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1. Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry

Author

Iaffaldano, Pietro, Lucisano, Giuseppe, Guerra, Tommaso, Patti, Francesco, Cocco, Eleonora, De Luca, Giovanna, Brescia Morra, Vincenzo, Pozzilli, Carlo, Zaffaroni, Mauro, Ferraro, Diana, Gasperini, Claudio, Salemi, Giuseppe, Bergamaschi, Roberto, Lus, Giacomo, Inglese, Matilde, Romano, Silvia, Bellantonio, Paolo, Di Monte, Elisabetta, Maniscalco, Giorgia Teresa, Conte, Antonella, Lugaresi, Alessandra, Vianello, Marika, Torri Clerici, Valentina Liliana Adriana, Di Sapio, Alessia, Pesci, Ilaria, Granella, Franco, Totaro, Rocco, Marfia, Girolama Alessandra, Danni, Maura Chiara, Cavalla, Paola, Valentino, Paola, Aguglia, Umberto, Montepietra, Sara, Ferraro, Elisabetta, Protti, Alessandra, Spitaleri, Daniele, Avolio, Carlo, De Riz, Milena, Maimone, Davide, Cavaletti, Guido, Gazzola, Paola, Tedeschi, Gioacchino, Sessa, Maria, Rovaris, Marco, Di Palma, Franco, Gatto, Maurizia, Cargnelutti, Daniela, De Robertis̄, Francesca, Logullo, Francesco Ottavio, Rini, Augusto, Meucci, Giuseppe, Ardito, Bonaventura, Banfi, Paola, Nasuelli, Davide, Paolicelli, Damiano, Rocca, Maria Assunta, Portaccio, Emilio, Chisari, Clara Grazia, Fenu, Giuseppe, Onofrj, Marco, Carotenuto, Antonio, Ruggieri, Serena, Tortorella, Carla, Ragonese, Paolo, Nica, Mihaela, Amato, Maria Pia, Filippi, Massimo, and Trojano, Maria

Published
2024
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2. An evidence-informed policymaking (EIPM) competency profile for the Brazilian Health System developed through consensus: process and outcomes

Author

Barreto, Jorge Otávio Maia, Romão, Davi Mamblona Marques, Setti, Cecilia, Machado, Maria Lúcia Teixeira, Riera, Rachel, Gomes, Romeu, Machado, Daienne Amaral, Abreu, João, de Andrade, Keitty Regina Cordeiro, Boeira, Laura dos Santos, Pozza, Letícia, Souza, Nathan Mendes, Logullo, Patrícia, Silva, Roberta Borges, de Oliveira, Sandra Maria do Valle Leone, Mota, Sara Emanuela de Carvalho, Dias, Tamille Sales, Toma, Tereza Setsuko, and da Silva, Silvio Fernandes

Published
2023
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4. Genome-wide Analyses Identify KIF5A as a Novel ALS Gene.

Author

Nicolas, Aude, Kenna, Kevin P, Renton, Alan E, Ticozzi, Nicola, Faghri, Faraz, Chia, Ruth, Dominov, Janice A, Kenna, Brendan J, Nalls, Mike A, Keagle, Pamela, Rivera, Alberto M, van Rheenen, Wouter, Murphy, Natalie A, van Vugt, Joke JFA, Geiger, Joshua T, Van der Spek, Rick A, Pliner, Hannah A, Shankaracharya, Smith, Bradley N, Marangi, Giuseppe, Topp, Simon D, Abramzon, Yevgeniya, Gkazi, Athina Soragia, Eicher, John D, Kenna, Aoife, ITALSGEN Consortium, Mora, Gabriele, Calvo, Andrea, Mazzini, Letizia, Riva, Nilo, Mandrioli, Jessica, Caponnetto, Claudia, Battistini, Stefania, Volanti, Paolo, La Bella, Vincenzo, Conforti, Francesca L, Borghero, Giuseppe, Messina, Sonia, Simone, Isabella L, Trojsi, Francesca, Salvi, Fabrizio, Logullo, Francesco O, D'Alfonso, Sandra, Corrado, Lucia, Capasso, Margherita, Ferrucci, Luigi, Genomic Translation for ALS Care (GTAC) Consortium, Moreno, Cristiane de Araujo Martins, Kamalakaran, Sitharthan, Goldstein, David B, ALS Sequencing Consortium, Gitler, Aaron D, Harris, Tim, Myers, Richard M, NYGC ALS Consortium, Phatnani, Hemali, Musunuri, Rajeeva Lochan, Evani, Uday Shankar, Abhyankar, Avinash, Zody, Michael C, Answer ALS Foundation, Kaye, Julia, Finkbeiner, Steven, Wyman, Stacia K, LeNail, Alex, Lima, Leandro, Fraenkel, Ernest, Svendsen, Clive N, Thompson, Leslie M, Van Eyk, Jennifer E, Berry, James D, Miller, Timothy M, Kolb, Stephen J, Cudkowicz, Merit, Baxi, Emily, Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe) Consortium, Benatar, Michael, Taylor, J Paul, Rampersaud, Evadnie, Wu, Gang, Wuu, Joanne, SLAGEN Consortium, Lauria, Giuseppe, Verde, Federico, Fogh, Isabella, Tiloca, Cinzia, Comi, Giacomo P, Sorarù, Gianni, Cereda, Cristina, French ALS Consortium, Corcia, Philippe, Laaksovirta, Hannu, Myllykangas, Liisa, Jansson, Lilja, Valori, Miko, Ealing, John, Hamdalla, Hisham, Rollinson, Sara, Pickering-Brown, Stuart, and Orrell, Richard W

