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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Introducci&#243;n</span><p id="par0005" class="elsevierStylePara elsevierViewall">La valoraci&#243;n de la calidad de vida en relaci&#243;n con la salud &#40;CVRS&#41; se ha convertido en un componente clave en el manejo de las heridas cr&#243;nicas&#44; ya que refleja la opini&#243;n del paciente acerca de la enfermedad y del tratamiento<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">1&#8211;5</span></a>&#46; En la actualidad se est&#225;n utilizando herramientas que ayudan a determinar la calidad de vida &#40;CdV&#41; de los pacientes&#44; tanto en la atenci&#243;n cl&#237;nica diaria<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">6&#8211;10</span></a> como en la gesti&#243;n de calidad<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">11&#8211;14</span></a> y en los ensayos cl&#237;nicos<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">15&#44;16</span></a>&#46; Diversos cuestionarios han sido validados y probados&#44; por ejemplo&#44; el &#171;Nottingham Health Profile&#187;&#44; el &#171;Cardiff Wound Impact Schedule&#187;<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">17</span></a>&#44; el &#171;W&#252;rzburg Wound Score&#187;<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">18</span></a> y el &#171;Freiburg Life Quality Assessment for wounds&#187; &#40;FLQA-w&#41;<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">19</span></a>&#46; Recientemente&#44; un estudio multinacional desarroll&#243; y aprob&#243; un instrumento derivado de los 3 cuestionarios validados y present&#243; datos acerca de los distintos tipos de heridas<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a>&#46; Este cuestionario llamado &#171;Wound-QoL&#187; es un cuestionario m&#225;s corto&#44; m&#225;s f&#225;cil de aplicar y mejor aceptado por los pacientes<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">4</span></a>&#46; Adem&#225;s&#44; parece que la validez de los &#237;tems de este cuestionario es mayor<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a>&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Siguiendo las directrices internacionales usadas en el desarrollo de los instrumentos para los &#171;resultados informados por el paciente&#187; &#40;PRO&#41;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">2&#44;21</span></a>&#44; el Wound-QoL fue validado ling&#252;&#237;sticamente en diferentes idiomas&#44; como en el ingl&#233;s&#44; alem&#225;n&#44; franc&#233;s&#44; italiano&#44; holand&#233;s&#44; sueco&#44; polaco y dan&#233;s&#46; Adem&#225;s de realizar el proceso formal de traducci&#243;n&#44; se comprobaron las caracter&#237;sticas operativas y las propiedades psicom&#233;tricas de la versi&#243;n en espa&#241;ol con la finalidad de su uso cl&#237;nico&#46; Para realizar un estudio intercultural riguroso y evaluar los resultados de nuevos tratamientos&#44; as&#237; como poder generalizar los efectos observados de los tratamientos m&#225;s all&#225; de las fronteras nacionales&#44; se analizaron las caracter&#237;sticas operativas comparando las muestras originales alemanas y las espa&#241;olas&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">El objetivo del presente estudio fue traducir y validar el cuestionario Wound-QoL en espa&#241;ol para su uso en la atenci&#243;n cl&#237;nica y en ensayos cl&#237;nicos en Espa&#241;a&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Material y m&#233;todos</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Dise&#241;o y muestra del estudio</span><p id="par0020" class="elsevierStylePara elsevierViewall">En primer lugar&#44; se realiz&#243; un proceso de traducci&#243;n validado&#46; Posteriormente se llev&#243; a cabo un estudio prospectivo&#44; longitudinal no intervencionista de validaci&#243;n en una cohorte de pacientes con heridas cr&#243;nicas localizadas en las extremidades inferiores&#46; Para el estudio longitudinal los pacientes fueron examinados y completaron cuestionarios al inicio del estudio &#40;T1&#41; y posteriormente a los 2-3 meses de seguimiento &#40;T2&#41;&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Se reclutaron pacientes de los servicios de dermatolog&#237;a de 5 hospitales universitarios espa&#241;oles&#44; quienes presentaban &#250;lceras de diversas etiolog&#237;as&#46; Los criterios de inclusi&#243;n fueron el tener una herida cr&#243;nica activa&#44; una edad &#8805;<span class="elsevierStyleHsp" style=""></span>18<span class="elsevierStyleHsp" style=""></span>a&#241;os y tener capacidad de comprensi&#243;n y cumplimentaci&#243;n de un cuestionario en espa&#241;ol&#46; &#218;nicamente se incluy&#243; a los pacientes despu&#233;s de dar su consentimiento informado&#46; El 27 de julio del 2016&#44; este estudio fue aprobado por el Comit&#233; &#201;tico de Investigaci&#243;n Cl&#237;nica del Hospital General Universitario Gregorio Mara&#241;&#243;n con el c&#243;digo &#171;Wound-PRO&#187;&#46; Los licenciatarios del Wound-QoL tambi&#233;n estuvieron de acuerdo con la adaptaci&#243;n y la validaci&#243;n del presente cuestionario&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">El cuestionario Wound-QoL consta de 17 preguntas o &#237;tems&#46; Cada &#237;tem se punt&#250;a en una escala Likert de 5 puntos&#44; que van desde 0 &#40;nada&#41; hasta 4 &#40;mucho&#41;&#46; La calificaci&#243;n media de todas las preguntas proporciona el resultado de la puntuaci&#243;n global&#46; Las 3 subescalas acerca de las caracter&#237;sticas de vida diaria&#44; el cuerpo y la psique se realizaron de acuerdo con la versi&#243;n del Wound-QoL original<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">22</span></a>&#46; Para su uso cl&#237;nico&#44; la traducci&#243;n directa e inversa de la versi&#243;n original en alem&#225;n del cuestionario Wound-QoL se realizaron siguiendo las directrices internacionales<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">15</span></a>&#46; La versi&#243;n original en alem&#225;n se envi&#243; tambi&#233;n a nativos hispanohablantes que la tradujeron al espa&#241;ol de forma independiente&#46; As&#237; mismo&#44; estas 2 versiones fueron traducidas al alem&#225;n por otros 2 nativos germanohablantes&#46; Las 2 versiones en alem&#225;n resultantes se compararon luego con la versi&#243;n original y posteriormente se realiz&#243; una discusi&#243;n sem&#225;ntica acerca de las diferencias observadas en alguno de los t&#233;rminos utilizados&#46; En esta discusi&#243;n se incluy&#243; al autor original del cuestionario&#44; a 2 m&#233;dicos y psic&#243;logos familiarizados con los idiomas alem&#225;n y espa&#241;ol&#44; y a un ling&#252;ista&#46; Despu&#233;s de perfeccionar la versi&#243;n en espa&#241;ol&#44; se realiz&#243; una prueba de la viabilidad de esta versi&#243;n en 10 pacientes de Espa&#241;a&#46; El objetivo de realizar esta prueba fue analizar si los pacientes se sent&#237;an c&#243;modos con el cuestionario&#44; as&#237; como saber si comprend&#237;an de manera adecuada las preguntas&#46; As&#237; mismo&#44; se busc&#243; determinar cu&#225;nto tiempo se requer&#237;a para completar el cuestionario en condiciones rutinarias&#46; El cuestionario no mostr&#243; problemas en cuanto a su comprensi&#243;n y viabilidad&#46; No