array:23 [ "pii" => "S0025775300715764" "issn" => "00257753" "doi" => "10.1016/S0025-7753(00)71576-4" "estado" => "S300" "fechaPublicacion" => "2000-01-01" "aid" => "71576" "copyright" => "Elsevier España, S.L.. Todos los derechos reservados" "copyrightAnyo" => "2000" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Med Clin. 2000;115:410-7" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 1984 "formatos" => array:3 [ "EPUB" => 6 "HTML" => 1780 "PDF" => 198 ] ] "itemSiguiente" => array:18 [ "pii" => "S0025775300715776" "issn" => "00257753" "doi" => "10.1016/S0025-7753(00)71577-6" "estado" => "S300" "fechaPublicacion" => "2000-01-01" "aid" => "71577" "copyright" => "Elsevier España, S.L." 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"documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Med Clin. 2000;115:405-9" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 1734 "formatos" => array:3 [ "EPUB" => 8 "HTML" => 1587 "PDF" => 139 ] ] "es" => array:10 [ "idiomaDefecto" => true "titulo" => "Feocromocitoma asociado a neoplasia endocrina múltiple 2A y esporádico: características diferenciales" "tienePdf" => "es" "tieneTextoCompleto" => 0 "tieneResumen" => array:2 [ 0 => "es" 1 => "en" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "405" "paginaFinal" => "409" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Distinctive clinic features of pheochromocytoma in the setting of multiple endocrine neoplasia 2A" ] ] "contieneResumen" => array:2 [ "es" => true "en" => true ] "contienePdf" => array:1 [ "es" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Albert Lecube, Cristina Hernández, Josep Oriola, José Luis Tovar, Enrique Gémar, Juan Antonio Baena, Jordi Mesa, Rafael Simó" "autores" => array:8 [ 0 => array:2 [ "nombre" => "Albert" "apellidos" => "Lecube" ] 1 => array:2 [ "nombre" => "Cristina" "apellidos" => "Hernández" ] 2 => array:2 [ "nombre" => "Josep" "apellidos" => "Oriola" ] 3 => array:2 [ "nombre" => "José" "apellidos" => "Luis Tovar" ] 4 => array:2 [ "nombre" => "Enrique" "apellidos" => "Gémar" ] 5 => array:2 [ "nombre" => "Juan" "apellidos" => "Antonio Baena" ] 6 => array:2 [ "nombre" => "Jordi" "apellidos" => "Mesa" ] 7 => array:2 [ "nombre" => "Rafael" "apellidos" => "Simó" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775300715752?idApp=UINPBA00004N" "url" => "/00257753/0000011500000011/v1_201307291745/S0025775300715752/v1_201307291745/es/main.assets" ] "es" => array:14 [ "idiomaDefecto" => true "titulo" => "Evaluación de la comprensión de un nuevo modelo de prospecto del medicamento" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "410" "paginaFinal" => "417" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Ángels Vidal Miquel, Francisca Ortín Font, Jaume Marrugat, Marco Pavesi" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Ángels" "apellidos" => "Vidal Miquel" "email" => array:1 [ 0 => "mavidal@piushospital.org" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Francisca" "apellidos" => "Ortín Font" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Jaume" "apellidos" => "Marrugat" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "Marco" "apellidos" => "Pavesi" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Servei de Farmácia. Pius Hospital de Valls. Tarragona." "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Regió Sanitária de Tortosa. Servei Catalá de la Salut." "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Unitat de Lípids i Epidemiologia Cardiovascular. Institut Municipal Investigació Médica (IMIM). Barcelona." "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "*" "correspondencia" => "Correspondencia: Dra. A. Vidal. servicio de Farmacia. Pius Hospital de Valls. Plaza. Sant Francesc, s/n. 43800 Valls. Tarragona" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Assessment of the comprehension of a new rephrasing drug package inserts" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "1999-08-27" "fechaAceptado" => "2000-02-22" "PalabrasClave" => array:1 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec223089" "palabras" => array:2 [ 0 => "Prospectos" 1 => "Información de medicamentos" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Fundamento</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">La información que contienen los prospectos de los medicamentos es a menudo difícil de comprender por los usuarios. Se ha evaluado el impacto de una nueva redacción de los prospectos sobre su comprensión.