Revisión crítica del ensayo clínico pragmático
A critical review of the pragmatic clinical trial
Carles Vallvé
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vallve@telefonica.net
Correspondencia: Dr. C. Vallvé Apdo. de Correos 157. 08440 Cardedeu. Barcelona. España.
Correspondencia: Dr. C. Vallvé Apdo. de Correos 157. 08440 Cardedeu. Barcelona. España.
a Farmacología clínica. Cardedeu. Barcelona. España
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"documento" => "article" "crossmark" => 0 "subdocumento" => "edi" "cita" => "Med Clin. 2003;121:381-3" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 3126 "formatos" => array:3 [ "EPUB" => 9 "HTML" => 2706 "PDF" => 411 ] ] "es" => array:7 [ "idiomaDefecto" => true "titulo" => "Péptido natriurético ventricular tipo B" "tienePdf" => "es" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "381" "paginaFinal" => "383" ] ] "contienePdf" => array:1 [ "es" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Jordi Forteza-Rey, A.n.a. García Raja" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Jordi" "apellidos" => "Forteza-Rey" ] 1 => array:2 [ "nombre" => "A.n.a." "apellidos" => "García Raja" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775303739566?idApp=UINPBA00004N" "url" => "/00257753/0000012100000010/v1_201307291717/S0025775303739566/v1_201307291717/es/main.assets" ] "es" => array:14 [ "idiomaDefecto" => true "titulo" => "Revisión crítica del ensayo clínico pragmático" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "384" "paginaFinal" => "388" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Carles Vallvé" "autores" => array:1 [ 0 => array:4 [ "nombre" => "Carles" "apellidos" => "Vallvé" "email" => array:1 [ 0 => "vallve@telefonica.net" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:3 [ "entidad" => "Farmacología clínica. Cardedeu. Barcelona. España" "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "*" "correspondencia" => "Correspondencia: Dr. C. Vallvé Apdo. de Correos 157. 08440 Cardedeu. Barcelona. España." ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "A critical review of the pragmatic clinical trial" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2003-01-31" "fechaAceptado" => "2003-05-14" "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec222818" "palabras" => array:5 [ 0 => "Ensayo clínico" 1 => "Ensayo pragmático" 2 => "Ensayo explicativo" 3 => "Teorema de Bayes" 4 => "Revisión" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec222819" "palabras" => array:5 [ 0 => "Clinical trial" 1 => "Pragmatic trial" 2 => "Explanatory trial" 3 => "Bayes theorem" 4 => "Review" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:1 [ "resumen" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">En 1967 Schwartz y Lellouch propusieron distinguir entre ensayo clínicoexplicativo y ensayo clínico pragmático. El último concepto ha sidoobjeto de diferentes interpretaciones y de numerosas críticas. No obstante,muchos autores han reclamado la realización de ensayos pragmáticos,especialmente cuando es preciso tomar una decisión terapéutica.A fin de aclarar la situación actual del ensayo pragmático, se ha efectuadouna revisión bibliográfica: entre 1976 y 2002 se registran 95artículos que informan acerca de ensayos realizados según dicho diseñoexperimental; sólo 4 siguieron de forma estricta el método descritopor Schwartz et al.