetamine.

Published
2022

11. Preeclampsia and COVID-19: results from the INTERCOVID prospective longitudinal study.

Author

Papageorghiou, Aris T, Deruelle, Philippe, Gunier, Robert B, Rauch, Stephen, García-May, Perla K, Mhatre, Mohak, Usman, Mustapha Ado, Abd-Elsalam, Sherief, Etuk, Saturday, Simmons, Lavone E, Napolitano, Raffaele, Deantoni, Sonia, Liu, Becky, Prefumo, Federico, Savasi, Valeria, do Vale, Marynéa Silva, Baafi, Eric, Zainab, Ghulam, Nieto, Ricardo, Maiz, Nerea, Aminu, Muhammad Baffah, Cardona-Perez, Jorge Arturo, Craik, Rachel, Winsey, Adele, Tavchioska, Gabriela, Bako, Babagana, Oros, Daniel, Rego, Albertina, Benski, Anne Caroline, Hassan-Hanga, Fatimah, Savorani, Mónica, Giuliani, Francesca, Sentilhes, Loïc, Risso, Milagros, Takahashi, Ken, Vecchiarelli, Carmen, Ikenoue, Satoru, Thiruvengadam, Ramachandran, Soto Conti, Constanza P, Ferrazzi, Enrico, Cetin, Irene, Nachinab, Vincent Bizor, Ernawati, Ernawati, Duro, Eduardo A, Kholin, Alexey, Firlit, Michelle L, Easter, Sarah Rae, Sichitiu, Joanna, Bowale, Abimbola, Casale, Roberto, Cerbo, Rosa Maria, Cavoretto, Paolo Ivo, Eskenazi, Brenda, Thornton, Jim G, Bhutta, Zulfiqar A, Kennedy, Stephen H, and Villar, José

Subjects
Humans, Pregnancy Complications, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Premature Birth, Pregnancy Outcome, Risk Factors, Longitudinal Studies, Prospective Studies, Pregnancy, Adult, Female, COVID-19, SARS-CoV-2, SARS-CoV 2, aspirin, cohort, gestational hypertension, hypertension, hypertensive disorders in pregnancy, infection, morbidity, mortality, obesity, overweight, preeclampsia, pregnancy, preterm birth, proteinuria, relative risk, renal disease, risk ratio, small for gestational age, Cardiovascular, Perinatal Period - Conditions Originating in Perinatal Period, Contraception/Reproduction, Clinical Research, Preterm, Low Birth Weight and Health of the Newborn, Infant Mortality, Hypertension, Pediatric, Reproductive health and childbirth, Good Health and Well Being, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Abstract

BackgroundIt is unclear whether the suggested link between COVID-19 during pregnancy and preeclampsia is an independent association or if these are caused by common risk factors.ObjectiveThis study aimed to quantify any independent association between COVID-19 during pregnancy and preeclampsia and to determine the effect of these variables on maternal and neonatal morbidity and mortality.Study designThis was a large, longitudinal, prospective, unmatched diagnosed and not-diagnosed observational study assessing the effect of COVID-19 during pregnancy on mothers and neonates. Two consecutive not-diagnosed women were concomitantly enrolled immediately after each diagnosed woman was identified, at any stage during pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed until hospital discharge using the standardized INTERGROWTH-21st protocols and electronic data management system. A total of 43 institutions in 18 countries contributed to the study sample. The independent association between the 2 entities was quantified with the risk factors known to be associated with preeclampsia analyzed in each group. The outcomes were compared among women with COVID-19 alone, preeclampsia alone, both conditions, and those without either of the 2 conditions.ResultsWe enrolled 2184 pregnant women; of these, 725 (33.2%) were enrolled in the COVID-19 diagnosed and 1459 (66.8%) in the COVID-19 not-diagnosed groups. Of these women, 123 had preeclampsia of which 59 of 725 (8.1%) were in the COVID-19 diagnosed group and 64 of 1459 (4.4%) were in the not-diagnosed group (risk ratio, 1.86; 95% confidence interval, 1.32-2.61). After adjustment for sociodemographic factors and conditions associated with both COVID-19 and preeclampsia, the risk ratio for preeclampsia remained significant among all women (risk ratio, 1.77; 95% confidence interval, 1.25-2.52) and nulliparous women specifically (risk ratio, 1.89; 95% confidence interval, 1.17-3.05). There was a trend but no statistical significance among parous women (risk ratio, 1.64; 95% confidence interval, 0.99-2.73). The risk ratio for preterm birth for all women diagnosed with COVID-19 and preeclampsia was 4.05 (95% confidence interval, 2.99-5.49) and 6.26 (95% confidence interval, 4.35-9.00) for nulliparous women. Compared with women with neither condition diagnosed, the composite adverse perinatal outcome showed a stepwise increase in the risk ratio for COVID-19 without preeclampsia, preeclampsia without COVID-19, and COVID-19 with preeclampsia (risk ratio, 2.16; 95% confidence interval, 1.63-2.86; risk ratio, 2.53; 95% confidence interval, 1.44-4.45; and risk ratio, 2.84; 95% confidence interval, 1.67-4.82, respectively). Similar findings were found for the composite adverse maternal outcome with risk ratios of 1.76 (95% confidence interval, 1.32-2.35), 2.07 (95% confidence interval, 1.20-3.57), and 2.77 (95% confidence interval, 1.66-4.63). The association between COVID-19 and gestational hypertension and the direction of the effects on preterm birth and adverse perinatal and maternal outcomes, were similar to preeclampsia, but confined to nulliparous women with lower risk ratios.ConclusionCOVID-19 during pregnancy is strongly associated with preeclampsia, especially among nulliparous women. This association is independent of any risk factors and preexisting conditions. COVID-19 severity does not seem to be a factor in this association. Both conditions are associated independently of and in an additive fashion with preterm birth, severe perinatal morbidity and mortality, and adverse maternal outcomes. Women with preeclampsia should be considered a particularly vulnerable group with regard to the risks posed by COVID-19.

Published
2021

12. The American College of Surgeons Responds to COVID-19

Author

Rusch, Valerie W, Wexner, Steven D, Atala, Anthony, Atkinson, John LD, Denneny, James C, Eberlein, Timothy J, Elsey, James K, Farmer, Diana L, Ford, Henri R, Fried, Gerald M, Gigantelli, James W, Hancock, BJ, Hernandez, Enrique, Jacobs, Lenworth M, Levin, L Scott, Meredith, J Wayne, Michelassi, Fabrizio, Napolitano, Lena M, Phillips, Linda G, Sharp, Kenneth W, Sidawy, Anton N, Stain, Steven C, Sutton, Beth H, Timmerman, Gary L, and Wood, Douglas E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Patient Safety, 8.1 Organisation and delivery of services, Health and social care services research, Good Health and Well Being, Betacoronavirus, COVID-19, Coronavirus Infections, General Surgery, Humans, Infection Control, Leadership, Pandemics, Pneumonia, Viral, SARS-CoV-2, Societies, Medical, United States, American College of Surgeons COVID-19 Communications Committee, Board of Regents, and Officers, Surgery, Clinical sciences
Abstract

The COVID-19 pandemic abruptly, and perhaps irrevocably, changed the way we live, conduct our business affairs, and practice medicine and surgery. In mid-March 2020, as COVID-19 infections escalated exponentially across many areas of the US, the Centers for Disease Control (CDC), the Surgeon General, and the American College of Surgeons (ACS) recommended that hospitals and surgeons postpone non-urgent operations in order to provide care to COVID-19 patients.1-3 It quickly became obvious that the COVID-19 pandemic presented unprecedented medical challenges. ACS leadership, including the Board of Regents and Officers (Appendix), worked with the ACS Executive Director (Dr David Hoyt) and staff to rapidly organize a response to the COVID-19 crisis. The aim of this effort was to support ACS members and Fellows, as well as the broader medical community, in continuing to provide optimal patient care. Because other similar public health crises could arise in the future, we report the measures taken by the ACS to respond to the COVID-19 pandemic.

Published
2020

13. Liver trauma: WSES 2020 guidelines.

Author

Coccolini, Federico, Coimbra, Raul, Ordonez, Carlos, Kluger, Yoram, Vega, Felipe, Moore, Ernest, Biffl, Walt, Peitzman, Andrew, Horer, Tal, Abu-Zidan, Fikri, Sartelli, Massimo, Fraga, Gustavo, Cicuttin, Enrico, Ansaloni, Luca, Parra, Michael, Millán, Mauricio, DeAngelis, Nicola, Inaba, Kenji, Velmahos, George, Maier, Ron, Khokha, Vladimir, Sakakushev, Boris, Augustin, Goran, di Saverio, Salomone, Pikoulis, Emanuil, Chirica, Mircea, Reva, Viktor, Leppaniemi, Ari, Manchev, Vassil, Chiarugi, Massimo, Damaskos, Dimitrios, Weber, Dieter, Parry, Neil, Demetrashvili, Zaza, Civil, Ian, Napolitano, Lena, Corbella, Davide, and Catena, Fausto

Subjects
Adult, Classification, Guidelines, Hemorrhage, Intensive care, Interventional, Liver trauma, Minor, Moderate, Non-operative management, Operative management, Pediatric, Radiology, Severe, Surgery, Abdominal Injuries, Evidence-Based Medicine, Hemodynamics, Humans, Injury Severity Score, Liver, Patient Care Management
Abstract

Liver injuries represent one of the most frequent life-threatening injuries in trauma patients. In determining the optimal management strategy, the anatomic injury, the hemodynamic status, and the associated injuries should be taken into consideration. Liver trauma approach may require non-operative or operative management with the intent to restore the homeostasis and the normal physiology. The management of liver trauma should be multidisciplinary including trauma surgeons, interventional radiologists, and emergency and ICU physicians. The aim of this paper is to present the World Society of Emergency Surgery (WSES) liver trauma management guidelines.

Published
2020

14. Who Initiates the Help Older Parents Give to Midlife Children.

Author

Huo, Meng, Napolitano, Laura, Furstenberg, Frank F, and Fingerman, Karen L

Subjects
Psychology, Pediatric, 7.1 Individual care needs, Management of diseases and conditions, Adult, Adult Children, Aged, Caregivers, Family Relations, Female, Helping Behavior, Humans, Male, Middle Aged, Parent-Child Relations, Parents, Social Support, Socioeconomic Factors, Intergenerational support, Needs, Obligation, Resources, Clinical Sciences, Sociology, Gerontology
Abstract

ObjectivesOlder parents continue to help children after these children have been adults for decades. We utilize a typology approach to assess who initiates the help. We ask whether profiles of help initiation are associated with how often older parents help and how they evaluate their helping behaviors.MethodsOlder parents (N = 241; Mage = 80.12) indicated the extent to which they volunteered to help children and helped per child's request. Parents reported their resources and obligation to help, child problems, frequency, and evaluation (rewards/stresses) of helping.ResultsLatent profile analysis reveals four profiles representing parents who are initiators (n = 65), responders (n = 56), initiators/responders (n = 50), and uninvolved (n = 69). Resources, needs, and individual beliefs differentiate profiles. Parents offer the same amount of help regardless of who initiates such help. Parents who are initiators/responders view helping as more rewarding than parents who are initiators and more stressful than uninvolved parents.DiscussionThis study reveals variation in the initiation of older parents' help and refines our understanding of family help in late life. Findings may suggest a parental expectation for children to be competent in adulthood regardless of their resources and willingness to help.

Published
2020

15. The open abdomen in trauma and non-trauma patients: WSES guidelines

Author

Coccolini, Federico, Roberts, Derek, Ansaloni, Luca, Ivatury, Rao, Gamberini, Emiliano, Kluger, Yoram, Moore, Ernest E, Coimbra, Raul, Kirkpatrick, Andrew W, Pereira, Bruno M, Montori, Giulia, Ceresoli, Marco, Abu-Zidan, Fikri M, Sartelli, Massimo, Velmahos, George, Fraga, Gustavo Pereira, Leppaniemi, Ari, Tolonen, Matti, Galante, Joseph, Razek, Tarek, Maier, Ron, Bala, Miklosh, Sakakushev, Boris, Khokha, Vladimir, Malbrain, Manu, Agnoletti, Vanni, Peitzman, Andrew, Demetrashvili, Zaza, Sugrue, Michael, Di Saverio, Salomone, Martzi, Ingo, Soreide, Kjetil, Biffl, Walter, Ferrada, Paula, Parry, Neil, Montravers, Philippe, Melotti, Rita Maria, Salvetti, Francesco, Valetti, Tino M, Scalea, Thomas, Chiara, Osvaldo, Cimbanassi, Stefania, Kashuk, Jeffry L, Larrea, Martha, Hernandez, Juan Alberto Martinez, Lin, Heng-Fu, Chirica, Mircea, Arvieux, Catherine, Bing, Camilla, Horer, Tal, De Simone, Belinda, Masiakos, Peter, Reva, Viktor, DeAngelis, Nicola, Kike, Kaoru, Balogh, Zsolt J, Fugazzola, Paola, Tomasoni, Matteo, Latifi, Rifat, Naidoo, Noel, Weber, Dieter, Handolin, Lauri, Inaba, Kenji, Hecker, Andreas, Kuo-Ching, Yuan, Ordoñez, Carlos A, Rizoli, Sandro, Gomes, Carlos Augusto, De Moya, Marc, Wani, Imtiaz, Mefire, Alain Chichom, Boffard, Ken, Napolitano, Lena, and Catena, Fausto

Subjects
Rare Diseases, Physical Injury - Accidents and Adverse Effects, Clinical Research, Cardiovascular, Abdomen, Abdominal Cavity, Abdominal Wound Closure Techniques, Guidelines as Topic, Humans, Intra-Abdominal Hypertension, Negative-Pressure Wound Therapy, Postoperative Complications, Prophylactic Surgical Procedures, Resuscitation, Open abdomen, Laparostomy, Non-trauma, Trauma, Peritonitis, Pancreatitis, Vascular emergencies, Intra-abdominal infection, Fistula, Nutrition, Re-exploration, Reintervention, Closure, Biological, Synthetic, Mesh, Technique, Timing, Guidelines, Surgery
Abstract

Damage control resuscitation may lead to postoperative intra-abdominal hypertension or abdominal compartment syndrome. These conditions may result in a vicious, self-perpetuating cycle leading to severe physiologic derangements and multiorgan failure unless interrupted by abdominal (surgical or other) decompression. Further, in some clinical situations, the abdomen cannot be closed due to the visceral edema, the inability to control the compelling source of infection or the necessity to re-explore (as a "planned second-look" laparotomy) or complete previously initiated damage control procedures or in cases of abdominal wall disruption. The open abdomen in trauma and non-trauma patients has been proposed to be effective in preventing or treating deranged physiology in patients with severe injuries or critical illness when no other perceived options exist. Its use, however, remains controversial as it is resource consuming and represents a non-anatomic situation with the potential for severe adverse effects. Its use, therefore, should only be considered in patients who would most benefit from it. Abdominal fascia-to-fascia closure should be done as soon as the patient can physiologically tolerate it. All precautions to minimize complications should be implemented.

Published
2018

16. American Association of Physicists in Medicine Task Group 263: Standardizing Nomenclatures in Radiation Oncology

Author

Mayo, Charles S, Moran, Jean M, Bosch, Walter, Xiao, Ying, McNutt, Todd, Popple, Richard, Michalski, Jeff, Feng, Mary, Marks, Lawrence B, Fuller, Clifton D, Yorke, Ellen, Palta, Jatinder, Gabriel, Peter E, Molineu, Andrea, Matuszak, Martha M, Covington, Elizabeth, Masi, Kathryn, Richardson, Susan L, Ritter, Timothy, Morgas, Tomasz, Flampouri, Stella, Santanam, Lakshmi, Moore, Joseph A, Purdie, Thomas G, Miller, Robert C, Hurkmans, Coen, Adams, Judy, Wu, Qing-Rong Jackie, Fox, Colleen J, Siochi, Ramon Alfredo, Brown, Norman L, Verbakel, Wilko, Archambault, Yves, Chmura, Steven J, Dekker, Andre L, Eagle, Don G, Fitzgerald, Thomas J, Hong, Theodore, Kapoor, Rishabh, Lansing, Beth, Jolly, Shruti, Napolitano, Mary E, Percy, James, Rose, Mark S, Siddiqui, Salim, Schadt, Christof, Simon, William E, Straube, William L, St. James, Sara T, Ulin, Kenneth, Yom, Sue S, and Yock, Torunn I

Subjects
Medical and Biological Physics, Biomedical and Clinical Sciences, Clinical Sciences, Physical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Networking and Information Technology R&D (NITRD), Advisory Committees, Clinical Trials as Topic, Humans, Radiation Oncology, Radiotherapy Dosage, Radiotherapy Planning, Computer-Assisted, Reference Standards, Societies, Scientific, Software, Terminology as Topic, United States, Other Physical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Theoretical and computational chemistry, Medical and biological physics
Abstract

A substantial barrier to the single- and multi-institutional aggregation of data to supporting clinical trials, practice quality improvement efforts, and development of big data analytics resource systems is the lack of standardized nomenclatures for expressing dosimetric data. To address this issue, the American Association of Physicists in Medicine (AAPM) Task Group 263 was charged with providing nomenclature guidelines and values in radiation oncology for use in clinical trials, data-pooling initiatives, population-based studies, and routine clinical care by standardizing: (1) structure names across image processing and treatment planning system platforms; (2) nomenclature for dosimetric data (eg, dose-volume histogram [DVH]-based metrics); (3) templates for clinical trial groups and users of an initial subset of software platforms to facilitate adoption of the standards; (4) formalism for nomenclature schema, which can accommodate the addition of other structures defined in the future. A multisociety, multidisciplinary, multinational group of 57 members representing stake holders ranging from large academic centers to community clinics and vendors was assembled, including physicists, physicians, dosimetrists, and vendors. The stakeholder groups represented in the membership included the AAPM, American Society for Radiation Oncology (ASTRO), NRG Oncology, European Society for Radiation Oncology (ESTRO), Radiation Therapy Oncology Group (RTOG), Children's Oncology Group (COG), Integrating Healthcare Enterprise in Radiation Oncology (IHE-RO), and Digital Imaging and Communications in Medicine working group (DICOM WG); A nomenclature system for target and organ at risk volumes and DVH nomenclature was developed and piloted to demonstrate viability across a range of clinics and within the framework of clinical trials. The final report was approved by AAPM in October 2017. The approval process included review by 8 AAPM committees, with additional review by ASTRO, European Society for Radiation Oncology (ESTRO), and American Association of Medical Dosimetrists (AAMD). This Executive Summary of the report highlights the key recommendations for clinical practice, research, and trials.

