6 research outputs found
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial
Background:
Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke.
Methods:
We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515.
Findings:
Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group.
Interpretation:
In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes.
Funding:
GlaxoSmithKline
4Th Pediatric Allergy And Asthma Meeting (Paam)
WORKSHOP 4: Challenging clinical scenarios (CS01–CS06), CS01 Bullous lesions in two children: solitary mastocytoma, S. Tolga Yavuz, Ozan Koc, Ali Gungor, Faysal Gok, CS02 Multi-System Allergy (MSA) of cystic fibrosis: our institutional experience, Jessica Hawley, Christopher O’Brien, Matthew Thomas, Malcolm Brodlie, Louise Michaelis, CS03 Cold urticaria in pediatric age: an invisible cause for severe reactions, Inês Mota, Ângela Gaspar, Susana Piedade, Graça Sampaio, José Geraldo Dias, Miguel Paiva, Mário Morais-Almeida, CS04 Angioedema with C1 inhibitor deficiency in a girl: a challenge diagnosis, Cristina Madureira, Tânia Lopes, Susana Lopes, Filipa Almeida, Alexandra Sequeira, Fernanda Carvalho, José Oliveira, CS05 A child with unusual multiple organ allergy disease: what is the primer?, Fabienne Gay-Crosier, CS06 A case of uncontrolled asthma in a 6-year-old patient, Ioana-Valentina Nenciu, Andreia Florina Nita, Alexandru Ulmeanu, Dumitru Oraseanu, Carmen Zapucioiu, ORAL ABSTRACT SESSION 1: Food allergy (OP01–OP06), OP01 Food protein-induced enterocolitis syndrome: oral food challenge outcomes for tolerance evaluation in a Pediatric Hospital, Adrianna Machinena, Olga Domínguez Sánchez, Montserrat Alvaro Lozano, Rosa Jimenez Feijoo, Jaime Lozano Blasco, Mònica Piquer Gibert, Mª Teresa Giner Muñoz, Marcia Dias da Costa, Ana Maria Plaza Martín, OP02 Characteristics of infants with food protein-induced enterocolitis syndrome and allergic proctocolitis, Ebru Arik Yilmaz, Özlem Cavkaytar, Betul Buyuktiryaki, Ozge Soyer, Cansin Sackesen, OP03 The clinical and immunological outcomes after consumption of baked egg by 1–5 year old egg allergic children: results of a randomised controlled trial, MerrynNetting, Adaweyah El-Merhibi, Michael Gold, PatrickQuinn, IrmeliPenttila, Maria Makrides, OP04 Oral immunotherapy for treatment of egg allergy using low allergenic, hydrolysed egg, Stavroula Giavi, Antonella Muraro, Roger Lauener, Annick Mercenier, Eugen Bersuch, Isabella M. Montagner, Maria Passioti, Nicolò Celegato, Selina Summermatter, Sophie Nutten, Tristan Bourdeau, Yvonne M. Vissers, Nikolaos G. Papadopoulos, OP05 Chemical modification of a peanut extract results in an increased safety profile while maintaining efficacy, Hanneke van der Kleij, Hans Warmenhoven, Ronald van Ree, Raymond Pieters, Dirk Jan Opstelten, Hans van Schijndel, Joost Smit, OP06 Administration of the yellow fever vaccine in egg allergic children, Roisin Fitzsimons, Victoria Timms, George Du Toit, ORAL ABSTRACT SESSION 2: Asthma (OP07–OP12), OP07 Previous exacerbation is the most important risk factor for future exacerbations in school-age children with asthma, S. Tolga Yavuz, Guven Kaya, Mustafa Gulec, Mehmet Saldir, Osman Sener, Faysal Gok, OP08 Comparative study of degree of severity and laboratory changes between asthmatic children using