fue necesario realizar una adaptaci&#243;n del contenido&#46; La <a class="elsevierStyleCrossRef" href="#fig0005">figura 1</a> muestra la versi&#243;n en espa&#241;ol que se utiliz&#243; en el estudio de validaci&#243;n del cuestionario Wound-QoL&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">La informaci&#243;n acerca de los antecedentes socioecon&#243;micos y cl&#237;nicos de los pacientes se obtuvo utilizando un informe cl&#237;nico est&#225;ndar tras realizar una valoraci&#243;n espec&#237;fica de la situaci&#243;n de la herida&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Adem&#225;s de la versi&#243;n en espa&#241;ol del Wound-QoL&#44; se utilizaron los siguientes cuestionarios&#58;<ul class="elsevierStyleList" id="lst0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0045" class="elsevierStylePara elsevierViewall">El Cuestionario EuroQoL de 5 dimensiones &#40;EQ-5D&#41;&#58; instrumento gen&#233;rico que refleja el estado de salud y la calidad de vida en una versi&#243;n validada en espa&#241;ol<a class="elsevierStyleCrossRef" href="#bib0265"><span class="elsevierStyleSup">23</span></a>&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Dolor&#58; escalas de calificaci&#243;n num&#233;rica &#40;NRS&#41; de 0 a 10<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">24</span></a>&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Las 3 escalas visuales anal&#243;gicas &#40;EVA&#41; incluidas en la evaluaci&#243;n de la calidad de vida FLQA-w<a class="elsevierStyleCrossRef" href="#bib0275"><span class="elsevierStyleSup">25</span></a>&#46; Este es un cuestionario espec&#237;fico acerca de la calidad de vida de los pacientes en relaci&#243;n con las heridas&#44; el cual ha sido validado y se viene utilizando ampliamente&#46; Este cuestionario fue traducido al espa&#241;ol de la misma forma que el WoundQoL &#40;traducci&#243;n independiente&#47;inversa&#41;<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">24</span></a>&#46;</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">An&#225;lisis estad&#237;stico</span><p id="par0060" class="elsevierStylePara elsevierViewall">Debido a la ausencia de recomendaciones para el c&#225;lculo inicial del tama&#241;o de la muestra en los estudios de validaci&#243;n<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">26</span></a>&#44; el tama&#241;o de la poblaci&#243;n de estudio se determin&#243; con base en experiencias obtenidas previamente y se corresponde con otros estudios de validaci&#243;n del Wound-QoL<a class="elsevierStyleCrossRefs" href="#bib0285"><span class="elsevierStyleSup">27&#44;28</span></a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Se determinaron las caracter&#237;sticas de la distribuci&#243;n de los diversos &#237;tems&#44; como fueron la media&#44; la desviaci&#243;n est&#225;ndar &#40;DE&#41;&#44; as&#237; como el porcentaje de los &#237;tems localizados en el extremo inferior &#40;efecto suelo&#41; y en el extremo superior &#40;efecto techo&#41;&#46; Para la consistencia interna&#44; se midi&#243; el coeficiente alfa de Cronbach&#46; Las puntuaciones superiores a 0&#44;70 se interpretaron como aceptables<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">29</span></a>&#46; Se llev&#243; a cabo un an&#225;lisis factorial exploratorio para comprobar la validez estructural&#46; La diferencia de las puntuaciones entre T1 y T2 se evalu&#243; mediante la prueba de Wilcoxon&#46; Para comprobar la capacidad de respuesta y la validez convergente&#44; las puntuaciones del Wound-QoL se correlacionaron con el EQ-5D y FLQA-w &#40;correlaci&#243;n de Spearman&#41;&#46; Todos los an&#225;lisis se realizaron utilizando el SPSS versi&#243;n 23 &#40;IBM&#44; Armonk&#44; NY&#44; EE&#46;<span class="elsevierStyleHsp" style=""></span>UU&#46;&#41;&#46;</p></span></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Resultados</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Caracter&#237;sticas basales</span><p id="par0070" class="elsevierStylePara elsevierViewall">Un total de 115 pacientes se reclutaron en los 5 centros&#46; Se incluyeron 45 pacientes &#40;39&#44;1&#37;&#41; con &#250;lceras venosas&#44; 4 &#40;3&#44;5&#37;&#41; con &#250;lceras mixtas del miembro inferior y 4 &#40;3&#44;5&#37;&#41; con &#250;lceras arteriales del miembro inferior &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46; La edad media fue de 69&#44;5 &#40;DE 14&#44;5&#41; a&#241;os &#40;mediana 73&#44; min&#46; 28<span class="elsevierStyleHsp" style=""></span>-<span class="elsevierStyleHsp" style=""></span>max&#46; 97&#41; y el 60&#44;0&#37; fueron pacientes del sexo femenino&#46; El tiempo medio de observaci&#243;n fue de 9&#44;6 &#40;DE 6&#44;6&#41; semanas&#46; El tama&#241;o medio de la herida en T1 fue de 18&#44;9 &#40;DE 36&#44;1&#41;<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span> y 1&#44;9 &#40;DE 8&#44;0&#41;<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span> en T2 &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46; En general&#44; 78 &#40;67&#44;8&#37;&#41; de las heridas mostraron una curaci&#243;n completa y 110 &#40;95&#44;7&#37;&#41; una mejora de m&#225;s del 10&#37; que se consider&#243; como relevante&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Calidad de vida</span><p id="par0075" class="elsevierStylePara elsevierViewall">La puntuaci&#243;n Wound-QoL media de la herida en T1 fue de 1&#44;9 &#40;DE 1&#44;0&#41; y 0&#44;8 &#40;DE 0&#44;9&#41; en T2 &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#44; el estado de salud medio del FLQA-w con respecto a la herida fue de 5&#44;1 &#40;DE 2&#44;7&#41; en T1 y 8&#44;1 &#40;DE 2&#44;1&#41; en T2 &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">tabla 2</a>&#41;&#46; El dolor por EVA se redujo de 4&#44;9 &#40;DE 3&#44;4&#41; a 0&#44;9 &#40;DE 1&#44;7&#41; &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Consistencia interna</span><p id="par0080" class="elsevierStylePara elsevierViewall">La puntuaci&#243;n global del Wound-QoL de la versi&#243;n espa&#241;ola mostr&#243; una alta fiabilidad presentando un coeficiente alfa de Cronbach &#62;<span class="elsevierStyleHsp" style=""></span>0&#44;80 en todas las escalas&#46; Las caracter&#237;sticas de distribuci&#243;n de la puntuaci&#243;n global y de las subescalas fueron satisfactorias&#46; En T1 el 0&#44;9&#37; tuvo la puntuaci&#243;n global m&#225;s baja y alta posible&#46; En T2 el 18&#44;3&#37; ten&#237;a la puntuaci&#243;n global m&#225;s baja posible y el 0&#44;9&#37; la m&#225;s alta posible&#46; Para las subescalas&#44; el porcentaje de pacientes con la puntuaci&#243;n m&#225;s baja posible oscil&#243; entre el 2&#44;6&#37; y el 12&#44;2&#37; en T1 y entre el 20&#44;9&#37; y el 48&#44;7&#37; en T2&#46; El porcentaje de la puntuaci&#243;n m&#225;s alta posible en las subescalas estuvo entre el 7&#44;8&#37; y el 15&#44;7&#37; en T1 y entre el 0&#44;9&#37; y el 2&#44;6&#37; en T2&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Validez estructural</span><p id="par0085" class="elsevierStylePara elsevierViewall">En el an&#225;lisis factorial exploratorio&#44; se incluyeron 115 pacientes &#40;N&#41; que completaron el Wound-QoL en la visita T1&#46; Se encontraron 3 factores con un valor propio &#62;<span class="elsevierStyleHsp" style=""></span>1&#44; lo que explica el 