Published
2018

17. Splenic trauma: WSES classification and guidelines for adult and pediatric patients

Author

Coccolini, Federico, Montori, Giulia, Catena, Fausto, Kluger, Yoram, Biffl, Walter, Moore, Ernest E, Reva, Viktor, Bing, Camilla, Bala, Miklosh, Fugazzola, Paola, Bahouth, Hany, Marzi, Ingo, Velmahos, George, Ivatury, Rao, Soreide, Kjetil, Horer, Tal, ten Broek, Richard, Pereira, Bruno M, Fraga, Gustavo P, Inaba, Kenji, Kashuk, Joseph, Parry, Neil, Masiakos, Peter T, Mylonas, Konstantinos S, Kirkpatrick, Andrew, Abu-Zidan, Fikri, Gomes, Carlos Augusto, Benatti, Simone Vasilij, Naidoo, Noel, Salvetti, Francesco, Maccatrozzo, Stefano, Agnoletti, Vanni, Gamberini, Emiliano, Solaini, Leonardo, Costanzo, Antonio, Celotti, Andrea, Tomasoni, Matteo, Khokha, Vladimir, Arvieux, Catherine, Napolitano, Lena, Handolin, Lauri, Pisano, Michele, Magnone, Stefano, Spain, David A, de Moya, Marc, Davis, Kimberly A, De Angelis, Nicola, Leppaniemi, Ari, Ferrada, Paula, Latifi, Rifat, Navarro, David Costa, Otomo, Yashuiro, Coimbra, Raul, Maier, Ronald V, Moore, Frederick, Rizoli, Sandro, Sakakushev, Boris, Galante, Joseph M, Chiara, Osvaldo, Cimbanassi, Stefania, Mefire, Alain Chichom, Weber, Dieter, Ceresoli, Marco, Peitzman, Andrew B, Wehlie, Liban, Sartelli, Massimo, Di Saverio, Salomone, and Ansaloni, Luca

Subjects
Physical Injury - Accidents and Adverse Effects, Childhood Injury, Emergency Care, Patient Safety, Pediatric, Hematology, Injuries and accidents, Abdominal Injuries, Adult, Conservative Treatment, Guidelines as Topic, Hemodynamics, Humans, Spleen, Wounds and Injuries, Trauma, Classification, Guidelines, Embolization, Surgery, Non-operative, Conservative
Abstract

Spleen injuries are among the most frequent trauma-related injuries. At present, they are classified according to the anatomy of the injury. The optimal treatment strategy, however, should keep into consideration the hemodynamic status, the anatomic derangement, and the associated injuries. The management of splenic trauma patients aims to restore the homeostasis and the normal physiopathology especially considering the modern tools for bleeding management. Thus, the management of splenic trauma should be ultimately multidisciplinary and based on the physiology of the patient, the anatomy of the injury, and the associated lesions. Lastly, as the management of adults and children must be different, children should always be treated in dedicated pediatric trauma centers. In fact, the vast majority of pediatric patients with blunt splenic trauma can be managed non-operatively. This paper presents the World Society of Emergency Surgery (WSES) classification of splenic trauma and the management guidelines.

Published
2017

18. Longer-Duration Antimicrobial Therapy Does Not Prevent Treatment Failure in High-Risk Patients with Complicated Intra-Abdominal Infections

Author

Hassinger, Taryn E, Guidry, Christopher A, Rotstein, Ori D, Duane, Therese M, Evans, Heather L, Cook, Charles H, O'Neill, Patrick J, Mazuski, John E, Askari, Reza, Napolitano, Lena M, Namias, Nicholas, Miller, Preston R, Dellinger, E Patchen, Coimbra, Raul, Cocanour, Christine S, Banton, Kaysie L, Cuschieri, Joseph, Popovsky, Kimberley, and Sawyer, Robert G

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Infectious Diseases, Clinical Trials and Supportive Activities, Prevention, Patient Safety, Antimicrobial Resistance, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Aged, Anti-Infective Agents, Female, Humans, Intraabdominal Infections, Male, Middle Aged, Retrospective Studies, Risk Factors, Time Factors, Treatment Failure, Surgery, Clinical sciences
Abstract

BackgroundRecent studies have suggested the length of treatment of intra-abdominal infections (IAIs) can be shortened without detrimental effects on patient outcomes. However, data from high-risk patient populations are lacking. We hypothesized that patients at high risk for treatment failure will benefit from a longer course of antimicrobial therapy.MethodsPatients enrolled in the Study to Optimize Peritoneal Infection Therapy (STOP-IT) trial were evaluated retrospectively to identify risk factors associated with treatment failure, which was defined as the composite outcome of recurrent IAI, surgical site infection, or death. Variables were considered risk factors if there was a positive statistical association with treatment failure. Patients were then stratified according to the presence and number of these risk factors. Univariable analyses were performed using the Kruskal-Wallis, χ2, and Fisher exact tests. Logistic regression controlling for risk factors and original randomization group, either a fixed four-day antimicrobial regimen (experimental) or a longer course based on clinical response (control), also was performed.ResultsWe identified corticosteroid use, Acute Physiology and Chronic Health Evaluation II score ≥5, hospital-acquired infection, or a colonic source of IAI as risk factors associated with treatment failure. Of the 517 patients enrolled, 263 (50.9%) had one or two risk factors and 16 (3.1%) had three or four risk factors. The rate of treatment failure rose as the number of risk factors increased. When controlling for randomization group, the presence and number of risk factors were independently associated with treatment failure, but the duration of antimicrobial therapy was not.ConclusionsWe were able to identify patients at high risk for treatment failure in the STOP-IT trial. Such patients did not benefit from a longer course of antibiotic administration. Further study is needed to determine the optimum duration of antimicrobial therapy in high-risk patients.

Published
2017

19. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Author

Beigel, John H, Tebas, Pablo, Elie-Turenne, Marie-Carmelle, Bajwa, Ednan, Bell, Todd E, Cairns, Charles B, Shoham, Shmuel, Deville, Jaime G, Feucht, Eric, Feinberg, Judith, Luke, Thomas, Raviprakash, Kanakatte, Danko, Janine, O'Neil, Dorothy, Metcalf, Julia A, King, Karen, Burgess, Timothy H, Aga, Evgenia, Lane, H Clifford, Hughes, Michael D, Davey, Richard T, Team, IRC002 Study, Quinn, Joseph, Jiang, Yan, Hoelle, Robyn, Iovine, Nicole, Wills, Robert Shawn, Pata, Socorro, Huggins, Monique, Manukian, Belinda, Holland, Carrie, Brait, Kelsey, Hunt, Taylor, Stowell, Christopher, Slater, Amy, Townsends, Mary, Quackenbush, Eugenia B, Park, Yara A, Jordan, Paul Gaither, Blanchet, Cherie, Chronowski, Kevin, Alvarez, Kathleen, Ostrander, Darin, Woessner, Terry, Thoman, Sandra, Lin, James, Ziman, Alyssa, Shankar, Kavita, Blok, Tom, Batts, Don, Beck, Bob, Massey, Gail, Bradley, Carol, Carey, Patricia, Baer, Jenifer, Whitehead, Eva Moore, Kohrs, Sharon, Giulitto, Robert, Schofield, Christina, Fairchok, Mary, Chambers, Susan, Baker, Cindy, RN, Parker, Michelle, Harshbarger, Marta, Nguyen, M Hong, Carey, Mary Ellen, Paronish, Julie, Cornell, Frank, Cramer, Jim, Pakstis, Diana Lynn, Ison, Michael G, Wunderink, Richard, Glesby, Marshall, Ham, Kirsis, Hughes, Valery, Cushing, Melissa, Goss, Cheryl, Grenade, Joanne, Park, Pauline K, Napolitano, Lena M, Raghavendran, Krishnan, Hyzy, Robert C, Davenport, Robertson, Brierley, Kristin, Downs, Theresa, Gong, Michelle Ng, Uehlinger, Joan, Lin, Michael, Fritsche, Janice, and Green, Tondria

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Health Services, Clinical Research, Influenza, Pneumonia & Influenza, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Aged, Blood Component Transfusion, Case-Control Studies, Female, Humans, Influenza, Human, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Plasma, Respiration, Artificial, Treatment Outcome, IRC002 Study Team, Public Health and Health Services, Other Medical and Health Sciences, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundInfluenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza.MethodsIn this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20-38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480.FindingsBetween Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96-3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02-1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4-16] vs 11 days [5-25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0-6] vs 3 days [0-14], p=0·14). Fewer plasma plus standard care participants had serious adverse events compared with standard care alone recipients (nine [20%] of 46 vs 20 [38%] of 52, p=0·041), the most frequent of which were acute respiratory distress syndrome (one [2%] vs two [4%] patients) and stroke (one [2%] vs two [4%] patients).InterpretationAlthough there was no significant effect of plasma treatment on the primary endpoint, the treatment seemed safe and well tolerated. A phase 3 randomised trial is now underway to further assess this intervention.FundingNational Institute of Allergy and Infectious Diseases, US National Institutes of Health.

Published
2017

20. Noninvasive quantification of blood potassium concentration from ECG in hemodialysis patients

Author

Corsi, Cristiana, Cortesi, Marilisa, Callisesi, Giulia, De Bie, Johan, Napolitano, Carlo, Santoro, Antonio, Mortara, David, and Severi, Stefano

Subjects
Biomedical and Clinical Sciences, Engineering, Biomedical Engineering, Bioengineering, Clinical Research, Adolescent, Adult, Child, Electrocardiography, Female, Humans, Long QT Syndrome, Male, Middle Aged, Potassium, Renal Dialysis, Young Adult
Abstract

Blood potassium concentration ([K+]) influences the electrocardiogram (ECG), particularly T-wave morphology. We developed a new method to quantify [K+] from T-wave analysis and tested its clinical applicability on data from dialysis patients, in whom [K+] varies significantly during the therapy. To elucidate the mechanism linking [K+] and T-wave, we also analysed data from long QT syndrome type 2 (LQT2) patients, testing the hypothesis that our method would have underestimated [K+] in these patients. Moreover, a computational model was used to explore the physiological processes underlying our estimator at the cellular level. We analysed 12-lead ECGs from 45 haemodialysis and 12 LQT2 patients. T-wave amplitude and downslope were calculated from the first two eigenleads. The T-wave slope-to-amplitude ratio (TS/A) was used as starting point for an ECG-based [K+] estimate (KECG). Leave-one-out cross-validation was performed. Agreement between KECG and reference [K+] from blood samples was promising (error: -0.09 ± 0.59 mM, absolute error: 0.46 ± 0.39 mM). The analysis on LQT2 patients, also supported by the outcome of computational analysis, reinforces our interpretation that, at the cellular level, delayed-rectifier potassium current is a main contributor of KECG correlation to blood [K+]. Following a comprehensive validation, this method could be effectively applied to monitor patients at risk for hyper/hypokalemia.

Published
2017

21. Cost effectiveness of a mail-delivered individually tailored physical activity intervention for Latinas vs. a mailed contact control

Author

Larsen, Britta, Gilmer, Todd, Pekmezi, Dori, Napolitano, Melissa A, and Marcus, Bess H

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Cancer, Health Services, Prevention, Cardiovascular, Comparative Effectiveness Research, Clinical Research, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Prevention of disease and conditions, and promotion of well-being, Oral and gastrointestinal, Stroke, Adolescent, Adult, Aged, Communication, Cost-Benefit Analysis, Cultural Competency, Exercise, Female, Health Behavior, Health Promotion, Hispanic or Latino, Humans, Language, Middle Aged, Motor Activity, Postal Service, Young Adult, Medical and Health Sciences, Education, Nutrition and dietetics, Epidemiology, Sports science and exercise
Abstract

BackgroundPhysical inactivity is high in Latinas, as are chronic health conditions. There is a need for physical activity (PA) interventions that are not only effective but have potential for cost-effective widespread dissemination. The purpose of this paper was to assess the costs and cost effectiveness of a Spanish-language print-based mail-delivered PA intervention that was linguistically and culturally adapted for Latinas.MethodsAdult Latinas (N = 266) were randomly assigned to receive mail-delivered individually tailored intervention materials or wellness information mailed on the same schedule (control). PA was assessed at baseline, six months (post-intervention) and 12 months (maintenance phase) using the 7-Day Physical Activity Recall Interview. Costs were calculated from a payer perspective, and included personnel time (wage, fringe, and overhead), materials, equipment, software, and postage costs.ResultsAt six months, the PA intervention cost $29/person/month, compared to $15/person/month for wellness control. These costs fell to $17 and $9 at 12 months, respectively. Intervention participants increased their PA by an average of 72 min/week at six months and 94 min/week at 12 months, while wellness control participants increased their PA by an average of 30 min/week and 40 min/week, respectively. At six months, each minute increase in PA cost $0.18 in the intervention group compared to $0.23 in wellness control, which fell to $0.07 and $0.08 at 12 months, respectively. The incremental cost per increase in physical activity associated with the intervention was $0.15 at 6 months and $0.05 at 12 months.ConclusionsWhile the intervention was more costly than the wellness control, costs per minute of increase in PA were lower in the intervention. The print-based mail-delivered format has potential for broad, cost-effective dissemination, which could help address disparities in this at-risk population.Trial registrationNCT01583140; Date of Registration: 03/06/2012; Funding Source of Trial: National Institute of Nursing Research (NINR); Name of Institutional Review Board: Brown University IRB; Date of Approval: 05/19/2009.

Published
2015

22. Trial of Short-Course Antimicrobial Therapy for Intraabdominal Infection

Author

Sawyer, Robert G, Claridge, Jeffrey A, Nathens, Avery B, Rotstein, Ori D, Duane, Therese M, Evans, Heather L, Cook, Charles H, O’Neill, Patrick J, Mazuski, John E, Askari, Reza, Wilson, Mark A, Napolitano, Lena M, Namias, Nicholas, Miller, Preston R, Dellinger, E Patchen, Watson, Christopher M, Coimbra, Raul, Dent, Daniel L, Lowry, Stephen F, Cocanour, Christine S, West, Michaela A, Banton, Kaysie L, Cheadle, William G, Lipsett, Pamela A, Guidry, Christopher A, and Popovsky, Kimberley

Subjects
Prevention, Infectious Diseases, Infection, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Appendicitis, Drug Administration Schedule, Female, Fever, Humans, Intraabdominal Infections, Kaplan-Meier Estimate, Leukocytosis, Male, Medication Adherence, Middle Aged, Peritonitis, Recurrence, Sepsis, Surgical Wound Infection, Young Adult, STOP-IT Trial Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics. The appropriate duration of antimicrobial therapy remains unclear.MethodsWe randomly assigned 518 patients with complicated intraabdominal infection and adequate source control to receive antibiotics until 2 days after the resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy (control group), or to receive a fixed course of antibiotics (experimental group) for 4±1 calendar days. The primary outcome was a composite of surgical-site infection, recurrent intraabdominal infection, or death within 30 days after the index source-control procedure, according to treatment group. Secondary outcomes included the duration of therapy and rates of subsequent infections.ResultsSurgical-site infection, recurrent intraabdominal infection, or death occurred in 56 of 257 patients in the experimental group (21.8%), as compared with 58 of 260 patients in the control group (22.3%) (absolute difference, -0.5 percentage point; 95% confidence interval [CI], -7.0 to 8.0; P=0.92). The median duration of antibiotic therapy was 4.0 days (interquartile range, 4.0 to 5.0) in the experimental group, as compared with 8.0 days (interquartile range, 5.0 to 10.0) in the control group (absolute difference, -4.0 days; 95% CI, -4.7 to -3.3; P

Published
2015

23. Identification of Equine Lactadherin-derived Peptides That Inhibit Rotavirus Infection via Integrin Receptor Competition*

Author

Civra, Andrea, Giuffrida, Maria Gabriella, Donalisio, Manuela, Napolitano, Lorenzo, Takada, Yoshikazu, Coulson, Barbara S, Conti, Amedeo, and Lembo, David

Subjects
Biochemistry and Cell Biology, Biological Sciences, Pediatric, Infectious Diseases, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Infection, Amino Acid Motifs, Amino Acid Sequence, Animals, Antigens, Surface, Cattle, Cell Membrane, Cell Survival, Equidae, Glycolipids, Glycoproteins, Horses, Humans, Inhibitory Concentration 50, Integrins, Lipid Droplets, Membrane Glycoproteins, Milk, Milk Proteins, Molecular Sequence Data, Peptides, Proteomics, Rotavirus, Rotavirus Infections, Sequence Homology, Amino Acid, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, antiviral agent, integrin, peptides, proteomics, RNA virus, donkey, lactadherin, milk, rotavirus, Chemical Sciences, Medical and Health Sciences, Biochemistry & Molecular Biology, Biological sciences, Biomedical and clinical sciences, Chemical sciences
Abstract

Human rotavirus is the leading cause of severe gastroenteritis in infants and children under the age of 5 years in both developed and developing countries. Human lactadherin, a milk fat globule membrane glycoprotein, inhibits human rotavirus infection in vitro, whereas bovine lactadherin is not active. Moreover, it protects breastfed infants against symptomatic rotavirus infections. To explore the potential antiviral activity of lactadherin sourced by equines, we undertook a proteomic analysis of milk fat globule membrane proteins from donkey milk and elucidated its amino acid sequence. Alignment of the human, bovine, and donkey lactadherin sequences revealed the presence of an Asp-Gly-Glu (DGE) α2β1 integrin-binding motif in the N-terminal domain of donkey sequence only. Because integrin α2β1 plays a critical role during early steps of rotavirus host cell adhesion, we tested a minilibrary of donkey lactadherin-derived peptides containing DGE sequence for anti-rotavirus activity. A 20-amino acid peptide containing both DGE and RGD motifs (named pDGE-RGD) showed the greatest activity, and its mechanism of antiviral action was characterized; pDGE-RGD binds to integrin α2β1 by means of the DGE motif and inhibits rotavirus attachment to the cell surface. These findings suggest the potential anti-rotavirus activity of equine lactadherin and support the feasibility of developing an anti-rotavirus peptide that acts by hindering virus-receptor binding.