different acupuncture modalities, Nagwa Hassan, Hala Shaaban, Hazem El-Hariri, Ahmed Kamel Inas E. Mahfouz, OP09 The concentration of exhaled carbon monoxide in asthmatic children with different controlled stadium, Papp Gabor, Biro Gabor, Kovacs Csaba, OP10 Effect of vitamin D3 supplementation during pregnancy on risk of persistent wheeze in the offspring: a randomised clinical trial, Bo Chawes, Klaus Bønnelykke, Jakob Stokholm, Lene Heickendorff, Susanne Brix, Morten Rasmussen, Hans Bisgaard, OP11 Lung function development in childhood, Henrik Wegener Hallas, Bo Chawes, Lambang Arianto, Hans Bisgaard, OP12 Is the effect of maternal and paternal asthma different in female and male children before puberty?, Maike Pincus, Thomas Keil, Andreas Reich, Ulrich Wahn, Susanne Lau, Linus Grabenhenrich, ORAL ABSTRACT SESSION 3: Epidemiology—genetics (OP13–OP18), OP13 Lifestyle is associated with incidence and category of allergen sensitisation: the ALADDIN birth cohort, Sara Fagerstedt, Helena Marell Hesla, Emelie Johansson, Helen Rosenlund, Axel Mie, Annika Scheynius, Johan Alm, OP15 Maternal filaggrin mutations increase the risk of atopic dermatitis in children: an effect independent of mutation inheritance, Jorge Esparza-Gordillo, Anja Matanovic, Ingo Marenholz, Anja Bauerfeind, Klaus Rohde, Katja Nemat, Min-Ae Lee-Kirsch, Magnus Nordenskjöld, Marten C. G. Winge, Thomas Keil, Renate Krüger, Susanne Lau, Kirsten Beyer, Birgit Kalb, Bodo Niggemann, Norbert Hübner, Heather J. Cordell, Maria Bradley, Young-Ae Lee, OP16 Allergic multimorbidity of asthma, rhinitis and eczema in the first 2 decades of the German MAS birth cohort, Thomas Keil, Hannah Gough, Linus Grabenhenrich, Dirk Schramm, Andreas Reich, John Beschorner, Antje Schuster, Carl-Peter Bauer, Johannes Forster, Fred Zepp, Young-Ae Lee, Renate Bergmann, Karl Bergmann, Ulrich Wahn, Susanne Lau, OP17 Childhood anaphylaxis: a growing concern, Filipe Benito Garcia, Inês Mota, Susana Piedade, Ângela Gaspar, Natacha Santos, Helena Pité, Mário Morais-Almeida, OP18 Indoor exposure to molds and dampness in infancy and its association to persistent atopic dermatitis in school age. Results from the Greek ISAAC II study, Athina Papadopoulou, Despina Mermiri, Elpida Xatziagorou, Ioannis Tsanakas, Stavroula Lampidi, Kostas Priftis, ORAL ABSTRACT SESSION 4: Pediatric rhinitis—immunotherapy (OP19–OP24), OP19 Associations between residential greenness and childhood allergic rhinitis and aeroallergen sensitisation in seven birth cohorts, Elaine Fuertes, Iana Markevych, Gayan Bowatte, Olena Gruzieva, Ulrike Gehring, Allan Becker, Dietrich Berdel, Michael Brauer, Chris Carlsten, Barbara Hoffmann, Anita Kozyrskyj, Caroline Lodge, Göran Pershagen, Alet Wijga, Heinrich Joachim, OP20 Full symptom control in pediatric patients with allergic rhinitis and asthma: results of a 2-year sublingual allergen immunotherapy study, Zorica Zivkovic, Ivana Djuric-Filipovic, Jasmina Jocić-Stevanovic, Snežana Zivanovic, OP21 Nasal epithelium of different ages of atopic subjects present increased levels of oxidative stress and increased cell cytotoxicity upon rhinovirus infection, Styliani Taka, Dimitra Kokkinou, Aliki Papakonstantinou, Panagiota Stefanopoulou, Anastasia Georgountzou, Paraskevi Maggina, Sofia Stamataki, Vassiliki