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1.  Proceedings of the 3rd IPLeiria’s International Health Congress 
Tomás, Catarina Cardoso | Oliveira, Emanuel | Sousa, D. | Uba-Chupel, M. | Furtado, G. | Rocha, C. | Teixeira, A. | Ferreira, P. | Alves, Celeste | Gisin, Stefan | Catarino, Elisabete | Carvalho, Nelma | Coucelo, Tiago | Bonfim, Luís | Silva, Carina | Franco, Débora | González, Jesús Alcoba | Jardim, Helena G. | Silva, Rita | Baixinho, Cristina L. | Presado, Mª Helena | Marques, Mª Fátima | Cardoso, Mário E. | Cunha, Marina | Mendes, Joana | Xavier, Ana | Galhardo, Ana | Couto, Margarida | Frade, João G. | Nunes, Carla | Mesquita, João R. | Nascimento, Maria S. | Gonçalves, Guilherme | Castro, Conceição | Mártires, Alice | Monteiro, Mª João | Rainho, Conceição | Caballero, Francisco P. | Monago, Fatima M. | Guerrero, Jose T. | Monago, Rocio M. | Trigo, Africa P. | Gutierrez, Milagros L. | Milanés, Gemma M. | Reina, Mercedes G. | Villanueva, Ana G. | Piñero, Ana S. | Aliseda, Isabel R. | Ramirez, Francisco B. | Ribeiro, Andrea | Quelhas, Ana | Manso, Conceição | Caballero, Francisco P. | Guerrero, Jose T. | Monago, Fatima M. | Santos, Rafael B. | Jimenez, Nuria R. | Nuñez, Cristina G. | Gomez, Inmaculada R. | Fernandez, Mª Jose L. | Marquez, Laura A. | Moreno, Ana L. | Huertas, Mª Jesus Tena | Ramirez, Francisco B. | Seabra, Daniel | Salvador, Mª Céu | Braga, Luciene | Parreira, Pedro | Salgueiro-Oliveira, Anabela | Arreguy-Sena, Cristina | Oliveira, Bibiana F. | Henriques, Mª Adriana | Santos, Joana | Lebre, Sara | Marques, Alda | Festas, Clarinda | Rodrigues, Sandra | Ribeiro, Andrea | Lumini, José | Figueiredo, Ana G. | Hernandez-Martinez, Francisco J. | Campi, Liliana | Quintana-Montesdeoca, Mª Pino | Jimenez-Diaz, Juan F. | Rodriguez-De-Vera, Bienvenida C. | Parente, Alexandra | Mata, Mª Augusta | Pereira, Ana Mª | Fernandes, Adília | Brás, Manuel | Pinto, Mª Rosário | Parreira, Pedro | Basto, Marta L. | Rei, Ana C. | Mónico, Lisete M. | Sousa, Gilberta | Morna, Clementina | Freitas, Otília | Freitas, Gregório | Jardim, Ana | Vasconcelos, Rita | Horta, Lina G. | Rosa, Roger S. | Kranz, Luís F. | Nugem, Rita C. | Siqueira, Mariana S. | Bordin, Ronaldo | Kniess, Rosiane | Lacerda, Josimari T. | Guedes, Joana | Machado, Idalina | Almeida, Sidalina | Zilhão, Adriano | Alves, Helder | Ribeiro, Óscar | Amaral, Ana P. | Santos, Ana | Monteiro, Joana | Rocha, Mª Clara | Cruz, Rui | Amaral, Ana P. | Lourenço, Marina | Rocha, Mª Clara | Cruz, Rui | Antunes, Sandra | Mendonça, Verónica | Andrade, Isabel | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Cabral, Lídia | Ferreira, Manuela | Gonçalves, Amadeu | Luz, Tatiana D. | Luz, Leonardo | Martins, Raul | Morgado, Alice | Vale-Dias, Maria L. | Porta-Nova, Rui | Fleig, Tânia C. | Reuter, Éboni M. | Froemming, Miriam B. | Guerreiro, Sabrina L. | Carvalho, Lisiane L. | Guedelha, Daniel | Coelho, P. | Pereira, A. | Calha, António | Cordeiro, Raul | Gonçalves, Ana | Certo, Ana | Galvão, Ana | Mata, Mª Augusta | Welter, Aline | Pereira, Elayne | Ribeiro, Sandra | Kretzer, Marcia | Jiménez-Díaz, Juan-Fernando | Jiménez-Rodríguez, Carla | Hernández-Martínez, Francisco-José | Rodríguez-De-Vera, Bienvenida-Del-Carmen | Marques-Rodrigues, Alexandre | Coelho, Patrícia | Bernardes, Tiago | Pereira, Alexandre | Sousa, Patrícia | Filho, João G. | Nazario, Nazare | Kretzer, Marcia | Amaral, Odete | Garrido, António | Veiga, Nélio | Nunes, Carla | Pedro, Ana R. | Pereira, Carlos | Almeia, António | Fernandes, Helder M. | Vasconcelos, Carlos | Sousa, Nelson | Reis, Victor M. | Monteiro, M. João | Mendes, Romeu | Pinto, Isabel C. | Pires, Tânia | Gama, João | Preto, Vera | Silva, Norberto | Magalhães, Carlos | Martins, Matilde | Duarte, Mafalda | Paúl, Constança | Martín, Ignácio | Pinheiro, Arminda A. | Xavier, Sandra | Azevedo, Julieta | Bento, Elisabete | Marques, Cristiana | Marques, Mariana | Macedo, António | Pereira, Ana T. | Almeida, José P. | Almeida, António | Alves, Josiane | Sousa, Nelson | Saavedra, Francisco | Mendes, Romeu | Maia, Ana S. | Oliveira, Michelle T. | Sousa, Anderson R. | Ferreira, Paulo P. | Lopes, Luci S. | Santiago, Eujcely C. | Monteiro, Sílvia | Jesus, Ângelo | Colaço, Armanda | Carvalho, António | Silva, Rita P. | Cruz, Agostinho | Ferreira, Ana | Marques, Catarina | Figueiredo, João P. | Paixão, Susana | Ferreira, Ana | Lopes, Carla | Moreira, Fernando | Figueiredo, João P. | Ferreira, Ana | Ribeiro, Diana | Moreira, Fernando | Figueiredo, João P. | Paixão, Susana | Fernandes, Telma | Amado, Diogo | Leal, Jéssica | Azevedo, Marcelo | Ramalho, Sónia | Mangas, Catarina | Ribeiro, Jaime | Gonçalves, Rita | Nunes, Amélia F | Tuna, Ana R. | Martins, Carlos R. | Forte, Henriqueta D. | Costa, Cláudia | Tenedório, José A. | Santana, Paula | Andrade, J. A. | Pinto, J. L. | Campofiorito, C. | Nunes, S. | Carmo, A. | Kaliniczenco, A. | Alves, B. | Mendes, F. | Jesus, C. | Fonseca, F. | Gehrke, F. | Albuquerque, Carlos | Batista, Rita | Cunha, Madalena | Madureira, António | Ribeiro, Olivério | Martins, Rosa | Madeira, Teresa | Peixoto-Plácido, Catarina | Santos, Nuno | Santos, Osvaldo | Bergland, Astrid | Bye, Asta | Lopes, Carla | Alarcão, Violeta | Goulão, Beatriz | Mendonça, Nuno | Nicola, Paulo | Clara, João G. | Gomes, João | Querido, Ana | Tomás, Catarina | Carvalho, Daniel | Cordeiro, Marina | Rosa, Marlene C. | Marques, Alda | Brandão, Daniela | Ribeiro, Óscar | Araújo, Lia | Paúl, Constança | Minghelli, Beatriz | Richaud, Sylvina | Mendes, Ana L. | Marta-Simões, Joana | Trindade, Inês A. | Ferreira, Cláudia | Carvalho, Teresa | Cunha, Marina | Pinto-Gouveia, José | Fernandes, Morgana C. | Rosa, Roger S. | Nugem, Rita C. | Kranz, Luís F. | Siqueira, Mariana S. | Bordin, Ronaldo | Martins, Anabela C. | Medeiros, Anabela | Pimentel, Rafaela | Fernandes, Andreia | Mendonça, Carlos | Andrade, Isabel | Andrade, Susana | Menezes, Ruth L. | Bravo, Rafael | Miranda, Marta | Ugartemendia, Lierni | Tena, José Mª | Pérez-Caballero, Francisco L. | Fuentes-Broto, Lorena | Rodríguez, Ana B. | Carmen, Barriga | Carneiro, M. A. | Domingues, J. N. | Paixão, S. | Figueiredo, J. | Nascimento, V. B. | Jesus, C. | Mendes, F | Gehrke, F. | Alves, B. | Azzalis, L. | Fonseca, F. | Martins, Ana R. | Nunes, Amélia | Jorge, Arminda | Veiga, Nélio | Amorim, Ana | Silva, André | Martinho, Liliana | Monteiro, Luís | Silva, Rafael | Coelho, Carina | Amaral, Odete | Coelho, Inês | Pereira, Carlos | Correia, André | Rodrigues, Diana | Marante, Nídia | Silva, Pedro | Carvalho, Sara | Araujo, André Rts | Ribeiro, Maximiano | Coutinho, Paula | Ventura, Sandra | Roque, Fátima | Calvo, Cristina | Reses, Manoela | Conde, Jorge | Ferreira, Ana | Figueiredo, João | Silva, David | Seiça, Luís | Soares, Raquel | Mourão, Ricardo | Kraus, Teresa | Abreu, Ana C. | Padilha, José M. | Alves, Júlia M. | Sousa, Paulino | Oliveira, Manuel | Sousa, Joana | Novais, Sónia | Mendes, Felismina | Pinto, Joana | Cruz, Joana | Marques, Alda | Duarte, Hugo | Dixe, Maria Dos Anjos | Sousa, Pedro | Cruz, Inês | Bastos, Fernanda | Pereira, Filipe | Carvalho, Francisco L. | Oliveira, Teresa T. | Raposo, Vítor R. | Rainho, Conceição | Ribeiro, José C. | Barroso, Isabel | Rodrigues, Vítor | Neves, Carmo | Oliveira, Teresa C. | Oliveira, Bárbara | Morais, Mª Carminda | Baylina, Pilar | Rodrigues, Rogério | Azeredo, Zaida | Vicente, Corália | Dias, Hélia | Sim-Sim, Margarida | Parreira, Pedro | Salgueiro-Oliveira, Anabela | Castilho, Amélia | Melo, Rosa | Graveto, João | Gomes, José | Vaquinhas, Marina | Carvalho, Carla | Mónico, Lisete | Brito, Nuno | Sarroeira, Cassilda | Amendoeira, José | Cunha, Fátima | Cândido, Anabela | Fernandes, Patrícia | Silva, Helena R. | Silva, Elsa | Barroso, Isabel | Lapa, Leila | Antunes, Cristina | Gonçalves, Ana | Galvão, Ana | Gomes, Mª José | Escanciano, Susana R. | Freitas, Maria | Parreira, Pedro | Marôco, João | Fernandes, Ana R. | Cabral, Cremilde | Alves, Samuel | Sousa, Pedro | Ferreira, António | Príncipe, Fernanda | Seppänen, Ulla-Maija | Ferreira, Margarida | Carvalhais, Maribel | Silva, Marilene | Ferreira, Manuela | Silva, Joana | Neves, Jéssica | Costa, Diana | Santos, Bruno | Duarte, Soraia | Marques, Sílvia | Ramalho, Sónia | Mendes, Isabel | Louro, Clarisse | Menino, Eva | Dixe, Maria | Dias, Sara S. | Cordeiro, Marina | Tomás, Catarina | Querido, Ana | Carvalho, Daniel | Gomes, João | Valim, Frederico C. | Costa, Joyce O. | Bernardes, Lúcia G. | Prebianchi, Helena | Rosa, Marlene Cristina | Gonçalves, Narcisa | Martins, Maria M. | Kurcgant, Paulina | Vieira, André | Bento, Sandrina | Deodato, Sérgio | Rabiais, Isabel | Reis, Laura | Torres, Ana | Soares, Sérgio | Ferreira, Margarida | Graça, Pedro | Leitão, Céu | Abreu, Renato | Bellém, Fernando | Almeida, Ana | Ribeiro-Varandas, Edna | Tavares, Ana | Frade, João G. | Henriques, Carolina | Menino, Eva | Louro, Clarisse | Jordão, Célia | Neco, Sofia | Morais, Carminda | Ferreira, Pedro | Silva, Carla R. | Brito, Alice | Silva, Antónia | Duarte, Hugo | Dixe, Maria Dos Anjos | Sousa, Pedro | Postolache, Gabriela | Oliveira, Raul | Moreira, Isabel | Pedro, Luísa | Vicente, Sónia | Domingos, Samuel | Postolache, Octavian | Silva, Darlen | Filho, João G. | Nazario, Nazare | Kretzer, Marcia | Schneider, Dulcineia | Marques, Fátima M. | Parreira, Pedro | Carvalho, Carla | Mónico, Lisete M. | Pinto, Carlos | Vicente, Sara | Breda, São João | Gomes, José H. | Melo, Rosa | Parreira, Pedro | Salgueiro, Anabela | Graveto, João | Vaquinhas, Marina | Castilho, Amélia | Jesus, Ângelo | Duarte, Nuno | Lopes, José C. | Nunes, Hélder | Cruz, Agostinho | Salgueiro-Oliveira, Anabela | Parreira, Pedro | Basto, Marta L. | Braga, Luciene M. | Ferreira, António | Araújo, Beatriz | Alves, José M. | Ferreira, Margarida | Carvalhais, Maribel | Silva, Marilene | Novais, Sónia | Sousa, Ana S. | Ferrito, Cândida | Ferreira, Pedro L. | Rodrigues, Alexandre | Ferreira, Margarida | Oliveira, Isabel | Ferreira, Manuela | Neves, Jéssica | Costa, Diana | Duarte, Soraia | Silva, Joana | Santos, Bruno | Martins, Cristina | Macedo, Ana P. | Araújo, Odete | Augusto, Cláudia | Braga, Fátima | Gomes, Lisa | Silva, Maria A. | Rosário, Rafaela | Pimenta, Luís | Carreira, Diana | Teles, Patrícia | Barros, Teresa | Tomás, Catarina | Querido, Ana | Carvalho, Daniel | Gomes, João | Cordeiro, Marina | Carvalho, Daniel | Querido, Ana | Tomás, Catarina | Gomes, João | Cordeiro, Marina | Jácome, Cristina | Marques, Alda | Capelas, Sylvie | Hall, Andreia | Alves, Dina | Lousada, Marisa | Loureiro, Mª Helena | Camarneiro, Ana | Silva, Margarida | Mendes, Aida | Pedreiro, Ana | G.Silva, Anne | Coelho, Elza S. | Melo, Flávio | Ribeiro, Fernando | Torres, Rui | Costa, Rui | Pinho, Tânia | Jácome, Cristina | Marques, Alda | Cruz, Bárbara | Seabra, Daniel | Carreiras, Diogo | Ventura, Maria | Cruz, x | Brooks, Dina | Marques, Alda | Pinto, M Rosário | Parreira, Pedro | Lima-Basto, Marta | Neves, Miguel | Mónico, Lisete M. | Bizarro, Carla | Cunha, Marina | Galhardo, Ana | Margarida, Couto | Amorim, Ana P. | Silva, Eduardo | Cruz, Susana | Padilha, José M. | Valente, Jorge | Guerrero, José T. | Caballero, Francisco P. | Santos, Rafael B. | Gonzalez, Estefania P. | Monago, Fátima M. | Ugalde, Lierni U. | Vélez, Marta M. | Tena, Maria J. | Guerrero, José T. | Bravo, Rafael | Pérez-Caballero, Francisco L. | Becerra, Isabel A. | Agudelo, Mª Elizabeth | Acedo, Guadalupe | Bajo, Roberto | Malheiro, Isabel | Gaspar, Filomena | Barros, Luísa | Furtado, Guilherme | Uba-Chupel, Mateus | Marques, Mariana | Rama, Luís | Braga, Margarida | Ferreira, José P. | Teixeira, Ana Mª | Cruz, João | Barbosa, Tiago | Simões, Ângela | Coelho, Luís | Rodrigues, Alexandre | Jiménez-Díaz, Juan-Fernando | Martinez-Hernandez, Francisco | Rodriguez-De-Vera, Bienvenida | Ferreira, Pedro | Rodrigues, Alexandrina | Ramalho, André | Petrica, João | Mendes, Pedro | Serrano, João | Santo, Inês | Rosado, António | Mendonça, Paula | Freitas, Kátia | Ferreira, Dora | Brito, António | Fernandes, Renato | Gomes, Sofia | Moreira, Fernando | Pinho, Cláudia | Oliveira, Rita | Oliveira, Ana I. | Mendonça, Paula | Casimiro, Ana P. | Martins, Patrícia | Silva, Iryna | Evangelista, Diana | Leitão, Catarina | Velosa, Fábia | Carecho, Nélio | Coelho, Luís | Menino, Eva | Dixe, Anjos | Catarino, Helena | Soares, Fátima | Gama, Ester | Gordo, Clementina | Moreira, Eliana | Midões, Cristiana | Santos, Marlene | Machado, Sara | Oliveira, Vânia P. | Santos, Marlene | Querido, Ana | Dixe, Anjos | Marques, Rita | Charepe, Zaida | Antunes, Ana | Santos, Sofia | Rosa, Marlene C. | Rosa, Marlene C. | Marques, Silvana F. | Minghelli, Beatriz | CaroMinghelli, Eulália | Luís, Mª José | Brandão, Teresa | Mendes, Pedro | Marinho, Daniel | Petrica, João | Monteiro, Diogo | Paulo, Rui | Serrano, João | Santo, Inês | Monteiro, Lina | Ramalho, Fátima | Santos-Rocha, Rita | Morgado, Sónia | Bento, Teresa | Sousa, Gilberta | Freitas, Otília | Silva, Isabel | Freitas, Gregório | Morna, Clementina | Vasconcelos, Rita | Azevedo, Tatiana | Soares, Salete | Pisco, Jacinta | Ferreira, Paulo P. | Olszewer, Efrain O. | Oliveira, Michelle T. | Sousa, Anderson R. | Maia, Ana S. | Oliveira, Sebastião T. | Santos, Erica | Oliveira, Ana I. | Maia, Carla | Moreira, Fernando | Santos, Joana | Mendes, Maria F. | Oliveira, Rita F. | Pinho, Cláudia | Barreira, Eduarda | Pereira, Ana | Vaz, Josiana A. | Novo, André | Silva, Luís D. | Maia, Bruno | Ferreira, Eduardo | Pires, Filipa | Andrade, Renato | Camarinha, Luís | Silva, Luís D. | Maia, Bruno | Ferreira, Eduardo | Pires, Filipa | Andrade, Renato | Camarinha, Luís | César, Ana F. | Poço, Mariana | Ventura, David | Loura, Raquel | Gomes, Pedro | Gomes, Catarina | Silva, Cláudia | Melo, Elsa | Lindo, João | Domingos, Joana | Mendes, Zaida | Poeta, Susana | Carvalho, Tiago | Tomás, Catarina | Catarino, Helena | Dixe, Mª Anjos | Ramalho, André | Rosado, António | Mendes, Pedro | Paulo, Rui | Garcia, Inês | Petrica, João | Rodrigues, Sandra | Meneses, Rui | Afonso, Carlos | Faria, Luís | Seixas, Adérito | Cordeiro, Marina | Granjo, Paulo | Gomes, José C. | Souza, Nelba R. | Furtado, Guilherme E. | Rocha, Saulo V. | Silva, Paula | Carvalho, Joana | Morais, Marina Ana | Santos, Sofia | Lebre, Paula | Antunes, Ana | Calha, António | Xavier, Ana | Cunha, Marina | Pinto-Gouveia, José | Alencar, Liana | Cunha, Madalena | Madureira, António | Cardoso, Ilda | Galhardo, Ana | Daniel, Fernanda | Rodrigues, Vítor | Luz, Leonardo | Luz, Tatiana | Ramos, Maurício R. | Medeiros, Dayse C. | Carmo, Bruno M. | Seabra, André | Padez, Cristina | Silva, Manuel C. | Rodrigues, António | Coelho, Patrícia | Coelho, Alexandre | Caminha, Madson | Matheus, Filipe | Mendes, Elenice | Correia, Jony | Kretzer, Marcia | Hernandez-Martinez, Francisco J. | Jimenez-Diaz, Juan F. | Rodriguez-De-Vera, Bienvendida C. | Jimenez-Rodriguez, Carla | Armas-Gonzalez, Yadira | Rodrigues, Cátia | Pedroso, Rosa | Apolinário-Hagen, Jennifer | Vehreschild, Viktor | Veloso, Milene | Magalhães, Celina | Cabral, Isabel | Ferraz, Maira | Nave, Filipe | Costa, Emília | Matos, Filomena | Pacheco, José | Dias, António | Pereira, Carlos | Duarte, João | Cunha, Madalena | Silva, Daniel | Mónico, Lisete M. | Alferes, Valentim R. | Brêda, Mª São João | Carvalho, Carla | Parreira, Pedro M. | Morais, Mª Carminda | Ferreira, Pedro | Pimenta, Rui | Boavida, José | Pinto, Isabel C. | Pires, Tânia | Silva, Catarina | Ribeiro, Maria | Viega-Branco, Maria | Pereira, Filomena | Pereira, Ana Mª | Almeida, Fabrícia M. | Estevez, Gustavo L. | Ribeiro, Sandra | Kretzer, Marcia R. | João, Paulo V. | Nogueira, Paulo | Novais, Sandra | Pereira, Ana | Carneiro, Lara | Mota, Maria | Cruz, Rui | Santiago, Luiz | Fontes-Ribeiro, Carlos | Furtado, Guilherme | Rocha, Saulo V. | Coutinho, André P. | Neto, João S. | Vasconcelos, Lélia R. | Souza, Nelba R. | Dantas, Estélio | Dinis, Alexandra | Carvalho, Sérgio | Castilho, Paula | Pinto-Gouveia, José | Sarreira-Santos, Alexandra | Figueiredo, Amélia | Medeiros-Garcia, Lurdes | Seabra, Paulo | Rodrigues, Rosa | Morais, Mª Carminda | Fernandes, Paula O. | Santiago, Conceição | Figueiredo, Mª Henriqueta | Basto, Marta L. | Guimarães, Teresa | Coelho, André | Graça, Anabela | Silva, Ana M. | Fonseca, Ana R. | Vale-Dias, Luz | Minas, Bárbara | Franco-Borges, Graciete | Simões, Cristina | Santos, Sofia | Serra, Ana | Matos, Maria | Jesus, Luís | Tavares, Ana S. | Almeida, Ana | Leitão, Céu | Varandas, Edna | Abreu, Renato | Bellém, Fernando | Trindade, Inês A. | Ferreira, Cláudia | Pinto-Gouveia, José | Marta-Simões, Joana | Amaral, Odete | Miranda, Cristiana | Guimarães, Pedro | Gonçalves, Rodrigo | Veiga, Nélio | Pereira, Carlos | Fleig, Tânia C. | San-Martin, Elisabete A. | Goulart, Cássia L. | Schneiders, Paloma B. | Miranda, Natacha F. | Carvalho, Lisiane L. | Silva, Andrea G. | Topa, Joana | Nogueira, Conceição | Neves, Sofia | Ventura, Rita | Nazaré, Cristina | Brandão, Daniela | Freitas, Alberto | Ribeiro, Óscar | Paúl, Constança | Mercê, Cristiana | Branco, Marco | Almeida, Pedro | Nascimento, Daniela | Pereira, Juliana | Catela, David | Rafael, Helga | Reis, Alcinda C. | Mendes, Ana | Valente, Ana R. | Lousada, Marisa | Sousa, Diana | Baltazar, Ana L. | Loureiro, Mª Helena | Oliveira, Ana | Aparício, José | Marques, Alda | Marques, Alda | Oliveira, Ana | Neves, Joana | Ayoub, Rodrigo | Sousa, Luís | Marques-Vieira, Cristina | Severino, Sandy | José, Helena | Cadorio, Inês | Lousada, Marisa | Cunha, Marina | Andrade, Diogo | Galhardo, Ana | Couto, Margarida | Mendes, Fernando | Domingues, Cátia | Schukg, Susann | Abrantes, Ana M. | Gonçalves, Ana C. | Sales, Tiago | Teixo, Ricardo | Silva, Rita | Estrela, Jéssica | Laranjo, Mafalda | Casalta-Lopes, João | Rocha, Clara | Simões, Paulo C. | Sarmento-Ribeiro, Ana B. | Botelho, Mª Filomena | Rosa, Manuel S. | Fonseca, Virgínia | Colaço, Diogo | Neves, Vanessa | Jesus, Carlos | Hesse, Camilla | Rocha, Clara | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Svensson, Lola | Mendes, Fernando | Siba, Wafa A. | Pereira, Cristina | Tomaz, Jorge | Carvalho, Teresa | Pinto-Gouveia, José | Cunha, Marina | Duarte, Diana | Lopes, Nuno V. | Fonseca-Pinto, Rui | Duarte, Diana | Lopes, Nuno V. | Fonseca-Pinto, Rui | Martins, Anabela C. | Brandão, Piedade | Martins, Laura | Cardoso, Margarida | Morais, Nuno | Cruz, Joana | Alves, Nuno | Faria, Paula | Mateus, Artur | Morouço, Pedro | Alves, Nuno | Ferreira, Nelson | Mateus, Artur | Faria, Paula | Morouço, Pedro | Malheiro, Isabel | Gaspar, Filomena | Barros, Luísa | Parreira, Pedro | Cardoso, Andreia | Mónico, Lisete | Carvalho, Carla | Lopes, Albino | Salgueiro-Oliveira, Anabela | Seixas, Adérito | Soares, Valter | Dias, Tiago | Vardasca, Ricardo | Gabriel, Joaquim | Rodrigues, Sandra | Paredes, Hugo | Reis, Arsénio | Marinho, Sara | Filipe, Vítor | Lains, Jorge | Barroso, João | Da Motta, Carolina | Carvalho, Célia B. | Pinto-Gouveia, José | Peixoto, Ermelindo | Gomes, Ana A. | Costa, Vanessa | Couto, Diana | Marques, Daniel R. | Leitão, José A. | Tavares, José | Azevedo, Maria H. | Silva, Carlos F. | Freitas, João | Parreira, Pedro | Marôco, João | Garcia-Gordillo, Miguel A. | Collado-Mateo, Daniel | Chen, Gang | Iezzi, Angelo | Sala, José A. | Parraça, José A. | Gusi, Narcis | Sousa, Jani | Marques, Mariana | Jardim, Jacinto | Pereira, Anabela | Simões, Sónia | Cunha, Marina | Sardo, Pedro | Guedes, Jenifer | Lindo, João | Machado, Paulo | Melo, Elsa | Carvalho, Célia B. | Benevides, Joana | Sousa, Marina | Cabral, Joana | Da Motta, Carolina | Pereira, Ana T. | Xavier, Sandra | Azevedo, Julieta | Bento, Elisabete | Marques, Cristiana | Carvalho, Rosa | Marques, Mariana | Macedo, António | Silva, Ana M. | Alves, Juliana | Gomes, Ana A. | Marques, Daniel R. | Azevedo, Mª Helena | Silva, Carlos | Mendes, Ana | Lee, Huei D. | Spolaôr, Newton | Oliva, Jefferson T. | Chung, Wu F. | Fonseca-Pinto, Rui | Bairros, Keila | Silva, Cláudia D. | Souza, Clóvis A. | Schroeder, Silvana S. | Araújo, Elsa | Monteiro, Helena | Costa, Ricardo | Dias, Sara S. | Torgal, Jorge | Henriques, Carolina G. | Santos, Luísa | Caceiro, Elisa F. | Ramalho, Sónia A. | Oliveira, Rita | Afreixo, Vera | Santos, João | Mota, Priscilla | Cruz, Agostinho | Pimentel, Francisco | Marques, Rita | Dixe, Mª Anjos | Querido, Ana | Sousa, Patrícia | Benevides, Joana | Da Motta, Carolina | Sousa, Marina | Caldeira, Suzana N. | Carvalho, Célia B. | Querido, Ana | Tomás, Catarina | Carvalho, Daniel | Gomes, João | Cordeiro, Marina | Costa, Joyce O. | Valim, Frederico C. | Ribeiro, Lígia C. | Charepe, Zaida | Querido, Ana | Figueiredo, Mª Henriqueta | Aquino, Priscila S. | Ribeiro, Samila G. | Pinheiro, Ana B. | Lessa, Paula A. | Oliveira, Mirna F. | Brito, Luísa S. | Pinto, Ítalo N. | Furtado, Alessandra S. | Castro, Régia B. | Aquino, Caroline Q. | Martins, Eveliny S. | Pinheiro, Ana B | Aquino, Priscila S. | Oliveira, Lara L. | Pinheiro, Patrícia C. | Sousa, Caroline R. | Freitas, Vívien A. | Silva, Tatiane M. | Lima, Adman S. | Aquino, Caroline Q. | Andrade, Karizia V. | Oliveira, Camila A. | Vidal, Eglidia F. | Ganho-Ávila, Ana | Moura-Ramos, Mariana | Gonçalves, Óscar | Almeida, Jorge | Silva, Armando | Brito, Irma | Amado, João | Rodrigo, António | Santos, Sofia | Gomes, Fernando | Rosa, Marlene C. | Marques, Silvana F. | Luís, Sara | Cavalheiro, Luís | Ferreira, Pedro | Gonçalves, Rui | Lopes, Rui S. | Cavalheiro, Luís | Ferreira, Pedro | Gonçalves, Rui | Fiorin, Bruno H. | Santos, Marina S. | Oliveira, Edmar S. | Moreira, Rita L. | Oliveira, Elizabete A. | Filho, Braulio L. | Palmeira, Lara | Garcia, Teresa | Pinto-Gouveia, José | Cunha, Marina | Cardoso, Sara | Palmeira, Lara | Cunha, Marina | Pinto-Gouveia, José | Marta-Simões, Joana | Mendes, Ana L. | Trindade, Inês A. | Oliveira, Sara | Ferreira, Cláudia | Mendes, Ana L. | Marta-Simões, Joana | Trindade, Inês A. | Ferreira, Cláudia | Nave, Filipe | Campos, Mariana | Gaudêncio, Iris | Martins, Fernando | Ferreira, Lino | Lopes, Nuno | Fonseca-Pinto, Rui | Rodrigues, Rogério | Azeredo, Zaida | Vicente, Corália | Silva, Joana | Sousa, Patrícia | Marques, Rita | Mendes, Isabel | Rodrigues, Rogério | Azeredo, Zaida | Vicente, Corália | Vardasca, Ricardo | Marques, Ana R. | Seixas, Adérito | Carvalho, Rui | Gabriel, Joaquim | Ferreira, Paulo P. | Oliveira, Michelle T. | Sousa, Anderson R. | Maia, Ana S. | Oliveira, Sebastião T. | Costa, Pablo O. | Silva, Maiza M. | Arreguy-Sena, Cristina | Alvarenga-Martins, Nathália | Pinto, Paulo F. | Oliveira, Denize C. | Parreira, Pedro D. | Gomes, Antônio T. | Braga, Luciene M. | Araújo, Odete | Lage, Isabel | Cabrita, José | Teixeira, Laetitia | Marques, Rita | Dixe, Mª Anjos | Querido, Ana | Sousa, Patrícia | Silva, Sara | Cordeiro, Eugénio | Pimentel, João | Ferro-Lebres, Vera | Souza, Juliana A. | Tavares, Mariline | Dixe, Mª Anjos | Sousa, Pedro | Passadouro, Rui | Peralta, Teresa | Ferreira, Carlos | Lourenço, Georgina | Serrano, João | Petrica, João | Paulo, Rui | Honório, Samuel | Mendes, Pedro | Simões, Alexandra | Carvalho, Lucinda | Pereira, Alexandre | Silva, Sara | Sousa, Paulino | Padilha, José M. | Figueiredo, Daniela | Valente, Carolina | Marques, Alda | Ribas, Patrícia | Sousa, Joana | Brandão, Frederico | Sousa, Cesar | Martins, Matilde | Sousa, Patrícia | Marques, Rita | Mendes, Francisco | Fernandes, Rosina | Martins, Emília | Magalhães, Cátia | Araújo, Patrícia | Grande, Carla | Mata, Mª Augusta | Vieitez, Juan G. | Bianchini, Bruna | Nazario, Nazare | Filho, João G. | Kretzer, Marcia | Costa, Tânia | Almeida, Armando | Baffour, Gabriel | Almeida, Armando | Costa, Tânia | Baffour, Gabriel | Azeredo, Zaida | Laranjeira, Carlos | Guerra, Magda | Barbeiro, Ana P. | Ferreira, Regina | Lopes, Sara | Nunes, Liliana | Mendes, Ana | Martins, Julian | Schneider, Dulcineia | Kretzer, Marcia | Magajewski, Flávio | Soares, Célia | Marques, António | Batista, Marco | Castuera, Ruth J. | Mesquita, Helena | Faustino, António | Santos, Jorge | Honório, Samuel | Vizzotto, Betina P. | Frigo, Leticia | Pivetta, Hedioneia F. | Sardo, Dolores | Martins, Cristina | Abreu, Wilson | Figueiredo, Mª Céu | Batista, Marco | Jimenez-Castuera, Ruth | Petrica, João | Serrano, João | Honório, Samuel | Paulo, Rui | Mendes, Pedro | Sousa, Patrícia | Marques, Rita | Faustino, António | Silveira, Paulo | Serrano, João | Paulo, Rui | Mendes, Pedro | Honório, Samuel | Oliveira, Catarina | Bastos, Fernanda | Cruz, Inês | Rodriguez, Cláudia K. | Kretzer, Márcia R. | Nazário, Nazaré O. | Cruz, Pedro | Vaz, Daniela C. | Ruben, Rui B. | Avelelas, Francisco | Silva, Susana | Campos, Mª Jorge | Almeida, Maria | Gonçalves, Liliana | Antunes, Lígia | Sardo, Pedro | Guedes, Jenifer | Simões, João | Machado, Paulo | Melo, Elsa | Cardoso, Susana | Santos, Osvaldo | Nunes, Carla | Loureiro, Isabel | Santos, Flávia | Alves, Gilberto | Soar, Cláudia | Marsi, Teresa O. | Silva, Ernestina | Pedrosa, Dora | Leça, Andrea | Silva, Daniel | Galvão, Ana | Gomes, Maria | Fernandes, Paula | Noné, Ana | Combadão, Jaime | Ramalhete, Cátia | Figueiredo, Paulo | Caeiro, Patrícia | Fontana, Karine C. | Lacerda, Josimari T. | Machado, Patrícia O. | Borges, Raphaelle | Barbosa, Flávio | Sá, Dayse | Brunhoso, Germana | Aparício, Graça | Carvalho, Amâncio | Garcia, Ana P. | Fernandes, Paula O. | Santos, Adriana | Veiga, Nélio | Brás, Carina | Carvalho, Inês | Batalha, Joana | Glória, Margarida | Bexiga, Filipa | Coelho, Inês | Amaral, Odete | Pereira, Carlos | Pinho, Cláudia | Paraíso, Nilson | Oliveira, Ana I. | Lima, Cristóvão F. | Dias, Alberto P. | Silva, Pedro | Espada, Mário | Marques, Mário | Pereira, Ana | Pereira, Ana Mª | Veiga-Branco, Mª | Pereira, Filomena | Ribeiro, Maria | Lima, Vera | Oliveira, Ana I. | Pinho, Cláudia | Cruz, Graça | Oliveira, Rita F. | Barreiros, Luísa | Moreira, Fernando | Camarneiro, Ana | Loureiro, Mª Helena | Silva, Margarida | Duarte, Catarina | Jesus, Ângelo | Cruz, Agostinho | Mota, Maria | Novais, Sandra | Nogueira, Paulo | Pereira, Ana | Carneiro, Lara | João, Paulo V. | Lima, Teresa Maneca | Salgueiro-Oliveira, Anabela | Vaquinhas, Marina | Parreira, Pedro | Melo, Rosa | Graveto, João | Castilho, Amélia | Gomes, José H. | Medina, María S. | Blanco, Valeriana G. | Santos, Osvaldo | Lopes, Elisa | Virgolino, Ana | Dinis, Alexandra | Ambrósio, Sara | Almeida, Inês | Marques, Tatiana | Heitor, Mª João | Garcia-Gordillo, Miguel A. | Collado-Mateo, Daniel | Olivares, Pedro R. | Parraça, José A. | Sala, José A. | Castilho, Amélia | Graveto, João | Parreira, Pedro | Oliveira, Anabela | Gomes, José H. | Melo, Rosa | Vaquinhas, Marina | Cheio, Mónica | Cruz, Agostinho | Pereira, Olívia R. | Pinto, Sara | Oliveira, Adriana | Manso, M. Conceição | Sousa, Carla | Vinha, Ana F. | Machado, Mª Manuela | Vieira, Margarida | Fernandes, Beatriz | Tomás, Teresa | Quirino, Diogo | Desouzart, Gustavo | Matos, Rui | Bordini, Magali | Mouroço, Pedro | Matos, Ana R. | Serapioni, Mauro | Guimarães, Teresa | Fonseca, Virgínia | Costa, André | Ribeiro, João | Lobato, João | Martin, Inmaculada Z. | Björklund, Anita | Tavares, Aida I. | Ferreira, Pedro | Passadouro, Rui | Morgado, Sónia | Tavares, Nuno | Valente, João | Martins, Anabela C. | Araújo, Patrícia | Fernandes, Rosina | Mendes, Francisco | Magalhães, Cátia | Martins, Emília | Mendes, Pedro | Paulo, Rui | Faustino, António | Mesquita, Helena | Honório, Samuel | Batista, Marco | Lacerda, Josimari T. | Ortiga, Angela B. | Calvo, Mª Cristina | Natal, Sônia | Pereira, Marta | Ferreira, Manuela | Prata, Ana R. | Nelas, Paula | Duarte, João | Carneiro, Juliana | Oliveira, Ana I. | Pinho, Cláudia | Couto, Cristina | Oliveira, Rita F. | Moreira, Fernando | Maia, Ana S. | Oliveira, Michelle T. | Sousa, Anderson R. | Ferreira, Paulo P. | Souza, Géssica M. | Almada, Lívia F. | Conceição, Milena A. | Santiago, Eujcely C. | Rodrigues, Sandra | Domingues, Gabriela | Ferreira, Irina | Faria, Luís | Seixas, Adérito | Costa, Ana R. | Jesus, Ângelo | Cardoso, Américo | Meireles, Alexandra | Colaço, Armanda | Cruz, Agostinho | Vieira, Viviane L. | Vincha, Kellem R. | Cervato-Mancuso, Ana Mª | Faria, Melissa | Reis, Cláudia | Cova, Marco P. | Ascenso, Rita T. | Almeida, Henrique A. | Oliveira, Eunice G. | Santana, Miguel | Pereira, Rafael | Oliveira, Eunice G. | Almeida, Henrique A. | Ascenso, Rita T. | Jesus, Rita | Tapadas, Rodrigo | Tim-Tim, Carolina | Cezanne, Catarina | Lagoa, Matilde | Dias, Sara S. | Torgal, Jorge | Lopes, João | Almeida, Henrique | Amado, Sandra | Carrão, Luís | Cunha, Madalena | Saboga-Nunes, Luís | Albuquerque, Carlos | Ribeiro, Olivério | Oliveira, Suzete | Morais, Mª Carminda | Martins, Emília | Mendes, Francisco | Fernandes, Rosina | Magalhães, Cátia | Araújo, Patrícia | Pedro, Ana R. | Amaral, Odete | Escoval, Ana | Assunção, Victor | Luís, Henrique | Luís, Luís | Apolinário-Hagen, Jennifer | Vehreschild, Viktor | Fotschl, Ulrike | Lirk, Gerald | Martins, Anabela C. | Andrade, Isabel | Mendes, Fernando | Mendonça, Verónica | Antunes, Sandra | Andrade, Isabel | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Silva, Paula A. | Mónico, Lisete M. | Parreira, Pedro M. | Carvalho, Carla | Carvalho, Carla | Parreira, Pedro M. | Mónico, Lisete M. | Ruivo, Joana | Silva, Vânia | Sousa, Paulino | Padilha, José M. | Ferraz, Vera | Aparício, Graça | Duarte, João | Vasconcelos, Carlos | Almeida, António | Neves, Joel | Correia, Telma | Amorim, Helena | Mendes, Romeu | Saboga-Nunes, Luís | Cunha, Madalena | Albuquerque, Carlos | Pereira, Elsa S. | Santos, Leonino S. | Reis, Ana S. | Silva, Helena R. | Rombo, João | Fernandes, Jorge C. | Fernandes, Patrícia | Ribeiro, Jaime | Mangas, Catarina | Freire, Ana | Silva, Sara | Francisco, Irene | Oliveira, Ana | Catarino, Helena | Dixe, Mª Anjos | Louro, Mª Clarisse | Lopes, Saudade | Dixe, Anjos | Dixe, Mª Anjos | Menino, Eva | Catarino, Helena | Soares, Fátima | Oliveira, Ana P. | Gordo, Sara | Kraus, Teresa | Tomás, Catarina | Queirós, Paulo | Rodrigues, Teresa | Sousa, Pedro | Frade, João G. | Lobão, Catarina | Moura, Cynthia B. | Dreyer, Laysa C. | Meneghetti, Vanize | Cabral, Priscila P. | Pinto, Francisca | Sousa, Paulino | Esteves, Mª Raquel | Galvão, Sofia | Tytgat, Ite | Andrade, Isabel | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Casas-Novas, Mónica | Bernardo, Helena | Andrade, Isabel | Sousa, Gracinda | Sousa, Ana P. | Rocha, Clara | Belo, Pedro | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Martins, Fátima | Pulido-Fuentes, Montserrat | Barroso, Isabel | Cabral, Gil | Monteiro, M. João | Rainho, Conceição | Prado, Alessandro | Carvalho, Yara M. | Campos, Maria | Moreira, Liliana | Ferreira, José | Teixeira, Ana | Rama, Luís | Campos, Maria | Moreira, Liliana | Ferreira, José | Teixeira, Ana | Rama, Luís
BMC Health Services Research  2016;16(Suppl 3):200.