Published
2015

24. Biallelic mutations in SNX14 cause a syndromic form of cerebellar atrophy and lysosome-autophagosome dysfunction

Author

Akizu, Naiara, Cantagrel, Vincent, Zaki, Maha S, Al-Gazali, Lihadh, Wang, Xin, Rosti, Rasim Ozgur, Dikoglu, Esra, Gelot, Antoinette Bernabe, Rosti, Basak, Vaux, Keith K, Scott, Eric M, Silhavy, Jennifer L, Schroth, Jana, Copeland, Brett, Schaffer, Ashleigh E, Gordts, Philip LSM, Esko, Jeffrey D, Buschman, Matthew D, Field, Seth J, Napolitano, Gennaro, Abdel-Salam, Ghada M, Ozgul, R Koksal, Sagıroglu, Mahmut Samil, Azam, Matloob, Ismail, Samira, Aglan, Mona, Selim, Laila, Mahmoud, Iman G, Abdel-Hadi, Sawsan, Badawy, Amera El, Sadek, Abdelrahim A, Mojahedi, Faezeh, Kayserili, Hulya, Masri, Amira, Bastaki, Laila, Temtamy, Samia, Müller, Ulrich, Desguerre, Isabelle, Casanova, Jean-Laurent, Dursun, Ali, Gunel, Murat, Gabriel, Stacey B, de Lonlay, Pascale, and Gleeson, Joseph G

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Brain Disorders, Clinical Research, Animals, Atrophy, Autophagy, Cerebellar Diseases, Cerebellum, Child, Preschool, Female, Gene Frequency, Humans, Infant, Lod Score, Lysosomal Storage Diseases, Lysosomes, Male, Mutation, Phagosomes, Sorting Nexins, Spinocerebellar Ataxias, Syndrome, Zebrafish, Medical and Health Sciences, Developmental Biology, Agricultural biotechnology, Bioinformatics and computational biology, Genetics
Abstract

Pediatric-onset ataxias often present clinically as developmental delay and intellectual disability, with prominent cerebellar atrophy as a key neuroradiographic finding. Here we describe a new clinically distinguishable recessive syndrome in 12 families with cerebellar atrophy together with ataxia, coarsened facial features and intellectual disability, due to truncating mutations in the sorting nexin gene SNX14, encoding a ubiquitously expressed modular PX domain-containing sorting factor. We found SNX14 localized to lysosomes and associated with phosphatidylinositol (3,5)-bisphosphate, a key component of late endosomes/lysosomes. Patient-derived cells showed engorged lysosomes and a slower autophagosome clearance rate upon autophagy induction by starvation. Zebrafish morphants for snx14 showed dramatic loss of cerebellar parenchyma, accumulation of autophagosomes and activation of apoptosis. Our results characterize a unique ataxia syndrome due to biallelic SNX14 mutations leading to lysosome-autophagosome dysfunction.

Published
2015

25. Impairment of chaperone‐mediated autophagy leads to selective lysosomal degradation defects in the lysosomal storage disease cystinosis

Author

Napolitano, Gennaro, Johnson, Jennifer L, He, Jing, Rocca, Celine J, Monfregola, Jlenia, Pestonjamasp, Kersi, Cherqui, Stephanie, and Catz, Sergio D

Subjects
Biochemistry and Cell Biology, Biological Sciences, Rare Diseases, Brain Disorders, Orphan Drug, 2.1 Biological and endogenous factors, Aetiology, Amino Acid Transport Systems, Neutral, Animals, Autophagy, Cystine, Cystinosis, Humans, Lysosomal-Associated Membrane Protein 2, Lysosomes, Mice, Mice, Inbred C57BL, Mice, Knockout, Molecular Chaperones, autophagy, CTNS, cystinosis, lysosomal storage disorder, lysosomal trafficking, Lysosomal storage disorder, Lysosomal trafficking, Medical and Health Sciences, Biochemistry and cell biology
Abstract

Metabolite accumulation in lysosomal storage disorders (LSDs) results in impaired cell function and multi-systemic disease. Although substrate reduction and lysosomal overload-decreasing therapies can ameliorate disease progression, the significance of lysosomal overload-independent mechanisms in the development of cellular dysfunction is unknown for most LSDs. Here, we identify a mechanism of impaired chaperone-mediated autophagy (CMA) in cystinosis, a LSD caused by defects in the cystine transporter cystinosin (CTNS) and characterized by cystine lysosomal accumulation. We show that, different from other LSDs, autophagosome number is increased, but macroautophagic flux is not impaired in cystinosis while mTOR activity is not affected. Conversely, the expression and localization of the CMA receptor LAMP2A are abnormal in CTNS-deficient cells and degradation of the CMA substrate GAPDH is defective in Ctns(-/-) mice. Importantly, cysteamine treatment, despite decreasing lysosomal overload, did not correct defective CMA in Ctns(-/-) mice or LAMP2A mislocalization in cystinotic cells, which was rescued by CTNS expression instead, suggesting that cystinosin is important for CMA activity. In conclusion, CMA impairment contributes to cell malfunction in cystinosis, highlighting the need for treatments complementary to current therapies that are based on decreasing lysosomal overload.

Published
2015

26. Risk of Breast Cancer With CXCR4-Using HIV Defined by V3 Loop Sequencing

Author

Goedert, James J, Swenson, Luke C, Napolitano, Laura A, Haddad, Mojgan, Anastos, Kathryn, Minkoff, Howard, Young, Mary, Levine, Alexandra, Adeyemi, Oluwatoyin, Seaberg, Eric C, Aouizerat, Bradley, Rabkin, Charles S, Harrigan, P Richard, and Hessol, Nancy A

Subjects
Biomedical and Clinical Sciences, Health Sciences, Oncology and Carcinogenesis, HIV/AIDS, Sexually Transmitted Infections, Cancer, Women's Health, Breast Cancer, Infectious Diseases, Clinical Research, Infection, Adult, Breast Neoplasms, Case-Control Studies, Female, Genetic Predisposition to Disease, HIV, HIV Infections, Humans, Middle Aged, Receptors, CXCR4, chemokine receptors, AIDS, breast cancer, parallel sequencing, women, Clinical Sciences, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

ObjectiveEvaluate the risk of female breast cancer associated with HIV-CXCR4 (X4) tropism as determined by various genotypic measures.MethodsA breast cancer case-control study, with pairwise comparisons of tropism determination methods, was conducted. From the Women's Interagency HIV Study repository, one stored plasma specimen was selected from 25 HIV-infected cases near the breast cancer diagnosis date and 75 HIV-infected control women matched for age and calendar date. HIV-gp120 V3 sequences were derived by Sanger population sequencing (PS) and 454-pyro deep sequencing (DS). Sequencing-based HIV-X4 tropism was defined using the geno2pheno algorithm, with both high-stringency DS [false-positive rate (3.5) and 2% X4 cutoff], and lower stringency DS (false-positive rate, 5.75 and 15% X4 cutoff). Concordance of tropism results by PS, DS, and previously performed phenotyping was assessed with kappa (κ) statistics. Case-control comparisons used exact P values and conditional logistic regression.ResultsIn 74 women (19 cases, 55 controls) with complete results, prevalence of HIV-X4 by PS was 5% in cases vs 29% in controls (P = 0.06; odds ratio, 0.14; confidence interval: 0.003 to 1.03). Smaller case-control prevalence differences were found with high-stringency DS (21% vs 36%, P = 0.32), lower stringency DS (16% vs 35%, P = 0.18), and phenotyping (11% vs 31%, P = 0.10). HIV-X4 tropism concordance was best between PS and lower stringency DS (93%, κ = 0.83). Other pairwise concordances were 82%-92% (κ = 0.56-0.81). Concordance was similar among cases and controls.ConclusionsHIV-X4 defined by population sequencing (PS) had good agreement with lower stringency DS and was significantly associated with lower odds of breast cancer.