Subjects
ITALSGEN Consortium, Genomic Translation for ALS Care (GTAC) Consortium, ALS Sequencing Consortium, NYGC ALS Consortium, Answer ALS Foundation, Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe) Consortium, SLAGEN Consortium, French ALS Consortium, Project MinE ALS Sequencing Consortium, Humans, Amyotrophic Lateral Sclerosis, Cohort Studies, Amino Acid Sequence, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Genome-Wide Association Study, Young Adult, Loss of Function Mutation, Kinesins, ALS, GWAS, KIF5A, WES, WGS, axonal transport, cargo, Brain Disorders, Genetics, Human Genome, Rare Diseases, Neurosciences, Neurodegenerative, Aetiology, 2.1 Biological and endogenous factors, Neurological, Psychology, Cognitive Sciences, Neurology & Neurosurgery
Abstract

To identify novel genes associated with ALS, we undertook two lines of investigation. We carried out a genome-wide association study comparing 20,806 ALS cases and 59,804 controls. Independently, we performed a rare variant burden analysis comparing 1,138 index familial ALS cases and 19,494 controls. Through both approaches, we identified kinesin family member 5A (KIF5A) as a novel gene associated with ALS. Interestingly, mutations predominantly in the N-terminal motor domain of KIF5A are causative for two neurodegenerative diseases: hereditary spastic paraplegia (SPG10) and Charcot-Marie-Tooth type 2 (CMT2). In contrast, ALS-associated mutations are primarily located at the C-terminal cargo-binding tail domain and patients harboring loss-of-function mutations displayed an extended survival relative to typical ALS cases. Taken together, these results broaden the phenotype spectrum resulting from mutations in KIF5A and strengthen the role of cytoskeletal defects in the pathogenesis of ALS.

Published
2018

12. Aedes fluviatilis cell lines as new tools to study metabolic and immune interactions in mosquito-Wolbachia symbiosis

Author

Conceição, Christiano Calixto, da Silva, Jhenifer Nascimento, Arcanjo, Angélica, Nogueira, Cíntia Lopes, de Abreu, Leonardo Araujo, de Oliveira, Pedro Lagerblad, Gondim, Katia C., Moraes, Bruno, de Carvalho, Stephanie Serafim, da Silva, Renato Martins, da Silva Vaz, Jr., Itabajara, Moreira, Luciano Andrade, and Logullo, Carlos

Published
2021
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15. The emerging role of neutrophil extracellular traps in severe acute respiratory syndrome coronavirus 2 (COVID-19)

Author

Arcanjo, Angélica, Logullo, Jorgete, Menezes, Camilla Cristie Barreto, de Souza Carvalho Giangiarulo, Thais Chrispim, dos Reis, Mirella Carneiro, de Castro, Gabriellen Menezes Migliani, da Silva Fontes, Yasmin, Todeschini, Adriane Regina, Freire-de-Lima, Leonardo, Decoté-Ricardo, Debora, Ferreira-Pereira, Antônio, Freire-de-Lima, Celio Geraldo, Barroso, Shana Priscila Coutinho, Takiya, Christina, Conceição-Silva, Fátima, Savino, Wilson, and Morrot, Alexandre

Published
2020
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16. A physiologic overview of the organ-specific transcriptome of the cattle tick Rhipicephalus microplus

Author

Tirloni, Lucas, Braz, Gloria, Nunes, Rodrigo Dutra, Gandara, Ana Caroline Paiva, Vieira, Larissa Rezende, Assumpcao, Teresa Cristina, Sabadin, Gabriela Alves, da Silva, Renato Martins, Guizzo, Melina Garcia, Machado, Josias Alves, Costa, Evenilton Pessoa, Santos, Daniele, Gomes, Helga Fernandes, Moraes, Jorge, dos Santos Mota, Maria Beatriz, Mesquita, Rafael Dias, de Souza Leite, Milane, Alvarenga, Patricia Hessab, Lara, Flavio Alves, Seixas, Adriana, da Fonseca, Rodrigo Nunes, Fogaça, Andrea C., Logullo, Carlos, Tanaka, Aparecida Sadae, Daffre, Sirlei, Oliveira, Pedro L., da Silva Vaz, Jr., Itabajara, and Ribeiro, José M. C.