Table of contents
S1 Health literacy and health education in adolescence
Catarina Cardoso Tomás
S2 The effect of a walking program on the quality of life and well-being of people with schizophrenia
Emanuel Oliveira, D. Sousa, M. Uba-Chupel, G. Furtado, C. Rocha, A. Teixeira, P. Ferreira
S3 Diagnosis and innovative treatments - the way to a better medical practice
Celeste Alves
S4 Simulation-based learning and how it is a high contribution
Stefan Gisin
S5 Formative research about acceptability, utilization and promotion of a home fortification programme with micronutrient powders (MNP) in the Autonomous Region of Príncipe, São Tomé and Príncipe
Elisabete Catarino, Nelma Carvalho, Tiago Coucelo, Luís Bonfim, Carina Silva
S6 Safety culture of the patient: a reflexion about the therapeutic approach on the patient with vocal pathology
Débora Franco
S7 About wine, fortune cookies and patient experience
Jesús Alcoba González
O1 The psychological impact on the emergency crews after the disaster event on February 20, 2010
Helena G. Jardim, Rita Silva
O2 Musculoskeletal disorders in midwives
Cristina L. Baixinho, Mª Helena Presado, Mª Fátima Marques, Mário E. Cardoso
O3 Negative childhood experiences and fears of compassion: Implications for psychological difficulties in adolescence
Marina Cunha, Joana Mendes, Ana Xavier, Ana Galhardo, Margarida Couto
O4 Optimal age to give the first dose of measles vaccine in Portugal
João G. Frade, Carla Nunes, João R. Mesquita, Maria S. Nascimento, Guilherme Gonçalves
O5 Functional assessment of elderly in primary care
Conceição Castro, Alice Mártires, Mª João Monteiro, Conceição Rainho
O6 Smoking and coronary events in a population of Spanish health-care centre: An observational study
Francisco P. Caballero, Fatima M. Monago, Jose T. Guerrero, Rocio M. Monago, Africa P. Trigo, Milagros L. Gutierrez, Gemma M. Milanés, Mercedes G. Reina, Ana G. Villanueva, Ana S. Piñero, Isabel R. Aliseda, Francisco B. Ramirez
O7 Prevalence of musculoskeletal injuries in Portuguese musicians
Andrea Ribeiro, Ana Quelhas, Conceição Manso
O8 Hip fractures, psychotropic drug consumption and comorbidity in patients of a primary care practice in Spain
Francisco P. Caballero, Jose T. Guerrero, Fatima M. Monago, Rafael B. Santos, Nuria R. Jimenez, Cristina G. Nuñez, Inmaculada R. Gomez, Mª Jose L. Fernandez, Laura A. Marquez, Ana L. Moreno, Mª Jesus Tena Huertas, Francisco B. Ramirez
O9 The role of self-criticism and shame in social anxiety in a clinical SAD sample
Daniel Seabra, Mª Céu Salvador
O10 Obstruction and infiltration: a proposal of a quality indicator
Luciene Braga, Pedro Parreira, Anabela Salgueiro-Oliveira, Cristina Arreguy-Sena, Bibiana F. Oliveira, Mª Adriana Henriques
O11 Balance and anxiety and depression symptoms in old age people
Joana Santos, Sara Lebre, Alda Marques
O12 Prevalence of postural changes and risk factors in school children and adolescents in a northern region (Porto)
Clarinda Festas, Sandra Rodrigues, Andrea Ribeiro, José Lumini
O13 Ischemic stroke vs. haemorrhagic stroke survival rate
Ana G. Figueiredo
O14 Chronobiological factors as responsible for the appearance of locomotor pathology in adolescents
Francisco J. Hernandez-Martinez, Liliana Campi, Mª Pino Quintana-Montesdeoca, Juan F. Jimenez-Diaz, Bienvenida C. Rodriguez-De-Vera
O15 Risk of malnutrition in the elderly of Bragança
Alexandra Parente, Mª Augusta Mata, Ana Mª Pereira, Adília Fernandes, Manuel Brás
O16 A Lifestyle Educational Programme for primary care diabetic patients: the design of a complex nursing intervention
Mª Rosário Pinto, Pedro Parreira, Marta L. Basto, Ana C. Rei, Lisete M. Mónico
O17 Medication adherence in elderly people
Gilberta Sousa, Clementina Morna, Otília Freitas, Gregório Freitas, Ana Jardim, Rita Vasconcelos
O18 Hospitalization for cervical cancer of residents in the metropolitan region of Porto Alegre, Southern Brazil, 2012 to 2014
Lina G. Horta, Roger S. Rosa, Luís F. Kranz, Rita C. Nugem, Mariana S. Siqueira, Ronaldo Bordin
O19 Oncologic assistance of high complexity: evaluation of regulating accesses
Rosiane Kniess, Josimari T. Lacerda
O20 Perceived barriers for using health care services by the older population as seen by the social sector: findings from the Vila Nova de Gaia Gerontological Plan
Joana Guedes, Idalina Machado, Sidalina Almeida, Adriano Zilhão, Helder Alves, Óscar Ribeiro
O21 Sleep difficulties and depressive symptoms in college students
Ana P. Amaral, Ana Santos, Joana Monteiro, Mª Clara Rocha, Rui Cruz
O22 Psychopathological symptoms and medication use in higher education
Ana P. Amaral, Marina Lourenço, Mª Clara Rocha, Rui Cruz
O23 Sexually transmitted diseases in higher education institutions
Sandra Antunes, Verónica Mendonça, Isabel Andrade, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
O24 Alcohol consumption and suicide ideation in higher education students
Lídia Cabral, Manuela Ferreira, Amadeu Gonçalves
O25 Quality of life in university students
Tatiana D. Luz, Leonardo Luz, Raul Martins
O26 Male and female adolescent antisocial behaviour: characterizing vulnerabilities in a Portuguese sample
Alice Morgado, Maria L. Vale-Dias
O27 Risk factors for mental health in higher education students of health sciences
Rui Porta-Nova
O28 International classification of functioning disability and health as reflexive reasoning in primary attention in health
Tânia C. Fleig, Éboni M. Reuter, Miriam B. Froemming, Sabrina L. Guerreiro, Lisiane L. Carvalho
O29 Risk factors and cardiovascular disease in Portalegre
Daniel Guedelha, P. Coelho, A. Pereira
O30 Health status of the elderly population living in Portalegre historic city centre: A longitudinal study
António Calha, Raul Cordeiro
O31 Student’s sleep in higher education: sleep quality among students of the IPB
Ana Gonçalves, Ana Certo, Ana Galvão, Mª Augusta Mata
O32 Trend in mortality from cervical cancer in the metropolitan area of Florianópolis, state of Santa Catarina, Brazil, 2000 to 2013
Aline Welter, Elayne Pereira, Sandra Ribeiro, Marcia Kretzer
O33 Adherence to treatment in the elderly in an urban environment in Spain
Juan-Fernando Jiménez-Díaz, Carla Jiménez-Rodríguez, Francisco-José Hernández-Martínez, Bienvenida-Del-Carmen Rodríguez-De-Vera, Alexandre Marques-Rodrigues
O34 Beira Baixa Blood Pressure Study (Study PABB)
Patrícia Coelho, Tiago Bernardes, Alexandre Pereira
O35 Trends in cervical cancer mortality statistics in Santa Catarina State, Brazil, by age group and macro-region, from 2000 to 2013
Patrícia Sousa, João G. Filho, Nazare Nazario, Marcia Kretzer
O36 Sleep problems among Portuguese adolescents: a public health issue
Odete Amaral, António Garrido, Nélio Veiga, Carla Nunes, Ana R. Pedro, Carlos Pereira
O37 Association between body fat and health-related quality of life in patients with type 2 diabetes
António Almeia, Helder M. Fernandes, Carlos Vasconcelos, Nelson Sousa, Victor M. Reis, M. João Monteiro, Romeu Mendes
O38 Therapy adherence and polypharmacy in non-institutionalized elderly from Amares county, Portugal
Isabel C. Pinto, Tânia Pires, João Gama
O39 Prevalence of surgical site infection in adults at a hospital unit in the North of Portugal
Vera Preto, Norberto Silva, Carlos Magalhães, Matilde Martins
O40 Frailty phenotype in old age: implications to intervention
Mafalda Duarte, Constança Paúl, Ignácio Martín
O41 Portuguese women: sexual symptoms in perimenopause
Arminda A. Pinheiro
O42 Predictive ability of the Perinatal Depression Screening and Prevention Tool – preliminary results of the categorical approach
Sandra Xavier, Julieta Azevedo, Elisabete Bento, Cristiana Marques, Mariana Marques, António Macedo, Ana T. Pereira
O43 Aging and muscle strength in patients with type 2 diabetes: cross sectional analysis
José P. Almeida, António Almeida, Josiane Alves, Nelson Sousa, Francisco Saavedra, Romeu Mendes
O44 Accessibility of the elderly in the prevention of hypertension in a family health unit
Ana S. Maia, Michelle T. Oliveira, Anderson R. Sousa, Paulo P. Ferreira, Luci S. Lopes, Eujcely C. Santiago
O45 Community Health screenings and self-reported chronic diseases
Sílvia Monteiro, Ângelo Jesus, Armanda Colaço, António Carvalho, Rita P. Silva, Agostinho Cruz
O46 Evaluation of indoor air quality in Kindergartens
Ana Ferreira, Catarina Marques, João P. Figueiredo, Susana Paixão
O47 Atmospheric exposure to chemical agents under the occupational activity of pathology technicians
Ana Ferreira, Carla Lopes, Fernando Moreira, João P. Figueiredo
O48 Occupational exposure to air pollutants in night entertainment venues workers
Ana Ferreira, Diana Ribeiro, Fernando Moreira, João P. Figueiredo, Susana Paixão
O49 Beliefs and attitudes of young people towards breastfeeding
Telma Fernandes, Diogo Amado, Jéssica Leal, Marcelo Azevedo, Sónia Ramalho
O50 Profiling informal caregivers: surveying needs in the care of the elderly
Catarina Mangas, Jaime Ribeiro, Rita Gonçalves
O51 Visual health in teenagers
Amélia F Nunes, Ana R. Tuna, Carlos R. Martins, Henriqueta D. Forte
O52 Amenable mortality and the geographic accessibility to healthcare in Portugal
Cláudia Costa, José A. Tenedório, Paula Santana
O53 Bacterial contamination of door handles in a São Paulo See Metropolitan Cathedral public restrooms in Brazil
J. A. Andrade, J. L. Pinto, C. Campofiorito, S. Nunes, A. Carmo, A. Kaliniczenco, B. Alves, F. Mendes, C. Jesus, F. Fonseca, F. Gehrke
O54 Adherence of patients to rehabilitation programmes
Carlos Albuquerque, Rita Batista, Madalena Cunha, António Madureira, Olivério Ribeiro, Rosa Martins
O55 Prevalence of malnutrition among Portuguese elderly living in nursing homes: preliminary results of the PEN-3S project
Teresa Madeira, Catarina Peixoto-Plácido, Nuno Santos, Osvaldo Santos, Astrid Bergland, Asta Bye, Carla Lopes, Violeta Alarcão, Beatriz Goulão, Nuno Mendonça, Paulo Nicola, João G. Clara
O56 Relation between emotional intelligence and mental illness in health students
João Gomes, Ana Querido, Catarina Tomás, Daniel Carvalho, Marina Cordeiro
P1 Fall risk factors in people older than 50 years old – a pilot report
Marlene C. Rosa, Alda Marques
P2 What about the Portuguese oldest old? A global overview using census data
Daniela Brandão, Óscar Ribeiro, Lia Araújo, Constança Paúl
P3 Prevalence of injuries in senior amateur volleyball athletes in Alentejo and Algarve clubs, Portugal: factors associated
Beatriz Minghelli, Sylvina Richaud
P4 Shame feelings and quality of life: the role of acceptance and decentring
Ana L. Mendes, Joana Marta-Simões, Inês A. Trindade, Cláudia Ferreira
P5 Assessment of social support during deployment in portuguese colonial war veterans
Teresa Carvalho, Marina Cunha, José Pinto-Gouveia
P6 Hospitalization for acute viral bronchiolitis of residents in the metropolitan region of Porto Alegre, Southern Brazil, 2012 to 2014
Morgana C. Fernandes, Roger S. Rosa, Rita C. Nugem, Luís F. Kranz, Mariana S. Siqueira, Ronaldo Bordin
P7 Falls-risk screening – an opportunity for preventing falls in the elderly from Nordeste
Anabela C. Martins, Anabela Medeiros, Rafaela Pimentel, Andreia Fernandes, Carlos Mendonça, Isabel Andrade, Susana Andrade, Ruth L. Menezes
P8 Aging provokes chronodisruption in mature people in temperature circadian rhythm
Rafael Bravo, Marta Miranda, Lierni Ugartemendia, José Mª Tena, Francisco L. Pérez-Caballero, Lorena Fuentes-Broto, Ana B. Rodríguez, Barriga Carmen
P9 The influence of climate and pollution factors in dengue cases of great ABC region, São Paulo
M. A. Carneiro, J. N. Domingues, S. Paixão, J. Figueiredo, V. B. Nascimento, C. Jesus, F Mendes, F. Gehrke, B. Alves, L. Azzalis, F. Fonseca
P10 Visual function and impact of visual therapy in children with learning disabilities: a pilot study
Ana R. Martins, Amélia Nunes, Arminda Jorge
P11 Edentulism and the need of oral rehabilitation among institutionalized elderly
Nélio Veiga, Ana Amorim, André Silva, Liliana Martinho, Luís Monteiro, Rafael Silva, Carina Coelho, Odete Amaral, Inês Coelho, Carlos Pereira, André Correia
P12 Therapy adherence of outpatients in the pharmacy services of a hospital unit
Diana Rodrigues, Nídia Marante, Pedro Silva, Sara Carvalho, André Rts Araujo, Maximiano Ribeiro, Paula Coutinho, Sandra Ventura, Fátima Roque
P13 Universal access and comprehensive care of oral health: an availability study
Cristina Calvo, Manoela Reses
P14 Is the respiratory function of children a predictor of air quality? Coimbra as a case study
Jorge Conde, Ana Ferreira, João Figueiredo
P15 Meaning-in-life of college students
David Silva, Luís Seiça, Raquel Soares, Ricardo Mourão, Teresa Kraus
O57 Training needs for nurses in palliative care
Ana C. Abreu, José M. Padilha, Júlia M. Alves
O58 Impact of computerized information systems in the global nurses’ workload: nurses’ perceptions and real-time
Paulino Sousa, Manuel Oliveira, Joana Sousa
O59 The perspective of health care professionals on self-care in hereditary neurodegenerative disease: a qualitative study
Sónia Novais, Felismina Mendes
O60 Contribution for health-related physical fitness reference values in healthy adolescents
Joana Pinto, Joana Cruz, Alda Marques
School of Health Sciences, University of Aveiro, 3810-193 Aveiro, Portugal
O61 Perception of learning, satisfaction and self-efficacy of nursing students about High-Fidelity Simulation
Hugo Duarte, Maria Dos Anjos Dixe, Pedro Sousa
O62 Analysis of statements of diagnosis about health deviation in self-care requisites customized in a Nursing Practice Support System (SAPE®): Management of therapeutic regimen
Inês Cruz, Fernanda Bastos, Filipe Pereira
O63 Hybrid management and hospital governance: doctors and nurses as managers
Francisco L. Carvalho, Teresa T. Oliveira, Vítor R. Raposo
O64 Time management in health professionals
Conceição Rainho, José C. Ribeiro, Isabel Barroso, Vítor Rodrigues
O65 Financial rewards and wellbeing in primary health care
Carmo Neves, Teresa C. Oliveira
O66 Patient safety promotion in the operating room
Bárbara Oliveira, Mª Carminda Morais, Pilar Baylina
O67 Difficulties and needs of pre-graduate nursing students in the area of Geriatrics/Gerontology
Rogério Rodrigues, Zaida Azeredo, Corália Vicente
O68 Teaching and learning sexuality in nursing education
Hélia Dias, Margarida Sim-Sim
O69 Entrepreneurial Motivations Questionnaire: AFC and CFA in academy
Pedro Parreira, Anabela Salgueiro-Oliveira, Amélia Castilho, Rosa Melo, João Graveto, José Gomes, Marina Vaquinhas, Carla Carvalho, Lisete Mónico, Nuno Brito
O70 Nursing intervention to patient with Permanent Pacemakers and Implantable Cardioverter Defibrillators: a qualitative analysis
Cassilda Sarroeira, José Amendoeira, Fátima Cunha, Anabela Cândido, Patrícia Fernandes, Helena R. Silva, Elsa Silva
O71 Alcohol consumption among nursing students: where does education fail?
Isabel Barroso, Leila Lapa, Cristina Antunes
O72 Labour stress in nursing
Ana Gonçalves, Ana Galvão, Mª José Gomes, Susana R. Escanciano
O73 The influence of safe staff nursing in patient satisfaction with nursing care
Maria Freitas, Pedro Parreira, João Marôco
O74 Intention to use eHealth strategies with nursing students
Ana R. Fernandes, Cremilde Cabral, Samuel Alves, Pedro Sousa
O75 Community Based Mental Health: contributions of an interdisciplinary international program for students in higher health education
António Ferreira, Fernanda Príncipe, Ulla-Maija Seppänen, Margarida Ferreira, Maribel Carvalhais, Marilene Silva
O76 Study of satisfaction at work of graduates in nursing: 2002-2014
Manuela Ferreira, Joana Silva, Jéssica Neves, Diana Costa, Bruno Santos, Soraia Duarte
O77 Health professionals’ attitudes towards breastfeeding
Sílvia Marques, Sónia Ramalho, Isabel Mendes
O78 Continuity of nursing care to person with type 2 diabetes
Clarisse Louro, Eva Menino, Maria Dixe, Sara S. Dias
O79 Stigma toward mental illness among future health professionals
Marina Cordeiro, Catarina Tomás, Ana Querido, Daniel Carvalho, João Gomes
O80 Working with fears and anxieties of medical students in search of a humanized care
Frederico C. Valim, Joyce O. Costa, Lúcia G. Bernardes
P16 Surgical paediatrics patients’ psycho prophylaxis at a teaching hospital
Helena Prebianchi
P17 Patient-perceived outcomes in physiotherapy – a pilot study
Marlene Cristina Rosa
P18 Building competencies for managers in nursing
Narcisa Gonçalves, Maria M. Martins, Paulina Kurcgant
P19 Theoretical basis underlying physiotherapy practice in stroke rehabilitation
André Vieira
P20 When the life-cycle ends: the nurse’s confrontation with death
Sandrina Bento, Sérgio Deodato, Isabel Rabiais
P21 Nursing students’ opinion about the supervision relationship during their first clinical experience
Laura Reis
P22 Nursing Relational Laboratory: Pedagogical, dialogic and critical project
Ana Torres, Sérgio Soares, Margarida Ferreira, Pedro Graça
P23 Job satisfaction of bioscientists at a Lisbon hospital
Céu Leitão, Renato Abreu, Fernando Bellém, Ana Almeida, Edna Ribeiro-Varandas, Ana Tavares
P24 Sociodemographic and professional profile of nurses and its relation with the importance of family in nursing practices
João G. Frade, Carolina Henriques, Eva Menino, Clarisse Louro, Célia Jordão
P25 Professional satisfaction of rehabilitation nurses
Sofia Neco, Carminda Morais, Pedro Ferreira
P26 The person living with a stoma: the formalization of knowledge in nursing
Carla R. Silva, Alice Brito, Antónia Silva
P27 Validation of the Portuguese versions of the nursing students’ perceptions of learning and learner satisfaction with simulation tool
Hugo Duarte, Maria Dos Anjos Dixe, Pedro Sousa
P28 Physiotherapists’ perceived knowledge on technologies for electronic health records for physiotherapy
Gabriela Postolache, Raul Oliveira, Isabel Moreira, Luísa Pedro, Sónia Vicente, Samuel Domingos, Octavian Postolache
P29 Quality of life and physical activity of medicine undergraduate students in the University of Southern Santa Catarina, Brazil
Darlen Silva, João G. Filho, Nazare Nazario, Marcia Kretzer, Dulcineia Schneider
P30 The curricular skills for decision making education in a Nursing Degree
Fátima M. Marques
P31 Effect of nurses’ mobilization in satisfaction at work and turnover: An empirical study in the hospital setting
Pedro Parreira, Carla Carvalho, Lisete M. Mónico, Carlos Pinto, Sara Vicente, São João Breda
P32 Entrepreneurial skills of students of polytechnic higher education in Portugal: Business influences
José H. Gomes, Rosa Melo, Pedro Parreira, Anabela Salgueiro, João Graveto, Marina Vaquinhas, Amélia Castilho
P33 Design and assessment of e-learning modules for Pharmacology
Ângelo Jesus, Nuno Duarte, José C. Lopes, Hélder Nunes, Agostinho Cruz
P34 Perspective of nurses involved in an action-research study on the changes observed in care provision: results from a focus group
Anabela Salgueiro-Oliveira, Pedro Parreira, Marta L. Basto, Luciene M. Braga
P35 Use of peer feedback by nursing students during clinical training: teacher’s perception
António Ferreira, Beatriz Araújo, José M. Alves, Margarida Ferreira, Maribel Carvalhais, Marilene Silva, Sónia Novais
P36 What’s new on endotracheal suctioning recommendations
Ana S. Sousa, Cândida Ferrito
P37 Assessment of the nurses satisfaction on the Central Region of Portugal
Pedro L. Ferreira, Alexandre Rodrigues, Margarida Ferreira, Isabel Oliveira
P38 Study of graduate’s satisfaction with the school of nursing
Manuela Ferreira, Jéssica Neves, Diana Costa, Soraia Duarte, Joana Silva, Bruno Santos
P39 Partnership between the school of nursing and the hospital: Supervisors´ perspectives
Cristina Martins, Ana P. Macedo, Odete Araújo, Cláudia Augusto, Fátima Braga, Lisa Gomes, Maria A. Silva, Rafaela Rosário
P40 Coping strategies of college students
Luís Pimenta, Diana Carreira, Patrícia Teles, Teresa Barros
P41 Emotional intelligence and mental health stigma in health students
Catarina Tomás, Ana Querido, Daniel Carvalho, João Gomes, Marina Cordeiro
P42 Stigma of mental health assessment: Comparison between health courses
Daniel Carvalho, Ana Querido, Catarina Tomás, João Gomes, Marina Cordeiro
O81 Short- and long-term effects of pulmonary rehabilitation in mild COPD
Cristina Jácome, Alda Marques
O82 Phonological awareness programme for preschool children
Sylvie Capelas, Andreia Hall, Dina Alves, Marisa Lousada
O83 REforma ATIVA: An efficient health promotion program to be implemented during retirement
Mª Helena Loureiro, Ana Camarneiro, Margarida Silva, Aida Mendes, Ana Pedreiro
O84 Intervention for men who batter women, a case report
Anne G.Silva, Elza S. Coelho
O85 Immediate effects of Bowen Therapy on muscle tone and flexibility
Flávio Melo, Fernando Ribeiro, Rui Torres, Rui Costa
O86 Predictive equation for incremental shuttle walk test in adolescents
Tânia Pinho, Cristina Jácome, Alda Marques
O87 Life satisfaction and psychopathology in institutionalized elderly people: The results of an adapted Mindfulness-Based Stress Reduction program
Bárbara Cruz, Daniel Seabra, Diogo Carreira, Maria Ventura
O88 Outcome changes in COPD rehabilitation: exploring the relationship between physical activity and health-related outcomes
Joana Cruz, Dina Brooks, Alda Marques
O89 Assessing the effectiveness of a Complex Nursing Intervention
M Rosário Pinto, Pedro Parreira, Marta Lima-Basto, Miguel Neves, Lisete M. Mónico
O90 Psychotherapeutic intervention in addiction disorders: Change in psychopathological symptoms and emotional states
Carla Bizarro, Marina Cunha, Ana Galhardo, Couto Margarida, Ana P. Amorim, Eduardo Silva
O91 Economic impact of a nursing intervention program to promote self-management in COPD
Susana Cruz, José M. Padilha, Jorge Valente
O92 Multimodal acute pain management during uterine artery embolization in treatment of uterine myomas
José T. Guerrero, Francisco P. Caballero, Rafael B. Santos, Estefania P. Gonzalez, Fátima M. Monago, Lierni U. Ugalde, Marta M. Vélez, Maria J. Tena
O93 Fluid administration strategies in major surgery: Goal-directed therapy
José T. Guerrero, Rafael Bravo, Francisco L. Pérez-Caballero, Isabel A. Becerra, Mª Elizabeth Agudelo, Guadalupe Acedo, Roberto Bajo
O94 Development and implementation of a self-management educational programme using lay-led’s in adolescents Spina Bifida: A pilot study
Isabel Malheiro, Filomena Gaspar, Luísa Barros
O95 Influence of chair-based yoga exercises on salivary anti-microbial proteins in institutionalized frail-elderly women: a preliminary study
Guilherme Furtado, Mateus Uba-Chupel, Mariana Marques, Luís Rama, Margarida Braga, José P. Ferreira, Ana Mª Teixeira
O96 High intensity interval training vs moderate intensity continuous training impact on diabetes 2
João Cruz, Tiago Barbosa, Ângela Simões, Luís Coelho
O97 Family caregiver of people with pressure ulcer: Nursing intervention plan
Alexandre Rodrigues, Juan-Fernando Jiménez-Díaz, Francisco Martinez-Hernández, Bienvenida Rodriguez-De-Vera, Pedro Ferreira, Alexandrina Rodrigues
O98 Chronic effects of exercise on motor memory consolidation in elderly people
André Ramalho, João Petrica, Pedro Mendes, João Serrano, Inês Santo, António Rosado
O99 Impression cytology of the ocular surface: Collection technique and sample processing
Paula Mendonça, Kátia Freitas
O100 Does sport practice affect the reaction time in neuromuscular activity?
Dora Ferreira, António Brito, Renato Fernandes
O101 Efficiency of the enteral administration of fibbers in the treatment of chronic obstipation
Sofia Gomes, Fernando Moreira, Cláudia Pinho, Rita Oliveira, Ana I. Oliveira
O102 Fast decalcifier in compact bone and spongy bone
Paula Mendonça, Ana P. Casimiro, Patrícia Martins, Iryna Silva
O103 Health promotion in the elderly – Intervention project in dementia
Diana Evangelista
O104 Prevention of musculoskeletal disorders through an exercise protocol held in labour context
Catarina Leitão, Fábia Velosa, Nélio Carecho, Luís Coelho
O105 Knowledge of teachers and other education agents on diabetes type 1: Effectiveness of an intervention program
Eva Menino, Anjos Dixe, Helena Catarino, Fátima Soares, Ester Gama, Clementina Gordo
O106 Treatment of diabetic peripheral neuropathic pain: a systematic review of clinical trials of phase II and III
Eliana Moreira, Cristiana Midões, Marlene Santos
O107 New drugs for osteoporosis treatment: Systematic review of clinical trials of phase II and III
Sara Machado, Vânia P. Oliveira, Marlene Santos
O108 Promoting hope at the end of life: Effectiveness of an Intervention Programme
Ana Querido, Anjos Dixe, Rita Marques, Zaida Charepe
P43 Psychomotor therapy effects on adaptive behaviour and motor proficiency of adults with intellectual disability
Ana Antunes, Sofia Santos
P44 The effect of exercise therapy in multiple sclerosis – a single study case
Marlene C. Rosa
P45 Physical condition and self-efficacy in people with fall risk – a preliminary study
Marlene C. Rosa, Silvana F. Marques
P46 Shock waves: their effectiveness in improving the symptoms of calcifying tendinitis of the shoulder
Beatriz Minghelli, Eulália Caro
P47 Pacifier – construction and pilot application of a parenting intervention for parents of babies until six months in primary health care
Mª José Luís, Teresa Brandão
P48 The influence of Motor Imagery in fine motor skills of individuals with disabilities
Pedro Mendes, Daniel Marinho, João Petrica, Diogo Monteiro, Rui Paulo, João Serrano, Inês Santo
P49 Evaluation of the effects of a walking programme on the fall risk factors in older people – a longitudinal pilot study
Lina Monteiro, Fátima Ramalho, Rita Santos-Rocha, Sónia Morgado, Teresa Bento
P50 Nursing intervention programme in lifestyles of adolescents
Gilberta Sousa, Otília Freitas, Isabel Silva, Gregório Freitas, Clementina Morna, Rita Vasconcelos
P51 The person submitted to hip replacement rehabilitation, at home
Tatiana Azevedo, Salete Soares, Jacinta Pisco
P52 Effects of Melatonin use in the treatment of neurovegetative diseases
Paulo P. Ferreira, Efrain O. Olszewer, Michelle T. Oliveira, Anderson R. Sousa, Ana S. Maia, Sebastião T. Oliveira
P53 Review of Phytotherapy and other natural substances in alcohol abuse and alcoholism
Erica Santos, Ana I. Oliveira, Carla Maia, Fernando Moreira, Joana Santos, Maria F. Mendes, Rita F. Oliveira, Cláudia Pinho
P54 Dietary programme impact on biochemical markers in diabetics: systematic review
Eduarda Barreira, Ana Pereira, Josiana A. Vaz, André Novo
P55 Biological approaches to knee osteoarthritis: platelet-rich plasma and hyaluronic acid
Luís D. Silva, Bruno Maia, Eduardo Ferreira, Filipa Pires, Renato Andrade, Luís Camarinha
P56 Platelet-rich plasma and hyaluronic acid intra-articular injections for the treatment of ankle osteoarthritis
Luís D. Silva, Bruno Maia, Eduardo Ferreira, Filipa Pires, Renato Andrade, Luís Camarinha
P57 The impact of preventive measures in the incidence of diabetic foot ulcers: a systematic review
Ana F. César, Mariana Poço, David Ventura, Raquel Loura, Pedro Gomes, Catarina Gomes, Cláudia Silva, Elsa Melo, João Lindo
P58 Dating violence among young adolescents
Joana Domingos, Zaida Mendes, Susana Poeta, Tiago Carvalho, Catarina Tomás, Helena Catarino, Mª Anjos Dixe
P59 Physical activity and motor memory in pedal dexterity
André Ramalho, António Rosado, Pedro Mendes, Rui Paulo, Inês Garcia, João Petrica
P60 The effects of whole body vibration on the electromyographic activity of thigh muscles
Sandra Rodrigues, Rui Meneses, Carlos Afonso, Luís Faria, Adérito Seixas
P61 Mental health promotion in the workplace
Marina Cordeiro, Paulo Granjo, José C. Gomes
P62 Influence of physical exercise on the self-perception of body image in elderly women: A systematic review of qualitative studies
Nelba R. Souza, Guilherme E. Furtado, Saulo V. Rocha, Paula Silva, Joana Carvalho
O109 Psychometric properties of the Portuguese version of the Éxamen Geronto-Psychomoteur (P-EGP)
Marina Ana Morais, Sofia Santos, Paula Lebre, Ana Antunes
O110 Symptoms of depression in the elderly population of Portugal, Spain and Italy
António Calha
O111 Emotion regulation strategies and psychopathology symptoms: A comparison between adolescents with and without deliberate self-harm
Ana Xavier, Marina Cunha, José Pinto-Gouveia
O112 Prevalence of physical disability in people with leprosy
Liana Alencar, Madalena Cunha, António Madureira
O113 Quality of life and self-esteem in type 1 and type 2 diabetes mellitus patients
Ilda Cardoso, Ana Galhardo, Fernanda Daniel, Vítor Rodrigues
O114 Cross-cultural comparison of gross motor coordination in children from Brazil and Portugal
Leonardo Luz, Tatiana Luz, Maurício R. Ramos, Dayse C. Medeiros, Bruno M. Carmo, André Seabra, Cristina Padez, Manuel C. Silva
O115 Electrocardiographic differences between African and Caucasian people
António Rodrigues, Patrícia Coelho, Alexandre Coelho
O116 Factors associated with domestic, sexual and other types of violence in the city of Palhoça - Brazil
Madson Caminha, Filipe Matheus, Elenice Mendes, Jony Correia, Marcia Kretzer
O117 Tinnitus prevalence study of users of a hospital of public management - Spain
Francisco J. Hernandez-Martinez, Juan F. Jimenez-Diaz, Bienvendida C. Rodriguez-De-Vera, Carla Jimenez-Rodriguez, Yadira Armas-Gonzalez
O118 Difficulties experienced by parents of children with diabetes mellitus of preschool age in therapeutic and nutritional management
Cátia Rodrigues, Rosa Pedroso
O119 E-mental health - “nice to have” or “must have”? Exploring the attitudes towards e-mental health in the general population
Jennifer Apolinário-Hagen, Viktor Vehreschild
O120 Violence against children and adolescents and the role of health professionals: Knowing how to identify and care
Milene Veloso, Celina Magalhães, Isabel Cabral, Maira Ferraz
O121 Marital violence. A study in the Algarve population
Filipe Nave, Emília Costa, Filomena Matos, José Pacheco
O122 Clinical factors and adherence to treatment in ischemic heart disease
António Dias, Carlos Pereira, João Duarte, Madalena Cunha, Daniel Silva
O123 Can religiosity improve optimism in participants in states of illness, when controlling for life satisfaction?