Published
2015

27. Effects of hospital facilities on patient outcomes after cancer surgery

Author

Knight, Sr, Chu, K, Lapitan, Mc, Dare, Aj, Pius, R, Shaw, Ca, Drake, Tm, Norman, L, Ademuyiwa, Ao, Adisa, Ao, Aguilera, Ml, Al-Saqqa, Sw, Al-Slaibi, I, Bhangu, A, Biccard, Bm, Brocklehurst, P, Costas-Chavarri, A, Elhadi, M, Fairfield, Cj, Fitzgerald, Je, Ghosh, D, Glasbey, J, Henegouwen, Miv, Ingabire, Jca, Kingham, Tp, Lawani, I, Lieske, B, Lilford, R, Martin, J, Mclean, Ka, Moore, R, Morton, D, Nepogodiev, D, Ntirenganya, F, Pata, F, Pinkney, T, Stephen, R Knight, Catherine, A Shaw, Riinu, Pius, Thomas, M Drake, Lisa, Norman, Adesoji, O Ademuyiwa, Adewale, O Adisa, Maria Lorena Aguilera, Sara, W Al-Saqqa, Ibrahim, Al-Slaibi, Aneel, Bhangu, Bruce, M Biccard, Peter, Brocklehurst, Ainhoa, Costas-Chavarri, Kathryn, Chu, Anna, Dare, Muhammed, Elhadi, Cameron, J Fairfield, J Edward Fitzgerald, Dhruv, Ghosh, James, Glasbey, Mark, I van Berge Henegouwen, C Allen Ingabire, J, T Peter Kingham, Marie Carmela Lapitan, Ismaïl, Lawani, Bettina, Lieske, Richard, Lilford, Janet, Martin, Kenneth, A McLean, Rachel, Moore, Dion, Morton, Dmitri, Nepogodiev, Faustin, Ntirenganya, Francesco, Pata, Thomas, Pinkney, Ahmad Uzair Qureshi, Antonio Ramos-De la Medina, Aya, Riad, Hosni Khairy Salem, Joana, Simões, Richard, Spence, Neil, Smart, Stephen, Tabiri, Hannah, Thomas, Thomas, G Weiser, Malcolm, West, John, Whitaker, Ewen, M Harrison, Arben, Gjata, Maria Marta Modolo, Sebastian, King, Erick, Chan, Sayeda Nazmun Nahar, Ade, Waterman, Dominique, Vervoort, Alemayehu Ginbo Bedada, Bernardo De Azevedo, Ana Gabriela Figueiredo, Manol, Sokolov, Venerand, Barendegere, Gerald, Ekwen, Arnav, Agarwal, Qinyang, Liu, Juan Camilo Correa, Kalisya Luc Malemo, Jacques, Bake, Jakov, Mihanovic, Kamila, Kunčarová, Julius, Orhalmi, Hosni, Salem, Jyri, Teras, Aristotelis, Kechagias, Alexis, P Arnaud, Judith, Lindert, Vasileios, Kalles, Maria-Lorena, Aguilera-Arevalo, Gustavo, Recinos, Zsolt, Baranyai, Basant, Kumar, Harish Neelamraju Lakshmi, Sanoop Koshy Zachariah, Philip, Alexander, Sunil Kumar Venkatappa, Pramesh, C, Radhian, Amandito, Christina, Fleming, Luca, Ansaloni, Gianluca, Pellino, Ahmed, M Altibi, Ibrahim, Nour, Intisar, Hamdun, Ali, M Ghellai, Donatas, Venskutonis, Tomas, Poskus, Justas, Zilinskas, Precious, Malemia, Yong Yong Tew, Elaine, Borg, Sarah, Ellul, Fatima Zahraa Wafqui, David, W Borowski, Anne Sophie van Dalen, Cameron, Wells, Harissou, Adamou, Adesoji, Ademuyiwa, Adewale, Adisa, Kjetil, Søreide, Sara Al Saqqa, Osaid, Alser, Haya, Tahboub, Helmut Alfredo Segovia Lohse, Sebastian Shu Yip, Piotr, Major, António Sampaio Soares, Matei Razvan Bratu, Andrey, Litvin, Armen, Vardanyan, Ahmad, Gudal, Naif, Albati, Jovan, Juloski, Miran, Rems, Sarah, Rayne, Stephanie Van Straten, Yoshan, Moodley, Irene Ortega Vázquez, Jaime, Ruiz-Tovar, Kithsiri Janakantha Senanayake, Sujeewa Priyantha Bandara Thalgaspitiya, Omer Abdelbagi Omer, Anmar, Homeida, Yucel, Cengiz, Daniel, Clerc, Muhammad, Alshaar, Hanen, Bouaziz, Yuksel, Altinel, Matthew, Doe, Maryna, Freigofer, Ella, Teasdale, Rakan, Kabariti, Joshua Michael Clements, Stephen Richard Knight, Ahsan, Ashfaq, Ijeoma, Azodo, Gabriela, Wagner, Ivan, Trostchansky, Mayaba, Maimbo, David, Linyama, Helidon, Nina, Amanda, Zeko, Claudio Gabriel Fermani, Santiago, Villalobos, Federico, Carballo, Pablo, Farina, Sebastian, Guckenheimer, Marilla, Dickfos, Ankit, Ajmera, Chester, Chong, Ralph, Gourlay, Sikandar, Hussaini, Yi Jia Lee, Adeeb, Majid, Peter, Martin, Rebecca, Miles, Owen James Morris, Jamie, Phua, William, Ridley, Tarunpreet, Saluja, Ryan Renxin Tan, Jen, Teh, Anna, Wells, Bharti, Arora, Qaasim, Dollie, Debbie, Ho, Yanru, Ma, Omattage Mahasha Perera, Anthony, Truong, Amanda Caroline Dawson, Bryan, Lim, Upuli, Pahalawatta, Jacqueline, Phan, Xiao-Ming Sarah Woon-Shoo-Tong, Andrea, Yeoh, Lillian, Charman, Andrew, Drane, Sharon, Laura, Charmaine Chu Wen Lo, Amy, Mozes, Rita, Poon, Hao Han Tan, Ellen, Wall, Prakshi, Chopra, Jasmine De Giovanni, Bal, Dhital, Brian, Draganic, Alexander, Duller, Jonathan, Gani, Yao Kuan Goh, Jun Young Jeong, Brendan, Mcmanus, Prakash, Nagappan, Peter, Pockney, Anya, Rugendyke, Mahsa, Sarrami, Stephen, Smith, Vanessa, Wills, Hsu Ven Wong, Geoffrey, Ye, Geoffrey, Zhang, Ethan, Brooker, Daniel, Feng, Bonnie, Lau, Carlin, Ngai, Sarah, Birks, David, Gyorki, Jaime Otero de Pablos, Ali, Abbosh, Chris, Gillespie, Ahmed, Mahmoud, Bianca, Kwan, Joshua, Lawson, Andrea, Warwick, Janne, Bingham, Andrew, J Cockbain, Nagendra Naidu Dudi-Venkata, Jordan, Ellaby-Hall, Ben, Finlay, Emily, Humphries, Jade, Pisaniello, Monique, Pisaniello, Salma, Salih, Tarik, Sammour, Haidar Hadri Abd Wahab, April De Silva, Nicola, Hayward, Kartik, Iyer, Guy, Maddern, Gian Andrea Prevost, Naga, Annapureddy, Krishna Pranathi Settipalli, Jeremy, Yeo, Lucy, Hempenstall, Lily, Pham, Shaun, Purcell, Cherry, Talavera, Ashish, I Vaska, Gurpreet, Chaggar, Phillip, Chrapko, Annelise, Cocco, Sarah Michelle Crystal Jade Coulter-Nile, Grahame, Ctercteko, James, French, Houchen, Gong, Martijn, Gosselink, Thuvarahan, Jegathees, Ivan, Jin, Michelle, Kalachov, Kathryn, Kiefhaber, Katherine, Lee, Jason, Luong, Steven, Phan, Henry, Pleass, Kelly, Veale, Zhi, Zeng, Angela, Au, Ashe, Debiasio, Idy, Deng, Jananee, Myooran, Amrita, Nair, Peter, Stewart, Anton, Stift, Lukas Walter Unger, Kerstin, Wimmer, Nabila, Ahmed, Syed, Hasan, Saber, Rahman, Margaret, O'Shea, Greg, Padmore, Adrian, Peters, Pietro, Perduca, Guenda, Pulcina, Nicolas, Tinton, Frederic, Buxant, Elsa, Dabin, Giulia, Garofalo, Francis, Dossou, Freddy Houehanou Rodrigue Gnangnon, Yacoubou Imorou Souaibou, Pako, Motlaleselelo, Omphile, Tlhomelang, Igor Lima Buarque, Gustavo Mendonça Ataíde Gomes, Aldo Vieira Barros, Ilia, Batashki, Nikolai, Damianov, Vladislav, Stoyanov, Dragomir, Dardanov, Svilen, Maslyankov, Plamen, Petkov, George, Todorov, Evgeni, Zhivkov, Aygulya, Akisheva, Miguel Angel Castilla Moreno, Geno, Genov, Ivelina, Ilieva, Tsvetomir, Ivanov, Martin, Karamanliev, Azhar, Khan, Emil, Mitkov, Tsanko, Yotsov, Boyko, Atanasov, Nikolay, Belev, Mihail, Slavchev, Carlos, Nsengiyumva, Elgan, Jones, Simon, Stock, Steve, Kyota, James, Brown, Tresor Mabanza, K, Lemery Nigo Samuel, Chidi, Otuneme, Ngwang, Prosper, Franklin, Umenze, Marylise, Boutros, Natasha, Caminsky, Sinziana, Dumitra, Richard, Garfinkle, Dominique, Morency, Ebram, Salama, Alexander, Banks, Lorenzo, Ferri, Haitian, He, Amit, Katz, Alexander Sender Liberman, Sarkis, Meterissian, Allison, Pang, Elena, Parvez, Usmaan, Hameed, Fahima, Osman, Sangita, Sequeira, Natalie, Coburn, Alisha, Jaffer, Paul, Karanicolas, Matthew, Mosseler, Reilly, Musselman, Xinyuan, Liu, Ching Wan Yip, Juan Sebastian Garces-Otero, Carolina, Guzman, Sebastian, Sierra, Andres Uribe Valencia, Paulo Andrés Cabrera Rivera, Saul, Camelo, Andrea, Gonzalez, Alejandro, González-Orozco, Manuel Santiago Mosquera Paz, Carlos J- Perez Rivera, Felipe, Gonzalez, Andres, Isaza-Restrepo, Laura, Nino-Torres, Natalia Arias Madrid, Maria Clara Mendoza Arango, Justin, Tsandiraki, Damir, Jemendžić, Branislav, Kocman, Oliver, Šuman, Renata, Canic, Darko, Jurišić, Ivana, Karakas, Ana Krizanovic Rupcic, Vlatka, Pitlovic, Josip, Samardžić, Mario, Kopljar, Ivan, Bacic, Edgar, Domini, Robert, Karlo, Danijela, Miljanić, Andrea, Simic, Mariam, Ahmed, Majdi Al Nassrallah, Rabiya, Altaf, Talal, Amjad, Ruba, Eltoum, Heba, Haidar, Alhassan, Hassan, Omar, Khalil, Marwan, Qasem, Rommel, Ramesh, Gautham, Sajith, Maham, Wisal, Jan, Žatecký, Michele, Bujda, Katerina, Jirankova, Ales, Paclik, Aya, Abdallah, Mariam Abdulgawad Almogy, Esraa Ayman El-Sawy, Ahmed Moustafa ElFayoumy, Nourhan, Elghareeb, Nourhan Ahmed Esmat, Ahmed, Fadel, Abdullah, Habater, Heba, Hamdy, Amr, Hefni, Marwa, Kamal, Norhan Mohamed Abobakr, Ahmed, Sayed, Nancy, Shaker, Ehab, Taha, Hoda, Tharwat, Omar, Zakaria, Ibrahem, Abdelmotaleb, Ali, Al-Dhufri, Hamza, S Al-Himyari, Enas El Sheikh, Asmaa, Eldmaty, Aya, Elkhalawy, Ahmed, M Elkhashen, Kithara, Magdy, Safa, Mostafa, Habib Doutoum Sadia, Mohamed Mahmoud Saleh, Dina, Samir, Mohamed Yahia Mohamed Ali, Mahmoud, A Nassar, Samar, Abdelhady, Aly, Abdelrazek, Israa, Abdelsalam, Aya, El-Sawy, Eman, Essam, Mohamed, Gadelkarim, Khaled, Ghaly, Mohamed, Hassabalnaby, Rana, Masarani, Nourhan Mohamed Shaaban, Ahmed, Sabry, Menatalla, Salem, Nourhan Akram Soliman, Diaaaldin, Zahran, Moustafa Ramadan Abou El Soud, Esraa Tarek Badr, Hala, Borham, Nehal, Elmeslemany, Mohammad, Elsayed, Fawzia, Elsherif, Sara, Eslam, Gehad, Gaber, Sondos, Ibrahim, Yara, Kamh, Abdelrahman, Mahmoud, Shimaa Gamal Mohamed, Eman, Morshedy, Cinderella, Omar, Fatima Salem Soliman, Shaza, Abdelkawy, Naglaa, Abdelmohsen, Mahmoud, Abdelshakour, Ahmed, Dahy, Norhan, Gamal, Mohammed, Gamal, Ahmad, Hasan, Helal, Hetta, Nehad, Mousa, Mohamed, Omar, Somia, Rabie, Mahmoud, Saad, Bakeer, Saleh, Marwa Sayed Mohamed, Muhammad, Shawqi, Heba Abdelhady Mousa, Mostafa, Alnoury, Mohamed, Elbealawy, Ahmed, Elshafey, Muhammad Essam Ibrahim El Desouki Muhammad Ahmed, Mennatullah, Ghonaim, Fawzy, 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Taqwa, Sayed, Tarneem, Shehada, Ahmed Mohy Zidan, Khalid, Abbas, Amr, Ali, Mohamed, Attia, Mohamed, Balata, Ayman El Nakeeb, Mohamed Ibrahim Elsayed Elewaily, Ahmed, Elfallal, Hossam, Elfeki, Ahmed, Elkhadragy, Sameh, Emile, Helmy, Ezzat, Hasnaa, Hosni, Islam, Mansour, Waleed, Omar, Gehad, Othman, Kareem, Sadek, Mostafa, Shalaby, Noura, Shehab-Eldeen, Rawda Anas Khalifa, Helmy, Badr, Mostafa, Eldeep, Ahmed, Eldeep, Amany Eldoseuky Mohammed, Salwa, Khallaf, Eman Magdy Hegazy, Rokia, Mahmoud, Pola, Mikhail, Mahmoud, Morsi, Sara, Mowafy, Dina, Raafat, Amina, Safy, Marwa, Sera, Ahmed Shible Sera, Mostafa Salim Mohamed AbdAllah, Muhammad, Abdelkader, Abdulrahman Osama Abdou, Ahmedgaber, Ahmed, Shireen, Gaafar, Fatma Ibrahim Negm, Mina, Lapic, Ahmed, Maher, Hagar, Mahmoud, Ahmed, Mostafa, Mohamed, Samir, Fatma, Samy, Nourhan, Semeda, Hind, I Shalaby, Alaa, El-Taweel, Ahmed Galal Elnagar, Ahmed Gamal Hemidan, Mohamed, Hussein, Ahmed, A Kandil, Moawad, Mf, Ayat Allah Nasser Hamamah, Mostafa, 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Ahmed Tarek, Muad Fathi Khalleefah Abu Hallalah, Saleh Abujamra, Hazem Abdelkarem Ahmed, Tagwa Alsharef, Abdulsalam Ali Ben Saoud, Tasnim El Gharmoul, Ahmed Elhadi, Safa Elrais, Abdulhalim Shebani, Heba Zarti, Asaid Zeiton, Marijus Ambrazevicius, Nerijus Kaselis, Migle Stakyte, Oleg Aliosin, Agne Cizauskaite, Sarunas Dailidenas, Vitalijus Eismontas, Migle Kybransiene, Vitalija Nutautiene, Narimantas Samalavicius, Dainius Simcikas, Algirdas Slepavicius, Albinas Tamosiunas, Nerijus Ubartas, Paulius Zeromskas, Saulius Bradulskis, Edvinas Dainius, Juozas Juočas, Egle Kubiliute, Juozas Kutkevičius, Aurimas Opolskis, Audrius Parseliunas, Andrejus Subocius, Donatas Venskutonis, Egle Virbickaite, Diana Zuikyte, Algirdas Bogusevicius, Kristina Buzaite, Daiva Čepuliené, Ieva Cesleviciene, Vaidotas Cesna, Jolanta Gribauskaite, Povilas Ignatavicius, Mantas Jokubauskas, Monika Liugailaitè, Ernest Margelis, Ruta Mazelyte, Lina Pankratjevaitè, Matas Pažusis, Agne Rackeviciute, Justina Saladyte, 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Noor, Reantha Pillay, Leandi Steynfaardt, Lucía González González, José Miguel Marín Santos, Paula Martín-Borregón, Javier Martínez Caballero, Cristina Nevado García, Pastora Rodriguez Fraga, Gonzalo De Castro Parga, Maria Pilar Fernández Veiga, Lucía Garrido López, Hugo Infante Pino, Irene Lages Cal, Marta López Otero, Manuel Nogueira Sixto, Marta Paniagua García Señorans, Laura Rodríguez Fernández, Alejandro Ruano Poblador, Erika Rufo Crespo, Raquel Sanchez-Santos, Vincenzo Vigorita, Ester Alonso Batanero, Dorisme Asnel, Isabel Cifrian Canales, Elisa Contreras Saiz, Irene De Santiago Alvarez, Tamara Díaz Vico, Sebastian Fernandez Arias, Daniel Fernández Martínez, Carmen García Bernardo, Luis Joaquín García Flórez, Carmen Garcia Gutierrez, Manuel García Munar, Carlos Alberto Márquez Zorrilla Molina, Marta Merayo, José Luis Michi Campos, Maria Moreno Gijon, Jorge L Otero-Diez, Jose Luis Rodicio Miravalles, Lorena Solar-Garcia, Aida Suárez Sánchez, Nuria Truan, Cristina Alejandre 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M., Mohsine, R., Rafik, A., Oung, T., Tin, M. M., Plarre, P., Alberga, A., Sluiter, N., Tuynman, J., Blok, R., Comert, D., Hompes, R., Kalff, M., Stellingwerf, M. E., Tanis, P., van Berge Henegouwen, M., van Praag, E. M., Wisselink, D., Gerhards, M., Lopes Cardozo, J., Westerduin, E., de Jonge, J., van Geloven, A., van Schilt, K., den Boer, F., Stoots, S., Vlek, S., Adams, J., Al-Busaidi, I. S., Budd, G., Choi, S. I., Chu, M. J. J., Ganugapati, A., Mckinstry, L., Pascoe, R., Richards, S., Rosser, K., Stevenson, A., White, R., Farik, S., Kwun, J., Murad, A., Cowan, S., Hall, T., Hayton, M., Malam Sani, L., Oumarou Garba, S., Amadou Magagi, I., Habou, O., Aliyu, H., Daniyan, M., Sholadoye, T. T., Abdullahi, L., Anyanwu, L. -J., Mohammad Mohammad, A., Muhammad, A. B., Sheshe, A. A., Suleiman, I., Adesina, A., Awolowo, A., Onuoha, C., Salami, O., Taiwo, O., Taiwo, A., Kache, S., Makama, J. G., Sale, D., Abiola, O., Ajao, A., Ajiboye, A., Etonyeaku, A., Olaogun, J., Adebanjo, A., Adesanya, O., Afolayan, M. O., Balogun, O., Makanjuola, A., Nwokocha, S., Ojewola, R. W., Olajide, T. O., Aderounmu, A., Adesunkanmi, A. -R., Agbakwuru, A., Akeem Aderogba, A., Alatise, O. I., Arowolo, O., Lawal, O., Mohammed, T., Ndegbu, C., Olasehinde, O., Wuraola, F., Akinkuolie, A., Mosanya, A., Ayandipo, O., Elemile, P., Lawal, T. A., Ali SANI, S., Garba, S., Hauwa SANI, R., Olori, S., Onyebuashi, H., Umoke, I., Adenuga, A., Adeyeye, A., Habeeb, O., Lawal, B., Nasir, A., Aahlin, E. K., Kjonas, D., Myrseth, E., Abbasy, J., Alvi, A., Saleem, O., Afzal, A., Nazir, A., Farooq, M., Liaqat, A., Naqi, S. A., Raza, A., Sarfraz, M., Sarwar, M., Banglani, M., Munir, A., Sehrish, R., Ayub, B., Sayyed, R., Altaf, A., Ayub, S., Saeed, K., Syed, B., Akbar, S. A., Anwer, A. W., Khan, R. N., Khan, A. I., Khattak, S., Mohtasham, S., Parvaiz, M. A., Syed, A. A., Ansari, A. B., Shahzad, N., Khaliq, T., Rashid, I., Waqar, S. H., Abu Al-saleem, H., Abu Alqumboz, A., Alqadi, M., Amro, A., Assa, R., Awesat, E., Ayyad, R., Hammad, M., Haymony, A., Hijazi, B., Hmeidat, B., Lahaseh, R., Qawasmi, A., Rajabi, A., Shehada, M., Shkokani, S., Yaghi, Y., Yaghi, N., Alzohour, M., Farid, M., Habes, Y. M., Juba, W., Nubani, Y., Rabee, A., Sa'Deh, M., Abed, S., Al basos, I., Alswerki, M., Ashour, D., Awad, I., Diab, S., El Jamassi, A., El-Kahlout, S., Elhout, S., Hajjaj, A. N. K., Hasanain, D., Nabil hajjaj, B., Obaid, M., Saikaly, E., Salhi, A., Al-Tammam, H., Almasri, M., Baniowda, M., Beshtawi, D., Horoub, A., Misk, R., Mohammad, B., Qasrawi, R., Sholi, T., Abu-Nimeh, S., Abu-srour, A., Abukhalaf, S. A., Adawi, S., Alsalameh, B., Ayesh, K., Elqadi, M., Hammouri, A., Karim Mustafa, F., Marzouqa, N., Melhem, S., Miqdad, D., Mohamad, B., Rawhi, M., Abu Ahammala, A. B., Abu Ataya, A., Abu Jayyab, I., Al-Shwaikh, S., Alagha, O., Alasttal, M., Awadallah, H., Elblbessy, M., Fares, J., Jarbou, A., Mahfouz, I., Albahnasawi, M. A., Abo mahadi, A., Abuelhatal, H., Abuelqomboz, A., Almoqayyad, A., Alwali, A., Balaawi, R., Hamouda, M., Humeid, M., Jedyan, A., Mahmoud Abu hamam, T., Matar, G., Salem, A., Samra, T., Shaheen, N., Shihada, K., A. Nemer, A., Abu Al Amrain, M., Abu Alamrain, A., Abu Jamie, N., Abu-Rous, M. R., Alfarra, N., Altaweel, M., Alwhaidi, N., Hamed, R., Saqqa, B., Shaheen, A., Aljaber, D., Aljaberi, L., Alwaheidi, M., Jawaada, A., Khaldi, H., Qahoush, R., Qari, J., Saadeh, R., Salim, A., Yacoub, A., Abbas, A., Abu shua'ib, R., Abu Zainah, B., Abusirrees, M., Babaa, B., Barhoush, O., Belal qadomi, A., Daraghmeh, L., Haji, R., Khatatbeh, A., Khatib, L., Qarariah, S., Quzmar, Y., Safadi, K., Salameh, R., Hassan, M., Herzallah, S., Massad, L., Nazzal, A., Nazzal, R., Escobar, D., Machain V, G. M., Rodriguez Gonzalez, A., Chachaima Mar, J. E., Chinchihualpa Paredes, N. O., Cuba, V., Lopez, W., Niquen Jimenez, M. M., Sanchez Bartra, N. A., Sapallanay Ojeda, O., Sequeiros, D., Toscano Pacheco, A., Vergara, M., Abarca, S., Alcorta, R., Borda-Luque, G., Eusebio Zegarra, I. E., Lujan Lopez, C., Marrufo, M., Mogrovejo, C., Nomura, A., Rodriguez Angeles, Y., Vidal Meza, M. R., Zavala, G., Castillo Arrascue, J. N., Hidrogo Cabrera, J. C., Larrea vera, J. J. M., Osorio, M., Ylatoma Diaz, E. A., Fontanilla, M. A., Fuentes, J. R., Salazar, A. L., Dominguez, G., Lopez, M. P., Macalindong, S., Onglao, M. A., Ramirez, A., Sacdalan, M. D., Tampo, M. M., Uy, G. L., Mangahas, J., Yabut, K., Canete, J. P., Cansana, B. E., Castro, E. J., Lipana, M. K., Roxas, M. F., Zara, V. 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M., Guimaraes, A., Marques, J., Nico Albano, M., Silva, M., Valente da Costa, A., Vieira Caroco, T., Almeida Braga, S., Capunge, I., Fragoso, M., Guimaraes, J., Pinto, B., Ribeiro, J., Angel, M., Fialho, G., Guerrero, M., Campos Costa, F., Cardoso, D., Cardoso, V., Alves, M., Estalagem, I., Louro, T., Marques, C., Martelo, R., Morgado, M., Canotilho, R., Correia, A. M., Martins, P., Peyroteo, M., Gomes, J., Monteiro, R., Romano, M., Alves, D. M., Peixoto, R., Quintela, C., Jervis, M. J., Melo, D., Pacheco, A., Paixao, V., Pedro, V., Pimenta, J., Pimenta de Castro, J., Rocha, A., Beuran, M., Ciubotaru, C., Diaconescu, B., Hostiuc, S., Negoi, I., Stoica, B., Anokhin, E., Kuznetsov, G., Oganezov, G., Paramzin, F., Romanova, E., Rutkovskii, V., Shushval, M., Zabiyaka, M., Dzhumabaev, K., Ivanov, V., Mamedli, Z., Achkasov, S., Balkarov, A., Nabiev, E., Nagudov, M., Rybakov, E., Saifutdinova, K., Sushkov, O., Joseph, L., Ndayishimiye, I., Faustin, N., Mutabazi, A. Z., Mvukiyehe, J. 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K., Rencuzogullari, A., Isik, A., Leventoglu, S., Yalcinkaya, A., Yuksel, O., Kalayci, M. U., Kara, Y., Sarici, I. S., Akin, A., Alemdag, G. N., Arslan, E., Baki, B. E., Bodur, M. S., Calik, A., Candas Altinbas, B., Cihanyurdu, I., Erkul, O., Gul, B., Guner, A., Kose, B., Semiz, A., Sevim, Tayar, S., Tomas, K., Tufek, O. Y., Turkyilmaz, S., Ulusahin, M., Usta, A., Yildirim, R., Guler, S. A., Tatar, O. C., Varol, E., Kirimtay, B., Uysal, M., Yildiz, A., Kose, E., Ciftci, A. B., Colak, E., Eraslan, H., Kucuk, G. O., Yemez, K., Lule, H., Bienfait, M., Bua, E., Okalany, N., Basarab, M., Bielosludtsev, O., Kolhanova, K., Perepelytsia, K., Romanukha, K., Savenkov, D., Siryi, S., Tereshchenko, M., Viacheslav, N., Volovetskyi, A., Kebkalo, A., Tryliskyy, Y., Tyselskiy, V., Bruce, E., Chow, B. L., Iddles, E., Mcguckin, S., Newall, N., Ramsay, G., Sharma, P., Stewart, C., Wong, J., Badran, A., Bath, M., Belais, F., Butt, E., Joshi, K., Kapur, M., Shaw, M., Townson, A., Williams, C. Y. K., Gray, T., Greig, R., Husain, M., Murray, E., Mustafa, A., Asif, A., Gokul, A., Shah, M., Akitikori, M. T., Charalabopoulos, A., Davidson, S., Mcnally, S., Rupani, S., Juma, F., Mills, S. C., Muirhead, L., Sellars, K., Walsh, U., Warren, O., Chambers, A., Hunt, R., Boyce, S., Cornwall, H., Tol, I., Argyriou, E. O., Eardley, N., Povey, M., Aithie, J. M. S., Irfan, A., Mcguigan, M. -C., Starr, R., Warren, C. R., Archibald, J., Kirby, G., Kisyov, I., Khoo, C. K., Lee, R., Photiou, D., Davis, R., Prasad, U., Yang, P. Z., Bird, J., Leung, E., Summerour, V., Currow, C., Kiam, J., Tan, G. J. S., Muthusami, A., Pegba-Otemolu, I., Urbonas, T., Nunoo-Mensah, J., Smolskas, E., Boddy, A., Gravante, G., Hunter, D., Andrew, D., Koh, A., Thompson, A., Adams, L., Clements, H. 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S., Mitchell, R., Monaghan, E., Crawford, J., Moug, S., Blackwell, J., Boyd-Carson, H., Herrod, P., Al-Allaf, O., Beattie, M., Bullock, C., Burman, S., Clark, G., Flamey, N., Flannery, O., Harding, A., Kodiatt, B., Lawday, S., Mahapatra, S., Mukundu Nagesh, N., Ng, M., Rye, D., Yoong, A., Clark, L., Deans, C., Edirisooriya, M., Carrington, E. V., Wong, T. L. E., Yusuf, B., Chamberlain, C., Duke, K., Kmiotek, E., Botes, A., Condie, N., Schrire, T., Shah, R., Thomas-Jones, I., Yates, C., Anthony, N., Matthews, E., Sahnan, K., Tankel, J., Tucker, S., Winter Beatty, J., Ziprin, P., Duggan, W., Kantartzi, A., Sridhar, S., Khaw, R. A., Srivastava, P., Underwood, C., Alves do Canto Brum, H., Chopra, S., Davis, L., Hughes, R., Tulley, J., Alberts, J., Athisayaraj, T., Olugbemi, M., Ahmad, K., Chan, C., Chapman, G., Fleming, H., Fox, B., Grewar, J., Hulse, K., Rutherford, D., Sinead, M., Speake, D., Vaughan-Shaw, P. G., Christodoulides, N., Kudhail, S., Welch, M., Husaini, S. M., Lambracos, S., Anyanwu, C., Suresh, R., Thomas, J. S., Gleeson, E., Platoff, R., Saif, A., Enumah, Z., Etchill, E., Gabre-Kidan, A., Bernstein, M., Carrano, F. M., Connors, J., Lynn, P., Melis, M., Newman, E., Foster, D. S., Perrone, K., Titan, A., Ahmad, S., Bafford, A. C. M. D., Dal Molin, M., Hanna, N., Zafar, S. N., Hemmila, M., Napolitano, L., Wong, J. J., Chandler, J., Wood, L., Wren, S., Ottesen, T., You, L., Yu, K., Arcienega Yanez, M. D. P., Ferreira Fernandes, M., Gonzalez, D., Cubas, S., Gonzalez, M. C., Zubiaurre, V., Demolin, R., Giroff, N., Sciuto, P., Campos, M., Rodriguez Cantera, G., Deepika, G., Simuchimba, E., Bulaya, A., Chibuye, C., Chirengendure, B., Kabale, M. -R., Kabongo, K., Munthali, J., Mweso, O., Pikiti, F., Otieno, J., Lai, L. T., Blackman, B., Subramaniam, S., Karim, R., Kok, N., Lee, Y. D., Ali, S., Sinha, A., Corrigan, R., Barnes, N., Wong, F., Dennis, G., Jedamzik, J., Phillips, E., Piette, W., Van hentenryck, M., Koco, H., Lawani, S., Kassa, M. W., Santos Bezerra, T., Gribnev, P., Dimitrov, D., Krastev, P., Oum, S., Bonghaseh, D. T., Al Farsi, M., Alsharqawi, N., Acevedo, V., Castillo Barbosa, A. C., Giron, F., Leon Rodriguez, J. P., Kucan, D., Rosko, D., Barsic, N., Zupan, D., Hegazi, A., Truncikova, V., Fryba, V., Mohamed, M., Nagi, A., Rashad Temerik, A., Elshawy, M. E., Mahmoud, M. I., Anwar, M., Rageh, T., Elmokadem, A., Gaballa, K., Teppo, S., Pengerma, P., Ballouhey, Q., Bergeat, D., Weyl, A., Hain, E., Gyedu, A., Yenli, E., Osei-Poku, D., Rompou, V. -A., Zoikas, A., Gaitanidis, A., Koukis, G., Perivoliotis, K., Tavlas, P., Galanos-Demiris, K., Zografos, G., Karavokyros, I., Xanthopoulou, G., Iordanidou, E., Ayau, F., Garcia, A., Damjan, P., Wason, D., B L, A., Rangganata, E., Kamath, P., O'Connor, D. B., Pinto, M., Perrone, F., Tropeano, F. P., Troilo, F., Bossi, D., Scala, D., Pulitano, L., Carella, M., Pietrabissa, A., Gori, A., Giraudo, G., De Simone, V., Russo, A. A., Braccio, B., Al-Taher, R., Athamneh, S., Parker, A., Sawiee, A., Kattia, A., Tababa, O., Shaeeb, Z., Syminas, V., Jurgaitis, J., Damuleviciene, G., Svagzdys, S., Razafimanjato, N. N. M., Chieng Loo, L., Tiong, I. C., Wan Muhmad, W. F., Vijeyan, H., Li Ying, T., Grech, G., Arrangoiz, R., Jimenez Ley, V. B., Arizpe, D., Lagunes Lara, E., Castro Lopez, E. V., Eaazim, J., Gordinou de Gouberville, M., Bastiaenen, V., Rottier, S., Nahab, F., Ji, M. Y., Seyoji, M., Nwachukwu, C., Emeghara, O., Muhammed, S. E., Idowu, A., Sowemimo, O., Ogundoyin, O., Akande, O., Lott, A., Nadeem, M., Laghari, A. A., Loya, A., Mushtaq, H., Abdullah, M. T., Abuhilal, B., Atawneh, M., Hamdan, H., Alhabil, B., Srour, A., Mousa, I., Da Silva Medina, L., Bartosiak, K., Ferreira, P., Francisco, V., Lemos, R., Frutuoso, L., Fernandes, S., Fonseca, T., Pereira, J., Rachadell, J., Torre, A., Madeira Martins, F., Carvalho, A. C., Rodrigues Ferreira, J., Ribeiro da Silva, B., Devesa, H., Vieira, A., Monica, I., Amaro, M., Sousa, D., Reia, M., Louro, J., Martins, A., Dominguez, J., Santos, I., Freitas Oliveira, N. M., Pereira, J. C., Silva-Vaz, P., Freire, L., Escrevente, R., Negoita, V. M., Shakhmatov, D., Nezerwa, Y., Radulovic, R., Obery, G., Viljoen, F., Mendes, T., Suarez, A., Moncada, E., Fernandez-Hevia, M., Curtis Martinez, C., Gil Garcia, J. M., Gonzalez Zunzarren, M., Idris, T., Eklov, K., Grahn, O., Amin, L., Blomqvist, M., Ajani, C., Kraus, R., Seeger, N., Willemin, M., Rayya, F., Ayash, M., Msouti, R., Kannas, I., Abazid, E., Esper, A., Slim, S., Kavcar, A. S., Aytac, E., Dural, A. C., Ilker, A., Eray, I. C., Kurnaz, E., Altiner, S., Tepe, M. D., Sahin, C., Savli, E., Innocent, A., Babirye, L., Diachenko, A., Hordoskiy, V., Curry, H., Chau, C. Y. C., Robertson, H., Lennon, H., Loi, L., Kirkham, E., Mccann, C., Watts, D., Gurung, B., Wilson, M., Tribedi, T., Garofalo, E., Zahra, B., Macdonald, S., Daniels, I., Ng, N., Khosla, S., Olivier, J., Yue, S. Y. P., Suresh, G., Wellington, J., Lorejo, E., Mossaad, M., Crutcher, M., Alimi, M., Baiu, I., Abdou, H., Conway, A., Peck, C., Perdomo Perez, M. A., Zulu, S., Nakazwe, M., Burger, S., Davies, J., Donaldson, R., Ede, C., Garden, O. J., Lesetedi, C., Mabedi, C., Magill, L., Makinde Alakaloko, F., Makupe, A., Monahan, M., Mulira, S., Muller, E., Musowoyo, J., Olory-Togbe, J. L., Roberts, T., Smith, M., Tayler, V., Windsor, J., Yepez, R., Sundar, S., Runigamugabo, E., Verjee, A., Chen, J., Daya, L., El Aroussi, N., Farina, V., Gnintedeme Olivier, T., Gonzales Nacarino, M., Hammani, A., Honjo, S., Jacobs, R., Kimura, H., Nkoronko, M., Oscullo Yepez, J. J., Pin Hung, W., Raj, A., Romani Pozo, A., Rommaneh, M., Sassamela Fabiano, S. C., Shiroma Gago, C. M., Srinivas, A., Sung, C. -Y., Tai, A., Valle Aranda, Y. C., Venturini, S., Wilguens Lartigue, J., Public and occupational health, AMS - Sports, APH - Health Behaviors & Chronic Diseases, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, and Albarella, Sara