Papaevanggelou, Evangelos Andreakos, Nikolaos G. Papadopoulos, OP22 Cluster subcutaneous immunotherapy schedule: tolerability profile in children, Monica Piquer Gibert, Montserrat Alvaro Lozano, Jaime Lozano Blasco, Olga Domínguez Sánchez, Rosa Jiménez Feijoo, Marcia Dias da Costa, Mª Teresa Giner Muñoz, Adriana Machinena Spera, Ana Maria Plaza Martín, OP23 Rhinitis as a risk factor for asthma severity in 11-year old children: population-based cohort study, Matea Deliu, Danielle Belgrave, Angela Simpson, Adnan Custovic, OP24 The Global Lung Function Initiative equations in airway obstruction evaluation of asthmatic children, João Gaspar Marques, Pedro Carreiro-Martins, Joana Belo, Sara Serranho, Isabel Peralta, Nuno Neuparth, Paula Leiria-Pinto, POSTER DISCUSSION SESSION 1: Food allergy (PD01–PD05), PD01 Allergen-specific humoral and cellular responses in children who fail egg oral immunotherapy due to allergic reactions, Marta Vazquez-Ortiz, Mariona Pascal, Ana Maria Plaza, Manel Juan, PD02 FoxP3 epigenetic features in children with cow milk allergy, Lorella Paparo, Rita Nocerino, Rosita Aitoro, Ilaria Langella, Antonio Amoroso, Alessia Amoroso, Carmen Di Scala, Roberto Berni Canani, PD04 Combined milk and egg allergy in early childhood: let them eat cake?, Santanu Maity, Giuseppina Rotiroti, Minal Gandhi, PD05 Introduction of complementary foods in relation to allergy and gut microbiota in farm and non-farm children, Karin Jonsson, Annika Ljung, Bill Hesselmar, Ingegerd Adlerbert, Hilde Brekke, Susanne Johansen, Agnes Wold, Ann-Sofie Sandberg, POSTER DISCUSSION SESSION 2: Asthma and wheeze (PD06–PD16), PD06 The association between asthma and exhaled nitric oxide is influenced by genetics and sensitisation, Björn Nordlund, Cecilia Lundholm, Villhelmina Ullemar, Marianne van Hage, Anne Örtqvist, Catarina Almqvist, PD09 Prevalence patterns of infant wheeze across Europe, Anna Selby, Kate Grimshaw, Thomas Keil, Linus Grabenhenrich, Michael Clausen, Ruta Dubakiene, Alessandro Fiocchi, Marek Kowalski, Nikos Papadopoulos, Marta Reche, Sigurveig Sigurdardottir, Aline Sprikkleman, Paraskevi Xepapadaki, Clare Mills, Kirsten Beyer, Graham Roberts, PD10 Epidemiologic changes in recurrent wheezing infants, Herberto Jose Chong Neto, Gustavo Falbo Wandalsen, Ana Carolina Dela Bianca, Carolina Aranda, Nelson Augusto Rosário, Dirceu Solé, Javier Mallol, Luis García Marcos, PD13 A single nucleotide polymorphism in the GLCCI1 gene is associated with response to asthma treatment in children, IvanaBanic, Matija Rijavec, Davor Plavec, Peter Korosec, Mirjana Turkalj, PD14 Pollen induced asthma: Could small molecules in pollen exacerbate the protein-mediated allergic response?, Alen Bozicevic, Maria De Mieri, Matthias Hamburger, PD15 A qualitative study to understand how we can empower teenagers to better self-manage their asthma, Simone Holley, Ruth Morris, Frances Mitchell, Rebecca Knibb, Susan Latter, Christina Liossi, Graham Roberts, PD16 Polymorphism of endothelial nitric oxide synthase (eNOS) gene among Egyptian children with bronchial asthma, Mostafa M. M. Hassan, POSTER DISCUSSION SESSION 3: Mechanisms—Epidemiology (PD17–PD21), PD17 Pregnancy outcomes in relation to development of allergy in a Swedish birth cohort, Malin Barman, Anna Sandin, Agnes