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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Introduction</span><p class="elsevierStyleSimplePara elsevierViewall">Advances in genomic analysis technologies have led to the development of new diagnostic tests with clinical application&#46;Therefore&#44; as in other diagnostic fields&#44; awareness of the methodological limitations of genetic investigation will facilitate the application of the results&#46;</p> <span class="elsevierStyleSectionTitle">Methods</span><p class="elsevierStyleSimplePara elsevierViewall">44 articles which studied the diagnostic accuracy of genetic&#44; molecular and proteomic tests&#44; and published in <span class="elsevierStyleItalic">JAMA&#44; Lancet&#44; New England Journal of Medicine&#44; Cancer Research y Clinical Cancer Research</span> from 2002 to June 2005 were analysed&#46; 24 methodological criteria of the STARD guide &#40;<span class="elsevierStyleItalic">Standards for Reporting of Diagnostic Accuracy</span>&#41; were applied&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p class="elsevierStyleSimplePara elsevierViewall">The mean number of methodological criteria satisfied was 9&#46;8 &#40;95&#37;&#44; CI 8&#46;8-10&#46;6&#41;&#44; with the greatest deficiencies observed in the aspects related to the description of patient selection&#44; 9 &#40;20&#37;&#41;&#44; the treatment of indeterminate results&#44; 5 &#40;11&#37;&#41;&#44; and the determination of the technique&#39;s reproducibility&#44; 6 &#40;13&#37;&#41;&#46; In contrast&#44; a high frequency was observed in the description of the reference standard&#44; 39 &#40;87&#37;&#41;&#44; and the method used&#44; 28 &#40;62&#37;&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Discussion</span><p class="elsevierStyleSimplePara elsevierViewall">The articles evaluated fail to fulfil many of the quality requirements laid out in the STARD proposal&#44; with the methodological quality being lower than in other diagnostic fields&#46; The aspects most in need of improvement are those related to the description of patient selection and the determination of reproducibility&#46; Research and progress in new genetic-molecular technologies require improved fulfilment of the epidemiological and clinical standards which are already applied by other diagnostic fields&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p class="elsevierStyleSimplePara elsevierViewall">El avance en las tecnolog&#237;as del an&#225;lisis gen&#243;mico ha supuesto el desarrollo de nuevas pruebas diagn&#243;sticas con potencial aplicaci&#243;n cl&#237;nica&#46; As&#237; como ha sucedido en otros campos del diagn&#243;stico&#44; conocer las limitaciones metodol&#243;gicas de la investigaci&#243;n en gen&#233;tica facilitar&#225; la aplicaci&#243;n de sus resultados&#46;</p> <span class="elsevierStyleSectionTitle">M&#233;todos</span><p class="elsevierStyleSimplePara elsevierViewall">Se analizaron 44 art&#237;culos publicados en <span class="elsevierStyleItalic">JAMA&#44; Lancet&#44; New England Journal of Medicine&#44; Cancer Research y Clinical Cancer Research</span>&#44; de 2002 a junio de 2005&#44; que estudiaban la exactitud diagn&#243;stica de pruebas gen&#233;ticas&#44; moleculares y de prote&#243;mica&#46; Se aplicaron 24 criterios metodol&#243;gicos de la gu&#237;a STARD &#40;Standards for Reporting of Diagnostic Accuracy&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p class="elsevierStyleSimplePara elsevierViewall">La media de cumplimiento de los criterios aplicados fue de 9&#44;8 &#40;intervalo de confianza &#91;IC&#93; del 95&#37;&#44; 8&#44;8-10&#44;6&#41;&#44; y las mayores deficiencias se observaron en los aspectos relacionados con la descripci&#243;n de la selecci&#243;n de los pacientes &#40;9&#59; 20&#37;&#41;&#44; el tratamiento de los resultados indeterminados &#40;5&#59;11&#37;&#41; y la determinaci&#243;n de la reproducibilidad de la t&#233;cnica &#40;6&#59; 13&#37;&#41;&#46; En cambio&#44; s&#237; se observ&#243; una alta frecuencia en la descripci&#243;n del patr&#243;n de referencia &#40;39&#59; 87&#37;&#41; y del m&#233;todo usado &#40;28&#59; 62&#37;&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Discusi&#243;n</span><p class="elsevierStyleSimplePara elsevierViewall">Los art&#237;culos evaluados incumplen gran parte de los requisitos de calidad recogidos en la propuesta STARD&#44; observ&#225;ndose una peor calidad metodol&#243;gica que en otros campos diagn&#243;sticos&#46; Los aspectos que m&#225;s necesitan mejorar son los relacionados con la descripci&#243;n de la selecci&#243;n de los pacientes y la determinaci&#243;n de la reproducibilidad&#46; La investigaci&#243;n y el avance en nuevas tecnolog&#237;as gen&#233;tico-moleculares requieren un mejor cumplimiento de los est&#225;ndares epidemiol&#243;gicos y cl&#237;nicos que ya se aplican a otros campos diagn&#243;sticos&#46;</p>"
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                      "titulo" => "Empirical evidence of design-related bias in studies of diagnostic tests"
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Originales
Evaluation of the research methodology in genetic, molecular and proteomic tests
Valoración de la metodología de la investigación en pruebas de genética, molecular y proteómica
Blanca Lumbreras
Autor para correspondencia
blumbreras@umh.es

Correspondence: Dra. Blanca Lumbreras. Departamento de Salud Pública, Historia de la Ciencia y Ginecología. Campus de San Juan. Facultad de Medicina. Universidad Miguel Hernández. Ctra. de Valencia, km 8,7. 03550 San Juan de Alicante. España.