</p><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">En el ensayo pragmático, en general, el enmascaramiento de las intervencionesno es posible, lo que implica que la asignación al azar esimperfecta. Esta limitación pone en duda la validez de aplicar métodosfrecuentistas a la valoración de los resultados según intención detratar en un ensayo clínico pragmático. Esta orientación experimentalexige una valoración acorde con la teoría de las decisiones.</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Según el teorema de Bayes, la probabilidad posterior de una hipótesisestá condicionada por su probabilidad previa y por su verosimilitud.Existe el convencimiento de que la estadística bayesiana es un instrumentoidóneo para la valoración del ensayo clínico pragmático, pero lafalta de programas informáticos adecuados ha limitado su aplicaciónde forma importante. Recientemente se han desarrollado algunos programas(WinBUGS, TreeAge) que se han mostrado adecuados para elanálisis de decisiones en problemas terapéuticos propios de la atenciónprimaria. Es posible predecir que, gracias a la aplicación de losmencionados programas, el ensayo clínico pragmático experimentaráa corto plazo un importante renacer.</p>" ] "en" => array:1 [ "resumen" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Schwartz and Lellouch proposed in 1967 to differentiate betweenpragmatic and explanatory clinical trials. The pragmatic approach hasbeen understood in different ways and has also been the object ofsome criticism. Yet different authors have asked to perform pragmaticclinical trials, especially in issues requiring a therapeutical decision.In order to clarify the present situation of the pragmatic trial, a bibliographicreview has been performed. Between 1976 and 2002, 95 originalarticles on clinical trials conducted following a pragmatic designhave been found. Only four followed strictly the approach developedby Schwartz et al.</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">In a pragmatic clinical trial, it is usually not possible to blind the interventionsand for this reason randomization is imperfect. This limitationcasts doubts about the validity of the frequentistic methods inthe intention-to-treat evaluation of the results of a pragmatic trial.This experimental approach demands an evaluation according to thedecision-making theory.</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Following the Bayes theorem, the credibility and the previous probabilityof a hypothesis conditions its posterior probability. It has beenagreed that Bayesian statistics is a suitable instrument for the evaluationof a pragmatic clinical trial, but the lack of adequate informatics'programs has limited seriously its application. Recently, some newprograms (WinBUGS, TreeAge) have been developed and applied tothe decision analysis in some primary care therapeutic questions. Itseems possible to predict that, thanks to the new informatics' programson Bayesian statistics, the pragmatic clinical trial will experience,in the short term, an important revival.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Referencias Bibliográficas" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:43 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Explanatory and pragmatic attitudes in therapeutical trials" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "D. Schwartz" 1 => "J. 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| 2024 Marzo | 0 | 39 | 39 |