Lisete M. Mónico, Valentim R. Alferes, Mª São João Brêda, Carla Carvalho, Pedro M. Parreira
O124 Empowerment, knowledge and quality of life of people with diabetes type 2 in the Alto Minho Health Local Unit
Mª Carminda Morais, Pedro Ferreira, Rui Pimenta, José Boavida
O125 Antihypertensive therapy adherence among hypertensive patients from Bragança county, Portugal
Isabel C. Pinto, Tânia Pires, Catarina Silva
O126 Subjective perception of sexual achievement - An exploratory study on people with overweight
Maria Ribeiro, Maria Viega-Branco, Filomena Pereira, Ana Mª Pereira
O127 Physical activity level and associated factors in hypertensive individuals registered in the family health strategy of a basic health unit from the city of Palhoça, Santa Catarina, Brazil
Fabrícia M. Almeida, Gustavo L. Estevez, Sandra Ribeiro, Marcia R. Kretzer
O128 Perception of functional fitness and health in non-institutionalised elderly from rural areas
Paulo V. João, Paulo Nogueira, Sandra Novais, Ana Pereira, Lara Carneiro, Maria Mota
O129 Medication adherence in patients with type 2 diabetes mellitus treated at primary health care in Coimbra
Rui Cruz, Luiz Santiago, Carlos Fontes-Ribeiro
O130 Multivariate association between body mass index and multi-comorbidities in elderly people living in low socio-economic status context
Guilherme Furtado, Saulo V. Rocha, André P. Coutinho, João S. Neto, Lélia R. Vasconcelos, Nelba R. Souza, Estélio Dantas
O131 Metacognition, rumination and experiential avoidance in Borderline Personality Disorder
Alexandra Dinis, Sérgio Carvalho, Paula Castilho, José Pinto-Gouveia
O132 Health issues in a vulnerable population: nursing consultation in a public bathhouse in Lisbon
Alexandra Sarreira-Santos, Amélia Figueiredo, Lurdes Medeiros-Garcia, Paulo Seabra
O133 The perception of quality of life in people with multiple sclerosis accompanied in External Consultation of the Local Health Unit of Alto Minho
Rosa Rodrigues, Mª Carminda Morais, Paula O. Fernandes
O134 Representation of interaction established between immigrant women and nurse during pregnancy to postpartum, from the perspective of immigrant women
Conceição Santiago, Mª Henriqueta Figueiredo, Marta L. Basto
O135 Illness perceptions and medication adherence in hypertension
Teresa Guimarães, André Coelho, Anabela Graça, Ana M. Silva, Ana R. Fonseca
O136 A Portuguese study on adults’ intimate partner violence, interpersonal trust and hope
Luz Vale-Dias, Bárbara Minas, Graciete Franco-Borges
P63 QOL’ predictors of people with intellectual disability and general population
Cristina Simões, Sofia Santos
P64 Content validation of the Communication Disability Profile (CDP) - Portuguese Version
Ana Serra, Maria Matos, Luís Jesus
P65 Study of biochemical and haematological changes in football players
Ana S. Tavares, Ana Almeida, Céu Leitão, Edna Varandas, Renato Abreu, Fernando Bellém
P66 Body image dissatisfaction in inflammatory bowel disease: exploring the role of chronic illness-related shame
Inês A. Trindade, Cláudia Ferreira, José Pinto-Gouveia, Joana Marta-Simões
P67 Obesity and sleep in the adult population - a systematic review
Odete Amaral, Cristiana Miranda, Pedro Guimarães, Rodrigo Gonçalves, Nélio Veiga, Carlos Pereira
P68 Frequency of daytime sleepiness and obstructive sleep apnea risk in COPD patients
Tânia C. Fleig, Elisabete A. San-Martin, Cássia L. Goulart, Paloma B. Schneiders, Natacha F. Miranda, Lisiane L. Carvalho, Andrea G. Silva
P69 Working with immigrant-origin clients: discourses and practices of health professionals
Joana Topa, Conceição Nogueira, Sofia Neves
P70 Systemic Lupus Erythematosus – what are audiovestibular changes?
Rita Ventura, Cristina Nazaré
P71 Mental disorders in the oldest old: findings from the Portuguese national hospitalization database
Daniela Brandão, Alberto Freitas, Óscar Ribeiro, Constança Paúl
P72 Recurrence analysis in postural control in children with cerebral palsy
Cristiana Mercê, Marco Branco, Pedro Almeida, Daniela Nascimento, Juliana Pereira, David Catela
P73 The experience of self-care in the elderly with COPD: contributions to reflect proximity care
Helga Rafael
P74 Culturally competent nurses: managing unpredictability in clinical practice with immigrants
Alcinda C. Reis
O137 Paediatric speech and language screening: An instrument for health professionals
Ana Mendes, Ana R. Valente, Marisa Lousada
O138 Anthropometric and nutritional assessment in bodybuilders
Diana Sousa, Ana L. Baltazar, Mª Helena Loureiro
O139 Computerized adventitious respiratory sounds in children with lower respiratory tract infections
Ana Oliveira, José Aparício, Alda Marques
O140 Role of computerized respiratory sounds as a marker in LRTI
Alda Marques, Ana Oliveira, Joana Neves, Rodrigo Ayoub
O141 Confirmatory factor analysis of the Personal Wellbeing Index in people with chronic kidney disease
Luís Sousa, Cristina Marques-Vieira, Sandy Severino, Helena José
O142 Phonological awareness skills in school aged children
Inês Cadorio, Marisa Lousada
O143 Assessment of early memories of warmth and safeness in interaction with peers: its relationship with psychopathology in adolescence
Marina Cunha, Diogo Andrade, Ana Galhardo, Margarida Couto
O144 The molecular effects induced by single shot irradiation on a diffuse large B cell lymphoma cell line
Fernando Mendes, Cátia Domingues, Susann Schukg, Ana M. Abrantes, Ana C. Gonçalves, Tiago Sales, Ricardo Teixo, Rita Silva, Jéssica Estrela, Mafalda Laranjo, João Casalta-Lopes, Clara Rocha, Paulo C. Simões, Ana B. Sarmento-Ribeiro, Mª Filomena Botelho, Manuel S. Rosa
O145 Morpho-functional characterization of cardiac chambers by Transthoracic Echocardiography, in young athletes of gymnastics competition
Virgínia Fonseca, Diogo Colaço, Vanessa Neves
O146 Prevalence of the antibodies of the new histo-blood system – FORS system
Carlos Jesus, Camilla Hesse, Clara Rocha, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Lola Svensson, Fernando Mendes, Wafa A. Siba, Cristina Pereira, Jorge Tomaz
O147 Assessment of the war-related perceived threat in Portuguese Colonial War Veterans
Teresa Carvalho, José Pinto-Gouveia, Marina Cunha
O148 Pulse transit time estimation for continuous blood pressure measurement: A comparative study
Diana Duarte, Nuno V. Lopes, Rui Fonseca-Pinto
O149 Blood pressure assessment during standard clinical manoeuvres: A non-invasive PPT based approach
Diana Duarte, Nuno V. Lopes, Rui Fonseca-Pinto
O150 Development and initial validation of the Activities and Participation Profile related to Mobility (APPM)
Anabela C. Martins
O151 MEASYCare-2010 Standard–A geriatric evaluation system in primary health care: Reliability and validity of the latest version in Portugal
Piedade Brandão, Laura Martins, Margarida Cardoso
O152 Interrater and intrarater reliability and agreement of the range of shoulder flexion in the standing upright position through photographic assessment
Nuno Morais, Joana Cruz
O153 Three-dimensional biofabrication techniques for tissue regeneration
Nuno Alves, Paula Faria, Artur Mateus, Pedro Morouço
O154 A new computer tool for biofabrication applied to tissue engineering
Nuno Alves, Nelson Ferreira, Artur Mateus, Paula Faria, Pedro Morouço
O155 Development and psychometric qualities of a scale to measure the functional independence of adolescents with motor impairment
Isabel Malheiro, Filomena Gaspar, Luísa Barros
O156 Organizational Trust in Health services: Exploratory and Confirmatory factor analysis of the Organizational Trust Inventory- Short Form (OTI-SF)
Pedro Parreira, Andreia Cardoso, Lisete Mónico, Carla Carvalho, Albino Lopes, Anabela Salgueiro-Oliveira
O157 Thermal symmetry: An indicator of occupational task asymmetries in physiotherapy
Adérito Seixas, Valter Soares, Tiago Dias, Ricardo Vardasca, Joaquim Gabriel, Sandra Rodrigues
O158 A study of ICT active monitoring adoption in stroke rehabilitation
Hugo Paredes, Arsénio Reis, Sara Marinho, Vítor Filipe, João Barroso
O159 Paranoia Checklist (Portuguese Version): Preliminary studies in a mixed sample of patients and healthy controls
Carolina Da Motta, Célia B. Carvalho, José Pinto-Gouveia, Ermelindo Peixoto
O160 Reliability and validity of the Composite Scale on Morningness: European Portuguese version, in adolescents and young adults
Ana A. Gomes, Vanessa Costa, Diana Couto, Daniel R. Marques, José A. Leitão, José Tavares, Maria H. Azevedo, Carlos F. Silva
O161 Evaluation scale of patient satisfaction with nursing care: Psychometric properties evaluation
João Freitas, Pedro Parreira, João Marôco
O162 Impact of fibromyalgia on quality of life: Comparing results from generic instruments and FIQR
Miguel A. Garcia-Gordillo, Daniel Collado-Mateo, Gang Chen, Angelo Iezzi, José A. Sala, José A. Parraça, Narcis Gusi
O163 Preliminary study of the adaptation and validation of the Rating Scale of Resilient Self: Resilience, self-harm and suicidal ideation in adolescents
Jani Sousa, Mariana Marques, Jacinto Jardim, Anabela Pereira, Sónia Simões, Marina Cunha
O164 Development of the first pressure ulcer in inpatient setting: Focus on length of stay
Pedro Sardo, Jenifer Guedes, João Lindo, Paulo Machado, Elsa Melo
O165 Forms of Self-Criticizing and Self-Reassuring Scale: Adaptation and early findings in a sample of Portuguese children
Célia B. Carvalho, Joana Benevides, Marina Sousa, Joana Cabral, Carolina Da Motta
O166 Predictive ability of the Perinatal Depression Screening and Prevention Tool – Preliminary results of the dimensional approach
Ana T. Pereira, Sandra Xavier, Julieta Azevedo, Elisabete Bento, Cristiana Marques, Rosa Carvalho, Mariana Marques, António Macedo
O167 Psychometric properties of the BaSIQS-Basic Scale on insomnia symptoms and quality of sleep, in adults and in the elderly
Ana M. Silva, Juliana Alves, Ana A. Gomes, Daniel R. Marques, Mª Helena Azevedo, Carlos Silva
O168 Enlightening the human decision in health: The skin melanocytic classification challenge
Ana Mendes, Huei D. Lee, Newton Spolaôr, Jefferson T. Oliva, Wu F. Chung, Rui Fonseca-Pinto
O169 Test-retest reliability household life study and health questionnaire Pomerode (SHIP-BRAZIL)
Keila Bairros, Cláudia D. Silva, Clóvis A. Souza, Silvana S. Schroeder
O170 Characterization of sun exposure behaviours among medical students from Nova Medical School
Elsa Araújo, Helena Monteiro, Ricardo Costa, Sara S. Dias, Jorge Torgal
O171 Spirituality in pregnant women
Carolina G. Henriques, Luísa Santos, Elisa F. Caceiro, Sónia A. Ramalho
O172 Polypharmacy in older patients with cancer
Rita Oliveira, Vera Afreixo, João Santos, Priscilla Mota, Agostinho Cruz, Francisco Pimentel
O173 Quality of life of caregivers of people with advanced chronic disease: Translation and validation of the quality of life in life threatening illness - family carer version (QOLLTI-C-PT)
Rita Marques, Mª Anjos Dixe, Ana Querido, Patrícia Sousa
O174 The psychometric properties of the brief Other as Shamer Scale for Children (OAS-C): preliminary validation studies in a sample of Portuguese children
Joana Benevides, Carolina Da Motta, Marina Sousa, Suzana N. Caldeira, Célia B. Carvalho
O175 Measuring emotional intelligence in health care students – Revalidation of WLEIS-P
Ana Querido, Catarina Tomás, Daniel Carvalho, João Gomes, Marina Cordeiro
O176 Health indicators in prenatal assistance: The impact of computerization and of under-production in basic health centres
Joyce O. Costa, Frederico C. Valim, Lígia C. Ribeiro
O177 Hope genogram: Assessment of resources and interaction patterns in the family of the child with cerebral palsy
Zaida Charepe, Ana Querido, Mª Henriqueta Figueiredo
O178 The influence of childbirth type in postpartum quality of life
Priscila S. Aquino, Samila G. Ribeiro, Ana B. Pinheiro, Paula A. Lessa, Mirna F. Oliveira, Luísa S. Brito, Ítalo N. Pinto, Alessandra S. Furtado, Régia B. Castro, Caroline Q. Aquino, Eveliny S. Martins
O179 Women’s beliefs about pap smear test and cervical cancer: influence of social determinants
Ana B Pinheiro, Priscila S. Aquino, Lara L. Oliveira, Patrícia C. Pinheiro, Caroline R. Sousa, Vívien A. Freitas, Tatiane M. Silva, Adman S. Lima, Caroline Q. Aquino, Karizia V. Andrade, Camila A. Oliveira, Eglidia F. Vidal
O180 Validity of the Portuguese version of the ASI-3: Is anxiety sensitivity a unidimensional or multidimensional construct?
Ana Ganho-Ávila, Mariana Moura-Ramos, Óscar Gonçalves, Jorge Almeida
O181 Lifestyles of higher education students: the influence of self-esteem and psychological well-being
Armando Silva, Irma Brito, João Amado
P75 Assessing the quality of life of persons with significant intellectual disability: Portuguese version of Escala de San Martín
António Rodrigo, Sofia Santos, Fernando Gomes
P76 Childhood obesity and breastfeeding - A systematic review
Marlene C. Rosa, Silvana F. Marques
P77 Cross-cultural adaptation of the Foot and Ankle Ability Measure (FAAM) for the Portuguese population
Sara Luís, Luís Cavalheiro, Pedro Ferreira, Rui Gonçalves
P78 Cross-cultural adaptation of the Patient-Rated Wrist Evaluation score (PRWE) for the Portuguese population
Rui S. Lopes, Luís Cavalheiro, Pedro Ferreira, Rui Gonçalves
P79 Cross-cultural adaptation of the Myocardial Infraction Dimensional Assessment Scale (MIDAS) for Brazilian Portuguese language
Bruno H. Fiorin, Marina S. Santos, Edmar S. Oliveira, Rita L. Moreira, Elizabete A. Oliveira, Braulio L. Filho
P80 The revised Portuguese version of the Three-Factor Eating Questionnaire: A confirmatory factor analysis
Lara Palmeira, Teresa Garcia, José Pinto-Gouveia, Marina Cunha
P81 Assessing weight-related psychological inflexibility: An exploratory factor analysis of the AAQW’s Portuguese version
Sara Cardoso, Lara Palmeira, Marina Cunha; José Pinto-Gouveia
P82 Validation of the Body Appreciation Scale-2 for Portuguese women
Joana Marta-Simões, Ana L. Mendes, Inês A. Trindade, Sara Oliveira, Cláudia Ferreira
P83 The Portuguese validation of the Dietary Intent Scale
Ana L. Mendes, Joana Marta-Simões, Inês A. Trindade, Cláudia Ferreira
P84 Construction and validation of the Inventory of Marital Violence (IVC)
Filipe Nave
P85 Portable continuous blood pressure monitor system
Mariana Campos, Iris Gaudêncio, Fernando Martins, Lino Ferreira, Nuno Lopes, Rui Fonseca-Pinto
P86 Construction and validation of the Scale of Perception of the Difficulties in Caring for the Elderly (SPDCE)
Rogério Rodrigues, Zaida Azeredo, Corália Vicente
P87 Development and validation of a comfort rating scale for the elderly hospitalized with chronic illness
Joana Silva, Patrícia Sousa, Rita Marques
P88 Construction and validation of the Postpartum Paternal Quality of Life Questionnaire (PP-QOL)
Isabel Mendes, Rogério Rodrigues, Zaida Azeredo, Corália Vicente
P89 Infrared thermal imaging: A tool for assessing diabetic foot ulcers
Ricardo Vardasca, Ana R. Marques, Adérito Seixas, Rui Carvalho, Joaquim Gabriel
P90 Pressure ulcers in an intensive care unit: An experience report
Paulo P. Ferreira, Michelle T. Oliveira, Anderson R. Sousa, Ana S. Maia, Sebastião T. Oliveira, Pablo O. Costa, Maiza M. Silva
P91 Validation of figures used in evocations: instrument to capture representations
Cristina Arreguy-Sena, Nathália Alvarenga-Martins, Paulo F. Pinto, Denize C. Oliveira, Pedro D. Parreira, Antônio T. Gomes, Luciene M. Braga
P92 Telephone assistance to decrease burden in informal caregivers of stroke older people: Monitoring and diagnostic evaluation
Odete Araújo, Isabel Lage, José Cabrita, Laetitia Teixeira
P93 Hope of informal caregivers of people with chronic and advanced disease
Rita Marques, Mª Anjos Dixe, Ana Querido, Patrícia Sousa
P94 Functionality and quality information from the Portuguese National Epidemiological Surveillance System
Sara Silva, Eugénio Cordeiro, João Pimentel
P95 Resting metabolic rate objectively measured vs. Harris and Benedict formula
Vera Ferro-Lebres, Juliana A. Souza, Mariline Tavares
O182 Characteristics of non-urgent patients: Cross-sectional study of an emergency department
Mª Anjos Dixe, Pedro Sousa, Rui Passadouro, Teresa Peralta, Carlos Ferreira, Georgina Lourenço
O183 Physical fitness and health in children of the 1st Cycle of Education
João Serrano, João Petrica, Rui Paulo, Samuel Honório, Pedro Mendes
O184 The impact of physical activity on sleep quality, in children
Alexandra Simões, Lucinda Carvalho, Alexandre Pereira
O185 What is the potential for using Information and Communication Technologies in Arterial Hypertension self-management?
Sara Silva, Paulino Sousa, José M. Padilha
O186 Exploring psychosocial factors associated with risk of falling in older patients undergoing haemodialysis
Daniela Figueiredo, Carolina Valente, Alda Marques
O187 Development of pressure ulcers on the face in patients undergoing non-invasive ventilation
Patrícia Ribas, Joana Sousa, Frederico Brandão, Cesar Sousa, Matilde Martins
O188 The elder hospitalized: Limiting factors of comfort
Patrícia Sousa, Rita Marques
O189 Physical activity and health state self-perception by Portuguese adults
Francisco Mendes, Rosina Fernandes, Emília Martins, Cátia Magalhães, Patrícia Araújo
O190 Satisfaction with social support in the elderly of the district of Bragança
Carla Grande, Mª Augusta Mata, Juan G. Vieitez
O191 Prevalence of death by traumatic brain injury and associated factors in intensive care unit of a general hospital, Brazil
Bruna Bianchini, Nazare Nazario, João G. Filho, Marcia Kretzer
O192 Relation between family caregivers burden and health status of elderly dependents
Tânia Costa, Armando Almeida, Gabriel Baffour
O193 Phenomena sensitive to nursing care in day centre
Armando Almeida, Tânia Costa, Gabriel Baffour
O194 Frailty: what do the elderly think?
Zaida Azeredo, Carlos Laranjeira, Magda Guerra, Ana P. Barbeiro
O195 The therapeutic self-care as a nursing-sensitive outcome: A correlational study
Regina Ferreira
O196 Phonetic-phonological acquisition for the European Portuguese from 18 months to 6 years and 12 months
Sara Lopes, Liliana Nunes, Ana Mendes
O197 Quality of life of patients undergoing liver transplant surgery
Julian Martins, Dulcineia Schneider, Marcia Kretzer, Flávio Magajewski
O198 Professional competences in health: views of older people from different European Countries
Célia Soares, António Marques
O199 Life satisfaction of working adults due to the number of hours of weekly exercise
Marco Batista, Ruth J. Castuera, Helena Mesquita, António Faustino, Jorge Santos, Samuel Honório
O200 Therapeutic itinerary of women with breast cancer in Santa Maria City/RS
Betina P. Vizzotto, Leticia Frigo, Hedioneia F. Pivetta
O201 The breastfeeding prevalence at 4 months: Maternal experience as a determining factor
Dolores Sardo
O202 The impact of the transition to parenthood in health and well-being
Cristina Martins, Wilson Abreu, Mª Céu Figueiredo
P96 Self-determined motivation and well-being in Portuguese active adults of both genders
Marco Batista, Ruth Jimenez-Castuera, João Petrica, João Serrano, Samuel Honório, Rui Paulo, Pedro Mendes
P97 The geriatric care: ways and means of comforting
Patrícia Sousa, Rita Marques
P98 The influence of relative age, subcutaneous adiposity and physical growth on Castelo Branco under-15 soccer players 2015
António Faustino, Paulo Silveira, João Serrano, Rui Paulo, Pedro Mendes, Samuel Honório
P99 Data for the diagnostic process focused on self-care – managing medication regime: An integrative literature review
Catarina Oliveira, Fernanda Bastos, Inês Cruz
P100 Art therapy as mental health promotion for children
Cláudia K. Rodriguez, Márcia R. Kretzer, Nazaré O. Nazário
P101 Chemical characterization of fungal chitosan for industrial applications
Pedro Cruz, Daniela C. Vaz, Rui B. Ruben, Francisco Avelelas, Susana Silva, Mª Jorge Campos
P102 The impact of caring older people at home
Maria Almeida, Liliana Gonçalves, Lígia Antunes
P103 Development of the first pressure ulcer in an inpatient setting: Focus on patients’ characteristics
Pedro Sardo, Jenifer Guedes, João Simões, Paulo Machado, Elsa Melo
P104 Association between General Self-efficacy and Physical Activity among Adolescents
Susana Cardoso, Osvaldo Santos, Carla Nunes, Isabel Loureiro
O203 Characterization of the habits of online acquisition of medicinal products in Portugal
Flávia Santos, Gilberto Alves
O204 Waiting room – A space for health education
Cláudia Soar, Teresa O. Marsi
O205 Safey culture evaluation in hospitalized children
Ernestina Silva, Dora Pedrosa, Andrea Leça, Daniel Silva
O206 Sexual Self-awareness and Body Image
Ana Galvão, Maria Gomes, Paula Fernandes, Ana Noné
O207 Perception of a Portuguese population regarding the acquisition and consumption of functional foods
Jaime Combadão, Cátia Ramalhete, Paulo Figueiredo, Patrícia Caeiro
O208 The work process in primary health care: evaluation in municipalities of southern Brazil
Karine C. Fontana, Josimari T. Lacerda, Patrícia O. Machado
O209 Exploration and evaluation of potential probiotic lactic acid bacteria isolated from Amazon buffalo milk
Raphaelle Borges, Flávio Barbosa, Dayse Sá
O210 Road safety for children: Using children’s observation, as a passenger
Germana Brunhoso, Graça Aparício, Amâncio Carvalho
O211 Perception and application of quality-by-design by the Pharmaceutical industry in Portugal
Ana P. Garcia, Paula O. Fernandes, Adriana Santos
O212 Oral health among Portuguese children and adolescents: a public health issue
Nélio Veiga, Carina Brás, Inês Carvalho, Joana Batalha, Margarida Glória, Filipa Bexiga, Inês Coelho, Odete Amaral, Carlos Pereira
O213 Plant species as a medicinal resource in Igatu-Chapada Diamantina (Bahia, Brazil)
Cláudia Pinho, Nilson Paraíso, Ana I. Oliveira, Cristóvão F. Lima, Alberto P. Dias
O214 Characterization of cognitive and functional performance in everyday tasks: Implications for health in institutionalised older adults
Pedro Silva, Mário Espada, Mário Marques, Ana Pereira
O215 BMI and the perception of the importance given to sexuality in obese and overweight people
Ana Mª Pereira, Mª Veiga-Branco, Filomena Pereira, Maria Ribeiro
O216 Analysis and comparison of microbiological contaminations of two different composition pacifiers
Vera Lima, Ana I. Oliveira, Cláudia Pinho, Graça Cruz, Rita F. Oliveira, Luísa Barreiros, Fernando Moreira
O217 Experiences of couple relationships in the transition to retirement
Ana Camarneiro, Mª Helena Loureiro, Margarida Silva
O218 Preventive and corrective treatment of drug-induced calcium deficiency: an analysis in a community pharmacy setting
Catarina Duarte, Ângelo Jesus, Agostinho Cruz
O219 Profile of mood states in physically active elderly subjects: Is there a relation with health perception?
Maria Mota, Sandra Novais, Paulo Nogueira, Ana Pereira, Lara Carneiro, Paulo V. João
O220 (Un)Safety behaviour at work: the role of education towards a health and safety culture
Teresa Maneca Lima
O221 Analysis of the entrepreneurial profile of students attending higher education in Portugal: the Carland Entrepreneurship Index application
Anabela Salgueiro-Oliveira, Marina Vaquinhas, Pedro Parreira, Rosa Melo, João Graveto, Amélia Castilho, José H. Gomes
O222 Evaluation of welfare and quality of life of pregnant working women regarding the age of the pregnant
María S. Medina, Valeriana G. Blanco
O223 Psychological wellbeing protection among unemployed and temporary workers: Uncovering effective community-based interventions with a Delphi panel
Osvaldo Santos, Elisa Lopes, Ana Virgolino, Alexandra Dinis, Sara Ambrósio, Inês Almeida, Tatiana Marques, Mª João Heitor
O224 Chilean population norms derived from the Health-related quality of life SF-6D
Miguel A. Garcia-Gordillo, Daniel Collado-Mateo, Pedro R. Olivares, José A. Parraça, José A. Sala
O225 Motivation of college students toward Entrepreneurship: The influence of social and economic instability
Amélia Castilho, João Graveto, Pedro Parreira, Anabela Oliveira, José H. Gomes, Rosa Melo, Marina Vaquinhas
O226 Use of aromatic and medicinal plants, drugs and herbal products in Bragança city
Mónia Cheio, Agostinho Cruz, Olívia R. Pereira
O227 Edible flowers as new novel foods concept for health promotion
Sara Pinto, Adriana Oliveira, M. Conceição Manso, Carla Sousa, Ana F. Vinha
O228 The influence of leisure activities on the health and welfare of older people living in nursing homes
Mª Manuela Machado, Margarida Vieira
O229 Risk of falling, fear of falling and functionality in community-dwelling older adults
Beatriz Fernandes, Teresa Tomás, Diogo Quirino
O230 Musculoskeletal pain and postural habits in children and teenage students
Gustavo Desouzart, Rui Matos, Magali Bordini, Pedro Mouroço
O231 What's different in Southern Europe? The question of citizens’ participation in health systems
Ana R. Matos, Mauro Serapioni
O232 Occupational stress in Portuguese police officers
Teresa Guimarães, Virgínia Fonseca, André Costa, João Ribeiro, João Lobato
O233 Is occupational therapy culturally relevant to promote mental health in Burkina Faso?
Inmaculada Z. Martin, Anita Björklund
P105 Pay-for-performance satisfaction and quality in primary care
Aida I. Tavares, Pedro Ferreira, Rui Passadouro
P106 Economic development through life expectancy lenses
Sónia Morgado
P107 What is the effectiveness of exercise on smoking cessation to prevent clinical complications of smoking?
Nuno Tavares, João Valente, Anabela C. Martins
P108 A systematic review of the effects of yoga on mental health
Patrícia Araújo, Rosina Fernandes, Francisco Mendes, Cátia Magalhães, Emília Martins
P109 Healthy lifestyle: comparison between higher education students that lived until adult age in rural and urban environment
Pedro Mendes, Rui Paulo, António Faustino, Helena Mesquita, Samuel Honório, Marco Batista
P110 Evaluation of the Mobile Emergency Care Service (SAMU) in Brazil
Josimari T. Lacerda, Angela B. Ortiga, Mª Cristina Calvo, Sônia Natal
P111 Bioactive compounds - antioxidant activity of tropical fruits
Marta Pereira
P112 Use of non-pharmacological methods to relieve pain in labour
Manuela Ferreira, Ana R. Prata, Paula Nelas, João Duarte
P113 Mechanical safety of pacifiers sold in Portuguese pharmacies and childcare stores
Juliana Carneiro, Ana I. Oliveira, Cláudia Pinho, Cristina Couto, Rita F. Oliveira, Fernando Moreira
P114 The importance of prenatal consultation: Information to pregnant women given on a unit of primary care
Ana S. Maia, Michelle T. Oliveira, Anderson R. Sousa, Paulo P. Ferreira, Géssica M. Souza, Lívia F. Almada, Milena A. Conceição, Eujcely C. Santiago
P115 Influence of different backpack loading conditions on neck and lumbar muscles activity of elementary school children
Sandra Rodrigues, Gabriela Domingues, Irina Ferreira, Luís Faria, Adérito Seixas
P116 Efficacy and safety of dry extract Hedera helix in the treatment of productive cough
Ana R. Costa, Ângelo Jesus, Américo Cardoso, Alexandra Meireles, Armanda Colaço, Agostinho Cruz
P117 A portrait of the evaluation processes of education groups in primary health care
Viviane L. Vieira, Kellem R. Vincha, Ana Mª Cervato-Mancuso
P118 Benefits of vitamins C and E in sensorineural hearing loss: a review
Melissa Faria, Cláudia Reis
P119 BODY SNAPSHOT – a web-integrated anthropometric evaluation system
Marco P. Cova, Rita T. Ascenso, Henrique A. Almeida, Eunice G. Oliveira
P120 Anthropometric evaluation and variation during pregnancy
Miguel Santana, Rafael Pereira, Eunice G. Oliveira, Henrique A. Almeida, Rita T. Ascenso
P121 Knowledge of college students on the amendments of their eating habits and physical activity index in the transition to higher education
Rita Jesus, Rodrigo Tapadas, Carolina Tim-Tim, Catarina Cezanne, Matilde Lagoa, Sara S. Dias, Jorge Torgal
P122 Muscular activity of a rally race car driver
João Lopes, Henrique Almeida, Sandra Amado, Luís Carrão
O234 Literacy and results in health
Madalena Cunha, Luís Saboga-Nunes, Carlos Albuquerque, Olivério Ribeiro
O235 Literacy promotion and empowerment of type 2 diabetics elderly in four family health units of the group of health centers of Dão Lafões
Suzete Oliveira, Mª Carminda Morais
O236 Mediterranean diet, health and life quality among Portuguese children
Emília Martins, Francisco Mendes, Rosina Fernandes, Cátia Magalhães, Patrícia Araújo
O237 Health literacy, from data to action - translation, validation and application of the European Health Literacy Survey in Portugal (HLS-EU-PT)
Ana R. Pedro, Odete Amaral, Ana Escoval
O238 Oral health literacy evaluation in a Portuguese military population
Victor Assunção, Henrique Luís, Luís Luís
O239 Preferences to Internet-based cognitive behavioural therapy – do attachment orientations matter?
Jennifer Apolinário-Hagen, Viktor Vehreschild
O240 A comparative transnational study in health literacy between Austria and Portugal
Ulrike Fotschl, Gerald Lirk, Anabela C. Martins, Isabel Andrade, Fernando Mendes
O241 Health literacy and social behaviours: relationship with sexually transmitted diseases?
Verónica Mendonça, Sandra Antunes, Isabel Andrade, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
O242 Parenting styles and attachment to parents: what relationships?
Paula A. Silva, Lisete M. Mónico, Pedro M. Parreira, Carla Carvalho
O243 Work-life balance in health professionals and professors: comparative study of workers with shift work and fixed schedule
Carla Carvalho, Pedro M. Parreira, Lisete M. Mónico, Joana Ruivo
O244 Technology literacy in self-management of diabetes
Vânia Silva, Paulino Sousa, José M. Padilha
O245 Satisfaction with therapeutic education and its relationship with clinical variables in children with type 1 diabetes
Vera Ferraz, Graça Aparício, João Duarte
O246 Nutrition-related knowledge in middle-age and older patients with type 2 diabetes
Carlos Vasconcelos, António Almeida, Joel Neves, Telma Correia, Helena Amorim, Romeu Mendes
O247 Validating the HLS-EU-(PT) questionnaire to measure health literacy in adolescents (CrAdLiSa project: HLS-EU-PT)
Luís Saboga-Nunes, Madalena Cunha, Carlos Albuquerque
O248 Health education in people with coronary heart disease: Experience of the cardiology department of a hospital on the outskirts of Lisbon
Elsa S. Pereira, Leonino S. Santos, Ana S. Reis, Helena R. Silva, João Rombo, Jorge C. Fernandes, Patrícia Fernandes
O249 Information and training needs of informal caregivers of individuals with stroke sequelae: a qualitative survey
Jaime Ribeiro, Catarina Mangas, Ana Freire
O250 Prevention of psychoactive substances consumption in students from 6th grade of Albergaria-a-Velha´s School Group
Sara Silva, Irene Francisco, Ana Oliveira
O251 Promoting healthy sexuality: shared responsibility for family, youth and educators
Helena Catarino, Mª Anjos Dixe, Mª Clarisse Louro
O252 Sexual risk behaviour in adolescents and young people
Saudade Lopes, Anjos Dixe
O253 Knowledge of school staff on type 1 diabetes
Mª Anjos Dixe, Eva Menino, Helena Catarino, Fátima Soares, Ana P. Oliveira, Sara Gordo, Teresa Kraus
O254 Sexual health in adolescents: the impact of information search in literacy
Catarina Tomás, Paulo Queirós, Teresa Rodrigues
P123 Improving basic life support skills in adolescents through a training programme
Pedro Sousa, João G. Frade, Catarina Lobão
P124 Difficulties in sexual education reported by basic education teachers in the city of Foz do Iguaçu - Brazil
Cynthia B. Moura, Laysa C. Dreyer, Vanize Meneghetti, Priscila P. Cabral
P125 Breast cancer survivors: subjects and resources for information. A qualitative systematic review
Francisca Pinto, Paulino Sousa, Mª Raquel Esteves
P126 Relationship between health literacy and prevalence of STI in Biomedical Laboratory Science students
Sofia Galvão, Ite Tytgat, Isabel Andrade, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
P127 Health literacy, risk behaviours and sexually transmitted diseases among blood donors
Mónica Casas-Novas, Helena Bernardo, Isabel Andrade, Gracinda Sousa, Ana P. Sousa, Clara Rocha, Pedro Belo, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
P128 Promoting literacy in pregnancy health-care
Fátima Martins, Montserrat Pulido-Fuentes
P129 The lifestyles of the operating assistants of education
Isabel Barroso, Gil Cabral, M. João Monteiro, Conceição Rainho
P130 Experiences of service-learning health and the literary art: reflections about the health education
Alessandro Prado, Yara M. Carvalho
P131 Life long swimming – a European Erasmus + project
Maria Campos, Liliana Moreira, José Ferreira, Ana Teixeira, Luís Rama
doi:10.1186/s12913-016-1423-5
PMCID: PMC4943498  PMID: 27409075
2.  The Reversal of Fortunes: Trends in County Mortality and Cross-County Mortality Disparities in the United States  
PLoS Medicine  2008;5(4):e66.