Published
2020
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19. Potential premalignant status of gastric portion excluded after Roux en-Y gastric bypass in obese women: A pilot study

Author

Ravacci, Graziela Rosa, Ishida, Robson, Torrinhas, Raquel Suzana, Sala, Priscila, Machado, Natasha Mendonça, Fonseca, Danielle Cristina, André Baptista Canuto, Gisele, Pinto, Ernani, Nascimento, Viviane, Franco Maggi Tavares, Marina, Sakai, Paulo, Faintuch, Joel, Santo, Marco Aurelio, Moura, Eduardo Guimarães Hourneaux, Neto, Ricardo Artigiani, Logullo, Angela Flávia, and Waitzberg, Dan Linetzky

Published
2019
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22. AGREE-S: AGREE II extension for surgical interventions – United European Gastroenterology and European Association for Endoscopic Surgery methodological guide

Author

Logullo, P, Florez, ID, Antoniou, GA, Markar, S, López‐Cano, M, Silecchia, G, Tsokani, S, Mavridis, D, Brouwers, M, Antoniou, SA, Sami Abdel Dayem Amer, Y, Bertolaccini, L, Alonso‐Coello, P, Akl, EA, Chand, M, Como, JJ, Borst, GJ, Di Saverio, S, Emile, S, Eom, BW, Gorter, R, Hanna, G, Immonen, K, Lai, Q, Lumen, N, Mathew, JL, Montendori, A, Moya, M, Pellino, G, Sanabria, A, Saratzis, A, Smart, N, Stefanidis, D, Zaninotto, G, Paediatric Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam Reproduction & Development (AR&D), Pediatric surgery, Patricia, Logullo, Ivan D, Florez, George A, Antoniou, Sheraz, Markar, Manuel, López-Cano, Gianfranco, Silecchia, Sofia, Tsokani, Dimitrios, Mavridi, Melissa, Brouwer, Stavros A, Antoniou, Sami Abdel Dayem Amer, Yasser, Bertolaccini, Luca, Alonso-Coello, Pablo, A Akl, Elie, Chand, Manish, J Como, John, J de Borst, Gert, Di Saverio, Salomone, Emile, Sameh, Wool Eom, Bang, Gorter, Ramon, Hanna, George, Immonen, Kaisa, Lai, Quirino, Lumen, Nicolaa, L Mathew, Joseph, Montendori, Alessandro, Moya, Martin, Pellino, Gianluca, Sanabria, Alvaro, Saratzis, Athanasio, Smart, Neil, Stefanidis, Dimitrio, Zaninotto, Giovanni, Institut Català de la Salut, [Logullo P] Department Nuffield of Orthopaedics, Rheumatology & Musculoskeletal Sciences, UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, UK. [Florez ID] Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada. Department of Pediatrics, University of Antioquia, Medellin, Colombia. [Antoniou GA] Department of Vascular and Endovascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK. Division of Cardiovascular Sciences, School of Medical Sciences, The University of Manchester, Manchester, UK. [Markar S] Nuffield Department of Surgery, University of Oxford, Oxford, Oxfordshire, UK. Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden. [López-Cano M] Unitat de Cirurgia de la Paret Abdominal, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Silecchia G] Department of Medico‐Surgical Sciences and Translation Medicine, Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Surgical Procedures, Operative [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], evidence, gastroenterology, factor analysis, methodology, intervenciones quirúrgicas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], agree ii, agree-s, guidelines, quality, endoscopy, factor analysis, statistical, humans, Oncology, Operacions quirúrgiques, Factor Analysis, Statistical, Gastroenterologia, Health Occupations::Medicine::Internal Medicine::Gastroenterology [DISCIPLINES AND OCCUPATIONS], guideline, statistical, profesiones sanitarias::medicina::medicina interna::gastroenterología [DISCIPLINAS Y OCUPACIONES], Human
Abstract

Evidence; Guidelines; Quality Evidencia; Pautas; Calidad Evidència; Pautes; Qualitat Background The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument has been developed to inform the methodology, reporting and appraisal of clinical practice guidelines. Evidence suggests that the quality of surgical guidelines can be improved, and the structure and content of AGREE II can be modified to help enhance the quality of guidelines of surgical interventions. Objective To develop an extension of AGREE II specifically designed for guidelines of surgical interventions. Methods In the tripartite Guideline Assessment Project (GAP) funded by United European Gastroenterology and the European Association for Endoscopic Surgery, (i) we assessed the quality of surgical guidelines and we identified factors associated with higher quality (GAP I); (ii) we applied correlation analysis, factor analysis and the item response theory to inform an adaption of AGREE II for the purposes of surgical guidelines (GAP II); and (iii) we developed an AGREE II extension for surgical interventions, informed by the results of GAP I, GAP II, and a Delphi process of stakeholders, including representation from interventional and surgical disciplines; the Guideline International Network (GIN); the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group; the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) initiative; and representation of surgical journal editors and patient/public. Results We developed AGREE-S, an AGREE II extension for surgical interventions, which comprises 24 items organized in 6 domains; Scope and purpose, Stakeholders, Evidence synthesis, Development of recommendations, Editorial independence, and Implementation and update. The panel of stakeholders proposed 3 additional items: development of a guideline protocol, consideration of practice variability and surgical/interventional expertise in different settings, and specification of infrastructures required to implement the recommendations. Three of the existing items were amended, 7 items were rearranged among the domains, and one item was removed. The domain Rigour of Development was divided into domains on Evidence Synthesis and Development of Recommendations. The new domain Development of Recommendations incorporates items from the original AGREE II domain Clarity of Presentation. Conclusion AGREE-S is an evidence-based and stakeholder-informed extension of the AGREE II instrument, that can be used as a guide for the development and adaption of guidelines on surgical interventions. The Guideline Assessment Project (GAP) III received financial support from the United European Gastroenterology (UEG) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES), both non-profit organizations. The funders had no role in the design or development of this project.

