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3. Lung-protective ventilation during Trendelenburg pneumoperitoneum surgery: A randomized clinical trial

Author

Grieco, Domenico Luca, Russo, Andrea, Anzellotti, Gian Marco, Romanò, Bruno, Bongiovanni, Filippo, Dell’Anna, Antonio M., Mauti, Luigi, Cascarano, Laura, Gallotta, Valerio, Rosà, Tommaso, Varone, Francesco, Menga, Luca S., Polidori, Lorenzo, D’Indinosante, Marco, Cappuccio, Serena, Galletta, Claudia, Tortorella, Lucia, Costantini, Barbara, Gueli Alletti, Salvatore, Sollazzi, Liliana, Scambia, Giovanni, and Antonelli, Massimo

Published
2023
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4. Concordance and Prognostic Relevance of Different Definitions of Systemic Sclerosis Interstitial Lung Disease Progression.

Author

De Lorenzis, Enrico, Del Galdo, Francesco, Natalello, Gerlando, Varone, Francesco, Di Donato, Stefano, Verardi, Lucrezia, Calandriello, Lucio, Kakkar, Vishal, Cerasuolo, Pier Giacomo, Larici, Anna Rita, D'Agostino, Maria Antonietta, Bosello, Silvia Laura, and Richeldi, Luca

Subjects
SYSTOLIC blood pressure, SYSTEMIC scleroderma, PULMONARY artery, DEATH rate, PROGNOSIS, INTERSTITIAL lung diseases
Abstract

Rationale: Interstitial lung disease (ILD) in systemic sclerosis (SSc) is a common complication that has a varied progression rate and prognosis. Different progression definitions are available, including minimal clinically important worsening of FVC, EUSTAR (European Scleroderma Trials and Research Group) progression, OMERACT (Outcome Measures in Rheumatology Clinical Trials) progression, and Erice ILD working group progression. Pulmonary function and symptom changes may act as specific confounding factors when applying these definitions in SSc. Objectives: To assess the concordance and prognostic value of four different definitions in patients with SSc-ILD overall and in specific clinical groups. Methods: Progression status in consecutive patients with SSc-ILD was assessed over 24 months, and 60-month disease-related mortality risk was compared between progressors and nonprogressors using four definitions. Measurements and Main Results: Among 245 patients, 26 SSc-related deaths were reported. Mortality was linked to progression for minimal clinically important worsening of FVC (hazard ratio [HR], 2.27; 95% confidence interval [CI], 1.03–4.97), OMERACT (HR, 2.90; 95% CI, 1.28–6.57), and Erice definitions (HR, 2.69; 95% CI, 1.23–5.89). The association between progression and mortality was poor in patients with disease duration ≥3 years, mild functional impairment, and pulmonary artery systolic pressure ≥40 mm Hg. Erice criteria appeared superior in patients with duration ≥3 years, limited cutaneous variant, and pulmonary artery systolic pressure <40 mm Hg. OMERACT criteria performed better in diffuse cutaneous variant patients with severe functional impairment. Conclusions: The four evaluated definitions of progression in SSc-ILD are not interchangeable, resulting in up to one-third of cases being classified differently on the basis of adopted criteria and presenting different prognostic values, particularly within specific clinical groups. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Ventilatory Support in Patients with COVID-19

Author

Leone, Paolo Maria, Siciliano, Matteo, Simonetti, Jacopo, Lopez, Angelena, Zaman, Tanzira, Varone, Francesco, Richeldi, Luca, Crusio, Wim E., Series Editor, Dong, Haidong, Series Editor, Radeke, Heinfried H., Series Editor, Rezaei, Nima, Series Editor, and Xiao, Junjie, Series Editor

Published
2021
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7. Case of a 33-Year-Old Woman With Hemoptysis and Migrant Nodular Cavitary Lesions

Author

Varone, Francesco, Martini, Alessia, Cicchetti, Giuseppe, Iovene, Bruno, Sgalla, Giacomo, Richeldi, Luca, Cancellieri, Alessandra, Sgalla, Giacomo (ORCID:0000-0003-3130-9388), Richeldi, Luca (ORCID:0000-0001-8594-1448), Varone, Francesco, Martini, Alessia, Cicchetti, Giuseppe, Iovene, Bruno, Sgalla, Giacomo, Richeldi, Luca, Cancellieri, Alessandra, Sgalla, Giacomo (ORCID:0000-0003-3130-9388), and Richeldi, Luca (ORCID:0000-0001-8594-1448)

Abstract

We describe the case of a young 33 -year -old woman that was referred to our clinic for evidence of migrant cavitary nodules at CT scan, dyspnea, and blood sputum. Her physical examination showed translucent and thin skin, evident venous vascular pattern, vermilion of the lip thin, micrognathia, thin nose, and occasional Raynaud phenomenon. We prescribed another CT scan that showed multiple pulmonary nodules in both lungs, some of which had evidence of cavitation. Because bronchoscopy was not diagnostic, we decided to perform surgical lung biopsy. At histologic examination, we found the presence of irregularly shaped, but mainly not dendritic, foci of ossi fication that often contained bone marrow and were embedded or surrounded by tendinous -like fibrous tissue. After incorporating data from the histologic examination, we decided to perform genetic counseling and genetic testing with the use of whole-exome sequencing. The genetic test revealed a heterozygous de novo missense mutation of COL3A1 gene, which encodes for type III collagen synthesis, and could cause vascular Ehlers-Danlos syndrome. CHEST 2024; 165(5):e133 -e136

Published
2024

10. Fibrotic Hypersensitivity Pneumonitis: Diagnosis and Management

Author

Varone, Francesco, Iovene, Bruno, Sgalla, Giacomo, Calvello, Mariarosaria, Calabrese, Angelo, Larici, Anna Rita, and Richeldi, Luca

Subjects
Medical research, Medicine, Experimental, Bacterial pneumonia -- Diagnosis -- Care and treatment, Pneumonia -- Diagnosis -- Care and treatment, Health
Abstract

Fibrotic hypersensitivity pneumonitis is a complex interstitial lung disease that is not entirely understood. In its chronic and fibrotic form, hypersensitivity pneumonitis is one of the main mimickers of idiopathic pulmonary fibrosis (IPF). Distinguishing between these two conditions is challenging but is of particular clinical relevance. Two approved therapies are available for IPF, and a considerable number of clinical trials are now exploring newer pharmacological options. This impressive research effort is a consequence of new pathogenetic understanding, updated diagnostic criteria and a long history of pharmacological trials. Conversely, current knowledge gaps on pathogenesis of chronic hypersensitivity pneumonitis, coupled with lack of validated diagnostic criteria, make the management of this disease an unsolved clinical challenge. This also reflects the paucity of therapeutic clinical trials in this field. In this review, we describe the current evidence and the possible future options to approach this complex disease., Author(s): Francesco Varone [sup.1] , Bruno Iovene [sup.1] , Giacomo Sgalla [sup.1] , Mariarosaria Calvello [sup.1] , Angelo Calabrese [sup.1] , Anna Rita Larici [sup.1] [sup.2] , Luca Richeldi [sup.1] [...]

Published
2020
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13. Predictors of Stability/Improvement of Forced Vital Capacity in Patients With Idiopathic Pulmonary Fibrosis After One Year of Treatment With Nintedanib

Author

Mondoni, Michele, primary, Varone, Francesco, additional, Alfano, Fausta, additional, Muscato, Giuseppe, additional, Conti, Caterina, additional, Saderi, Laura, additional, Iovene, Bruno, additional, Marco, Fabiano Di, additional, Vancheri, Carlo, additional, Richeldi, Luca, additional, Centanni, Stefano, additional, and Sotgiu, Giovanni, additional

Published
2023
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17. Malnutrition in COVID-19 survivors: prevalence and risk factors

Author

Tosato, Matteo, Calvani, Riccardo, Ciciarello, Francesca, Galluzzo, Vincenzo, Martone, Anna Maria, Zazzara, Maria Beatrice, Pais, Cristina, Savera, Giulia, Camprubi Robles, Maria, Ramirez, Maria, Landi, Francesco, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Romano Settanni, Carlo, Porcari, Serena, Benvenuto, Francesca, Bramato, Giulia, Brandi, Vincenzo, Carfì, Angelo, Rita Lo Monaco, Maria, Maria Martone, Anna, Marzetti, Emanuele, Napolitano, Carmen, Pagano, Francesco, Rocchi, Sara, Rota, Elisabetta, Salerno, Andrea, Tritto, Marcello, Beatrice Zazzara, Maria, Catalano, Lucio, Picca, Anna, D’Elia, Mariaelena, Biscotti, Damiano, Cauda, Roberto, Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, Eleonora, Moschese, Davide, Ciccullo, Arturo, Stella, Leonardo, Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Gertrude, Assunta Zocco, Maria, Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Posteraro, Brunella, Sali, Michela, Bizzarro, Alessandra, Lauria, Alessandra, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Maria Cozzupoli, Grazia, Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, Fabrizio, Di Cintio, Giovanni, Longobardi, Ylenia, Tricarico, Laura, Santantonio, Mariaconsiglia, Di Cesare, Tiziana, Guarino, Mariateresa, Corbò, Marco, Settimi, Stefano, Mele, Dario, Brigato, Francesca, Buonsenso, Danilo, Valentini, Piero, Sinatti, Dario, De Rose, Gabriella, Richeldi, Luca, Lombardi, Francesco, Calabrese, Angelo, Varone, Francesco, Maria Leone, Paolo, Siciliano, Matteo, Corbo, Giuseppe Maria, Montemurro, Giuliano, Calvello, Mariarosaria, Intini, Enrica, Simonetti, Jacopo, Pasciuto, Giuliana, Adiletta, Veronica, Sofia, Carmelo, Angela Licata, Maria, Sani, Gabriele, Janiri, Delfina, Simonetti, Alessio, Modica, Marco, Silvia, Montanari, Catinari, Antonello, Terenzi, Beatrice, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Pirronti, Tommaso, Infante, Amato, Paglionico, Annamaria, Petricca, Luca, Tolusso, Barbara, Alivernini, Stefano, Di Mario, Clara, Santoliquido, Angelo, Santoro, Luca, Nesci, Antonio, Di Giorgio, Angela, D’Alessandro, Alessia, Matteo Tosato, Riccardo Calvani (ORCID:0000-0001-5472-2365), Francesca Ciciarello, Vincenzo Galluzzo, Anna Maria Martone, Maria Beatrice Zazzara, Giulia Savera, Francesco Landi (ORCID:0000-0002-3472-1389), Elisa Gremese (ORCID:0000-0002-2248-1058), Roberto Bernabei (ORCID:0000-0002-9197-004X), Massimo Fantoni (ORCID:0000-0001-6913-8460), Emanuele Marzetti (ORCID:0000-0001-9567-6983), Roberto Cauda (ORCID:0000-0002-1498-4229), Giulio Ventura (ORCID:0000-0002-0304-7264), Giovanni Addolorato (ORCID:0000-0002-1522-9946), Francesco Franceschi (ORCID:0000-0001-6266-445X), Maurizio Sanguinetti (ORCID:0000-0002-9780-7059), Paola Cattani (ORCID:0000-0003-4678-4763), Brunella Posteraro (ORCID:0000-0002-1663-7546), Stanislao Rizzo (ORCID:0000-0001-6302-063X), Maria Cristina Savastano (ORCID:0000-0003-1397-4333), Giulio Cesare Passali (ORCID:0000-0002-8176-0962), Jacopo Galli (ORCID:0000-0001-6353-6249), Piero Valentini (ORCID:0000-0001-6095-9510), Luca Richeldi (ORCID:0000-0001-8594-1448), Giuseppe Maria Corbo (ORCID:0000-0002-8104-4659), Gabriele Sani (ORCID:0000-0002-9767-8752), Luigi Natale (ORCID:0000-0002-7949-5119), Anna Rita Larici (ORCID:0000-0002-1882-6244), Riccardo Marano (ORCID:0000-0003-2710-2093), Stefano Alivernini (ORCID:0000-0002-7383-4212), Angelo Santoliquido (ORCID:0000-0003-1539-4017), Tosato, Matteo, Calvani, Riccardo, Ciciarello, Francesca, Galluzzo, Vincenzo, Martone, Anna Maria, Zazzara, Maria Beatrice, Pais, Cristina, Savera, Giulia, Camprubi Robles, Maria, Ramirez, Maria, Landi, Francesco, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Romano Settanni, Carlo, Porcari, Serena, Benvenuto, Francesca, Bramato, Giulia, Brandi, Vincenzo, Carfì, Angelo, Rita Lo Monaco, Maria, Maria Martone, Anna, Marzetti, Emanuele, Napolitano, Carmen, Pagano, Francesco, Rocchi, Sara, Rota, Elisabetta, Salerno, Andrea, Tritto, Marcello, Beatrice Zazzara, Maria, Catalano, Lucio, Picca, Anna, D’Elia, Mariaelena, Biscotti, Damiano, Cauda, Roberto, Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, Eleonora, Moschese, Davide, Ciccullo, Arturo, Stella, Leonardo, Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Gertrude, Assunta Zocco, Maria, Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Posteraro, Brunella, Sali, Michela, Bizzarro, Alessandra, Lauria, Alessandra, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Maria Cozzupoli, Grazia, Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, Fabrizio, Di Cintio, Giovanni, Longobardi, Ylenia, Tricarico, Laura, Santantonio, Mariaconsiglia, Di Cesare, Tiziana, Guarino, Mariateresa, Corbò, Marco, Settimi, Stefano, Mele, Dario, Brigato, Francesca, Buonsenso, Danilo, Valentini, Piero, Sinatti, Dario, De Rose, Gabriella, Richeldi, Luca, Lombardi, Francesco, Calabrese, Angelo, Varone, Francesco, Maria Leone, Paolo, Siciliano, Matteo, Corbo, Giuseppe Maria, Montemurro, Giuliano, Calvello, Mariarosaria, Intini, Enrica, Simonetti, Jacopo, Pasciuto, Giuliana, Adiletta, Veronica, Sofia, Carmelo, Angela Licata, Maria, Sani, Gabriele, Janiri, Delfina, Simonetti, Alessio, Modica, Marco, Silvia, Montanari, Catinari, Antonello, Terenzi, Beatrice, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Pirronti, Tommaso, Infante, Amato, Paglionico, Annamaria, Petricca, Luca, Tolusso, Barbara, Alivernini, Stefano, Di Mario, Clara, Santoliquido, Angelo, Santoro, Luca, Nesci, Antonio, Di Giorgio, Angela, D’Alessandro, Alessia, Matteo Tosato, Riccardo Calvani (ORCID:0000-0001-5472-2365), Francesca Ciciarello, Vincenzo Galluzzo, Anna Maria Martone, Maria Beatrice Zazzara, Giulia Savera, Francesco Landi (ORCID:0000-0002-3472-1389), Elisa Gremese (ORCID:0000-0002-2248-1058), Roberto Bernabei (ORCID:0000-0002-9197-004X), Massimo Fantoni (ORCID:0000-0001-6913-8460), Emanuele Marzetti (ORCID:0000-0001-9567-6983), Roberto Cauda (ORCID:0000-0002-1498-4229), Giulio Ventura (ORCID:0000-0002-0304-7264), Giovanni Addolorato (ORCID:0000-0002-1522-9946), Francesco Franceschi (ORCID:0000-0001-6266-445X), Maurizio Sanguinetti (ORCID:0000-0002-9780-7059), Paola Cattani (ORCID:0000-0003-4678-4763), Brunella Posteraro (ORCID:0000-0002-1663-7546), Stanislao Rizzo (ORCID:0000-0001-6302-063X), Maria Cristina Savastano (ORCID:0000-0003-1397-4333), Giulio Cesare Passali (ORCID:0000-0002-8176-0962), Jacopo Galli (ORCID:0000-0001-6353-6249), Piero Valentini (ORCID:0000-0001-6095-9510), Luca Richeldi (ORCID:0000-0001-8594-1448), Giuseppe Maria Corbo (ORCID:0000-0002-8104-4659), Gabriele Sani (ORCID:0000-0002-9767-8752), Luigi Natale (ORCID:0000-0002-7949-5119), Anna Rita Larici (ORCID:0000-0002-1882-6244), Riccardo Marano (ORCID:0000-0003-2710-2093), Stefano Alivernini (ORCID:0000-0002-7383-4212), and Angelo Santoliquido (ORCID:0000-0003-1539-4017)