Background
Counties are the smallest unit for which mortality data are routinely available, allowing consistent and comparable long-term analysis of trends in health disparities. Average life expectancy has steadily increased in the United States but there is limited information on long-term mortality trends in the US counties This study aimed to investigate trends in county mortality and cross-county mortality disparities, including the contributions of specific diseases to county level mortality trends.
Methods and Findings
We used mortality statistics (from the National Center for Health Statistics [NCHS]) and population (from the US Census) to estimate sex-specific life expectancy for US counties for every year between 1961 and 1999. Data for analyses in subsequent years were not provided to us by the NCHS. We calculated different metrics of cross-county mortality disparity, and also grouped counties on the basis of whether their mortality changed favorably or unfavorably relative to the national average. We estimated the probability of death from specific diseases for counties with above- or below-average mortality performance. We simulated the effect of cross-county migration on each county's life expectancy using a time-based simulation model. Between 1961 and 1999, the standard deviation (SD) of life expectancy across US counties was at its lowest in 1983, at 1.9 and 1.4 y for men and women, respectively. Cross-county life expectancy SD increased to 2.3 and 1.7 y in 1999. Between 1961 and 1983 no counties had a statistically significant increase in mortality; the major cause of mortality decline for both sexes was reduction in cardiovascular mortality. From 1983 to 1999, life expectancy declined significantly in 11 counties for men (by 1.3 y) and in 180 counties for women (by 1.3 y); another 48 (men) and 783 (women) counties had nonsignificant life expectancy decline. Life expectancy decline in both sexes was caused by increased mortality from lung cancer, chronic obstructive pulmonary disease (COPD), diabetes, and a range of other noncommunicable diseases, which were no longer compensated for by the decline in cardiovascular mortality. Higher HIV/AIDS and homicide deaths also contributed substantially to life expectancy decline for men, but not for women. Alternative specifications of the effects of migration showed that the rise in cross-county life expectancy SD was unlikely to be caused by migration.
Conclusions
There was a steady increase in mortality inequality across the US counties between 1983 and 1999, resulting from stagnation or increase in mortality among the worst-off segment of the population. Female mortality increased in a large number of counties, primarily because of chronic diseases related to smoking, overweight and obesity, and high blood pressure.
Majid Ezzati and colleagues analyze US county-level mortality data for 1961 to 1999, and find a steady increase in mortality inequality across counties between 1983 and 1999.
Editors' Summary
Background.
It has long been recognized that the number of years that distinct groups of people in the United States would be expected to live based on their current mortality patterns (“life expectancy”) varies enormously. For example, white Americans tend to live longer than black Americans, the poor tend to have shorter life expectancies than the wealthy, and women tend to outlive men. Where one lives might also be a factor that determines his or her life expectancy, because of social conditions and health programs in different parts of the country.
Why Was the Study Done?
While life expectancies have generally been rising across the United States over time, there is little information, especially over the long term, on the differences in life expectancies across different counties. The researchers therefore set out to examine whether there were different life expectancies across different US counties over the last four decades. The researchers chose to look at counties—the smallest geographic units for which data on death rates are collected in the US—because it allowed them to make comparisons between small subgroups of people that share the same administrative structure.
What Did the Researchers Do and Find?
The researchers looked at differences in death rates between all counties in US states plus the District of Columbia over four decades, from 1961 to 1999. They obtained the data on number of deaths from the National Center for Health Statistics, and they obtained data on the number of people living in each county from the US Census. The NCHS did not provide death data after 2001. They broke the death rates down by sex and by disease to assess trends over time for women and men, and for different causes of death.
Over these four decades, the researchers found that the overall US life expectancy increased from 67 to 74 years of age for men and from 74 to 80 years for women. Between 1961 and 1983 the death rate fell in both men and women, largely due to reductions in deaths from cardiovascular disease (heart disease and stroke). During this same period, 1961–1983, the differences in death rates among/across different counties fell. However, beginning in the early 1980s the differences in death rates among/across different counties began to increase. The worst-off counties no longer experienced a fall in death rates, and in a substantial number of counties, mortality actually increased, especially for women, a shift that the researchers call “the reversal of fortunes.” This stagnation in the worst-off counties was primarily caused by a slowdown or halt in the reduction of deaths from cardiovascular disease coupled with a moderate rise in a number of other diseases, such as lung cancer, chronic lung disease, and diabetes, in both men and women, and a rise in HIV/AIDS and homicide in men. The researchers' key finding, therefore, was that the differences in life expectancy across different counties initially narrowed and then widened.
What Do these Findings Mean?
The findings suggest that beginning in the early 1980s and continuing through 1999 those who were already disadvantaged did not benefit from the gains in life expectancy experienced by the advantaged, and some became even worse off. The study emphasizes how important it is to monitor health inequalities between different groups, in order to ensure that everyone—and not just the well-off—can experience gains in life expectancy. Although the “reversal of fortune” that the researchers found applied to only a minority of the population, the authors argue that their study results are troubling because an oft-stated aim of the US health system is the improvement of the health of “all people, and especially those at greater risk of health disparities” (see, for example http://www.cdc.gov/osi/goals/SIHPGPostcard.pdf).
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050066.
A study by Nancy Krieger and colleagues, published in PLoS Medicine in February 2008, documented a similar “fall and rise” in health inequities. Krieger and colleagues reported that the difference in health between rich and poor and between different racial/ethnic groups, as measured by rates of dying young and of infant deaths, shrank in the US from 1966 to 1980 then widened from 1980 to 2002
Murray and colleagues, in a 2006 PLoS Medicine article, calculated US mortality rates according to “race-county” units and divided into the “eight Americas,” and found disparities in life expectancy across them
The US Centers for Disease Control has an Office of Minority Health and Health Disparities. The office “aims to accelerate CDC's health impact in the US population and to eliminate health disparities for vulnerable populations as defined by race/ethnicity, socioeconomic status, geography, gender, age, disability status, risk status related to sex and gender, and among other populations identified to be at-risk for health disparities”
Wikipedia has a chapter on health disparities (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
In 2001 the US Agency for Healthcare Research and Quality sponsored a workshop on “strategies to reduce health disparities”
doi:10.1371/journal.pmed.0050066
PMCID: PMC2323303  PMID: 18433290
3.  Respiratory symptoms in adults are related to impaired quality of life, regardless of asthma and COPD: results from the European community respiratory health survey 
Background
Respiratory symptoms are common in the general population, and their presence is related to Health-related quality of life (HRQoL). The objective was to describe the association of respiratory symptoms with HRQoL in subjects with and without asthma or COPD and to investigate the role of atopy, bronchial hyperresponsiveness (BHR), and lung function in HRQoL.
Methods
The European Community Respiratory Health Survey (ECRHS) I and II provided data on HRQoL, lung function, respiratory symptoms, asthma, atopy, and BHR from 6009 subjects. Generic HRQoL was assessed through the physical component summary (PCS) score and the mental component summary (MCS) score of the SF-36.
Factor analyses and linear regressions adjusted for age, gender, smoking, occupation, BMI, comorbidity, and study centre were conducted.
Results
Having breathlessness at rest in ECRHS II was associated with mean score (95% CI) impairment in PCS of -8.05 (-11.18, -4.93). Impairment in MCS score in subjects waking up with chest tightness was -4.02 (-5.51, -2.52). The magnitude of HRQoL impairment associated with respiratory symptoms was similar for subjects with and without asthma/COPD. Adjustments for atopy, BHR, and lung function did not explain the association of respiratory symptoms and HRQoL in subjects without asthma and/or COPD.
Conclusion
Subjects with respiratory symptoms had poorer HRQoL; including subjects without a diagnosis of asthma or COPD. These findings suggest that respiratory symptoms in the absence of a medical diagnosis of asthma or COPD are by no means trivial, and that clarifying the nature and natural history of respiratory symptoms is a relevant challenge.
Several community studies have estimated the prevalence of common respiratory symptoms like cough, dyspnoea, and wheeze in adults [1-3]. Although the prevalence varies to a large degree between studies and geographical areas, respiratory symptoms are quite common. The prevalences of respiratory symptoms in the European Community Respiratory Health Study (ECRHS) varied from one percent to 35% [1]. In fact, two studies have reported that more than half of the adult population suffers from one or more respiratory symptoms [4,5].
Respiratory symptoms are important markers of the risk of having or developing disease. Respiratory symptoms have been shown to be predictors for lung function decline [6-8], asthma [9,10], and even all-cause mortality in a general population study [11]. In patients with a known diagnosis of asthma or chronic obstructive pulmonary disease (COPD), respiratory symptoms are important determinants of reduced health related quality of life (HRQoL) [12-15]. The prevalence of respiratory symptoms exceeds the combined prevalences of asthma and COPD, and both asthma and COPD are frequently undiagnosed diseases [16-18]. Thus, the high prevalence of respipratory symptoms may mirror undiagnosed and untreated disease.
The common occurrence of respiratory symptoms calls for attention to how these symptoms affect health also in subjects with no diagnosis of obstructive airways disease. Impaired HRQoL in the presence of respiratory symptoms have been found in two population-based studies [6,19], but no study of respiratory sypmtoms and HRQoL have separate analyses for subjects with and without asthma and COPD, and no study provide information about extensive objective measurements of respiratory health.
The ECRHS is a randomly sampled, multi-cultural, population based cohort study. The ECRHS included measurements of atopy, bronchial hyperresponsiveness (BHR), and lung function, and offers a unique opportunity to investigate how respiratory symptoms affect HRQoL among subjects both with and without obstructive lung disease.
In the present paper we aimed to: 1) Describe the relationship between respiratory symptoms and HRQoL in an international adult general population and: 2) To assess whether this relationship varied with presence of asthma and/or COPD, or presence of objective functional markers like atopy and BHR.
doi:10.1186/1477-7525-8-107
PMCID: PMC2954977  PMID: 20875099
4.  Enhanced External Counterpulsation (EECP) 
Executive Summary
Objective
To assess the effectiveness, and cost effectiveness of EECP in patients with severe anginal symptoms, secondary to chronic coronary disease, who are unresponsive to exhaustive pharmacotherapy and not candidates for surgical/percutaneous revascularization procedures (e.g., angioplasty, coronary bypass surgery).
To assess the effectiveness, and cost effectiveness of EECP in patients with heart failure.
Clinical Need
Angina
Angina is a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back or arm. Angina usually occurs in patients with coronary artery disease (CAD) involving ≥1 large epicardial artery. However it can also occur in people with valvular heart disease, hypertrophic cardiomyopathy, and uncontrolled hypertension.
Conventional approaches to restoring the balance between oxygen supply and demand focus on the disruption of the underlying disease through: drug therapy (β blockers, calcium channel blockers, nitrates, antiplatelet agents, ACE inhibitors, statins); life-style modifications (smoking cessation, weight loss); or revascularization techniques such as coronary artery bypass graft surgery (CABG) or percutaneous coronary interventions (PCI). (1) Limitations of each of these approaches include: adverse drug effects, procedure-related mortality and morbidity, restenosis after PCI, and time dependent graft attrition after CABG. Furthermore, an increasing number of patients are not appropriate candidates for standard revascularization options, due to co-morbid conditions (HF, peripheral vascular disease), poor distal coronary artery targets, and patient preference. The morbidity and mortality associated with repeat surgical revascularization procedures are significantly higher, and often excludes these patients from consideration for further revascularizations. (2)
Patients with CAD who have chronic ischemic symptoms that are unresponsive to both conventional medical therapy and revascularization techniques have refractory angina pectoris. It has been estimated that greater than 100,000 patients each year in the US may be diagnosed as having this condition. (3) Patients with refractory angina have marked limitation of ordinary physical activity or are unable to perform any ordinary physical activity without discomfort (CCS functional class III/IV). Also, there must be some objective evidence of ischemia as demonstrated by exercise treadmill testing, stress imaging studies or coronary physiologic studies. (1)
Dejongste et al. (4)estimated that the prevalence of chronic refractory angina is about 100,000 patients in the United States. This would correspond to approximately 3,800 (100,000 x 3.8% [Ontario is approximately 3.8% of the population of the United States]) patients in Ontario having chronic refractory angina.
Heart Failure
Heart failure results from any structural or functional cardiac disorder that impairs the ability of the heart to act as a pump.
A recent study (5) revealed 28,702 patients were hospitalized for first-time HF in Ontario between April 1994 and March 1997. Women comprised 51% of the cohort. Eighty-five percent were aged 65 years or older, and 58% were aged 75 years or older.
Patients with chronic HF experience shortness of breath, a limited capacity for exercise, high rates of hospitalization and rehospitalization, and die prematurely. (6) The New York Heart Association (NYHA) has provided a commonly used functional classification for the severity of HF (7):
Class I: No limitation of physical activity. No symptoms with ordinary exertion.
Class II: Slight limitations of physical activity. Ordinary activity causes symptoms.
Class III: Marked limitation of physical activity. Less than ordinary activity causes symptoms. Asymptomatic at rest.
Class IV: Inability to carry out any physical activity without discomfort. Symptoms at rest.
The National Heart, Lung, and Blood Institute (7) estimates that 35% of patients with HF are in functional NYHA class I; 35% are in class II; 25%, class III; and 5%, class IV. Surveys (8) suggest that from 5% to 15% of patients with HF have persistent severe symptoms, and that the remainder of patients with HF is evenly divided between those with mild and moderately severe symptoms.
To date, the diagnosis and management of chronic HF has concentrated on patients with the clinical syndrome of HF accompanied by severe left ventricular systolic dysfunction. Major changes in treatment have resulted from a better understanding of the pathophysiology of HF and the results of large clinical trials. Treatment for chronic HF includes lifestyle management, drugs, cardiac surgery, or implantable pacemakers and defibrillators. Despite pharmacologic advances, which include diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, spironolactone, and digoxin, many patients remain symptomatic on maximally tolerated doses. (6)
The Technology
Patients are typically treated by a trained technician in a medically supervised environment for 1 hour daily for a total of 35 hours over 7 weeks. The procedure involves sequential inflation and deflation of compressible cuffs wrapped around the patient’s calves, lower thighs and upper thighs. In addition to 3 sets of cuffs, the patient has finger plethysmogram and electrocardiogram (ECG) attachments that are connected to a control and display console.
External counterpulsation was used in the United States to treat cardiogenic shock after acute myocardial infarction. (9;10) More recently, an enhanced version namely “enhanced external counterpulsation” (EECP) was introduced as a noninvasive procedure for outpatient treatment of patients with severe, uncontrollable cardiac ischemia. EECP is said to increase coronary perfusion pressure and reduce the myocardial oxygen demand. Currently, EECP is not applicable for all patients with refractory angina pectoris. For example, many patients are considered ineligible for therapy due to co-morbidities, including those with severe pulmonary vascular disease, deep vein thrombosis, phlebitis and irregular heart rhythms, and heart failure. (1)
Very recently, investigation began into EECP as an adjunctive treatment for patients with HF. Anecdotal reports suggested that EECP may benefit patients with coronary disease and left ventricular dysfunction. The safety and effectiveness of EECP in patients with symptomatic heart failure and coronary disease and its role in patients with nonischemic heart failure secondary to LV dysfunction is unclear. Furthermore, the safety and effectiveness of EECP in the different stages of HF and whether it is only for patients who are refractive to pharmacotherapy is unknown.
2003 Health Technology Assessment by the Medical Advisory Secretariat
The Medical Advisory Secretariat health technology assessment (originally published in February 2003) reported on the effectiveness of EECP for patients with angina and HF. The report concluded that there was insufficient evidence to support the use of EECP in patients with refractory stable CCS III/IV angina as well as insufficient evidence to support the use of EECP in patients with HF.
Review Strategy
The aim of this literature review was to assess the effectiveness, safety, and cost effectiveness of EECP for the treatment of refractory stable CCS III/IV angina or HF.
The standard search strategy used by the Medical Advisory Secretariat was used. This included a search of all international health technology assessments as well as a search of the medical literature from December 2002 to March 2006.
A modification of the GRADE approach (11) was used to make judgments about the quality of evidence and strength of recommendations systematically and explicitly. GRADE provides a framework for structured reflection and can help to ensure that appropriate judgments are made. GRADE takes into account a study’s design, quality, consistency, and directness in judging the quality of evidence for each outcome. The balance between benefits and harms, quality of evidence, applicability, and the certainty of the baseline risks are considered in judgments about the strength of recommendations.
Summary of Findings
The Cochrane and INAHTA databases yielded 3 HTAs or systematic reviews on EECP treatment (Blue Cross Blue Shield Technology Evaluation Center [BCBS TEC], ECRI, and the Centers for Medicare and Medicaid Services [CMS]). A search of Medline and Embase December 2005 – March 2006 (after the literature search cutoff from the most recent HTA) was conducted using key words enhanced external counterpulsation, EECP, angina, myocardial ischemia, congestive heart failure. This search produced 1 study which met the inclusion criteria. This level 4a study was inferior in quality to the RCT which formed the basis of the 2003 Medical Advisory Secretariat recommendation.
BCBS reviewed the evidence through November 2005 to determine if EECP improves health outcomes for refractory chronic stable angina pectoris or chronic stable HF. (12) BCBS concluded that the available evidence is not sufficient to permit conclusions of the effect of EECP on health outcomes. Both controlled trials had methodologic flaws (MUST EECP and MUST EECP quality of life studies). The case series and observational studies for both indications while suggestive of a treatment benefit from EECP have shortcomings as well.
On March 20 2006, CMS posted their proposed coverage decision memorandum for external counterpulsation therapy. (13) Overall, CMS stated that the evidence is not adequate to conclude that external counterpulsation therapy is reasonable and necessary for:
Canadian Cardiovascular Society Classification (CCSC) II angina
Heart failure
NYHA class II/III stable HF symptoms with an EF≤35%
NYHA class II/III stable HF symptoms with an EF≤40%
NYHA class IV HF
Acute HF
Cardiogenic shock
Acute MI
In January 2005, ECRI (14) stated that there was insufficient evidence available to draw conclusions about the long-term effectiveness of EECP, with respect to morbidity, survival, or quality of life, for any coronary indication (refractory angina, congestive heart failure, cardiogenic shock and acute MI).
GRADE Quality of the Studies
According to the GRADE Working Group criteria, the quality of the trials was examined (Table 1). (11)
Quality refers to the criteria such as the adequacy of allocation concealment, blinding and followup.
Consistency refers to the similarity of estimates of effect across studies. If there is important unexplained inconsistency in the results, our confidence in the estimate of effect for that outcome decreases. Differences in the direction of effect, the size of the differences in effect and the significance of the differences guide the decision about whether important inconsistency exists.
Directness refers to the extent to which the people interventions and outcome measures are similar to those of interest. For example, there may be uncertainty about the directness of the evidence if the people of interest are older, sicker or have more comorbidity than those in the studies.
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence. (11)
GRADE Quality of Studies
Economic Analysis - Literature Review
No economic analysis of EECP was identified in the published literature.
Estimated Prevalence of Angina in Ontario
3,800 patients with chronic refractory angina:
The number of patients with chronic refractory angina in the US is estimated to be approximately 100,000 (4), this corresponds to about 3,800 patients in Ontario (3.8% × 100,000) with refractory angina.
3,800 patients × $7,000 Cdn (approximate cost for a full course of therapy) ~ $26.6M Cdn.
Estimated Prevalence of Heart Failure in Ontario
23,700 patients EF ≤ 0.35:
This estimate is from an expert (personal communication) at the Institute for Clinical Evaluative Sciences (ICES), where they examined a sample of echocardiography studies drawn from a diagnostic lab in 2001. They found that the prevalence of EF ≤ 0.35 was 8.3%, and if generalized to all patients undergoing echocardiography, there would be 23,700 patients.
23,700 patients with EF ≤35% × $7,000 Cdn ~ $166 M Cdn.
Conclusions
There is insufficient evidence to support the effectiveness and safety of EECP treatment for patients with refractory stable CCS III-IV angina or HF.
As per the GRADE Working Group, overall recommendations consider 4 main factors. (11)
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence.
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. (11) Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 2 is the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For angina and heart failure, the overall GRADE and strength of the recommendations is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $26.6 M Cdn or $166 M Cdn respectively while the cost-effectiveness of EECP is unknown and difficult to estimate considering that there are no high quality studies of effectiveness.
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3379533  PMID: 23074496
5.  Socioeconomic Factors and All Cause and Cause-Specific Mortality among Older People in Latin America, India, and China: A Population-Based Cohort Study 
PLoS Medicine  2012;9(2):e1001179.
Cleusa Ferri and colleagues studied mortality rates in over 12,000 people aged 65 years and over in Latin America, India, and China and showed that chronic diseases are the main causes of death and that education has an important effect on mortality.
Background
Even in low and middle income countries most deaths occur in older adults. In Europe, the effects of better education and home ownership upon mortality seem to persist into old age, but these effects may not generalise to LMICs. Reliable data on causes and determinants of mortality are lacking.
Methods and Findings
The vital status of 12,373 people aged 65 y and over was determined 3–5 y after baseline survey in sites in Latin America, India, and China. We report crude and standardised mortality rates, standardized mortality ratios comparing mortality experience with that in the United States, and estimated associations with socioeconomic factors using Cox's proportional hazards regression. Cause-specific mortality fractions were estimated using the InterVA algorithm. Crude mortality rates varied from 27.3 to 70.0 per 1,000 person-years, a 3-fold variation persisting after standardisation for demographic and economic factors. Compared with the US, mortality was much higher in urban India and rural China, much lower in Peru, Venezuela, and urban Mexico, and similar in other sites. Mortality rates were higher among men, and increased with age. Adjusting for these effects, it was found that education, occupational attainment, assets, and pension receipt were all inversely associated with mortality, and food insecurity positively associated. Mutually adjusted, only education remained protective (pooled hazard ratio 0.93, 95% CI 0.89–0.98). Most deaths occurred at home, but, except in India, most individuals received medical attention during their final illness. Chronic diseases were the main causes of death, together with tuberculosis and liver disease, with stroke the leading cause in nearly all sites.
Conclusions
Education seems to have an important latent effect on mortality into late life. However, compositional differences in socioeconomic position do not explain differences in mortality between sites. Social protection for older people, and the effectiveness of health systems in preventing and treating chronic disease, may be as important as economic and human development.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, half of all deaths occur in people aged 60 or older. Yet mortality among older people is a neglected topic in global health. In high income countries, where 84% of people do not die until they are aged 65 years or older, the causes of death among older people and the factors (determinants) that affect their risk of dying are well documented. In Europe, for example, the leading causes of death among older people are heart disease, stroke, and other chronic (long-term) diseases. Moreover, as in younger age groups, having a better education and owning a house reduces the risk of death among older people. By contrast, in low and middle income countries (LMICs), where three-quarters of deaths of older people occur, reliable data on the causes and determinants of death among older people are lacking, in part because many LMICs have inadequate vital registration systems—official records of all births and deaths.
Why Was This Study Done?
In many LMICs, chronic diseases are replacing communicable (infectious) diseases as the leading causes of death and disability—health experts call this the epidemiological transition (epidemiology is the study of the distribution and causes of disease in populations)—and the average age of the population is increasing (the demographic transition). Faced with these changes, which occur when countries move from a pre-industrial to an industrial economy, policy makers in LMICs need to introduce measures to improve health and reduce deaths among older people. However, to do this, they need reliable data on the causes and determinants of death in this section of the population. In this longitudinal population-based cohort study (a type of study that follows a group of people from a defined population over time), researchers from the 10/66 Dementia Research Group, which is carrying out population-based research on dementia, aging, and non-communicable diseases in LMICs, investigate the patterns of mortality among older people living in Latin America, India, and China.
What Did the Researchers Do and Find?
Between 2003 and 2005, the researchers completed a baseline survey of people aged 65 years or older living in six Latin American LMICs, China, and India. Three to five years later, they determined the vital status of 12,373 of the study participants (that is, they determined whether the individual was alive or dead) and interviewed a key informant (usually a relative) about each death using a standardized “verbal autopsy” questionnaire that includes questions about date and place of death, and about medical help-seeking and signs and symptoms noted during the final illness. Finally, they used a tool called the InterVA algorithm to calculate the most likely causes of death from the verbal autopsies. Crude mortality rates varied from 27.3 per 1,000 person-years in urban Peru to 70.0 per 1,000 person-years in urban India, a three-fold difference in mortality rates that persisted even after allowing for differences in age, sex, education, occupational attainment, and number of assets among the study sites. Compared to the US, mortality rates were much higher in urban India and rural China; much lower in urban and rural Peru, Venezuela, and urban Mexico; but similar elsewhere. Although several socioeconomic factors were associated with mortality, only a higher education status provided consistent independent protection against death in statistical analyses. Finally, chronic diseases were the main causes of death; stroke was the leading cause of death at all the sites except those in rural Peru and Mexico.
What Do These Findings Mean?
These findings identify the main causes of death among older adults in a range of LMICs and suggest that there is an association of education with mortality that extends into later life. However, these findings may not be generalizable to other LMICs or even to other sites in the LMICs studied, and because some of the information provided by key informants may have been affected by recall error, the accuracy of the findings may be limited. Nevertheless, these findings suggest how health and mortality might be improved in elderly people in LMICs. Specifically, they suggest that efforts to ensure universal access to education should confer substantial health benefits and that interventions that target social and economic vulnerability in later life and promote access to effectively organized health care (particularly for stroke) should be considered.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001179.
The World Health Organization provides information on mortality around the world and projections of global mortality up to 2030
The 10/66 Dementia Research Group is building an evidence base to inform the development and implementation of policies for improving the health and social welfare of older people in LMICs, particularly people with dementia; its website includes background information about demographic and epidemiological aging in LMICs
Wikipedia has a page on the demographic transition (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
Information about the InterVA tool for interpreting verbal autopsy data is available
The US Centers for Disease Control and Prevention has information about healthy aging
doi:10.1371/journal.pmed.1001179
PMCID: PMC3289608  PMID: 22389633
6.  Biventricular Pacing (Cardiac Resynchronization Therapy) 
Executive Summary
Issue
In 2002, (before the establishment of the Ontario Health Technology Advisory Committee), the Medical Advisory Secretariat conducted a health technology policy assessment on biventricular (BiV) pacing, also called cardiac resynchronization therapy (CRT). The goal of treatment with BiV pacing is to improve cardiac output for people in heart failure (HF) with conduction defect on ECG (wide QRS interval) by synchronizing ventricular contraction. The Medical Advisory Secretariat concluded that there was evidence of short (6 months) and longer-term (12 months) effectiveness in terms of cardiac function and quality of life (QoL). More recently, a hospital submitted an application to the Ontario Health Technology Advisory Committee to review CRT, and the Medical Advisory Secretariat subsequently updated its health technology assessment.
Background
Chronic HF results from any structural or functional cardiac disorder that impairs the ability of the heart to act as a pump. It is estimated that 1% to 5% of the general population (all ages) in Europe have chronic HF. (1;2) About one-half of the patients with HF are women, and about 40% of men and 60% of women with this condition are aged older than 75 years.
The incidence (i.e., the number of new cases in a specified period) of chronic HF is age dependent: from 1 to 5 per 1,000 people each year in the total population, to as high as 30 to 40 per 1,000 people each year in those aged 75 years and older. Hence, in an aging society, the prevalence (i.e., the number of people with a given disease or condition at any time) of HF is increasing, despite a reduction in cardiovascular mortality.
A recent study revealed 28,702 patients were hospitalized for first-time HF in Ontario between April 1994 and March 1997. (3) Women comprised 51% of the cohort. Eighty-five percent were aged 65 years or older, and 58% were aged 75 years or older.
Patients with chronic HF experience shortness of breath, a limited capacity for exercise, high rates of hospitalization and rehospitalization, and die prematurely. (2;4) The New York Heart Association (NYHA) has provided a commonly used functional classification for the severity of HF (2;5):
Class I: No limitation of physical activity. No symptoms with ordinary exertion.
Class II: Slight limitations of physical activity. Ordinary activity causes symptoms.
Class III: Marked limitation of physical activity. Less than ordinary activity causes symptoms. Asymptomatic at rest.
Class IV: Inability to carry out any physical activity without discomfort. Symptoms at rest.
The National Heart, Lung, and Blood Institute estimates that 35% of patients with HF are in functional NYHA class I; 35% are in class II; 25%, class III; and 5%, class IV. (5) Surveys (2) suggest that from 5% to 15% of patients with HF have persistent severe symptoms, and that the remainder of patients with HF is evenly divided between those with mild and moderately severe symptoms.
Overall, patients with chronic, stable HF have an annual mortality rate of about 10%. (2) One-third of patients with new-onset HF will die within 6 months of diagnosis. These patients do not survive to enter the pool of those with “chronic” HF. About 60% of patients with incident HF will die within 3 years, and there is limited evidence that the overall prognosis has improved in the last 15 years.
To date, the diagnosis and management of chronic HF has concentrated on patients with the clinical syndrome of HF accompanied by severe left ventricular systolic dysfunction. Major changes in treatment have resulted from a better understanding of the pathophysiology of HF and the results of large clinical trials. Treatment for chronic HF includes lifestyle management, drugs, cardiac surgery, or implantable pacemakers and defibrillators. Despite pharmacologic advances, which include diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, spironolactone, and digoxin, many patients remain symptomatic on maximally tolerated doses.
The Technology
Owing to the limitations of drug therapy, cardiac transplantation and device therapies have been used to try to improve QoL and survival of patients with chronic HF. Ventricular pacing is an emerging treatment option for patients with severe HF that does not respond well to medical therapy. Traditionally, indications for pacing include bradyarrhythmia, sick sinus syndrome, atrioventricular block, and other indications, including combined sick sinus syndrome with atrioventricular block and neurocardiogenic syncope. Recently, BiV pacing as a new, adjuvant therapy for patients with chronic HF and mechanical dyssynchrony has been investigated. Ventricular dysfunction is a sign of HF; and, if associated with severe intraventricular conduction delay, it can cause dyssynchronous ventricular contractions resulting in decreased ventricular filling. The therapeutic intent is to activate both ventricles simultaneously, thereby improving the mechanical efficiency of the ventricles.
About 30% of patients with chronic HF have intraventricular conduction defects. (6) These conduction abnormalities progress over time and lead to discoordinated contraction of an already hemodynamically compromised ventricle. Intraventricular conduction delay has been associated with clinical instability and an increased risk of death in patients with HF. (7) Hence, BiV pacing, which involves pacing left and right ventricles simultaneously, may provide a more coordinated pattern of ventricular contraction and thereby potentially reduce QRS duration, and intraventricular and interventricular asynchrony. People with advanced chronic HF, a wide QRS complex (i.e., the portion of the electrocardiogram comprising the Q, R, and S waves, together representing ventricular depolarization), low left ventricular ejection fraction and contraction dyssynchrony in a viable myocardium and normal sinus rhythm, are the target patients group for BiV pacing. One-half of all deaths in HF patients are sudden, and the mode of death is arrhythmic in most cases. Internal cardioverter defibrillators (ICDs) combined with BiV pacemakers are therefore being increasingly considered for patients with HF who are at high risk of sudden death.
Current Implantation Technique for Cardiac Resynchronization
Conventional dual-chamber pacemakers have only 2 leads: 1 placed in the right atrium and the other in the right ventricle. The technique used for BiV pacemaker implantation also uses right atrial and ventricular pacing leads, in addition to a left ventricle lead advanced through the coronary sinus into a vein that runs along the ventricular free wall. This permits simultaneous pacing of both ventricles to allow resynchronization of the left ventricle septum and free wall.
Mode of Operation
Permanent pacing systems consist of an implantable pulse generator that contains a battery and electronic circuitry, together with 1 (single-chamber pacemaker) or 2 (dual-chamber pacemaker) leads. Leads conduct intrinsic atrial or ventricular signals to the sensing circuitry and deliver the pulse generator charge to the myocardium (muscle of the heart).
Complications of Biventricular Pacemaker Implantation
The complications that may arise when a BiV pacemaker is implanted are similar to those that occur with standard pacemaker implantation, including pneumothorax, perforation of the great vessels or the myocardium, air embolus, infection, bleeding, and arrhythmias. Moreover, left ventricular pacing through the coronary sinus can be associated with rupture of the sinus as another complication.
Conclusion of 2003 Review of Biventricular Pacemakers by the Medical Advisory Secretariat
The randomized controlled trials (RCTs) the Medical Advisory Secretariat retrieved analyzed chronic HF patients that were assessed for up to 6 months. Other studies have been prospective, but nonrandomized, not double-blinded, uncontrolled and/or have had a limited or uncalculated sample size. Short-term studies have focused on acute hemodynamic analyses. The authors of the RCTs reported improved cardiac function and QoL up to 6 months after BiV pacemaker implantation; therefore, there is level 1 evidence that patients in ventricular dyssynchrony who remain symptomatic after medication might benefit from this technology. Based on evidence made available to the Medical Advisory Secretariat by a manufacturer, (8) it appears that these 6-month improvements are maintained at 12-month follow-up.
To date, however, there is insufficient evidence to support the routine use of combined ICD/BiV devices in patients with chronic HF with prolonged QRS intervals.
Summary of Updated Findings Since the 2003 Review
Since the Medical Advisory Secretariat’s review in 2003 of biventricular pacemakers, 2 large RCTs have been published: COMPANION (9) and CARE-HF. (10) The characteristics of each trial are shown in Table 1. The COMPANION trial had a number of major methodological limitations compared with the CARE-HF trial.
Characteristics of the COMPANION and CARE-HF Trials*
COMPANION; (9) CARE-HF. (10)
BiV indicates biventricular; ICD, implantable cardioverter defibrillator; EF, ejection fraction; QRS, the interval representing the Q, R and S waves on an electrocardiogram; FDA, United States Food and Drug Administration.
Overall, CARE-HF showed that BiV pacing significantly improves mortality, QoL, and NYHA class in patients with severe HF and a wide QRS interval (Tables 2 and 3).
CARE-HF Results: Primary and Secondary Endpoints*
BiV indicates biventricular; NNT, number needed to treat.
Cleland JGF, Daubert J, Erdmann E, Freemantle N, Gras D, Kappenberger L et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure (CARE-HF). New England Journal of Medicine 2005; 352:1539-1549; Copyright 2003 Massachusettes Medical Society. All rights reserved. (10)
CARE H-F Results: NYHA Class and Quality of Life Scores*
Minnesota Living with Heart Failure scores range from 0 to 105; higher scores reflect poorer QoL.
European Quality of Life–5 Dimensions scores range from -0.594 to 1.000; 1.000 indicates fully healthy; 0, dead
Cleland JGF, Daubert J, Erdmann E, Freemantle N, Gras D, Kappenberger L et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure (CARE-HF). New England Journal of Medicine 2005; 352:1539-1549; Copyright 2005 Massachusettes Medical Society. All rights reserved.(10)
GRADE Quality of Evidence
The quality of these 3 trials was examined according to the GRADE Working Group criteria, (12) (Table 4).
Quality refers to criteria such as the adequacy of allocation concealment, blinding, and follow-up.
Consistency refers to the similarity of estimates of effect across studies. If there is an important unexplained inconsistency in the results, confidence in the estimate of effect for that outcome decreases. Differences in the direction of effect, the size of the differences in effect, and the significance of the differences guide the decision about whether important inconsistency exists.
Directness refers to the extent to which the people interventions and outcome measures are similar to those of interest. For example, there may be uncertainty about the directness of the evidence if the people of interest are older, sicker, or have more comorbid conditions than do the people in the studies.
As stated by the GRADE Working Group, (12) the following definitions were used in grading the quality of the evidence:
High: Further research is very unlikely to change our confidence on the estimate of effect.
Moderate: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low: Any estimate of effect is very uncertain.
Quality of Evidence: CARE-HF and COMPANION
Conclusions
Overall, there is evidence that BiV pacemakers are effective for improving mortality, QoL, and functional status in patients with NYHA class III/IV HF, an EF less than 0.35, a QRS interval greater than 120 ms, who are refractory to drug therapy.
As per the GRADE Working Group, recommendations considered the following 4 main factors:
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates, and the relative value placed on the outcome
The quality of the evidence (Table 4)
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise
Uncertainty about the baseline risk for the population of interest
The GRADE Working Group also recommends that incremental costs of health care alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 5 shows the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For BiV pacing, the overall GRADE and strength of the recommendation is moderate: the quality of the evidence is moderate/high (because of some uncertainty due to methodological limitations in the study design, e.g., no blinding), but there is also some risk/uncertainty in terms of the estimated prevalence and wide cost-effectiveness estimates (Table 5).
For the combination BiV pacing/ICD, the overall GRADE and strength of the recommendation is weak—the quality of the evidence is low (because of uncertainty due to methodological limitations in the study design), but there is also some risk/uncertainty in terms of the estimated prevalence, high cost, and high budget impact (Table 5). There are indirect, low-quality comparisons of the effectiveness of BiV pacemakers compared with the combination BiV/ICD devices.