Published
2022
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23. The Uptake of the Core Outcome Set for Non-Specific Low Back Pain Clinical Trials is Poor: A Meta-Epidemiological Study of Trial Registrations

Author

Innocenti, Tiziano, Salvioli, Stefano, Logullo, Patricia, Giagio, Silvia, Ostelo, Raymond, and Chiarotto, Alessandro

Abstract

We conducted a meta-epidemiological study on all non-specific low back pain (NSLBP) trial registrations on the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. We aimed to 1) assess the uptake of the core outcome set (COS) for NSLBP in clinical trials; 2) assess the uptake of the core outcome measurement set for NSLBP in clinical trials; and 3) determine whether specific study characteristics are associated with the COS uptake.

Published
2024
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25. CO2laser, radiofrequency, and promestriene in the treatment of genitourinary syndrome of menopause in breast cancer survivors: a histomorphometric evaluation of the vulvar vestibule

Author

Fernandes, Marcela Furtado Roberto, Bianchi-Ferraro, Ana Maria Homem de Mello, Sartori, Marair Gracio Ferreira, Jármy Di Bella, Zsuzsanna Ilona Katalin de, Cantarelli, Gabriela Cruz, Dedonatto, Chayanne, Vanzin, Rafaela Brambatti, Dardes, Rita de Cassia Maio, Logullo, Ângela Flávia, and Patriarca, Marisa Teresinha

Published
2023
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37. Disease-Modifying Treatments and Time to Loss of Ambulatory Function in Patients With Primary Progressive Multiple Sclerosis

Author

Portaccio, Emilio, Fonderico, Mattia, Iaffaldano, Pietro, Pastò, Luisa, Razzolini, Lorenzo, Bellinvia, Angelo, De Luca, Giovanna, Ragonese, Paolo, Patti, Francesco, Brescia Morra, Vincenzo, Cocco, Eleonora, Sola, Patrizia, Inglese, Matilde, Lus, Giacomo, Pozzilli, Carlo, Maimone, Davide, Lugaresi, Alessandra, Gazzola, Paola, Comi, Giancarlo, Pesci, Ilaria, Spitaleri, Daniele, Rezzonico, Marta, Vianello, Marika, Avolio, Carlo, Logullo, Francesco O., Granella, Franco, Salvetti, Marco, Zaffaroni, Mauro, Lucisano, Giuseppe, Filippi, Massimo, Trojano, Maria, and Amato, Maria Pia

Abstract

IMPORTANCE: Except for ocrelizumab, treatment options in primary progressive multiple sclerosis (PPMS) are lacking. OBJECTIVE: To investigate the effectiveness of DMTs on the risk of becoming wheelchair dependent in a real-world population of patients with PPMS. DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, observational, retrospective, comparative effectiveness research study. Data were extracted on November 28, 2018, from the Italian multiple sclerosis register and analyzed from June to December 2021. Mean study follow-up was 11 years. Included in the study cohort were patients with a diagnosis of PPMS and at least 3 years of Expanded Disability Status Scale (EDSS) evaluations and 3 years of follow-up. MAIN OUTCOMES AND MEASURES: The risk of reaching an EDSS score of 7.0 was assessed through multivariable Cox regression models. EXPOSURES: Patients who received DMT before the outcome were considered treated. DMT was assessed as a time-dependent variable and by class of DMT (moderately and highly effective). RESULTS: From a total of 3298 patients with PPMS, 2633 were excluded because they did not meet the entry criteria for the phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of ocrelizumab in adults with PPMS (ORATORIO) trial. Among the remaining 665 patients (mean [SD] age, 43.0 [10.7] years; 366 female patients [55.0%]), 409 were further selected for propensity score matching (288 treated and 121 untreated patients). In the matched cohort, during the study follow-up, 37% of patients (152 of 409) reached an EDSS score of 7.0 after a mean (SD) follow-up of 10.6 (5.6) years. A higher EDSS score at baseline (adjusted hazard ratio [aHR], 1.32; 95% CI, 1.13-1.55; P < .001), superimposed relapses (aHR, 2.37; 95% CI, 1.24-4.54; P = .009), and DMT exposure (aHR, 1.75; 95% CI, 1.04-2.94; P = .03) were associated with a higher risk of an EDSS score of 7.0, whereas the interaction term between DMT and superimposed relapses was associated with a reduced risk of EDSS score of 7.0 (aHR, 0.33; 95% CI, 0.16-0.71; P = .004). Similar findings were obtained when treatment according to DMT class was considered and when DMT was included as a time-dependent covariate. These results were confirmed in the subgroup of patients with available magnetic resonance imaging data. CONCLUSIONS AND RELEVANCE: Results of this comparative effectiveness research study suggest that inflammation also occurs in patients with PPMS, may contribute to long-term disability, and may be associated with a reduced risk of becoming wheelchair dependent by current licensed DMTs.