71&#44;0&#37; de la varianza global&#46; Todos los &#237;tems asignados a los componentes y a las subescalas del cuerpo &#40;del n&#46;<span class="elsevierStyleSup">o</span> 1 al n&#46;<span class="elsevierStyleSup">o</span> 5&#41;&#44; la psique &#40;del n&#46;<span class="elsevierStyleSup">o</span> 6 al n&#46;<span class="elsevierStyleSup">o</span> 10&#41; y la vida cotidiana &#40;del n&#46;<span class="elsevierStyleSup">o</span> 11 al n&#46;<span class="elsevierStyleSup">o</span> 16&#41; se confirmaron&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Validez convergente y capacidad de respuesta</span><p id="par0090" class="elsevierStylePara elsevierViewall">La validez convergente en relaci&#243;n con otros instrumentos &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41; y la capacidad de respuesta fueron satisfactorias &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><elsevierMultimedia ident="tbl0020"></elsevierMultimedia></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Viabilidad</span><p id="par0095" class="elsevierStylePara elsevierViewall">El Wound-QoL fue considerado una herramienta simple y viable por la gran mayor&#237;a de los pacientes&#46; El tiempo medio necesario para completar las preguntas fue de 5&#44;2 &#40;DE 6&#44;4&#41; minutos en T1 y de 5&#44;5 &#40;DE 3&#44;6&#41; en T2&#46; En general&#44; al 99&#44;1&#37; de los participantes les result&#243; f&#225;cil entender las preguntas y el 94&#44;7&#37; afirm&#243; que el cuestionario se adaptaba a su situaci&#243;n personal&#46;</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discusi&#243;n</span><p id="par0100" class="elsevierStylePara elsevierViewall">La valoraci&#243;n del PRO es un componente esencial en el tratamiento de las heridas cr&#243;nicas<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">1</span></a>&#46; Los pacientes tienen una amplia variedad de formas de deterioro de su calidad de vida&#44; por lo que existe la necesidad de realizar tratamientos individualizados&#44; los cuales deber&#225;n ser evaluados e incluidos en el plan terap&#233;utico<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">2&#44;5</span></a>&#46; La medida de la CVRS como una forma clave para construir el concepto PRO ha sido recomendado por la mayor&#237;a de las autoridades y sociedades m&#233;dicas expertas en el cuidado de las heridas<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">24&#44;30</span></a>&#46; El Wound-QoL es un instrumento espec&#237;fico para la valoraci&#243;n de la CVRS&#59; se ha desarrollado y validado para su uso tanto en ensayos cl&#237;nicos como en la atenci&#243;n cl&#237;nica rutinaria<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">3&#44;4&#44;20</span></a>&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">El objetivo de realizar este estudio fue validar tanto ling&#252;&#237;sticamente como psicom&#233;tricamente en un mismo proyecto la versi&#243;n en espa&#241;ol del Wound-QoL&#46; Las validaciones siguieron los procedimientos est&#225;ndares internacionales&#46; Los pacientes se seleccionaron durante la atenci&#243;n rutinaria&#44; lo que proporcion&#243; una amplia muestra del diferente tipo de heridas tratadas en los diversos centros de atenci&#243;n m&#233;dica en Espa&#241;a&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">En cuanto a las limitaciones del presente estudio&#44; se puede enumerar el hecho de que los pacientes se reclutaron &#250;nicamente a partir de un n&#250;mero limitado de centros&#44; por lo que un sesgo de selecci&#243;n no puede ser excluido&#46; Sin embargo&#44; los pacientes se seleccionaron a partir de entornos de pr&#225;ctica cl&#237;nica real de diversos centros&#44; por lo que no existe evidencia de que la forma de selecci&#243;n haya afectado las propiedades de la validaci&#243;n&#46; Por otro lado&#44; el instrumento utilizado no se modific&#243;&#44; motivo por el cual cabe la posibilidad de que el cuestionario no sea representativo de toda la problem&#225;tica de la poblaci&#243;n espa&#241;ola&#46; No obstante&#44; con la finalidad de que el instrumento fuese comparable internacionalmente&#44; se prefiri&#243; que los &#237;tems se mantuvieran similares a la versi&#243;n original&#46; Finamente&#44; en el pretest no se observ&#243; una mayor tasa de &#237;tems ausentes u objeciones&#44; lo que hubiera sugerido una disminuci&#243;n en la aplicabilidad del cuestionario en espa&#241;ol&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">En general&#44; la versi&#243;n en espa&#241;ol del Wound-QoL mostr&#243; propiedades psicom&#233;tricas adecuadas que se asemejan a las caracter&#237;sticas de la versi&#243;n original<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a>&#46; Los efectos de suelo y de techo fueron bajos en T1&#46; En T2 se evidenciaron efectos de suelo m&#225;s elevados&#44; lo que se puede interpretar como un efecto positivo del tratamiento en la CVRS y&#44; por lo tanto&#44; indicar una adecuada sensibilidad del Wound-QoL a la mejor&#237;a cl&#237;nica&#46; As&#237; mismo&#44; los pacientes refirieron una muy buena comprensi&#243;n y aceptaci&#243;n del cuestionario&#46; Se tard&#243; aproximadamente 5<span class="elsevierStyleHsp" style=""></span>minutos en contestar las preguntas del cuestionario y se dejaron &#250;nicamente escasos datos sin contestar&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conclusiones</span><p id="par0120" class="elsevierStylePara elsevierViewall">La versi&#243;n espa&#241;ola del Wound-QoL es una herramienta v&#225;lida y una opci&#243;n factible&#44; que cuenta con una elevada aceptaci&#243;n por parte de los pacientes para la valoraci&#243;n de la CVRS en Espa&#241;a tanto en la atenci&#243;n cl&#237;nica como en los ensayos cl&#237;nicos&#46; Debido a que los procesos de traducci&#243;n y de validaci&#243;n se realizaron en Espa&#241;a&#44; se debe considerar realizar adaptaciones adicionales para su utilizaci&#243;n en diversas regiones&#44; como por ejemplo en Am&#233;rica Latina&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Conflicto de intereses</span><p id="par0125" class="elsevierStylePara elsevierViewall">M&#46; Augustin es el titular de la licencia del cuestionario Wound-QoL&#46; Por lo dem&#225;s&#44; los autores no tienen ning&#250;n otro conflicto de inter&#233;s&#46;</p></span></span>"