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| 2023 Octubre | 0 | 10 | 10 |
| 2023 Septiembre | 0 | 6 | 6 |
| 2023 Agosto | 0 | 2 | 2 |
| 2023 Julio | 7 | 32 | 39 |
| 2023 Junio | 0 | 3 | 3 |
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| 2023 Marzo | 2 | 7 | 9 |
| 2023 Febrero | 0 | 12 | 12 |
| 2023 Enero | 0 | 6 | 6 |
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| 2022 Abril | 1 | 4 | 5 |
| 2022 Marzo | 0 | 2 | 2 |
| 2022 Febrero | 0 | 1 | 1 |
| 2022 Enero | 0 | 5 | 5 |
| 2021 Diciembre | 0 | 3 | 3 |
| 2021 Noviembre | 0 | 2 | 2 |
| 2021 Octubre | 0 | 1 | 1 |
| 2021 Agosto | 0 | 2 | 2 |
| 2021 Julio | 0 | 6 | 6 |
| 2021 Marzo | 0 | 5 | 5 |
| 2021 Enero | 0 | 1 | 1 |
| 2020 Diciembre | 0 | 1 | 1 |
| 2020 Octubre | 1 | 2 | 3 |
| 2020 Septiembre | 1 | 0 | 1 |
| 2020 Agosto | 0 | 5 | 5 |
| 2020 Junio | 1 | 0 | 1 |
| 2020 Mayo | 0 | 3 | 3 |
| 2020 Abril | 2 | 5 | 7 |
| 2020 Marzo | 1 | 2 | 3 |
| 2020 Febrero | 0 | 14 | 14 |
| 2020 Enero | 1 | 18 | 19 |
| 2019 Diciembre | 1 | 51 | 52 |
| 2019 Noviembre | 1 | 11 | 12 |
| 2019 Octubre | 0 | 29 | 29 |
| 2019 Septiembre | 1 | 29 | 30 |
| 2019 Agosto | 1 | 12 | 13 |
| 2019 Julio | 0 | 24 | 24 |
| 2019 Junio | 1 | 25 | 26 |
| 2019 Mayo | 1 | 43 | 44 |
| 2019 Abril | 0 | 43 | 43 |
| 2019 Marzo | 0 | 1 | 1 |
| 2019 Febrero | 0 | 6 | 6 |
| 2019 Enero | 0 | 2 | 2 |
| 2018 Diciembre | 0 | 9 | 9 |
| 2018 Noviembre | 0 | 2 | 2 |
| 2018 Octubre | 0 | 2 | 2 |
| 2018 Mayo | 1 | 0 | 1 |
| 2018 Abril | 2 | 0 | 2 |
| 2018 Marzo | 2 | 0 | 2 |
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| 2017 Octubre | 56 | 33 | 89 |
| 2017 Septiembre | 52 | 40 | 92 |
| 2017 Agosto | 45 | 17 | 62 |
| 2017 Julio | 50 | 17 | 67 |
| 2017 Junio | 55 | 19 | 74 |
| 2017 Mayo | 53 | 21 | 74 |
| 2017 Abril | 50 | 26 | 76 |
| 2017 Marzo | 76 | 37 | 113 |
| 2017 Febrero | 102 | 35 | 137 |
| 2017 Enero | 86 | 19 | 105 |
| 2016 Diciembre | 91 | 24 | 115 |
| 2016 Noviembre | 149 | 26 | 175 |
| 2016 Octubre | 142 | 22 | 164 |
| 2016 Septiembre | 65 | 40 | 105 |
| 2016 Agosto | 36 | 14 | 50 |
| 2016 Julio | 61 | 4 | 65 |
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| 2016 Abril | 169 | 86 | 255 |
| 2016 Marzo | 126 | 81 | 207 |
| 2016 Febrero | 93 | 45 | 138 |
| 2016 Enero | 69 | 18 | 87 |
| 2015 Diciembre | 111 | 20 | 131 |
| 2015 Noviembre | 134 | 24 | 158 |
| 2015 Octubre | 141 | 29 | 170 |
| 2015 Septiembre | 135 | 25 | 160 |
| 2015 Agosto | 134 | 27 | 161 |
| 2015 Julio | 158 | 15 | 173 |
| 2015 Junio | 113 | 9 | 122 |
| 2015 Mayo | 134 | 28 | 162 |
| 2015 Abril | 123 | 17 | 140 |
| 2015 Marzo | 135 | 10 | 145 |
| 2015 Febrero | 191 | 24 | 215 |
| 2015 Enero | 88 | 4 | 92 |
| 2014 Diciembre | 120 | 12 | 132 |
| 2014 Noviembre | 121 | 6 | 127 |
| 2014 Octubre | 171 | 3 | 174 |
| 2014 Septiembre | 92 | 5 | 97 |
| 2014 Agosto | 77 | 3 | 80 |
| 2014 Julio | 96 | 6 | 102 |
| 2014 Junio | 130 | 4 | 134 |
| 2014 Mayo | 87 | 3 | 90 |
| 2014 Abril | 62 | 2 | 64 |
| 2014 Marzo | 95 | 5 | 100 |
| 2014 Febrero | 76 | 3 | 79 |
| 2014 Enero | 85 | 2 | 87 |
| 2013 Diciembre | 94 | 4 | 98 |
| 2013 Noviembre | 122 | 6 | 128 |
| 2013 Octubre | 71 | 8 | 79 |
| 2013 Septiembre | 38 | 10 | 48 |
| 2013 Agosto | 58 | 14 | 72 |
| 2013 Julio | 36 | 1 | 37 |
| 2013 Mayo | 1 | 0 | 1 |
| 2003 Septiembre | 2660 | 0 | 2660 |
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