Abstract

Background: Nutritional status is a critical factor throughout COVID-19 disease course. Malnutrition is associated with poor outcomes in hospitalized COVID-19 patients. Aim: To assess the prevalence of malnutrition and identify its associated factors in COVID-19 survivors. Methods: Study cohort included 1230 COVID-19 survivors aged 18-86 attending a post-COVID-19 outpatient service. Data on clinical parameters, anthropometry, acute COVID-19 symptoms, lifestyle habits were collected through a comprehensive medical assessment. Malnutrition was assessed according to Global Leadership Initiative on Malnutrition (GLIM) criteria. Results: Prevalence of malnutrition was 22% at 4-5 months after acute disease. Participants who were not hospitalized during acute COVID-19 showed a higher frequency of malnutrition compared to those who needed hospitalization (26% versus 19%, p < 0.01). Malnutrition was found in 25% COVID-19 survivors over 65 years of age compared to 21% younger participants (p < 0.01). After multivariable adjustment, the likelihood of being malnourished increased progressively and independently with advancing age (Odds ratio [OR] 1.02; 95% CI 1.01-1.03) and in male participants (OR 5.56; 95% CI 3.53-8.74). Malnutrition was associated with loss of appetite (OR 2.50; 95% CI 1.73-3.62), and dysgeusia (OR 4.05; 95% CI 2.30-7.21) during acute COVID-19. Discussion: In the present investigation we showed that malnutrition was highly prevalent in a large cohort of COVID-19 survivors at 4-5 months from acute illness. Conclusions: Our findings highlight the need to implement comprehensive nutritional assessment and therapy as an integral part of care for COVID-19 patients.

Published
2023

18. Predictors of Stability/Improvement of Forced Vital Capacity in Patients With Idiopathic Pulmonary Fibrosis After One Year of Treatment With Nintedanib

Author

Mondoni, Michele, Varone, Francesco, Alfano, Fausta, Muscato, Giuseppe, Conti, Caterina, Saderi, Laura, Iovene, Bruno, Marco, Fabiano Di, Vancheri, Carlo, Richeldi, Luca, Centanni, Stefano, Sotgiu, Giovanni, Richeldi, Luca (ORCID:0000-0001-8594-1448), Mondoni, Michele, Varone, Francesco, Alfano, Fausta, Muscato, Giuseppe, Conti, Caterina, Saderi, Laura, Iovene, Bruno, Marco, Fabiano Di, Vancheri, Carlo, Richeldi, Luca, Centanni, Stefano, Sotgiu, Giovanni, and Richeldi, Luca (ORCID:0000-0001-8594-1448)

Published
2023

19. Airway Closure during Surgical Pneumoperitoneum in Obese Patients

Author

Grieco, Domenico Luca, Anzellotti, Gian Marco, Russo, Andrea, Bongiovanni, Filippo, Costantini, Barbara, D’Indinosante, Marco, Varone, Francesco, Cavallaro, Fabio, Tortorella, Lucia, Polidori, Lorenzo, Romanò, Bruno, Gallotta, Valerio, Dell’Anna, Antonio Maria, Sollazzi, Liliana, Scambia, Giovanni, Conti, Giorgio, and Antonelli, Massimo

Published
2019
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21. Observational, Multicenter Study on the Efficacy, Tolerability, and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis Older than 80 Years

Author

Mondoni, Michele, primary, Alfano, Fausta, additional, Varone, Francesco, additional, Muscato, Giuseppe, additional, Conti, Caterina, additional, Saderi, Laura, additional, Chiesa, Amerigo, additional, Di Marco, Fabiano, additional, Vancheri, Carlo, additional, Richeldi, Luca, additional, Centanni, Stefano, additional, and Sotgiu, Giovanni, additional

Published
2022
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22. Contributors

Author

Agati, Sergio, Alfano, Fausta, Azuma, Arata, Biffi, Alice, Boerner, Eda, Bonella, Francesco, Brown, Stacey-Ann, Campo, Ilaria, Cannizzaro, Nunzia, Centanni, Stefano, Ceriani, Daniela, Cicchetti, Giuseppe, Cigala, Claudia, Corsico, Angelo Guido, Cottin, Vincent, Danoff, Sonye Karen, Elia, Stefano, Giussani, Federico, Handa, Tomohiro, Jehn, Lutz-Bernhard, Lettieri, Sara, Marchese, Roberto, Mariani, Francesca, Melone, Giulio, Messina, Riccardo, Mondoni, Michele, Negri, Stefano, Palladini, Giovanni, Piciucchi, Sara, Piloni, Davide, Pizzolato, Silvia, Poletti, Venerino, Prasse, Antje, Ravaglia, Claudia, Ruwisch, Jannik, Sakamoto, Ryo, Sambataro, Gianluca, Scichilone, Nicola, Sorino, Claudio, Spanevello, Antonio, Terraneo, Silvia, Tirelli, Claudio, Torre, Olga, Vancheri, Ada, Vancheri, Carlo, Vanetti, Marco, Varone, Francesco, Vassallo, Robert, Visca, Dina, Yoshizawa, Akihiko, and Zappa, Martina

Published
2025
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25. Incidence and management of post-lobectomy and pneumonectomy bronchopleural fistula

Author

Fuso, Leonello, Varone, Francesco, Nachira, Dania, Leli, Ilaria, Salimbene, Ivano, Congedo, Maria Teresa, Margaritora, Stefano, and Granone, Pierluigi

Subjects
Fistulas -- Research -- Care and treatment -- Complications and side effects, Lobectomy -- Usage -- Health aspects, Health
Abstract

Introduction Bronchopleural fistula is a rare but potentially fatal complication of pulmonary resections and proper management is essential for its resolution. In this study, we analyzed the incidence of fistula after pulmonary resection and reported data about endoscopic and conservative treatments of this complication. Methods From January 2003 to December 2013, 835 patients underwent anatomic lung resections: 786 (94.1 %) had a lobectomy and 49 (5.9 %) a pneumonectomy. Bronchopleural fistula was suspected by clinical signs and confirmed by endoscopic visualization. Results Eighteen patients (2.2 %) developed a bronchopleural fistula, 11 in lobectomy group (1.4 %) and 7 in pneumonectomy group (14.3 %). The fistula size ranged between Conclusion Endoscopic therapy, associated with a conservative treatment, is a safe and useful option in the management of the postoperative bronchopleural fistula., Author(s): Leonello Fuso[sup.1] [sup.3] , Francesco Varone[sup.1] , Dania Nachira[sup.2] , Ilaria Leli[sup.1] , Ivano Salimbene[sup.1] , Maria Teresa Congedo[sup.2] , Stefano Margaritora[sup.2] , Pierluigi Granone[sup.2] Author Affiliations: (1) Bronchoscopy [...]

Published
2016
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27. Observational, Multicenter Study on the Efficacy, Tolerability, and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis Older than 80 Years

Author

Mondoni, Michele, Alfano, Fausta, Varone, Francesco, Muscato, Giuseppe, Conti, Caterina, Saderi, Laura, Chiesa, Amerigo, Di Marco, Fabiano, Vancheri, Carlo, Richeldi, Luca, Centanni, Stefano, Sotgiu, Giovanni, Richeldi, Luca (ORCID:0000-0001-8594-1448), Mondoni, Michele, Alfano, Fausta, Varone, Francesco, Muscato, Giuseppe, Conti, Caterina, Saderi, Laura, Chiesa, Amerigo, Di Marco, Fabiano, Vancheri, Carlo, Richeldi, Luca, Centanni, Stefano, Sotgiu, Giovanni, and Richeldi, Luca (ORCID:0000-0001-8594-1448)

Abstract

Background: Idiopathic pulmonary fibrosis (IPF) primarily affects old patients. Old age is a predictor of mortality. Nintedanib, the only antifibrotic drug approved in Italy for patients aged >80 years, can slow the progression of IPF by reducing the rate of decline in forced vital capacity (FVC) and the risk of exacerbations. Objectives: The primary aim of the study was to compare the decline of FVC after 12 months of nintedanib in patients aged >80 years versus younger patients. Differences related to other functional data, safety, tolerability, hospitalizations, exacerbations, and mortality were evaluated. Methods: An observational, retrospective, multicenter study was carried out in Italy. Results: 159 (122 [76.7%] males) patients were recruited: 106 (66.7%) aged ≤80 years and 53 (33.3%) aged >80 years. FVC decline after 12 months of therapy was not significantly different (−45 mL [−170; 75] vs. −20 mL [−138; 110] mL; p: 0.51). No differences were found for other functional data. Diarrhea was the most frequent adverse event (AE). Rate and type of any AEs, permanent/temporary dose reduction, or drug discontinuation were not significantly different between patients aged ≤80 vs. >80 years. Furthermore, acute exacerbations, hospitalization, and mortality were not significantly different. Conclusions: Nintedanib is effective and safe in patients with IPF aged >80 years, and no significant differences were found when clinical outcomes were compared with those of younger patients. Thus, older age should not be a barrier for the early prescription of antifibrotic treatment in IPF patients.

