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"apellidos" => "Vilaplana Vilaplana" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1889183708717367?idApp=UINPBA00004N" "url" => "/18891837/0000002500000002/v1_201307261643/S1889183708717367/v1_201307261643/es/main.assets" ] "es" => array:14 [ "idiomaDefecto" => true "titulo" => "Análisis crítico de ensayos clínicos. ¿Es oro todo lo que reluce?" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "52" "paginaFinal" => "60" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "A. Etxeberria Aguirre, R. Rotaeche del Campo, J.M. Morán Barrios" "autores" => array:3 [ 0 => array:3 [ "nombre" => "A." "apellidos" => "Etxeberria Aguirre" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "aff0020" ] ] ] 1 => array:3 [ "nombre" => "R." "apellidos" => "Rotaeche del Campo" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "aff0020" ] ] ] 2 => array:4 [ "nombre" => "J.M." "apellidos" => "Morán Barrios" "email" => array:1 [ 0 => "jesusmanuel.moranbarrios@osakidetza.net" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "aff0020" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Servicio de Farmacia de Atención Primaria. Comarca Gipuzkoa Este-Ekialde. San Sebastián. Osakidetza-Servicio Vasco de Salud" "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Centro de Salud de Alza. San Sebastián. Guipuzcoa. España. Osakidetza-Servicio Vasco de Salud" "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Unidad de Investigación y Docencia. Hospital de Cruces. Baracaldo. Vizcaya. Osakidetza-Servicio Vasco de Salud. España" "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Miembros del grupo CASPe del País Vasco" "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "*" "correspondencia" => "Correspondencia: Unidad de Investigación y Docencia. Hospital de Cruces. 48903 Baracaldo. Vizcaya. España." ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Critical analysis of clinical trials. Is everything that shines gold?" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2007-02-05" "fechaAceptado" => "2007-06-18" "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec219053" "palabras" => array:4 [ 0 => "ensayos clínicos" 1 => "sesgos" 2 => "lectura crítica" 3 => "medicina basada en la evidencia" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec219054" "palabras" => array:4 [ 0 => "clinical trial" 1 => "biases" 2 => "critical reading" 3 => "evidence based medicine" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:1 [ "resumen" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">El volumen actual de la literatura médica es inabarcable y no toda la información disponible es relevante y válida. Un caso particular es el del ensayo clínico aleatorizado (ECA) que se considera el patrón de oro para medir la eficacia de una intervención (farmacológica o no). El enfoque de la medicina basada en la evidencia insiste en la importancia de la evaluación crítica de los ECA en cuanto a validez, impacto clínico y aplicabilidad. El profesional sanitario precisa utilizar la lectura crítica de la literatura médica para ser autónomo en sus decisiones. Para la interpretación de los ECA se requiere conocer algunas claves de su diseño, como son la correcta asignación aleatoria, el enmascaramiento o el cálculo del tamaño muestral, así como reflexionar sobre otros aspectos más sutiles (pero más intuitivos para el clínico) relacionados con la relevancia de la pregunta de investigación y con la forma de presentación de los resultados. En este artículo se revisan algunos conceptos como el sesgo de publicación, el sesgo en la presentación de resultados, la elección de variables (agregadas, principales o secundarias, subrogadas o finales) y cómo se miden los resultados. Finalmente debemos tener presente que el proceso de razonamiento clínico y de toma de decisiones es mucho más complejo que la mera aplicación de los resultados de la investigación, que siempre han de integrarse con la experiencia clínica individual, las características y preferencias de cada paciente y el contexto sanitario.</p>" ] "en" => array:1 [ "resumen" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">It is impossible to cover the current volume of medical literature and not all the information available is relevant and valid. A specific case is that of the randomized clinical trial (RCT) that is considered the gold standard to measure efficacy of an intervention (pharmacological or not). Evidence based medicine approach stresses the importance of critical evaluation of the RCTs in regards to validity, clinical impact and applicability. The health care professional must make a critical reading of the medical literature to be independent in his/her decisions. In order to interpret the RCTs, some key factors of their design, such as correct random allocation masking or calculation of the sample size, and reflecting on other more subtle aspects (but more intuitive for the clinician), related with the relevance of the research question and presentation from of the results must been known. In this review, some concepts such as publication bias, result presentation bias, choice of endpoints (aggregate, primary or secondary, subrogated or final) and how the results are measured are reviewed. Finally, we should keep in mind that the clinical reasoning process and decision making one is much more complex than the mere application of the research results that must always be accompanied by individual clinical experience, the characteristics and preferences of each patient and health care context.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Bibliografía" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:38 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "How do primary care physicians seek answers to clinical questions? A literature review" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "H.C. Coumou" 1 => "F.J. 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The Evidence-Based Medicine Working Group" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "A.D. Oxman" 1 => "D.L. Sackett" 2 => "G.H. Guyatt" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:7 [ "tituloSerie" => "JAMA" "fecha" => "1993" "volumen" => "270" "numero" => "17" "paginaInicial" => "2093" "paginaFinal" => "2095" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/8411577" "web" => "Medline" ] ] ] ] ] ] ] ] 11 => array:3 [ "identificador" => "bib0060" "etiqueta" => "12." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice?" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "A. Evans" 1 => "L. Kalra" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:7 [ "tituloSerie" => "Arch Intern Med" "fecha" => "2001" "volumen" => "161" "numero" => "11" "paginaInicial" => "1443" "paginaFinal" => "1447" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/11386894" "web" => "Medline" ] ] ] ] ] ] ] ] 12 => array:3 [ "identificador" => "bib0065" "etiqueta" => "13." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "B. Pitt" 1 => "F. Zannad" 2 => "W.J. Remme" 3 => "R. Cody" 4 => "A. Castaigne" 5 => "A. 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Journal Information
Análisis crítico de ensayos clínicos. ¿Es oro todo lo que reluce?
Critical analysis of clinical trials. Is everything that shines gold?
A. Etxeberria Aguirrea,*, R. Rotaeche del Campob,*, J.M. Morán Barriosc,
,
Corresponding author
jesusmanuel.moranbarrios@osakidetza.net
Correspondencia: Unidad de Investigación y Docencia. Hospital de Cruces. 48903 Baracaldo. Vizcaya. España.
Correspondencia: Unidad de Investigación y Docencia. Hospital de Cruces. 48903 Baracaldo. Vizcaya. España.
a Servicio de Farmacia de Atención Primaria. Comarca Gipuzkoa Este-Ekialde. San Sebastián. Osakidetza-Servicio Vasco de Salud
b Centro de Salud de Alza. San Sebastián. Guipuzcoa. España. Osakidetza-Servicio Vasco de Salud
c Unidad de Investigación y Docencia. Hospital de Cruces. Baracaldo. Vizcaya. Osakidetza-Servicio Vasco de Salud. España
* Miembros del grupo CASPe del País Vasco