Wold, Ann-Sofie Sandberg, PD18 Evolution of the IgE response to house dust mite molecules in childhood, Daniela Posa, Serena Perna, Carl-Peter Bauer, Ute Hoffmann, Johannes Forster, Fred Zepp, Antje Schuster, Ulrich Wahn, Thomas Keil, Susanne Lau, Kuan-Wei Chen, Yvonne Resch, Susanne Vrtala, Rudolf Valenta, Paolo Maria Matricardi, PD19 Antibody recognition of nsLTP-molecules as antigens but not as allergens in the German-MAS birth cohort, Olympia Tsilochristou, Alexander Rohrbach, Antonio Cappella, Stephanie Hofmaier, Laura Hatzler, Carl-Peter Bauer, Ute Hoffmann, Johannes Forster, Fred Zepp, Antje Schuster, RaffaeleD’Amelio, Ulrich Wahn, Thomas Keil, Susanne Lau, Paolo Maria Matricardi, PD20 Early life colonization with Lactobacilli and Staphylococcus aureus oppositely associates with the maturation and activation of FOXP3+ CD4 T-cells, Sophia Björkander, Maria A. Johansson, Gintare Lasaviciute, Eva Sverremark-Ekström, PD21 Genome-wide meta-analysis identifies 7 susceptibility loci involved in the atopic march, Ingo Marenholz, Jorge Esparza-Gordillo, Franz Rüschendorf, Anja Bauerfeind, David P. Strachan, Ben D. Spycher, Hansjörg Baurecht, Patricia Margaritte-Jeannin, Annika Sääf, Marjan Kerkhof, Markus Ege, Svetlana Baltic, Melanie C Matheson, Jin Li, Sven Michel, Wei Q. Ang, Wendy McArdle, Andreas Arnold, Georg Homuth, Florence Demenais, Emmanuelle Bouzigon, Cilla Söderhäll, Göran Pershagen, Johan C. de Jongste, Dirkje S Postma, Charlotte Braun-Fahrländer, Elisabeth Horak, Ludmila M. Ogorodova, Valery P. Puzyrev, Elena Yu Bragina, Thomas J Hudson, Charles Morin, David L Duffy, Guy B Marks, Colin F Robertson, Grant W Montgomery, Bill Musk, Philip J Thompson, Nicholas G. Martin, Alan James, Patrick Sleiman, Elina Toskala, Elke Rodriguez, Regina Fölster-Holst, Andre Franke, Wolfgang Lieb, Christian Gieger, Andrea Heinzmann, Ernst Rietschel, Thomas Keil, Sven Cichon, Markus M Nöthen, Craig E Pennell, Peter D Sly, Carsten O Schmidt, Anja Matanovic, Valentin Schneider, Matthias Heinig, Norbert Hübner, Patrick G. Holt, Susanne Lau, Michael Kabesch, Stefan Weidinger, Hakon Hakonarson, Manuel AR Ferreira, Catherine Laprise, Maxim B. Freidin, Jon Genuneit, Gerard H Koppelman, Erik Melén, Marie-Hélène Dizier, A. John Henderson, Young Ae Lee, POSTER DISCUSSION SESSION 4: Food allergy—Anaphylaxis (PD22–PD26), PD22 Atopy patch test in food protein induced enterocolitis caused by solid food, Purificacion González-Delgado, Esther Caparrós, Fernando Clemente, Begoña Cueva, Victoria M. Moreno, Jose Luis Carretero, Javier Fernández, PD23 Watermelon allergy: a novel presentation, Kate Swan, George Du Toit, PD24 A pilot study evaluating the usefulness of a guideline template for managing milk allergy in primary care, Mudiyur Gopi, Tim Smith, Edara Ramesh, Arun Sadasivam, PD26 Efficacy and safety of cow’s milk oral immunotherapy protocol, Inês Mota, Filipe Benito Garcia, Susana Piedade, Angela Gaspar, Graça Sampaio, Cristina Arêde, Luís Miguel Borrego, Graça Pires, Cristina Santa-Marta, Mário Morais-Almeida, POSTER DISCUSSION SESSION 5: Prevention and treatment—Allergy (PD27–PD36), PD27 Allergy-protection by the lactic acid bacterium Lactococcus lactis G121: mode-of-action as revealed in a murine model of experimental allergy, Stephanie Brand, Karina