Published
2022

28. Accuracy and Predictors of Success of EUS-B-FNA in the Diagnosis of Pulmonary Malignant Lesions: A Prospective Multicenter Italian Study

Author

Mondoni, Michele, Gasparini, Stefano, Varone, Francesco, Trisolini, Rocco, Mancino, Laura, Rossi, Giulio, Carlucci, Paolo, Bonifazi, Martina, Mei, Federico, Zuccatosta, Lina, Michieletto, Lucio, Pitari, Federica, Saderi, Laura, Richeldi, Luca, Centanni, Stefano, Sotgiu, Giovanni, Richeldi, Luca (ORCID:0000-0001-8594-1448), Mondoni, Michele, Gasparini, Stefano, Varone, Francesco, Trisolini, Rocco, Mancino, Laura, Rossi, Giulio, Carlucci, Paolo, Bonifazi, Martina, Mei, Federico, Zuccatosta, Lina, Michieletto, Lucio, Pitari, Federica, Saderi, Laura, Richeldi, Luca, Centanni, Stefano, Sotgiu, Giovanni, and Richeldi, Luca (ORCID:0000-0001-8594-1448)

Abstract

Background: The role of endoscopic ultrasound with bronchoscope fine-needle aspiration (EUS-B-FNA) in the diagnosis of suspected malignant pulmonary lesions adjacent to the esophagus has been poorly investigated. The aim of the present study was to assess the accuracy of EUS-B-FNA for the diagnosis and molecular profiling of paraesophageal pulmonary lesions, as well as its predictors of success. Materials and Methods: Patients who underwent EUS-B-FNA for the diagnosis of paraesophageal lesions were consecutively enrolled in four Italian centers. Demographic, clinical, procedural, pathological, and molecular characteristics of the malignant samples were collected. The primary outcome was the diagnostic accuracy for pulmonary malignancies. Secondary outcomes were diagnostic yield and predictors of success for diagnosis and molecular profiling. Results: 107 adult patients (60 [56.1%] males; median (interquartile range) age: 69 [60–70] years) were enrolled. The diagnostic accuracy of EUS-B-FNA was 95.3% in the overall cohort and 95.2% in the 99 patients with a final diagnosis of malignancy. Neither clinical nor procedural variables significantly affected the diagnostic accuracy, whereas rapid on-site evaluation (ROSE), performed by pathologists or trained pulmonologists, was a strong predictor for a complete molecular profiling (OR [95% CI]: 12.9 [1.2–137.4]; p value: 0.03). Conclusion: EUS-B-FNA is a safe and accurate method for the diagnosis of paraesophageal pulmonary lesions. The presence of ROSE is relevant for a complete molecular profiling in this selected cohort of patients with advanced lung cancer.

Published
2022

29. COVID-19 atypical Parsonage-Turner syndrome: a case report

Author

Zazzara, Maria Beatrice, Modoni, Anna, Bizzarro, Alessandra, Lauria, Alessandra, Ciciarello, Francesca, Pais, Cristina, Galluzzo, Vincenzo, Landi, Francesco, Tostato, Matteo, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Settanni, Carlo Romano, Porcari, Serena, Benvenuto, Francesca, Bramato, Giulia, Brandi, Vincenzo, Carfì, Angelo, Lo Monaco, Maria Rita, Martone, Anna Maria, Marzetti, Emanuele, Napolitano, Carmen, Pagano, Francesco Cosimo, Rocchi, Sara, Rota, Elisabetta, Salerno, Andrea Maria, Tosato, Matteo, Tritto, Marcello, Calvani, Riccardo, Catalano, Lucio, Picca, Anna, Savera, Giulia, Cauda, Roberto, Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, Eleonora, Moschese, Davide, Ciccullo, Arturo, Stella, Leonardo, Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Gertrude, Zocco, Maria Assunta, Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Posteraro, Brunella, Sali, Michela, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Cozzupoli, Maria Grazia, Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, Fabrizio, Di Cintio, Giovanni, Longobardi, Ylenia, Tricarico, Laura, Santantonio, Mariaconsiglia, Di Cesare, Tiziana, Guarino, Mariateresa, Corbò, Marco, Settimi, Stefano, Mele, Dario Antonio, Brigato, Francesca, Buonsenso, Danilo, Valentini, Piero, Sinatti, Dario, De Rose, Gabriella, Richeldi, Luca, Lombardi, Francesco, Calabrese, Angelo, Varone, Francesco, Leone, Paolo Maria, Siciliano, Matteo, Corbo, Giuseppe Maria, Montemurro, Giuliano, Calvello, Mariarosaria, Intini, Enrica, Simonetti, Jacopo, Pasciuto, Giuliana, Adiletta, Veronica, Sofia, Carmelo, Licata, Maria Angela Vittoria Anna Chiara, Sani, Gabriele, Janiri, Delfina, Simonetti, Alessio, Modica, Marco, Montanari, Silvia, Catinari, Antonello, Terenzi, Beatrice, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Pirronti, Tommaso, Infante, Amato, Paglionico, Annamaria, Petricca, Luca, Tolusso, Barbara, Alivernini, Stefano, Di Mario, Clara, Santoliquido, Angelo, Santoro, Luca, Nesci, Antonio, Di Giorgio, Angela, Null, Null, Landi, Francesco (ORCID:0000-0002-3472-1389), Gremese, Elisa (ORCID:0000-0002-2248-1058), Bernabei, Roberto (ORCID:0000-0002-9197-004X), Fantoni, Massimo (ORCID:0000-0001-6913-8460), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Lo Monaco, Maria Rita (ORCID:0000-0002-1457-7981), Marzetti, Emanuele (ORCID:0000-0001-9567-6983), Pagano, Francesco, Salerno, Andrea, Calvani, Riccardo (ORCID:0000-0001-5472-2365), Cauda, Roberto (ORCID:0000-0002-1498-4229), Murri, Rita (ORCID:0000-0003-4263-7854), Cingolani, Antonella (ORCID:0000-0002-3793-2755), Ventura, Giulio (ORCID:0000-0002-0304-7264), Addolorato, Giovanni (ORCID:0000-0002-1522-9946), Zocco, Maria Assunta (ORCID:0000-0002-0814-9542), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), Cattani, Paola (ORCID:0000-0003-4678-4763), Posteraro, Brunella (ORCID:0000-0002-1663-7546), Sali, Michela (ORCID:0000-0003-3609-2990), Rizzo, Stanislao (ORCID:0000-0001-6302-063X), Savastano, Maria Cristina (ORCID:0000-0003-1397-4333), Passali, Giulio Cesare (ORCID:0000-0002-8176-0962), Paludetti, Gaetano (ORCID:0000-0003-2480-1243), Galli, Jacopo (ORCID:0000-0001-6353-6249), Settimi, Stefano (ORCID:0000-0003-0104-1501), Mele, Dario, Valentini, Piero (ORCID:0000-0001-6095-9510), Richeldi, Luca (ORCID:0000-0001-8594-1448), Corbo, Giuseppe Maria (ORCID:0000-0002-8104-4659), Licata, Maria Angela, Sani, Gabriele (ORCID:0000-0002-9767-8752), Natale, Luigi (ORCID:0000-0002-7949-5119), Larici, Anna Rita (ORCID:0000-0002-1882-6244), Marano, Riccardo (ORCID:0000-0003-2710-2093), Pirronti, Tommaso (ORCID:0000-0003-3138-4097), Tolusso, Barbara (ORCID:0000-0002-9108-6609), Alivernini, Stefano (ORCID:0000-0002-7383-4212), Santoliquido, Angelo (ORCID:0000-0003-1539-4017), Zazzara, Maria Beatrice, Modoni, Anna, Bizzarro, Alessandra, Lauria, Alessandra, Ciciarello, Francesca, Pais, Cristina, Galluzzo, Vincenzo, Landi, Francesco, Tostato, Matteo, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Settanni, Carlo Romano, Porcari, Serena, Benvenuto, Francesca, Bramato, Giulia, Brandi, Vincenzo, Carfì, Angelo, Lo Monaco, Maria Rita, Martone, Anna Maria, Marzetti, Emanuele, Napolitano, Carmen, Pagano, Francesco Cosimo, Rocchi, Sara, Rota, Elisabetta, Salerno, Andrea Maria, Tosato, Matteo, Tritto, Marcello, Calvani, Riccardo, Catalano, Lucio, Picca, Anna, Savera, Giulia, Cauda, Roberto, Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, Eleonora, Moschese, Davide, Ciccullo, Arturo, Stella, Leonardo, Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Gertrude, Zocco, Maria Assunta, Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Posteraro, Brunella, Sali, Michela, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Cozzupoli, Maria Grazia, Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, Fabrizio, Di Cintio, Giovanni, Longobardi, Ylenia, Tricarico, Laura, Santantonio, Mariaconsiglia, Di Cesare, Tiziana, Guarino, Mariateresa, Corbò, Marco, Settimi, Stefano, Mele, Dario Antonio, Brigato, Francesca, Buonsenso, Danilo, Valentini, Piero, Sinatti, Dario, De Rose, Gabriella, Richeldi, Luca, Lombardi, Francesco, Calabrese, Angelo, Varone, Francesco, Leone, Paolo Maria, Siciliano, Matteo, Corbo, Giuseppe Maria, Montemurro, Giuliano, Calvello, Mariarosaria, Intini, Enrica, Simonetti, Jacopo, Pasciuto, Giuliana, Adiletta, Veronica, Sofia, Carmelo, Licata, Maria Angela Vittoria Anna Chiara, Sani, Gabriele, Janiri, Delfina, Simonetti, Alessio, Modica, Marco, Montanari, Silvia, Catinari, Antonello, Terenzi, Beatrice, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Pirronti, Tommaso, Infante, Amato, Paglionico, Annamaria, Petricca, Luca, Tolusso, Barbara, Alivernini, Stefano, Di Mario, Clara, Santoliquido, Angelo, Santoro, Luca, Nesci, Antonio, Di Giorgio, Angela, Null, Null, Landi, Francesco (ORCID:0000-0002-3472-1389), Gremese, Elisa (ORCID:0000-0002-2248-1058), Bernabei, Roberto (ORCID:0000-0002-9197-004X), Fantoni, Massimo (ORCID:0000-0001-6913-8460), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Lo Monaco, Maria Rita (ORCID:0000-0002-1457-7981), Marzetti, Emanuele (ORCID:0000-0001-9567-6983), Pagano, Francesco, Salerno, Andrea, Calvani, Riccardo (ORCID:0000-0001-5472-2365), Cauda, Roberto (ORCID:0000-0002-1498-4229), Murri, Rita (ORCID:0000-0003-4263-7854), Cingolani, Antonella (ORCID:0000-0002-3793-2755), Ventura, Giulio (ORCID:0000-0002-0304-7264), Addolorato, Giovanni (ORCID:0000-0002-1522-9946), Zocco, Maria Assunta (ORCID:0000-0002-0814-9542), Sanguinetti, Maurizio (ORCID:0000-0002-9780-7059), Cattani, Paola (ORCID:0000-0003-4678-4763), Posteraro, Brunella (ORCID:0000-0002-1663-7546), Sali, Michela (ORCID:0000-0003-3609-2990), Rizzo, Stanislao (ORCID:0000-0001-6302-063X), Savastano, Maria Cristina (ORCID:0000-0003-1397-4333), Passali, Giulio Cesare (ORCID:0000-0002-8176-0962), Paludetti, Gaetano (ORCID:0000-0003-2480-1243), Galli, Jacopo (ORCID:0000-0001-6353-6249), Settimi, Stefano (ORCID:0000-0003-0104-1501), Mele, Dario, Valentini, Piero (ORCID:0000-0001-6095-9510), Richeldi, Luca (ORCID:0000-0001-8594-1448), Corbo, Giuseppe Maria (ORCID:0000-0002-8104-4659), Licata, Maria Angela, Sani, Gabriele (ORCID:0000-0002-9767-8752), Natale, Luigi (ORCID:0000-0002-7949-5119), Larici, Anna Rita (ORCID:0000-0002-1882-6244), Marano, Riccardo (ORCID:0000-0003-2710-2093), Pirronti, Tommaso (ORCID:0000-0003-3138-4097), Tolusso, Barbara (ORCID:0000-0002-9108-6609), Alivernini, Stefano (ORCID:0000-0002-7383-4212), and Santoliquido, Angelo (ORCID:0000-0003-1539-4017)

Abstract

Background Neurological manifestations of Sars-CoV-2 infection have been described since March 2020 and include both central and peripheral nervous system manifestations. Neurological symptoms, such as headache or persistent loss of smell and taste, have also been documented in COVID-19 long-haulers. Moreover, long lasting fatigue, mild cognitive impairment and sleep disorders appear to be frequent long term neurological manifestations after hospitalization due to COVID-19. Less is known in relation to peripheral nerve injury related to Sars-CoV-2 infection. Case presentation We report the case of a 47-year-old female presenting with a unilateral chest pain radiating to the left arm lasting for more than two months after recovery from Sars-CoV-2 infection. After referral to our post-acute outpatient service for COVID-19 long haulers, she was diagnosed with a unilateral, atypical, pure sensory brachial plexus neuritis potentially related to COVID-19, which occurred during the acute phase of a mild Sars-CoV-2 infection and persisted for months after resolution of the infection. Conclusions We presented a case of atypical Parsonage-Turner syndrome potentially triggered by Sars-CoV-2 infection, with symptoms and repercussion lasting after viral clearance. A direct involvement of the virus remains uncertain, and the physiopathology is unclear. The treatment of COVID-19 and its long-term consequences represents a relatively new challenge for clinicians and health care providers. A multidisciplinary approach to following-up COVID-19 survivors is strongly advised.