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        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Antecedentes y objetivos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">El Wound-QoL es un cuestionario validado para medir la calidad de vida en pacientes con heridas cr&#243;nicas&#44; que fue desarrollado originalmente para su uso en alem&#225;n&#46;</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">El objetivo de este estudio fue traducir el cuestionario Wound-QoL para su uso en la pr&#225;ctica cl&#237;nica y estudios de investigaci&#243;n en Espa&#241;a&#44; as&#237; como validar esta versi&#243;n&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Materiales y m&#233;todos</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Se realizaron dos traducciones independientes del Wound-QoL&#44; directa e inversa&#44; a partir de la versi&#243;n original en alem&#225;n&#44; seguidas de un consenso de expertos sobre las versiones resultantes&#46; Despu&#233;s de su perfeccionamiento se realiz&#243; un estudio piloto y posteriormente el estudio de validaci&#243;n&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Resultados</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Se incluy&#243; un total de 115 pacientes&#46; La edad media fue de 69&#44;5 &#40;DE 14&#44;5&#41; a&#241;os&#44; y el 60&#44;0&#37; eran mujeres&#46; La versi&#243;n espa&#241;ola del Wound-QoL mostr&#243; una excelente consistencia interna &#40;&#237;ndice alfa de Cronbach<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#44;8 en todas las escalas&#41;&#46; El an&#225;lisis factorial dio como resultado las mismas escalas que la versi&#243;n original&#46; Se objetivaron caracter&#237;sticas satisfactorias de la distribuci&#243;n de la puntuaci&#243;n global y de las subescalas&#46; La validez de constructo y la validez convergente con otros resultados &#40;calidad de vida gen&#233;rica&#44; tasa de curaci&#243;n&#41; fueron satisfactorias&#46; La gran mayor&#237;a de los pacientes consideraron que el cuestionario era una herramienta sencilla y factible&#46; El tiempo medio necesario para completar el cuestionario fue de 5 minutos&#46; El 99&#44;1&#37; de los participantes consideraron que las preguntas eran f&#225;ciles de entender y el 94&#44;7&#37; declar&#243; que personal&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Conclusiones</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">La versi&#243;n espa&#241;ola del Wound-QoL muestra una excelente validez en la pr&#225;ctica cl&#237;nica&#46; Por lo tanto&#44; puede ser recomendada para su uso tanto en la rutina cl&#237;nica como en los ensayos&#46;</p></span>"
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        "resumen" => "<span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Background and aims</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds&#44; originally developed for use in German&#46;</p><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Materials and methods</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted&#44; followed by an expert consensus of the resulting versions&#46; After refinement&#44; the final tool was piloted in N<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>10 patients and then used in the validation study&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Results</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">A total of 115 patients were recruited&#46; Mean age was 69&#46;5 &#40;SD 14&#46;5&#41; years&#44; 60&#46;0&#37; were female&#46; The Spanish version of Wound-QoL showed high internal consistency &#40;Cronbach&#39;s alpha<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#46;8 in all scales&#41;&#46; Factor analysis resulted in the same scales as the original version&#46; There were satisfactory distribution characteristics of the global score and the subscales&#46; Construct validity and convergent validity with other outcomes &#40;generic QoL&#44; healing rate&#41; were satisfactory&#46; The vast majority of patients considered the Wound-QoL a simple and feasible tool&#46; Mean time needed for completing the questionnaire was 5<span class="elsevierStyleHsp" style=""></span>minutes&#46; Overall&#44; 99&#46;1&#37; of the participants found it easy to understand the questions and 94&#46;7&#37; stated that the questionnaire suits the personal situation&#46;</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conclusions</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">The Spanish version of the Wound-QoL shows good validity in clinical practice&#46; It can be recommended for use in clinical routine and trials&#46;</p></span>"
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>S&#237;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">88&#44;7&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t  " colspan="3" align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>De dec&#250;bito&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&#44;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Venosa&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Arterial&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Posquir&#250;rgica&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Otras&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Mediana&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">1&#46;<span class="elsevierStyleSup">er</span> cuartil&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">3&#46;<span class="elsevierStyleSup">er</span> cuartil&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Media&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">DE&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Mediana&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">1&#46;<span class="elsevierStyleSup">er</span> cuartil&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">3&#46;<span class="elsevierStyleSup">er</span> cuartil&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Wound-QoL&#44; puntuaci&#243;n global&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Wound-QoL&#44; subescala corporal&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#44;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Wound-QoL&#44; subescala psicol&#243;gica&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#44;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">3&#44;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Wound-QoL&#44; subescala de la vida diaria&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#44;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#44;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#44;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">0&#44;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">2&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#44;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#44;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#44;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">0&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">FLQA-w&#44; general&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">6&#44;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">2&#44;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">6&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">5&#44;0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">8&#44;0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">7&#44;3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2&#44;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">7&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">6&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">9&#44;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">FLQA-w&#44; en relaci&#243;n con la herida&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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Original
Validación de la versión española del cuestionario Wound-QoL
Validation of the Spanish Wound-QoL Questionnaire
E. Conde Monteroa,b,c, R. Sommerc, M. Augustinc, C. Blomec, R. Cabeza Martínezd, C. Horcajada Realese, M. Alsina Gibertf, R. Ramón Sapenag, A. Peral Vázqueza,b, J. Montoro Lópeza,b, S. Guisado Muñoza,b, L. Pérez Jerónimoa,b, P. de la Cueva Dobaoa,b, N. Kresselc, N. Mohrc,
Corresponding author
ni.mohr@uke.de

Autor para correspondencia.