, Inmaculada Jarrín, Ildefonso Hernández Aguado
Department of Public Health, History of Science and Gynaecology. Universidad Miguel Hernández, Alicante, Spain
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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Introduction</span><p class="elsevierStyleSimplePara elsevierViewall">Advances in genomic analysis technologies have led to the development of new diagnostic tests with clinical application&#46;Therefore&#44; as in other diagnostic fields&#44; awareness of the methodological limitations of genetic investigation will facilitate the application of the results&#46;</p> <span class="elsevierStyleSectionTitle">Methods</span><p class="elsevierStyleSimplePara elsevierViewall">44 articles which studied the diagnostic accuracy of genetic&#44; molecular and proteomic tests&#44; and published in <span class="elsevierStyleItalic">JAMA&#44; Lancet&#44; New England Journal of Medicine&#44; Cancer Research y Clinical Cancer Research</span> from 2002 to June 2005 were analysed&#46; 24 methodological criteria of the STARD guide &#40;<span class="elsevierStyleItalic">Standards for Reporting of Diagnostic Accuracy</span>&#41; were applied&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p class="elsevierStyleSimplePara elsevierViewall">The mean number of methodological criteria satisfied was 9&#46;8 &#40;95&#37;&#44; CI 8&#46;8-10&#46;6&#41;&#44; with the greatest deficiencies observed in the aspects related to the description of patient selection&#44; 9 &#40;20&#37;&#41;&#44; the treatment of indeterminate results&#44; 5 &#40;11&#37;&#41;&#44; and the determination of the technique&#39;s reproducibility&#44; 6 &#40;13&#37;&#41;&#46; In contrast&#44; a high frequency was observed in the description of the reference standard&#44; 39 &#40;87&#37;&#41;&#44; and the method used&#44; 28 &#40;62&#37;&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Discussion</span><p class="elsevierStyleSimplePara elsevierViewall">The articles evaluated fail to fulfil many of the quality requirements laid out in the STARD proposal&#44; with the methodological quality being lower than in other diagnostic fields&#46; The aspects most in need of improvement are those related to the description of patient selection and the determination of reproducibility&#46; Research and progress in new genetic-molecular technologies require improved fulfilment of the epidemiological and clinical standards which are already applied by other diagnostic fields&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p class="elsevierStyleSimplePara elsevierViewall">El avance en las tecnolog&#237;as del an&#225;lisis gen&#243;mico ha supuesto el desarrollo de nuevas pruebas diagn&#243;sticas con potencial aplicaci&#243;n cl&#237;nica&#46; As&#237; como ha sucedido en otros campos del diagn&#243;stico&#44; conocer las limitaciones metodol&#243;gicas de la investigaci&#243;n en gen&#233;tica facilitar&#225; la aplicaci&#243;n de sus resultados&#46;</p> <span class="elsevierStyleSectionTitle">M&#233;todos</span><p class="elsevierStyleSimplePara elsevierViewall">Se analizaron 44 art&#237;culos publicados en <span class="elsevierStyleItalic">JAMA&#44; Lancet&#44; New England Journal of Medicine&#44; Cancer Research y Clinical Cancer Research</span>&#44; de 2002 a junio de 2005&#44; que estudiaban la exactitud diagn&#243;stica de pruebas gen&#233;ticas&#44; moleculares y de prote&#243;mica&#46; Se aplicaron 24 criterios metodol&#243;gicos de la gu&#237;a STARD &#40;Standards for Reporting of Diagnostic Accuracy&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p class="elsevierStyleSimplePara elsevierViewall">La media de cumplimiento de los criterios aplicados fue de 9&#44;8 &#40;intervalo de confianza &#91;IC&#93; del 95&#37;&#44; 8&#44;8-10&#44;6&#41;&#44; y las mayores deficiencias se observaron en los aspectos relacionados con la descripci&#243;n de la selecci&#243;n de los pacientes &#40;9&#59; 20&#37;&#41;&#44; el tratamiento de los resultados indeterminados &#40;5&#59;11&#37;&#41; y la determinaci&#243;n de la reproducibilidad de la t&#233;cnica &#40;6&#59; 13&#37;&#41;&#46; En cambio&#44; s&#237; se observ&#243; una alta frecuencia en la descripci&#243;n del patr&#243;n de referencia &#40;39&#59; 87&#37;&#41; y del m&#233;todo usado &#40;28&#59; 62&#37;&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Discusi&#243;n</span><p class="elsevierStyleSimplePara elsevierViewall">Los art&#237;culos evaluados incumplen gran parte de los requisitos de calidad recogidos en la propuesta STARD&#44; observ&#225;ndose una peor calidad metodol&#243;gica que en otros campos diagn&#243;sticos&#46; Los aspectos que m&#225;s necesitan mejorar son los relacionados con la descripci&#243;n de la selecci&#243;n de los pacientes y la determinaci&#243;n de la reproducibilidad&#46; La investigaci&#243;n y el avance en nuevas tecnolog&#237;as gen&#233;tico-moleculares requieren un mejor cumplimiento de los est&#225;ndares epidemiol&#243;gicos y cl&#237;nicos que ya se aplican a otros campos diagn&#243;sticos&#46;</p>"
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