Published
2022

30. Road Toward a New Model of Care for Idiopathic Pulmonary Fibrosis in the Lazio Region

Author

Di Bidino, Rossella, primary, Rogliani, Paola, additional, Sebastiani, Alfredo, additional, Ricci, Alberto, additional, Varone, Francesco, additional, Sgalla, Giacomo, additional, Iovene, Bruno, additional, Bruni, Teresa, additional, Flore, Maria Chiara, additional, D'Ascanio, Michela, additional, Cavalli, Francesco, additional, Savi, Daniela, additional, Di Michele, Loreta, additional, Cicchetti, Americo, additional, and Richeldi, Luca, additional

Published
2022
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32. Accuracy and Predictors of Success of EUS-B-FNA in the Diagnosis of Pulmonary Malignant Lesions: A Prospective Multicenter Italian Study

Author

Mondoni, Michele, primary, Gasparini, Stefano, additional, Varone, Francesco, additional, Trisolini, Rocco, additional, Mancino, Laura, additional, Rossi, Giulio, additional, Carlucci, Paolo, additional, Bonifazi, Martina, additional, Mei, Federico, additional, Zuccatosta, Lina, additional, Michieletto, Lucio, additional, Pitari, Federica, additional, Saderi, Laura, additional, Richeldi, Luca, additional, Centanni, Stefano, additional, and Sotgiu, Giovanni, additional

Published
2022
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33. Essential Features of an Interstitial Lung Disease Multidisciplinary Meeting: An International Delphi Survey

Author

Teoh, Alan K. Y., primary, Holland, Anne E., additional, Morisset, Julie, additional, Flaherty, Kevin R., additional, Wells, Athol U., additional, Walsh, Simon L. F., additional, Glaspole, Ian, additional, Wuyts, Wim A., additional, Corte, Tamera J., additional, Adamali, Huzaifa, additional, Allam, J. Shirine, additional, Antillon, Sofia, additional, Antoniou, Katherina M., additional, Athanazio, Rodrigo, additional, Avdeev, Sergey, additional, Averyanov, Alexander, additional, Azuma, Arata, additional, Baldi, Bruno, additional, Balestro, Elisabetta, additional, Bascom, Rebecca, additional, Bastiampillai, Shalini, additional, Beckert, Lutz, additional, Behr, Jü¨ergen, additional, Beirne, Paul, additional, Bennett, David, additional, Borie, Raphael, additional, Bouros, Demosthenes, additional, Brockway, Ben, additional, Brown, Kevin, additional, Callejas González, Francisco Javier, additional, Castillo, Diego, additional, Chaves, Ronald Chacon, additional, Chambers, Daniel, additional, Chapman, Sally, additional, Chaudhuri, Nazia, additional, Collard, Harold, additional, Cottin, Vincent, additional, Crestani, Bruno, additional, Davidsen, Jesper Rømhild, additional, Dhasmana, Devesh J., additional, Dhooria, Sahajal, additional, Enghelmayer, Juan Ignacio, additional, Fabro, Alexandre Todorovic, additional, Garcha, Puneet, additional, Goh, Nicole, additional, Gomez, Alejandro, additional, Grainge, Christopher, additional, Handa, Tomohiro, additional, Huie, Tristan, additional, Hunninghake, Gary, additional, Inoue, Yoshikazu, additional, Jo, Helen, additional, Johannson, Kerri, additional, Jonkers, Rene, additional, Judge, Eoin, additional, Kabasakal, Yasemin, additional, Dourado, Leticia Kawano, additional, Keir, Gregory, additional, Khalil, Nasreen, additional, Khor, Yet Hong, additional, Biggs, Melissa King, additional, Kokosi, Maria, additional, Kondoh, Yasuhiro, additional, Kouranos, Vasillis, additional, Kreuter, Michael, additional, Lederer, David, additional, Low, Su Ying, additional, Quernheim, Joachim Mü¨ller, additional, Maher, Toby, additional, Mancuzo, Eliane, additional, Margaritopoulos, George, additional, Mason, Carol, additional, Mazeini, Mariano, additional, Mogulkoc, Nesrin, additional, Molina, Maria, additional, Moodley, Yuben, additional, Morais, António, additional, Nambiar, Anoop, additional, Noth, Imre, additional, Nunes, Hilario, additional, Ogura, Takashi, additional, Okutan, Oguzhan, additional, Patel, Nina, additional, Pereira, Carlos, additional, Piotrowski, Wojciech, additional, Poletti, Venerino, additional, Quadrelli, Silvia, additional, Radzikowska, Elzbieta, additional, Ortega, Pilar Rivera, additional, Ryerson, Christopher J., additional, Salinas, Mauricio, additional, Sanchez, Rafaela, additional, Savas, Recep, additional, Selman, Moises, additional, Shifren, Adrian, additional, Soares, Maria Raquel, additional, Sobh, Eman, additional, Song, Jin Woo, additional, Spagnolo, Paolo, additional, Sterclova, Martina, additional, Strambu, Irina, additional, Strek, Mary E., additional, Suda, Takafumi, additional, Tabaj, Gabriela, additional, Trkanjec, Jasna Tekavec, additional, Akyil, Fatma Tokgoz, additional, Toma, Claudia, additional, Tomic, Rade, additional, Tomioka, Hiromi, additional, Traila, Daniel, additional, Troy, Lauren, additional, Trukillo, Sergio, additional, Tzouvelekis, Argyrios, additional, Vancheri, Carlo, additional, Varela, Brenda Elena, additional, Varone, Francesco, additional, Vasakova, Martina, additional, Veitch, Elizabeth, additional, Zygmunt, Vanesa Vicens, additional, Wessendorf, Thomas, additional, Westall, Glen, additional, Wijsenbeek, Marlies, additional, Wilsher, Margaret L., additional, Wrobel, Jeremy, additional, Fukuda, Cesar Yoshito, additional, and Zappala, Chris, additional

Published
2022
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34. A machine-learning parsimonious multivariable predictive model of mortality risk in patients with Covid-19

Author

Murri, Rita, Lenkowicz, Jacopo, Masciocchi, Carlotta, Iacomini, C., Fantoni, Massimo, Damiani, Andrea, Marchetti, A., Sergi, P. D. A., Arcuri, G., Cesario, Alfredo, Patarnello, S., Antonelli, Massimo, Bellantone, Rocco Domenico Alfonso, Bernabei, Roberto, Boccia, Stefania, Calabresi, Paolo, Cambieri, Andrea, Cauda, Roberto, Colosimo, Cesare, Crea, Filippo, De Maria Marchiano, Ruggero, De Stefano, Valerio, Franceschi, Francesco, Gasbarrini, Antonio, Parolini, Ornella, Richeldi, Luca, Sanguinetti, Maurizio, Urbani, Andrea, Zega, Maurizio, Scambia, Giovanni, Valentini, Vincenzo, Armuzzi, Alessandro, Barba, Marta, Baroni, Silvia, Bellesi, Silvia, Bentivoglio, Anna Rita, Biasucci, Luigi Marzio, Biscetti, Federico, Candelli, Marcello, Capalbo, Gennaro, Cattani, P., Chiusolo, Patrizia, Cingolani, Antonella, Corbo, Giuseppe Maria, Covino, Marcello, Cozzolino, A. M., D'Alfonso, Maria Elena, De Angelis, G., De Pascale, Gennaro, Frisullo, Giovanni, Gabrielli, M., Gambassi, Giovanni, Garcovich, M., Gremese, Elisa, Grieco, D. L., Iaconelli, A., Iorio, Raffaele, Landi, Francesco, Larici, Anna Rita, Liuzzo, Giovanna, Maviglia, Riccardo, Miele, Luca, Montalto, Massimo, Natale, Luigi, Nicolotti, Nicola, Ojetti, Veronica, Pompili, Maurizio, Posteraro, Brunella, Rapaccini, Gian Ludovico, Rinaldi, R., Rossi, E., Santoliquido, Angelo, Sica, Simona, Tamburrini, Enrica, Teofili, Luciana, Testa, A., Tosoni, A., Trani, Carlo, Varone, Francesco, and Verme, L. Z. D.

Subjects
Male, medicine.medical_specialty, Multivariate analysis, Science, Youden's J statistic, Rome, Cross-validation, Article, Cohort Studies, Machine Learning, Models, Internal medicine, medicine, 80 and over, Humans, Hospital Mortality, Pandemics, Aged, Aged, 80 and over, Multidisciplinary, Framingham Risk Score, Models, Statistical, business.industry, SARS-CoV-2, COVID-19, Emergency department, Statistical, Middle Aged, Blood Cell Count, Oxygen, Quartile, Risk factors, ROC Curve, Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Multivariate Analysis, Absolute neutrophil count, Medicine, Female, business, Blood Chemical Analysis, Cohort study
Abstract

The COVID-19 pandemic is impressively challenging the healthcare system. Several prognostic models have been validated but few of them are implemented in daily practice. The objective of the study was to validate a machine-learning risk prediction model using easy-to-obtain parameters to help to identify patients with COVID-19 who are at higher risk of death. The training cohort included all patients admitted to Fondazione Policlinico Gemelli with COVID-19 from March 5, 2020, to November 5, 2020. Afterward, the model was tested on all patients admitted to the same hospital with COVID-19 from November 6, 2020, to February 5, 2021. The primary outcome was in-hospital case-fatality risk. The out-of-sample performance of the model was estimated from the training set in terms of Area under the Receiving Operator Curve (AUROC) and classification matrix statistics by averaging the results of fivefold cross validation repeated 3-times and comparing the results with those obtained on the test set. An explanation analysis of the model, based on the SHapley Additive exPlanations (SHAP), is also presented. To assess the subsequent time evolution, the change in paO2/FiO2 (P/F) at 48 h after the baseline measurement was plotted against its baseline value. Among the 921 patients included in the training cohort, 120 died (13%). Variables selected for the model were age, platelet count, SpO2, blood urea nitrogen (BUN), hemoglobin, C-reactive protein, neutrophil count, and sodium. The results of the fivefold cross-validation repeated 3-times gave AUROC of 0.87, and statistics of the classification matrix to the Youden index as follows: sensitivity 0.840, specificity 0.774, negative predictive value 0.971. Then, the model was tested on a new population (n = 1463) in which the case-fatality rate was 22.6%. The test model showed AUROC 0.818, sensitivity 0.813, specificity 0.650, negative predictive value 0.922. Considering the first quartile of the predicted risk score (low-risk score group), the case-fatality rate was 1.6%, 17.8% in the second and third quartile (high-risk score group) and 53.5% in the fourth quartile (very high-risk score group). The three risk score groups showed good discrimination for the P/F value at admission, and a positive correlation was found for the low-risk class to P/F at 48 h after admission (adjusted R-squared = 0.48). We developed a predictive model of death for people with SARS-CoV-2 infection by including only easy-to-obtain variables (abnormal blood count, BUN, C-reactive protein, sodium and lower SpO2). It demonstrated good accuracy and high power of discrimination. The simplicity of the model makes the risk prediction applicable for patients in the Emergency Department, or during hospitalization. Although it is reasonable to assume that the model is also applicable in not-hospitalized persons, only appropriate studies can assess the accuracy of the model also for persons at home.

Published
2021

35. Observational, Multicenter Study on the Efficacy, Tolerability, and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis Older than 80 Years.