a Servicio de Dermatología, Hospital Universitario Infanta Leonor, Madrid, España
b Centro de Especialidades Vicente Soldevilla, Hospital Virgen de la Torre, Madrid, España
c German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburgo, Alemania
d Servicio de Dermatología, Hospital Universitario Puerta de Hierro-Majadahonda (HUPHM), Madrid, España
e Servicio de Dermatología, Hospital Universitario de Fuenlabrada, Madrid, España
f Servicio de Dermatología, Hospital Clínic de Barcelona, Barcelona, España
g Servicio de Dermatología, Hospital General Universitario de Alicante, Alicante, España
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Adem&#225;s&#44; parece que la validez de los &#237;tems de este cuestionario es mayor<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a>&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Siguiendo las directrices internacionales usadas en el desarrollo de los instrumentos para los &#171;resultados informados por el paciente&#187; &#40;PRO&#41;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">2&#44;21</span></a>&#44; el Wound-QoL fue validado ling&#252;&#237;sticamente en diferentes idiomas&#44; como en el ingl&#233;s&#44; alem&#225;n&#44; franc&#233;s&#44; italiano&#44; holand&#233;s&#44; sueco&#44; polaco y dan&#233;s&#46; Adem&#225;s de realizar el proceso formal de traducci&#243;n&#44; se comprobaron las caracter&#237;sticas operativas y las propiedades psicom&#233;tricas de la versi&#243;n en espa&#241;ol con la finalidad de su uso cl&#237;nico&#46; Para realizar un estudio intercultural riguroso y evaluar los resultados de nuevos tratamientos&#44; as&#237; como poder generalizar los efectos observados de los tratamientos m&#225;s all&#225; de las fronteras nacionales&#44; se analizaron las caracter&#237;sticas operativas comparando las muestras originales alemanas y las espa&#241;olas&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">El objetivo del presente estudio fue traducir y validar el cuestionario Wound-QoL en espa&#241;ol para su uso en la atenci&#243;n cl&#237;nica y en ensayos cl&#237;nicos en Espa&#241;a&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Material y m&#233;todos</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Dise&#241;o y muestra del estudio</span><p id="par0020" class="elsevierStylePara elsevierViewall">En primer lugar&#44; se realiz&#243; un proceso de traducci&#243;n validado&#46; Posteriormente se llev&#243; a cabo un estudio prospectivo&#44; longitudinal no intervencionista de validaci&#243;n en una cohorte de pacientes con heridas cr&#243;nicas localizadas en las extremidades inferiores&#46; Para el estudio longitudinal los pacientes fueron examinados y completaron cuestionarios al inicio del estudio &#40;T1&#41; y posteriormente a los 2-3 meses de seguimiento &#40;T2&#41;&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Se reclutaron pacientes de los servicios de dermatolog&#237;a de 5 hospitales universitarios espa&#241;oles&#44; quienes presentaban &#250;lceras de diversas etiolog&#237;as&#46; Los criterios de inclusi&#243;n fueron el tener una herida cr&#243;nica activa&#44; una edad &#8805;<span class="elsevierStyleHsp" style=""></span>18<span class="elsevierStyleHsp" style=""></span>a&#241;os y tener capacidad de comprensi&#243;n y cumplimentaci&#243;n de un cuestionario en espa&#241;ol&#46; &#218;nicamente se incluy&#243; a los pacientes despu&#233;s de dar su consentimiento informado&#46; El 27 de julio del 2016&#44; este estudio fue aprobado por el Comit&#233; &#201;tico de Investigaci&#243;n Cl&#237;nica del Hospital General Universitario Gregorio Mara&#241;&#243;n con el c&#243;digo &#171;Wound-PRO&#187;&#46; Los licenciatarios del Wound-QoL tambi&#233;n estuvieron de acuerdo con la adaptaci&#243;n y la validaci&#243;n del presente cuestionario&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">El cuestionario Wound-QoL consta de 17 preguntas o &#237;tems&#46; Cada &#237;tem se punt&#250;a en una escala Likert de 5 puntos&#44; que van desde 0 &#40;nada&#41; hasta 4 &#40;mucho&#41;&#46; La calificaci&#243;n media de todas las preguntas proporciona el resultado de la puntuaci&#243;n global&#46; Las 3 subescalas acerca de las caracter&#237;sticas de vida diaria&#44; el cuerpo y la psique se realizaron de acuerdo con la versi&#243;n del Wound-QoL original<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">22</span></a>&#46; Para su uso cl&#237;nico&#44; la traducci&#243;n directa e inversa de la versi&#243;n original en alem&#225;n del cuestionario Wound-QoL se realizaron siguiendo las directrices internacionales<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">15</span></a>&#46; La versi&#243;n original en alem&#225;n se envi&#243; tambi&#233;n a nativos hispanohablantes que la tradujeron al espa&#241;ol de forma independiente&#46; As&#237; mismo&#44; estas 2 versiones fueron traducidas al alem&#225;n por otros 2 nativos germanohablantes&#46; Las 2 versiones en alem&#225;n resultantes se compararon luego con la versi&#243;n original y posteriormente se realiz&#243; una discusi&#243;n sem&#225;ntica acerca de las diferencias observadas en alguno de los t&#233;rminos utilizados&#46; En esta discusi&#243;n se incluy&#243; al autor original del cuestionario&#44; a 2 m&#233;dicos y psic&#243;logos familiarizados con los idiomas alem&#225;n y espa&#241;ol&#44; y a un ling&#252;ista&#46; Despu&#233;s de perfeccionar la versi&#243;n en espa&#241;ol&#44; se realiz&#243; una prueba de la viabilidad de esta versi&#243;n en 10 pacientes de Espa&#241;a&#46; El objetivo de realizar esta prueba fue analizar si los pacientes se sent&#237;an c&#243;modos con el cuestionario&#44; as&#237; como saber si comprend&#237;an de manera adecuada las preguntas&#46; As&#237; mismo&#44; se busc&#243; determinar cu&#225;nto tiempo se requer&#237;a para completar el cuestionario en condiciones rutinarias&#46; El cuestionario no mostr&#243; problemas en cuanto a su comprensi&#243;n y viabilidad&#46; No fue necesario realizar una adaptaci&#243;n del contenido&#46; La <a class="elsevierStyleCrossRef" href="#fig0005">figura 1</a> muestra la versi&#243;n en espa&#241;ol que se utiliz&#243; en el estudio de validaci&#243;n del cuestionario Wound-QoL&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">La informaci&#243;n acerca de los antecedentes socioecon&#243;micos y cl&#237;nicos de los pacientes se obtuvo utilizando un informe cl&#237;nico est&#225;ndar tras realizar una valoraci&#243;n espec&#237;fica de la situaci&#243;n de la herida&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Adem&#225;s de la versi&#243;n en espa&#241;ol del Wound-QoL&#44; se utilizaron los siguientes cuestionarios&#58;<ul class="elsevierStyleList" id="lst0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0045" class="elsevierStylePara elsevierViewall">El Cuestionario EuroQoL de 5 dimensiones &#40;EQ-5D&#41;&#58; instrumento