Subjects
global surgery, hospitals, humans, income, neoplasms, postoperative period, poverty, prospective studies, no keywords listed, General Medicine, Prospective Studie, Hospital, Settore MED/18 - Chirurgia Generale, outcome, Hospitals, Humans, Income, Neoplasms, surgery, Postoperative Period, Poverty, Prospective Studies, cancer surgery, Human, hospital facilities
Abstract

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p

Published
2022
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28. Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Author

Gabriella Fabbrocini, L Bonzano, Silvia Ferrucci, S Ribero, Simona Tavecchio, Giovanni Pellacani, Steven Paul Nisticò, C Detoraki, Franco Rongioletti, Cataldo Patruno, Paolo Romita, Eustachio Nettis, Viviana Piras, Michela Ortoncelli, M Carbonara, Giulia Calabrese, Danilo Di Bona, E. Di Leo, Luigi Macchia, Caterina Foti, G Argenziano, Maddalena Napolitano, Nettis, E, Ferrucci, S M, Ortoncelli, M, Pellacani, G, Foti, C, Di Leo, E, Patruno, C, Rongioletti, F, Argenziano, G, Macchia, L, Tavecchio, S, Napolitano, M, Ribero, S, Bonzano, L, Romita, P, Di Bona, D, Nisticò, S P, Piras, V, Calabrese, G, Detoraki, C, Carbonara, M, Fabbrocini, G, Nettis, E., Ferrucci, S. M., Ortoncelli, M., Pellacani, G., Foti, C., Di Leo, E., Patruno, C., Rongioletti, F., Argenziano, G., Macchia, L., Tavecchio, S., Napolitano, M., Ribero, S., Bonzano, L., Romita, P., Di Bona, D., Nistico, S. P., Piras, V., Calabrese, G., Detoraki, C., Carbonara, M., and Fabbrocini, G.

Subjects
Adult, medicine.medical_specialty, Immunology, Population, Dupilumab, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Interquartile range, Internal medicine, Humans, Immunology and Allergy, Medicine, Eosinophilia, Multicenter real-life study, education, Retrospective Studies, Atopic dermatitis, education.field_of_study, business.industry, Conjunctiviti, Retrospective cohort study, Dermatology Life Quality Index, Immunoglobulin E, Conjunctivitis, Atopic dermatiti, medicine.disease, Clinical trial, Treatment Outcome, 030228 respiratory system, Multicentric real-life study, medicine.symptom, business, Human
Abstract

BACKGROUND Dupilumab has been demonstrated to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, evidence of real-world experience with dupilumab in a broader population is limited to date. METHODS Adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at ten Italian academic centers, were included in the study. Physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index, DLQI) and serological markers [immunoglobulin (Ig) E and eosinophil count] after 16 weeks were analyzed. RESULTS We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median ± interquartile percentage change from baseline to 16 weeks of treatment in the EASI score was -87.5±22.0 (p

Published
2022
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29. A CASE-BASED REASONING SYSTEM FOR GENOTYPIC PREDICTION OF HIV-1 CO-RECEPTOR TROPISM

Author

EVANS, MARK C, PAQUET, AGNES C, HUANG, WEI, NAPOLITANO, LAURA, FRANTZELL, ARNE, TOMA, JONATHAN, STAWISKI, ERIC W, GOETZ, MATTHEW BIDWELL, PETROPOULOS, CHRISTOS J, WHITCOMB, JEANNETTE, COAKLEY, EOIN, and HADDAD, MOJGAN

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Algorithms, Genotype, HIV-1, Humans, Receptors, CXCR4, Support Vector Machine, Tropism, Tropism prediction, genotypic algorithm, HIV-1 co-receptor, V3, Biochemistry and Cell Biology, Artificial Intelligence and Image Processing, Bioinformatics, Bioinformatics and computational biology, Applied computing
Abstract

Accurate co-receptor tropism (CRT) determination is critical for making treatment decisions in HIV management. We created a genotypic tropism prediction tool by utilizing the case-based reasoning (CBR) technique that attempts to solve new problems through applying the solution from similar past problems. V3 loop sequences from 732 clinical samples with diverse characteristics were used to build a case library. Additional sequence and molecular properties of the V3 loop were examined and used for similarity assessment. A similarity metric was defined based on each attribute's frequency in the CXCR4-using viruses. We implemented three other genotype-based tropism predictors, support vector machines (SVM), position specific scoring matrices (PSSM), and the 11/25 rule, and evaluated their performance as the ability to predict CRT compared to Monogram's enhanced sensitivity Trofile(®) assay (ESTA). Overall concordance of the CBR based tropism prediction algorithm was 81%, as compared to ESTA. Sensitivity to detect CXCR4 usage was 90% and specificity was at 73%. In comparison, sensitivity of the SVM, PSSM, and the 11/25 rule were 85%, 81%, and 36% respectively while achieving a specificity of 90% by SVM, 75% by PSSM, and 97% by the 11/25 rule. When we evaluated these predictors in an unseen dataset, higher sensitivity was achieved by the CBR algorithm (87%), compared to SVM (82%), PSSM (76%), and the 11/25 rule (33%), while maintaining similar level of specificity. Overall this study suggests that CBR can be utilized as a genotypic tropism prediction tool, and can achieve improved performance in independent datasets compared to model or rule based methods.