Author

Mondoni, Michele, Alfano, Fausta, Varone, Francesco, Muscato, Giuseppe, Conti, Caterina, Saderi, Laura, Chiesa, Amerigo, Di Marco, Fabiano, Vancheri, Carlo, Richeldi, Luca, Centanni, Stefano, and Sotgiu, Giovanni

Subjects
HOSPITAL care evaluation, DRUG efficacy, RESEARCH, IDIOPATHIC pulmonary fibrosis, DRUG tolerance, SCIENTIFIC observation, DIARRHEA, ANTI-inflammatory agents, FIBROSIS, RETROSPECTIVE studies, VITAL capacity (Respiration), TREATMENT effectiveness, DESCRIPTIVE statistics, DRUG side effects, PATIENT safety, DISEASE exacerbation, EVALUATION, OLD age
Abstract

Background: Idiopathic pulmonary fibrosis (IPF) primarily affects old patients. Old age is a predictor of mortality. Nintedanib, the only antifibrotic drug approved in Italy for patients aged >80 years, can slow the progression of IPF by reducing the rate of decline in forced vital capacity (FVC) and the risk of exacerbations. Objectives: The primary aim of the study was to compare the decline of FVC after 12 months of nintedanib in patients aged >80 years versus younger patients. Differences related to other functional data, safety, tolerability, hospitalizations, exacerbations, and mortality were evaluated. Methods: An observational, retrospective, multicenter study was carried out in Italy. Results: 159 (122 [76.7%] males) patients were recruited: 106 (66.7%) aged ≤80 years and 53 (33.3%) aged >80 years. FVC decline after 12 months of therapy was not significantly different (−45 mL [−170; 75] vs. −20 mL [−138; 110] mL; p: 0.51). No differences were found for other functional data. Diarrhea was the most frequent adverse event (AE). Rate and type of any AEs, permanent/temporary dose reduction, or drug discontinuation were not significantly different between patients aged ≤80 vs. >80 years. Furthermore, acute exacerbations, hospitalization, and mortality were not significantly different. Conclusions: Nintedanib is effective and safe in patients with IPF aged >80 years, and no significant differences were found when clinical outcomes were compared with those of younger patients. Thus, older age should not be a barrier for the early prescription of antifibrotic treatment in IPF patients. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Residual respiratory impairment after COVID-19 pneumonia

Author

Lombardi, Francesco, Calabrese, Angelo, Iovene, Bruno, Pierandrei, Chiara, Lerede, Marialessia, Varone, Francesco, Richeldi, Luca, Sgalla, Giacomo, Landi, Francesco, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Settanni, Carlo Romano, Benvenuto, Francesca, Bramato, Giulia, Carfi', Angelo, Ciciarello, Francesca, Lo Monaco, Maria Rita, Martone, Anna Maria, Marzetti, Emanuele, Carmen, Napolitano, Pagano, Francesco Cosimo, Rocchi, Sara, Rota, Elisabetta, Salerno, Andrea, Tosato, Matteo, Tritto, Marcello, Calvani, Riccardo, Catalano, Lucio, Anna, Picca, Giulia, Savera, Tamburrini, Enrica, Borghetti, Alberto, Simona Di Gianbenedetto, Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, Eleonora, Davide, Moschese, Arturo, Ciccullo, Stella, Leonardo, Addolorato, Giovanni, Franceschi, Francesco, Gertrude, Mingrone, Zocco, Maria Assunta, Mauirizio, Sanguinetti, Cattani Franchi, Paola, Marchetti, Simona, Alessandro, Bizzarro, Lauria, Alessandra, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Maria Grazia Cozzupoli, Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, Fabrizio, Giovanni Di Cintio, Ylenia, Longobardi, Laura, Tricarico, Santantonio, Mariaconsiglia, Buonsenso, Danilo, Valentini, Piero, Davide, Pata, Davide, Sinatti, De Rose, Cristina, Aangelo, Calabrese, Sani, Gabriele, Delfina, Janiri, Giulia, Giuseppin, Marzia, Molinaro, Modica, Marco, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Annamaria, Paglionico, Petricca, Luca, Laura, Gigante, Gerlando, Natalello, Fedele, Anna Laura, Lizzio, Marco Maria, Santoliquido, Angelo, Santoro, Luca, Nesci, Antonio, and Valentina, Popolla

Subjects
Male, Pulmonary and Respiratory Medicine, Percent Predicted Total Lung Capacity, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Partial Pressure, Pneumonia, Viral, Walk Test, 030204 cardiovascular system & hematology, dyspnoea, Severity of Illness Index, Pulmonary function testing, Diseases of the respiratory system, 03 medical and health sciences, PFT, 0302 clinical medicine, Percent Predicted Residual Volume, DLCO, cough, Diffusing capacity, 6MWT, Humans, Medicine, Respiratory function, Lung volumes, Aged, COVID, Carbon Monoxide, Exercise Tolerance, RC705-779, SARS-CoV-2, business.industry, Research, Settore MED/09 - MEDICINA INTERNA, COVID-19, Middle Aged, Oxygen, Residual Volume, Dyspnea, 030228 respiratory system, Respiratory failure, Anesthesia, Pulmonary Diffusing Capacity, Female, ABG, Blood Gas Analysis, business
Abstract

Introduction The novel coronavirus SARS-Cov-2 can infect the respiratory tract causing a spectrum of disease varying from mild to fatal pneumonia, and known as COVID-19. Ongoing clinical research is assessing the potential for long-term respiratory sequelae in these patients. We assessed the respiratory function in a cohort of patients after recovering from SARS-Cov-2 infection, stratified according to PaO2/FiO2 (p/F) values. Method Approximately one month after hospital discharge, 86 COVID-19 patients underwent physical examination, arterial blood gas (ABG) analysis, pulmonary function tests (PFTs), and six-minute walk test (6MWT). Patients were also asked to quantify the severity of dyspnoea and cough before, during, and after hospitalization using a visual analogic scale (VAS). Seventy-six subjects with ABG during hospitalization were stratified in three groups according to their worst p/F values: above 300 (n = 38), between 200 and 300 (n = 30) and below 200 (n = 20). Results On PFTs, lung volumes were overall preserved yet, mean percent predicted residual volume was slightly reduced (74.8 ± 18.1%). Percent predicted diffusing capacity for carbon monoxide (DLCO) was also mildly reduced (77.2 ± 16.5%). Patients reported residual breathlessness at the time of the visit (VAS 19.8, p Conclusion Approximately one month after hospital discharge, patients with COVID-19 can have residual respiratory impairment, including lower exercise tolerance. The extent of this impairment seems to correlate with the severity of respiratory failure during hospitalization.

Published
2021

40. Residual respiratory impairment after COVID-19 pneumonia

Author

Lombardi, F., Calabrese, Anna Chiara, Iovene, Bruno, Pierandrei, C., Lerede, M., Varone, Francesco, Richeldi, Luca, Sgalla, Giacomo, Landi, Francesco, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Romano Settanni, C., Benvenuto, F., Bramato, Giulia, Carfi, A., Ciciarello, Francesca, Lo Monaco, Maria Rita, Maria Martone, A., Marzetti, Emanuele, Napolitano, C., Pagano, Francesco Cosimo, Rocchi, Sara, Rota, E., Salerno, Andrea Maria, Tosato, Matteo, Tritto, M., Calvani, Riccardo, Catalano, Lucio, Picca, A., Savera, Giulia, Tamburrini, Enrica, Borghetti, Alberto, Di Gianbenedetto, S., Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, E., Moschese, D., Ciccullo, A., Stella, L., Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Geltrude, Assunta Zocco, M., Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Bizzarro, Alessandra, Lauria, Alessandra, Rizzo, Stanislao, Cristina Savastano, M., Gambini, Gloria, Grazia Cozzupoli, M., Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, F., Di Cintio, G., Longobardi, Ylenia, Tricarico, Laura, Santantonio, M., Buonsenso, Danilo, Valentini, Piero, Pata, D., Sinatti, Dario, De Rose, Cristina, Sani, Gabriele, Janiri, Delfina, Giuseppin, G., Molinaro, M., Modica, Marco, Natale, Luigi, Rita Larici, A., Marano, Riccardo, Paglionico, A., Petricca, Luca, Gigante, Lavinia, Natalello, G., Laur, a. Fedele A., Maria Lizzio, M., Santoliquido, Angelo, Santoro, L., Nesci, A., Popolla, Valentina, Calabrese A., Iovene B., Varone F., Richeldi L. (ORCID:0000-0001-8594-1448), Sgalla G. (ORCID:0000-0003-3130-9388), Landi F. (ORCID:0000-0002-3472-1389), Gremese E. (ORCID:0000-0002-2248-1058), Bernabei R. (ORCID:0000-0002-9197-004X), Fantoni M. (ORCID:0000-0001-6913-8460), Gasbarrini A. (ORCID:0000-0002-7278-4823), Bramato G., Ciciarello F., Lo Monaco M. R. (ORCID:0000-0002-1457-7981), Marzetti E. (ORCID:0000-0001-9567-6983), Pagano F., Rocchi S., Salerno A., Tosato M., Calvani R. (ORCID:0000-0001-5472-2365), Catalano L., Savera G., Tamburrini E. (ORCID:0000-0003-4930-426X), Borghetti A., Murri R. (ORCID:0000-0003-4263-7854), Cingolani A. (ORCID:0000-0002-3793-2755), Ventura G. (ORCID:0000-0002-0304-7264), Addolorato G. (ORCID:0000-0002-1522-9946), Franceschi F. (ORCID:0000-0001-6266-445X), Mingrone G. (ORCID:0000-0003-2021-528X), Sanguinetti M. (ORCID:0000-0002-9780-7059), Cattani P. (ORCID:0000-0003-4678-4763), Marchetti S., Bizzarro A., Lauria A., Rizzo S. (ORCID:0000-0001-6302-063X), Gambini G., Culiersi C., Cesare Passali G. (ORCID:0000-0002-8176-0962), Paludetti G. (ORCID:0000-0003-2480-1243), Galli J. (ORCID:0000-0001-6353-6249), Longobardi Y., Tricarico L., Buonsenso D., Valentini P. (ORCID:0000-0001-6095-9510), Sinatti D., De Rose C., Sani G. (ORCID:0000-0002-9767-8752), Janiri D., Modica M., Natale L. (ORCID:0000-0002-7949-5119), Marano R. (ORCID:0000-0003-2710-2093), Petricca L., Gigante L., Santoliquido A. (ORCID:0000-0003-1539-4017), Popolla V., Lombardi, F., Calabrese, Anna Chiara, Iovene, Bruno, Pierandrei, C., Lerede, M., Varone, Francesco, Richeldi, Luca, Sgalla, Giacomo, Landi, Francesco, Gremese, Elisa, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Romano Settanni, C., Benvenuto, F., Bramato, Giulia, Carfi, A., Ciciarello, Francesca, Lo Monaco, Maria Rita, Maria Martone, A., Marzetti, Emanuele, Napolitano, C., Pagano, Francesco Cosimo, Rocchi, Sara, Rota, E., Salerno, Andrea Maria, Tosato, Matteo, Tritto, M., Calvani, Riccardo, Catalano, Lucio, Picca, A., Savera, Giulia, Tamburrini, Enrica, Borghetti, Alberto, Di Gianbenedetto, S., Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, E., Moschese, D., Ciccullo, A., Stella, L., Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Geltrude, Assunta Zocco, M., Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Bizzarro, Alessandra, Lauria, Alessandra, Rizzo, Stanislao, Cristina Savastano, M., Gambini, Gloria, Grazia Cozzupoli, M., Culiersi, Carola, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, F., Di Cintio, G., Longobardi, Ylenia, Tricarico, Laura, Santantonio, M., Buonsenso, Danilo, Valentini, Piero, Pata, D., Sinatti, Dario, De Rose, Cristina, Sani, Gabriele, Janiri, Delfina, Giuseppin, G., Molinaro, M., Modica, Marco, Natale, Luigi, Rita Larici, A., Marano, Riccardo, Paglionico, A., Petricca, Luca, Gigante, Lavinia, Natalello, G., Laur, a. Fedele A., Maria Lizzio, M., Santoliquido, Angelo, Santoro, L., Nesci, A., Popolla, Valentina, Calabrese A., Iovene B., Varone F., Richeldi L. (ORCID:0000-0001-8594-1448), Sgalla G. (ORCID:0000-0003-3130-9388), Landi F. (ORCID:0000-0002-3472-1389), Gremese E. (ORCID:0000-0002-2248-1058), Bernabei R. (ORCID:0000-0002-9197-004X), Fantoni M. (ORCID:0000-0001-6913-8460), Gasbarrini A. (ORCID:0000-0002-7278-4823), Bramato G., Ciciarello F., Lo Monaco M. R. (ORCID:0000-0002-1457-7981), Marzetti E. (ORCID:0000-0001-9567-6983), Pagano F., Rocchi S., Salerno A., Tosato M., Calvani R. (ORCID:0000-0001-5472-2365), Catalano L., Savera G., Tamburrini E. (ORCID:0000-0003-4930-426X), Borghetti A., Murri R. (ORCID:0000-0003-4263-7854), Cingolani A. (ORCID:0000-0002-3793-2755), Ventura G. (ORCID:0000-0002-0304-7264), Addolorato G. (ORCID:0000-0002-1522-9946), Franceschi F. (ORCID:0000-0001-6266-445X), Mingrone G. (ORCID:0000-0003-2021-528X), Sanguinetti M. (ORCID:0000-0002-9780-7059), Cattani P. (ORCID:0000-0003-4678-4763), Marchetti S., Bizzarro A., Lauria A., Rizzo S. (ORCID:0000-0001-6302-063X), Gambini G., Culiersi C., Cesare Passali G. (ORCID:0000-0002-8176-0962), Paludetti G. (ORCID:0000-0003-2480-1243), Galli J. (ORCID:0000-0001-6353-6249), Longobardi Y., Tricarico L., Buonsenso D., Valentini P. (ORCID:0000-0001-6095-9510), Sinatti D., De Rose C., Sani G. (ORCID:0000-0002-9767-8752), Janiri D., Modica M., Natale L. (ORCID:0000-0002-7949-5119), Marano R. (ORCID:0000-0003-2710-2093), Petricca L., Gigante L., Santoliquido A. (ORCID:0000-0003-1539-4017), and Popolla V.