gen&#233;rico que refleja el estado de salud y la calidad de vida en una versi&#243;n validada en espa&#241;ol<a class="elsevierStyleCrossRef" href="#bib0265"><span class="elsevierStyleSup">23</span></a>&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Dolor&#58; escalas de calificaci&#243;n num&#233;rica &#40;NRS&#41; de 0 a 10<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">24</span></a>&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Las 3 escalas visuales anal&#243;gicas &#40;EVA&#41; incluidas en la evaluaci&#243;n de la calidad de vida FLQA-w<a class="elsevierStyleCrossRef" href="#bib0275"><span class="elsevierStyleSup">25</span></a>&#46; Este es un cuestionario espec&#237;fico acerca de la calidad de vida de los pacientes en relaci&#243;n con las heridas&#44; el cual ha sido validado y se viene utilizando ampliamente&#46; Este cuestionario fue traducido al espa&#241;ol de la misma forma que el WoundQoL &#40;traducci&#243;n independiente&#47;inversa&#41;<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">24</span></a>&#46;</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">An&#225;lisis estad&#237;stico</span><p id="par0060" class="elsevierStylePara elsevierViewall">Debido a la ausencia de recomendaciones para el c&#225;lculo inicial del tama&#241;o de la muestra en los estudios de validaci&#243;n<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">26</span></a>&#44; el tama&#241;o de la poblaci&#243;n de estudio se determin&#243; con base en experiencias obtenidas previamente y se corresponde con otros estudios de validaci&#243;n del Wound-QoL<a class="elsevierStyleCrossRefs" href="#bib0285"><span class="elsevierStyleSup">27&#44;28</span></a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Se determinaron las caracter&#237;sticas de la distribuci&#243;n de los diversos &#237;tems&#44; como fueron la media&#44; la desviaci&#243;n est&#225;ndar &#40;DE&#41;&#44; as&#237; como el porcentaje de los &#237;tems localizados en el extremo inferior &#40;efecto suelo&#41; y en el extremo superior &#40;efecto techo&#41;&#46; Para la consistencia interna&#44; se midi&#243; el coeficiente alfa de Cronbach&#46; Las puntuaciones superiores a 0&#44;70 se interpretaron como aceptables<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">29</span></a>&#46; Se llev&#243; a cabo un an&#225;lisis factorial exploratorio para comprobar la validez estructural&#46; La diferencia de las puntuaciones entre T1 y T2 se evalu&#243; mediante la prueba de Wilcoxon&#46; Para comprobar la capacidad de respuesta y la validez convergente&#44; las puntuaciones del Wound-QoL se correlacionaron con el EQ-5D y FLQA-w &#40;correlaci&#243;n de Spearman&#41;&#46; Todos los an&#225;lisis se realizaron utilizando el SPSS versi&#243;n 23 &#40;IBM&#44; Armonk&#44; NY&#44; EE&#46;<span class="elsevierStyleHsp" style=""></span>UU&#46;&#41;&#46;</p></span></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Resultados</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Caracter&#237;sticas basales</span><p id="par0070" class="elsevierStylePara elsevierViewall">Un total de 115 pacientes se reclutaron en los 5 centros&#46; Se incluyeron 45 pacientes &#40;39&#44;1&#37;&#41; con &#250;lceras venosas&#44; 4 &#40;3&#44;5&#37;&#41; con &#250;lceras mixtas del miembro inferior y 4 &#40;3&#44;5&#37;&#41; con &#250;lceras arteriales del miembro inferior &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46; La edad media fue de 69&#44;5 &#40;DE 14&#44;5&#41; a&#241;os &#40;mediana 73&#44; min&#46; 28<span class="elsevierStyleHsp" style=""></span>-<span class="elsevierStyleHsp" style=""></span>max&#46; 97&#41; y el 60&#44;0&#37; fueron pacientes del sexo femenino&#46; El tiempo medio de observaci&#243;n fue de 9&#44;6 &#40;DE 6&#44;6&#41; semanas&#46; El tama&#241;o medio de la herida en T1 fue de 18&#44;9 &#40;DE 36&#44;1&#41;<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span> y 1&#44;9 &#40;DE 8&#44;0&#41;<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span> en T2 &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46; En general&#44; 78 &#40;67&#44;8&#37;&#41; de las heridas mostraron una curaci&#243;n completa y 110 &#40;95&#44;7&#37;&#41; una mejora de m&#225;s del 10&#37; que se consider&#243; como relevante&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Calidad de vida</span><p id="par0075" class="elsevierStylePara elsevierViewall">La puntuaci&#243;n Wound-QoL media de la herida en T1 fue de 1&#44;9 &#40;DE 1&#44;0&#41; y 0&#44;8 &#40;DE 0&#44;9&#41; en T2 &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#44; el estado de salud medio del FLQA-w con respecto a la herida fue de 5&#44;1 &#40;DE 2&#44;7&#41; en T1 y 8&#44;1 &#40;DE 2&#44;1&#41; en T2 &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">tabla 2</a>&#41;&#46; El dolor por EVA se redujo de 4&#44;9 &#40;DE 3&#44;4&#41; a 0&#44;9 &#40;DE 1&#44;7&#41; &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Consistencia interna</span><p id="par0080" class="elsevierStylePara elsevierViewall">La puntuaci&#243;n global del Wound-QoL de la versi&#243;n espa&#241;ola mostr&#243; una alta fiabilidad presentando un coeficiente alfa de Cronbach &#62;<span class="elsevierStyleHsp" style=""></span>0&#44;80 en todas las escalas&#46; Las caracter&#237;sticas de distribuci&#243;n de la puntuaci&#243;n global y de las subescalas fueron satisfactorias&#46; En T1 el 0&#44;9&#37; tuvo la puntuaci&#243;n global m&#225;s baja y alta posible&#46; En T2 el 18&#44;3&#37; ten&#237;a la puntuaci&#243;n global m&#225;s baja posible y el 0&#44;9&#37; la m&#225;s alta posible&#46; Para las subescalas&#44; el porcentaje de pacientes con la puntuaci&#243;n m&#225;s baja posible oscil&#243; entre el 2&#44;6&#37; y el 12&#44;2&#37; en T1 y entre el 20&#44;9&#37; y el 48&#44;7&#37; en T2&#46; El porcentaje de la puntuaci&#243;n m&#225;s alta posible en las subescalas estuvo entre el 7&#44;8&#37; y el 15&#44;7&#37; en T1 y entre el 0&#44;9&#37; y el 2&#44;6&#37; en T2&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Validez estructural</span><p id="par0085" class="elsevierStylePara elsevierViewall">En el an&#225;lisis factorial exploratorio&#44; se incluyeron 115 pacientes &#40;N&#41; que completaron el Wound-QoL en la visita T1&#46; Se encontraron 3 factores con un valor propio &#62;<span class="elsevierStyleHsp" style=""></span>1&#44; lo que explica el 71&#44;0&#37; de la varianza global&#46; Todos los &#237;tems asignados a los componentes y a las subescalas del cuerpo &#40;del n&#46;<span class="elsevierStyleSup">o</span> 1 al n&#46;<span class="elsevierStyleSup">o</span> 5&#41;&#44; la psique &#40;del n&#46;<span class="elsevierStyleSup">o</span> 6 al n&#46;<span class="elsevierStyleSup">o</span> 10&#41; y la vida cotidiana &#40;del n&#46;<span class="elsevierStyleSup">o</span> 11 al n&#46;<span class="elsevierStyleSup">o</span> 