</p> <span class="elsevierStyleSectionTitle">Sujetos y método</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Se realizó un ensayo en la comunidad, doble ciego, aleatorizando a dos tipos de prospectos: vigentes o modificados cambiando su presentación y estructura, y sustituyendo parte de su contenido técnico por un lenguaje más sencillo. Se evaluó mediante un cuestionario de comprensión del uso de cuatro medicamentos. Se analizaron los siguientes aspectos: indicaciones, intervalo de administración, toma en relación con las comidas, contraindicaciones, conservación y actuación en caso de olvidarse una dosis o de mejora.</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 1.560 participantes, de los que 770 recibieron aleatoriamente prospectos vigentes. El porcentaje medio de respuestas correctas fue del 45,7% en el grupo de los prospectos vigentes y del 75,5% en el de los modificados. En todos los grupos de edad, nivel de estudios, sexo y situación laboral, los participantes con prospectos modificados obtuvieron un porcentaje de respuestas correctas superior al de los vigentes. Se observó una mejora > 73% en la comprensión del intervalo de administración, la toma en relación con las comidas y actuación en caso de olvidarse una dosis. Con el prospecto modificado, la odds ratio de acertar más del 70% de las preguntas del cuestionario fue de 13,5 (intervalo de confianza del 95%, 10,5-17,5) respecto del prospecto vigente.</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La comprensión de los prospectos utilizados habitualmente se puede mejorar considerablemente mediante cambios sencillos en su contenido. Esto puede contribuir a evitar accidentes o uso inapropiado de los fármacos.</p>" ] "en" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Background</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The information included in drug package inserts is often difficult for users to understand. The impact of rephrasing inserts on comprehension was assessed.</p> <span class="elsevierStyleSectionTitle">Subjects and method</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">A community double-blind clinical trial was undertaken with random allocation of subjects to unmodified or modified inserts, in which presentation and structure had been improved and technical content expressed in plain language. A questionnaire on comprehension of the use of four common drugs was administered to all participants. The following aspects were analyzed: indications, interval of administration, administration in relation to meals, contraindications, storage and what to do in cases of missing a dose or improvement in symptoms.</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">1,560 participants were included, among whom 770 randomly received the unmodified inserts. The mean proportion of correct answers was 45.7% in the unmodified insert group and 75.5% among those who received the modified version. In all groups of age, study level and employement status, participants with modified texts achieved a higher correct response rate than the unmodified group. An improvement > 73% in the correct response rate was observed in interval of administration, administration in relation to meals and what to do in cases of missing a dose. With the modified leaflet the odds ratio of successfully answering more than 70% of questions was 13.5 (95% confidence interval, 10.5-17.5) compared with the unmodified leaflet.</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">The comprehension of drug package inserts may be considerably improved by making simple changes in their content. These changes may contribute to accident prevention or inappropriate use of commonly prescribed drugs.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Referencias bibliogrÁFicas" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:21 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1." 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Evaluación de la comprensión de un nuevo modelo de prospecto del medicamento
Assessment of the comprehension of a new rephrasing drug package inserts
Ángels Vidal Miquela,
, Francisca Ortín Fontb, Jaume Marrugatc, Marco Pavesic
Autor para correspondencia
mavidal@piushospital.org
Correspondencia: Dra. A. Vidal. servicio de Farmacia. Pius Hospital de Valls. Plaza. Sant Francesc, s/n. 43800 Valls. Tarragona
Correspondencia: Dra. A. Vidal. servicio de Farmacia. Pius Hospital de Valls. Plaza. Sant Francesc, s/n. 43800 Valls. Tarragona