Published
2022
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39. Abstracts

Author

Rosemberg, S., Telxelra, M. J., Alves, V. A. F., Perry J. R., Ang L. C., Bilbao J. M., Muller P. J., Min, Kyung -Whan, Cashman, Robert, Brumback, Roger A., Rao, C., Deloso, D., Anderson, V., Seymour, A., Wrzolek, M., Abdu, A., Swanson, R., Honavar, M., Waters, K. B., Wise, S. M., Kubota, T., Sato, K., Kabuto, M., Nakagawa, T., Kitai, R., Nitta, H., Yamashita, J., Vital, C., Rivel, J., Sangalli, F., Benjelloun, B., Vital, A., Leger, F., Riemens, V., Epardeau, B., Guerin, J., Coindre, J. M., Ruchoux, M. M., Dhellemmes, P., Hamon, M., Lecomte, M., Hassoun, J., Yagishita, Saburo, Kawano, Nobuyuki, Kameya, Toru, Bowman, R., Liwnicz, B. H., Peckham, N., Barbosa-Coutinho, L. M., Hilbig, L. M., Hilbig, A., Loiseau, H., Mouton, L., Delisle, H. B., Rummens, C., Akai, F., Taneda, M., Iwasaki, H., Suzuki, Y., Tsanaclis, A. M. C., Aguiar, P. H. P., Logullo, A. F., Matamores, M. R., Yacubian, A., Komatsu, H., Oka, H., Suwa, T., Stoltenburg-Didinger, G., Gotzia, C., Benndorf, G., Kepes, J. J., Baba-Ahmed, R., Wong, K., Raisanen, J., Taylor, S. L., McDermott, M. W., Gutin, P., Havlioglu, Necat, Manepalli, Anantha, Galindo, Lorenzo, Sotelo-Avila, Cirilo, Grosso, Leonard, Kavavattathayyil, S., Chen, P., Wrzolek, M. A., Cook, J., Woodward, D. E., Tracqui, P., Cruywagen, G. C., Murray, J. D., Bartoo, G. T., Alvord, Jr., E. C., Szymas, Janusz, Jelonek, Jacek, Krawiec, Krzysztof, Slowinski, Roman, Coons, S. W., Johnson, P. C., Uro, E., Bousquet, P. H., Delisle, M. B., Rangueil, C. H. U., Torp, S. H., Johannesen, E., Lindboe, C. F., Beil, Michael, Kato, S., Morita, T., Kato, M., Herz, F., Hirano, A., Ohama, E., Albuquerque, L., Pimentel, J., Távora, L., Antunes, N. L., Weis, S., Protopapa, D., Mäerz, U., Winkler, P. A., Reulen, H. J., Mehraein, P., Di, Xiao, Reifenberger, Julia, Reifenberger, Guido, Liu, Lu, James, C. David, Wechsler, Wolfgang, Collins, V. Peter, McLendon, R. E., Batra, S. K., Friedman, H. S., Rasheed, B. K. A., Bigner, D. D., Bigner, S. K., Patt, S., Thiel, G., Labrousse, F., de Néchaud, B., Gomès, D., Daumas-Duport, C., Allarmargot, C., Dupouey, P., Vrionis, F., Qi, P., Cherington, V., Cano, G., Wu, J., Lampson, L. A., Chen, A., Vortmeyer, A. O., Slack, R. S., Skerjanc, I. S., Lach, B., Craig, J., Jardine, K., McBurney, M. W., Macaulay, R. J. B., Dimitroulakos, J., Becker, L. E., Yeger, H., Rhodes, C. Harker, Honsinger, Charles, Sorenson, George D., Goumnerova L. C., Segal R. A., Kwon Y. K., Stiles C. D., Pomeroy S. L., Guha, A., Lau, N., Pawson, A., Engel, Ute, Gutowski, Nick J., Bevan, Karen, Noble, Mark, Gladson, C. L., Pijuan, V., Olman, M. A., Gillespie, G. Y., Yacoub, I., Yamasaki, T., Enomoto, K., Moritake, K., Akiyama, Y., Kawahara, M., Maeno, T., Merzak, A., Parker, C., Koocheckpour, S., Sherbet, G. V., Pilkington, G. J., Martin, K., Akinwunmi, J., Rooprai, H. K., Kennedy, A., Linke, A., Ognjenovic, N., Fujiwara, T., Matsumoto, Y., Miyake, K., Shin, M., Nagao, S., Pulido-Cejudo, G., Jamison, K., Hugenholtz, H., Campione-Piccardo, J., Maidment, S. L., Lins, C., Takyia, C. M., Garcia-Abreu, J., Rodrigues, F. F., Duarte, F., Chagas, C., Chneiweiss, H., and Neto, V. Moura