16&#41; se confirmaron&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Validez convergente y capacidad de respuesta</span><p id="par0090" class="elsevierStylePara elsevierViewall">La validez convergente en relaci&#243;n con otros instrumentos &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41; y la capacidad de respuesta fueron satisfactorias &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><elsevierMultimedia ident="tbl0020"></elsevierMultimedia></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Viabilidad</span><p id="par0095" class="elsevierStylePara elsevierViewall">El Wound-QoL fue considerado una herramienta simple y viable por la gran mayor&#237;a de los pacientes&#46; El tiempo medio necesario para completar las preguntas fue de 5&#44;2 &#40;DE 6&#44;4&#41; minutos en T1 y de 5&#44;5 &#40;DE 3&#44;6&#41; en T2&#46; En general&#44; al 99&#44;1&#37; de los participantes les result&#243; f&#225;cil entender las preguntas y el 94&#44;7&#37; afirm&#243; que el cuestionario se adaptaba a su situaci&#243;n personal&#46;</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discusi&#243;n</span><p id="par0100" class="elsevierStylePara elsevierViewall">La valoraci&#243;n del PRO es un componente esencial en el tratamiento de las heridas cr&#243;nicas<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">1</span></a>&#46; Los pacientes tienen una amplia variedad de formas de deterioro de su calidad de vida&#44; por lo que existe la necesidad de realizar tratamientos individualizados&#44; los cuales deber&#225;n ser evaluados e incluidos en el plan terap&#233;utico<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">2&#44;5</span></a>&#46; La medida de la CVRS como una forma clave para construir el concepto PRO ha sido recomendado por la mayor&#237;a de las autoridades y sociedades m&#233;dicas expertas en el cuidado de las heridas<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">24&#44;30</span></a>&#46; El Wound-QoL es un instrumento espec&#237;fico para la valoraci&#243;n de la CVRS&#59; se ha desarrollado y validado para su uso tanto en ensayos cl&#237;nicos como en la atenci&#243;n cl&#237;nica rutinaria<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">3&#44;4&#44;20</span></a>&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">El objetivo de realizar este estudio fue validar tanto ling&#252;&#237;sticamente como psicom&#233;tricamente en un mismo proyecto la versi&#243;n en espa&#241;ol del Wound-QoL&#46; Las validaciones siguieron los procedimientos est&#225;ndares internacionales&#46; Los pacientes se seleccionaron durante la atenci&#243;n rutinaria&#44; lo que proporcion&#243; una amplia muestra del diferente tipo de heridas tratadas en los diversos centros de atenci&#243;n m&#233;dica en Espa&#241;a&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">En cuanto a las limitaciones del presente estudio&#44; se puede enumerar el hecho de que los pacientes se reclutaron &#250;nicamente a partir de un n&#250;mero limitado de centros&#44; por lo que un sesgo de selecci&#243;n no puede ser excluido&#46; Sin embargo&#44; los pacientes se seleccionaron a partir de entornos de pr&#225;ctica cl&#237;nica real de diversos centros&#44; por lo que no existe evidencia de que la forma de selecci&#243;n haya afectado las propiedades de la validaci&#243;n&#46; Por otro lado&#44; el instrumento utilizado no se modific&#243;&#44; motivo por el cual cabe la posibilidad de que el cuestionario no sea representativo de toda la problem&#225;tica de la poblaci&#243;n espa&#241;ola&#46; No obstante&#44; con la finalidad de que el instrumento fuese comparable internacionalmente&#44; se prefiri&#243; que los &#237;tems se mantuvieran similares a la versi&#243;n original&#46; Finamente&#44; en el pretest no se observ&#243; una mayor tasa de &#237;tems ausentes u objeciones&#44; lo que hubiera sugerido una disminuci&#243;n en la aplicabilidad del cuestionario en espa&#241;ol&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">En general&#44; la versi&#243;n en espa&#241;ol del Wound-QoL mostr&#243; propiedades psicom&#233;tricas adecuadas que se asemejan a las caracter&#237;sticas de la versi&#243;n original<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a>&#46; Los efectos de suelo y de techo fueron bajos en T1&#46; En T2 se evidenciaron efectos de suelo m&#225;s elevados&#44; lo que se puede interpretar como un efecto positivo del tratamiento en la CVRS y&#44; por lo tanto&#44; indicar una adecuada sensibilidad del Wound-QoL a la mejor&#237;a cl&#237;nica&#46; As&#237; mismo&#44; los pacientes refirieron una muy buena comprensi&#243;n y aceptaci&#243;n del cuestionario&#46; Se tard&#243; aproximadamente 5<span class="elsevierStyleHsp" style=""></span>minutos en contestar las preguntas del cuestionario y se dejaron &#250;nicamente escasos datos sin contestar&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conclusiones</span><p id="par0120" class="elsevierStylePara elsevierViewall">La versi&#243;n espa&#241;ola del Wound-QoL es una herramienta v&#225;lida y una opci&#243;n factible&#44; que cuenta con una elevada aceptaci&#243;n por parte de los pacientes para la valoraci&#243;n de la CVRS en Espa&#241;a tanto en la atenci&#243;n cl&#237;nica como en los ensayos cl&#237;nicos&#46; Debido a que los procesos de traducci&#243;n y de validaci&#243;n se realizaron en Espa&#241;a&#44; se debe considerar realizar adaptaciones adicionales para su utilizaci&#243;n en diversas regiones&#44; como por ejemplo en Am&#233;rica Latina&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Conflicto de intereses</span><p id="par0125" class="elsevierStylePara elsevierViewall">M&#46; Augustin es el titular de la licencia del cuestionario Wound-QoL&#46; Por lo dem&#225;s&#44; los autores no tienen ning&#250;n otro conflicto de inter&#233;s&#46;</p></span></span>"
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          "titulo" => "Abstract"
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          "secciones" => array:6 [
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              "titulo" => "Caracter&#237;sticas basales"
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            1 => array:2 [
              "identificador" => "sec0035"
              "titulo" => "Calidad de vida"
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              "identificador" => "sec0040"
              "titulo" => "Consistencia interna"
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              "identificador" => "sec0045"
              "titulo" => "Validez estructural"
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              "titulo" => "Validez convergente y capacidad de respuesta"
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              "titulo" => "Viabilidad"
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          "titulo" => "Discusi&#243;n"