Stein, Holger Heine, Marion Kauth, PD29 The relationship between quality of life and morning salivary cortisol after acute bronchiolitis in infancy, Leif Bjarte Rolfsjord, Egil Bakkeheim, Johan Alm, Håvard Ove Skjerven, Kai-Håkon Carlsen, Jon Olav Hunderi, Teresa Løvold Berents, Petter Mowinckel, Karin C. Lødrup Carlsen, PD30 Randomised trial of the efficacy of MP29-02* compared with fluticasone propionate nasal spray in children aged ≥6 years to <12 years with allergic rhinitis, Ulrich Wahn, Ullrich Munzel, William Berger, PD31 10 mg of oral bilastine in 2 to 11 years old children has similar exposure to the adult therapeutic dose (20 mg), Ulrich Wahn, Román Valiente, Valvanera Vozmediano, John C. Lukas, Mónica Rodríguez, PD33 Daily symptoms, nocturnal symptoms, activity limitations and reliever therapies during the three steps of IOEASMA programme: a comparison, Sebastiano Guarnaccia, Luigi Vitale, Ada Pluda, Emanuele D’Agata, Denise Colombo, Stefano Felici, Valeria Gretter, Susanna Facchetti, Gaia Pecorelli, Cristina Quecchia, PD34 Sensitisation to an inert aeroallergen in weaning rats and longstanding disease, in a sensitisation-tolerant and easily tolerisable rodent strain, George Guibas, Evangelia Spandou, Spyridon Megremis, Peter West, Nikolaos Papadopoulos, PD35 Bacterial and fungi exposure in school and allergic sensitisation in children, João Cavaleiro Rufo, Joana Madureira, Inês Paciência, Lívia Aguiar, Patrícia Padrão, Mariana Pinto, Luís Delgado, Pedro Moreira, João Paulo Teixeira, Eduardo Oliveira Fernandes, André Moreira, PD36 Comparative study of allergy rhinitis between two populations: children vs. adults, Adriana Izquierdo Dominguez, Antonio Valero, Joaquim Mullol, Alfonso Del Cuvillo, Javier Montoro, Ignacio Jauregui, Joan Bartra, Ignacio Davila, Marta Ferrer, Joaquin Sastre, POSTER VIEWING SESSION 1: Inflammation—Genetics—Immunology—Dermatology (PP01–PP09), PP01 Immune profile in late pregnancy: immunological markers in atopic asthmaticwomen as risk factors for atopy in the progeny, Catarina Martins, Jorge Lima, Maria José Leandro, Glória Nunes, Jorge Cunha Branco, Hélder Trindade, Luis Miguel Borrego, PP02 The impact of neonatal sepsis on development of allergic diseases, Secil Conkar, Mehtap Kilic, Canan Aygun, Recep Sancak, PP03 Clinical overview of selective IgE deficiency in childhood, Athina Papadopoulou, Eleni Tagalaki, Lambros Banos, Anna Vlachou, Fotini Giannoula, Despina Mermiri, PP04 Inverse relationship between serum 25(ΟΗ) vitamin D3 and total IgE in children and adolescence, Athina Papadopoulou, Stavroula Lampidi, Marina Pavlakou, Maria Kryoni, Kostas Makris, PP05, PP06, PP07 Asthma control questionnaire and specific IgE in children, Snezhina Lazova, Guergana Petrova, Dimitrinka Miteva, Penka Perenovska, PP08 Features of chronic urticaria of adolescents, Aliya Klyucharova, Olesya Skorohodkina, PP09 Cutaneous mastocytosis in children: a clinical analysis of 8 cases in Greece, Dimitra Koumaki, Alkisti Manousaki, Maria Agrapidi, Lida Iatridou, Omima Eruk, Konstantinos Myridakis, Emmanouil Manousakis, Vasiliki Koumaki, POSTER VIEWING SESSION 2: Food allergy—Anaphylaxis (PP10–PP47), PP10 Prognostic factors in egg allergy, Maria Dimou, Maria Ingemansson, Gunilla Hedlin, PP11 Evaluation of the efficacy of an