Abstract

Introduction: The novel coronavirus SARS-Cov-2 can infect the respiratory tract causing a spectrum of disease varying from mild to fatal pneumonia, and known as COVID-19. Ongoing clinical research is assessing the potential for long-term respiratory sequelae in these patients. We assessed the respiratory function in a cohort of patients after recovering from SARS-Cov-2 infection, stratified according to PaO2/FiO2 (p/F) values. Method: Approximately one month after hospital discharge, 86 COVID-19 patients underwent physical examination, arterial blood gas (ABG) analysis, pulmonary function tests (PFTs), and six-minute walk test (6MWT). Patients were also asked to quantify the severity of dyspnoea and cough before, during, and after hospitalization using a visual analogic scale (VAS). Seventy-six subjects with ABG during hospitalization were stratified in three groups according to their worst p/F values: above 300 (n = 38), between 200 and 300 (n = 30) and below 200 (n = 20). Results: On PFTs, lung volumes were overall preserved yet, mean percent predicted residual volume was slightly reduced (74.8 ± 18.1%). Percent predicted diffusing capacity for carbon monoxide (DLCO) was also mildly reduced (77.2 ± 16.5%). Patients reported residual breathlessness at the time of the visit (VAS 19.8, p < 0.001). Patients with p/F below 200 during hospitalization had lower percent predicted forced vital capacity (p = 0.005), lower percent predicted total lung capacity (p = 0.012), lower DLCO (p < 0.001) and shorter 6MWT distance (p = 0.004) than patients with higher p/F. Conclusion: Approximately one month after hospital discharge, patients with COVID-19 can have residual respiratory impairment, including lower exercise tolerance. The extent of this impairment seems to correlate with the severity of respiratory failure during hospitalization.

Published
2021

41. Interstitial Lung Disease Associated With Autoimmune Rheumatic Diseases: Checklists for Clinical Practice

Author

Bosello, Silvia Laura, Beretta, Lorenzo, Del Papa, Nicoletta, Harari, Sergio, Palmucci, Stefano, Pesci, Alberto, Rechichi, Gilda, Varone, Francesco, Sebastiani, Marco, Bosello, Silvia Laura (ORCID:0000-0002-4837-447X), Bosello, Silvia Laura, Beretta, Lorenzo, Del Papa, Nicoletta, Harari, Sergio, Palmucci, Stefano, Pesci, Alberto, Rechichi, Gilda, Varone, Francesco, Sebastiani, Marco, and Bosello, Silvia Laura (ORCID:0000-0002-4837-447X)

Abstract

Background: Interstitial lung diseases (ILDs) are often associated with rheumatic diseases. Their early diagnosis and management are not only difficult, but also crucial, because they are associated with major morbidity and mortality and can be the first cause of death in autoimmune rheumatic diseases (ARDs).Objectives: By using methodologies, such as Nominal Group Technique (NGT) and Delphi Survey, the aims of this study were (1) to measure consensus between pulmonologists, radiologists, and rheumatologists experienced in the management of ARD-ILD; (2) to highlight the importance of a multidisciplinary approach; and (3) to provide clinicians with a practical tool aimed at improving the prompt recognition and follow-up of ILD associated with ARDs and of any possible rheumatic conditions underlying ILD.Results: During the NGT round, the Steering Committee defined 57 statements to be used in the Delphi survey. A total of 78 experts participated in the Delphi survey, namely 28 pulmonologists, 33 rheumatologists, and 17 radiologists. During this round, consensus on agreement was reached in 47 statements, while disagreement was not reached in any statements. A secondary questionnaire was drafted by the Steering Committee to obtain clearer indications on ILD-ARD "red-flags" and follow-up. Delphi Panelists took part also in the second-questionnaire survey. Answers from both surveys were used to draft two checklists of "red flags" sign or symptom suggestive of ILD and ARD, respectively, and two checklists on identification and monitoring of rheumatoid arthritis (RA) and systemic sclerosis (SSc) ILD.Limitations: This study is a consensus work, which cannot produce empiric data, and is limited to the Italian scenario.Conclusions: This work showed a high level of agreement, but also shows some divergent opinions between different experts. This underlines the importance of a multidisciplinary approach. Eventually, we believe the drafted checklists can help clinicians in the dia

Published
2021

42. Patient-reported outcomes and patient-reported outcome measures in interstitial lung disease: where to go from here?

Author

Kalluri, M, Luppi, F, Vancheri, A, Vancheri, C, Balestro, E, Varone, F, Mogulkoc, N, Cacopardo, G, Bargagli, E, Renzoni, E, Torrisi, S, Calvello, M, Libra, A, Pavone, M, Bonella, F, Cottin, V, Valenzuela, C, Wijsenbeek, M, Bendstrup, E, Kalluri, Meena, Luppi, Fabrizio, Vancheri, Ada, Vancheri, Carlo, Balestro, Elisabetta, Varone, Francesco, Mogulkoc, Nesrin, Cacopardo, Giulia, Bargagli, Elena, Renzoni, Elizabeth, Torrisi, Sebastiano, Calvello, Mariarosaria, Libra, Alessandro, Pavone, Mauro, Bonella, Francesco, Cottin, Vincent, Valenzuela, Claudia, Wijsenbeek, Marlies, Bendstrup, Elisabeth, Kalluri, M, Luppi, F, Vancheri, A, Vancheri, C, Balestro, E, Varone, F, Mogulkoc, N, Cacopardo, G, Bargagli, E, Renzoni, E, Torrisi, S, Calvello, M, Libra, A, Pavone, M, Bonella, F, Cottin, V, Valenzuela, C, Wijsenbeek, M, Bendstrup, E, Kalluri, Meena, Luppi, Fabrizio, Vancheri, Ada, Vancheri, Carlo, Balestro, Elisabetta, Varone, Francesco, Mogulkoc, Nesrin, Cacopardo, Giulia, Bargagli, Elena, Renzoni, Elizabeth, Torrisi, Sebastiano, Calvello, Mariarosaria, Libra, Alessandro, Pavone, Mauro, Bonella, Francesco, Cottin, Vincent, Valenzuela, Claudia, Wijsenbeek, Marlies, and Bendstrup, Elisabeth

Abstract

Patient-reported outcome measures (PROMs), tools to assess patient self-report of health status, are now increasingly used in research, care and policymaking. While there are two well-developed disease-specific PROMs for interstitial lung diseases (ILD) and idiopathic pulmonary fibrosis (IPF), many unmet and urgent needs remain. In December 2019, 64 international ILD experts convened in Erice, Italy to deliberate on many topics, including PROMs in ILD. This review summarises the history of PROMs in ILD, shortcomings of the existing tools, challenges of development, validation and implementation of their use in clinical trials, and the discussion held during the meeting. Development of disease-specific PROMs for ILD including IPF with robust methodology and validation in concordance with guidance from regulatory authorities have increased user confidence in PROMs. Minimal clinically important difference for bidirectional changes may need to be developed. Cross-cultural validation and linguistic adaptations are necessary in addition to robust psychometric properties for effective PROM use in multinational clinical trials. PROM burden of use should be reduced through appropriate use of digital technologies and computerised adaptive testing. Active patient engagement in all stages from development, testing, choosing and implementation of PROMs can help improve probability of success and further growth.

Published
2021

43. Patient-reported outcomes and patient-reported outcome measures in interstitial lung disease:Where to go from here?

Author

Kalluri, Meena, Luppi, Fabrizio, Vancheri, Ada, Vancheri, Carlo, Balestro, Elisabetta, Varone, Francesco, Mogulkoc, Nesrin, Cacopardo, Giulia, Bargagli, Elena, Renzoni, Elisabetta, Torrisi, Sebastiano, Calvello, Mariarosaria, Libra, Alessandro, Pavone, Mauro, Bonella, Francesco, Cottin, Vincent, Valenzuela, Claudia, Wijsenbeek, Marlies, Bendstrup, Elisabeth, Kalluri, Meena, Luppi, Fabrizio, Vancheri, Ada, Vancheri, Carlo, Balestro, Elisabetta, Varone, Francesco, Mogulkoc, Nesrin, Cacopardo, Giulia, Bargagli, Elena, Renzoni, Elisabetta, Torrisi, Sebastiano, Calvello, Mariarosaria, Libra, Alessandro, Pavone, Mauro, Bonella, Francesco, Cottin, Vincent, Valenzuela, Claudia, Wijsenbeek, Marlies, and Bendstrup, Elisabeth

Abstract

Patient-reported outcome measures (PROMs), tools to assess patient self-report of health status, are now increasingly used in research, care and policymaking. While there are two well-developed disease-specific PROMs for interstitial lung diseases (ILD) and idiopathic pulmonary fibrosis (IPF), many unmet and urgent needs remain. In December 2019, 64 international ILD experts convened in Erice, Italy to deliberate on many topics, including PROMs in ILD. This review summarises the history of PROMs in ILD, shortcomings of the existing tools, challenges of development, validation and implementation of their use in clinical trials, and the discussion held during the meeting. Development of disease-specific PROMs for ILD including IPF with robust methodology and validation in concordance with guidance from regulatory authorities have increased user confidence in PROMs. Minimal clinically important difference for bidirectional changes may need to be developed. Cross-cultural validation and linguistic adaptations are necessary in addition to robust psychometric properties for effective PROM use in multinational clinical trials. PROM burden of use should be reduced through appropriate use of digital technologies and computerised adaptive testing. Active patient engagement in all stages from development, testing, choosing and implementation of PROMs can help improve probability of success and further growth.