A stronger recommendation can be made for BiV pacing only compared with the combination BiV/ICD device for patients with an EF less than or equal to 0.35, and a QRS interval over or equal to 120 ms, and NYHA III/IV symptoms, and refractory to optimal medical therapy (Table 5).
There is moderate/high-quality evidence that BiV pacemakers significantly improve mortality, QoL, and functional status.
There is low-quality evidence that combined BiV/ICD devices significantly improve mortality, QoL, and functional status.
To date, there are no direct comparisons of the effectiveness of BiV pacemakers compared with the combined BiV/ICD devices in terms of mortality, QoL, and functional status.
Overall GRADE and Strength of Recommendation
BiV refers to biventricular; ICD, implantable cardioverter defibrillator; NNT, number needed to treat.
PMCID: PMC3382419  PMID: 23074464
7.  Prevalence, Distribution, and Impact of Mild Cognitive Impairment in Latin America, China, and India: A 10/66 Population-Based Study 
PLoS Medicine  2012;9(2):e1001170.
A set of cross-sectional surveys carried out in Cuba, Dominican Republic, Peru, Mexico, Venezuela, Puerto Rico, China, and India reveal the prevalence and between-country variation in mild cognitive impairment at a population level.
Background
Rapid demographic ageing is a growing public health issue in many low- and middle-income countries (LAMICs). Mild cognitive impairment (MCI) is a construct frequently used to define groups of people who may be at risk of developing dementia, crucial for targeting preventative interventions. However, little is known about the prevalence or impact of MCI in LAMIC settings.
Methods and Findings
Data were analysed from cross-sectional surveys established by the 10/66 Dementia Research Group and carried out in Cuba, Dominican Republic, Peru, Mexico, Venezuela, Puerto Rico, China, and India on 15,376 individuals aged 65+ without dementia. Standardised assessments of mental and physical health, and cognitive function were carried out including informant interviews. An algorithm was developed to define Mayo Clinic amnestic MCI (aMCI). Disability (12-item World Health Organization disability assessment schedule [WHODAS]) and informant-reported neuropsychiatric symptoms (neuropsychiatric inventory [NPI-Q]) were measured. After adjustment, aMCI was associated with disability, anxiety, apathy, and irritability (but not depression); between-country heterogeneity in these associations was only significant for disability. The crude prevalence of aMCI ranged from 0.8% in China to 4.3% in India. Country differences changed little (range 0.6%–4.6%) after standardization for age, gender, and education level. In pooled estimates, aMCI was modestly associated with male gender and fewer assets but was not associated with age or education. There was no significant between-country variation in these demographic associations.
Conclusions
An algorithm-derived diagnosis of aMCI showed few sociodemographic associations but was consistently associated with higher disability and neuropsychiatric symptoms in addition to showing substantial variation in prevalence across LAMIC populations. Longitudinal data are needed to confirm findings—in particular, to investigate the predictive validity of aMCI in these settings and risk/protective factors for progression to dementia; however, the large number affected has important implications in these rapidly ageing settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Currently, more than 35 million people worldwide have dementia, a group of brain disorders characterized by an irreversible decline in memory, problem solving, communication, and other “cognitive” functions. Dementia, the commonest form of which is Alzheimer's disease, mainly affects older people and, because more people than ever are living to a ripe old age, experts estimate that, by 2050, more than 115 million people will have dementia. At present, there is no cure for dementia although drugs can be used to manage some of the symptoms. Risk factors for dementia include physical inactivity, infrequent participation in mentally or socially stimulating activities, and common vascular risk factors such as high blood pressure, diabetes, and smoking. In addition, some studies have reported that mild cognitive impairment (MCI) is associated with an increased risk of dementia. MCI can be seen as an intermediate state between normal cognitive aging (becoming increasingly forgetful) and dementia although many people with MCI never develop dementia, and some types of MCI can be static or self-limiting. Individuals with MCI have cognitive problems that are more severe than those normally seen in people of a similar age but they have no other symptoms of dementia and are able to look after themselves. The best studied form of MCI—amnestic MCI (aMCI)—is characterized by memory problems such as misplacing things and forgetting appointments.
Why Was This Study Done?
Much of the expected increase in dementia will occur in low and middle income countries (LAMICs) because these countries have rapidly aging populations. Given that aMCI is frequently used to define groups of people who may be at risk of developing dementia, it would be useful to know what proportion of community-dwelling older adults in LAMICs have aMCI (the prevalence of aMCI). Such information might help governments plan their future health care and social support needs. In this cross-sectional, population-based study, the researchers estimate the prevalence of aMCI in eight LAMICs using data collected by the 10/66 Dementia Research Group. They also investigate the association of aMCI with sociodemographic factors (for example, age, gender, and education), disability, and neuropsychiatric symptoms such as anxiety, apathy, irritability, and depression. A cross-sectional study collects data on a population at a single time point; the 10/66 Dementia Research Group is building an evidence base to inform the development and implementation of policies for improving the health and social welfare of older people in LAMICs, particularly people with dementia.
What Did the Researchers Do and Find?
In cross-sectional surveys carried out in six Latin American LAMICS, China, and India, more than 15,000 elderly individuals without dementia completed standardized assessments of their mental and physical health and their cognitive function. Interviews with relatives and carers provided further details about the participant's cognitive decline and about neuropsychiatric symptoms. The researchers developed an algorithm (set of formulae) that used the data collected in these surveys to diagnose aMCI in the study participants. Finally, they used statistical methods to analyze the prevalence, distribution, and impact of aMCI in the eight LAMICs. The researchers report that aMCI was associated with disability, anxiety, apathy, and irritability but not with depression and that the prevalence of aMCI ranged from 0.8% in China to 4.3% in India. Other analyses show that, considered across all eight countries, aMCI was modestly associated with being male (men had a slightly higher prevalence of aMCI than women) and with having fewer assets but was not associated with age or education.
What Do These Findings Mean?
These findings suggest that aMCI, as diagnosed using the algorithm developed by the researchers, is consistently associated with higher disability and with neuropsychiatric symptoms in the LAMICs studied but not with most sociodemographic factors. Because prevalidated and standardized measurements were applied consistently in all the countries and a common algorithm was used to define aMCI, these findings also suggest that the prevalence of aMCI varies markedly among LAMIC populations and is similar to or slightly lower than the prevalence most often reported for European and North American populations. Although longitudinal studies are now needed to investigate the extent to which aMCI can be used as risk marker for further cognitive decline and dementia in these settings, the large absolute numbers of older people with aMCI in LAMICs revealed here potentially has important implications for health care and social service planning in these rapidly aging and populous regions of the world.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001170.
Alzheimer's Disease International is the international federation of Alzheimer associations around the world; it provides links to individual associations, information about dementia, and links to three World Alzheimer Reports; information about the 10/66 Dementia Research Group is also available on this web site
The Alzheimer's Society provides information for patients and carers about dementia, including information on MCI and personal stories about living with dementia
The Alzheimer's Association also provides information for patients and carers about dementia and about MCI, and personal stories about dementia
A BBC radio program that includes an interview with a man with MCI is available
MedlinePlus provides links to further resources about MCI and dementia (in English and Spanish)
doi:10.1371/journal.pmed.1001170
PMCID: PMC3274506  PMID: 22346736
8.  Individual socio-demographic factors and perceptions of the environment as determinants of inequalities in adolescent physical and psychological health: the Olympic Regeneration in East London (ORiEL) study 
BMC Public Health  2015;15:150.
Background
Populations living in urban areas experience greater health inequalities as well as higher absolute burdens of illness. It is well-established that a range of social and environmental factors determine these differences. Less is known about the relative importance of these factors in determining adolescent health within a super diverse urban context.
Methods
A cross-sectional sample of 3,105 adolescent participants aged 11 to 12 were recruited from 25 schools in the London boroughs of Newham, Tower Hamlets, Hackney and Barking & Dagenham. Participants completed a pseudo-anonymised paper-based questionnaire incorporating: the Warwick-Edinburgh Mental Well-being Scale used for assessing positive mental well-being, the Short Moods and Feelings Questionnaire based on the DSM III-R criteria for assessment of depressive symptoms, the Youth-Physical Activity Questionnaire and a self-assessment of general health and longstanding illness. Prevalence estimates and unadjusted linear models estimate the extent to which positive well-being scores and time spent in physical/sedentary activity vary by socio-demographic and environmental indicators. Logistic regression estimated the unadjusted odds of having fair/(very)poor general health, a long standing illness, or depressive symptoms. Fully adjusted mixed effects models accounted for clustering within schools and for all socio-demographic and environmental indicators.
Results
Compared to boys, girls had significantly lower mental well-being and higher rates of depressive symptoms, reported fewer hours physically active and more hours sedentary, and had poorer general health after full adjustment. Positive mental well-being was significantly and positively associated with family affluence but the overall relationship between mental health and socioeconomic factors was weak. Mental health advantage increased as positive perceptions of the neighbourhood safety, aesthetics, walkability and services increased. Prevalence of poor health varied by ethnic group, particularly for depressive symptoms, general health and longstanding illness suggesting differences in the distribution of the determinants of health across ethnic groups.
Conclusions
During adolescence perceptions of the urban physical environment, along with the social and economic characteristics of their household, are important factors in explaining patterns of health inequality.
doi:10.1186/s12889-015-1459-1
PMCID: PMC4339478  PMID: 25884502
Public health; Adolescent; Health inequalities; East London; Social determinants; Neighbourhood; Mental health; Physical activity; Self-rated general health; Longstanding illness
9.  Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this analysis was to determine the effectiveness of the influenza vaccination and the pneumococcal vaccination in patients with chronic obstructive pulmonary disease (COPD) in reducing the incidence of influenza-related illness or pneumococcal pneumonia.
Clinical Need: Condition and Target Population
Influenza Disease
Influenza is a global threat. It is believed that the risk of a pandemic of influenza still exists. Three pandemics occurred in the 20th century which resulted in millions of deaths worldwide. The fourth pandemic of H1N1 influenza occurred in 2009 and affected countries in all continents.
Rates of serious illness due to influenza viruses are high among older people and patients with chronic conditions such as COPD. The influenza viruses spread from person to person through sneezing and coughing. Infected persons can transfer the virus even a day before their symptoms start. The incubation period is 1 to 4 days with a mean of 2 days. Symptoms of influenza infection include fever, shivering, dry cough, headache, runny or stuffy nose, muscle ache, and sore throat. Other symptoms such as nausea, vomiting, and diarrhea can occur.
Complications of influenza infection include viral pneumonia, secondary bacterial pneumonia, and other secondary bacterial infections such as bronchitis, sinusitis, and otitis media. In viral pneumonia, patients develop acute fever and dyspnea, and may further show signs and symptoms of hypoxia. The organisms involved in bacterial pneumonia are commonly identified as Staphylococcus aureus and Hemophilus influenza. The incidence of secondary bacterial pneumonia is most common in the elderly and those with underlying conditions such as congestive heart disease and chronic bronchitis.
Healthy people usually recover within one week but in very young or very old people and those with underlying medical conditions such as COPD, heart disease, diabetes, and cancer, influenza is associated with higher risks and may lead to hospitalization and in some cases death. The cause of hospitalization or death in many cases is viral pneumonia or secondary bacterial pneumonia. Influenza infection can lead to the exacerbation of COPD or an underlying heart disease.
Streptococcal Pneumonia
Streptococcus pneumoniae, also known as pneumococcus, is an encapsulated Gram-positive bacterium that often colonizes in the nasopharynx of healthy children and adults. Pneumococcus can be transmitted from person to person during close contact. The bacteria can cause illnesses such as otitis media and sinusitis, and may become more aggressive and affect other areas of the body such as the lungs, brain, joints, and blood stream. More severe infections caused by pneumococcus are pneumonia, bacterial sepsis, meningitis, peritonitis, arthritis, osteomyelitis, and in rare cases, endocarditis and pericarditis.
People with impaired immune systems are susceptible to pneumococcal infection. Young children, elderly people, patients with underlying medical conditions including chronic lung or heart disease, human immunodeficiency virus (HIV) infection, sickle cell disease, and people who have undergone a splenectomy are at a higher risk for acquiring pneumococcal pneumonia.
Technology
Influenza and Pneumococcal Vaccines
Trivalent Influenza Vaccines in Canada
In Canada, 5 trivalent influenza vaccines are currently authorized for use by injection. Four of these are formulated for intramuscular use and the fifth product (Intanza®) is formulated for intradermal use.
The 4 vaccines for intramuscular use are:
Fluviral (GlaxoSmithKline), split virus, inactivated vaccine, for use in adults and children ≥ 6 months;
Vaxigrip (Sanofi Pasteur), split virus inactivated vaccine, for use in adults and children ≥ 6 months;
Agriflu (Novartis), surface antigen inactivated vaccine, for use in adults and children ≥ 6 months; and
Influvac (Abbott), surface antigen inactivated vaccine, for use in persons ≥ 18 years of age.
FluMist is a live attenuated virus in the form of an intranasal spray for persons aged 2 to 59 years. Immunization with current available influenza vaccines is not recommended for infants less than 6 months of age.
Pneumococcal Vaccine
Pneumococcal polysaccharide vaccines were developed more than 50 years ago and have progressed from 2-valent vaccines to the current 23-valent vaccines to prevent diseases caused by 23 of the most common serotypes of S pneumoniae. Canada-wide estimates suggest that approximately 90% of cases of pneumococcal bacteremia and meningitis are caused by these 23 serotypes. Health Canada has issued licenses for 2 types of 23-valent vaccines to be injected intramuscularly or subcutaneously:
Pneumovax 23® (Merck & Co Inc. Whitehouse Station, NJ, USA), and
Pneumo 23® (Sanofi Pasteur SA, Lion, France) for persons 2 years of age and older.
Other types of pneumococcal vaccines licensed in Canada are for pediatric use. Pneumococcal polysaccharide vaccine is injected only once. A second dose is applied only in some conditions.
Research Questions
What is the effectiveness of the influenza vaccination and the pneumococcal vaccination compared with no vaccination in COPD patients?
What is the safety of these 2 vaccines in COPD patients?
What is the budget impact and cost-effectiveness of these 2 vaccines in COPD patients?
Research Methods
Literature search
Search Strategy
A literature search was performed on July 5, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2000 to July 5, 2010. The search was updated monthly through the AutoAlert function of the search up to January 31, 2011. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established. Data extraction was carried out by the author.
Inclusion Criteria
studies comparing clinical efficacy of the influenza vaccine or the pneumococcal vaccine with no vaccine or placebo;
randomized controlled trials published between January 1, 2000 and January 31, 2011;
studies including patients with COPD only;
studies investigating the efficacy of types of vaccines approved by Health Canada;
English language studies.
Exclusion Criteria
non-randomized controlled trials;
studies investigating vaccines for other diseases;
studies comparing different variations of vaccines;
studies in which patients received 2 or more types of vaccines;
studies comparing different routes of administering vaccines;
studies not reporting clinical efficacy of the vaccine or reporting immune response only;
studies investigating the efficacy of vaccines not approved by Health Canada.
Outcomes of Interest
Primary Outcomes
Influenza vaccination: Episodes of acute respiratory illness due to the influenza virus.
Pneumococcal vaccination: Time to the first episode of community-acquired pneumonia either due to pneumococcus or of unknown etiology.
Secondary Outcomes
rate of hospitalization and mechanical ventilation
mortality rate
adverse events
Quality of Evidence
The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses. The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Efficacy of the Influenza Vaccination in Immunocompetent Patients With COPD
Clinical Effectiveness
The influenza vaccination was associated with significantly fewer episodes of influenza-related acute respiratory illness (ARI). The incidence density of influenza-related ARI was:
All patients: vaccine group: (total of 4 cases) = 6.8 episodes per 100 person-years; placebo group: (total of 17 cases) = 28.1 episodes per 100 person-years, (relative risk [RR], 0.2; 95% confidence interval [CI], 0.06−0.70; P = 0.005).
Patients with severe airflow obstruction (forced expiratory volume in 1 second [FEV1] < 50% predicted): vaccine group: (total of 1 case) = 4.6 episodes per 100 person-years; placebo group: (total of 7 cases) = 31.2 episodes per 100 person-years, (RR, 0.1; 95% CI, 0.003−1.1; P = 0.04).
Patients with moderate airflow obstruction (FEV1 50%−69% predicted): vaccine group: (total of 2 cases) = 13.2 episodes per 100 person-years; placebo group: (total of 4 cases) = 23.8 episodes per 100 person-years, (RR, 0.5; 95% CI, 0.05−3.8; P = 0.5).
Patients with mild airflow obstruction (FEV1 ≥ 70% predicted): vaccine group: (total of 1 case) = 4.5 episodes per 100 person-years; placebo group: (total of 6 cases) = 28.2 episodes per 100 person-years, (RR, 0.2; 95% CI, 0.003−1.3; P = 0.06).
The Kaplan-Meier survival analysis showed a significant difference between the vaccinated group and the placebo group regarding the probability of not acquiring influenza-related ARI (log-rank test P value = 0.003). Overall, the vaccine effectiveness was 76%. For categories of mild, moderate, or severe COPD the vaccine effectiveness was 84%, 45%, and 85% respectively.
With respect to hospitalization, fewer patients in the vaccine group compared with the placebo group were hospitalized due to influenza-related ARIs, although these differences were not statistically significant. The incidence density of influenza-related ARIs that required hospitalization was 3.4 episodes per 100 person-years in the vaccine group and 8.3 episodes per 100 person-years in the placebo group (RR, 0.4; 95% CI, 0.04−2.5; P = 0.3; log-rank test P value = 0.2). Also, no statistically significant differences between the 2 groups were observed for the 3 categories of severity of COPD.
Fewer patients in the vaccine group compared with the placebo group required mechanical ventilation due to influenza-related ARIs. However, these differences were not statistically significant. The incidence density of influenza-related ARIs that required mechanical ventilation was 0 episodes per 100 person-years in the vaccine group and 5 episodes per 100 person-years in the placebo group (RR, 0.0; 95% CI, 0−2.5; P = 0.1; log-rank test P value = 0.4). In addition, no statistically significant differences between the 2 groups were observed for the 3 categories of severity of COPD. The effectiveness of the influenza vaccine in preventing influenza-related ARIs and influenza-related hospitalization was not related to age, sex, severity of COPD, smoking status, or comorbid diseases.
safety
Overall, significantly more patients in the vaccine group than the placebo group experienced local adverse reactions (vaccine: 17 [27%], placebo: 4 [6%]; P = 0.002). Significantly more patients in the vaccine group than the placebo group experienced swelling (vaccine 4, placebo 0; P = 0.04) and itching (vaccine 4, placebo 0; P = 0.04). Systemic reactions included headache, myalgia, fever, and skin rash and there were no significant differences between the 2 groups for these reactions (vaccine: 47 [76%], placebo: 51 [81%], P = 0.5).
With respect to lung function, dyspneic symptoms, and exercise capacity, there were no significant differences between the 2 groups at 1 week and at 4 weeks in: FEV1, maximum inspiratory pressure at residual volume, oxygen saturation level of arterial blood, visual analogue scale for dyspneic symptoms, and the 6 Minute Walking Test for exercise capacity.
There was no significant difference between the 2 groups with regard to the probability of not acquiring total ARIs (influenza-related and/or non-influenza-related); (log-rank test P value = 0.6).
Summary of Efficacy of the Pneumococcal Vaccination in Immunocompetent Patients With COPD
Clinical Effectiveness
The Kaplan-Meier survival analysis showed no significant differences between the group receiving the penumoccocal vaccination and the control group for time to the first episode of community-acquired pneumonia due to pneumococcus or of unknown etiology (log-rank test 1.15; P = 0.28). Overall, vaccine efficacy was 24% (95% CI, −24 to 54; P = 0.33).
With respect to the incidence of pneumococcal pneumonia, the Kaplan-Meier survival analysis showed a significant difference between the 2 groups (vaccine: 0/298; control: 5/298; log-rank test 5.03; P = 0.03).
Hospital admission rates and median length of hospital stays were lower in the vaccine group, but the difference was not statistically significant. The mortality rate was not different between the 2 groups.
Subgroup Analysis
The Kaplan-Meier survival analysis showed significant differences between the vaccine and control groups for pneumonia due to pneumococcus and pneumonia of unknown etiology, and when data were analyzed according to subgroups of patients (age < 65 years, and severe airflow obstruction FEV1 < 40% predicted). The accumulated percentage of patients without pneumonia (due to pneumococcus and of unknown etiology) across time was significantly lower in the vaccine group than in the control group in patients younger than 65 years of age (log-rank test 6.68; P = 0.0097) and patients with a FEV1 less than 40% predicted (log-rank test 3.85; P = 0.0498).
Vaccine effectiveness was 76% (95% CI, 20−93; P = 0.01) for patients who were less than 65 years of age and −14% (95% CI, −107 to 38; P = 0.8) for those who were 65 years of age or older. Vaccine effectiveness for patients with a FEV1 less than 40% predicted and FEV1 greater than or equal to 40% predicted was 48% (95% CI, −7 to 80; P = 0.08) and −11% (95% CI, −132 to 47; P = 0.95), respectively. For patients who were less than 65 years of age (FEV1 < 40% predicted), vaccine effectiveness was 91% (95% CI, 35−99; P = 0.002).
Cox modelling showed that the effectiveness of the vaccine was dependent on the age of the patient. The vaccine was not effective in patients 65 years of age or older (hazard ratio, 1.53; 95% CI, 0.61−a2.17; P = 0.66) but it reduced the risk of acquiring pneumonia by 80% in patients less than 65 years of age (hazard ratio, 0.19; 95% CI, 0.06−0.66; P = 0.01).
safety
No patients reported any local or systemic adverse reactions to the vaccine.
PMCID: PMC3384373  PMID: 23074431
10.  Gastric Electrical Stimulation 
Executive Summary
Objective
The objective of this analysis was to assess the effectiveness, safety and cost-effectiveness of gastric electrical stimulation (GES) for the treatment of chronic, symptomatic refractory gastroparesis and morbid obesity.
Background
Gastroparesis - Epidemiology
Gastroparesis (GP) broadly refers to impaired gastric emptying in the absence of obstruction. Clinically, this can range from the incidental detection of delayed gastric emptying in an asymptomatic person to patients with severe nausea, vomiting and malnutrition. Symptoms of GP are nonspecific and may mimic structural disorders such as ulcer disease, partial gastric or small bowel obstruction, gastric cancer, and pancreaticobiliary disorders.
Gastroparesis may occur in association with diabetes, gastric surgery (consequence of peptic ulcer surgery and vagotomy) or for unknown reasons (idiopathic gastroparesis). Symptoms include early satiety, nausea, vomiting, abdominal pain and weight loss. The majority of patients with GP are women.
The relationship between upper gastrointestinal symptoms and the rate of gastric emptying is considered to be weak. Some patients with markedly delayed gastric emptying are asymptomatic and sometimes, severe symptoms may remit spontaneously.
Idiopathic GP may represent the most common form of GP. In one tertiary referral retrospective series, the etiologies in 146 GP patients were 36% idiopathic, 29% diabetic, 13% postgastric surgery, 7.5% Parkinson’s disease, 4.8% collagen vascular disorders, 4.1% intestinal pseudoobstruction and 6% miscellaneous causes.
The true prevalence of digestive symptoms in patients with diabetes and the relationship of these symptoms to delayed gastric emptying are unknown. Delayed gastric emptying is present in 27% to 58% of patients with type 1 diabetes and 30% with type 2 diabetes. However, highly variable rates of gastric emptying have been reported in type 1 and 2 diabetes, suggesting that development of GP in patients with diabetes is neither universal nor inevitable. In a review of studies examining gastric emptying in patients with diabetes compared to control patients, investigators noted that in many cases the magnitude of the delay in gastric emptying is modest.
GP may occur as a complication of a number of different surgical procedures. For example, vagal nerve injury may occur in 4% to 40% of patients who undergo laparoscopic fundoplication1 for gastroesophageal reflux disease.
The prevalence of severe, refractory GP is scantily reported in the literature. Using data from a past study, it has been estimated that the prevalence of severe, symptomatic and refractory GP in the United States population is 0.017%. Assuming an Ontario population of 13 million, this would correspond to approximately 2,000 people in Ontario having severe, symptomatic, refractory GP.
The incidence of severe refractory GP estimated by the United States Food and Drug Administration (FDA) is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year.
Treatment for Gastroparesis
To date, there have been no long-term studies confirming the beneficial effects of maintaining euglycemia on GP symptoms. However, it has been suggested that consistent findings of physiologic studies in healthy volunteers and diabetes patients provides an argument to strive for near-normal blood glucose levels in affected diabetes patients.
Dietary measures (e.g., low fibre, low fat food), prokinetic drugs (e.g., domperidone, metoclopramide and erythromycin) and antiemetic or antinausea drugs (e.g, phenothiazines, diphenhydramine) are generally effective for symptomatic relief in the majority of patients with GP.
For patients with chronic, symptomatic GP who are refractory to drug treatment, surgical options may include jejunostomy tube for feeding, gastrotomy tube for stomach decompression and pyloroplasty for gastric emptying.
Few small studies examined the use of botulinum toxin injections into the pyloric sphincter. However, the contribution of excessive pyloric contraction to GP has been insufficiently defined and there have been no controlled studies of this therapy.
Treatment with GES is reversible and may be a less invasive option compared to stomach surgery for the treatment of patients with chronic, drug-refractory nausea and vomiting secondary to GP. In theory, GES represents an intermediate step between treatment directed at the underlying pathophysiology, and the treatment of symptoms. It is based on studies of gastric electrical patterns in GP that have identified the presence of a variety of gastric arrhythmias. Similar to a cardiac pacemaker, it was hypothesized that GES could override the abnormal rhythms, stimulate gastric emptying and eliminate symptoms.
Morbid Obesity Epidemiology
Obesity is defined as a body mass index (BMI) of at last 30 kg/m2. Morbid obesity is defined as a BMI of at least 40 kg/m2 or at least 35 kg/m2 with comorbid conditions. Comorbid conditions associated with obesity include diabetes, hypertension, dyslipidemias, obstructive sleep apnea, weight-related arthropathies, and stress urinary incontinence.
In the United States, the age-adjusted prevalence of extreme obesity (BMI ≥ 40 kg/m2) for adults aged 20 years and older has increased significantly in the population, from 2.9% (1988–1994) to 4.7% (1999–2000). An expert estimated that about 160,000 to 180,000 people are morbidly obese in Ontario.
Treatment for Morbid Obesity
Diet, exercise, and behavioural therapy are used to help people lose weight.
Bariatric surgery for morbid obesity is considered an intervention of last resort for patients who have attempted first-line forms of medical management.
Gastric stimulation has been investigated for the treatment of morbid obesity; the intention being to reduce appetite and induce early satiety possibly due to inhibitory effects on gastric motility and effects on the central nervous system (CNS) and hormones related to satiety and/or appetite.
Possible advantages to GES for the treatment of morbid obesity include reversibility of the procedure, less invasiveness than some bariatric procedures, e.g., gastric bypass, and less side effects (e.g., dumping syndrome).
The Device
Electrical stimulation is delivered via an implanted system that consists of a neurostimulator and 2 leads. The surgical procedure can be performed via either an open or laparoscopic approach. An external programmer used by the physician can deliver instructions to the GES, i.e., adjust the rate and amplitude of stimulation (Figure 1). GES may be turned off by the physician at any time or may be removed. The battery life is approximately 4-5 years
For treatment of GP, the GES leads are secured in the muscle of the lower stomach, 10 cm proximal to the pylorus (the opening from the stomach to the intestine), 1 cm apart and connected to an implantable battery-powered neurostimulator which is placed in a small pocket in the abdominal wall
For treatment of morbid obesity, GES leads are implanted along the lesser curvature of the stomach where the vagal nerve branches spread, approximately 8 cm proximal to the pylorus. However, the implant positioning of the leads has been variably reported in the literature.
Regulatory Status
The Enterra Therapy System and the Transcend II Implantable Gastric Stimulation System (Medtronic Inc.) are both licensed as class 3 devices by Health Canada (license numbers 60264 and 66948 respectively). The Health Canada indications for use are:
Enterra Therapy System
“For use in the treatment of chronic intractable (drug-refractory) nausea and vomiting.”
Transcend II Implantable Gastric Stimulation System
“For use in weight reduction for obese adults with a body mass index greater than 35.”
The GES device that is licensed by Health Canada for treatment of GP, produces high-frequency GES. Most clinical studies examining GES for GP have used high-frequency (4 times the intrinsic slow wave frequency, i.e., 12 cycles per minute), low energy, short duration pulses. This type of stimulation does not alter gastric muscular contraction and has no effect on slow wave dysrhythmias. The mechanism of action is unclear but it is hypothesized that high-frequency GES may act on sensory fibers directed to the CNS.
The GES device licensed by Health Canada for treatment of morbid obesity produces low-frequency GES, which is close to or just above the normal/native gastric slow wave cycle (approximately 3 cycles/min.). This pacing uses low-frequency, high-energy, long-duration pulses to induce propagated slow waves that replace the spontaneous ones. Low-frequency pacing does not invoke muscular contractions.
Most studies examining the use of GES for the treatment of morbid obesity use low-frequency GES. Under normal circumstances, the gastric slow wave propagates distally and determines the frequency and propagation direction of gastric peristalsis. Low-frequency GES aims to produce abnormal gastric slow waves that can induce gastric dysrhythmia, disrupt regular propagation of slow waves, cause hypomotility of the stomach, delay gastric emptying, reduce food intake, prolong satiety, and produce weight loss.
In the United States, the Enterra Therapy System is a Humanitarian Use Device (HUD), meaning it is a medical device designated by the FDA for use in the treatment of medical conditions that affect fewer than 4,000 individuals per year.2 The Enterra Therapy System is indicated for “the treatment of chronic, drug- refractory nausea and vomiting secondary to GP of diabetes or idiopathic etiology” (not postsurgical etiologies).
GES for morbid obesity has not been approved by the FDA and is for investigational use only in the United States.
Review Strategy
The Medical Advisory Secretariat systematically reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of GES to treat patients who have: a) chronic refractory symptomatic GP; or b) morbid obesity.
The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases.
The GRADE approach was used to systematically and explicitly make judgments about the quality of evidence and strength of recommendations.
Findings
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence in Tables 1 and 2.
GRADE Quality of Studies – Gastroparesis
Confounders related to diabetes.
Possible Type 2 error for subgroup analyses.
Subjective self-reported end point.
Posthoc change in primary end point analysis.
No sample size justification.
Concomitant prokinetic/antiemetic therapy.
Only 1 RCT (with different results for FDA and publication).
GES originally hypothesized to correct gastric rhythms, stimulate gastric emptying and therefore eliminate symptoms.
Now hypothesized to directly act on neurons to the CNS to control symptoms.
Weak correlation between symptoms and gastric emptying.
Unclear whether gastric emptying is still considered an end point to investigate.
GRADE Quality of Studies – Morbid Obesity
No sample size calculation.
Small sample size.
No ITT analysis.
Lack of detail regarding dropouts.
Possible Type 2 error.
Sparse details about randomization/blinding.
Full, final results not published.
Only 1 RCT (technically grey literature).
Economic Analysis
No formal economic analysis was identified in the literature search.
The Alberta Heritage Foundation for Medical Research reported that the cost of implanting a GES in the United States for the treatment of GP is estimated to be $30,000 US. In Canada, the device costs approximately $10,700 Cdn; this does not include costs associated with the physician’s training, the implantation procedure, or device programming and maintenance.
Ontario Context
There is no Schedule of Benefits code for GES.
There is no Canadian Classification of Health Interventions Index (CCI) procedure code for GES.
Since the ICD-10 diagnosis code for gastroparesis falls under K31.8 “Other specified diseases of the stomach and duodenum”, it is impossible to determine how many patients in Ontario had discharge abstracts because of gastroparesis.
In 2005, there were less than 5 out-of-country requests for GES (for either consultation only or for surgery).
Gastroparesis
The prevalence of severe, refractory GP is variably reported in the literature.
The Alberta Heritage Foundation for Medical Research estimated that the prevalence of severe, symptomatic and medically refractory GP in the United States population was 0.017%. Assuming a total Ontario population of 13 million, this would correspond to a budget impact of approximately $23.6 M
Cdn ($10,700 Cdn x 2,210 patients) for the device cost alone.
The incidence of severe refractory GP estimated by the FDA is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year. This corresponds to a budget impact of approximately $107,000 Cdn to $1.6M Cdn per year for the device cost alone.
Morbid Obesity
An expert in the field estimated that there are 160,000 to 180,000 people in Ontario who are morbidly obese. This would correspond to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake). However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective).
Conclusion
As per the GRADE Working Group, overall recommendations consider 4 main factors.
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence.
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 shows the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For GP, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality, consistency and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $107,000 Cdn to $1.6M Cdn for the device cost alone, while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high-quality studies of effectiveness. Further evidence of effectiveness should be available in the future since there is a RCT underway that is examining the use of GES in patients with severe refractory GP associated with diabetes and idiopathic etiologies (ClinicalTrials.gov identifier NCT00157755).
For morbid obesity, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and consistency), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake) while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high quality studies of effectiveness. However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective).
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3413096  PMID: 23074486
11.  Veterans and Risk of Heart Disease in the United States: A Cohort with 20 Years of Follow Up 
Background:
The aim of the current study was twofold: To investigate the effect of veteran status on risk of developing heart disease over a period of 20 years in the United States and to test if socio-economic characteristics, chronic conditions, health behaviors, body mass index (BMI) and depressive symptoms explain the association between veteran status and risk of heart disease.
Methods:
Data came from the Health and Retirement Study, a 20 year national cohort from 1992 to 2012. The study enrolled a representative sample of Americans over the age of 50. We included 8,375 individuals who were older than 50 years at entry, did not have heart disease at baseline and provided data on heart disease over the next 20 years. Veteran status was considered to be the independent variable. Self-reported data on physician diagnosis of heart disease, which was measured on a biannual basis, was the outcome. Baseline socio-economic data (i.e. age, gender, race, marital status and education), chronic conditions (diabetes and hypertension), health behaviors (i.e. drinking, smoking, and exercise), BMI and depressive symptoms (modified Center for Epidemiologic Studies Depression Scale) were entered into logistic regressions. Logistic regression was used for data analysis.
Results:
Veterans were at higher risk of having a new onset of heart disease (unadjusted relative risk [RR] = 1.996, 95% confidence interval [CI] =1.694-2.351), compared with non-veterans. Logistic regression confirmed the association between veteran status and heart disease (adjusted RR = 1.483, 95% CI = 1.176-1.871) after controlling for all covariates.
Conclusions:
Veterans may be at higher risk for heart disease over time and this link may be independent of baseline socio-economic characteristics, chronic medical conditions, health behaviors, BMI and depressive symptoms. Veterans may require more rigorous cardiovascular prevention programs.
PMCID: PMC4085922  PMID: 25013689
Cohort; depression; drinking; exercise; heart disease; smoking; veterans
12.  Child Mortality Estimation: Consistency of Under-Five Mortality Rate Estimates Using Full Birth Histories and Summary Birth Histories 
PLoS Medicine  2012;9(8):e1001296.
Romesh Silva assesses and analyzes differences in direct and indirect methods of estimating under-five mortality rates using data collected from full and summary birth histories in Demographic and Health Surveys from West Africa, East Africa, Latin America, and South/Southeast Asia.
Background
Given the lack of complete vital registration data in most developing countries, for many countries it is not possible to accurately estimate under-five mortality rates from vital registration systems. Heavy reliance is often placed on direct and indirect methods for analyzing data collected from birth histories to estimate under-five mortality rates. Yet few systematic comparisons of these methods have been undertaken. This paper investigates whether analysts should use both direct and indirect estimates from full birth histories, and under what circumstances indirect estimates derived from summary birth histories should be used.
Methods and Findings
Usings Demographic and Health Surveys data from West Africa, East Africa, Latin America, and South/Southeast Asia, I quantify the differences between direct and indirect estimates of under-five mortality rates, analyze data quality issues, note the relative effects of these issues, and test whether these issues explain the observed differences. I find that indirect estimates are generally consistent with direct estimates, after adjustment for fertility change and birth transference, but don't add substantial additional insight beyond direct estimates. However, choice of direct or indirect method was found to be important in terms of both the adjustment for data errors and the assumptions made about fertility.
Conclusions
Although adjusted indirect estimates are generally consistent with adjusted direct estimates, some notable inconsistencies were observed for countries that had experienced either a political or economic crisis or stalled health transition in their recent past. This result suggests that when a population has experienced a smooth mortality decline or only short periods of excess mortality, both adjusted methods perform equally well. However, the observed inconsistencies identified suggest that the indirect method is particularly prone to bias resulting from violations of its strong assumptions about recent mortality and fertility. Hence, indirect estimates of under-five mortality rates from summary birth histories should be used only for populations that have experienced either smooth mortality declines or only short periods of excess mortality in their recent past.
Please see later in the article for the Editors' Summary.