amino acid-based formula in infants who are intolerant to extensively hydrolysed protein formula, Nitida Pastor, Delphine de Boissieu, Jon Vanderhoof, Nancy Moore, Kaitlin Maditz, PP12 Anaphylaxis and epinephrine auto-injector use: a survey of pediatric trainees, Adeli Mehdi, Shaza Elhassan, Carolin Beck, Ahmed Al-Hammadi, PP13 Anaphylaxis in children: acute management in the Emergency Department, Ioana Maris, Ronan O’Sullivan, Jonathan Hourihane,, PP14 Understanding Cumbrian schools preparedness in managing children at risk of anaphylaxis in order to provide training and support which will create healthy and safe environments for children with allergies, George Raptis, Louise Michaelis, PP15 A new valid and reliable parent and child questionnaire to measure the impact of food protein enterocolitis syndrome on children: the FPIES Quality of Life Questionnaire (FPIESQL), Parent and Child Short Form, Audrey DunnGalvin, Matthew Greenhawt, Carina Venter, Jonathan Hourihane, PP16 An in-depth case study investigation of the experiences of teenagers and young adults in growing up and living with food allergy with emphasis on coping, management and risk, support, and social and self-identity, Evelyn O’Regan, Duncan Cronin, Jonathan Hourihane, Anna O’Reilly, Audrey DunnGalvin, PP17 Cow’s milk protein allergy in Constantine. A retrospective study of 62 cases between 1996 and 2013, Foued Abdelaziz, Dounia Khelifi-Touhami, Nihad Selim, Tahar Khelifi-Touhami, PP18, PP19 Cow’s milk and egg oral immunotherapy in children older than 5 years, Pablo Merida, Ana Mª Plaza, Juan Heber Castellanos, Adrianna Machinena, Montserrat Alvaro Lozano, Jaime Lozano, Olga Dominguez, Monica Piquer, Rosa Jimenez, Mª Teresa Giner, PP20 Professionals’ awareness of management of Cow’s Milk Protein Allergy (CMPA) in North Wales Hospitals, Konstantinos Kakleas, Manohar Joishy, Wendmu Maskele, Huw R. Jenkins, PP21, PP22 Anaphylaxis: the great unknown for teachers. Presentation of a protocol for schools, Mercedes Escarrer, Agustín Madroñero, Maria Teresa Guerra, Juan Carlos Julia, Juan Carlos Cerda, Javier Contreras, Eulalia Tauler, Maria Jesus Vidorreta, Ana Rojo, Silvia Del Valle, PP23 Challenges facing children with food allergies and their parents in out of school activity sectors, Niamh Flynn, PP24 A review of food challenges at a Regional Irish Centre, Gary Foley, Carol Harmon, John Fitzsimons, PP25 The use of epinephrine in infants with anaphylaxis, Krasimira Baynova, Ávila Maria Del Robledo, Labella Marina, PP26, PP27, PP28 Mother’s psychological state predicts the expression of symptoms in food allergic children, Aaron Cortes, Alicia Sciaraffia, Angela Castillo, PP29 The correlation between sIgE towards tree nuts and birch pollen in a Danish Pediatric Allergy Clinic, Nanna Juel-Berg, Kirsten Skamstrup Hansen, Lars Kærgaard Poulsen, PP30 Food allergy in children: evaluation of parents’ use of online social media, Andreia Florina Nita, Ioana Valentina Nenciu, Adina Lazar, Dumitru Oraseanu, PP31 The impact of food allergy on quality of life: FAQLQ questionnaire, Rita Aguiar, Anabela Lopes, Maria J. Paes, Amélia S. Santos, M. A. Pereira-Barbosa, PP32 An unexpected cause of anaphylaxis: potato, Hatice Eke Gungor, Salih Uytun, Umit Murat Sahiner, Yasemin Altuner Torun, PP33 