Published
2013

30. Upregulation of the Rab27a-Dependent Trafficking and Secretory Mechanisms Improves Lysosomal Transport, Alleviates Endoplasmic Reticulum Stress, and Reduces Lysosome Overload in Cystinosis

Author

Johnson, Jennifer L, Napolitano, Gennaro, Monfregola, Jlenia, Rocca, Celine J, Cherqui, Stephanie, and Catz, Sergio D

Subjects
Biochemistry and Cell Biology, Medical Physiology, Biomedical and Clinical Sciences, Biological Sciences, Orphan Drug, Neurosciences, Rare Diseases, Biotechnology, Aetiology, 2.1 Biological and endogenous factors, Amino Acid Transport Systems, Neutral, Animals, Biological Transport, Calcium, Cell Line, Cells, Cultured, Cystine, Cystinosis, Down-Regulation, Endoplasmic Reticulum Chaperone BiP, Endoplasmic Reticulum Stress, Exocytosis, Humans, Lysosomes, Mice, Mice, Inbred C57BL, Up-Regulation, rab GTP-Binding Proteins, rab27 GTP-Binding Proteins, Medical and Health Sciences, Developmental Biology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Cystinosis is a lysosomal storage disorder caused by the accumulation of the amino acid cystine due to genetic defects in the CTNS gene, which encodes cystinosin, the lysosomal cystine transporter. Although many cellular dysfunctions have been described in cystinosis, the mechanisms leading to these defects are not well understood. Here, we show that increased lysosomal overload induced by accumulated cystine leads to cellular abnormalities, including vesicular transport defects and increased endoplasmic reticulum (ER) stress, and that correction of lysosomal transport improves cellular function in cystinosis. We found that Rab27a was expressed in proximal tubular cells (PTCs) and partially colocalized with the lysosomal marker LAMP-1. The expression of Rab27a but not other small GTPases, including Rab3 and Rab7, was downregulated in kidneys from Ctns-/- mice and in human PTCs from cystinotic patients. Using total internal reflection fluorescence microscopy, we found that lysosomal transport is impaired in Ctns-/- cells. Ctns-/- cells showed significant ER expansion and a marked increase in the unfolded protein response-induced chaperones Grp78 and Grp94. Upregulation of the Rab27a-dependent vesicular trafficking mechanisms rescued the defective lysosomal transport phenotype and reduced ER stress in cystinotic cells. Importantly, reconstitution of lysosomal transport mediated by Rab27a led to decreased lysosomal overload, manifested as reduced cystine cellular content. Our data suggest that upregulation of the Rab27a-dependent lysosomal trafficking and secretory pathways contributes to the correction of some of the cellular defects induced by lysosomal overload in cystinosis, including ER stress.

Published
2013

31. Non-covalent small molecule partnership for redox-active films: Beyond polydopamine technology

Author

Rita Argenziano, Maria Laura Alfieri, Youri Arntz, Rachele Castaldo, Davide Liberti, Daria Maria Monti, Gennaro Gentile, Lucia Panzella, Orlando Crescenzi, Vincent Ball, Alessandra Napolitano, Marco d'Ischia, Argenziano, Rita, Alfieri, Maria Laura, Arntz, Yourib, Castaldo, Rachele, Liberti, Davide, Maria Monti, Daria, Gentile, Gennaro, Panzella, Lucia, Crescenzi, Orlando, Ball, Vincent, Napolitano, Alessandra, and D'Ischia, Marco

Subjects
Technology, Indoles, UV stressed HaCaT cell, Polymers, pH dependent hydrophobicity, Reducing activity, Yellowish homogeneous films, Film component structural analysi, Hexamethylenediamine, Surfaces, Coatings and Films, Electronic, Optical and Magnetic Materials, Biomaterials, Methyl 5,6-dihydroxyindole-2-carboxylate, Colloid and Surface Chemistry, Redox active film, UVA absorbing film, Humans, Oxidation-Reduction, Non-covalent interaction
Abstract

Hypothesis: The possibility to use hexamethylenediamine (HMDA) to impart film forming ability to natural polymers including eumelanins and plant polyphenols endowed with biological activity and functional properties has been recently explored with the aim to broaden the potential of polydopamine (PDA)-based films overcoming their inherent limitations. 5,6-dihydroxyindole-2-carboxylic acid, its methyl ester (MeDHICA) and eumelanins thereof were shown to exhibit potent reducing activity. Experiments: MeDHICA and HMDA were reacted in aqueous buffer, pH 9.0 in the presence of different substrates to assess the film forming ability. The effect of different reaction parameters (pH, diamine chain length) on film formation was investigated. Voltammetric and AFM /SEM methods were applied for analysis of the film redox activity and morphology. HPLC, MALDI-MS and 1HNMR were used for chemical characterization. The film reducing activity was evaluated in comparison with PDA by chemical assays and using UV stressed human immortalized keratinocytes (HaCat) cells model. Findings: Regular and homogeneous yellowish films were obtained with moderately hydrophobic properties. Film deposition was optimal at pH 9, and specifically induced by HMDA. The film consisted of HMDA and monomeric MeDHICA accompanied by dimers/small oligomers, but no detectable MeDHICA/HMDA covalent conjugation products. Spontaneous assembly of self-organized networks held together mainly by electrostatic interactions of MeDHICA in the anion form and HMDA as the dication is proposed as film deposition mechanism. The film displayed potent reducing properties and exerted significant protective effects from oxidative stress on HaCaT

Published
2022
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32. Caffeine prevents transcription inhibition and P-TEFb/7SK dissociation following UV-induced DNA damage.

Author

Napolitano, Giuliana, Amente, Stefano, Castiglia, Virginia, Gargano, Barbara, Ruda, Vera, Darzacq, Xavier, Bensaude, Olivier, Majello, Barbara, and Lania, Luigi

Subjects
Hela Cells, Humans, DNA Damage, Caffeine, DNA Polymerase II, Ribonucleoproteins, Small Nuclear, Positive Transcriptional Elongation Factor B, Ultraviolet Rays, Transcription, Genetic, Protein Binding, HeLa Cells, Ribonucleoproteins, Small Nuclear, Transcription, Genetic, General Science & Technology
Abstract

BackgroundThe mechanisms by which DNA damage triggers suppression of transcription of a large number of genes are poorly understood. DNA damage rapidly induces a release of the positive transcription elongation factor b (P-TEFb) from the large inactive multisubunit 7SK snRNP complex. P-TEFb is required for transcription of most class II genes through stimulation of RNA polymerase II elongation and cotranscriptional pre-mRNA processing.Methodology/principal findingsWe show here that caffeine prevents UV-induced dissociation of P-TEFb as well as transcription inhibition. The caffeine-effect does not involve PI3-kinase-related protein kinases, because inhibition of phosphatidylinositol 3-kinase family members (ATM, ATR and DNA-PK) neither prevents P-TEFb dissociation nor transcription inhibition. Finally, caffeine prevention of transcription inhibition is independent from DNA damage.Conclusion/significancePharmacological prevention of P-TEFb/7SK snRNP dissociation and transcription inhibition following UV-induced DNA damage is correlated.

Published
2010

33. Real-World Activity and Safety of Trifluridine-Tipiracil Plus Bevacizumab Therapy in Patients with Refractory Metastatic Colorectal Cancer

Author

Gianluca Arrichiello, Alessandra Perrone, Stefania Napolitano, Giulia Martini, Vincenzo De Falco, Pasquale Incoronato, Maria Maddalena Laterza, Gaetano Facchini, Vincenzo Famiglietti, Valeria Nacca, Fernando Paragliola, Rossella Napolitano, Gabriella Suarato, Antonella Nicastro, Erika Martinelli, Davide Ciardiello, Fortunato Ciardiello, Teresa Troiani, Arrichiello, Gianluca, Perrone, Alessandra, Napolitano, Stefania, Martini, Giulia, De Falco, Vincenzo, Incoronato, Pasquale, Laterza, Maria Maddalena, Facchini, Gaetano, Famiglietti, Vincenzo, Nacca, Valeria, Paragliola, Fernando, Napolitano, Rossella, Suarato, Gabriella, Nicastro, Antonella, Martinelli, Erika, Ciardiello, Davide, Ciardiello, Fortunato, and Troiani, Teresa

Subjects
Male, Adult, Aged, 80 and over, Cancer Research, Antineoplastic Combined Chemotherapy Protocol, Colorectal Neoplasm, Middle Aged, Trifluridine, Bevacizumab, Oncology, Retrospective Studie, Colonic Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Humans, Pharmacology (medical), Female, Uracil, Colorectal Neoplasms, Human, Aged, Retrospective Studies
Abstract

Background The combination of trifluridine-tipiracil and bevacizumab was compared with trifluridine-tipiracil monotherapy in a randomized, open-label, phase II trial, resulting in a statistically significant and clinically relevant improvement in progression-free survival (PFS), with tolerable toxicity in patients with refractory metastatic colorectal cancer (mCRC); however, evidence supporting the role of this combination in a real-world setting is limited. Objective The aim of our work was to provide further evidence on the activity and safety of this combination in a real-world series of Western mCRC patients refractory or intolerant to previous therapies. Patient and Methods We conducted a retrospective, observational study of patients with mCRC refractory or intolerant to standard therapies. Patients were treated with trifluridine-tipiracil and bevacizumab. Previous therapy with fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab, aflibercept, regorafenib, and cetuximab or panitumumab (only RAS wild-type) was allowed, as was previous participation in clinical trials. Clinicopathological characteristics, overall response rate (ORR), disease control rate (DCR), overall survival (OS), PFS, and safety data were retrospectively collected and analyzed. Results We recorded 31 patients treated between 1 December 2017 and 30 June 2022. Median age was 69 years (range 38-82 years), 39% were male, 100% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1, tumor location was left-sided in 77% of cases, 54% had synchronous presentation, 35% were RAS mutant, 3% were BRAF mutant, and 71% underwent primary tumor resection; 64% of patients had liver metastases, 55% had lung metastases, and 23% had peritoneal carcinomatosis. The median number of previous treatment lines was 2 (range 0-5), and 84% of patients received at least one previous anti-angiogenic agent. The ORR and DCR were 3% and 71%, respectively. With a median follow-up of 8 months (range 2-39), median PFS was 6 months (95% confidence interval [CI] 3.1-8.9 months) and median OS was 14 months (95% CI 10.1-17.8 months). Adverse events of any grade were reported in 58% of patients. The most common grade 3-4 toxicities were neutropenia (19%) and anemia (6%); 35% of patients required either dose delays or dose reductions due to toxicity. Granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered either on first or subsequent cycles of treatment in 35% of patients. No treatment-related deaths occurred. Sixty percent of the patients who discontinued treatment eventually received one or more lines of subsequent therapy. Conclusions Our series provides further evidence on the activity and safety of the combination of trifluridine-tipiracil and bevacizumab in a real-world series of Western refractory mCRC patients.

Published
2022

34. Premature ejaculation in the era of mobile health application: A current analysis and evaluation of adherence to EAU guidelines

Author

Luigi Napolitano, Luigi Cirillo, Giovanni Maria Fusco, Marco Abate, Alfonso Falcone, Vincenzo Morgera, Gianluigi Cacace, Luigi De Luca, Pasquale Reccia, Claudia Mirone, Felice Crocetto, Giuseppe Celentano, Simone Morra, Biagio Barone, Ciro Imbimbo, Nicola Longo, Vincenzo Mirone, Roberto La Rocca, Napolitano, Luigi, Cirillo, Luigi, Fusco, Giovanni Maria, Abate, Marco, Falcone, Alfonso, Morgera, Vincenzo, Cacace, Gianluigi, De Luca, Luigi, Reccia, Pasquale, Mirone, Claudia, Crocetto, Felice, Celentano, Giuseppe, Morra, Simone, Barone, Biagio, Imbimbo, Ciro, Longo, Nicola, Mirone, Vincenzo, and La Rocca, Roberto

Subjects
Male, Urology, Quality of Life, Humans, Premature Ejaculation, Mobile Applications, Telemedicine
Abstract

Introduction: Several mobile health applications (MHAs) have been developed to assist and improve the quality of life of patients affected by premature ejaculation, but the scientific quality and adherence to guidelines are not yet addressed. Materials and methods: On 25 May 2022, we conducted a search in the Apple App Store and Google Play Store. We reviewed all mobile apps from Apple App Store and Google Play Store for premature ejaculation and evaluated their usage in screening, prevention, management, and adherence to EAU guidelines. Results: In total 9 MHA were reviewed. All MHAs are geared towards the patient and provide information about diagnoses and treatment of PE. The mean score were 2.87, 3.69, 2.77, 2.55, 2.86 for Engagement, Functionality, Aesthetics, Information, and Subjective quality respectively. MHAs reported low and medium adherence to EAU guidelines. Conclusions: MHAs provide different services in many medical fields, including male sexual dysfunction. Their development is constantly increasing, but the problems of scientific validation, content, and quality are not yet solved. Much future research is necessary to improve the quality of the apps and promote new user designed, and high-quality apps.

Published
2022
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35. Chemotherapy in patients with localized angiosarcoma of any site: A retrospective european study

Author

Fabio Conforti, Alessandro Gronchi, Nicholas Penel, Robin L. Jones, Javier M. Broto, Isabella Sala, Vincenzo Bagnardi, Andrea Napolitano, Laura Pala, Elisabetta Pennacchioli, Chiara Catania, Paola Queirolo, Giovanni Grigani, Alessandra Merlini, Silvia Stacchiotti, Alessandro Comandone, Bruno Vincenzi, Vittorio Quagliuolo, Alexia Bertuzzi, Antonella Boglione, Elena Palassini, Giacomo G. Baldi, Jean-Yves Blay, Thomas Ryckewaert, Maud Toulmonde, Antoine Italiano, Axel Le Cesne, Isabelle Ray-Coquard, Josefina Cruz, Carmen N. Hernández-León, Javier M. Trufero, David da Silva Moura, Nadia H. Muñiz, Tommaso De Pas, Conforti, F, Gronchi, A, Penel, N, Jones, R, Broto, J, Sala, I, Bagnardi, V, Napolitano, A, Pala, L, Pennacchioli, E, Catania, C, Queirolo, P, Grigani, G, Merlini, A, Stacchiotti, S, Comandone, A, Vincenzi, B, Quagliuolo, V, Bertuzzi, A, Boglione, A, Palassini, E, Baldi, G, Blay, J, Ryckewaert, T, Toulmonde, M, Italiano, A, Le Cesne, A, Ray-Coquard, I, Cruz, J, Hernandez-Leon, C, Trufero, J, da Silva Moura, D, Muniz, N, and De Pas, T

Subjects
Cancer Research, Oncology, Chemotherapy, Adjuvant, (neo)adjuvant chemotherapy, Antineoplastic Combined Chemotherapy Protocols, Hemangiosarcoma, Humans, Sarcoma, Sarculator, Localized angiosarcoma, Retrospective Studies
Abstract

Background: We retrospectively investigated the role of (neo)adjuvant chemotherapy in patients with primary, localized angiosarcoma. Methods: We selected all patients with primary, localized angiosarcoma, who had received radical surgery between January 2005 and December 2019 at 33 European sarcoma reference centers. The primary objective was to compare the outcome of patients who received (neo)adjuvant chemotherapy versus those who did not, in terms of overall survival (OS), disease-free survival (DFS) and distant metastasis-free survival (DMFS). To reduce the risk of confounding due to imbalance, a propensity-score matching(PSM) was performed. Finally, subgroups analysis was performed according to tumor site, tumor size (< 50 mm or ≥ 50 mm) and patients predicted 10-years OS according to the nomogram sarculator (two different cutoff-values were applied: ≤ 33% or > 33% and < 60% or ≥ 60%). Results: 362 patients were analyzed: 149 (41.2%; treated group) received (neo) adjuvant chemotherapy and 213 (58.6%; control group) did not. The median follow-up for the OS endpoint was 5.1 years (95% CI: 4.0–5.5). The OS-HR was 0.58 (95%CI: 0.40–0.83; p-value = 0.003) in the univariate analysis and 0.74 (95% CI: 0.38–1.43; p = 0.367) in the PSM analysis. The DFS-HR was 0.75 (95% CI: 0.57–0.98; p-value = 0.036) in the univariate analysis, and 0.91 (95% CI:0.56–1.48; p-value = 0.7) in the PSM analysis. The DMFS-HR was 0.75 (95% CI: 0.55–1.02; p-value = 0.065) in univariate analysis and 0.92 (95% CI: 0.53–1.61; p-value = 0.769) in the PSM analysis. Subgroup analysis revealed no heterogeneity of results in strata of tumor site. On the contrary, there was a trend for heterogeneity according to tumor size and patient's risk of death. For all the endpoints analyzed, patients with tumors smaller than 50 mm or at lower risk of death seem to have no benefit from chemotherapy, while patients with larger tumors or at higher risk of death at 10 years seem to derive substantial benefit. Conclusion: This large, retrospective study suggests that patients affected by > 50 mm and/or high-risk primary, localized angiosarcoma could benefit from (neo)adjuvant chemotherapy.