Editors' Summary
Background
In 1990, 12 million children died before they reached their fifth birthday. Faced with this largely avoidable loss of young lives, in 2000, world leaders set a target of reducing under-five mortality (death) to one-third of its 1990 level by 2015 as Millennium Development Goal 4 (MDG 4); this goal, together with seven others, aims to eradicate extreme poverty globally. To track progress towards MDG 4, experts need accurate estimates of the global and country-specific under-five mortality rate (U5MR, the probability of a child dying before age five). The most reliable sources of data for U5MR estimation are vital registration systems—national records of all births and deaths. Unfortunately, developing countries, which are where most childhood deaths occur, rarely have such records, so full or summary birth histories provide the data for U5MR estimation instead. In full birth histories (FBHs), which are collected through household surveys such as those conducted by Demographic and Health Surveys (DHS), women are asked for the date of birth of all their children and the age at death of any children who have died. In summary birth histories (SBHs), which are collected through household surveys and censuses, women are asked how many children they have had and how many are alive at the time of the survey.
Why Was This Study Done?
“Direct” estimates of U5MRs can be obtained from FBHs because FBHs provide detailed information about the date of death and the exposure of children to the risk of dying. By contrast, because SBHs do not contain information on children's exposure to the risk of dying, “indirect” estimates of U5MR are obtained from SBHs using model life tables (mathematical models of the variation of mortality with age). Indirect estimates are often also derived from FBHs, but few systematic comparisons of direct and indirect methods for U5MR estimation have been undertaken. In this study, Romesh Silva investigates whether direct and indirect methods provide consistent U5MR estimates from FBHs and whether there are any circumstances under which indirect methods provide more reliable U5MR estimates than direct methods.
What Did the Researcher Do and Find?
The researcher used DHS data from West Africa, East Africa, Latin America, and South/Southeast Asia to quantify the differences between direct and indirect estimates of U5MR calculated from the same data and analyzed possible reasons for these differences. Estimates obtained using a version of the “Brass” indirect estimation method were uniformly higher than those obtained using direct estimation. Indirect and direct estimates generally agreed, however, after adjustment for changes in fertility—the Brass method assumes that country-specific fertility (the number of children born to a woman during her reproductive life) remains constant—and for birth transference, an important source of data error in FBHs that arises because DHS field staff can lessen their workload by recording births as occurring before a preset cutoff date rather than after that date. Notably, though, for countries that had experienced political or economic crises, periods of excess mortality due to conflicts, or periods during which the health transition had stalled (as countries become more affluent, overall mortality rates decline and noncommunicable diseases replace infectious diseases as the major causes of death), marked differences between indirect and direct estimates of U5MR remained, even after these adjustments.
What Do These Findings Mean?
Because the countries included in this study do not have vital registration systems, these findings provide no information about the validity of either direct or indirect estimation methods for U5MR estimation. They suggest, however, that for countries where there has been a smooth decline in mortality or only short periods of excess mortality, both direct and indirect methods of U5MR estimation work equally well, after adjustment for changes in fertility and for birth transference, and that indirect estimates add little to the insights provided into childhood mortality by direct estimates. Importantly, the inconsistencies observed between the two methods that remain after adjustment suggest that indirect U5MR estimation is more susceptible to bias (systematic errors that arise because of the assumptions used to estimate U5MR) than direct estimation. Thus, indirect estimates of U5MR from SBHs should be used only for populations that have experienced either smooth mortality declines or only short periods of excess mortality in their recent past.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001296.
This paper is part of a collection of papers on Child Mortality Estimation Methods published in PLOS Medicine
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on Millennium Development Goal 4, and its Childinfo website provides detailed statistics about child survival and health, including a description of the United Nations Inter-agency Group for Child Mortality Estimation; the 2011 UN IGME report Levels & Trends in Child Mortality is available
The World Health Organization has information about Millennium Development Goal 4 and provides estimates of child mortality rates (some information in several languages)
Further information about the Millennium Development Goals is available
Information is available about infant and child mortality data collected by Demographic and Health Surveys
doi:10.1371/journal.pmed.1001296
PMCID: PMC3429405  PMID: 22952436
13.  Recent advances in oesophageal diseases 
Abstract
Dong Y, Qi B, Feng XY, Jiang CM. Meta-analysis of Barrett's esophagus in China. World J Gastroenterol 2013;19(46):8770-8779
The disease pattern of Barrett's esophagus (BE) in China is poorly characterised particularly in comparison with other developed countries. This meta-analysis of 3873 cases of BE collated from 69 clinical studies conducted in 25 provinces between 2000 and 2011 investigated the epidemiology and characteristics of BE in China compared to Western countries. The total endoscopic detection rate of BE was 1.0% (95%CI: 0.1%-1.8%) with an average patient age of 49.07 ± 5.09 years, lower than many Western countries.The authors postulate this may be attributed to environmental risk factor variation, distinct genetics and different medical practice including diagnostic criteria for BE and expertise in endoscopy. This study identified a 1.781 male predominancefor BE in China, consistent with Western reports. Short-segment BE accounted for 80.3% of cases with island type and cardiac type the most common endoscopic (44.8%) and histological (40.0%) manifestations respectively. Of the 1283 BE cases followed up for three to 36 months the incidence of esophageal cancer was 1.418 per 1000 person-years, lower than the incidence reported in Western countries.
Lee HS, Jeon SW. Barrett esophagus in Asia: same disease with different pattern. ClinEndosc 2014;47(1):15-22
Barrett's esophagus (BE) is a common, pre-cancerous condition characterised by intestinal metaplasia of squamous esophageal epithelium usually attributed to chronic gastric acid exposure. This review article explores important differences in the disease pattern of BE between Asian and the Western countries.
Overall the prevalence of BE is lower in Asia compared to the West with a greater proportion of short-segment type. The authors identify great variability in the endoscopic and pathologic diagnostic criteria for BE. Many of the studies in Asian countries did not use a standardised four-quadrant biopsy protocol which may have led to an underestimation of BE prevalence. The review highlights an increasing incidence of esophageal adenocarcinoma in the West but unclear disease trend in Asia with inter-country variability. Similarly in Asian and Western countries BE is associated with the presence of hiatus hernia, advancing age, male gender, alcohol consumption, smoking, abdominal obesity and longer duration of gastro-esophageal reflux disease. The authors postulate that Helicobacter pylori infection, more prevalent in Asia than the West, may have a protective effect on BE.
There is a need for larger, prospective studies to further clarify the disease pattern of BE in Asian countries. Clearly standardisation of the diagnostic process for BE is important to validate the differences in disease trends between Asian and Western countries.
Kiadaliri AA. Gender and social disparities in esophagus cancer incidence in Iran, 2003-2009: a time trend province-level study.Asian Pac J Cancer Prev 2014;15(2):623-7
Esophageal cancer (EC) is a major cause of morbidity and mortality particuarly in Iran where the incidence rate exceeds the global average. An understanding of the factors influencing the province-specific incidence of EC in Iran is important to inform disease-prevention strategies and address health inequalities. This ecological study used cancer registry data to investigate the relationship between gender and social class and the incidence of EC in Iran at province-level between 2003 and 2009. The age standardised incidence rates (ASIR) of EC were greatest in the Northern provinces of Iran, specifically Razavi Khorasan in males and Kordestan in females. Overall the EC incidence did not significantly differ according to gender.
Interestingly, during the study period the ASIR increased by 4.6% per year in females (p=0.08) and 6.5% per year in males (p=0.02). This may reflect increasing rates of establised risk factors for EC including obsesity and gastro-esophageal reflux disease alongside more vigilant recording of new cases. Social class was inversely associated with the ASIR of EC regardless of gender which may be attributed to class differences in risk factor distribution particularly smoking, diet and obesity. An appreciation for the limitations of an epidemiological study is important when interpreting results which should be further evaluated in future studies.
Islami F et al.Determinants of gastroesophageal reflux disease, including hookah smoking and opium use- A cross-sectional analysis of 50,000 individuals. PLoS One 2014;9(2):e89256
Gastroesophageal reflux disease (GERD) is a highly prevalent cause of gastrointestinal symptoms worldwide incurring great cost to the primary and secondary healthcare sectors. An improved understanding of the factors which influence GERD symptoms in low- to medium- income countries may inform public health initiatives. This study analysed prospective data from the Golestan cohort study, primarily established to investigate determinants of upper gastrointestinal cancers, toexplore the risk factors influencing GERD symptoms (regurgitation and/or heartburn) in 50,045 individuals aged 40-75 years in Golestan Province, Iran enrolled between 01/2004 and 06/2008.Of note, 39.12% of individuals denied ever experiencing GERD symptoms. A further 19.89% reported at least once weekly GERD symptoms with 11.83% experiencing daily symptoms. Severe symptoms, defined as disturbing daily work or sleep, were recorded by 11.33% of individuals.
Separately the occurrence of daily GERD symptoms and severe symptoms were inversely associated with male gender (OR 0.36, 95% CI 0.33-0.39 both), level of formal education (p=0.01 and p=0.001 respectively), wealth score (p<0.001 both) and regular nass chewing (OR 0.86, 95% CI 0.75-0.98 and OR 0.87, 95% CI 0.76-0.99 respectively)and were positively associated with body mass index (p<0.001 both), intensity of physical activity (p=0.04 both), cigarette pack years (p<0.001 both), alcohol consumption (OR 1.36, 95% CI 1.13-1.64 and OR 1.53, 95% CI 1.28-1.83 respectively) and opium use (OR 1.82, 95% CI 1.67-1.99 and OR 1.70, 95% CI 1.55-1.87 respectively).In addition hookah smoking had a borderline significant correlation with mild and moderate severity GERD symptoms in individuals who had never smoked cigarettes (OR 1.41, 95% CI 1.00-1.99 and OR 1.25, 95% CI 0.99-1.57 respectively).
Overall this large study contributes useful data to inform the prevention and management of GERD symptoms particularly regarding the use of hookah, opium and nass which was previously unclear.
Barbera M et al. The human squamous oesophagus has widespread capacity for clonal expansion from cells at diverse stages of differentiation. Gut 2014;0:1–9. doi:10.1136/gutjnl-2013-306171
Current knowledge on human esophageal tissue homeostasis and injury repair is derived predominantly from murine models and hence may be inaccurate due to cellular and architectural differences. This study used 3D imaging in conjunction withstaining for cell lineage markers to investigate the cellular mechanisms involved in homeostasis of the normal human squamous esophagus in 10 participants undergoing esophagectomy for esophageal cancer. The self-renewal potential of cell subpopulations was also assessed using in vitro and in vivo assays.
A decreasing gradient of cell proliferation was observed from the inter-papillary basal layer to the tip of the papilla where there was no evidence of mitosis. The expression ofβ1-integrin, a putative stem cell marker, was consistent throughout the basal layer and therefore the entire basal layer can be considered undifferentiated. Quiescent β1-integrin/CD34-positive cells which failed to stain for CD45, S-100 or F4-80were identified at the tip of the papilla suggesting this is an extension of the basal layer. Contrary to previous data, this study found progenitor cells widely distributed in human esophageal tissue and included already differentiated epithelial cells. This insight into esophageal homeostasis may inform future studies exploring the pathological mechanisms underpinning homeostatic disruption in disease states such as Barrett's esophagus.
Papers were prepared by:
Drs Ishfaq Ahmad and Luke Materacki, Department of Medicine, Alexandra Hospital, Redditch, UK
PMCID: PMC4129572  PMID: 25120902
14.  Domestic Violence and Perinatal Mental Disorders: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(5):e1001452.
Louise Howard and colleagues conduct a systematic review and meta-analysis to estimate the prevalence and odds of experience of domestic violence experience among women with antenatal and postnatal mental health disorders.
Please see later in the article for the Editors' Summary
Background
Domestic violence in the perinatal period is associated with adverse obstetric outcomes, but evidence is limited on its association with perinatal mental disorders. We aimed to estimate the prevalence and odds of having experienced domestic violence among women with antenatal and postnatal mental disorders (depression and anxiety disorders including post-traumatic stress disorder [PTSD], eating disorders, and psychoses).
Methods and Findings
We conducted a systematic review and meta-analysis (PROSPERO reference CRD42012002048). Data sources included searches of electronic databases (to 15 February 2013), hand searches, citation tracking, update of a review on victimisation and mental disorder, and expert recommendations. Included studies were peer-reviewed experimental or observational studies that reported on women aged 16 y or older, that assessed the prevalence and/or odds of having experienced domestic violence, and that assessed symptoms of perinatal mental disorder using a validated instrument. Two reviewers screened 1,125 full-text papers, extracted data, and independently appraised study quality. Odds ratios were pooled using meta-analysis.
Sixty-seven papers were included. Pooled estimates from longitudinal studies suggest a 3-fold increase in the odds of high levels of depressive symptoms in the postnatal period after having experienced partner violence during pregnancy (odds ratio 3.1, 95% CI 2.7–3.6). Increased odds of having experienced domestic violence among women with high levels of depressive, anxiety, and PTSD symptoms in the antenatal and postnatal periods were consistently reported in cross-sectional studies. No studies were identified on eating disorders or puerperal psychosis. Analyses were limited because of study heterogeneity and lack of data on baseline symptoms, preventing clear findings on causal directionality.
Conclusions
High levels of symptoms of perinatal depression, anxiety, and PTSD are significantly associated with having experienced domestic violence. High-quality evidence is now needed on how maternity and mental health services should address domestic violence and improve health outcomes for women and their infants in the perinatal period.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Domestic violence—physical, sexual, or emotional abuse by an intimate partner or family member—is a major public health problem and although more common in women, can also affect men. Due to the nature of the problem, it is difficult to collect accurate figures on the scale of domestic violence, but a study by the World Health Organization in ten countries found that 15%–71% of women aged 15–49 years reported physical and/or sexual violence by an intimate partner at some point in their lives. Women experiencing domestic violence have significant short- and long-term health problems, particularly regarding their mental health: experience of domestic violence can lead to a range of mental health disorders such as depression, psychosis, eating disorders, and even suicide attempts.
Why Was This Study Done?
As perinatal mental health disorders are among the commonest health problems in pregnancy and the postpartum period, and given the rate of domestic violence during pregnancy (previous studies have suggested a domestic violence prevalence of 4%–8% during pregnancy and the postnatal period), it is plausible that there may be a link between perinatal mental health disorders and having experienced domestic violence. Indeed, previous reviews have suggested the existence of such an association but were limited by the small number of included studies and focused on depression only, rather than the full range of antenatal and postnatal mental health disorders. So in this study the researchers systematically reviewed published studies to provide more robust estimates of the prevalence of having experienced domestic violence among women with antenatal and postnatal mental health disorders; the researchers also used a meta-analysis to estimate the odds (chance) of having experienced domestic violence among women with antenatal and postnatal mental health disorders.
What Did the Researchers Do and Find?
The researchers searched multiple databases and hand searched three relevant journals using key search terms to identify all types of relevant studies. Using specific criteria, the researchers retrieved and assessed over 1,000 full papers, of which 67 met the criteria for their systematic review. The researchers assessed the quality of each selected study and included only those studies that used validated diagnostic instruments and screening tools to assess mental health disorders in their calculations of the pooled (combined) odds ratio (OR) through meta-analysis.
Using these methods, in cross-sectional studies (studies conducted at one point in time), the researchers found that women with probable depression in the antenatal period reported a high prevalence and increased odds of having experienced partner violence during their lifetime (OR = 3), during the past year (OR = 2.8), and during pregnancy (OR = 5). The results were similar for the postnatal period. The evidence was less robust for anxiety disorders: among women with probable anxiety in the antenatal period, the researchers found an OR of 2.9 of having experienced lifetime partner violence. The odds were less in the postnatal period (OR = 1.4) In their analysis of longitudinal studies (follow-up studies over a period of time), the researchers found an increased odds of probable postnatal depression both among women who reported having ever experienced partner violence in their lifetime (OR = 2.9) and among women who reported having experienced partner violence during pregnancy (OR = 3.1). The researchers also found a combined prevalence estimate of 12.7% for probable depression during the postnatal period following experiences of partner violence during pregnancy. Because of limited data, the researchers could not calculate an OR of the association between probable antenatal depression and later experiences of partner violence.
What Do These Findings Mean?
These findings suggest that women with high levels of symptoms of perinatal mental health disorders—antenatal and postnatal anxiety, depression, and post-traumatic stress disorder—have a high prevalence and increased odds of having experienced domestic violence both over their lifetime and during pregnancy. However, these findings cannot prove causality, they fail to show a two-way association (that is, perinatal mental health disorders leading to subsequent domestic violence), and no information on other perinatal mental disorders, such as eating disorders and puerperal psychosis, was available. The variation of the quality of the included studies also limits the results, highlighting the need for high-quality data to suggest how maternity and mental health services could address domestic violence and improve health outcomes for women and their infants in the future. Nevertheless, this study emphasizes the importance of identifying and responding to possible domestic violence among women attending antenatal and mental health services.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001452.
The World Health Organization provides information and statistics about violence against women and also about mental health disorders during pregnancy
The UK Royal College of Psychiatrists has information for professionals and patients about mental health disorders during pregnancy
doi:10.1371/journal.pmed.1001452
PMCID: PMC3665851  PMID: 23723741
15.  Self-reported symptoms of chronic cough and breathlessness in working-age men in the city of Izhevsk, Russia: associations with cardiovascular disease risk factors and comorbidities 
BMJ Open Respiratory Research  2015;2(1):e000104.
Introduction
Very little is known about the prevalence of respiratory symptoms or their associations with other health conditions in Russia.
Methods
Between 2008 and 2010, a sample of 983 men resident in Izhevsk, Russia, took part in a cross-sectional survey. Presence of respiratory symptoms was determined from self-report of chronic productive cough and breathlessness assessed using the British Medical Research Council (MRC) breathlessness scale. Self-reported physical and mental health were measured using the 12-Item Short-Form Health Survey (SF-12). Hypertension was assessed from mean blood pressure measured at the health check and/or self-reported use of antihypertensive medication. Other comorbidities were assessed from self-report. Logistic regression models were fitted assessing the association between respiratory symptoms and comorbidities. Linear regression models were fitted to investigate the association between respiratory symptoms and self-reported health scores. All models were adjusted for age, education and smoking status.
Results
The age-standardised prevalence of cough and breathlessness was 20.9% (prevalence with breathlessness MRC grade 3 or above 3.7%). The majority of men with respiratory symptoms (87.3%) were current smokers. Cough and breathlessness were associated with substantially worse self-reported physical and mental health (test for trend with severity of breathlessness p<0.001). Those with chronic cough and grade 3 or above breathlessness had higher odds of having hypertension (OR 3.03; 95% CI 1.36 to 6.74), diabetes (OR 10.55; 95% CI 2.69 to 41.37), angina pectoris (OR 7.54; 95% CI 3.61 to 15.73), previous myocardial infarction (OR 7.61; 95% CI 2.10 to 27.4) and previous stroke (OR 6.61; 95% CI 1.75 to 23.34) compared with those without respiratory symptoms.
Conclusions
The prevalence of respiratory symptoms was high. Strong associations were found between respiratory symptoms and cardiovascular comorbidities. These are of particular importance given the extremely high level of cardiovascular disease mortality in Russia.
doi:10.1136/bmjresp-2015-000104
PMCID: PMC4709862  PMID: 26793315
Clinical Epidemiology; COPD epidemiology
16.  Stenting for Peripheral Artery Disease of the Lower Extremities 
Executive Summary
Background
Objective
In January 2010, the Medical Advisory Secretariat received an application from University Health Network to provide an evidentiary platform on stenting as a treatment management for peripheral artery disease. The purpose of this health technology assessment is to examine the effectiveness of primary stenting as a treatment management for peripheral artery disease of the lower extremities.
Clinical Need: Condition and Target Population
Peripheral artery disease (PAD) is a progressive disease occurring as a result of plaque accumulation (atherosclerosis) in the arterial system that carries blood to the extremities (arms and legs) as well as vital organs. The vessels that are most affected by PAD are the arteries of the lower extremities, the aorta, the visceral arterial branches, the carotid arteries and the arteries of the upper limbs. In the lower extremities, PAD affects three major arterial segments i) aortic-iliac, ii) femoro-popliteal (FP) and iii) infra-popliteal (primarily tibial) arteries. The disease is commonly classified clinically as asymptomatic claudication, rest pain and critical ischemia.
Although the prevalence of PAD in Canada is not known, it is estimated that 800,000 Canadians have PAD. The 2007 Trans Atlantic Intersociety Consensus (TASC) II Working Group for the Management of Peripheral Disease estimated that the prevalence of PAD in Europe and North America to be 27 million, of whom 88,000 are hospitalizations involving lower extremities. A higher prevalence of PAD among elderly individuals has been reported to range from 12% to 29%. The National Health and Nutrition Examination Survey (NHANES) estimated that the prevalence of PAD is 14.5% among individuals 70 years of age and over.
Modifiable and non-modifiable risk factors associated with PAD include advanced age, male gender, family history, smoking, diabetes, hypertension and hyperlipidemia. PAD is a strong predictor of myocardial infarction (MI), stroke and cardiovascular death. Annually, approximately 10% of ischemic cardiovascular and cerebrovascular events can be attributed to the progression of PAD. Compared with patients without PAD, the 10-year risk of all-cause mortality is 3-fold higher in patients with PAD with 4-5 times greater risk of dying from cardiovascular event. The risk of coronary heart disease is 6 times greater and increases 15-fold in patients with advanced or severe PAD. Among subjects with diabetes, the risk of PAD is often severe and associated with extensive arterial calcification. In these patients the risk of PAD increases two to four fold. The results of the Canadian public survey of knowledge of PAD demonstrated that Canadians are unaware of the morbidity and mortality associated with PAD. Despite its prevalence and cardiovascular risk implications, only 25% of PAD patients are undergoing treatment.
The diagnosis of PAD is difficult as most patients remain asymptomatic for many years. Symptoms do not present until there is at least 50% narrowing of an artery. In the general population, only 10% of persons with PAD have classic symptoms of claudication, 40% do not complain of leg pain, while the remaining 50% have a variety of leg symptoms different from classic claudication. The severity of symptoms depends on the degree of stenosis. The need to intervene is more urgent in patients with limb threatening ischemia as manifested by night pain, rest pain, ischemic ulcers or gangrene. Without successful revascularization those with critical ischemia have a limb loss (amputation) rate of 80-90% in one year.
Diagnosis of PAD is generally non-invasive and can be performed in the physician offices or on an outpatient basis in a hospital. Most common diagnostic procedure include: 1) Ankle Brachial Index (ABI), a ratio of the blood pressure readings between the highest ankle pressure and the highest brachial (arm) pressure; and 2) Doppler ultrasonography, a diagnostic imaging procedure that uses a combination of ultrasound and wave form recordings to evaluate arterial flow in blood vessels. The value of the ABI can provide an assessment of the severity of the disease. Other non invasive imaging techniques include: Computed Tomography (CT) and Magnetic Resonance Angiography (MRA). Definitive diagnosis of PAD can be made by an invasive catheter based angiography procedure which shows the roadmap of the arteries, depicting the exact location and length of the stenosis / occlusion. Angiography is the standard method against which all other imaging procedures are compared for accuracy.
More than 70% of the patients diagnosed with PAD remain stable or improve with conservative management of pharmacologic agents and life style modifications. Significant PAD symptoms are well known to negatively influence an individual quality of life. For those who do not improve, revascularization methods either invasive or non-invasive can be used to restore peripheral circulation.
Technology Under Review
A Stent is a wire mesh “scaffold” that is permanently implanted in the artery to keep the artery open and can be combined with angioplasty to treat PAD. There are two types of stents: i) balloon-expandable and ii) self expandable stents and are available in varying length. The former uses an angioplasty balloon to expand and set the stent within the arterial segment. Recently, drug-eluting stents have been developed and these types of stents release small amounts of medication intended to reduce neointimal hyperplasia, which can cause re-stenosis at the stent site. Endovascular stenting avoids the problem of early elastic recoil, residual stenosis and flow limiting dissection after balloon angioplasty.
Research Questions
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting more effective than percutaneous transluminal angioplasty (PTA) in improving patency?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), does primary stenting provide immediate success compared to PTA?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting associated with less complications compared to PTA?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), does primary stenting compared to PTA reduce the rate of re-intervention?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion) is primary stenting more effective than PTA in improving clinical and hemodynamic success?
Are drug eluting stents more effective than bare stents in improving patency, reducing rates of re-interventions or complications?
Research Methods
Literature Search
A literature search was performed on February 2, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA). Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Inclusion Criteria
English language full-reports from 1950 to January Week 3, 2010
Comparative randomized controlled trials (RCTs), systematic reviews and meta-analyses of RCTs
Proven diagnosis of PAD of the lower extremities in all patients.
Adult patients at least 18 years of age.
Stent as at least one treatment arm.
Patency, re-stenosis, re-intervention, technical success, hemodynamic (ABI) and clinical improvement and complications as at least an outcome.
Exclusion Criteria
Non-randomized studies
Observational studies (cohort or retrospective studies) and case report
Feasibility studies
Studies that have evaluated stent but not as a primary intervention
Outcomes of Interest
The primary outcome measure was patency. Secondary measures included technical success, re-intervention, complications, hemodynamic (ankle brachial pressure index, treadmill walking distance) and clinical success or improvement according to Rutherford scale. It was anticipated, a priori, that there would be substantial differences among trials regarding the method of examination and definitions of patency or re-stenosis. Where studies reported only re-stenosis rates, patency rates were calculated as 1 minus re-stenosis rates.
Statistical Analysis
Odds ratios (for binary outcomes) or mean difference (for continuous outcomes) with 95% confidence intervals (CI) were calculated for each endpoint. An intention to treat principle (ITT) was used, with the total number of patients randomized to each study arm as the denominator for each proportion. Sensitivity analysis was performed using per protocol approach. A pooled odds ratio (POR) or mean difference for each endpoint was then calculated for all trials reporting that endpoint using a fixed effects model. PORs were calculated for comparisons of primary stenting versus PTA or other alternative procedures. Level of significance was set at alpha=0.05. Homogeneity was assessed using the chi-square test, I2 and by visual inspection of forest plots. If heterogeneity was encountered within groups (P < 0.10), a random effects model was used. All statistical analyses were performed using RevMan 5. Where sufficient data were available, these analyses were repeated within subgroups of patients defined by time of outcome assessment to evaluate sustainability of treatment benefit. Results were pooled based on the diseased artery and stent type.
Summary of Findings
Balloon-expandable stents vs PTA in superficial femoral artery disease
Based on a moderate quality of evidence, there is no significant difference in patency between primary stenting using balloon-expandable bare metal stents and PTA at 6, 12 and 24 months in patients with superficial femoral artery disease. The pooled OR for patency and their corresponding 95% CI are: 6 months 1.26 (0.74, 2.13); 12 months 0.95 (0.66, 1.38); and 24 months 0.72 (0.34. 1.55).
There is no significant difference in clinical improvement, re-interventions, peri and post operative complications, mortality and amputations between primary stenting using balloon-expandable bare stents and PTA in patients with superficial femoral artery. The pooled OR and their corresponding 95% CI are clinical improvement 0.85 (0.50, 1.42); ankle brachial index 0.01 (-0.02, 0.04) re-intervention 0.83 (0.26, 2.65); complications 0.73 (0.43, 1.22); all cause mortality 1.08 (0.59, 1.97) and amputation rates 0.41 (0.14, 1.18).
Self-expandable stents vs PTA in superficial femoral artery disease
Based on a moderate quality of evidence, primary stenting using self-expandable bare metal stents is associated with significant improvement in patency at 6, 12 and 24 months in patients with superficial femoral artery disease. The pooled OR for patency and their corresponding 95% CI are: 6 months 2.35 (1.06, 5.23); 12 months 1.54 (1.01, 2.35); and 24 months 2.18 (1.00. 4.78). However, the benefit of primary stenting is not observed for clinical improvement, re-interventions, peri and post operative complications, mortality and amputation in patients with superficial femoral artery disease. The pooled OR and their corresponding 95% CI are clinical improvement 0.61 (0.37, 1.01); ankle brachial index 0.01 (-0.06, 0.08) re-intervention 0.60 (0.36, 1.02); complications 1.60 (0.53, 4.85); all cause mortality 3.84 (0.74, 19.22) and amputation rates 1.96 (0.20, 18.86).
Balloon expandable stents vs PTA in iliac artery occlusive disease
Based on moderate quality of evidence, despite immediate technical success, 12.23 (7.17, 20.88), primary stenting is not associated with significant improvement in patency, clinical status, treadmill walking distance and reduction in re-intervention, complications, cardiovascular events, all cause mortality, QoL and amputation rates in patients with intermittent claudication caused by iliac artery occlusive disease. The pooled OR and their corresponding 95% CI are: patency 1.03 (0.56, 1.87); clinical improvement 1.08 (0.60, 1.94); walking distance 3.00 (12.96, 18.96); re-intervention 1.16 (0.71, 1.90); complications 0.56 (0.20, 1.53); all cause mortality 0.89 (0.47, 1.71); QoL 0.40 (-4.42, 5.52); cardiovascular event 1.16 (0.56, 2.40) and amputation rates 0.37 (0.11, 1.23). To date no RCTs are available evaluating self-expandable stents in the common or external iliac artery stenosis or occlusion.
Drug-eluting stent vs balloon-expandable bare metal stents in crural arteries
Based on a very low quality of evidence, at 6 months of follow-up, sirolimus drug-eluting stents are associated with a reduction in target vessel revascularization and re-stenosis rates in patients with atherosclerotic lesions of crural (tibial) arteries compared with balloon-expandable bare metal stent. The OR and their corresponding 95% CI are: re-stenosis 0.09 (0.03, 0.28) and TVR 0.15 (0.05, 0.47) in patients with atherosclerotic lesions of the crural arteries at 6 months follow-up. Both types of stents offer similar immediate success. Limitations of this study include: short follow-up period, small sample and no assessment of mortality as an outcome. Further research is needed to confirm its effect and safety.
PMCID: PMC3377569  PMID: 23074395
17.  Gender Differences in Health Status and Adverse Outcomes Among Patients With Peripheral Arterial Disease 
Background
Few studies have examined gender differences in health status and cardiovascular outcomes in patients with peripheral artery disease (PAD). This study assessed (1) self‐reported health status at PAD diagnosis and 12‐months later, and explored (2) whether outcomes in women with PAD differ with regard to long‐term major adverse events.
Methods and Results
A total of 816 patients (285 women) with PAD were enrolled from 2 vascular clinics in the Netherlands. Baseline clinical data and subsequent adverse events were recorded and patients completed the Short Form‐12 (SF‐12, Physical Component Score [PCS] and Mental Component Score [MCS]) upon PAD diagnosis and 12‐months later. Women had similar ages and clinical characteristics, but poorer socio‐economic status and more depressive symptoms at initial diagnosis, as compared with men. Women also had poorer physical (PCS: 37±10 versus 40±10, P=0.004) and mental (MCS: 47±12 versus 49±11, P=0.005) health status at the time of presentation. At 12‐months, women still reported a poorer overall PCS score (41±12 versus 46±11, P=0.006) and MCS score (42±14 versus 49±12, P=0.002). Female gender was an independent determinant of a poorer baseline and 12‐month PCS and MCS scores. However, there were no significant differences by gender on either mortality (unadjusted hazard ratio [HR]=0.93, 95% CI 0.60;1.44, P=0.74) or major adverse events (unadjusted HR=0.90, 95% CI 0.63;1.29, P=0.57), after a median follow‐up of 3.2 years.
Conclusions
Women's physical and mental health status is compromised both at initial PAD diagnosis and at 12‐month follow‐up, despite experiencing a similar magnitude of change in their health scores throughout the first 12‐months after diagnosis.
doi:10.1161/JAHA.114.000863
PMCID: PMC4330046  PMID: 25537275
gender differences; health status; outcomes research; peripheral artery disease; women
18.  Drivers of Inequality in Millennium Development Goal Progress: A Statistical Analysis 
PLoS Medicine  2010;7(3):e1000241.
David Stuckler and colleagues examine the impact of the HIV and noncommunicable disease epidemics on low-income countries' progress toward the Millennium Development Goals for health.
Background
Many low- and middle-income countries are not on track to reach the public health targets set out in the Millennium Development Goals (MDGs). We evaluated whether differential progress towards health MDGs was associated with economic development, public health funding (both overall and as percentage of available domestic funds), or health system infrastructure. We also examined the impact of joint epidemics of HIV/AIDS and noncommunicable diseases (NCDs), which may limit the ability of households to address child mortality and increase risks of infectious diseases.
Methods and Findings
We calculated each country's distance from its MDG goals for HIV/AIDS, tuberculosis, and infant and child mortality targets for the year 2005 using the United Nations MDG database for 227 countries from 1990 to the present. We studied the association of economic development (gross domestic product [GDP] per capita in purchasing-power-parity), the relative priority placed on health (health spending as a percentage of GDP), real health spending (health system expenditures in purchasing-power-parity), HIV/AIDS burden (prevalence rates among ages 15–49 y), and NCD burden (age-standardised chronic disease mortality rates), with measures of distance from attainment of health MDGs. To avoid spurious correlations that may exist simply because countries with high disease burdens would be expected to have low MDG progress, and to adjust for potential confounding arising from differences in countries' initial disease burdens, we analysed the variations in rates of change in MDG progress versus expected rates for each country. While economic development, health priority, health spending, and health infrastructure did not explain more than one-fifth of the differences in progress to health MDGs among countries, burdens of HIV and NCDs explained more than half of between-country inequalities in child mortality progress (R2-infant mortality  = 0.57, R2-under 5 mortality  = 0.54). HIV/AIDS and NCD burdens were also the strongest correlates of unequal progress towards tuberculosis goals (R2 = 0.57), with NCDs having an effect independent of HIV/AIDS, consistent with micro-level studies of the influence of tobacco and diabetes on tuberculosis risks. Even after correcting for health system variables, initial child mortality, and tuberculosis diseases, we found that lower burdens of HIV/AIDS and NCDs were associated with much greater progress towards attainment of child mortality and tuberculosis MDGs than were gains in GDP. An estimated 1% lower HIV prevalence or 10% lower mortality rate from NCDs would have a similar impact on progress towards the tuberculosis MDG as an 80% or greater rise in GDP, corresponding to at least a decade of economic growth in low-income countries.
Conclusions
Unequal progress in health MDGs in low-income countries appears significantly related to burdens of HIV and NCDs in a population, after correcting for potentially confounding socioeconomic, disease burden, political, and health system variables. The common separation between NCDs, child mortality, and infectious syndromes among development programs may obscure interrelationships of illness affecting those living in poor households—whether economic (e.g., as money spent on tobacco is lost from child health expenditures) or biological (e.g., as diabetes or HIV enhance the risk of tuberculosis).
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 2000, 189 countries adopted the United Nations (UN) Millennium Declaration, which commits the world to the eradication of extreme poverty by 2015. The Declaration lists eight Millennium Development Goals (MDGs), 21 quantifiable targets, and 60 indicators of progress. So, for example, MDG 4 aims to reduce child mortality (deaths). The target for this goal is to reduce the number of children who die each year before they are five years old (the under-five mortality rate) to two-thirds of its 1990 value by 2015. Indicators of progress toward this goal include the under-five mortality rate and the infant mortality rate. Because poverty and ill health are inextricably linked—ill health limits the ability of individuals and nations to improve their economic status, and poverty contributes to the development of many illnesses—two other MDGs also tackle public health issues. MDG 5 sets a target of reducing maternal mortality by three-quarters of its 1990 level by 2015. MDG 6 aims to halt and begin to reverse the spread of HIV/AIDS, malaria, and other major diseases such as tuberculosis by 2015.
Why Was This Study Done?
Although progress has been made toward achieving the MDGs, few if any of the targets are likely to be met by 2015. Worryingly, low-income countries are falling furthest behind their MDG targets. For example, although child mortality has been declining globally, in many poor countries there has been little or no progress. What is the explanation for this and other inequalities in progress toward the health MDGs? Some countries may simply lack the financial resources needed to combat epidemics or may allocate only a low proportion of their gross domestic product (GDP) to health. Alternatively, money allocated to health may not always reach the people who need it most because of an inadequate health infrastructure. Finally, coexisting epidemics may be hindering progress toward the MDG health targets. Thus, the spread of HIV/AIDS may be hindering attempts to limit the spread of tuberculosis because HIV infection increases the risk of active tuberculosis, and ongoing epidemics of diabetes and other noncommunicable diseases (NCDs) may be affecting the attainment of health MDGs by diverting scarce resources. In this study, the researchers investigate whether any of these possibilities is driving the inequalities in MDG progress.
What Did the Researchers Do and Find?