Is it clinical phenotype of allergic diseases determined by sensitisation to food?, Mirjana Zivanovic, Marina Atanasković-Marković, PP34, PP35 Prescribing adrenaline auto-injectors in children in 2014: the data from regional pediatricians, Tina Vesel, Mihaela Nahtigal, Andreja Obermayer-Temlin, Eva Šoster Križnik, Mirjana Maslar, Ruben Bizjak, Marjeta Tomšič-Matic, Sonja Posega-Devetak, Maja Skerbinjek-Kavalar, Mateja Predalič, Tadej Avčin, PP36 Who should have an adrenaline autoinjector? Adherence to the European and French guidelines among 121 allergists from the Allergy Vigilance Network, Guillaume Pouessel, Etienne Beaudouin, Anne M. Moneret-Vautrin, Antoine Deschildre, Allergy Vigilance Network, PP37 Anaphylaxis by Anacardium Occidentale, Marta Viñas, Bartolomé Borja, Nora Hernández, Mª José Castillo, Adriana Izquierdo, Marcel Ibero, PP38 Anaphylaxis with honey in a child, S. Tolga Yavuz, Ali Gungor, Betul Buyuktiryaki, Ozan Koc, Can Naci Kocabas, Faysal Gok, PP39 Evaluation of courses adopted to children on prevention, recognition and management of anaphylaxis, Tina Vesel, Mihaela Nahtigal, PP40 Symptomatic dust mites and shrimp allergy: three pediatric case reports, Filipa Almeida, Susana Lopes, Cristina Madureira, Tânia Lopes, Fernanda Carvalho, PP41 Poor identification rates of nuts by high risk individuals: a call for improved education and support for families, Camille Heming, Emily Garrett, Adam Blackstock, Santanu Maity, Rahul Chodhari, PP42 DAFALL: database of food allergies in the Czech Republic, Simona Belohlavkova, Eliska Kopelentova, Petr Visek, Ivana Setinova, Ivana Svarcova, PP43 Serological cross-reactivity between grass and wheat is not only caused by profilins and CCDs, Sigrid Sjölander, Nora Nilsson, Malin Berthold, Helena Ekoff, Gunilla Hedlin, Magnus Borres, Caroline Nilsson, PP44 Oil body associated proteins in children with nuts allergy. Allergens to consider in IgE-mediated nuts allergy, Loreto González Domínguez, Cristina Muñoz Archidona, Ana Moreira Jorge, Sergio Quevedo Teruel, Teresa Bracamonte Bermejo, Miriam Castillo Fernández, Fernando Pineda de la Losa, Luis Ángel Echeverría Zudaire, PP45, PP46 Protective effect of helicobacter pylori infection against food allergy in children, Olga Vrani, Antigone Mavroudi, Maria Fotoulaki, Maria Emporiadou, Kleomenis Spiroglou, Ioannis Xinias, PP47 Anaphylaxis pathway: A road tryp-tase to success?, Helyeh A. Sadreddini, Mia Warnes, Donna Traves, POSTER VIEWING SESSION 3: Miscell
Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries
© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 licenseBackground: 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods: This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov, NCT03471494. Findings: Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation: Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding: National Institute for Health Research Global Health Research Unit
Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p<0·0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63·0% vs 82·7%; OR 0·35 [0·23–0·53]; p<0·0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer. Interpretation: Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised. Funding: National Institute for Health and Care Research