Published
2022
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36. Diagnosis and treatment of chronic synovitis in patients with haemophilia: consensus statements from the Italian Association of Haemophilia Centres

Author

Di Minno, Matteo Nicola Dario, Napolitano, Mariasanta, Giuffrida, Anna Chiara, Baldacci, Erminia, Carulli, Christian, Boccalandro, Elena, Bruno, Clarissa, Forneris, Eleonora, Ricca, Irene, Passeri, Walter, Martinelli, Marco, Rivolta, Gianna Franca, Solimeno, Luigi Piero, Martinoli, Carlo, Rocino, Angiola, Pasta, Gianluigi, Aru, Brigida, Balestri, Elena, Biasoli, Chiara, Cantori, Isabella, Coluccia, Antonella, Contino, Laura, Coppola, Antonio, Cultrera, Dorina, Daniele, Filomena, Ettorre, Cosimo Pietro, Giordano, Paola, Iannaccaro, Piergiorgio, Lassandro, Giuseppe, Linari, Silvia, Luciani, Matteo, Malcangi, Giuseppe, Mancuso, Maria Elisa, Marchesini, Emanuela, Marino, Renato, Mazucconi, Maria Gabriella, Molinari, Angelo Claudio, Notarangelo, Lucia Dora, Pasca, Samantha, Quintavalle, Gabriele, Radossi, Paolo, Raso, Simona, Sabatino, Vincenzo, Santagostino, Elena, Santoro, Cristina, Scaturro, Dalila, Zanon, Ezio, Di Minno, Matteo Nicola Dario, Napolitano, Mariasanta, Giuffrida, Anna Chiara, Baldacci, Erminia, Carulli, Christian, Boccalandro, Elena, Bruno, Clarissa, Forneris, Eleonora, Ricca, Irene, Passeri, Walter, Martinelli, Marco, Rivolta, Gianna Franca, Solimeno, Luigi Piero, Martinoli, Carlo, Rocino, Angiola, Pasta, Gianluigi, Aru, Brigida, Balestri, Elena, Biasoli, Chiara, Cantori, Isabella, Coluccia, Antonella, Contino, Laura, Coppola, Antonio, Cultrera, Dorina, Daniele, Filomena, Ettorre, Cosimo Pietro, Giordano, Paola, Iannaccaro, Piergiorgio, Lassandro, Giuseppe, Linari, Silvia, Luciani, Matteo, Malcangi, Giuseppe, Mancuso, Maria Elisa, Marchesini, Emanuela, Marino, Renato, Mazucconi, Maria Gabriella, Molinari, Angelo Claudio, Notarangelo, Lucia Dora, Pasca, Samantha, Quintavalle, Gabriele, Radossi, Paolo, Raso, Simona, Sabatino, Vincenzo, Santagostino, Elena, Santoro, Cristina, Scaturro, Dalila, Zanon, Ezio, and Matteo Nicola Dario Di Minno, Mariasanta Napolitano, Anna Chiara Giuffrida, Erminia Baldacci, Christian Carulli, Elena Boccalandro, Clarissa Bruno, Eleonora Forneris, Irene Ricca, Walter Passeri, Marco Martinelli, Gianna Franca Rivolta, Luigi Piero Solimeno, Carlo Martinoli, Angiola Rocino, Gianluigi Pasta, Dalila Scaturro

Subjects
haemophilia, haemophilic arthropathy, synovitis, Chronic Disease, Consensus, Hemophilia A, Humans, Italy, Synovitis, haemophilia, haemophilic arthropathy, synovitis, Hematology
Abstract

Although synovitis is recognized as a marker of joint disease activity, its periodic assessment is not included in routine clinical surveillance of patients with haemophilia (PwH). In order to evaluate the current knowledge and to identify controversial issues, a preliminary literature search by the Musculoskeletal Committee of the Italian Association of Haemophilia Centres (AICE) has been conducted. Statements have been established and sent to the Italian AICE members to collect their level of agreement or disagreement by a Delphi process. Thirty-seven consensus recommendations have been drafted. We found a general agreement on the indication to consider the presence of synovitis as a marker of joint disease activity in PwH. Accordingly, there was agreement on the indication to search for synovitis both in patients reporting joint pain and in asymptomatic ones, recognizing ultrasound as the most practical imaging technique to perform periodic joint screening. Interestingly, after detection of synovitis, there was agreement on the indication to modify the therapeutic approach, suggesting prophylaxis in patients treated on demand and tailoring treatment in patients already under prophylaxis. Whereas the need of an early consultation with a physiotherapist is recommended for PwH affected by chronic synovitis, the exact timing for an orthopaedic surgeon consultation is currently unknown.

Published
2021
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37. Final results of the CAVE trial in RAS wild type metastatic colorectal cancer patients treated with cetuximab plus avelumab as rechallenge therapy: Neutrophil to lymphocyte ratio predicts survival

Author

Davide Ciardiello, Vincenzo Famiglietti, Stefania Napolitano, Lucia Esposito, Filippo Pietrantonio, Antonio Avallone, Evaristo Maiello, Chiara Cremolini, Teresa Troiani, Erika Martinelli, Fortunato Ciardiello, Giulia Martini, Ciardiello, Davide, Famiglietti, Vincenzo, Napolitano, Stefania, Esposito, Lucia, Pietrantonio, Filippo, Avallone, Antonio, Maiello, Evaristo, Cremolini, Chiara, Troiani, Teresa, Martinelli, Erika, Ciardiello, Fortunato, and Martini, Giulia

Subjects
Proto-Oncogene Proteins B-raf, Neutrophils, Rectal Neoplasms, fungi, anti-EGFR drug, Gastroenterology, Cetuximab, colorectal cancer, Antibodies, Monoclonal, Humanized, Circulating Tumor DNA, Oncology, NLR, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms, Humans, Lymphocytes, immunotherapy, rechallenge treatment, Colorectal Neoplasms
Abstract

Background: High neutrophil-to-lymphocyte ratio (NLR) is a poor prognostic factor in metastatic colorectal cancer (mCRC). Here we provide final results of CAVE mCRC trial, of cetuximab plus avelumab rechallenge in chemo-refractory mCRC patients and investigated the predictive role of NLR. Methods: All the 77 patients enrolled were included in the analysis. A cut-off of 3 was used to correlate baseline NLR with with overall survival (OS) and with progression free survival (PFS), in intention to treat (ITT) and in circulating tumor DNA (ctDNA) RAS/BRAF Wild Type (WT) patients. Results: In ITT population, NLR

Published
2022
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38. Impact of a cardio‐oncology unit on prevention of cardiovascular events in cancer patients

Author

Alessandra Cuomo, Valentina Mercurio, Gilda Varricchi, Maria Rosaria Galdiero, Francesca Wanda Rossi, Antonio Carannante, Grazia Arpino, Luigi Formisano, Roberto Bianco, Chiara Carlomagno, Carmine De Angelis, Mario Giuliano, Elide Matano, Marco Picardi, Domenico Salvatore, Ferdinando De Vita, Erika Martinelli, Carminia Maria Della Corte, Floriana Morgillo, Michele Orditura, Stefania Napolitano, Teresa Troiani, Carlo G. Tocchetti, Cuomo, A., Mercurio, V., Varricchi, G., Galdiero, M. R., Rossi, F. W., Carannante, A., Arpino, G., Formisano, L., Bianco, R., Carlomagno, C., De Angelis, C., Giuliano, M., Matano, E., Picardi, M., Salvatore, D., De Vita, F., Martinelli, E., Della Corte, C. M., Morgillo, F., Orditura, M., Napolitano, S., Troiani, T., and Tocchetti, C. G.

Subjects
Cardio-oncology, Heart Diseases, Cardiovascular Diseases, Neoplasms, Humans, Heart failure, Antineoplastic Agents, Medical Oncology, Cardiology and Cardiovascular Medicine, Cardiovascular risk factor, Cardiotoxicity, Cancer
Abstract

Aims: As the world population grows older, the co-existence of cancer and cardiovascular comorbidities becomes more common, complicating management of these patients. Here, we describe the impact of a large Cardio-Oncology unit in Southern Italy, characterizing different types of patients and discussing challenges in therapeutic management of cardiovascular complications. Methods and results: We enrolled 231 consecutive patients referred to our Cardio-Oncology unit from January 2015 to February 2020. Three different types were identified, according to their chemotherapeutic statuses at first visit. Type 1 included patients naïve for oncological treatments, Type 2 patients already being treated with oncological treatments, and Type 3 patients who had already completed cancer treatments. Type 2 patients presented the highest incidence of cardiovascular events (46.2% vs. 12.3% in Type 1 and 17.9% in Type 3) and withdrawals from oncological treatments (5.1% vs. none in Type 1) during the observation period. Type 2 patients presented significantly worse 48month-survival (32.1% vs. 16.7% in Type 1 and 17.9% in Type 3), and this was more evident when in the three groups we focused on patients with uncontrolled cardiovascular risk factors or overt cardiovascular disease at the first cardiologic assessment. Nevertheless, these patients showed the greatest benefit from our cardiovascular assessments, as witnessed by a small, but significant improvement in ejection fraction during follow-up (Type 2b: from 50 [20; 67] to 55 [35; 65]; P=0.04). Conclusions: Patients who start oncological protocols without an accurate baseline cardiovascular evaluation are at major risk of developing cardiac complications due to antineoplastic treatments.

Published
2022
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39. Achilles Tendon Injuries Requiring Surgical Treatment in the Pediatric and Adolescent Population: A Case Series

Author

Daniel L, Chen, Matthew C, Beran, Molly, Duncan, Julie A, Young, Jonathan T, Napolitano, and James, MacDonald

Subjects
Rupture, Adolescent, Rupture, Spontaneous, Public Health, Environmental and Occupational Health, General Medicine, Achilles Tendon, Lacerations, Treatment Outcome, Tendon Injuries, Acute Disease, Humans, Orthopedics and Sports Medicine, Ankle Injuries, Child, Retrospective Studies
Abstract

Pediatric Achilles tendon injuries requiring surgical treatment are considered rare and have not been well described. A retrospective chart review was conducted from 2010 to 2020 to identify cases of acute Achilles tendon rupture or laceration that required surgical repair in individuals 19 years or younger. A total of 24 individuals with acute Achilles tendon ruptures (n = 8) and lacerations (n = 16) were identified. All spontaneous ruptures occurred in skeletally mature individuals during sports. One subject was on minocycline at the time of injury, while two had a body mass index (BMI) ≥ 99% for age. Another had a history of clubfoot surgery on the injured side. Patients with lacerations were younger (9.9 ± 3.3 vs 16.3 ± 1.6 years) and had lower BMI (17.3 ± 3.8 vs. 28.0 ± 9.4) than those with spontaneous ruptures. The majority of cases had good outcomes with no postoperative complications.

Published
2022
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40. MRI data quality assessment for the RIN - Neuroimaging Network using the ACR phantoms

Author

Palesi, Fulvia, Nigri, Anna, Gianeri, Ruben, Aquino, Domenico, Redolfi, Alberto, Biagi, Laura, Carne, Irene, De Francesco, Silvia, Ferraro, Stefania, Martucci, Paola, Paul Medina, Jean, Napolitano, Antonio, Pirastru, Alice, Baglio, Francesca, Tagliavini, Fabrizio, Grazia Bruzzone, Maria, Tosetti, Michela, Gandini Wheeler-Kingshott, Claudia A M, Giulietti, Giovanni, and the RIN, – Neuroimaging Network

Subjects
ACR, Multisite, Quality control, Biophysics, Humans, Reproducibility of Results, General Physics and Astronomy, Radiology, Nuclear Medicine and imaging, General Medicine, Data Accuracy
Abstract

Generating big-data is becoming imperative with the advent of machine learning. RIN-Neuroimaging Network addresses this need by developing harmonized protocols for multisite studies to identify quantitative MRI (qMRI) biomarkers for neurological diseases. In this context, image quality control (QC) is essential. Here, we present methods and results of how the RIN performs intra- and inter-site reproducibility of geometrical and image contrast parameters, demonstrating the relevance of such QC practice.American College of Radiology (ACR) large and small phantoms were selected. Eighteen sites were equipped with a 3T scanner that differed by vendor, hardware/software versions, and receiver coils. The standard ACR protocol was optimized (in-plane voxel, post-processing filters, receiver bandwidth) and repeated monthly. Uniformity, ghosting, geometric accuracy, ellipse's ratio, slice thickness, and high-contrast detectability tests were performed using an automatic QC script.Measures were mostly within the ACR tolerance ranges for both T1- and T2-weighted acquisitions, for all scanners, regardless of vendor, coil, and signal transmission chain type. All measurements showed good reproducibility over time. Uniformity and slice thickness failed at some sites. Scanners that upgraded the signal transmission chain showed a decrease in geometric distortion along the slice encoding direction. Inter-vendor differences were observed in uniformity and geometric measurements along the slice encoding direction (i.e. ellipse's ratio).Use of the ACR phantoms highlighted issues that triggered interventions to correct performance at some sites and to improve the longitudinal stability of the scanners. This is relevant for establishing precision levels for future multisite studies of qMRI biomarkers.

Published
2022
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41. Management of Common Postoperative Infections in the Surgical Intensive Care Unit

Author

Staci T, Aubry and Lena M, Napolitano

Subjects
Microbiology (medical), Intensive Care Units, Postoperative Complications, Infectious Diseases, Critical Care, Sepsis, Humans, Comorbidity
Abstract

Postoperative infection and sepsis in the surgical intensive care unit (SICU) are common problems, and can be the reason for SICU admission or can be acquired during the SICU stay. Both diagnosis and management of infection and sepsis in the SICU can be complex, related to the surgical procedures performed, patient comorbidities, and resistant pathogens. The need for "source control" of postoperative infections can pose specific challenges and significant complexity in patient management. Postoperative infections in the SICU are associated with increased morbidity, mortality, and resource utilization, and therefore a strong focus on infection preventive strategies is warranted.

Published
2022
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42. Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study

Author

Claudia Angela Maria Fulgenzi, Jaekyung Cheon, Antonio D'Alessio, Naoshi Nishida, Celina Ang, Thomas U. Marron, Linda Wu, Anwaar Saeed, Brooke Wietharn, Antonella Cammarota, Tiziana Pressiani, Nicola Personeni, Matthias Pinter, Bernhard Scheiner, Lorenz Balcar, Andrea Napolitano, Yi-Hsiang Huang, Samuel Phen, Abdul Rafeh Naqash, Caterina Vivaldi, Francesca Salani, Gianluca Masi, Dominik Bettinger, Arndt Vogel, Martin Schönlein, Johann von Felden, Kornelius Schulze, Henning Wege, Peter R. Galle, Masatoshi Kudo, Lorenza Rimassa, Amit G. Singal, Rohini Sharma, Alessio Cortellini, Vincent E. Gaillard, Hong Jae Chon, and David James Pinato

Subjects
Male, Venous Thrombosis, History, Cancer Research, Carcinoma, Hepatocellular, Polymers and Plastics, Liver Neoplasms, Antineoplastic Agents, Bilirubin, Sorafenib, Antibodies, Monoclonal, Humanized, Industrial and Manufacturing Engineering, Bevacizumab, Oncology, Albumins, Humans, Female, alpha-Fetoproteins, Business and International Management
Abstract

IMbrave150 has established the superiority of atezolizumab plus bevacizumab over sorafenib in patients with unresectable hepatocellular carcinoma (HCC).We generated a prospectively maintained database including patients treated with atezolizumab plus bevacizumab for unresectable HCC across Europe, Asia and USA. Clinico-pathologic characteristics were assessed for their prognostic influence on overall survival (OS) and progression-free survival (PFS) in univariable and multivariate analyses. Overall response rate by RECIST v1.1 and treatment-related adverse events (TRAEs) per CTCAE v.5.0 were reported.Out of 433 patients, 296 Child-Pugh A and ECOG performance status01 patients received atezolizumab plus bevacizumab in first line and were included. Patients were mostly male (82.7%), cirrhotic (75%) with history of viral hepatitis (65.9%). Overall, 68.9% had Barcelona Clinic Liver Cancer C-stage HCC with portal vein tumour thrombosis (PVTT, 35%) and extrahepatic spread (EHS, 51.7%). After a median follow-up of 10.0 months (95% confidence interval (CI): 9.4-10.4), median OS and PFS were 15.7 (95% CI: 14.5-NE) and 6.9 months (95% CI: 6.1-8.3), respectively. In the response-evaluable patients (n = 273), overall response rate was 30.8%. Overall, 221 patients (74.6%) developed TRAEs, with 70 (23.6%) reporting grade 3 or higher TRAEs; 25 (8.4%) patients had bleeding events. OS was independently associated with baseline Albumin-bilirubin (ALBI) grade and PVTT. Shorter PFS was associated with AFP≥ 400 ng/ml, worse ALBI and presence of EHS.This global observational study confirms the reproducible safety and efficacy of atezolizumab plus bevacizumab in routine clinical practice. Within Child-Pugh-A criteria, the presence of PVTT and higher ALBI grade identify patients with poorer survival.