Published
1995
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43. Peripheral neuropathy and headache in cancer patients treated with immunotherapy and immuno-oncology combinations: the MOUSEION-02 study

Author

Rizzo, Alessandro, Santoni, Matteo, Mollica, Veronica, Logullo, Francesco, Rosellini, Matteo, Marchetti, Andrea, Faloppi, Luca, Battelli, Nicola, and Massari, Francesco

Abstract

ABSTRACTIntroductionTreatment-related neurotoxicity is a common side effect in cancer patients. However, few data are available regarding the risk of several neurotoxicities in patients treated with immune checkpoint inhibitors.Areas coveredThe MOUSEION-02 study is an up-to-date meta-analysis aimed at assessing the risk of peripheral neuropathy, peripheral sensory neuropathy, and headache in cancer patients receiving immunotherapy and immuno-oncology combinations. Patients receiving immunotherapy (as monotherapy or in combination with other anticancer agents) showed lower risk of all-grade peripheral neuropathy (RR, 0.50; 95% CI, 0.35–0.70) and all-grade peripheral sensory neuropathy (RR, 0.49; 95% CI, 0.30–0.79). Similarly, in patients treated with immune checkpoint inhibitor monotherapy, we observed lower risk of all-grade peripheral neuropathy (RR, 0.05; 95% CI, 0.03–0.10) and all-grade peripheral sensory neuropathy (RR, 0.11; 95% CI, 0.05–0.23). No differences were observed in terms of all-grade headache.Expert opinionAlthough the results of this meta-analysis should be interpreted with caution due to several issues, our study draws attention to immunotherapy-related neurotoxicity with the aim of maximizing clinical outcomes of cancer patients experiencing these not uncommon, and yet poorly studied, adverse events.

Published
2021
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45. Electromyoneurography and laboratory findings in a case of Guillain-Barré syndrome after second dose of Pfizer COVID-19 vaccine

Author

Scendoni, Roberto, Petrelli, Cristina, Scaloni, Giorgia, and Logullo, Francesco Ottavio

Abstract

ABSTRACTGuillain-Barre syndrome (GBS) is an acute immune-mediated disease of the peripheral nerves and nerve roots (polyradiculoneuropathy) that is usually elicited by various infections. We present a case of GBS after receiving the second dose of Pfizer-COVID 19 vaccine. Diagnosis was made after performing an accurate clinical examination, electromyoneurography and laboratory tests. In particular, anti-ganglioside antibodies have tested positive. During this pandemic with ongoing worldwide mass vaccination campaign, it is critically important for clinicians to rapidly recognize neurological complications or other side effects associated with COVID-19 vaccination.

Published
2021
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46. Association of Variants in the SPTLC1 Gene With Juvenile Amyotrophic Lateral Sclerosis