The researchers calculated how far 227 countries were from their MDG targets for HIV, tuberculosis, and infant and child mortality in 2005 using information collected by the UN. They then used statistical methods to study the relationship between this distance and economic development (GDP per person), health spending as a proportion of GDP (health priority), actual health system expenditures, health infrastructure, HIV burden, and NCD burden in each country. Economic development, health priority, health spending, and health infrastructure explained no more than one-fifth of the inequalities in progress toward health MDGs. By contrast, the HIV and NCD burdens explained more than half of inequalities in child mortality progress and were strongly associated with unequal progress toward tuberculosis goals. Furthermore, the researchers calculated that a 1% reduction in the number of people infected with HIV or a 10% reduction in rate of deaths from NCDs in a population would have a similar impact on progress toward the tuberculosis MDG target as a rise in GDP corresponding to at least a decade of growth in low-income countries.
What Do These Findings Mean?
These findings are limited by the quality of the available data on health indicators in low-income countries and, because the researchers used country-wide data, their findings only reveal possible drivers of inequalities in progress toward MDGs in whole countries and may mask drivers of within-country inequalities. Nevertheless, as one of the first attempts to analyze the determinants of global inequalities in progress toward the health MDGs, these findings have important implications for global health policy. Most importantly, the finding that unequal progress is related to the burdens of HIV and NCDs in populations suggests that programs designed to achieve health MDGs must consider all the diseases and factors that can trap households in vicious cycles of illness and poverty, especially since the achievement of feasible reductions in NCDs in low-income countries could greatly enhance progress towards health MDGs.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000241.
The United Nations Millennium Development Goals website provides detailed information about the Millennium Declaration, the MDGs, their targets and their indicators
The Millennium Development Goals Report 2009 and its progress chart provide an up-to-date assessment of progress towards the MDGs
The World Health Organization provides information about poverty and health and health and development
doi:10.1371/journal.pmed.1000241
PMCID: PMC2830449  PMID: 20209000
19.  Intimate Partner Violence and Depression Symptom Severity among South African Women during Pregnancy and Postpartum: Population-Based Prospective Cohort Study 
PLoS Medicine  2016;13(1):e1001943.
Background
Violence against women by intimate partners remains unacceptably common worldwide. The evidence base for the assumed psychological impacts of intimate partner violence (IPV) is derived primarily from studies conducted in high-income countries. A recently published systematic review identified 13 studies linking IPV to incident depression, none of which were conducted in sub-Saharan Africa. To address this gap in the literature, we analyzed longitudinal data collected during the course of a 3-y cluster-randomized trial with the aim of estimating the association between IPV and depression symptom severity.
Methods and Findings
We conducted a secondary analysis of population-based, longitudinal data collected from 1,238 pregnant women during a 3-y cluster-randomized trial of a home visiting intervention in Cape Town, South Africa. Surveys were conducted at baseline, 6 mo, 18 mo, and 36 mo (85% retention). The primary explanatory variable of interest was exposure to four types of physical IPV in the past year. Depression symptom severity was measured using the Xhosa version of the ten-item Edinburgh Postnatal Depression Scale. In a pooled cross-sectional multivariable regression model adjusting for potentially confounding time-fixed and time-varying covariates, lagged IPV intensity had a statistically significant association with depression symptom severity (regression coefficient b = 1.04; 95% CI, 0.61–1.47), with estimates from a quantile regression model showing greater adverse impacts at the upper end of the conditional depression distribution. Fitting a fixed effects regression model accounting for all time-invariant confounding (e.g., history of childhood sexual abuse) yielded similar findings (b = 1.54; 95% CI, 1.13–1.96). The magnitudes of the coefficients indicated that a one–standard-deviation increase in IPV intensity was associated with a 12.3% relative increase in depression symptom severity over the same time period. The most important limitations of our study include exposure assessment that lacked measurement of sexual violence, which could have caused us to underestimate the severity of exposure; the extended latency period in the lagged analysis, which could have caused us to underestimate the strength of the association; and outcome assessment that was limited to the use of a screening instrument for depression symptom severity.
Conclusions
In this secondary analysis of data from a population-based, 3-y cluster-randomized controlled trial, IPV had a statistically significant association with depression symptom severity. The estimated associations were relatively large in magnitude, consistent with findings from high-income countries, and robust to potential confounding by time-invariant factors. Intensive health sector responses to reduce IPV and improve women’s mental health should be explored.
In a population-based prospective cohort study, Alexander C. Tsai and colleagues examine bidirectional associations between intimate partner violence and depressed mood among pregnant and postpartum women living near Cape Town, South Africa.
Editors' Summary
Background
Violence against women perpetrated by an intimate partner is a common and widespread problem. Rates of intimate partner violence (IPV, also called domestic violence) vary widely between countries but, globally, nearly a third of women experience IPV at some time in their life. IPV is defined as physical, sexual, or emotional violence that is perpetrated on an individual by a current or former partner or spouse. Physical violence includes slapping, pushing or shoving, hitting with a fist or another object, and threatening or attacking a partner with a weapon; sexual violence means forcing a partner to take part in a sex act when the partner does not give consent; and emotional violence includes threatening a partner by, for example, preventing them seeing their family. The adverse effects of IPV against women include physical injury and sexual and reproductive health problems such as HIV infection and unwanted pregnancies.
Why Was This Study Done?
Studies undertaken in high-income countries have also shown an association between IPV and adverse mental health outcomes among women, such as depression (long-lasting and overwhelming feelings of sadness and hopelessness) and suicidal behavior. However, few if any studies on the association between IPV and depression have been conducted in sub-Saharan Africa, where the rates of IPV against women are among the highest in the world. In this population-based prospective cohort study, the researchers analyze longitudinal data collected during a cluster-randomized trial that involved more than 1,200 women living in townships near Cape Town, South Africa. The primary aim of this randomized trial was to investigate whether regular visits by “mentor mothers” (women who had successfully raised children in the face of adversity) improved maternal and child health in the 3 y following the child’s birth. As part of this trial, the researchers collected data at multiple time points (longitudinal data) on women’s experiences of IPV and symptoms of depression. Here, the researchers conduct a secondary analysis of these data to estimate the association between IPV severity and depression symptom severity among women during and following pregnancy.
What Did the Researchers Do and Find?
During the cluster-randomized trial, the researchers asked the women about their exposure to physical IPV during the past year in surveys undertaken at baseline, 6 mo, 18 mo, and 36 mo. Depression symptom severity was also measured in the women at these time points using a version of the ten-item Edinburgh Postnatal Depression Scale in the local language Xhosa; this scale is an instrument that screens for postnatal depression by asking questions about depressive symptoms experienced during the past seven days by women who have recently had a baby, such as how often they have felt sad or miserable. Statistical analyses of these data indicated that, after allowing for other factors that might affect depression symptom severity, IPV intensity had a statistically significant association (an association unlikely to have arisen by chance) with depression symptom severity. That is, an increase in IPV severity among the study participants was associated with an increase in depression symptom severity over the same period. Notably, this association was bidirectional. That is, depression symptom severity also had a statistically significant association with IPV intensity.
What Do These Findings Mean?
These findings show that, among women living in poor neighborhoods in Cape Town who have recently had a baby, IPV severity had a statistically significant association with depression symptom severity. The magnitude of this association was relatively large and consistent with findings from high-income countries. The accuracy of these findings may be limited by certain aspects of this study. For example, because the study participants were not asked about sexual violence, the severity of IPV exposure may be underestimated. Nevertheless, these findings—in particular, the demonstration that the association between IPV and depression is bilateral—have important policy and programmatic implications for women’s health in sub-Saharan Africa. Specifically, because IPV and depression may be intertwined in a vicious cycle, with IPV increasing the risk of future depression and depression increasing the risk of future victimization, multi-component interventions that combine a broad-based package of services (for example, provision of legal aid, transitional housing, and childcare support) with interventions designed to treat depression (for example cognitive-behavioral therapy) may be needed to reduce IPV and improve women’s mental health.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001943.
A PLOS Medicine Research Article by Devries et al. reviews the evidence from high-income countries for an association between IPV and depression
The World Health Organization provides detailed information on intimate partner violence and on depression (some information in several languages)
The UK National Health Service Choices website provides information about intimate partner violence, including some personal stories, and detailed information about depression
The US Centers for Disease Control and Prevention provides information about intimate partner violence and links to further resources
The US National Domestic Violence Hotline provides confidential help and support to people experiencing IPV; its website includes personal stories of IPV
The US National Institute of Mental Health provides information on all aspects of depression
MedlinePlus provides links to other resources about domestic violence and about depression (in English and Spanish)
More information about the "mentor mother" trial is available
doi:10.1371/journal.pmed.1001943
PMCID: PMC4718639  PMID: 26784110
20.  Clinical Utility of Serologic Testing for Celiac Disease in Ontario 
Executive Summary
Objective of Analysis
The objective of this evidence-based evaluation is to assess the accuracy of serologic tests in the diagnosis of celiac disease in subjects with symptoms consistent with this disease. Furthermore the impact of these tests in the diagnostic pathway of the disease and decision making was also evaluated.
Celiac Disease
Celiac disease is an autoimmune disease that develops in genetically predisposed individuals. The immunological response is triggered by ingestion of gluten, a protein that is present in wheat, rye, and barley. The treatment consists of strict lifelong adherence to a gluten-free diet (GFD).
Patients with celiac disease may present with a myriad of symptoms such as diarrhea, abdominal pain, weight loss, iron deficiency anemia, dermatitis herpetiformis, among others.
Serologic Testing in the Diagnosis Celiac Disease
There are a number of serologic tests used in the diagnosis of celiac disease.
Anti-gliadin antibody (AGA)
Anti-endomysial antibody (EMA)
Anti-tissue transglutaminase antibody (tTG)
Anti-deamidated gliadin peptides antibodies (DGP)
Serologic tests are automated with the exception of the EMA test, which is more time-consuming and operator-dependent than the other tests. For each serologic test, both immunoglobulin A (IgA) or G (IgG) can be measured, however, IgA measurement is the standard antibody measured in celiac disease.
Diagnosis of Celiac Disease
According to celiac disease guidelines, the diagnosis of celiac disease is established by small bowel biopsy. Serologic tests are used to initially detect and to support the diagnosis of celiac disease. A small bowel biopsy is indicated in individuals with a positive serologic test. In some cases an endoscopy and small bowel biopsy may be required even with a negative serologic test. The diagnosis of celiac disease must be performed on a gluten-containing diet since the small intestine abnormalities and the serologic antibody levels may resolve or improve on a GFD.
Since IgA measurement is the standard for the serologic celiac disease tests, false negatives may occur in IgA-deficient individuals.
Incidence and Prevalence of Celiac Disease
The incidence and prevalence of celiac disease in the general population and in subjects with symptoms consistent with or at higher risk of celiac disease based on systematic reviews published in 2004 and 2009 are summarized below.
Incidence of Celiac Disease in the General Population
Adults or mixed population: 1 to 17/100,000/year
Children: 2 to 51/100,000/year
In one of the studies, a stratified analysis showed that there was a higher incidence of celiac disease in younger children compared to older children, i.e., 51 cases/100,000/year in 0 to 2 year-olds, 33/100,000/year in 2 to 5 year-olds, and 10/100,000/year in children 5 to 15 years old.
Prevalence of Celiac Disease in the General Population
The prevalence of celiac disease reported in population-based studies identified in the 2004 systematic review varied between 0.14% and 1.87% (median: 0.47%, interquartile range: 0.25%, 0.71%). According to the authors of the review, the prevalence did not vary by age group, i.e., adults and children.
Prevalence of Celiac Disease in High Risk Subjects
Type 1 diabetes (adults and children): 1 to 11%
Autoimmune thyroid disease: 2.9 to 3.3%
First degree relatives of patients with celiac disease: 2 to 20%
Prevalence of Celiac Disease in Subjects with Symptoms Consistent with the Disease
The prevalence of celiac disease in subjects with symptoms consistent with the disease varied widely among studies, i.e., 1.5% to 50% in adult studies, and 1.1% to 17% in pediatric studies. Differences in prevalence may be related to the referral pattern as the authors of a systematic review noted that the prevalence tended to be higher in studies whose population originated from tertiary referral centres compared to general practice.
Research Questions
What is the sensitivity and specificity of serologic tests in the diagnosis celiac disease?
What is the clinical validity of serologic tests in the diagnosis of celiac disease? The clinical validity was defined as the ability of the test to change diagnosis.
What is the clinical utility of serologic tests in the diagnosis of celiac disease? The clinical utility was defined as the impact of the test on decision making.
What is the budget impact of serologic tests in the diagnosis of celiac disease?
What is the cost-effectiveness of serologic tests in the diagnosis of celiac disease?
Methods
Literature Search
A literature search was performed on November 13th, 2009 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1st 2003 and November 13th 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Studies that evaluated diagnostic accuracy, i.e., both sensitivity and specificity of serology tests in the diagnosis of celiac disease.
Study population consisted of untreated patients with symptoms consistent with celiac disease.
Studies in which both serologic celiac disease tests and small bowel biopsy (gold standard) were used in all subjects.
Systematic reviews, meta-analyses, randomized controlled trials, prospective observational studies, and retrospective cohort studies.
At least 20 subjects included in the celiac disease group.
English language.
Human studies.
Studies published from 2000 on.
Clearly defined cut-off value for the serology test. If more than one test was evaluated, only those tests for which a cut-off was provided were included.
Description of small bowel biopsy procedure clearly outlined (location, number of biopsies per patient), unless if specified that celiac disease diagnosis guidelines were followed.
Patients in the treatment group had untreated CD.
Studies on screening of the general asymptomatic population.
Studies that evaluated rapid diagnostic kits for use either at home or in physician’s offices.
Studies that evaluated diagnostic modalities other than serologic tests such as capsule endoscopy, push enteroscopy, or genetic testing.
Cut-off for serologic tests defined based on controls included in the study.
Study population defined based on positive serology or subjects pre-screened by serology tests.
Celiac disease status known before study enrolment.
Sensitivity or specificity estimates based on repeated testing for the same subject.
Non-peer-reviewed literature such as editorials and letters to the editor.
Population
The population consisted of adults and children with untreated, undiagnosed celiac disease with symptoms consistent with the disease.
Serologic Celiac Disease Tests Evaluated
Anti-gliadin antibody (AGA)
Anti-endomysial antibody (EMA)
Anti-tissue transglutaminase antibody (tTG)
Anti-deamidated gliadin peptides antibody (DGP)
Combinations of some of the serologic tests listed above were evaluated in some studies
Both IgA and IgG antibodies were evaluated for the serologic tests listed above.
Outcomes of Interest
Sensitivity
Specificity
Positive and negative likelihood ratios
Diagnostic odds ratio (OR)
Area under the sROC curve (AUC)
Small bowel biopsy was used as the gold standard in order to estimate the sensitivity and specificity of each serologic test.
Statistical Analysis
Pooled estimates of sensitivity, specificity and diagnostic odds ratios (DORs) for the different serologic tests were calculated using a bivariate, binomial generalized linear mixed model. Statistical significance for differences in sensitivity and specificity between serologic tests was defined by P values less than 0.05, where “false discovery rate” adjustments were made for multiple hypothesis testing. The bivariate regression analyses were performed using SAS version 9.2 (SAS Institute Inc.; Cary, NC, USA). Using the bivariate model parameters, summary receiver operating characteristic (sROC) curves were produced using Review Manager 5.0.22 (The Nordiac Cochrane Centre, The Cochrane Collaboration, 2008). The area under the sROC curve (AUC) was estimated by bivariate mixed-efects binary regression modeling framework. Model specification, estimation and prediction are carried out with xtmelogit in Stata release 10 (Statacorp, 2007). Statistical tests for the differences in AUC estimates could not be carried out.
The study results were stratified according to patient or disease characteristics such as age, severity of Marsh grade abnormalities, among others, if reported in the studies. The literature indicates that the diagnostic accuracy of serologic tests for celiac disease may be affected in patients with chronic liver disease, therefore, the studies identified through the systematic literature review that evaluated the diagnostic accuracy of serologic tests for celiac disease in patients with chronic liver disease were summarized. The effect of the GFD in patiens diagnosed with celiac disease was also summarized if reported in the studies eligible for the analysis.
Summary of Findings
Published Systematic Reviews
Five systematic reviews of studies that evaluated the diagnostic accuracy of serologic celiac disease tests were identified through our literature search. Seventeen individual studies identified in adults and children were eligible for this evaluation.
In general, the studies included evaluated the sensitivity and specificity of at least one serologic test in subjects with symptoms consistent with celiac disease. The gold standard used to confirm the celiac disease diagnosis was small bowel biopsy. Serologic tests evaluated included tTG, EMA, AGA, and DGP, using either IgA or IgG antibodies. Indirect immunoflurorescence was used for the EMA serologic tests whereas enzyme-linked immunosorbent assay (ELISA) was used for the other serologic tests.
Common symptoms described in the studies were chronic diarrhea, abdominal pain, bloating, unexplained weight loss, unexplained anemia, and dermatitis herpetiformis.
The main conclusions of the published systematic reviews are summarized below.
IgA tTG and/or IgA EMA have a high accuracy (pooled sensitivity: 90% to 98%, pooled specificity: 95% to 99% depending on the pooled analysis).
Most reviews found that AGA (IgA or IgG) are not as accurate as IgA tTG and/or EMA tests.
A 2009 systematic review concluded that DGP (IgA or IgG) seems to have a similar accuracy compared to tTG, however, since only 2 studies identified evaluated its accuracy, the authors believe that additional data is required to draw firm conclusions.
Two systematic reviews also concluded that combining two serologic celiac disease tests has little contribution to the accuracy of the diagnosis.
MAS Analysis
Sensitivity
The pooled analysis performed by MAS showed that IgA tTG has a sensitivity of 92.1% [95% confidence interval (CI) 88.0, 96.3], compared to 89.2% (83.3, 95.1, p=0.12) for IgA DGP, 85.1% (79.5, 94.4, p=0.07) for IgA EMA, and 74.9% (63.6, 86.2, p=0.0003) for IgA AGA. Among the IgG-based tests, the results suggest that IgG DGP has a sensitivity of 88.4% (95% CI: 82.1, 94.6), 44.7% (30.3, 59.2) for tTG, and 69.1% (56.0, 82.2) for AGA. The difference was significant when IgG DGP was compared to IgG tTG but not IgG AGA. Combining serologic celiac disease tests yielded a slightly higher sensitivity compared to individual IgA-based serologic tests.
IgA deficiency
The prevalence of total or severe IgA deficiency was low in the studies identified varying between 0 and 1.7% as reported in 3 studies in which IgA deficiency was not used as a referral indication for celiac disease serologic testing. The results of IgG-based serologic tests were positive in all patients with IgA deficiency in which celiac disease was confirmed by small bowel biopsy as reported in four studies.
Specificity
The MAS pooled analysis indicates a high specificity across the different serologic tests including the combination strategy, pooled estimates ranged from 90.1% to 98.7% depending on the test.
Likelihood Ratios
According to the likelihood ratio estimates, both IgA tTG and serologic test combinationa were considered very useful tests (positive likelihood ratio above ten and the negative likelihood ratio below 0.1).
Moderately useful tests included IgA EMA, IgA DGP, and IgG DGP (positive likelihood ratio between five and ten and the negative likelihood ratio between 0.1 and 0.2).
Somewhat useful tests: IgA AGA, IgG AGA, generating small but sometimes important changes from pre- to post-test probability (positive LR between 2 and 5 and negative LR between 0.2 and 0.5)
Not Useful: IgG tTG, altering pre- to post-test probability to a small and rarely important degree (positive LR between 1 and 2 and negative LR between 0.5 and 1).
Diagnostic Odds Ratios (DOR)
Among the individual serologic tests, IgA tTG had the highest DOR, 136.5 (95% CI: 51.9, 221.2). The statistical significance of the difference in DORs among tests was not calculated, however, considering the wide confidence intervals obtained, the differences may not be statistically significant.
Area Under the sROC Curve (AUC)
The sROC AUCs obtained ranged between 0.93 and 0.99 for most IgA-based tests with the exception of IgA AGA, with an AUC of 0.89.
Sensitivity and Specificity of Serologic Tests According to Age Groups
Serologic test accuracy did not seem to vary according to age (adults or children).
Sensitivity and Specificity of Serologic Tests According to Marsh Criteria
Four studies observed a trend towards a higher sensitivity of serologic celiac disease tests when Marsh 3c grade abnormalities were found in the small bowel biopsy compared to Marsh 3a or 3b (statistical significance not reported). The sensitivity of serologic tests was much lower when Marsh 1 grade abnormalities were found in small bowel biopsy compared to Marsh 3 grade abnormalities. The statistical significance of these findings were not reported in the studies.
Diagnostic Accuracy of Serologic Celiac Disease Tests in Subjects with Chronic Liver Disease
A total of 14 observational studies that evaluated the specificity of serologic celiac disease tests in subjects with chronic liver disease were identified. All studies evaluated the frequency of false positive results (1-specificity) of IgA tTG, however, IgA tTG test kits using different substrates were used, i.e., human recombinant, human, and guinea-pig substrates. The gold standard, small bowel biopsy, was used to confirm the result of the serologic tests in only 5 studies. The studies do not seem to have been designed or powered to compare the diagnostic accuracy among different serologic celiac disease tests.
The results of the studies identified in the systematic literature review suggest that there is a trend towards a lower frequency of false positive results if the IgA tTG test using human recombinant substrate is used compared to the guinea pig substrate in subjects with chronic liver disease. However, the statistical significance of the difference was not reported in the studies. When IgA tTG with human recombinant substrate was used, the number of false positives seems to be similar to what was estimated in the MAS pooled analysis for IgA-based serologic tests in a general population of patients. These results should be interpreted with caution since most studies did not use the gold standard, small bowel biopsy, to confirm or exclude the diagnosis of celiac disease, and since the studies were not designed to compare the diagnostic accuracy among different serologic tests. The sensitivity of the different serologic tests in patients with chronic liver disease was not evaluated in the studies identified.
Effects of a Gluten-Free Diet (GFD) in Patients Diagnosed with Celiac Disease
Six studies identified evaluated the effects of GFD on clinical, histological, or serologic improvement in patients diagnosed with celiac disease. Improvement was observed in 51% to 95% of the patients included in the studies.
Grading of Evidence
Overall, the quality of the evidence ranged from moderate to very low depending on the serologic celiac disease test. Reasons to downgrade the quality of the evidence included the use of a surrogate endpoint (diagnostic accuracy) since none of the studies evaluated clinical outcomes, inconsistencies among study results, imprecise estimates, and sparse data. The quality of the evidence was considered moderate for IgA tTg and IgA EMA, low for IgA DGP, and serologic test combinations, and very low for IgA AGA.
Clinical Validity and Clinical Utility of Serologic Testing in the Diagnosis of Celiac Disease
The clinical validity of serologic tests in the diagnosis of celiac disease was considered high in subjects with symptoms consistent with this disease due to
High accuracy of some serologic tests.
Serologic tests detect possible celiac disease cases and avoid unnecessary small bowel biopsy if the test result is negative, unless an endoscopy/ small bowel biopsy is necessary due to the clinical presentation.
Serologic tests support the results of small bowel biopsy.
The clinical utility of serologic tests for the diagnosis of celiac disease, as defined by its impact in decision making was also considered high in subjects with symptoms consistent with this disease given the considerations listed above and since celiac disease diagnosis leads to treatment with a gluten-free diet.
Economic Analysis
A decision analysis was constructed to compare costs and outcomes between the tests based on the sensitivity, specificity and prevalence summary estimates from the MAS Evidence-Based Analysis (EBA). A budget impact was then calculated by multiplying the expected costs and volumes in Ontario. The outcome of the analysis was expected costs and false negatives (FN). Costs were reported in 2010 CAD$. All analyses were performed using TreeAge Pro Suite 2009.
Four strategies made up the efficiency frontier; IgG tTG, IgA tTG, EMA and small bowel biopsy. All other strategies were dominated. IgG tTG was the least costly and least effective strategy ($178.95, FN avoided=0). Small bowel biopsy was the most costly and most effective strategy ($396.60, FN avoided =0.1553). The cost per FN avoided were $293, $369, $1,401 for EMA, IgATTG and small bowel biopsy respectively. One-way sensitivity analyses did not change the ranking of strategies.
All testing strategies with small bowel biopsy are cheaper than biopsy alone however they also result in more FNs. The most cost-effective strategy will depend on the decision makers’ willingness to pay. Findings suggest that IgA tTG was the most cost-effective and feasible strategy based on its Incremental Cost-Effectiveness Ratio (ICER) and convenience to conduct the test. The potential impact of IgA tTG test in the province of Ontario would be $10.4M, $11.0M and $11.7M respectively in the following three years based on past volumes and trends in the province and basecase expected costs.
The panel of tests is the commonly used strategy in the province of Ontario therefore the impact to the system would be $13.6M, $14.5M and $15.3M respectively in the next three years based on past volumes and trends in the province and basecase expected costs.
Conclusions
The clinical validity and clinical utility of serologic tests for celiac disease was considered high in subjects with symptoms consistent with this disease as they aid in the diagnosis of celiac disease and some tests present a high accuracy.
The study findings suggest that IgA tTG is the most accurate and the most cost-effective test.
AGA test (IgA) has a lower accuracy compared to other IgA-based tests
Serologic test combinations appear to be more costly with little gain in accuracy. In addition there may be problems with generalizability of the results of the studies included in this review if different test combinations are used in clinical practice.
IgA deficiency seems to be uncommon in patients diagnosed with celiac disease.
The generalizability of study results is contingent on performing both the serologic test and small bowel biopsy in subjects on a gluten-containing diet as was the case in the studies identified, since the avoidance of gluten may affect test results.
PMCID: PMC3377499  PMID: 23074399
21.  Endovascular Radiofrequency Ablation for Varicose Veins 
Executive Summary
Objective
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost–effectiveness of endovascular radiofrequency ablation (RFA) for the treatment of primary symptomatic varicose veins.
Background
The Ontario Health Technology Advisory Committee (OHTAC) met on August 26th, 2010 to review the safety, effectiveness, durability, and cost-effectiveness of RFA for the treatment of primary symptomatic varicose veins based on an evidence-based review by the Medical Advisory Secretariat (MAS).
Clinical Condition
Varicose veins (VV) are tortuous, twisted, or elongated veins. This can be due to existing (inherited) valve dysfunction or decreased vein elasticity (primary venous reflux) or valve damage from prior thrombotic events (secondary venous reflux). The end result is pooling of blood in the veins, increased venous pressure and subsequent vein enlargement. As a result of high venous pressure, branch vessels balloon out leading to varicosities (varicose veins).
Symptoms typically affect the lower extremities and include (but are not limited to): aching, swelling, throbbing, night cramps, restless legs, leg fatigue, itching and burning. Left untreated, venous reflux tends to be progressive, often leading to chronic venous insufficiency (CVI). A number of complications are associated with untreated venous reflux: including superficial thrombophlebitis as well as variceal rupture and haemorrhage. CVI often results in chronic skin changes referred to as stasis dermatitis. Stasis dermatitis is comprised of a spectrum of cutaneous abnormalities including edema, hyperpigmentation, eczema, lipodermatosclerosis and stasis ulceration. Ulceration represents the disease end point for severe CVI. CVI is associated with a reduced quality of life particularly in relation to pain, physical function and mobility. In severe cases, VV with ulcers, QOL has been rated to be as bad or worse as other chronic diseases such as back pain and arthritis.
Lower limb VV is a very common disease affecting adults – estimated to be the 7th most common reason for physician referral in the US. There is a very strong familial predisposition to VV. The risk in offspring is 90% if both parents affected, 20% when neither affected and 45% (25% boys, 62% girls) if one parent affected. The prevalence of VV worldwide ranges from 5% to 15% among men and 3% to 29% among women varying by the age, gender and ethnicity of the study population, survey methods and disease definition and measurement. The annual incidence of VV estimated from the Framingham Study was reported to be 2.6% among women and 1.9% among men and did not vary within the age range (40-89 years) studied.
Approximately 1% of the adult population has a stasis ulcer of venous origin at any one time with 4% at risk. The majority of leg ulcer patients are elderly with simple superficial vein reflux. Stasis ulcers are often lengthy medical problems and can last for several years and, despite effective compression therapy and multilayer bandaging are associated with high recurrence rates. Recent trials involving surgical treatment of superficial vein reflux have resulted in healing and significantly reduced recurrence rates.
Endovascular Radiofrequency Ablation for Varicose Veins
RFA is an image-guided minimally invasive treatment alternative to surgical stripping of superficial venous reflux. RFA does not require an operating room or general anaesthesia and has been performed in an outpatient setting by a variety of medical specialties including surgeons and interventional radiologists. Rather than surgically removing the vein, RFA works by destroying or ablating the refluxing vein segment using thermal energy delivered through a radiofrequency catheter.
Prior to performing RFA, color-flow Doppler ultrasonography is used to confirm and map all areas of venous reflux to devise a safe and effective treatment plan. The RFA procedure involves the introduction of a guide wire into the target vein under ultrasound guidance followed by the insertion of an introducer sheath through which the RFA catheter is advanced. Once satisfactory positioning has been confirmed with ultrasound, a tumescent anaesthetic solution is injected into the soft tissue surrounding the target vein along its entire length. This serves to anaesthetize the vein, insulate the heat from damaging adjacent structures, including nerves and skin and compresses the vein increasing optimal contact of the vessel wall with the electrodes or expanded prongs of the RF device. The RF generator is then activated and the catheter is slowly pulled along the length of the vein. At the end of the procedure, hemostasis is then achieved by applying pressure to the vein entry point.
Adequate and proper compression stockings and bandages are applied after the procedure to reduce the risk of venous thromboembolism and to reduce postoperative bruising and tenderness. Patients are encouraged to walk immediately after the procedure. Follow-up protocols vary, with most patients returning 1 to 3 weeks later for an initial follow-up visit. At this point, the initial clinical result is assessed and occlusion of the treated vessels is confirmed with ultrasound. Patients often have a second follow-up visit 1 to 3 months following RFA at which time clinical evaluation and ultrasound are repeated. If required, additional procedures such as phlebectomy or sclerotherapy may be performed during the RFA procedure or at any follow-up visits.
Regulatory Status
The Closure System® radiofrequency generator for endovascular thermal ablation of varicose veins was approved by Health Canada as a class 3 device in March 2005, registered under medical device license 67865. The RFA intravascular catheter was approved by Health Canada in November 2007 for the ClosureFast catheter, registered under medical device license 16574. The Closure System® also has regulatory approvals in Australia, Europe (CE Mark) and the United States (FDA clearance). In Ontario, RFA is not an insured service and is currently being introduced in private clinics.
Methods
Literature Search
The MAS evidence–based review was performed to support public financing decisions. The literature search was performed on March 9th, 2010 using standard bibliographic databases for studies published up until March, 2010.
Inclusion Criteria
English language full-reports and human studies Original reports with defined study methodologyReports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction Reports involving RFA for varicose veins (great or small saphenous veins)Randomized controlled trials (RCTs), systematic reviews and meta-analysesCohort and controlled clinical studies involving ≥ 1 month ultrasound imaging follow-up
Exclusion Criteria
Non systematic reviews, letters, comments and editorials Reports not involving outcome events such as safety, effectiveness, durability, or patient satisfaction following an intervention with RFAReports not involving interventions with RFA for varicose veinsPilot studies or studies with small samples (< 50 subjects)
Summary of Findings
The MAS evidence search on the safety and effectiveness of endovascular RFA ablation of VV identified the following evidence: three HTAs, nine systematic reviews, eight randomized controlled trials (five comparing RFA to surgery and three comparing RFA to ELT), five controlled clinical trials and fourteen cohort case series (four were multicenter registry studies).
The majority (12⁄14) of the cohort studies (3,664) evaluating RFA for VV involved treatment with first generation RFA catheters and the great saphenous vein (GSV) was the target vessel in all studies. Major adverse events were uncommonly reported and the overall pooled major adverse event rate extracted from the cohort studies was 2.9% (105⁄3,664). Imaging defined treatment effectiveness of vein closure rates were variable ranging from 68% to 96% at post-operative follow-up. Vein ablation rate at 6-month follow-up was reported in four studies with rates close to 90%. Only one study reported vein closure rates at 2 years but only for a minority of the eligible cases. The two studies reporting on RFA ablation with the more efficient second generation catheters involved better follow-up and reported higher ablation rates close to 100% at 6-month follow-up with no major adverse events. A large prospective registry trial that recruited over 1,000 patients at thirty-four largely European centers reported on treatment success in six overlapping reports on selected patient subgroups at various follow-up points up to 5 year. However, the follow-up for eligible recruited patients at all time points was low resulting in inadequate estimates of longer term treatment efficacy.
The overall level of evidence of randomized trials comparing RFA with surgical ligation and vein stripping (n = 5) was graded as low to moderate. In all trials RFA ablation was performed with first generation catheters in the setting of the operating theatre under general anaesthesia, usually without tumescent anaesthesia. Procedure times were significantly longer after RFA than surgery. Recovery after treatment was significantly quicker after RFA both with return to usual activity and return to work with on average a one week less of work loss. Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) than after RFA but not significantly. Treatment effectiveness measured by imaging defined vein absence or vein closure was comparable in the two treatment groups. Significant improvements in vein symptoms and quality of life over baseline were reported for both treatment groups. Improvements in these outcomes were significantly greater in the RFA group than the surgery group in the peri-operative period but not in later follow-up. Follow-up in these trials was inadequate to evaluate longer term recurrence for either treatment. Patient satisfaction was reported to be high for both treatments but was higher for RFA.
The studies comparing endovascular treatment approaches for VV (RFA and ELT) were more limited. Three RCT studies compared RFA (two with the second generation catheter) with ELT but mainly focused on peri-procedural outcomes such as pain, complications and recovery. Vein ablation rates were not evaluated in the trials, except for one small trial involving bilateral VV. Pain responses in patients undergoing ablation were extremely variable and up to 2 weeks, mean pain levels were significantly less with RFA than ELT ablation but differences were not significant at one month. Recovery, evaluated as return to usual activity or return to work, however, was similar in the treatment groups. Vein symptom and QOL improvements were improved in both groups but were significantly better in the RFA group than the ELT group at 2 weeks, but not at one month. Vein ablation rates were evaluated in several controlled clinical studies comparing the treatments between centers or within centers between individuals or over time. Comparisons in these studies were inconsistent with vein ablation rates for RFA reported to be similar to, higher than and lower than those with ELT.
Economic Analysis
RFA and surgical vein stripping, the main comparator reimbursed by the public system, are comparable in clinical benefits. Hence a cost-analysis was conducted to identify the differences in resources and costs between both procedures and a budgetary impact analysis (BIA) was conducted to project costs over a 5- year period in the province of Ontario. The target population of this economic analysis was patients with symptomatic varicose veins and the primary analytic perspective was that of the Ministry of Health and Long-Term Care.
The average case cost (based on Ontario hospital costs and medical resources) for surgical vein stripping was estimated to be $1,799. In order to calculate a procedural cost for RFA it was assumed that the hospital cost and physician labour fees, excluding anaesthesia and surgical assistance, were the same as vein stripping surgery. The manufacturer also provided details on the generator with a capital cost of $27,500 and a lifespan of 5 years and the disposables (catheter, sheath, guidewire) with a cost of $673 per case. The average case cost for RFA was therefore estimated to be $1,356. One-way sensitivity analysis was also conducted with hospital cost of RFA varied to 60% that of vein stripping surgery (average cost per case = $627.08) to calculate an impact to the province.
Historical volumes of vein stripping surgeries in Ontario were used to project surgeries in a linear fashion up to five years into the future. Volumes for RFA and ELT were calculated based on share capture from the surgery market based on discussion with clinical expert opinion and existing private data based on discussion with the manufacturer. RFA is expected to compete with ELT and capture some of the market. If ELT is reimbursed by the public sector then numbers will continue to increase from previous private data and share capture from the conventional surgical treatment market. Therefore, RFA cases will also increase since it will be capturing a share of the ELT market. A budget impact to the province was then calculated by multiplying volumes by the cost of the procedure.
RFA is comparable in clinical benefits to vein stripping surgery. It has the extra upfront cost of the generator and cost per case for disposables but does not require an operating theater, anaesthetist or surgical assistant fees. The impact to the province is expected to be 5 M by Year 5 with the introduction of new ELT and RFA image guided endovascular technologies and existing surgery for varicose veins.
Conclusion
The conclusions on the comparative outcomes between endovascular RFA and surgical ligation and saphenous vein stripping and between endovascular RFA and laser ablation for VV treatment are summarized in the table below (ES Table 1).
Outcome comparisons of RFA vs. surgery and RFA vs ELT for varicose veins
ELT refers to endovascular laser ablation; RFA, radiofrequency ablation
The outcomes of the evidence-based review on these treatments for VV based on different perspectives are summarized below:
RFA First versus Second Generation Catheters and Segmental Ablation
Ablation with second generation catheters and segmental ablation offered technical advantages with improved ease and significant decreases in procedure time. RFA ablation with second generation catheters is also no longer restricted to smaller (< 12 mm diameter) saphenous veins. The safety profile with the new device and method of energy delivery is as good as or improved over the first generation device. No major adverse events were reported in two multicenter prospective cohort studies in 6 month follow-up with over 500 patients. Post-operative complications such as bruising and pain were significantly less with RFA ablation with second generation catheters than ELT in two RCT trials.RFA treatment with second generation catheters has ablation rates that are higher than with first generation catheters and are more comparable with the consistently high rates of ELT.