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          "titulo" => "Agradecimientos"
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          "titulo" => "Bibliograf&#237;a"
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    "fechaRecibido" => "2020-03-09"
    "fechaAceptado" => "2020-09-26"
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          "identificador" => "xpalclavsec1313033"
          "palabras" => array:6 [
            0 => "Herida cr&#243;nica"
            1 => "Investigaci&#243;n sanitaria"
            2 => "Carga para el paciente"
            3 => "Cuidado de la herida"
            4 => "Cuidado centrado en el paciente"
            5 => "Calidad de vida"
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          "clase" => "keyword"
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          "identificador" => "xpalclavsec1313032"
          "palabras" => array:6 [
            0 => "Chronic wound"
            1 => "Health care research"
            2 => "Patient burden"
            3 => "Wound care"
            4 => "Patient-centred care"
            5 => "Quality of life"
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        "titulo" => "Resumen"
        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Antecedentes y objetivos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">El Wound-QoL es un cuestionario validado para medir la calidad de vida en pacientes con heridas cr&#243;nicas&#44; que fue desarrollado originalmente para su uso en alem&#225;n&#46;</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">El objetivo de este estudio fue traducir el cuestionario Wound-QoL para su uso en la pr&#225;ctica cl&#237;nica y estudios de investigaci&#243;n en Espa&#241;a&#44; as&#237; como validar esta versi&#243;n&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Materiales y m&#233;todos</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Se realizaron dos traducciones independientes del Wound-QoL&#44; directa e inversa&#44; a partir de la versi&#243;n original en alem&#225;n&#44; seguidas de un consenso de expertos sobre las versiones resultantes&#46; Despu&#233;s de su perfeccionamiento se realiz&#243; un estudio piloto y posteriormente el estudio de validaci&#243;n&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Resultados</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Se incluy&#243; un total de 115 pacientes&#46; La edad media fue de 69&#44;5 &#40;DE 14&#44;5&#41; a&#241;os&#44; y el 60&#44;0&#37; eran mujeres&#46; La versi&#243;n espa&#241;ola del Wound-QoL mostr&#243; una excelente consistencia interna &#40;&#237;ndice alfa de Cronbach<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#44;8 en todas las escalas&#41;&#46; El an&#225;lisis factorial dio como resultado las mismas escalas que la versi&#243;n original&#46; Se objetivaron caracter&#237;sticas satisfactorias de la distribuci&#243;n de la puntuaci&#243;n global y de las subescalas&#46; La validez de constructo y la validez convergente con otros resultados &#40;calidad de vida gen&#233;rica&#44; tasa de curaci&#243;n&#41; fueron satisfactorias&#46; La gran mayor&#237;a de los pacientes consideraron que el cuestionario era una herramienta sencilla y factible&#46; El tiempo medio necesario para completar el cuestionario fue de 5 minutos&#46; El 99&#44;1&#37; de los participantes consideraron que las preguntas eran f&#225;ciles de entender y el 94&#44;7&#37; declar&#243; que personal&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Conclusiones</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">La versi&#243;n espa&#241;ola del Wound-QoL muestra una excelente validez en la pr&#225;ctica cl&#237;nica&#46; Por lo tanto&#44; puede ser recomendada para su uso tanto en la rutina cl&#237;nica como en los ensayos&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Antecedentes y objetivos"
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          1 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Materiales y m&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Resultados"
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            "identificador" => "abst0025"
            "titulo" => "Conclusiones"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Background and aims</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds&#44; originally developed for use in German&#46;</p><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Materials and methods</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted&#44; followed by an expert consensus of the resulting versions&#46; After refinement&#44; the final tool was piloted in N<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>10 patients and then used in the validation study&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Results</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">A total of 115 patients were recruited&#46; Mean age was 69&#46;5 &#40;SD 14&#46;5&#41; years&#44; 60&#46;0&#37; were female&#46; The Spanish version of Wound-QoL showed high internal consistency &#40;Cronbach&#39;s alpha<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#46;8 in all scales&#41;&#46; Factor analysis resulted in the same scales as the original version&#46; There were satisfactory distribution characteristics of the global score and the subscales&#46; Construct validity and convergent validity with other outcomes &#40;generic QoL&#44; healing rate&#41; were satisfactory&#46; The vast majority of patients considered the Wound-QoL a simple and feasible tool&#46; Mean time needed for completing the questionnaire was 5<span class="elsevierStyleHsp" style=""></span>minutes&#46; Overall&#44; 99&#46;1&#37; of the participants found it easy to understand the questions and 94&#46;7&#37; stated that the questionnaire suits the personal situation&#46;</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conclusions</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">The Spanish version of the Wound-QoL shows good validity in clinical practice&#46; It can be recommended for use in clinical routine and trials&#46;</p></span>"
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                  \t\t\t\t">Wound-QoL&#44; subescala corporal&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Wound-QoL&#44; subescala psicol&#243;gica&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Wound-QoL&#44; subescala de la vida diaria&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">FLQA-w&#44; general&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">FLQA-w&#44; en relaci&#243;n con la herida&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t">FLQA-w&#44; relacionada con la calidad de vida&nbsp;\t\t\t\t\t\t\n
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Article information
ISSN: 00017310
Original language: Spanish
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