Published
2021

44. COVID-19 and intestinal inflammation: Role of fecal calprotectin

Author

Abbate, Valeria, Acampora, Nicola, Addolorato, Giovanni, Agostini, Fabiana, Ainora, Maria Elena, Akacha, Karim, Amato, Elena, Andreani, Francesca, Andriollo, Gloria, Annetta, Maria Giuseppina, Annicchiarico, Brigida Eleonora, Antonelli, Mariangela, Antonucci, Gabriele, Anzellotti, Gian Marco, Armuzzi, Alessandro, Baldi, Fabiana, Barattucci, Ilaria, Barillaro, Christian, Barone, Fabiana, Bellantone, Rocco Domenico Alfonso, Bellieni, Andrea, Bello, Giuseppe, Benicchi, Andrea, Benvenuto, Francesca, Berardini, Ludovica, Berloco, Filippo, Bernabei, Roberto, Bianchi, Antonio, Biasucci, Daniele Guerino, Biasucci, Luigi Marzio, Bibbò, Stefano, Bini, Alessandra, Bisanti, Alessandra, Biscetti, Federico, Bocci, Maria Grazia, Bonadia, Nicola, Bongiovanni, Filippo, Borghetti, Alberto, Bosco, Giulia, Bosello, Silvia, Bove, Vincenzo, Bramato, Giulia, Brandi, Vincenzo, Bruni, Teresa, Bruno, Carmine, Bruno, Dario, Bungaro, Maria Chiara, Buonomo, Alessandro, Burzo, Livia, Calabrese, Angelo, Calvello, Maria Rosaria, Cambieri, Andrea, Cambise, Chiara, Cammà, Giulia, Candelli, Marcello, Canistro, Gennaro, Cantanale, Antonello, Capalbo, Gennaro, Capaldi, Lorenzo, Capone, Emanuele, Capristo, Esmeralda, Carbone, Luigi, Cardone, Silvia, Carelli, Simone, Carfì, Angelo, Carnicelli, Annamaria, Caruso, Cristiano, Casciaro, Francesco Antonio, Catalano, Lucio, Cauda, Roberto, Cecchini, Andrea Leonardo, Cerrito, Lucia, Cesarano, Melania, Chiarito, Annalisa, Cianci, Rossella, Cicchinelli, Sara, Ciccullo, Arturo, Cicetti, Marta, Ciciarello, Francesca, Cingolani, Antonella, Cipriani, Maria Camilla, Consalvo, Maria Ludovica, Coppola, Gaetano, Corbo, Giuseppe Maria, Corsello, Andrea, Costante, Federico, Costanzi, Matteo, Covino, Marcello, Crupi, Davide, Cutuli, Salvatore Lucio, D'Addio, Stefano, D'Alessandro, Alessia, D'AlfonsoD'Angelo, Maria ElenaEmanuela, D'Aversa, Francesca, Damiano, Fernando, De Berardinis, Gian Maria, De Cunzo, Tommaso, De Gaetano, Donati Katleen, De Luca, Giulio, De Matteis, Giuseppe, De Pascale, Gennaro, De Santis, Paolo, De Siena, Martina, De Vito, Francesco, Del Gatto, Valeria, Del Giacomo, Paola, Del Zompo, Fabio, Dell'Anna, Antonio Maria, Polla, Davide Della, Di Gialleonardo, Luca, Di Giambenedetto, Simona, Di Luca, Roberta, Di Maurizio, Luca, Di Muro, Mariangela, Dusina, Alex, Eleuteri, Davide, Esperide, Alessandra, Fachechi, Daniele, Faliero, Domenico, Falsiroli, Cinzia, Fantoni, Massimo, Fedele, Annalaura, Feliciani, Daniela, Ferrante, Cristina, Ferrone, Giuliano, Festa, Rossano, Fiore, Maria Chiara, Flex, Andrea, Forte, Evelina, Franceschi, Francesco, Francesconi, Alessandra, Franza, Laura, Funaro, Barbara, Fuorlo, Mariella, Fusco, Domenico, Gabrielli, Maurizio, Gaetani, Eleonora, Galletta, Claudia, Gallo, Antonella, Gambassi, Giovanni, Garcovich, Matteo, Gasbarrini, Antonio, Gasparrini, Irene, Gelli, Silvia, Giampietro, Antonella, Gigante, Laura, Giuliano, Gabriele, Giuliano, Giorgia, Giupponi, Bianca, Gremese, Elisa, Grieco, Domenico Luca, Guerrera, Manuel, Guglielmi, Valeria, Guidone, Caterina, Gullì, Antonio, Iaconelli, Amerigo, Iafrati, Aurora, Ianiro, Gianluca, Iaquinta, Angela, Impagnatiello, Michele, Inchingolo, Riccardo, Intini, Enrica, Iorio, Raffaele, Izzi, Immacolata Maria, Jovanovic, Tamara, Kadhim, Cristina, La Macchia, Rosa, La Milia, Daniele Ignazio, Landi, Francesco, Landi, Giovanni, Landi, Rosario, Landolfi, Raffaele, Leo, Massimo, Leone, Paolo Maria, Levantesi, Laura, Liguori, Antonio, Liperoti, Rosa, Lizzio, Marco Maria, Monaco, Maria Rita Lo, Locantore, Pietro, Lombardi, Francesco, Lombardi, Gianmarco, Lopetuso, Loris, Loria, Valentina, Losito, Angela Raffaella, Lucia, Mothanje Barbara Patricia, Macagno, Francesco, Macerola, Noemi, Maggi, Giampaolo, Maiuro, Giuseppe, Mancarella, Francesco, Mangiola, Francesca, Manno, Alberto, Marchesini, Debora, Maresca, Gian Marco, Marrone, Giuseppe, Martis, Ilaria, Martone, Anna Maria, Marzetti, Emanuele, Mattana, Chiara, Matteo, Maria Valeria, Maviglia, Riccardo, Mazzarella, Ada, Memoli, Carmen, Miele, Luca, Migneco, Alessio, Mignini, Irene, Milani, Alessandro, Milardi, Domenico, Montalto, Massimo, Montemurro, Giuliano, Monti, Flavia, Montini, Luca, Morena, Tony Christian, Morra, Vincenzina, Morretta, Chiara, Moschese, Davide, Murace, Celeste Ambra, Murdolo, Martina, Murri, Rita, Napoli, Marco, Nardella, Elisabetta, Natalello, Gerlando, Natalini, Daniele, Navarra, Simone Maria, Nesci, Antonio, Nicoletti, Alberto, Nicoletti, Rocco, Nicoletti, Tommaso Filippo, Nicolò, Rebecca, Nicolotti, Nicola, Nista, Enrico Celestino, Nuzzo, Eugenia, Oggiano, Marco, Ojetti, Veronica, Pagano, Francesco Cosimo, Paiano, Gianfranco, Pais, Cristina, Pallavicini, Federico, Palombo, Andrea, Paolillo, Federico, Papa, Alfredo, Papanice, Domenico, Papparella, Luigi Giovanni, Paratore, Mattia, Parrinello, Giuseppe, Pasciuto, Giuliana, Pasculli, Pierpaolo, Pecorini, Giovanni, Perniola, Simone, Pero, Erika, Petricca, Luca, Petrucci, Martina, Picarelli, Chiara, Piccioni, Andrea, Piccolo, Annalisa, Piervincenzi, Edoardo, Pignataro, Giulia, Pignataro, Raffaele, Pintaudi, Gabriele, Pisapia, Luca, Pizzoferrato, Marco, Pizzolante, Fabrizio, Pola, Roberto, Policola, Caterina, Pompili, Maurizio, Pontecorvi, Flavia, Pontecorvi, Valerio, Ponziani, Francesca, Popolla, Valentina, Porceddu, Enrica, Porfidia, Angelo, Porro, Lucia Maria, Potenza, Annalisa, Pozzana, Francesca, Privitera, Giuseppe, Pugliese, Daniela, Pulcini, Gabriele, Racco, Simona, Raffaelli, Francesca, Ramunno, Vittoria, Rapaccini, Gian Ludovico, Richeldi, Luca, Rinninella, Emanuele, Rocchi, Sara, Romanò, Bruno, Romano, Stefano, Rosa, Federico, Rossi, Laura, Rossi, Raimondo, Rossini, Enrica, Rota, Elisabetta, Rovedi, Fabiana, Rubino, Carlotta, Rumi, Gabriele, Russo, Andrea, Sabia, Luca, Salerno, Andrea, Salini, Sara, Salvatore, Lucia, Samori, Dehara, Sandroni, Claudio, Sanguinetti, Maurizio, Santarelli, Luca, Santini, Paolo, Santolamazza, Danilo, Santoliquido, Angelo, Santopaolo, Francesco, Santoro, Michele Cosimo, Sardeo, Francesco, Sarnari, Caterina, Saviano, Angela, Saviano, Luisa, Scaldaferri, Franco, Scarascia, Roberta, Schepis, Tommaso, Schiavello, Francesca, Scoppettuolo, Giancarlo, Sedda, Davide, Sessa, Flaminio, Sestito, Luisa, Settanni, Carlo, Siciliano, Matteo, Siciliano, Valentina, Sicuranza, Rossella, Simeoni, Benedetta, Simonetti, Jacopo, Smargiassi, Andrea, Soave, Paolo Maurizio, Sonnino, Chiara, Staiti, Domenico, Stella, Claudia, Stella, Leonardo, Stival, Eleonora, Taddei, Eleonora, Talerico, Rossella, Tamburello, Elio, Tamburrini, Enrica, Tanzarella, Eloisa Sofia, Tarascio, Elena, Tarli, Claudia, Tersali, Alessandra, Tilli, Pietro, Timpano, Jacopo, Torelli, Enrico, Torrini, Flavia, Tosato, Matteo, Tosoni, Alberto, Tricoli, Luca, Tritto, Marcello, Tumbarello, Mario, Tummolo, Anita Maria, Vallecoccia, Maria Sole, Valletta, Federico, Varone, Francesco, Vassalli, Francesco, Ventura, Giulio, Verardi, Lucrezia, Vetrone, Lorenzo, Vetrugno, Giuseppe, Visconti, Elena, Visconti, Felicia, Viviani, Andrea, Zaccaria, Raffaella, Zaccone, Carmelina, Zelano, Lorenzo, Dal Verme, Lorenzo Zileri, Zuccalà, Giuseppe, and Troiani, Eliana

Published
2020
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45. Patient-reported outcomes and patient-reported outcome measures in interstitial lung disease: where to go from here?

Author

Kalluri, Meena, primary, Luppi, Fabrizio, additional, Vancheri, Ada, additional, Vancheri, Carlo, additional, Balestro, Elisabetta, additional, Varone, Francesco, additional, Mogulkoc, Nesrin, additional, Cacopardo, Giulia, additional, Bargagli, Elena, additional, Renzoni, Elisabetta, additional, Torrisi, Sebastiano, additional, Calvello, Mariarosaria, additional, Libra, Alessandro, additional, Pavone, Mauro, additional, Bonella, Francesco, additional, Cottin, Vincent, additional, Valenzuela, Claudia, additional, Wijsenbeek, Marlies, additional, and Bendstrup, Elisabeth, additional

Published
2021
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46. Assessment of neurological manifestations in hospitalized patients with COVID-19