Author

Johnson, Janel O., Chia, Ruth, Miller, Danny E., Li, Rachel, Kumaran, Ravindran, Abramzon, Yevgeniya, Alahmady, Nada, Renton, Alan E., Topp, Simon D., Gibbs, J. Raphael, Cookson, Mark R., Sabir, Marya S., Dalgard, Clifton L., Troakes, Claire, Jones, Ashley R., Shatunov, Aleksey, Iacoangeli, Alfredo, Al Khleifat, Ahmad, Ticozzi, Nicola, Silani, Vincenzo, Gellera, Cinzia, Blair, Ian P., Dobson-Stone, Carol, Kwok, John B., Bonkowski, Emily S., Palvadeau, Robin, Tienari, Pentti J., Morrison, Karen E., Shaw, Pamela J., Al-Chalabi, Ammar, Brown, Robert H., Calvo, Andrea, Mora, Gabriele, Al-Saif, Hind, Gotkine, Marc, Leigh, Fawn, Chang, Irene J., Perlman, Seth J., Glass, Ian, Scott, Anna I., Shaw, Christopher E., Basak, A. Nazli, Landers, John E., Chiò, Adriano, Crawford, Thomas O., Smith, Bradley N., Traynor, Bryan J., Smith, Bradley N., Ticozzi, Nicola, Fallini, Claudia, Gkazi, Athina Soragia, Topp, Simon D., Scotter, Emma L., Kenna, Kevin P., Keagle, Pamela, Tiloca, Cinzia, Vance, Caroline, Troakes, Claire, Colombrita, Claudia, King, Andrew, Pensato, Viviana, Castellotti, Barbara, Baas, Frank, ten Asbroek, Anneloor L. M. A., McKenna-Yasek, Diane, McLaughlin, Russell L., Polak, Meraida, Asress, Seneshaw, Esteban-Pérez, Jesús, Stevic, Zorica, D’Alfonso, Sandra, Mazzini, Letizia, Comi, Giacomo P., Del Bo, Roberto, Ceroni, Mauro, Gagliardi, Stella, Querin, Giorgia, Bertolin, Cinzia, van Rheenen, Wouter, Rademakers, Rosa, van Blitterswijk, Marka, Lauria, Giuseppe, Duga, Stefano, Corti, Stefania, Cereda, Cristina, Corrado, Lucia, Sorarù, Gianni, Williams, Kelly L., Nicholson, Garth A., Blair, Ian P., Leblond-Manry, Claire, Rouleau, Guy A., Hardiman, Orla, Morrison, Karen E., Veldink, Jan H., van den Berg, Leonard H., Al-Chalabi, Ammar, Pall, Hardev, Shaw, Pamela J., Turner, Martin R., Talbot, Kevin, Taroni, Franco, García-Redondo, Alberto, Wu, Zheyang, Glass, Jonathan D., Gellera, Cinzia, Ratti, Antonia, Brown, Robert H., Silani, Vincenzo, Shaw, Christopher E., Landers, John E., Dalgard, Clifton L., Adeleye, Adelani, Soltis, Anthony R., Alba, Camille, Viollet, Coralie, Bacikova, Dagmar, Hupalo, Daniel N., Sukumar, Gauthaman, Pollard, Harvey B., Wilkerson, Matthew D., Martinez, Elisa McGrath, Abramzon, Yevgeniya, Ahmed, Sarah, Arepalli, Sampath, Baloh, Robert H., Bowser, Robert, Brady, Christopher B., Brice, Alexis, Broach, James, Campbell, Roy H., Camu, William, Chia, Ruth, Cooper-Knock, John, Ding, Jinhui, Drepper, Carsten, Drory, Vivian E., Dunckley, Travis L., Eicher, John D., England, Bryce K., Faghri, Faraz, Feldman, Eva, Floeter, Mary Kay, Fratta, Pietro, Geiger, Joshua T., Gerhard, Glenn, Gibbs, J. Raphael, Gibson, Summer B., Glass, Jonathan D., Hardy, John, Harms, Matthew B., Heiman-Patterson, Terry D., Hernandez, Dena G., Jansson, Lilja, Kirby, Janine, Kowall, Neil W., Laaksovirta, Hannu, Landeck, Natalie, Landi, Francesco, Le Ber, Isabelle, Lumbroso, Serge, MacGowan, Daniel J. L., Maragakis, Nicholas J., Mora, Gabriele, Mouzat, Kevin, Murphy, Natalie A., Myllykangas, Liisa, Nalls, Mike A., Orrell, Richard W., Ostrow, Lyle W., Pamphlett, Roger, Pickering-Brown, Stuart, Pioro, Erik P., Pletnikova, Olga, Pliner, Hannah A., Pulst, Stefan M., Ravits, John M., Renton, Alan E., Rivera, Alberto, Robberecht, Wim, Rogaeva, Ekaterina, Rollinson, Sara, Rothstein, Jeffrey D., Scholz, Sonja W., Sendtner, Michael, Shaw, Pamela J., Sidle, Katie C., Simmons, Zachary, Singleton, Andrew B., Smith, Nathan, Stone, David J., Tienari, Pentti J., Troncoso, Juan C., Valori, Miko, Van Damme, Philip, Van Deerlin, Vivianna M., Van Den Bosch, Ludo, Zinman, Lorne, Landers, John E., Chiò, Adriano, Traynor, Bryan J., Angelocola, Stefania M., Ausiello, Francesco P., Barberis, Marco, Bartolomei, Ilaria, Battistini, Stefania, Bersano, Enrica, Bisogni, Giulia, Borghero, Giuseppe, Brunetti, Maura, Cabona, Corrado, Calvo, Andrea, Canale, Fabrizio, Canosa, Antonio, Cantisani, Teresa A., Capasso, Margherita, Caponnetto, Claudia, Cardinali, Patrizio, Carrera, Paola, Casale, Federico, Chiò, Adriano, Colletti, Tiziana, Conforti, Francesca L., Conte, Amelia, Conti, Elisa, Corbo, Massimo, Cuccu, Stefania, Dalla Bella, Eleonora, D’Errico, Eustachio, DeMarco, Giovanni, Dubbioso, Raffaele, Ferrarese, Carlo, Ferraro, Pilar M., Filippi, Massimo, Fini, Nicola, Floris, Gianluca, Fuda, Giuseppe, Gallone, Salvatore, Gianferrari, Giulia, Giannini, Fabio, Grassano, Maurizio, Greco, Lucia, Iazzolino, Barbara, Introna, Alessandro, La Bella, Vincenzo, Lattante, Serena, Lauria, Giuseppe, Liguori, Rocco, Logroscino, Giancarlo, Logullo, Francesco O., Lunetta, Christian, Mandich, Paola, Mandrioli, Jessica, Manera, Umberto, Manganelli, Fiore, Marangi, Giuseppe, Marinou, Kalliopi, Marrosu, Maria Giovanna, Martinelli, Ilaria, Messina, Sonia, Moglia, Cristina, Mora, Gabriele, Mosca, Lorena, Murru, Maria R., Origone, Paola, Passaniti, Carla, Petrelli, Cristina, Petrucci, Antonio, Pozzi, Susanna, Pugliatti, Maura, Quattrini, Angelo, Ricci, Claudia, Riolo, Giulia, Riva, Nilo, Russo, Massimo, Sabatelli, Mario, Salamone, Paolina, Salivetto, Marco, Salvi, Fabrizio, Santarelli, Marialuisa, Sbaiz, Luca, Sideri, Riccardo, Simone, Isabella, Simonini, Cecilia, Spataro, Rossella, Tanel, Raffaella, Tedeschi, Gioacchino, Ticca, Anna, Torriello, Antonella, Tranquilli, Stefania, Tremolizzo, Lucio, Trojsi, Francesca, Vasta, Rosario, Vacchiano, Veria, Vita, Giuseppe, Volanti, Paolo, Zollino, Marcella, and Zucchi, Elisabetta