Endovascular RFA versus Surgery
RFA has a quicker recovery attributable to decreased pain and lower minor complications.RFA, in the short term was comparable to surgery in treatment effectiveness as assessed by imaging defined anatomic outcomes such as vein closure, flow or reflux. Other treatment outcomes such as symptomatic relief and HRQOL were significantly improved in both groups and between group differences in the early peri-operative period were likely influenced by pain experiences. Longer term follow-up was inadequate to evaluate recurrence after either treatment.Patient satisfaction was high after both treatments but was higher for RFA than surgery.
Endovascular RFA versus ELT
RFA has significantly less post-operative pain than ELT but differences were not significant when pain was adjusted for analgesic use and pain differences between groups did not persist at 1 month follow-up.Treatment effectiveness, measured as symptom relief and QOL improvement were similar between the endovascular treatments in the short term (within 1 month) Treatment effectiveness measured as imaging defined vein ablation was not measured in any RCT trials (only for bilateral VV disease) and results were inconsistently reported in observational trials.Longer term follow-up was not available to assess recurrence after either treatment.
System Outcomes – RFA Replacing Surgery or Competing with ELT
RFA may offer system advantages in that the treatment can be offered by several medical specialties in outpatient settings and because it does not require an operating theatre or general anaesthesia. The treatment may result in decanting of patients from OR with decreased pre-surgical investigations, demand on anaesthetists’ time, hospital stay and wait time for VV treatment. It may also provide more reliable outpatient scheduling. Procedure costs may be less for endovascular approaches than surgery but the budget impact may be greater with insurance of RFA because of the transfer of cases from the private market to the public payer system.Competition between RFA and ELT endovascular approaches is likely to continue to stimulate innovation and technical changes to advance patient care and result in competitive pricing.
PMCID: PMC3377553  PMID: 23074413
22.  A Transdiagnostic Community-Based Mental Health Treatment for Comorbid Disorders: Development and Outcomes of a Randomized Controlled Trial among Burmese Refugees in Thailand 
PLoS Medicine  2014;11(11):e1001757.
In a randomized controlled trial, Paul Bolton and colleagues investigate whether a transdiagnostic community-based intervention is effective for improving mental health symptoms among Burmese refugees in Thailand.
Please see later in the article for the Editors' Summary
Background
Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting.
Methods and Findings
We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was −0.49 (95% CI: −0.59, −0.40) for depression, −0.43 (95% CI: −0.51, −0.35) for PTS, −0.42 (95% CI: −0.58, −0.27) for functional impairment, −0.48 (95% CI: −0.61, −0.34) for anxiety, −0.24 (95% CI: −0.34, −0.15) for aggression, and −0.03 (95% CI: −0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention.
Conclusions
CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs.
Trial registration
ClinicalTrials.gov NCT01459068
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, one in four people will experience a mental health disorder at some time during their life. Although many evidence-based treatments (EBTs), most involving some sort of cognitive behavioral therapy (talking therapies that help people manage their mental health problems by changing the way they think and behave), are now available, many people with mental health disorders never receive any treatment for their condition. The situation is particularly bad for people living in low-resource settings, where a delivery model for EBTs based on referral to mental health professionals is problematic given that mental health professionals are scarce. To facilitate widespread access to mental health care among poor and/or rural populations in low-resource settings, EBTs need to be deliverable at the primary or community level by non-professionals. Moreover, because there is a large burden of trauma-related mental health disorders in low-resource settings and because trauma increases the risk of multiple mental health problems, treatment options that address comorbid (coexisting) mental health problems in low-resource settings are badly needed.
Why Was This Study Done?
One possible solution to the problem of delivering EBTs for comorbid mental health disorders in low-resource settings is “transdiagnostic” treatment. Many mental health EBTs for different disorders share common components. Transdiagnostic treatments recognize these facts and apply these common components to a range of disorders rather than creating a different structured treatment for each diagnosis. The Common Elements Treatment Approach (CETA), for example, trains counselors in a range of components that are similar across EBTs and teaches counselors how to choose components, their order, and dose, based on their client's problems. This flexible approach, which was designed for delivery by non-professional providers in low-resource settings, provides counselors with the skills needed to treat depression, anxiety, and posttraumatic stress—three trauma-related mental health disorders. In this randomized controlled trial, the researchers investigate the use of CETA among Burmese refugees living in Thailand, many of whom are survivors of decades-long harsh military rule in Myanmar. A randomized controlled trial compares the outcomes of individuals chosen to receive different interventions through the play of chance.
What Did the Researchers Do and Find?
The researchers assigned Burmese survivors or witnesses of imprisonment, torture, and related traumas who met symptom criteria for significant depression and/or posttraumatic stress to either the CETA or wait-list control arm of their trial. Lay counselors treated the participants in the CETA arm by delivering CETA components—for example, “psychoeducation” (which teaches clients that their symptoms are normal and experienced by many people) and “cognitive coping” (which helps clients understand that how they think about an event can impact their feelings and behavior)—chosen to reflect the client's priority problems at presentation. Participants in the control arm received regular calls from the trial coordinator to check on their safety but no other intervention. Participants in the CETA arm experienced greater reductions of baseline symptoms of depression, posttraumatic stress, anxiety, and aggression than participants in the control arm. For example, there was a 77% reduction in the average depression score from before the intervention to after the intervention among participants in the CETA arm, but only a 40% reduction in the depression score among participants in the control arm. Importantly, the effect size of CETA (a statistical measure that quantifies the importance of the difference between two groups) was large for depression and posttraumatic stress, the primary outcomes of the trial. That is, compared to no treatment, CETA had a large effect on the symptoms of depression and posttraumatic stress experienced by the trial participants.
What Do These Findings Mean?
These findings suggest that, among Burmese survivors and witnesses of torture and other trauma living in Thailand, CETA delivered by lay counselors was a highly effective treatment for comorbid mental disorders compared to no treatment (the wait-list control). These findings may not be generalizable to other low-resource settings, they provide no information about long-term outcomes, and they do not identify which aspects of CETA were responsible for symptom improvement or explain the improvements seen among the control participants. Given that the study compared CETA to no treatment rather than a placebo (dummy) or active comparison intervention, it is not possible to conclude that CETA works better that existing treatments. Nevertheless, these findings support the continued development and assessment of transdiagnostic approaches for the treatment of mental health disorders in low-resource settings where treatment access and comorbid mental health disorders are important challenges.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001757.
The World Health Organization provides background information about mental health
The US National Institute of Mental Health provides information about a range of mental health disorders and about cognitive behavioral therapy
The UK National Health Service Choices website has information about cognitive behavioral therapy, including some personal stories and links to other related mental health resources on the Choices website
A short introduction to transdiagnosis and CETA written by one of the trial authors is available
Information about this trial is available on the ClinicalTrials.gov website
The UN Refugee Agency provides information about Burmese (Myanmar) refugees in Thailand
doi:10.1371/journal.pmed.1001757
PMCID: PMC4227644  PMID: 25386945
23.  Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy 
Executive Summary
Subject of the Evidence-Based Analysis
The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT).
Clinical Need: Target Population and Condition
Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population.
Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0.
The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis.
Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a routine basis and that patients are in the therapeutic range only 64% of the time.
Overview of POC INR Devices
POC INR devices offer an alternative to laboratory-based testing and venipuncture, enabling INR determination from a fingerstick sample of whole blood. Independent evaluations have shown POC devices to have an acceptable level of precision. They permit INR results to be determined immediately, allowing for more rapid medication adjustments.
POC devices can be used in a variety of settings including physician offices, ACCs, long-term care facilities, pharmacies, or by the patients themselves through self-testing (PST) or self-management (PSM) techniques. With PST, patients measure their INR values and then contact their physician for instructions on dose adjustment, whereas with PSM, patients adjust the medication themselves based on pre-set algorithms. These models are not suitable for all patients and require the identification and education of suitable candidates.
Potential advantages of POC devices include improved convenience to patients, better treatment compliance and satisfaction, more frequent monitoring and fewer thromboembolic and hemorrhagic complications. Potential disadvantages of the device include the tendency to underestimate high INR values and overestimate low INR values, low thromboplastin sensitivity, inability to calculate a mean normal PT, and errors in INR determination in patients with antiphospholipid antibodies with certain instruments. Although treatment satisfaction and quality of life (QoL) may improve with POC INR monitoring, some patients may experience increased anxiety or preoccupation with their disease with these strategies.
Evidence-Based Analysis Methods
Research Questions
1. Effectiveness
Does POC INR monitoring improve clinical outcomes in various settings compared to standard laboratory-based testing?
Does POC INR monitoring impact patient satisfaction, QoL, compliance, acceptability, convenience compared to standard laboratory-based INR determination?
Settings include primary care settings with use of POC INR devices by general practitioners or nurses, ACCs, pharmacies, long-term care homes, and use by the patient either for PST or PSM.
2. Cost-effectiveness
What is the cost-effectiveness of POC INR monitoring devices in various settings compared to standard laboratory-based INR determination?
Inclusion Criteria
English-language RCTs, systematic reviews, and meta-analyses
Publication dates: 1996 to November 25, 2008
Population: patients on OAT
Intervention: anticoagulation monitoring by POC INR device in any setting including anticoagulation clinic, primary care (general practitioner or nurse), pharmacy, long-term care facility, PST, PSM or any other POC INR strategy
Minimum sample size: 50 patients Minimum follow-up period: 3 months
Comparator: usual care defined as venipuncture blood draw for an INR laboratory test and management provided by an ACC or individual practitioner
Outcomes: Hemorrhagic events, thromboembolic events, all-cause mortality, anticoagulation control as assessed by proportion of time or values in the therapeutic range, patient reported outcomes including satisfaction, QoL, compliance, acceptability, convenience
Exclusion criteria
Non-RCTs, before-after studies, quasi-experimental studies, observational studies, case reports, case series, editorials, letters, non-systematic reviews, conference proceedings, abstracts, non-English articles, duplicate publications
Studies where POC INR devices were compared to laboratory testing to assess test accuracy
Studies where the POC INR results were not used to guide patient management
Method of Review
A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database) was undertaken to identify evidence published from January 1, 1998 to November 25, 2008. Studies meeting the inclusion criteria were selected from the search results. Reference lists of selected articles were also checked for relevant studies.
Summary of Findings
Five existing reviews and 22 articles describing 17 unique RCTs met the inclusion criteria. Three RCTs examined POC INR monitoring devices with PST strategies, 11 RCTs examined PSM strategies, one RCT included both PST and PSM strategies and two RCTs examined the use of POC INR monitoring devices by health care professionals.
Anticoagulation Control
Anticoagulation control is measured by the percentage of time INR is within the therapeutic range or by the percentage of INR values in the therapeutic range. Due to the differing methodologies and reporting structures used, it was deemed inappropriate to combine the data and estimate whether the difference between groups would be significant. Instead, the results of individual studies were weighted by the number of person-years of observation and then pooled to calculate a summary measure.
Across most studies, patients in the intervention groups tended to have a higher percentage of time and values in the therapeutic target range in comparison to control patients. When the percentage of time in the therapeutic range was pooled across studies and weighted by the number of person-years of observation, the difference between the intervention and control groups was 4.2% for PSM, 7.2% for PST and 6.1% for POC use by health care practitioners. Overall, intervention patients were in the target range 69% of the time and control patients were in the therapeutic target range 64% of the time leading to an overall difference between groups of roughly 5%.
Major Complications and Deaths
There was no statistically significant difference in the number of major hemorrhagic events between patients managed with POC INR monitoring devices and patients managed with standard laboratory testing (OR =0.74; 95% CI: 0.52- 1.04). This difference was non-significant for all POC strategies (PSM, PST, health care practitioner).
Patients managed with POC INR monitoring devices had significantly fewer thromboembolic events than usual care patients (OR =0.52; 95% CI: 0.37 - 0.74). When divided by POC strategy, PSM resulted in significantly fewer thromboembolic events than usual care (OR =0.46.; 95% CI: 0.29 - 0.72). The observed difference in thromboembolic events for PSM remained significant when the analysis was limited to major thromboembolic events (OR =0.40; 95% CI: 0.17 - 0.93), but was non-significant when the analysis was limited to minor thromboembolic events (OR =0.73; 95% CI: 0.08 - 7.01). PST and GP/Nurse strategies did not result in significant differences in thromboembolic events, however there were only a limited number of studies examining these interventions.
No statistically significant difference was observed in the number of deaths between POC intervention and usual care control groups (OR =0.67; 95% CI: 0.41 - 1.10). This difference was non-significant for all POC strategies. Only one study reported on survival with 10-year survival rate of 76.1% in the usual care control group compared to 84.5% in the PSM group (P=0.05).
Summary Results of Meta-Analyses of Major Complications and Deaths in POC INR Monitoring Studies
Patient Satisfaction and Quality of Life
Quality of life measures were reported in eight studies comparing POC INR monitoring to standard laboratory testing using a variety of measurement tools. It was thus not possible to calculate a quantitative summary measure. The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring. Results from a pre-analysis patient and caregiver focus group conducted in Ontario also indicated improved patient QoL with POC monitoring.
Quality of the Evidence
Studies varied with regard to patient eligibility, baseline patient characteristics, follow-up duration, and withdrawal rates. Differential drop-out rates were observed such that the POC intervention groups tended to have a larger number of patients who withdrew. There was a lack of consistency in the definitions and reporting for OAT control and definitions of adverse events. In most studies, the intervention group received more education on the use of warfarin and performed more frequent INR testing, which may have overestimated the effect of the POC intervention. Patient selection and eligibility criteria were not always fully described and it is likely that the majority of the PST/PSM trials included a highly motivated patient population. Lastly, a large number of trials were also sponsored by industry.
Despite the observed heterogeneity among studies, there was a general consensus in findings that POC INR monitoring devices have beneficial impacts on the risk of thromboembolic events, anticoagulation control and patient satisfaction and QoL (ES Table 2).
GRADE Quality of the Evidence on POC INR Monitoring Studies
CI refers to confidence interval; Interv, intervention; OR, odds ratio; RCT, randomized controlled trial.
Economic Analysis
Using a 5-year Markov model, the health and economic outcomes associated with four different anticoagulation management approaches were evaluated:
Standard care: consisting of a laboratory test with a venipuncture blood draw for an INR;
Healthcare staff testing: consisting of a test with a POC INR device in a medical clinic comprised of healthcare staff such as pharmacists, nurses, and physicians following protocol to manage OAT;
PST: patient self-testing using a POC INR device and phoning in results to an ACC or family physician; and
PSM: patient self-managing using a POC INR device and self-adjustment of OAT according to a standardized protocol. Patients may also phone in to a medical office for guidance.
The primary analytic perspective was that of the MOHLTC. Only direct medical costs were considered and the time horizon of the model was five years - the serviceable life of a POC device.
From the results of the economic analysis, it was found that POC strategies are cost-effective compared to traditional INR laboratory testing. In particular, the healthcare staff testing strategy can derive potential cost savings from the use of one device for multiple patients. The PSM strategy, however, seems to be the most cost-effective method i.e. patients are more inclined to adjust their INRs more readily (as opposed to allowing INRs to fall out of range).
Considerations for Ontario Health System
Although the use of POC devices continues to diffuse throughout Ontario, not all OAT patients are suitable or have the ability to practice PST/PSM. The use of POC is currently concentrated at the institutional setting, including hospitals, ACCs, long-term care facilities, physician offices and pharmacies, and is much less commonly used at the patient level. It is, however, estimated that 24% of OAT patients (representing approximately 32,000 patients in Ontario), would be suitable candidates for PST/PSM strategies and willing to use a POC device.
There are several barriers to the use and implementation of POC INR monitoring devices, including factors such as lack of physician familiarity with the devices, resistance to changing established laboratory-based methods, lack of an approach for identifying suitable patients and inadequate resources for effective patient education and training. Issues of cost and insufficient reimbursement strategies may also hinder implementation and effective quality assurance programs would need to be developed to ensure that INR measurements are accurate and precise.
Conclusions
For a select group of patients who are highly motivated and trained, PSM resulted in significantly fewer thromboembolic events compared to conventional laboratory-based INR testing. No significant differences were observed for major hemorrhages or all-cause mortality. PST and GP/Nurse use of POC strategies are just as effective as conventional laboratory-based INR testing for thromboembolic events, major hemorrhages, and all-cause mortality. POC strategies may also result in better OAT control as measured by the proportion of time INR is in the therapeutic range and there appears to be beneficial impacts on patient satisfaction and QoL. The use of POC devices should factor in patient suitability, patient education and training, health system constraints, and affordability.
Keywords
anticoagulants, International Normalized Ratio, point-of-care, self-monitoring, warfarin.
PMCID: PMC3377545  PMID: 23074516
24.  Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this evidence-based analysis was to examine the effectiveness, safety, and cost-effectiveness of noninvasive positive pressure ventilation (NPPV) in the following patient populations: patients with acute respiratory failure (ARF) due to acute exacerbations of chronic obstructive pulmonary disease (COPD); weaning of COPD patients from invasive mechanical ventilation (IMV); and prevention of or treatment of recurrent respiratory failure in COPD patients after extubation from IMV.
Clinical Need and Target Population
Acute Hypercapnic Respiratory Failure
Respiratory failure occurs when the respiratory system cannot oxygenate the blood and/or remove carbon dioxide from the blood. It can be either acute or chronic and is classified as either hypoxemic (type I) or hypercapnic (type II) respiratory failure. Acute hypercapnic respiratory failure frequently occurs in COPD patients experiencing acute exacerbations of COPD, so this is the focus of this evidence-based analysis. Hypercapnic respiratory failure occurs due to a decrease in the drive to breathe, typically due to increased work to breathe in COPD patients.
Technology
There are several treatment options for ARF. Usual medical care (UMC) attempts to facilitate adequate oxygenation and treat the cause of the exacerbation, and typically consists of supplemental oxygen, and a variety of medications such as bronchodilators, corticosteroids, and antibiotics. The failure rate of UMC is high and has been estimated to occur in 10% to 50% of cases.
The alternative is mechanical ventilation, either invasive or noninvasive. Invasive mechanical ventilation involves sedating the patient, creating an artificial airway through endotracheal intubation, and attaching the patient to a ventilator. While this provides airway protection and direct access to drain sputum, it can lead to substantial morbidity, including tracheal injuries and ventilator-associated pneumonia (VAP).
While both positive and negative pressure noninvasive ventilation exists, noninvasive negative pressure ventilation such as the iron lung is no longer in use in Ontario. Noninvasive positive pressure ventilation provides ventilatory support through a facial or nasal mask and reduces inspiratory work. Noninvasive positive pressure ventilation can often be used intermittently for short periods of time to treat respiratory failure, which allows patients to continue to eat, drink, talk, and participate in their own treatment decisions. In addition, patients do not require sedation, airway defence mechanisms and swallowing functions are maintained, trauma to the trachea and larynx are avoided, and the risk for VAP is reduced. Common complications are damage to facial and nasal skin, higher incidence of gastric distension with aspiration risk, sleeping disorders, and conjunctivitis. In addition, NPPV does not allow direct access to the airway to drain secretions and requires patients to cooperate, and due to potential discomfort, compliance and tolerance may be low.
In addition to treating ARF, NPPV can be used to wean patients from IMV through the gradual removal of ventilation support until the patient can breathe spontaneously. Five to 30% of patients have difficultly weaning. Tapering levels of ventilatory support to wean patients from IMV can be achieved using IMV or NPPV. The use of NPPV helps to reduce the risk of VAP by shortening the time the patient is intubated.
Following extubation from IMV, ARF may recur, leading to extubation failure and the need for reintubation, which has been associated with increased risk of nosocomial pneumonia and mortality. To avoid these complications, NPPV has been proposed to help prevent ARF recurrence and/or to treat respiratory failure when it recurs, thereby preventing the need for reintubation.
Research Questions
What is the effectiveness, cost-effectiveness, and safety of NPPV for the treatment of acute hypercapnic respiratory failure due to acute exacerbations of COPD compared with
usual medical care, and
invasive mechanical ventilation?
What is the effectiveness, cost-effectiveness, and safety of NPPV compared with IMV in COPD patients after IMV for the following purposes:
weaning COPD patients from IMV,
preventing ARF in COPD patients after extubation from IMV, and
treating ARF in COPD patients after extubation from IMV?
Research Methods
Literature Search
A literature search was performed on December 3, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Wiley Cochrane, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2004 until December 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Since there were numerous studies that examined the effectiveness of NPPV for the treatment of ARF due to exacerbations of COPD published before 2004, pre-2004 trials which met the inclusion/exclusion criteria for this evidence-based review were identified by hand-searching reference lists of included studies and systematic reviews.
Inclusion Criteria
English language full-reports;
health technology assessments, systematic reviews, meta-analyses, and randomized controlled trials (RCTs);
studies performed exclusively in patients with a diagnosis of COPD or studies performed with patients with a mix of conditions if results are reported for COPD patients separately;
patient population: (Question 1) patients with acute hypercapnic respiratory failure due to an exacerbation of COPD; (Question 2a) COPD patients being weaned from IMV; (Questions 2b and 2c) COPD patients who have been extubated from IMV.
Exclusion Criteria
< 18 years of age
animal studies
duplicate publications
grey literature
studies examining noninvasive negative pressure ventilation
studies comparing modes of ventilation
studies comparing patient-ventilation interfaces
studies examining outcomes not listed below, such as physiologic effects including heart rate, arterial blood gases, and blood pressure
Outcomes of Interest
mortality
intubation rates
length of stay (intensive care unit [ICU] and hospital)
health-related quality of life
breathlessness
duration of mechanical ventilation
weaning failure
complications
NPPV tolerance and compliance
Statistical Methods
When possible, results were pooled using Review Manager 5 Version 5.1, otherwise, the results were summarized descriptively. Dichotomous data were pooled into relative risks using random effects models and continuous data were pooled using weighted mean differences with a random effects model. Analyses using data from RCTs were done using intention-to-treat protocols; P values < 0.05 were considered significant. A priori subgroup analyses were planned for severity of respiratory failure, location of treatment (ICU or hospital ward), and mode of ventilation with additional subgroups as needed based on the literature. Post hoc sample size calculations were performed using STATA 10.1.
Quality of Evidence
The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
NPPV for the Treatment of ARF due to Acute Exacerbations of COPD
NPPV Plus Usual Medical Care Versus Usual Medical Care Alone for First Line Treatment
A total of 1,000 participants were included in 11 RCTs1; the sample size ranged from 23 to 342. The mean age of the participants ranged from approximately 60 to 72 years of age. Based on either the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD stage criteria or the mean percent predicted forced expiratory volume in 1 second (FEV1), 4 of the studies included people with severe COPD, and there was inadequate information to classify the remaining 7 studies by COPD severity. The severity of the respiratory failure was classified into 4 categories using the study population mean pH level as follows: mild (pH ≥ 7.35), moderate (7.30 ≤ pH < 7.35), severe (7.25 ≤ pH < 7.30), and very severe (pH < 7.25). Based on these categories, 3 studies included patients with a mild respiratory failure, 3 with moderate respiratory failure, 4 with severe respiratory failure, and 1 with very severe respiratory failure.
The studies were conducted either in the ICU (3 of 11 studies) or general or respiratory wards (8 of 11 studies) in hospitals, with patients in the NPPV group receiving bilevel positive airway pressure (BiPAP) ventilatory support, except in 2 studies, which used pressure support ventilation and volume cycled ventilation, respectively. Patients received ventilation through nasal, facial, or oronasal masks. All studies specified a protocol or schedule for NPPV delivery, but this varied substantially across the studies. For example, some studies restricted the amount of ventilation per day (e.g., 6 hours per day) and the number of days it was offered (e.g., maximum of 3 days); whereas, other studies provided patients with ventilation for as long as they could tolerate it and recommended it for much longer periods of time (e.g., 7 to 10 days). These differences are an important source of clinical heterogeneity between the studies. In addition to NPPV, all patients in the NPPV group also received UMC. Usual medical care varied between the studies, but common medications included supplemental oxygen, bronchodilators, corticosteroids, antibiotics, diuretics, and respiratory stimulators.
The individual quality of the studies ranged. Common methodological issues included lack of blinding and allocation concealment, and small sample sizes.
Need for Endotracheal Intubation
Eleven studies reported the need for endotracheal intubation as an outcome. The pooled results showed a significant reduction in the need for endotracheal intubation in the NPPV plus UMC group compared with the UMC alone group (relative risk [RR], 0.38; 95% confidence interval [CI], 0.28−0.50). When subgrouped by severity of respiratory failure, the results remained significant for the mild, severe, and very severe respiratory failure groups.
GRADE: moderate
Inhospital Mortality
Nine studies reported inhospital mortality as an outcome. The pooled results showed a significant reduction in inhospital mortality in the NPPV plus UMC group compared with the UMC group (RR, 0.53; 95% CI, 0.35−0.81). When subgrouped by severity of respiratory failure, the results remained significant for the moderate and severe respiratory failure groups.
GRADE: moderate
Hospital Length of Stay
Eleven studies reported hospital length of stay (LOS) as an outcome. The pooled results showed a significant decrease in the mean length of stay for the NPPV plus UMC group compared with the UMC alone group (weighted mean difference [WMD], −2.68 days; 95% CI, −4.41 to −0.94 days). When subgrouped by severity of respiratory failure, the results remained significant for the mild, severe, and very severe respiratory failure groups.
GRADE: moderate
Complications
Five studies reported complications. Common complications in the NPPV plus UMC group included pneumonia, gastrointestinal disorders or bleeds, skin abrasions, eye irritation, gastric insufflation, and sepsis. Similar complications were observed in the UMC group including pneumonia, sepsis, gastrointestinal disorders or bleeds, pneumothorax, and complicated endotracheal intubations. Many of the more serious complications in both groups occurred in those patients who required endotracheal intubation. Three of the studies compared complications in the NPPV plus UMC and UMC groups. While the data could not be pooled, overall, the NPPV plus UMC group experienced fewer complications than the UMC group.
GRADE: low
Tolerance/Compliance
Eight studies reported patient tolerance or compliance with NPPV as an outcome. NPPV intolerance ranged from 5% to 29%. NPPV tolerance was generally higher for patients with more severe respiratory failure. Compliance with the NPPV protocol was reported by 2 studies, which showed compliance decreases over time, even over short periods such as 3 days.
NPPV Versus IMV for the Treatment of Patients Who Failed Usual Medical Care
A total of 205 participants were included in 2 studies; the sample sizes of these studies were 49 and 156. The mean age of the patients was 71 to 73 years of age in 1 study, and the median age was 54 to 58 years of age in the second study. Based on either the GOLD COPD stage criteria or the mean percent predicted FEV1, patients in 1 study had very severe COPD. The COPD severity could not be classified in the second study. Both studies had study populations with a mean pH less than 7.23, which was classified as very severe respiratory failure in this analysis. One study enrolled patients with ARF due to acute exacerbations of COPD who had failed medical therapy. The patient population was not clearly defined in the second study, and it was not clear whether they had to have failed medical therapy before entry into the study.
Both studies were conducted in the ICU. Patients in the NPPV group received BiPAP ventilatory support through nasal or full facial masks. Patients in the IMV group received pressure support ventilation.
Common methodological issues included small sample size, lack of blinding, and unclear methods of randomization and allocation concealment. Due to the uncertainty about whether both studies included the same patient population and substantial differences in the direction and significance of the results, the results of the studies were not pooled.
Mortality
Both studies reported ICU mortality. Neither study showed a significant difference in ICU mortality between the NPPV and IMV groups, but 1 study showed a higher mortality rate in the NPPV group (21.7% vs. 11.5%) while the other study showed a lower mortality rate in the NPPV group (5.1% vs. 6.4%). One study reported 1-year mortality and showed a nonsignificant reduction in mortality in the NPPV group compared with the IMV group (26.1% vs. 46.1%).
GRADE: low to very low
Intensive Care Unit Length of Stay
Both studies reported LOS in the ICU. The results were inconsistent. One study showed a statistically significant shorter LOS in the NPPV group compared with the IMV group (5 ± 1.35 days vs. 9.29 ± 3 days; P < 0.001); whereas, the other study showed a nonsignificantly longer LOS in the NPPV group compared with the IMV group (22 ± 19 days vs. 21 ± 20 days; P = 0.86).
GRADE: very low
Duration of Mechanical Ventilation
Both studies reported the duration of mechanical ventilation (including both invasive and noninvasive ventilation). The results were inconsistent. One study showed a statistically significant shorter duration of mechanical ventilation in the NPPV group compared with the IMV group (3.92 ± 1.08 days vs. 7.17 ± 2.22 days; P < 0.001); whereas, the other study showed a nonsignificantly longer duration of mechanical ventilation in the NPPV group compared with the IMV group (16 ± 19 days vs. 15 ± 21 days; P = 0.86). GRADE: very low
Complications
Both studies reported ventilator-associated pneumonia and tracheotomies. Both showed a reduction in ventilator-associated pneumonia in the NPPV group compared with the IMV group, but the results were only significant in 1 study (13% vs. 34.6%, P = 0.07; and 6.4% vs. 37.2%, P < 0.001, respectively). Similarly, both studies showed a reduction in tracheotomies in the NPPV group compared with the IMV group, but the results were only significant in 1 study (13% vs. 23.1%, P = 0.29; and 6.4% vs. 34.6%; P < 0.001).
GRADE: very low
Other Outcomes
One of the studies followed patients for 12 months. At the end of follow-up, patients in the NPPV group had a significantly lower rate of needing de novo oxygen supplementation at home. In addition, the IMV group experienced significant increases in functional limitations due to COPD, while no increase was seen in the NPPV group. Finally, no significant differences were observed for hospital readmissions, ICU readmissions, and patients with an open tracheotomy, between the NPPV and IMV groups.
NPPV for Weaning COPD Patients From IMV
A total of 80 participants were included in the 2 RCTs; the sample sizes of the studies were 30 and 50 patients. The mean age of the participants ranged from 58 to 69 years of age. Based on either the GOLD COPD stage criteria or the mean percent predicted FEV1, both studies included patients with very severe COPD. Both studies also included patients with very severe respiratory failure (mean pH of the study populations was less than 7.23). Chronic obstructive pulmonary disease patients receiving IMV were enrolled in the study if they failed a T-piece weaning trial (spontaneous breathing test), so they could not be directly extubated from IMV.
Both studies were conducted in the ICU. Patients in the NPPV group received weaning using either BiPAP or pressure support ventilation NPPV through a face mask, and patients in the IMV weaning group received pressure support ventilation. In both cases, weaning was achieved by tapering the ventilation level.
The individual quality of the studies ranged. Common methodological problems included unclear randomization methods and allocation concealment, lack of blinding, and small sample size.
Mortality
Both studies reported mortality as an outcome. The pooled results showed a significant reduction in ICU mortality in the NPPV group compared with the IMV group (RR, 0.47; 95% CI, 0.23−0.97; P = 0.04).
GRADE: moderate
Intensive Care Unit Length of Stay
Both studies reported ICU LOS as an outcome. The pooled results showed a nonsignificant reduction in ICU LOS in the NPPV group compared with the IMV group (WMD, −5.21 days; 95% CI, −11.60 to 1.18 days).
GRADE: low
Duration of Mechanical Ventilation
Both studies reported duration of mechanical ventilation (including both invasive and noninvasive ventilation) as an outcome. The pooled results showed a nonsignificant reduction in duration of mechanical ventilation (WMD, −3.55 days; 95% CI, −8.55 to 1.44 days).
GRADE: low
Nosocomial Pneumonia
Both studies reported nosocominal pneumonia as an outcome. The pooled results showed a significant reduction in nosocomial pneumonia in the NPPV group compared with the IMV group (RR, 0.14; 95% CI, 0.03−0.71; P = 0.02).
GRADE: moderate
Weaning Failure
One study reported a significant reduction in weaning failure in the NPPV group compared with the IMV group, but the results were not reported in the publication. In this study, 1 of 25 patients in the NPPV group and 2 of 25 patients in the IMV group could not be weaned after 60 days in the ICU.
NPPV After Extubation of COPD Patients From IMV
The literature was reviewed to identify studies examining the effectiveness of NPPV compared with UMC in preventing recurrence of ARF after extubation from IMV or treating acute ARF which has recurred after extubation from IMV. No studies that included only COPD patients or reported results for COPD patients separately were identified for the prevention of ARF postextubation.
One study was identified for the treatment of ARF in COPD patients that recurred within 48 hours of extubation from IMV. This study included 221 patients, of whom 23 had COPD. A post hoc subgroup analysis was conducted examining the rate of reintubation in the COPD patients only. A nonsignificant reduction in the rate of reintubation was observed in the NPPV group compared with the UMC group (7 of 14 patients vs. 6 of 9 patients, P = 0.67). GRADE: low
Conclusions
NPPV Plus UMC Versus UMC Alone for First Line Treatment of ARF due to Acute Exacerbations of COPD
Moderate quality of evidence showed that compared with UMC, NPPV plus UMC significantly reduced the need for endotracheal intubation, inhospital mortality, and the mean length of hospital stay.
Low quality of evidence showed a lower rate of complications in the NPPV plus UMC group compared with the UMC group.
NPPV Versus IMV for the Treatment of ARF in Patients Who Have Failed UMC
Due to inconsistent and low to very low quality of evidence, there was insufficient evidence to draw conclusions on the comparison of NPPV versus IMV for patients who failed UMC.
NPPV for Weaning COPD Patients From IMV
Moderate quality of evidence showed that weaning COPD patients from IMV using NPPV results in significant reductions in mortality, nosocomial pneumonia, and weaning failure compared with weaning with IMV.
Low quality of evidence showed a nonsignificant reduction in the mean LOS and mean duration of mechanical ventilation in the NPPV group compared with the IMV group.
NPPV for the Treatment of ARF in COPD Patients After Extubation From IMV
Low quality of evidence showed a nonsignificant reduction in the rate of reintubation in the NPPV group compared with the UMC group; however, there was inadequate evidence to draw conclusions on the effectiveness of NPPV for the treatment of ARF in COPD patients after extubation from IMV
PMCID: PMC3384377  PMID: 23074436
25.  Health Seeking Behaviour and Utilization of Health Facilities for Schistosomiasis-Related Symptoms in Ghana 
Background
Schistosomiasis causes long-term illness and significant economic burden. Morbidity control through integration within existing health care delivery systems is considered a potentially sustainable and cost-effective approach, but there is paucity of information about health-seeking behaviour.
Methods
A questionnaire-based study involving 2,002 subjects was conducted in three regions of Ghana to investigate health-seeking behaviour and utilization of health facilities for symptoms related to urinary (blood in urine and painful urination) and intestinal schistosomiasis (diarrhea, blood in stool, swollen abdomen and abdominal pain). Fever (for malaria) was included for comparison.
Results
Only 40% of patients with urinary symptoms sought care compared to >70% with intestinal symptoms and >90% with fever. Overall, about 20% of schistosomiasis-related symptoms were reported to a health facility (hospital or clinic), compared to about 30% for fever. Allopathic self-medication was commonly practiced as alternative action. Health-care seeking was relatively lower for patients with chronic symptoms, but if they took action, they were more likely to visit a health facility. In a multivariate logistic regression analysis, perceived severity was the main predictor for seeking health care or visiting a health facility. Age, socio-economic status, somebody else paying for health care, and time for hospital visit occasionally showed a significant impact, but no clear trend. The effect of geographic location was less marked, although people in the central region, and to a lesser extent the north, were usually less inclined to seek health care than people in the south. Perceived quality of health facility did not demonstrate impact.
Conclusion
Perceived severity of the disease is the most important determinant of seeking health care or visiting a health facility in Ghana. Schistosomiasis control by passive case-finding within the regular health care delivery looks promising, but the number not visiting a health facility is large and calls for supplementary control options.
Author Summary
The World Health Organization recommends that long-term benefit of schistosomiasis control should include treatment in local health facilities. This means that patients should visit a hospital or clinic with their complaints. However, little is known about whether they do so. We conducted a study in three regions of Ghana and interviewed two thousand people about whether they recently had schistosomiasis-related symptoms such as blood in urine or blood in faeces, and what they had done about it. We included fever (mostly caused by malaria) for comparison. We found that 40% of patients with urinary symptoms sought care compared to 70% of those with intestinal symptoms and 90% with fever. Overall, only 20% of all schistosomiasis-related symptoms were reported to a hospital or clinic, compared to 30% for fever. Self-medication with allopathic (i.e., orthodox) medicines was the main alternative. Our study showed that the most important determinant for seeking health care or visiting a health facility is perceived severity of the symptom. Factors such as age, sex, socio-economic status and geographic region showed no impact or a clear pattern. We conclude that many schistosomiasis patients do not visit a health facility, the only place with effective drugs, necessitating additional control measures.
doi:10.1371/journal.pntd.0000867
PMCID: PMC2970540  PMID: 21072229

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