Published
2022
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43. Percutaneous cryoablation for desmoid fibromatosis: initial experience at a UK centre

Author

E.W. Johnston, A. Alves, C. Messiou, A. Napolitano, D. Strauss, A. Hayes, M.J. Smith, C. Benson, R.L. Jones, S. Gennatas, and N. Fotiadis

Subjects
Fibromatosis, Aggressive, Treatment Outcome, Ice, Humans, Female, Radiology, Nuclear Medicine and imaging, General Medicine, Middle Aged, Cryosurgery, United Kingdom, Retrospective Studies
Abstract

To report the first UK experience of cryoablation in desmoid fibromatosis (DF) with particular focus on technique, safety, and efficacy.Patients were selected at multidisciplinary tumour board meetings at a specialist cancer hospital. Radiation dose, procedure duration, and number of cryoprobes were compared for small versus large tumours (10 cm long axis). Response at magnetic resonance imaging (MRI) was evaluated using different criteria, and percentage agreement with clinical response as assessed in oncology clinic calculated.Thirteen procedures were performed in 10 patients (eight women, median age 51 years, IQR 42-69 years) between February 2019 and August 2021. Procedures for large tumours had higher radiation dose (2,012 ± 1,012 versus 1,076 ± 519 mGy·cm, p=0.048) used more cryoprobes (13 ± 7 versus 4 ± 2, p=0.009), and were more likely to have residual unablated tumour (38 ± 37% versus 7.5 ± 10%, p=0.045). Adverse events were minor apart from one transient radial nerve palsy. Eight of 10 patients had symptomatic benefit at clinical follow-up (median 353 days, IQR 86-796 days), and three started systemic therapy mean 393 days later. All patients who had complete ablation demonstrated symptomatic response, with no instances of repeat treatment, recurrence, or need for systemic therapy during the study period. All progression occurred outside ablation zones.Cryoablation for symptomatic DF is a reproducible technique with low, transient toxicity, where one or two treatments can achieve a meaningful response. Where possible, the ablation ice ball should fully cover DF tumours.

Published
2022
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44. Looking for cystoscopy on YouTube: Are videos a reliable information tool for internet users?

Author

Carmine Turco, Claudia Collà Ruvolo, Simone Cilio, Giuseppe Celentano, Gianluigi Califano, Massimiliano Creta, Marco Capece, Roberto La Rocca, Luigi Napolitano, Francesco Mangiapia, Lorenzo Spirito, Simone Morra, Alberto Melchionna, Ferdinando Fusco, Vincenzo Mirone, Nicola Longo, Turco, Carmine, Collà Ruvolo, Claudia, Cilio, Simone, Celentano, Giuseppe, Califano, Gianluigi, Creta, Massimiliano, Capece, Marco, La Rocca, Roberto, Napolitano, Luigi, Mangiapia, Francesco, Spirito, Lorenzo, Morra, Simone, Melchionna, Alberto, Fusco, Ferdinando, Mirone, Vincenzo, and Longo, Nicola

Subjects
Urology, Video Recording, Humans, Cystoscopy, Social Media, Human
Abstract

Objective: The Internet is an important and easily accessible source of information. The aim of the current study was to investigate the quality of YouTube videos on cystoscopy and to establish if they can be used as a reliable information tool for internet users. Materials and methods: The search term “cystoscopy” was used on YouTube platform and the first 120 YouTube videos were analyzed. To assess the video quality Patient Education Materials Assessment Tool (PEMAT) for Audiovisual (A/V) Materials (Understandability and Actionability sections), Misinformation score and Global Quality Score (GQS) were used. Results: Of all 120 videos, 72 were included in the analyses. Of all videos, 59.7% (n = 43), and 40.3% (n = 29) were targeted to General Public and Healthcare Workers. Moreover, “technical aspects” was the main topic addressed (n = 29, 40.3%). The median PEMAT A/V Understandability and Actionability scores were 50.0% (IQR: 39.1-70.0) and 66.7% (IQR: 33.3- 100.0), respectively. The median Misinformation score ranged from 1.0 to 3.0. According to GQS, 22 (30.6%), 26 (36.1%), 16 (22.2%), 8 (11.1%) videos were poor, generally poor, moderate, and good, respectively. No video was evaluated as excellent. Conclusions: Today, YouTube videos on cystoscopy are more frequently uploaded by healthcare workers, who share information about specific aspects of this procedure. However, the quality of YouTube contents on cystoscopy is still poor. Therefore, currently users interested in cystoscopy cannot rely on YouTube to get good informative material on this topic. In consequence, future authors should focus on improving the quality of video contents on cystoscopy

Published
2022
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45. Knowledge, attitudes, and behavior of incarcerated people regarding COVID-19 and related vaccination: a survey in Italy

Author

Gabriella Di Giuseppe, Concetta P. Pelullo, Raffaele Lanzano, Francesco Napolitano, Maria Pavia, DI GIUSEPPE, Gabriella, Pelullo, Concetta P., Lanzano, Raffaele, Napolitano, Francesco, and Pavia, Maria

Subjects
Adult, Male, Health Knowledge, Attitudes, Practice, COVID-19 Vaccines, Adolescent, Science, Diseases, Article, Young Adult, Surveys and Questionnaires, Humans, Aged, Multidisciplinary, SARS-CoV-2, Prisoners, Vaccination, COVID-19, Respiratory Aerosols and Droplets, Middle Aged, Cross-Sectional Studies, Italy, Infectious diseases, Medicine, Female, Vaccination Hesitancy
Abstract

The cross-sectional study assessed knowledge, attitudes, and preventive practices toward COVID-19 disease of incarcerated people. A total of 685 subjects were surveyed. 94% were aware that respiratory droplets are involved in the transmission of COVID-19, and 77.2% that patients with chronic conditions are at risk of a more severe disease. Overall, 92.7% of respondents considered COVID-19 a more severe disease compared to influenza, and 85.4% believed that COVID-19 could cause serious consequences in their institution. Only 22.6% were self-confident about their ability to protect themselves from SARS-CoV-2 infection. This attitude was significantly higher in those who were involved in working activities in the institution, who did not report at least one common symptom compatible with COVID-19 in the previous 3 months, who did not show generalized anxiety symptoms, and did not need additional information. 63.9% of incarcerated people expressed willingness to receive COVID-19 vaccination. Older subjects, who knew that a COVID-19 vaccination is available, believed that COVID-19 is more serious than influenza, and were self-confident about their ability to protect themselves from SARS-CoV-2 infection, were significantly more willing to undergo COVID-19 vaccination. Public health response to COVID-19 in prisons should address vaccine hesitancy to increase vaccine confidence among incarcerated people.

Published
2022

46. Clinical management of metastatic colorectal cancer in the era of precision medicine

Author

Fortunato Ciardiello, Davide Ciardiello, Giulia Martini, Stefania Napolitano, Josep Tabernero, Andres Cervantes, Institut Català de la Salut, [Ciardiello F, Martini G, Napolitano S] Division of Medical Oncology, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy. [Ciardiello D] Division of Medical Oncology, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy. Division of Medical Oncology, IRCCS Foundation Home for the Relief of Suffering, San Giovanni Rotondo, Italy. [Tabernero J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Institute of Oncology, University of Vic/Central University of Catalonia, Barcelona, Spain. Oncology Institute of BarcelonaQuironsalud, Biomedical Research Center in Cancer, Barcelona, Spain. [Cervantes A] Medical Oncology Department, Instituto de Investigación Sanitaria Valencia Biomedical Research Institute, University of Valencia, Valencia Spain. Carlos III Institute of Health, Biomedical Research Center in Cancer, Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus, Ciardiello, Fortunato, Ciardiello, Davide, Martini, Giulia, Napolitano, Stefania, Tabernero, Josep, and Cervantes, Andres

Subjects
Rectal Neoplasms, metastatic colorectal cancer, precision medicine, tumor molecular profiling, Hematology, Other subheadings::/therapy [Other subheadings], Prognosis, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales [ENFERMEDADES], digestive system diseases, Còlon - Càncer - Tractament, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [DISEASES], Oncology, terapéutica::medicina de precisión [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], molecular target therapy, Colonic Neoplasms, Recte - Càncer - Tractament, Biomarkers, Tumor, Tumor Microenvironment, Humans, immunotherapy, Medicina personalitzada, Colorectal Neoplasms, Therapeutics::Precision Medicine [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Otros calificadores::/terapia [Otros calificadores]
Abstract

Immunotherapy; Metastatic colorectal cancer; Precision medicine Inmunoterapia; Cáncer colorrectal metastásico; Medicina de precisión Immunoteràpia; Càncer colorectal metastàtic; Medicina de precisió Colorectal cancer (CRC) represents approximately 10% of all cancers and is the second most common cause of cancer deaths. Initial clinical presentation as metastatic CRC (mCRC) occurs in approximately 20% of patients. Moreover, up to 50% of patients with localized disease eventually develop metastases. Appropriate clinical management of these patients is still a challenging medical issue. Major efforts have been made to unveil the molecular landscape of mCRC. This has resulted in the identification of several druggable tumor molecular targets with the aim of developing personalized treatments for each patient. This review summarizes the improvements in the clinical management of patients with mCRC in the emerging era of precision medicine. In fact, molecular stratification, on which the current treatment algorithm for mCRC is based, although it does not completely represent the complexity of this disease, has been the first significant step toward clinically informative genetic profiling for implementing more effective therapeutic approaches. This has resulted in a clinically relevant increase in mCRC disease control and patient survival. The next steps in the clinical management of mCRC will be to integrate the comprehensive knowledge of tumor gene alterations, of tumor and microenvironment gene and protein expression profiling, of host immune competence as well as the application of the resulting dynamic changes to a precision medicine-based continuum of care for each patient. This approach could result in the identification of individual prognostic and predictive parameters, which could help the clinician in choosing the most appropriate therapeutic program(s) throughout the entire disease journey for each patient with mCRC. Fortunato Ciardiello was supported by a grant from Regione Campania (I-Cure Research Project Cup 21C17000030007). Andres Cervantes was supported by grants from the Instituto de Salud Carlos III (PI18/01909 and PI21/00689). Fortunato Ciardiello reports institutional research grants from Amgen, Merck KGaA, Merck Sharp & Dohme, Pfizer, Pierre Fabre, Roche, and Servier; and service on advisory boards for Bayer, Merck KGaA, Merck Sharp & Dohme, Pierre Fabre, Roche, and Servier outside the submitted work. Davide Ciardiello reports a travel grant from Sanofi outside the submitted work. Stefania Napolitano reports honoraria from Bristol Myers Squibb and Novartis outside the submitted work. Josep Tabernero reports advisory board or scientific consultancy fees from Array Biopharma, AstraZeneca, Avvinity, Bayer, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Roche, Genentech, HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, Inspirna Inc, IQVIA, Lilly, Menarini, Merck KGaA, Merus, Merck Sharp & Dohme, Mirati, Neophore, Novartis, Ona Therapeutics, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Seattle Genetics, Scandion Oncology, Servier, SotioBiotech, Taiho, Tessa Therapeutics, and TheraMyc outside the submitted work. Andres Cervantes reports institutional research grants from Genentech, Merck KGaA, Bristol Myers Squibb, Merck Sharp & Dohme, Roche, Beigene, Bayer, Servier, Lilly, Novartis, Takeda, Astellas, Takeda, and Fibrogen; and honoraria or speaker’s fees from Amgen, Merck KGaA, Roche, Bayer, Servier, and Pierre Fabre outside the submitted work. Giulia Martini reports no conflicts of interest.

Published
2022

47. The roles of personality traits and close social contact in the expression of momentary borderline personality disorder symptoms in daily life

Author

Cassandra Trumbower, Skye C. Napolitano, Timothy J. Trull, Johanna Hepp, Sean P. Lane, and Abigail McDonald

Subjects
Agreeableness, Neuroticism, media_common.quotation_subject, Ecological Momentary Assessment, medicine.disease, Moderation, Impulsivity, Personality disorders, Personality Disorders, Psychiatry and Mental health, Clinical Psychology, Borderline Personality Disorder, mental disorders, medicine, Personality, Humans, medicine.symptom, Big Five personality traits, Psychology, Borderline personality disorder, Clinical psychology, media_common
Abstract

Dimensional models of personality, such as the five-factor model (FFM), have demonstrated strong coherence with the presentation of personality disorders, including borderline personality disorder (BPD). Given that select personality trait elevations have been linked to impairments in multiple life domains across diagnostic groups, we sought to replicate findings from a previous investigation of the utility of the FFM in predicting BPD-relevant outcomes (i.e., negative affect intensity and instability, impulsivity, and interpersonal disagreements) in the daily lives of those with BPD (Hepp et al., 2016) and community participants. As interpersonal context is instrumental in determining the strength of effects observed in studies examining individuals with BPD, we utilized ecological momentary assessment across 3 weeks (6 times daily; ntotal = 15,889) to test whether close social contact (CSC) would moderate the effects of personality on momentary outcomes. Overall, results suggest that CSC is an important moderator between the effects of personality and daily life outcomes for individuals with BPD (N = 56), but not for community individuals (N = 60). For individuals with BPD, CSC may function as both a protective buffer and a risk factor, depending on outcome. For example, CSC attenuates experience of negative affect intensity for individuals with elevated neuroticism, but CSC may predict more frequent disagreements for individuals who report lower agreeableness. We replicated approximately half of the original study's findings, and results support that FFM personality is predictive of BPD-relevant outcomes broadly. However, interpersonal context is key to understanding these relationships for individuals with BPD. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Published
2023

48. Comparison of Bedside and Video-Based Capillary Refill Time Assessment in Children

Author

Amanda J, Nickel, Ryan Brandon, Hunter, Shen, Jiang, John R, Boulet, Jasmine, Hanks, Natalie, Napolitano, Vinay M, Nadkarni, and Akira, Nishisaki

Subjects
Pediatrics, Perinatology and Child Health, Hemodynamics, Emergency Medicine, Humans, Reproducibility of Results, General Medicine, Child
Abstract

Capillary refill time (CRT) to assess peripheral perfusion in children with suspected shock may be subject to poor reproducibility. Our objectives were to compare video-based and bedside CRT assessment using a standardized protocol and evaluate interrater and intrarater consistency of video-based CRT (VB-CRT) assessment. We hypothesized that measurement errors associated with raters would be low for both standardized bedside CRT and VB-CRT as well as VB-CRT across raters.Ninety-nine children (aged 1-12 y) had 5 consecutive bedside CRT assessments by an experienced critical care clinician following a standardized protocol. Each CRT assessment was video recorded on a black background. Thirty video clips (10 with bedside CRT1 s, 10 with CRT 1-2 s, and 10 with CRT2 s) were randomly selected and presented to 10 clinicians twice in randomized order. They were instructed to push a button when they visualized release of compression and completion of a capillary refill. The correlation and absolute difference between bedside and VB-CRT were assessed. Consistency across raters and within each rater was analyzed using the intraclass correlation coefficient (ICC). A Generalizability study was performed to evaluate sources of variation.We found moderate agreement between bedside and VB-CRT observations (r = 0.65; P0.001). The VB-CRT values were shorter by 0.17 s (95% confidence interval, 0.09-0.25; P0.001) on average compared with bedside CRT. There was moderate agreement in VB-CRT across raters (ICC = 0.61). Consistency of repeated VB-CRT within each rater was moderate (ICC = 0.71). Generalizability study revealed the source of largest variance was from individual patient video clips (57%), followed by interaction of the VB-CRT reviewer and patient video clip (10.7%).Bedside and VB-CRT observations showed moderate consistency. Using video-based assessment, moderate consistency was also observed across raters and within each rater. Further investigation to standardize and automate CRT measurement is warranted.

Published
2022
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49. Validation of a novel risk score to predict early and late recurrence in solitary fibrous tumour

Author

Tatiana Georgiesh, Ninna Aggerholm-Pedersen, Patrick Schöffski, Yifan Zhang, Andrea Napolitano, Judith V. M. G. Bovée, Åse Hjelle, Gordon Tang, Mateusz Spalek, Margherita Nannini, David Swanson, Thomas Baad-Hansen, Raf Sciot, Asle C. Hesla, Paul Huang, Desiree Dorleijn, Hans Kristian Haugland, Maribel Lacambra, Jacek Skoczylas, Maria A. Pantaleo, Rick L. Haas, Leonardo A. Meza-Zepeda, Florian Haller, Anna M. Czarnecka, Herbert Loong, Nina L. Jebsen, Michiel van de Sande, Robin L. Jones, Felix Haglund, Iris Timmermans, Akmal Safwat, Bodil Bjerkehagen, and Kjetil Boye

Subjects
Cohort Studies, Cancer Research, Oncology, Risk Factors, Solitary Fibrous Tumors, Chronic Disease, Humans, Neoplasm Recurrence, Local, Prognosis, BEHAVIOR
Abstract

Background: Current risk models in solitary fibrous tumour (SFT) were developed using cohorts with short follow-up and cannot reliably identify low-risk patients. We recently developed a novel risk model (G-score) to account for both early and late recurrences. Here, we aimed to validate the G-score in a large international cohort with long-term follow-up. Methods: Data were collected from nine sarcoma referral centres worldwide. Recurrence-free interval (RFi) was the primary endpoint. Results: The cohort comprised 318 patients with localised extrameningeal SFTs. Disease recurrence occurred in 96 patients (33%). The estimated 5-year RFi rate was 72%, and the 10-year RFi rate was 52%. G-score precisely predicted recurrence risk with estimated 10-year RFi rate of 84% in low risk, 54% in intermediate risk and 36% in high risk (p < 0.001; C-index 0.691). The mDemicco (p < 0.001; C-index 0.749) and Salas OS (p < 0.001; C-index 0.674) models also predicted RFi but identified low-risk patients less accurate with 10-year RFi rates of 72% and 70%, respectively. Conclusions: G-score is a highly significant predictor of early and late recurrence in SFT and is superior to other models to predict patients at low risk of relapse. A less intensive follow-up schedule could be considered for patients at low recurrence risk according to G-score.

Published
2022
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