Abstract

IMPORTANCE: Juvenile amyotrophic lateral sclerosis (ALS) is a rare form of ALS characterized by age of symptom onset less than 25 years and a variable presentation. OBJECTIVE: To identify the genetic variants associated with juvenile ALS. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter family-based genetic study, trio whole-exome sequencing was performed to identify the disease-associated gene in a case series of unrelated patients diagnosed with juvenile ALS and severe growth retardation. The patients and their family members were enrolled at academic hospitals and a government research facility between March 1, 2016, and March 13, 2020, and were observed until October 1, 2020. Whole-exome sequencing was also performed in a series of patients with juvenile ALS. A total of 66 patients with juvenile ALS and 6258 adult patients with ALS participated in the study. Patients were selected for the study based on their diagnosis, and all eligible participants were enrolled in the study. None of the participants had a family history of neurological disorders, suggesting de novo variants as the underlying genetic mechanism. MAIN OUTCOMES AND MEASURES: De novo variants present only in the index case and not in unaffected family members. RESULTS: Trio whole-exome sequencing was performed in 3 patients diagnosed with juvenile ALS and their parents. An additional 63 patients with juvenile ALS and 6258 adult patients with ALS were subsequently screened for variants in the SPTLC1 gene. De novo variants in SPTLC1 (p.Ala20Ser in 2 patients and p.Ser331Tyr in 1 patient) were identified in 3 unrelated patients diagnosed with juvenile ALS and failure to thrive. A fourth variant (p.Leu39del) was identified in a patient with juvenile ALS where parental DNA was unavailable. Variants in this gene have been previously shown to be associated with autosomal-dominant hereditary sensory autonomic neuropathy, type 1A, by disrupting an essential enzyme complex in the sphingolipid synthesis pathway. CONCLUSIONS AND RELEVANCE: These data broaden the phenotype associated with SPTLC1 and suggest that patients presenting with juvenile ALS should be screened for variants in this gene.

Published
2021
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48. The Brazilian Portuguese Version of the DISCERN Instrument: Translation Procedures and Psychometric Properties.

Author

Logullo, Patricia, Torloni, Maria Regina, de O. C. Latorraca, Carolina, and Riera, Rachel

Abstract

To report on the translation procedures and psychometric properties of the DISCERN tool in Brazilian Portuguese. Three people translated the DISCERN from English into Brazilian Portuguese. A committee of experts and community representatives evaluated the quality of the 3 versions in 2 online voting rounds. Two native speakers back-translated the questionnaire into English. We compared these versions to the original DISCERN and made small adjustments. The final Brazilian Portuguese version of DISCERN was tested twice by journalism students to evaluate the quality of a text about smoking cessation treatments. We evaluated participants' health literacy with the Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHL-PA) tool, assessed the internal consistency of the translated questionnaire with the Cronbach test, and measured its reproducibility with the intraclass correlation coefficient (ICC). We then investigated the relationship between DISCERN and SAHL-PA scores and demographic variables. The participants (n = 126) had no difficulty in using the questionnaire. Cronbach's alpha was 0.865 (95% confidence interval [CI], 0.826-0.898), and the ICC between the 2 evaluations was 0.845 (CI 0.717-0.912). The mean health literacy of the participants was adequate. There was no correlation between the DISCERN score and the SAHL-PA score, age, or sex (P >.05). The Brazilian Portuguese version of the DISCERN questionnaire has excellent internal consistency and good reproducibility. The evaluators' ages, sex, and health literacy did not interfere with the score resulting from the evaluation of the quality of the text. [ABSTRACT FROM AUTHOR]

Published
2019
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