Author

Luigetti, M., Iorio, R., Bentivoglio, A. R., Tricoli, L., Riso, V., Marotta, J., Piano, C., Primiano, G., Zileri Del Verme, L., Lo Monaco, M. R., Calabresi, P., Abbate, Valeria, Acampora, Nicola, Addolorato, Giovanni, Agostini, Fabiana, Ainora, Maria Elena, Akacha, Karim, Amato, Elena, Andreani, Francesca, Andriollo, Gloria, Annetta, Maria Giuseppina, Annicchiarico, Brigida Eleonora, Antonelli, Mariangela, Antonucci, Gabriele, Anzellotti, Gian Marco, Armuzzi, Alessandro, Baldi, Fabiana, Barattucci, Ilaria, Barillaro, Christian, Barone, Fabiana, Bellantone, Rocco Domenico Alfonso, Bellieni, Andrea, Bello, Giuseppe, Benicchi, Andrea, Benvenuto, Francesca, Berardini, Ludovica, Berloco, Filippo, Bernabei, Roberto, Bianchi, Antonio, Biasucci, Daniele Guerino, Biasucci, Luigi Marzio, Bibbò, Stefano, Bini, Alessandra, Bisanti, Alessandra, Biscetti, Federico, Bocci, Maria Grazia, Bonadia, Nicola, Bongiovanni, Filippo, Borghetti, Alberto, Bosco, Giulia, Bosello, Silvia, Bove, Vincenzo, Bramato, Giulia, Brandi, Vincenzo, Bruni, Teresa, Bruno, Carmine, Bruno, Dario, Bungaro, Maria Chiara, Buonomo, Alessandro, Burzo, Livia, Calabrese, Angelo, Calvello, Maria Rosaria, Cambieri, Andrea, Cambise, Chiara, Cammà, Giulia, Candelli, Marcello, Canistro, Gennaro, Cantanale, Antonello, Capalbo, Gennaro, Capaldi, Lorenzo, Capone, Emanuele, Capristo, Esmeralda, Carbone, Luigi, Cardone, Silvia, Carelli, Simone, Carfì, Angelo, Carnicelli, Annamaria, Caruso, Cristiano, Casciaro, Francesco Antonio, Catalano, Lucio, Cauda, Roberto, Cecchini, Andrea Leonardo, Cerrito, Lucia, Cesarano, Melania, Chiarito, Annalisa, Cianci, Rossella, Cicchinelli, Sara, Ciccullo, Arturo, Cicetti, Marta, Ciciarello, Francesca, Cingolani, Antonella, Cipriani, Maria Camilla, Consalvo, Maria Ludovica, Coppola, Gaetano, Corbo, Giuseppe Maria, Corsello, Andrea, Costante, Federico, Costanzi, Matteo, Covino, Marcello, Crupi, Davide, Cutuli, Salvatore Lucio, DAddio, Stefano, DAlessandro, Alessia, DAlfonso, Maria Elena, DAngelo, Emanuela, DAversa, Francesca, Damiano, Fernando, De Berardinis, Gian Maria, De Cunzo, Tommaso, De Gaetano, Donati Katleen, De Luca, Giulio, De Matteis, Giuseppe, De Pascale, Gennaro, De Santis, Paolo, De Siena, Martina, De Vito, Francesco, Del Gatto, Valeria, Del Giacomo, Paola, Del Zompo, Fabio, DellAnna, Antonio Maria, Della, Polla Davide, Di Gialleonardo, Luca, Di Giambenedetto, Simona, Di Luca, Roberta, Di Maurizio, Luca, Di Muro, Mariangela, Dusina, Alex, Eleuteri, Davide, Esperide, Alessandra, Fachechi, Daniele, Faliero, Domenico, Falsiroli, Cinzia, Fantoni, Massimo, Fedele, Annalaura, Feliciani, Daniela, Ferrante, Cristina, Ferrone, Giuliano, Festa, Rossano, Fiore, Maria Chiara, Flex, Andrea, Forte, Evelina, Franceschi, Francesco, Francesconi, Alessandra, Franza, Laura, Funaro, Barbara, Fuorlo, Mariella, Fusco, Domenico, Gabrielli, Maurizio, Gaetani, Eleonora, Galletta, Claudia, Gallo, Antonella, Gambassi, Giovanni, Garcovich, Matteo, Gasbarrini, Antonio, Gasparrini, Irene, Gelli, Silvia, Giampietro, Antonella, Gigante, Laura, Giuliano, Gabriele, Giuliano, Giorgia, Giupponi, Bianca, Gremese, Elisa, Grieco, Domenico Luca, Guerrera, Manuel, Guglielmi, Valeria, Guidone, Caterina, Gullì, Antonio, Iaconelli, Amerigo, Iafrati, Aurora, Ianiro, Gianluca, Iaquinta, Angela, Impagnatiello, Michele, Inchingolo, Riccardo, Intini, Enrica, Iorio, Raffaele, Izzi, Immacolata Maria, Jovanovic, Tamara, Kadhim, Cristina, La Macchia, Rosa, La Milia, Daniele Ignazio, Landi, Francesco, Landi, Giovanni, Landi, Rosario, Landolfi, Raffaele, Leo, Massimo, Leone, Paolo Maria, Levantesi, Laura, Liguori, Antonio, Liperoti, Rosa, Lizzio, Marco Maria, Lo Monaco Maria, Rita, Locantore, Pietro, Lombardi, Francesco, Lombardi, Gianmarco, Lopetuso, Loris, Loria, Valentina, Losito, Angela Raffaella, Lucia, Mothanje Barbara Patricia, Macagno, Francesco, Macerola, Noemi, Maggi, Giampaolo, Maiuro, Giuseppe, Mancarella, Francesco, Mangiola, Francesca, Manno, Alberto, Marchesini, Debora, Maresca, Gian Marco, Marrone, Giuseppe, Martis, Ilaria, Martone, Anna Maria, Marzetti, Emanuele, Mattana, Chiara, Matteo, Maria Valeria, Maviglia, Riccardo, Mazzarella, Ada, Memoli, Carmen, Miele, Luca, Migneco, Alessio, Mignini, Irene, Milani, Alessandro, Milardi, Domenico, Montalto, Massimo, Montemurro, Giuliano, Monti, Flavia, Montini, Luca, Morena, Tony Christian, Morra, Vincenzina, Morretta, Chiara, Moschese, Davide, Murace, Celeste Ambra, Murdolo, Martina, Murri, Rita, Napoli, Marco, Nardella, Elisabetta, Natalello, Gerlando, Natalini, Daniele, Navarra, Simone Maria, Nesci, Antonio, Nicoletti, Alberto, Nicoletti, Rocco, Nicoletti, Tommaso Filippo, Nicolò, Rebecca, Nicolotti, Nicola, Nista, Enrico Celestino, Nuzzo, Eugenia, Oggiano, Marco, Ojetti, Veronica, Pagano, Francesco Cosimo, Paiano, Gianfranco, Pais, Cristina, Pallavicini, Federico, Palombo, Andrea, Paolillo, Federico, Papa, Alfredo, Papanice, Domenico, Papparella, Luigi Giovanni, Paratore, Mattia, Parrinello, Giuseppe, Pasciuto, Giuliana, Pasculli, Pierpaolo, Pecorini, Giovanni, Perniola, Simone, Pero, Erika, Petricca, Luca, Petrucci, Martina, Picarelli, Chiara, Piccioni, Andrea, Piccolo, Annalisa, Piervincenzi, Edoardo, Pignataro, Giulia, Pignataro, Raffaele, Pintaudi, Gabriele, Pisapia, Luca, Pizzoferrato, Marco, Pizzolante, Fabrizio, Pola, Roberto, Policola, Caterina, Pompili, Maurizio, Pontecorvi, Flavia, Pontecorvi, Valerio, Ponziani, Francesca, Popolla, Valentina, Porceddu, Enrica, Porfidia, Angelo, Porro, Lucia Maria, Potenza, Annalisa, Pozzana, Francesca, Privitera, Giuseppe, Pugliese, Daniela, Pulcini, Gabriele, Racco, Simona, Raffaelli, Francesca, Ramunno, Vittoria, Rapaccini, Gian Ludovico, Richeldi, Luca, Rinninella, Emanuele, Rocchi, Sara, Romanò, Bruno, Romano, Stefano, Rosa, Federico, Rossi, Laura, Rossi, Raimondo, Rossini, Enrica, Rota, Elisabetta, Rovedi, Fabiana, Rubino, Carlotta, Rumi, Gabriele, Russo, Andrea, Sabia, Luca, Salerno, Andrea, Salini, Sara, Salvatore, Lucia, Samori, Dehara, Sandroni, Claudio, Sanguinetti, Maurizio, Santarelli, Luca, Santini, Paolo, Santolamazza, Danilo, Santoliquido, Angelo, Santopaolo, Francesco, Santoro, Michele Cosimo, Sardeo, Francesco, Sarnari, Caterina, Saviano, Angela, Saviano, Luisa, Scaldaferri, Franco, Scarascia, Roberta, Schepis, Tommaso, Schiavello, Francesca, Scoppettuolo, Giancarlo, Sedda, Davide, Sessa, Flaminio, Sestito, Luisa, Settanni, Carlo, Siciliano, Matteo, Siciliano, Valentina, Sicuranza, Rossella, Simeoni, Benedetta, Simonetti, Jacopo, Smargiassi, Andrea, Soave, Paolo Maurizio, Sonnino, Chiara, Staiti, Domenico, Stella, Claudia, Stella, Leonardo, Stival, Eleonora, Taddei, Eleonora, Talerico, Rossella, Tamburello, Elio, Tamburrini, Enrica, Tanzarella, Eloisa Sofia, Tarascio, Elena, Tarli, Claudia, Tersali, Alessandra, Tilli, Pietro, Timpano, Jacopo, Torelli, Enrico, Torrini, Flavia, Tosato, Matteo, Tosoni, Alberto, Tricoli, Luca, Tritto, Marcello, Tumbarello, Mario, Tummolo, Anita Maria, Vallecoccia, Maria Sole, Valletta, Federico, Varone, Francesco, Vassalli, Francesco, Ventura, Giulio, Verardi, Lucrezia, Vetrone, Lorenzo, Vetrugno, Giuseppe, Visconti, Elena, Visconti, Felicia, Viviani, Andrea, Zaccaria, Raffaella, Zaccone, Carmelina, Zelano, Lorenzo, Zileri Dal Verme, Lorenzo, and Zuccalà, Giuseppe

Subjects
Male, Hospitalized patients, muscle, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, neurological disorders, 0302 clinical medicine, Hyposmia, 030212 general & internal medicine, Respiratory system, education.field_of_study, Brain Diseases, Headache, virus diseases, Neuromuscular Diseases, Middle Aged, Hospitalization, medicine.anatomical_structure, Neurology, Female, medicine.symptom, Adult, medicine.medical_specialty, SARS‐CoV2, Coronavirus disease 2019 (COVID-19), Patients, Short Communication, Anosmia, precision medicine, Population, Encephalopathy, Short Communications, Clinical Neurology, Settore MED/26, 03 medical and health sciences, COVID‐19, Internal medicine, Throat, Influenza, Human, medicine, Humans, education, Aged, Retrospective Studies, business.industry, SARS-CoV-2, COVID-19, Hypoxia (medical), medicine.disease, respiratory tract diseases, body regions, Neurology (clinical), Nervous System Diseases, business, 030217 neurology & neurosurgery
Abstract

Background and purpose The objective of this study was to assess the neurological manifestations in a series of consecutive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients, comparing their frequency with a population hospitalized in the same period for flu/respiratory symptoms, finally not related to SARS-CoV-2. Methods Patients with flu/respiratory symptoms admitted to Fondazione Policlinico Gemelli hospital from 14 March 2020 to 20 April 2020 were retrospectively enrolled. The frequency of neurological manifestations of patients with SARS-CoV-2 infection was compared with a control group. Results In all, 213 patients were found to be positive for SARS-CoV-2, after reverse transcriptase polymerase chain reaction on nasal or throat swabs, whilst 218 patients were found to be negative and were used as a control group. Regarding central nervous system manifestations, in SARS-CoV-2-positive patients a higher frequency of headache, hyposmia and encephalopathy always related to systemic conditions (fever or hypoxia) was observed. Furthermore, muscular involvement was more frequent in SARS-CoV-2 infection. Conclusions Patients with COVID-19 commonly have neurological manifestations but only hyposmia and muscle involvement seem more frequent compared with other flu diseases.

Published
2020

47. Progressive fibrosing interstitial lung disease: clinical uncertainties, consensus recommendations, and research priorities

Author

George, P. M., Spagnolo, P., Kreuter, M., Altinisik, G., Bonifazi, M., Martinez, F. J., Molyneaux, P. L., Renzoni, E. A., Richeldi, Luca, Tomassetti, S., Valenzuela, C., Vancheri, C., Varone, Francesco, Cottin, V., Costabel, U., Richeldi L. (ORCID:0000-0001-8594-1448), Varone F., George, P. M., Spagnolo, P., Kreuter, M., Altinisik, G., Bonifazi, M., Martinez, F. J., Molyneaux, P. L., Renzoni, E. A., Richeldi, Luca, Tomassetti, S., Valenzuela, C., Vancheri, C., Varone, Francesco, Cottin, V., Costabel, U., Richeldi L. (ORCID:0000-0001-8594-1448), and Varone F.

Abstract

Within the spectrum of fibrosing interstitial lung diseases (ILDs) is a subset of patients who have inexorable progression of pulmonary fibrosis despite treatment, which is known as the progressive fibrotic phenotype. Although the concept of progressive fibrosing ILD has been applied largely to patients with idiopathic pulmonary fibrosis (IPF), there is now an increasing focus on irreversible progressive fibrosis in a proportion of patients with a range of underlying ILD diagnoses. Evidence has emerged to support a possible role for antifibrotic therapy in these patients. In this Position Paper, we discuss the importance of retaining diagnostic scrutiny within the multidisciplinary team and suggest a multidomain definition for progressive fibrosis. We consider the potential role of antifibrotic drugs as second-line therapy in the treatment algorithm for patients with progressive non-IPF ILD. We highlight risk factors that might predispose individuals to developing progressive fibrosis. Finally, we discuss key uncertainties and future directions for research and clinical practice.

Published
2020

48. Progressive Fibrosing Interstitial Lung Disease A Proposed Integrated Algorithm for Management

Author

Varone, Francesco, Sgalla, Giacomo, Iovene, Bruno, Richeldi, Luca, Varone F., Sgalla G. (ORCID:0000-0003-3130-9388), Iovene B., Richeldi L. (ORCID:0000-0001-8594-1448), Varone, Francesco, Sgalla, Giacomo, Iovene, Bruno, Richeldi, Luca, Varone F., Sgalla G. (ORCID:0000-0003-3130-9388), Iovene B., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

No abstract available

Published
2020

49. Disease progression across the spectrum of idiopathic pulmonary fibrosis: A multicentre study

Author

Sgalla, Giacomo, Lo Greco, E., Calvello, M., Varone, Francesco, Iovene, Bruno, Cerri, S., Donatelli, P., Vancheri, A., Pavone, Matteo, Luppi, F., Vancheri, C., Richeldi, Luca, Sgalla G. (ORCID:0000-0003-3130-9388), Varone F., Iovene B., Pavone M., Richeldi L. (ORCID:0000-0001-8594-1448), Sgalla, Giacomo, Lo Greco, E., Calvello, M., Varone, Francesco, Iovene, Bruno, Cerri, S., Donatelli, P., Vancheri, A., Pavone, Matteo, Luppi, F., Vancheri, C., Richeldi, Luca, Sgalla G. (ORCID:0000-0003-3130-9388), Varone F., Iovene B., Pavone M., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Background and objective: In clinical practice, a working diagnosis of IPF may be performed to provide effective antifibrotic treatment to patients who cannot undergo SLB. In this study, we compared the disease course across IPF diagnostic categories in a real-life clinical setting to clarify the appropriateness of a working diagnosis of IPF and treatment initiation in these patients. Methods: Longitudinal data from IPF patients receiving antifibrotic treatment (pirfenidone or nintedanib) were retrospectively collected at three tertiary centres in Italy. Univariate and multivariate analyses were performed to compare time to death and to a composite endpoint of disease progression between two diagnostic subgroups, that is, patients with UIP on HRCT and/or SLB, and patients with possible UIP and no histological confirmation. Results: A total of 249 IPF patients were included in the analysis. Among patients with a possible UIP pattern on HRCT, 41 (55%) were prescribed antifibrotic treatment (either nintedanib or pirfenidone) despite absence of histological confirmation. This group demonstrated similar mortality and disease progression as compared to patients with a definite diagnosis of IPF as per diagnostic guidelines (log-rank test P = 0.771 and P = 0.139, respectively). Such findings were confirmed on multivariate analysis (HR: 1.19, 95% CI: 0.49–2.89, P = 0.7 for death; HR: 1.42, 95% CI: 0.83–2.44, P = 0.201 for disease progression). Conclusion: In patients receiving antifibrotics following a working diagnosis of IPF, disease progression rates were similar to patients with a confident diagnosis of IPF according to consensus guidelines, supporting the rationale for treatment initiation in these patients by expert multidisciplinary teams.

Published
2020

50. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., Varone F., Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., and Varone F.

Abstract

Background: The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods: The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudo-random number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178. Findings: Participants were recruited between Feb 23, 2017, and April 27, 2018. Of 663 participants who received at least one dose of nintedanib or placebo, 173 (26%) had chronic hypersensitivity pneumonitis, 170 (26%) an autoimmune IL

Published
2020

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